James L. Benedict a Revised Consent Model for the Transplantation of Face and Upper Limbs: Covenant Consent International Library of Ethics, Law, and the New Medicine

International Library of Ethics, Law, and the New Medicine 73

James L. Benedict A Revised Consent Model for the Transplantation of Face and Upper Limbs: Covenant Consent International Library of Ethics, Law, and the New Medicine

Volume 73

Series editors David N. Weisstub, University of Montreal Fac. Medicine, Montreal, QC, Canada Dennis R. Cooley, North Dakota State University, History, Philosophy, and Religious Studies, Fargo, ND, USA

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A Revised Consent Model for the Transplantation of Face and Upper Limbs: Covenant Consent

123 James L. Benedict Center for Healthcare Ethics Duquesne University Pittsburgh, PA USA

ISSN 1567-8008 ISSN 2351-955X (electronic) International Library of Ethics, Law, and the New Medicine ISBN 978-3-319-56399-2 ISBN 978-3-319-56400-5 (eBook) DOI 10.1007/978-3-319-56400-5

Library of Congress Control Number: 2017937723

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This Springer imprint is published by Springer Nature The registered company is Springer International Publishing AG The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland The original version of the book was revised: Incorrect volume number of the book has been updated. The erratum to the book is available at 10.1007/978-3-319-56400-5_7

v Contents

1 Introduction...... 1 1.1 The Challenge of Medical Advancement for Healthcare Ethics ...... 2 1.2 Vascularized Composite Allotransplantation ...... 2 1.2.1 Emergence of the Field and Special Demands on Patients ...... 2 1.2.2 Implications of VCA for Consent ...... 5 1.3 Covenant Consent...... 6 1.4 Structure of the Book ...... 7 1.5 Conclusion ...... 7 2 Vascularized Composite Allotransplantation ...... 9 2.1 Introduction ...... 9 2.2 History and Development of Solid Organ Transplantation and Limb Replantation ...... 10 2.2.1 Ancient Evidence ...... 10 2.2.2 Developments in Transplantation Prior to 1954 ...... 11 2.2.3 Early Developments in Replantation ...... 13 2.2.4 Sixty Years of Successful Solid Organ Transplantation ...... 14 2.2.5 Developments in Replantation...... 15 2.3 History and Development of Vascularized Composite Allotransplantation ...... 15 2.3.1 Upper Extremity Transplantation...... 17 2.3.2 Face Transplantation ...... 20 2.3.3 Other VCA ...... 23 2.4 Similarities and Differences in VCA and SOT ...... 25 2.4.1 Similarities ...... 25 2.4.2 Unique Features of Solid Organ Transplants...... 26 2.4.3 Unique Features of Vascularized Composite Allotransplantation ...... 28

vii viii Contents

2.5 Practical and Ethical Concerns in the Field of Vascularized Composite Transplantation ...... 34 2.5.1 Immunological Concerns...... 34 2.5.2 Psycho-Social Issues ...... 40 2.5.3 Procurement and Allocation Concerns...... 47 2.5.4 Financial Costs ...... 48 2.5.5 Ethical Issues ...... 50 2.6 Conclusion ...... 71 3 The Ethics of Consent...... 73 3.1 History and Development of the Role of Consent in Health Care ...... 73 3.1.1 Pre-enlightenment Developments ...... 75 3.1.2 The Inﬂuence of Post-medieval Philosophy...... 79 3.1.3 Building on the Philosophical Foundation...... 81 3.2 The Current Understanding of Consent ...... 93 3.2.1 The Dominant Formulation ...... 93 3.2.2 Critiques and Alternatives ...... 94 3.3 A More Fundamental Critique ...... 102 3.3.1 Historical Origins ...... 103 3.3.2 Philosophical Origins ...... 105 3.3.3 Atypical Contexts ...... 109 3.3.4 Adapting Informed Consent for Treatment Contexts ...... 113 4 The Meaning of Covenant ...... 115 4.1 Introduction ...... 115 4.2 Covenant in the Ancient Near East...... 116 4.2.1 Etymological Roots...... 116 4.2.2 The Structure of Covenants...... 121 4.2.3 Covenants and Fictive Kinship ...... 122 4.2.4 The Role of Shame and Honor in Covenantal Relations ...... 123 4.2.5 Durability and Flexibility ...... 124 4.3 The Role of Covenant in Contemporary Religious Ethics...... 126 4.3.1 Jewish Ethics ...... 126 4.3.2 Christian Ethics...... 128 4.4 The Role of Covenant in Health Care Ethics ...... 131 4.4.1 General Use of the Covenant Concept ...... 131 4.4.2 Paul Ramsey ...... 135 4.4.3 William F. May...... 137 Contents ix

4.5 Covenant and Care Provider—Patient Relationships...... 140 4.5.1 Reciprocity, Loyalty and Disparities in Power ...... 142 4.5.2 Covenantal Relationships: Accompanying Characteristics ...... 144 4.5.3 A Covenant Approach to Care Provider—Patient Relations ...... 146 5 Covenant Consent ...... 149 5.1 Introduction ...... 149 5.2 Informed Consent: Dynamic and Evolving ...... 153 5.3 Incongruity: VCA and Standard Antecedent Consent ...... 161 5.4 The Concept of Covenant as a Resource ...... 169 5.4.1 Covenant Consent and the Duration of Treatment in VCA ...... 174 5.4.2 Covenant Consent and the Burdens and Risks of VCA ...... 175 5.4.3 Covenant Consent and Long-Term Active Participation by the Recipient in VCA ...... 176 5.4.4 Covenant Consent and the Role of Dignity and Vulnerability in VCA ...... 179 5.5 Covenant Consent for VCA ...... 182 5.5.1 Re-imagining Consent in Covenantal Terms ...... 183 5.5.2 Creating a Structure and Process for Covenant Consent ...... 188 6 Conclusion ...... 195 6.1 Summary and Restatement ...... 195 Erratum to: A Revised Consent Model for the Transplantation of Face and Upper Limbs: Covenant Consent ...... E1 Bibliography ...... 205 Index ...... 253 Chapter 1 Introduction

Abstract Vascularized composite allotransplantation (VCA) has emerged over the last two decades as a promising therapeutic option for persons who have suffered the loss of limbs or who have suffered major facial disfigurement. While this book will demonstrate familiarity with the technical aspects of VCA, and with a range of ethical issues, its focus will be on the role and structure of consent for this new therapeutic option. In particular, it will argue that the nature and duration of the treatment involved in upper extremity and face transplants makes necessary some modification to the theory and practice of consent. The concept of covenant will be put forward as a resource for this modification. Covenant consent is needed for VCA because it more adequately describes what is being asked of recipients and what is necessary for treatment to succeed. It is also needed because it appropriately honors the recipients by understanding them as active partners rather than as passive patients, as people assuming major burdens and risks while contributing meaningfully to the development of the field.

© Springer International Publishing AG 2017 1 J.L. Benedict, A Revised Consent Model for the Transplantation of Face and Upper Limbs: Covenant Consent, International Library of Ethics, Law, and the New Medicine 73, DOI 10.1007/978-3-319-56400-5_1 2 1 Introduction

1.1 The Challenge of Medical Advancement for Healthcare Ethics

The history of healthcare ethics is deeply intertwined with the history of social change1 and medical advancements.2 While there were significant efforts made in prior centuries to address ethical issues in the delivery of health care,3 the combination of rapid social change with rapid medical advancements created the perfect context for the development of bioethics as a distinctive field in the twentieth century. As we approach the end of the second decade of the twenty-first century, it is clear that the pace of medical advancement continues to be brisk4 and so the field of bioethics is challenged to respond.

1.2 Vascularized Composite Allotransplantation

1.2.1 Emergence of the Field and Special Demands on Patients

One of the most notable medical advancements in the last two decades has been the emergence of human vascularized composite allotransplantation (VCA) as a clinical

1Nan D. Hunter, “Rights Talk and Patient Subjectivity: The Role of Autonomy, Equality and Participation Norms,” Wake Forest Law Review 45 (2010): 106; David J. Rothman, “The Origins and Consequences of Patient Autonomy: A 25-Year Retrospective,” Health Care Analysis 9 (2001): 255–264; Mark A. Rothstein, “The Role of Law in the Development of American Bioethics,” Journal international de bioéthique 20, no. 4 (2009): 75; Janet L. Dolgin, “The Legal Development of the Informed Consent Doctrine: Past and Present,” Cambridge Quarterly of Healthcare Ethics 19 (2010): 99–100; Bruce Jennings, “Autonomy,” in The Oxford Handbook of Bioethics, ed. by Bonnie Steinbock, (New York: Oxford University Press, 2009), 78–79; Robert M. Veatch, Patient, Heal Thyself: How the New Medicine Puts the Patient in Charge (New York: Oxford University Press, 2009), 57–63; Robert D. Truog, “Patients and Doctors—The Evolution of a Relationship,” The New England Journal of Medicine 366, no. 7 (February 16, 2012): 581; Rosamond Rhodes, “Bioethics: Looking Forward and Looking Back,” The American Journal of Bioethics 13, no. 1 (2013): 13–14. 2Albert R. Jonsen, The Birth of Bioethics (New York: Oxford University Press, 1998), 196–324; Robert M. Veatch, Amy M. Haddad and Dan C. English, Case Studies in Bioemedical Ethics (New York: Oxford University Press, 2010), xxi–xxii; Rhodes, 13; 15; R. E. McWhirter, “The History of Bioethics: Implications for Current Debates in Health Research,” Perspectives in Biology and Medicine 55, no. 3 (Summer 2012): 336; Daniel Callahan, “The Hastings Center and the Early Years of Bioethics,” Theoretical Medicine and Bioethics 33 (2012): 12. 3This is particularly true of the Roman Catholic and Jewish religious traditions. See Jonsen, The Birth of Bioethics,35–37, Aaron Mackler, Jewish and Catholic Bioethics: A Comparative Analysis (Washington, D. C.: Georgetown University Press, 2003), 1; and Alan L. Mittleman, A Short History of Jewish Ethics (Chichester: Wiley-Blackwell, 2012), 10–12. 4Rhodes, 15. 1.2 Vascularized Composite Allotransplantation 3 reality.5 The practice of VCA, anchored in legend6 and ﬁrst attempted in the modern transplant era ﬁfty years ago,7 has at last become a viable clinical option for certain patients. Over the last two decades, vascularized composite allotransplantation (VCA) has been conducted in several medical centers throughout the world, with encouraging results.8 Multidisciplinary medical teams have been able to offer selected patients forms of physical restoration which are in many ways superior to treatment previously available.9 Still, a number of hurdles remain before VCA will

5Thomas E. Starzl and Clyde Barker, “The Shared Trail of Organ, Limb and Face Transplantation,” Proceedings of the American Philosophical Society, 155, no. 1 (March 2011): 1– 12; Linda Evans, “A Historical, Clinical and Ethical Overview of the Emerging Science of Facial Transplantation,” Plastic Surgery Nursing 31 (2011): 151–157; Abtin Foroohar et al., “The History and Evolution of Hand Transplantation,” Hand Clinics 27 (2011): 405–409; Jeffrey Levin, “Jewish Ethical Themes That Should Inform the National Healthcare Discussion: A Prolegomenon,” Journal of Religion and Health 51 (2012): 207; Scott M. Tintle et al., “Hand Transplantation,” Journal of Bone and Joint Surgery 2, no. 1 (2014): 2. 6Chad R. Gordon et al, “The Evolution of Composite Tissue Allotransplantation: the Twentieth Century Realization of ‘Cosmas and Damian,’” in Transplantation of Composite Tissue Allografts, edited by Charles W. Hewitt, W. P. Lee and Chad R. Gordon. (Boston: Springer, 2008), 13–14; K. V. Ravindra et al, “Composite Tissue Transplantation: A Rapidly Advancing Field,” Transplantation Proceedings 40, no. 5 (2008): 1237; Alexis Bergan, “Ancient Myth, Modern Reality: A Brief History of Transplantation,” Journal of Biocommunication 2, no. 4 (1997): 3; Jean-Paul Squifﬂet, “From Leg Transplantation by St. Cosmas and St. Damian to the Modern Era,” Acta Chirugica Belgica 103, no. 3 (2003): 6; D. Lippi, “The Transplant of the White Man’s Leg: A Novel Representation of Cosma and Damian’s Miracle,” International Journal of Immunopathology and Pharmacology 22, no. 2 (2009): 517–520. 7Ravindra et al, 1238; Gordon et al, 14. 8Pedro Infante-Cossio et al, “Facial Transplantation: A Concise Update,” Medicina Oral Patalog a Oral Y Cirug a Bucal 18, no. 2 (2013): e263–271; Annemarie Weissenbacher et al, “Vascularized Composite Allografts and Solid Organ Transplants: Similarities and Differences,” Current Opinion in Organ Transplantation 18, no. 6 (2013): 640–644; Christina L. Kaufman et al, “Monitoring Long-term Outcomes in Vascularized Composite Allotransplantation,” Current Opinion in Organ Transplantation 18, no. 6 (2013): 652–658; Maria Siemionow, Bahar Bassiri Gharb and Antonio Rampazzo. “Successes and Lessons Learned after More Than a Decade of Upper Extremity and Face Transplantation,” Current Opinion in Organ Transplantation 18, no. 6 (2013): 633–639; J. R. Diaz-Siso et al, “Vascularized Composite Tissue Allotransplantation—State of the Art,” Clinical Transplantation 27, no. 3 (2013): 330–337. 9Marina Ninkovic et al, “Functional Outcome after Hand and Forearm Transplantation: What Can Be Achieved?” Hand Clinics 27 (2011): 457–460; Palmina Petruzzo and Jean Michel Dubernard, “World Experience After More Than a Decade of Clinical Hand Transplantation: Update on the French Program,” Hand Clinics 27 (2011): 411–412; Jaime T. Shores, Joseph E. Imbriglia, and W. P. Andrew Lee, “The Current State of Hand Transplantation,” Journal of Hand Surgery 36A (November 2011): 1862; Chenggang Yi and Shuzhong Guo, “Facial Transplantation: Lessons So Far,” The Lancet 374 (2009): 177–78; Maria Siemionow and Can Ozturk, “Face Transplantation: Outcomes, Concerns, Controversies and Future Directions,” The Journal of Craniofacial Surgery 23, no. 1 (2012): 254; Joseph E. Losee, Derek R. Fletcher and Vijay S. Gorantla, “Human Facial Allotransplantation: Patient Selection and Pertinent Considerations,” The Journal of Craniofacial Surgery 23, no. 1 (2012): 260; Tintle et al, 1; 5–7. 4 1 Introduction be able to be considered a standard clinical treatment.10 Among those hurdles is the task of establishing a sound ethical foundation to support the practice going forward.11

10Tintle et al, 7; Siemionow, Gharb and Rampazzo, 636–638; Weissenbacher et al, 643; Tae Chong and Timothy L. Pruett, “Evolution of Face Transplant: An Argument for a National Donor Registry,” Plastic and Reconstructive Surgery 132, no. 5 (2013): 1370–1372; Sue V. McDiarmid, “Donor and Procurement Related Issues in Vascularized Composite Allograft Transplantation,” Current Opinion in Organ Transplantation 18, no. 6 (2013): 665–671; David A. Leonard, Josef M. Kurtz and Curtis L. Cetrulo, Jr., “Vascularized Composite Allotransplantation: Towards Tolerance and the Importance of Skin-specific Immunobiology,” Current Opinion in Organ Transplantation 18, no. 6 (2013): 645–651; Matthew J. Carty et al, “The Case for Lower Extremity Allotransplantation,” Plastic and Reconstructive Surgery 131, no. 6 (2013): 1272–1277; Alex Clarke and Peter E. M. Butler, “The Psychological Management of Facial Transplantation,” Expert Review of Neurotherapeutics 9, no. 7 (2009): 1090–1098; L. Allen Furr et al, “Psychosocial Implications of Disfigurement and the Future of Human Face Transplantation,” Plastic and Reconstructive Surgery 120, no. 2 (2007): 559–565; C. Giuglea et al, “Transplantation of Composite Tissue Allografts: Scientific Bases and Clinical Applications,” Journal of Medicine and Life 6, no. 1 (2013): 40–44; Chad R. Gordon et al, “Concomitant Face and Hand Transplantation: Perfect Solution or Perfect Storm?” Annals of Plastic Surgery 67, no. 3 (2011): 309–314; W. C. Huang et al, “Improving the Safety of Tolerance Induction: Chimerism and Cellular Co-treatment Strategies Applied to Vascularized Composite Allografts,” Clinical and Developmental Immunology (2012), epub doi:10.1155/2012/107901; S. E. Jensen et al, “Quality of Life Considerations in Upper Limb Transplantation: Review and Future Directions,” Journal of Hand Surgery 37, no. 10 (2012): 2126–2135; M. M. Klapheke et al, “Psychiatric Assessment of Candidates for Hand Transplantation,” Microsurgery 20, no. 8 (2000): 453–457; L. Lantieri, “A Paradigm Change in Facial Reconstruction,” The Journal of Craniofacial Surgery 23, no. 1 (2012): 250–253; Benoit G. Lengele, “Current Concepts and Future Challenges in Facial Transplantation,” Clinics in Plastic Surgery 36, no. 3 (2009): 507–521; D. A. Leonard et al, “Induction of Tolerance in Vascularized Composite Allografts,” Transplantation 95, no. 3 (2013): 403–409; K. Shanmugarajah, S. Hettiaratchy and Peter E. M. Butler, “Facial Transplantation,” Current Opinion in Otolaryngology and Head and Neck Surgery 20, no. 4 (2012): 291–297. 11Ruby Catsanos, Wendy Rogers and Mianna Lotz, “The Ethics of Uterus Transplantation,” Bioethics 27, no. 2 (2013): 65–73; James A. Edwards and David W. Mathes, “Facial Transplantation: A Review of Ethics, Progress and Future Targets,” Transplant Research and Risk Management 3 (2011): 113–125; M. Errico, N. H. Metcalfe and A. Platt, “History and Ethics of Hand Transplants,” JRSM Short Reports 10 (2012): 74; S. E. Johnson and M. J. Corsten, “Facial Transplantation in a New Era: What are the Ethical Implications?” Current Opinion in Otolaryngology and Head and Neck Surgery 17, no. 4 (2009): 274–278; L. K. Kalliainen, “Supporting Facial Transplantation with the Pillars of Bioethics,” Journal of Reconstructive Microsurgery 26, no. 8 (2010): 547–554; H. O’Neill and D. Godden, “Ethical Issues of Facial Transplantation,” British Journal of Oral and Maxillofacial Surgery 47, no. 6 (2009): 443–445; A. Renshaw et al, “Informed Consent for Facial Transplantation,” Transplant International 19, no. 11 (2006): 861–867; Maria Siemionow, “Ethical Considerations in Face Transplantation: Ethical Issues Related to Inclusion Criteria for Face Transplant Candidates,” Archivum Immunologiae et Therapiae Experimentalis 59, no. 3 (2011): 157–159; C. Strong, “An On-going Issue Concerning Facial Transplantation,” American Journal of Transplantation 10, no. 5 (2010): 1115–1116; C. J. Vercler, “Ethical Issues in Face Transplantation,” Virtual Mentor 12, no. 5 (2010): 378–382; Samuel Taylor-Alexander, “Facial Transplantation: Ethical Slippage and Quiet Death in Experimental Biomedicine,” Anthropology Today 29, no. 1 (2013): 13–16; Harriet Kiwanuka et al, “Evolution of Ethical Debate on Face Transplantation,” Plastic and Reconstructive Surgery 132, no. 6 (2013): 1558–1568. 1.2 Vascularized Composite Allotransplantation 5

While this book will demonstrate familiarity with many of the technical issues and explore the burdens, risks and potential benefits of VCA, it will focus primarily on the implications of this new therapeutic option for the manner in which consent is to be understood and practiced. In terms of surgical technique and subsequent physiotherapy, VCA is primarily an extension of well-established practices in solid organ transplantation and limb replantation.12 Yet it combines the risks and burdens of the two therapies while failing to offer the benefit of increased length of life associated with solid organ transplants. In fact, due to the toxicity of the immunosuppressant drugs commonly used, there exists a significant risk of shortening patient life expectancy with VCA. In addition, arduous and long lasting demands are placed upon the patient in VCA, including a rigorous physiotherapy program, a strict drug therapy protocol and the on-going need to self-monitor for signs of rejection.13 Given this unusual configuration of benefits, burdens and risks, VCA generates distinct ethical concerns. Among these concerns is the adequacy of the standard approach to informed consent.

1.2.2 Implications of VCA for Consent

The standard approach to informed consent, whether it is conceived of as autonomous authorization,14 waiver of responsibility,15 permission giving,16 a fair transaction17 or even shared decision-making,18 is designed for therapeutic

12Starzl and Barker, 1–12; Evans, 151–157; Abtin Foroohar et al, 405–409; Tintle et al, 1. 13T. Hautz et al, “How Reconstructive Transplantation is Different from Organ Transplantation— And How It Is Not,” Transplantation Proceedings 43 (2011): 3504–3509; Shanmugarajah, Hettiaratchy, and Butler, 294–295; Shores, Imbriglia and Lee, 1864–1865; P. Petruzzo et al, “Long-Term Follow-up in Composite Tissue Allotransplantation: In-Depth Study of Five (Hand and Face) Recipients,” American Journal of Transplantation 11 (2011): 810; Anne Hodges, Steve Chesher and Sandra Feranda, “Hand Transplantation: Rehabilitation: Case Report,” Microsurgery 20 (2000): 389–392; Tintle et al, 2; Weissenbacher et al, 643; Kaufman et al 653–654; Brooke M. Lamparello et al, “Face Time: Educating Face Transplant Candidates,” Eplasty (2013): 278–279. 14Tom L. Beauchamp and James F. Childress, Principles of Biomedical Ethics 6th Edition (New York: Oxford University Press, 2009), 117–140. 15Neil C. Manson and Onora O'Neill, Rethinking Informed Consent in Bioethics (Cambridge: Cambridge University Press, 2007), 68–96. 16Bernard Gert, Charles M. Culver and K. Danner Clouser, Bioethics: A Systematic Approach, 2nd Edition, New York: Oxford University Press, 2006, 21–50 and 191–282. 17Franklin G. Miller and Alan Wertheimer, “Preface to a Theory of Consent Transactions: Beyond Valid Consent,” The Ethics of Consent: Theory and Practice (New York: Oxford University Press, 2010), 79–106; Franklin G. Miller and Alan Wertheimer, “The Fair Transaction Model of Informed Consent: An Alternative to Autonomous Authorization,” Kennedy Institute of Ethics 21, no. 3 (2011): 201–218; Alan Wertheimer, “Voluntary Consent: Why A Value-Neutral Concept Won’t Work,” Journal of Medicine and Philosophy 37, no. 3 (June 2012): 4. 18Jaime S. King and Benjamin Moulton, “Rethinking Informed Consent: The Case for Shared Medical Decision-Making,” American Journal of Law and Medicine 32 (2006): 429–501; 6 1 Introduction interventions of relatively brief duration in which the role of the patient is primarily passive. Yet there exist atypical contexts in which these conditions are not present. VCA is one of those contexts. In VCA what is being asked of patients is consent to an extended relationship which will require much of them and in the course of which they are likely to encounter obstacles and demands which cannot be entirely foreseen. In addition, patients who are candidates for facial or upper extremity VCA may be in a condition of greater than usual vulnerability due to the nature and causes of their defects. In recognition of this and other atypical contexts, some attempts at modification of the standard consent process have already been tried.19 It will be argued in this book that these modifications, while well-intended and a step in the right direction, are not sufficient. Instead, some further modification must be made.

1.3 Covenant Consent

The concept of covenant will be put forward as a resource for this modification. Covenants are agreements which establish on-going personal relationships of mutual obligation and are designed to be both durable and flexible. Covenant consent, it will be argued, will encourage and support strong therapeutic alliances between health care providers and patients over the lengthy and demanding course of the therapeutic intervention of VCA. As noted earlier, successful VCA includes the need for the patient to participate in a rigorous physiotherapy program, to maintain a very demanding drug therapy regime, and to self-monitor for signs of rejection for many years.20 The claim that a new form of consent is needed for VCA and that this form of consent ought to be informed by the concept of covenant calls for a thorough and thoughtful justification. The remainder of this introduction will be devoted to laying

(Footnote 18 continued) William J. Sieber and Robert M. Kaplan, “Informed Adherence: The Need for Shared Medical Decision Making,” Controlled Clinical Trials 21 (2000): 234S–240S. 19P. Allmark and S. Mason, “Improving the Quality of Consent to Randomised Controlled Trials by Using Continuous Consent and Clinician Training in the Consent Process,” Journal of Medical Ethics 32, no. 8 (2006): 239–443; William Smith et al, “Empirical Evaluation of the Need for ‘On-going Consent’ in Clinical Research,” AIDS 25 (2011): 107–114; Gert Helgesson and Stefan Eriksson, “Does Informed Consent Have an Expiry Date?” Cambridge Quarterly of Healthcare Ethics 20 (2011): 85–92; Kristen J. Prentice et al, “Maintaining Informed Consent Validity During Lengthy Research Protocols,” IRB: Ethics and Human Research 29, no. 6 (November 2007): 1–6; Mary Rose Mueller and Susan Instone, “Beyond the Informed Consent Procedure: Continuing Consent in Human Research,” Ciência e Saúde Coletiva 13, no. 2 (March–April 2008): 381–389. 20Hainan Zhu et al, “Invited Review: Perioperative Risk Factors for Vascularized Composite Allotransplantation: A Systematic Review and Proposal of Identity-Deﬁning VCA,” Microsurgery 2013 Jul 9. doi:10.1002/micr.22125. 1.3 Covenant Consent 7 out the general structure of that justiﬁcation, which will begin with sections on the history and current practice of VCA, on the various theoretical and practical approaches to consent in health care, and on the concept of covenant, with a special focus on its prior uses in health care ethics. These three sections will prepare the way for a description of the form and function of “covenant consent” as it may be applied in the context of VCA.

1.4 Structure of the Book

Following this introduction, the book will proceed by exploring in turn the ﬁeld of VCA, the concept of consent as employed in bioethics, and the concept of covenant from its origins to its use in bioethics. Following the establishment of this foundation for consideration of covenant consent in VCA, the next chapter will attempt the creative and integrative efforts to justify covenant consent in the context of VCA, and to describe some of the ways the concept may be integrated into standard practice in VCA. A concluding chapter will review, summarize and explore further implications.

1.5 Conclusion

Medical teams and researchers are making steady progress in the effort to develop facial and upper extremity VCA into a standard clinical offering. Still, the burdens, risks and demands to which patients are subjected remain substantial and long-term viability of grafts is uncertain. Candidates for facial and upper extremity VCA may be rendered especially vulnerable both by the nature and consequences of their defects and by the burdens, risks and demands involved in treatment. As those especially vulnerable, they deserve special protections and support. It is hoped that covenant consent, as it is envisioned in this book, may become a means of providing that protection and support and thus a more robust ethical foundation for VCA. Chapter 2 Vascularized Composite Allotransplantation

Abstract In order to discuss the ethics of vascularized composite allotransplantation (VCA), it is necessary to have a firm grasp of this rapidly developing field, including its history, its present state and its anticipated future directions. The story of the development of VCA began in the imaginations of ancient peoples, but required important medical and surgical advances for the practice to become a reality. A survey of the history of VCA will emphasize the role of advances in surgical techniques, including anastomosis of blood vessels and nerves and the emergence of microsurgery. It will also review the emergence of a better understanding of immunology and the development of effective means of immunosuppression. A brief survey of the beginnings of solid organ transplantation and limb replantation will be offered, as they together formed the technical foundation for the first attempts at VCA. The current state of VCA, with a special focus on facial and upper extremity transplantation, will be explored, as will be issues of practical and ethical concern.

2.1 Introduction

Vascularized composite allotransplantation (VCA) holds out great promise as a treatment for devastating facial and upper extremity defects. However, it also demands a great deal from patients in terms of both foreseeable burdens and possible risks. In light of the fact that these burdens and risks are undertaken in the course of treatment which is not necessary to preserve or extend life, because VCA candidates may be regarded as especially vulnerable, and given that long term graft survival remains uncertain, serious ethical questions have been generated. Indeed, the ethical justiﬁcation of VCA has been developing simultaneously with the practice itself.1 As part of the effort to provide ethical justiﬁcation for facial and upper extremity VCA, this book proposes “covenant consent,” a more robust form

1Kiwanuka et al., 1558–1568; Chang and Mathes, 553–560.

© Springer International Publishing AG 2017 9 J.L. Benedict, A Revised Consent Model for the Transplantation of Face and Upper Limbs: Covenant Consent, International Library of Ethics, Law, and the New Medicine 73, DOI 10.1007/978-3-319-56400-5_2 10 2 Vascularized Composite Allotransplantation of consent which addresses some of the special conditions associated with VCA. In order to explain why covenant consent is especially ﬁtting for VCA, it is ﬁrst necessary to give a thorough description of VCA, including its development and its antecedents in solid organ transplantation (SOT) and limb replantation. Such a thorough description, including descriptions of ethical issues that have been raised concerning VCA, will be the focus of this chapter.

2.2 History and Development of Solid Organ Transplantation and Limb Replantation

Since 1988, more than a half million organ transplants have taken place in the United States alone, with recipients aged less than a year to over 80 years.2 The scale of SOT is all the more remarkable given that the earliest verifiably successful organ transplantations occurred little more than half a century ago.3 Yet, while SOT only became a well-established clinical practice in the last fifty years, there is ample evidence that the possibility of transplanting organs and tissues fired the imaginations of ancient peoples and the first experimental efforts in the modern age took place long before the surgical techniques and understanding of immunology necessary for success were available.

2.2.1 Ancient Evidence

According to historians of medicine, some of the earliest descriptions of transplantation come from Hindu literature, in which descriptions are found of skin transferred from a patient’s buttocks to repair defects of the face.4 Accounts of the transfer are found in the Sushutra Samhita Sanskrit texts and dated to the third millenia B. C. E.5 This method of autologous transplantation is essentially the same approach that is used in modern medical practice to treat most major facial defects due to traumatic injury. Other forms of transplantation which appear credible are also mentioned in ancient sources, including transplantation of teeth and bone. There are reports from ancient Egypt of slaves being forced to donate teeth to

2Organ Procurement and Transplantation Network Data, U.S. Department of Health and Human Services, accessed March 7, 2014. http://optn.transplant.hrsa.gov/latestData/rptData.asp. “Kidney Transplant at 84, Chicago Artist Proves New Start Possible at Any Age,” Northwestern Memorial News, Accessed March 7, 2014. http://www.nmh.org/nm/kidney-transplant-new-start. 3Credit for the ﬁrst “successful” organ transplant is usually given to a team headed by Joseph E. Murray at the Peter Bent Brigham Hospital of Boston in 1954. See, for example, Ortega, 17. 4Howard, Cornell and Cochran, 6; Linden, 165–166. 5S.D. Imahara and M.B. Klein, “Skin Grafts,” in Biomaterials for Treating Skin Loss, ed. by D.P. Orgill and C. Blanco. Abington Hall: Woodhouse Publishing, 2009: 61. 2.2 History and Development of Solid Organ Transplantation … 11 pharaohs who desired them for replacing their own.6 Other attempts at the transplantation of teeth took place in ancient Greece and Rome, and continued until the late 18th century when physicians became concerned that the transplants played a role in the transmission of contagious diseases, including syphillis.7 Bone grafts are also reported.8 In addition to these literary descriptions of relevant types of surgery, archeological evidence exists for trephination, the temporary removal and later replacement of skull bone to treat brain swelling.9 Less credible or more likely mythological descriptions of transplantation found in ancient sources include a double heart transplant by Chinese physician Pien Chi’ao10 and the transplantation of a leg by legendary Christian physicians, St. Cosmas and St. Damian.11

2.2.2 Developments in Transplantation Prior to 1954

In the 19th century, experimentation with transplantation began to ﬂourish. According to Alexis Bergan, human grafts attempted during that century included “skin, tendons, nerves, cartilage, adipose, corneas, adrenal and thyroid glands, ovaries, partial digestive and urinary tracts, and muscle”.12 Swiss surgeon Theodor Kocher attempted a thyroid transplant as early as 1883.13 Extensive experimentation with animals took place during the same period and into the ﬁrst half of the 20th century, including some work on xenotransplantation. Alexis Carrel, whose development of vascular anastomic suturing was critical to the development of transplantation, experimented with cats and performed a heart transplant in a dog.14 Others worked with rabbits, pigs and macaques.15 French physician Mathieu Jaboulay tried to implant kidneys from pigs and goats into humans.16

6A.S. Cohen, T.C. Shen and M.A. Pogrel, “Transplanting Teeth Successfully: Autografts and Allografts that Work,” JADA 126, no. 4 (1995): 481–485. 7Cohen, Shen and Pogrel, 481. 8Linden, 166. 9I.M. Rutkow, “Trephination: How Did They Do It?” Archives of Surgery 135, no. 9 (2000): 1119. 10Linden, 166; Howard, Cornell and Cochran, 6; B.D. Kahan, “Pien Ch’iao, The Legendary Exchange of Hearts, Traditional Chinese Medicine, and the Modern Era of Cyclosporine,” Transplantation Proceedings 20, no. 2 (1988): 2. 11Cosmas’ and Damian’s surgery would qualify as VCA rather than SOT, of course. See Linden, 166; Howard, Cornel and Cochran, 7; G. Androutsos, A. Diamantis and L. Vladimiros, “The First Leg Transplant for the Treatment of Cancer by Saints Cosmas and Damian,” Journal of the Balkan Union of Oncology, 13, no. 2 (2008): 297–304. 12Bergan, 3. See also Howard, Cornell and Cochran, 7, for a similar list dated to 1923. 13Thomas Schlich, “The Origins of Organ Transplantation,” The Lancet 378 (2011): 1372. 14Howard, Cornell and Cochran, 7; Linden, 166.; Schlich, 1373. 15Linden, 167. 16Schlich, 1373. 12 2 Vascularized Composite Allotransplantation

Among the more unusual early experiments with xenotransplantation were some which took place in the fourth decade of the 20th century. Notable among these were an attempt to transplant a uterus into a transgender woman in Denmark in 1931,17 and the efforts of the Russian Dr. Serge Voronoff to address loss of libido. Voronoff, after finding younger men reluctant to donate, attempted to treat reduced libido by transplanting monkey testicles into older men.18 Voronoff was likely inspired in part by the reports of physicians in the United States who had claimed success in human-to-human testicular transplants. Sources of such reports included Dr. Frank Lydston of Chicago, who claimed to have performed the surgery on himself as well as others, and Dr. L.L. Stanley of San Quentin prison, who reported transplanting the testicles of a deceased prisoner into a living prisoner in an attempt to reverse premature senility.19 Ortega describes this era of transplantation history as a “muddled period,”20 and many of the experiments do seem absurd in retrospect. Even so, important advances in technique were taking place. Chief among them was the achievement of Alexis Carrel in developing methods for successfully attaching donor and recipient blood vessels. His skill in doing so enabled him to succeed in autologous transplants, and this success paired with failure while using the same techniques in allotransplantation precipitated investigation into the dynamics of rejection.21 A second technical advancement relevant to transplantation took place during this same period, though it would not be applied to transplant surgery until much later. In 1921, Swedish otolaryngologist Carl Olof Nylen pioneered microsurgery. Nylen, a young assistant in the ENT department in Stockholm used a monoscope to repair the inner ear. Two and a half decades later, microsurgical techniques were first used in ophthalmic surgery, when Chicago ophthalmic surgeon Richard A. Perritt employed a binocular microscope. The use of microsurgery for the treatment of cataracts quickly became a standard procedure.22 Soon thereafter experiments in vascular microsurgery involving animals began.23 Only in 1960, however, did microsurgery first begin to be employed on humans for the purpose of vascular

17P. Hertoft and T. Sorenson, “Transexuality: some remarks based on clinical experience,” Ciba Foundation Symposium 62 (1978): 165–181. 18Howard, Cornell and Cochran, 7. 19Carol Haber, “Life Extension and History: The Continual Search for the Fountain of Youth,” Journal of Gerontology, 59A, no. 6 (2004): 517. 20Ortega, 14. 21Schlich, 1373; Linden, 166–167. 22D. Schultheiss and J. Denil, “History of the Microscope and Development of Microsurgery: A Revolution for Reproductive Tract Surgery,” Andrologia 34 (2002): 238. 23Tsu-Min Tsai, Juan M. Breyer, and Joao B. Pannatoni, “History of Microsurgeries: Curiosities from the Sixties and Seventies,” Microsurgery 33, no. 2 (2013): 85. 2.2 History and Development of Solid Organ Transplantation … 13 repair, anastomosis and nerve repair, all of which would prove critical to the success of limb replantation and VCA.24 The absence of an effective method of addressing transplant rejection cooled the ardor of researchers as the 20th century moved into its fourth and ﬁfth decades. Only a few transplants were attempted during this period, primarily involving kidneys for patients very near death. In 1933 Yury Voronoy of Russia transplanted a kidney into a young woman who had suffered mercury poisoning. Sources differ on whether the kidney functioned poorly or not at all, but agree that the woman died two days post-transplant.25 A certain degree of success was achieved with what may be characterized as a “bridge” transplant in 1947. A Boston surgeon placed a donor kidney into a woman whose own kidneys had stopped working due to a uterine infection. The donor kidney functioned for a few days, until the recipient’s infection subsided and her own kidneys began to function again.26 In 1952, French surgeons transplanted a kidney from a living donor into the donor’s son and that kidney functioned for three weeks before overwhelming rejection occurred.27 During the Second World War, research biologist Peter Medawar was called upon by the Medical Research Council of Great Britain to carry out studies to determine why skin grafts from donors consistently failed to survive when transplanted. Medawar took up experimentation on animals, and developed theories of immune response which ultimately led to his receiving the Nobel Prize.28 Based on Medawar’s work demonstrating that rejection was a reaction of the immune system, early efforts to suppress the immune system were attempted. These included sub-lethal whole body radiation and the use of prednisone.29 Unfortunately, rejection soon took place in every case.30

2.2.3 Early Developments in Replantation

Replantation of digits, limbs and other body parts has its own history, though many of the same techniques that would become essential for allotransplantation of solid

24Susumu Tamai, “History of Microsurgery,” Plastic and Reconstructive Surgery Journal 124, no. 6 (2009): 282e–285e; Mininder S. Kocher, “History of Replantation: From Miracle to Microsurgery,” World Journal of Surgery 19 (1995): 462–467. 25Ortega, 14; Howard, Cornell and Cochran, 7; Linden, 167; Bergan, 4. 26Bergan, 4; Howard, Cornell and Cochran, 7. 27Ortega, 17. 28Peter Medawar Biographical, accessed January 7, 2015. http://www.nobelprize.org/nobel_ prizes/medicine/laureates/1960/medawar-bio.html. 29Schlich, 1373; Linden, 168; Thomas E. Starzl, “France and the Early History of Organ Transplantation,” Perspectives in Biology and Medicine 37, no. 1 (1993): 35; Bergan, 4–5; Ortega, 15–16; Thomas E. Starzl and Clyde Barker, “The Origin of Clinical Organ Transplantation Revisited,” JAMA 301, no. 19 (2009): 2041. 30Linden, 167; Howard, Cornell and Cochran, 7. 14 2 Vascularized Composite Allotransplantation organs would also be critical in the development of more complex replantations. There is evidence for attempts at replantation during the Middle Ages, as one medical author of the period insists that it is not possible to replant body parts which have been amputated.31 Successful nose replantation is reported in the 16th century, and beginning in the 19th century there are reliable reports of digit replantation.32 Alexis Carrel, who established the technique of vascular anastomosis, employed it in the replantation of canine limbs, as did William Stewart Halstead, in the early 20th century.33 Replantation is not subject to immunological rejection, and given the success in animal models early on, it is somewhat surprising that the earliest successful vascularized limb replantation did not take place until some years after the earliest successful allotransplantation of an organ, though earlier attempts at limb replantation were made.34

2.2.4 Sixty Years of Successful Solid Organ Transplantation

The ﬁrst solid organ transplantation with long-term graft survival took place in 1954 at Peter Bent Brigham Hospital. Surgeons Joseph Murray and John Merrill successfully transplanted a kidney from the recipient’s identical twin. The recipient survived for eight years post-transplant.35 While certainly noteworthy, this success did not signal the beginning of large scale transplantation of organs, as it did not involve ﬁnding a solution to the immunological barriers. Not long afterward, however, the use of a combination of azathioprine and prednisone opened the door to successful solid organ transplantation on a large scale.36 Kidney dialysis expanded the pool of potential transplant candidates, and indirectly led to the development of a system of procurement and allocation.37 Within twenty years of Murray and Merrill’s successful kidney transplant, several other organs came to be transplanted successfully, including livers, hearts, and lungs.38 While graft and recipient survival increased substantially as experience was gained, problems persisted. In particular, the side effects of the immunosuppressant regimens compromised quality of life and sometimes proved fatal. Advancements

31Kocher, 462. 32Kocher, 462–463. 33Kocher, 464. 34Kocher, 465; Tamai, 283e. 35Bergan, 5; Howard, Cornell and Cochran, 7; Linden, 167. 36Howard, Cornell and Cochran, 7; Bergan, 6; Mohamed H. Sayegh and Charles B. Carpenter, “Transplantation 50 Years Later—Progress, Challenges and Promises,” New England Journal of Medicine 351, no. 26 (2004): 2761. 37Linden, 168. 38Linden, 169–170; Bergan, 8. 2.2 History and Development of Solid Organ Transplantation … 15 in immunosuppression, including the development of cyclosporine in the 1970s, tacrolimus in the 1980s, and mycophenolate mofetil in the 1990s, ameliorated but did not eliminate toxic side effects.39 Problems with the side effects of immunosuppression have spurred renewed interest and substantial research into immunomodulation and induced tolerance.40

2.2.5 Developments in Replantation

Roughly concurrent with the development of successful solid organ transplantation has been the emergence of established replantation programs. In 1962, Ronald A. Malt, then chief surgical resident at Massachusetts General Hospital, replanted the arm of a twelve-year old boy after the boy had suffered above the elbow amputation.41 From that point forward, efforts to replant upper extremities increased, with progress in technique coming from Japan and China as well as from the United States and Europe.42 Microsurgery played a key role, permitting the anastomosis of very small blood vessels and the repair of nerves, leading to much improved function. Of course, optimal restoration of function also depended on the development and application of appropriate physiotherapy following surgery. Limb and digit replantation has become a well-established practice, with thousands of procedures taking place since Malt’s pioneering efforts.43 Replantation for vascularized tissues other than upper extremities increased as the decades passed. This included work on ﬂaps containing skin, muscle and adipose tissue, preparing the way for face transplantation as well as upper extremity transplantation.44

2.3 History and Development of Vascularized Composite Allotransplantation

Vascularized composite allotransplantation (VCA) is the name now used for transplantation of anatomical structures composed of multiple tissue types. The term “reconstructive transplantation” is also used, and until recently, the term

39Linden, 169–170; Sayegh and Carpenter, 2762; Bergan, 6; Ortega, 22–24. 40Ortega, 25; Sayegh and Carpenter, 2764–2765; Thomas E. Starzl, “The Mystique of Organ Transplantation,” Journal of the American College of Surgeons, 201, no. 2 (2005): 165–168; Merrill et al., 2043. 41Kocher, 465; Tamai, 283e; Alexandros Beris et al., “Digit and Hand Replantation,” Archives of Orthopaedic and Trauma Surgery, 130, no. 9 (2010): 1141; Tsai, Breyer and Panattoni, 85. 42Tamai, 285e–287e. 43Roni Prucz and Jeffrey Friedrich, “Upper extremity replantation: current concepts,” Plastic and Reconstructive Surgery Journal 133, no. 2 (2014): 333. 44Tamai, 290e–291e. 16 2 Vascularized Composite Allotransplantation composite tissue allotransplantation was more common. The term, “Composite tissue transplantation,” was ﬁrst employed by Earle Peacock, Jr., in 1957 to describe his attempts to transplant ﬂexor tendons.45 Part of the rationale behind the change in nomenclature from composite tissue allotransplantation to vascularized composite allotransplantation was to avoid confusion as the system of procurement under U.S. law treats tissues very differently than it does organs.46 A similar shift in nomenclature and regulation has taken place in Europe, with VCAs being originally excluded from consideration as organs, but included as of 2012.47 VCA may also be understood as a sub-type of CTA, which includes both vascularized and non-vascularized tissues. Examples of the latter would include transplantations of tendons, subcutaneous fat and some bones.48 Much of the focus of VCA thus far has been on upper extremity and facial VCA, though other forms have also been attempted.49 Experience with solid organ transplantation and replantation led to the development of the necessary surgical and rehabilitative skills for successful VCA many years ago, but the high rate of immunogenicity of skin dampened enthusiasm for VCA procedures until more advanced immunosuppressants became available.50 In 1996, the use of cyclosporine and mycophenolate mofetil was demonstrated to sustain a vascularized composite allotransplantation of a rat hind limb, and interest in the possibility of human VCA was rekindled.51

45Foroohar et al., 406. 46Kodi Azari and Gerald Brandacher, “Vascularized Composite Allotransplantation,” Current Opinion in Organ Transplantation 18, no. 6 (2013): 631–632; Siemionow, Gharb and Rampazzo, 633; Schneeberger, Morelon and Landin, 1088–1089; “Vascularized Composite Allotransplantation Research,” Accessed March 14, 2014. http://www.myast.org/public-policy/ vascularized-composite-allotransplantation-vca-research; Linda C. Cendales, Axel Rahmel and Timothy L. Pruett, “Allocation of Vascularized Composite Allografts: What Is It?” Transplantation 93, no. 11 (2012): 1086. 47Axel Rahmel, “Vascularized Composite Allografts: Procurement, Allocation and Implementation,” Current Transplantation Reports (2014): 173. 48P. Petruzzo et al., “Long-term Follow-Up in Composite Tissue Allotransplantation,” 808; Shores, Imbriglia and Lee, 1863; Murphy, Zuker and Borschel, 2. 49Evans, “A Historical, Clinical, and Ethical Overview of the Emerging Science of Facial Transplantation,” 151; Diaz-Siso et al., 330. 50Shores, Imbriglia and Lee, 1862; Barker et al., “Research and Events,” 239; Errico, Metcalfe and Platt; Tintle et al., “Hand Transplantation,” 4; Curtis L. Cetrulo, Jr. and Stephen J. Kovach, “Procurement of Hand and Arm Allografts,” Techniques in Hand and Upper Extremity Surgery 17, no. 4 (2013): 232. 51Brendan J. MacKay, Eliot Nacke and Martin Posner, “Hand Transplantation: A Review,” Bulletin of the Hospital for Joint Diseases 72, no. 1 (2014): 76–77; D.M. Browning, “Sturdy for Common Things: Cultivating Moral Sense-Making on the Front Lines of Practice,” Journal of Medical Ethics 38, no. 4 (2012): 233–235. 2.3 History and Development of Vascularized Composite Allotransplantation 17

Since the development of better immunosuppression, programs have prolifer- ated, being established in several centers with sufﬁcient resources to create the multidisciplinary teams required. Linda A. Evans describes the typical VCA team as being composed of surgeons, nephrologists, pathologists, immunologists, anes- thesiologists, nurses, transplant coordinators, social workers, psychiatrists, dieti- cians, physical therapists and others.52 The total number of upper extremity and facial transplants attempted through early 2016 has surpassed one hundred.53

2.3.1 Upper Extremity Transplantation

Upper extremity transplantation aims to provide signiﬁcantly superior cosmetic and functional outcomes than are available through current prosthetic technology. Upper extremity amputation is much more likely to be experienced by young, otherwise healthy individuals than is lower extremity amputation, which is often the result of complications of diabetes in the elderly. By contrast, upper extremity amputation often occurs following a major sudden trauma to the limb, with the most common causes of injury being vehicle, farm and industrial accidents, blast injuries, electrical injuries and sepsis.54 Upper extremity amputation takes place at a number of levels, from wrist to shoulder disarticulation. Transradial amputation is the most common, and perhaps the most suited to later transplantation.55 One estimate of the scale of upper extremity loss suggests that more than a half million people currently contend with some degree of upper extremity loss in the United States alone.56 Upper extremity transplantation is an option for persons who have defects, either congenital or due to injury, and who are dissatisﬁed with

52Linda A. Evans, The Experience of Health Care Team Members Involved in Facial Transplant Surgery and Patient Care: A Dissertation, University of Massachusetts Medical School Graduate School of Nursing 2012: 13; 17–18. 53Ricardo Londono, Vijay S. Gorantla, and Stephen F. Badylak, “Emerging Implications for Extracellular Matrix-based Technologies in Vascularized Composite Allotransplantation,” Stem Cells International, epub (2015), doi:10.1155/2016/1541823; Bohdan Pomahac, Ryan M. Gobble and Stefan Schneeberger, “Facial and Hand Allotransplantation,” Cold Spring Harbor Perspectives in Medicine, epub ahead of print, accessed 22 Mar. 2014 at http:// perspectivesinmedicine.org/content/early/2014/01/28/cshperspect.a015651.full.pdf+html. 54Sheila G. Jowsey-Gregoire et al., “The Chauvet 2014 Meeting Report: Psychiatric and Psychosocial Evaluation and Outcomes of Upper Extremity Grafted Patients,” Transplantation Epub ahead of print (2015), online at http://dx.doi.org/10.1097/TP.0000000000001013. 55Scott M. Tintle et al., “Traumatic and Trauma-Related Amputations, Part II: Upper Extremity and Future Directions,” The Journal of Bone and Joint Surgery 92 (2010): 2934–2939; S. Salminger et al., “Hand Transplantation Versus Hand Prosthetics: Pros and Cons,” Current Surgery Reports 4, no. 8 (2016). 56MacKay, Nacke, and Posner, 77. 18 2 Vascularized Composite Allotransplantation mechanical prostheses.57 The transplant operation itself is basically the same as a replantation.58 Once the bone is fixed, tendons, arteries, nerves and veins are connected.59 The possibility of upper extremity transplantation intrigued surgeons during the Second World War, leading to extensive planning but no actual attempt.60 The first attempted human limb transplant in the modern era took place in Ecuador in 1964, just as early solid organ transplantation was beginning to flourish. A single hand was transplanted to a bilateral amputee. Unfortunately, anti-rejection measures were not yet adequate, and the graft was lost within weeks.61 Interest in limb transplantation waned thereafter, based on the belief that the immunogenic load was too great, only to wax again as new immunosuppressants were developed in the 1980s.62 Foroohar et al., describe how a series of experiments with rat hind limb transplantation demonstrated the effectiveness of a combination including tacrolimus, mycophenolate motefil, and cyclosporine in managing rejection, and how this spurred new enthusiasm toward the viability of VCA in humans.63 After substantial animal research and amidst ethical debate,64 a French team performed a limb transplant in 1998. Jean-Michael Dubernard led the team which transplanted the right forearm of a brain dead donor to a 48 year-old male in a 13 h surgery. Considered a success at first, the graft was later lost due to the decision of the recipient to discontinue anti-rejection medications. Psychological issues were a major factor in this failure.65 Just four months after the surgery in France, an American team in Louisville, Kentucky, performed a transplant to replace a left hand on 37 year old male, who retains the graft at the time of this writing.66 Other upper extremity transplants have followed elsewhere in the United States, as well as in Austria, China, Belgium, Italy, Great Britain, Spain, Poland, Turkey, Taiwan, Australia, Malaysia, Mexico

57S. Salminger et al., report the rejection rate of all prostheses has been approximately 20% over the last quarter of a century. See “Hand Transplantation Versus Hand Prosthetics: Pros and Cons,” Current Surgical Reports 4, no. 8 (2016), epub. 58Shores, Imbriglia and Lee, 1863. 59“Hand Transplantation,” Aetna Clinical Policy Bulletin, accessed March 14, 2014. http://www. aetna.com/cpb/medical/data/800_899/0816.html. 60Richard H. Hall, “Whole Upper Extremity Transplant for Human Beings: General Plans of Procedure and Operative Technic,” Annals of Surgery 120, no, 1 (1944): 12–23. 61Amer et al., 40; Errico, Metcalfe and Platt; Tintle et al., “Hand Transplantation,” 2; Ravindra et al., “Composite Tissue Transplantation,” 1238; Diaz-Siso et al., 330. 62Ravindra et al., 1238. 63Foroohar et al., 406. 64M. Siegler, 2779–2782. 65Ravindra et al., 1239; Amer et al., 40; Tintle et al., “Hand Transplantation,” 2; Errico, Metcalfe and Platt; Foroohar et al., 406. 66Composite Tissue Allotransplantation: The Patients. Accessed March 13, 2014. http://www. handtransplant.com/ThePatients/MatthewScott/tabid/83/Default.aspx; Foroohar et al., 406; Ravindra et al., 1242; Errico, Metcalfe and Platt. 2.3 History and Development of Vascularized Composite Allotransplantation 19 and Iran.67 In January 2014, Tintle et al., reported eighty-nine upper extremity transplants had been performed worldwide.68 By November 2014, Shores, Brandacher and Lee reported 107 known transplanted hand/upper extremities on 72 patients worldwide.69 Both single and double (bilateral) transplants of upper extremities have taken place, with the International Hand Registry established to track upper extremity transplantation showing nearly equal numbers of both types. The extent of transplant has also varied in terms of more distal and more proximal attachment sites. In general, the greatest return of function has taken place in the more distal grafts.70 The International Hand Registry (now the International Registry on Hand and Composite Tissue Transplantation) was founded in 2002 to collect information for the sake of supporting the practice and advancement of VCA.71 As of early 2014, 19 centers throughout the world had registered with the IRHCTT.72 Upper extremity transplantation has also been combined with facial transplantation. The first face-and-hand recipient died sixty-five days after transplant, and the second recipient’s upper extremity grafts were removed due to necrosis five days after the initial surgery.73 Two additional deaths of upper extremity recipients have been reported from Turkey, but these cases included concomitant lower extremity transplants as well.74 Results for upper extremity transplants only have been very good when patients adhere to the immunosuppressive regimen,75 with reports of high levels of patient satisfaction.76 Still, successful upper extremity transplantation

67Foroohar et al., 406–407; Petruzzo et al., “The International Registry on Hand and Composite Tissue Transplantation,” 1590–1594; Karen M. Dwyer et al., “First Hand Transplant Procedure in Australia: Outcome at 2 Years,” The Medical Journal of Australia 199, no. 4 (2013): 285–287; Martin Kumnig, Sheila G. Jowsey and Andrea F. DiMartini, “Psychological Aspects of Hand Transplantation,” Current Opinion in Organ Transplantation 19, no. 2 (2014): 188; Y.R. Kuo et al., “The First Hand Allotransplantation in Taiwan: A Report at 9 Months,” Annals of Plastic Surgery, epub ahead of print (2016), doi:10.1097/SAP.0000000000000758. 68Tintle et al., “Hand Transplantation,” 2. 69Jaime T. Shores, Gerald Brandacher and W.P. Andrew Lee, “Worldwide Update of Hand Transplantation,” Plastic and Reconstructive Surgery, epub ahead of print, November 2014. 70Shores, Brandacher and Lee. 71Pomahac, Gobble and Schneeberger, 1. 72MacKay, Nacke and Posner, 77. 73Gordon et al., 309–314; Petruzzo and Dubernard, 249; Siemionow, Gharb and Rampazzo, 638. 74Foroohar et al., 408; Tintle et al.; “Hand Transplantation,” 5. 75Shores, Brandacher and Lee, “Worldwide Update.” Tintle et al., “Hand Transplantation,” 4, report that 100% of grafts have survived at least 1 year when the conventional triple-drug immunosuppression has been used. 76Shores, Imbriglia and Lee, 1862–1864; Ninkovic et al., 457–460; Foroohar et al., 406–409; Jensen et al., 2126–2135; Diaz-Siso et al., 331; Petruzzo and Dubernard, “World Experience,” 416. However, there have been reports of less-than-satisfactory outcomes that did not result in graft loss or patient mortality. See Singh et al., “Functional Outcomes after Bilateral Hand Transplantation: A 3.5 Year Comprehensive Follow-Up,” Plastic and Reconstructive Surgery 137, no. 1 (2016): 185–189. Jowsey-Gregoire et al., note that function does not always correlate with satisfaction. 20 2 Vascularized Composite Allotransplantation involves signiﬁcant burdens and carries substantial risks, while yielding results that fall short of full restoration of function.77 In light of these limitations, it is not surprising that attitudes among hand surgeons toward the procedure have remained mixed, with many skeptical of the practice.78

2.3.2 Face Transplantation

Encouraged by the early successes in limb transplantation and experience with facial replantation following traumatic injury,79 surgeons and medical teams began to plan for the first facial transplants. Work in animal models was followed by practice on cadaveric models in humans. Important learning took place at this stage regarding both the appropriate methods of tissue retrieval and the optimal techniques for the attachment of donor tissues to the recipient.80 Severe facial defects, like upper extremity defects, may be congenital or may result from burns, ballistic trauma, human or animal attacks, or diseases such as neurofibromatosis.81 Defects that may be regarded as severe generally involve functional deficits as well as cosmetic ones. Such defects may interfere with normal feeding, speech and the individual’s ability to use facial expressions to communicate with others.82 Defects may also interfere with the function of periorbital structures of the eye, such as voluntary and spontaneous or involuntary blinking. Involuntary blinking is particularly important as the absence of involuntary blink can lead to vision loss.83

77Christina L. Kaufman et al., “Immunobiology in VCA,” Transplant International (2016) epub ahead of print, doi:10.1111/tri.12764. 78David W. Mathes et al., “A Survey of North American Hand Surgeons on Their Current Attitudes Toward Hand Transplantation,” Journal of Hand Surgery 34A (2009): 812. 79Bradon J. Wilhelmi et al., “First Successful Replantation of Face and Scalp with Single-Artery Repair: Model for Face and Scalp Transplantation,” Annals of Plastic Surgery 50, no. 5 (2003): 535–540. 80Faith Zor, “Facial Vascularized Composite Tissue Allotransplantation,” Gulhane Medical Journal 55 (2013): 158–159. 81Shanmugarajah, Hettiaratchy and Butler, 291Suzy Henry, “Disﬁgurement and Visible Difference: The Impact Upon Personality Development and the Implications for Therapy,” Person- Centered and Experiential Psychotherapies, 10, no. 4 (2011): 279; Zor, 156. 82Luccie Wo, Ericka Bueno and Bohdan Pomahac, “Facial Transplantation: worth the risks? A look at evolution of indications over the last decade,” Current Opinion in Organ Transplantation 20, no. 6 (2015): 615–616; Lengele. 508; Losee, Fletcher and Gorantla, 260; Andrew Edgar, “The Challenge of Transplants to an Intersubjectively Established Sense of Personal Identity,” Health Care Analysis 17 (2009): 126. 83Michael Sosin et al., “Eyelid Transplantation: Lessons from a Total Face Transplant and the Importance of Blink,” Plastic and Reconstructive Surgery Journal 135, no. 1 (2015): 167e–174e. 2.3 History and Development of Vascularized Composite Allotransplantation 21

For patients with severe defects, the standard treatment of autologous grafts produces only limited improvements, both functionally and cosmetically, with congenital or traumatic defects of the mid-face being especially problematic.84 Agich and Siemionow note that traditional methods typically result in skin dis- coloration, deforming contractures, and a visibly deformed appearance that is noticeable at a distance.85 While far from perfect, facial allografts produce far superior results, both esthetically and functionally.86 Functionally, patients who have previously needed gastrostomy tubes or who have been dependent on tra- cheostomies have been able to do without these interventions post-transplant.87 Significant improvements in speech intelligibility following facial VCA have also been demonstrated.88 In a recent report by Fischer et al., surveying a total of 29 face transplant recipients, improvements in the ability to smell, eat and feel (sensation) were seen in all, while breathing, speaking and facial expression showed benefitina large majority.89 In a similar review of 28 recipients, Khalifian et al., report improved ability to eat, drink, speak, smell and smile in almost all patients”.90 Peter Butler, of London’s Royal Free Hospital, was the first surgeon to propose a program be established for conducting facial transplantations. His suggestion at a 2002 meeting of the British Association of Plastic Surgeons was heavily covered in the media, and elicited the expression of widespread and profound ethical concerns. Within a year, the Royal College of Surgeons announced at a public debate in the London Museum that it would be “unwise to proceed” until more research was done.91 The first actual facial allograft, therefore, took place instead at Amiens, France. On November 27, 2005, a team led by surgeons Bernard Duvauchelle and Jean-Michael Dubernard transplanted a flap containing both the nose and mouth from a 46 year old brain-dead donor to a 38 year old recipient. The recipient had obtained her defect from dog bites while the patient was unconscious.92 Results

84Barker et al., “Research and Events Leading to Facial Transplantation,” 234; Wiggins et al., 3; Losee, Fletcher and Gorantla, 260. 85Agich and Siemionow, 708; Siemionow, 426; Zor, 157. 86Shanmugarajah, Hettiaratchy and Butler, 292–296; Sieminow and Ozturk, 254–255; Johnson and Corsten, 276; Infante-Cossio et al., e264; e268; Siemionow, 426; N. Roche et al., “Long-term multifunctional outcome and risks of face vascularized composite allotransplantation,” Journal of Cranio-facial Surgery 26, no. 7 (2015): 2039; Londono, Gorantla, and Badylak. 87Pomahac, Gobble and Schneeberger, 9. 88Kristiane M. Van Lierde et al., “Speech Characteristics One Year After First Belgian Facial Transplantation,” The Laryngoscope 124 (2014): 2026–2027. 89S. Fischer et al., “Functional Outcomes of Face Transplantation,” American Journal of Transplantation 15 (2015): 220. 90Saami Khalifian et al., “Facial Transplantation: The First 9 Years,” The Lancet (2014), epub ahead of print, Accessed April 28, 2014. http://dx.doi.org/10.1016/S0140-6736(13)62632-X. 91Barker et al., “Research and Events Leading to Facial Transplantation,” 240–41. 92Jean-Michael Dubernard et al., “Outcomes 18 Months after the First Human Partial Face Transplantation,” The New England Journal of Medicine 357, no. 24 (2007): 2451–2452. 22 2 Vascularized Composite Allotransplantation were good and the graft functioned well for several years, though there were complications associated with side effects of immunosuppression.93 At 90 months post-transplant, problems with the graft were detected, and eventually necrosis of the lips and perioral area occurred, requiring surgical removal of those portions of the graft in May 2015. The patient subsequently developed an aggressive small cell lung cancer, leading to her death in April 2016.94 Subsequent facial transplants have taken place in China, the United States, Spain, Turkey, Belgium, and Poland. France and the United States have had the largest number of cases thus far.95 The total number of procedures performed as of 2015 is thirty-four, with roughly half being partial face and the other half full face.96 Like the first patient, the cause of the defect in two other cases has been animal bites, while the most common form of trauma among facial transplant patients has been ballistic injuries.97 The average length of the transplant surgery has been 17.6 h.98 All of the recipients of facial grafts have had to deal with acute rejection and the side effects of immunosuppression.99 Along with the face-and-hand transplant recipient mentioned above and the first face transplant patient, four other facial transplant recipients have died. One was a Chinese victim of a bear attack who received a total nose, upper lip and parotid gland graft in 2006.100 The second was an HIV-positive recipient who later succumbed to a recurrence of cancer.101 The third was a Turkish patient who experienced organ failure and died following removal of the graft.102 The fourth resulted from suicide.103 Maintainance of the appearance of the graft has also been a concern, as over time changes have been

93Palmina Petruzzo et al., “First Human Face Transplantation: 5 Years Outcomes,” Transplantation 93, no. 2 (2012): 236–240. 94E. Morelon et al., “Face Transplantation: Partial Graft Loss of the First Case Ten Years Later,” American Journal of Transplantation Epub ahead of Print (January 2017), np. doi:10.1111/ajt. 14218. 95Siemionow, Gharb and Rampazzo, 635; Pomahac, Gobble and Schneeberger, 1. 96Nathalie A. Roche et al., “Complex Facial Reconstruction by Vascularized Composite Allotransplantation: The First Belgian Case,” Journal of Plastic, Reconstructive and Aesthetic Surgery,” Epub ahead of print (2014):7. doi:10.1016/j.bjps.2014.11.005; N.A. Roche et al., “Facial Transplantation: History and Update,” Acta Chiruga Belgica 115 (2015): 100; N. Roche et al., “Long-term multifunctional outcome and risks of face vascularized composite allotransplantation,” 2038. 97Pomahac, Gobble and Schneeberger, 1. 98Ralf Smeets et al., “Face Transplantation: On the Verge of Becoming Clinical Routine?” Accessed January 9, 2015. Biomed Research International (2014). http://www.hindawi.com/ journals/bmri/2014/907272/. 99Pomahac, Gobble and Schneeberger, 1–2. 100Siemionow, Gharb and Rampazzo, 635. 101Khaliﬁan et al., “Facial Transplantation: The First 9 Years.”; Wo, Bueno and Pomahac, 618. 102Roche et al., “Facial Transplantation: History and Update,” 102. 103Wo, Bueno and Pomahac, 619. 2.3 History and Development of Vascularized Composite Allotransplantation 23 observed that resemble rapid aging.104 On the whole, however, patients who have received facial tissue transplants have done well and are pleased with the results.105 Sensitivity and signiﬁcant motor function have returned over time, with appropriate therapy.106

2.3.3 Other VCA

A number of other types of vascularized grafts have been transplanted, with varying degrees of success. Early attempts with uterine transplantation in Saudi Arabia and Turkey did not lead to live births. More recently, a Swedish team has conducted a number of uterine transplants from living donors, with the hope of overcoming uterine-based infertility in the recipients.107 At six months post-transplant, seven of nine uteri remained viable. The capacity of these uteri to sustain a pregnancy was demonstrated by the birth of a baby boy in September 2014 to a 36-year-old woman who became pregnant via in vitro fertilization one year post-transplant. Four total live births had been reported as of mid-2015, with more expected later that year and in 2016.108

104M. Kueckelhaus et al., “Transformation of Face Transplants: Volumetric and Morphological Graft Changes Resemble Aging After Facial Allotransplantation,” American Journal of Transplantation 16, no. 3 (2016): 968–978. 105Sieminow, Gharb and Rampazzo, 634–636; Shanmugarajah, Hettiaratchy and Butler, 291–296. Londono, Gorantla and Badylak caution that an accurate picture of the quality of outcomes is difficult to obtain because a number of clinical failures “remain unpublished and unpublicized”. 106Lengele, 515. 107Like other forms of VCA, uterine transplantation is demanding for the patient and carries substantial risks. These burdens and risks include daily immunosuppression, potential effects on the in utero offspring, psychological and emotional complexities and expense. Further, because no nerves are reattached recipients do not experience movement of the fetus to the same degree that others do. See John A. Robertson, “Other women’s wombs: uterus transplants and gestational surrogacy,” Journal of Law and Biosciences, Advance Access (2016), doi:10.1093/jlb/lsw011. 108Mats Brannstrom et al., “The First Clinical Uterus Transplantation Trial: A Six-Month Report,” Fertility and Sterility (2014), epub ahead of print, doi:10.1016/j.fertnstert.2014.02.024. See also Catsanos, Rogers and Lotz, 65–73. For a discussion of the ethics of uterine transplants, see Gregory W. Rutecki, “‘Give Me Children or I’ll Die!’ Is It Time to Consider the Uterus as a Non-vital Organ Transplant?” Ethics and Medicine 25, no. 3 (2009): 177–186; Troy Brown, “World’s First Baby Born After Uterine Transplant,” Medscape Multispecialty Accessed October 4, 2014, http://www.medscape.com/viewarticle/832827; Nicola Williams, “Should deceased donation be morally preferred in uterine transplantation trials?” Bioethics, epub ahead of print (2016), doi:10.1111/bioe.12247. The first U.S. attempt at a uterus transplant failed in 2016. See “First U.S. Uterus Transplant Fails Due to Complications,” Scientific American March 10, 2016, online at http://www.scientificamerican.com/article/first-u-s-uterus-transplant-fails-due-to- complications/. Accessed May 5, 2016. 24 2 Vascularized Composite Allotransplantation

Other types of VCA which have been attempted include tongue, lower extremities, abdominal wall, esophagus, larynx, penis and vascularized knees. Abdominal wall transplantation is actually one of the more common forms of VCA, along with upper extremity transplants and facial transplants. Abdominal wall transplantation frequently takes place in conjunction with intestinal transplantation, since the patients have often endured numerous previous abdominal surgeries which may result in multiple fistulae and other damage.109 Esophageal transplants are also often combined with the transplant of viscera.110 Experience with several of these other forms of VCA raises concern. For example, the first total laryngeal transplant was explanted due to chronic rejection in 2012, fourteen years after transplant. Initial results were quite good, including voice quality and swallowing, but the graft went into serious decline in the twelfth year.111 Vascularized knee transplants have been unsuccessful on the whole, with Diefenbeck et al., reporting all six attempted grafts lost within fifty-six months of transplantation, including four from chronic rejection in spite of immunosuppression adherence.112 The double lower extremity transplantation performed by the team led by Cavadas required re-amputation when a lymphoproliferative disorder occurred and the patient chose to discontinue immunosuppression.113 While a later attempt at penile transplantation may be considered successful,114 in the initial case of human penile allotransplantation the recipient asked to have the graft removed within weeks, citing the psychological burden.115

109B.S.R. Allin, “A Single Center Experience of Abdominal Wall Graft Rejection After Combined Intestinal and Abdominal Wall Transplantation,” American Journal of Transplantation 13 (2013): 2211; G. Selvaggi et al., “Expanded Use of Transplantation Techniques: Abdominal Wall Transplantation and Intestinal Autotransplantation,” Transplantation Proceedings 36, no. 5 (2004): 1561–1563; Henk Giele et al., “Current State of Abdominal Wall Transplantation,” Current Opinion in Transplantation 21, no. 2 (2016): 159–164. 110K. Vakili and H.B. Kim, “Partial Esophageal Transplantation is Possible as Part of a Multivisceral Graft,” American Journal of Transplantation 14 (2014): 720. 111Robert R. Lorenz and Marshall Strome, “Total Laryngeal Transplant Explanted: 14 Years of Lessons Learned,” Otolaryngology—Head and Neck Surgery, 2014 epub ahead of print, doi:10. 1177/0194599813519748; Bruce Swearingen et al., “The Science of Composite Tissue Allotransplantation,” Transplantation 86, no. 5 (2008): 633–634. 112Michael Diefenbeck et al., “Outcome of Allogenic Vascularized Knee Transplants,” Transplant International 20 (2007): 410–418; Michael Diefenbeck et al., “Allograft Vasculopathy After Allogenic Vascularized Knee Transplantation,” Transplant International 24 (2011): e1–e5. 113Tintle et al., “Hand Transplantation,” 4. See also Matthew J. Carty et al., “The Case for Lower Extremity Allotransplantation,” Plastic and Reconstructive Surgery 131, no. 6 (2013): 1272–1277 and P.C. Cavadas et al., “Bilateral Transfemoral Lower Extremity Transplantation: Result at 1 Year,” American Journal of Transplantation 13 (2013): 1343–1349. 114Martin Kumnig and Sheila G. Jowsey-Gregoire, “Key psychological challenges in vascularized composite allotransplantation,” World Journal of Transplantation, 6, no. 1 (2016): 92. 115Li-Chao Zhang, Yong-Bing Zhao and Wei-Lie Hu, “Ethical Issues in Penile Transplantation,” Asian Journal of Andrology 12 (2010): 795–800; Tintle et al., “Hand Transplantation,” 7. 2.4 Similarities and Differences in VCA and SOT 25

2.4 Similarities and Differences in VCA and SOT

2.4.1 Similarities

Vascularized composite allotransplantation and solid organ transplantation share a number of similarities, as one might expect. For instance, in terms of surgical technique, both rely heavily on vascular anastomosis.116 SOT and VCA have a similar proﬁle of surgical risks, such as complications arising from anesthesia and blood loss.117 The use of immunosuppressants to control rejection is also very similar, as is the importance of patient adherence to the immunosuppressive regimen and the need to monitor patients for side effects of these medications.118 Side effects include increased infection risk, the development of diabetes in many patients, and malignancies in some.119 Both VCA and SOT use similar methods and solutions to preserve the organs and tissues to be transplanted, and require a skilled team to work in a timely fashion to obtain grafts from donors.120 Other similarities between SOT and VCA exist as well. Both must contend with the issue of donor consent and cope with a shortage of organs and tissues for transplantation.121 Likewise, both must address questions surrounding the appropriate allocation of the grafts that do become available, considering both matching (histological, size, etc.) and fairness.122 Both VCA and SOT recipients must be adequately informed prior to surgery and sufﬁciently supported after surgery, and both must contend with the psychological challenges of accepting the body part(s) of another as one’s own.123 Finally, both VCA and SOT are expensive treatments, far beyond the means of most people unless insurance or government funding is available.124

116Foroohar et al., 405; Shores, Imbriglia and Lee, 1863; Weissenbacher et al., 640. 117Wiggins et al., 3–4. 118Hautz et al., 3507–3509; Cavadas, Ibanez and Thione, 421; Morris et al., 114; 116–117; Shores, Imbriglia and Lee, 1862; Tintle et al., “Hand Transplantation,” 4. 119Agich and Siemionow, 708; Gaby Doumit et al., “Pediatric Vascularized Composite Allotransplantation,” Annals of Plastic Surgery, epub ahead of print, July 2014. 120Schneeberger et al., 1089; Pomahac, Gobble and Schneeberger, 2; Dwyer et al., 285; Cetrulo Jr. and Kovach, 236. 121Evans, 152; E.J. Caterson, “Future Directions for Face Transplantation,” The Journal of Craniofacial Surgery 25, no. 1 (2014): 3. 122Schneeburger et al., 1088; Murphy, Zuker and Borschel, 1450. 123Michael Freeman and Pauline Abou Jaoude, “Justifying Surgery’s Last Taboo: The Ethics of Face Transplants,” Journal of Medical Ethics 33 (2007): 76–77; Heinrich and Marcangelo, 402– 403; Siemionow and Ozturk, 256; Siemionow, Gharb and Rampazzo, 636; Morris et al., 115–116; 119; Kumnig, Jowsey and DiMartini, 191. 124Kalliainen, 549; Siemionow, Gharb and Rampazzo, 636; Edwards and Mathes, 121. 26 2 Vascularized Composite Allotransplantation

2.4.2 Unique Features of Solid Organ Transplants

While solid organ transplantation shares a considerable number of features with vascularized composite allotransplantation, as detailed in the immediately preceding section, solid organ transplantation also differs from vascularized composite allotransplantation in certain ways. Some of those differences are related to the much longer clinical history and far greater scale of solid organ transplantation. As early as 1962, the number of kidney transplants being performed led to the first attempts at creating a fair system of allocation.125 Organ procurement organizations (OPOs) developed in various regions around the United States during the decade of the 60s, primarily in response to the rapid growth of cadaveric donor kidney transplantation. That growth was accelerated by the federal law in 1972 which created Medicare payment support for individuals with end stage renal disease.126 In 1984 the United States federal government passed the National Organ Transplant Act, which established the Organ Procurement and Transplantation Network (OPTN). OPTN in turn has contracted with the United Network for Organ Sharing (UNOS) a private, nonprofit organization, to oversee allocation through regional organ procurement organizations. In the intervening years, sophisticated systems of allocation have been developed. Allocation protocols differ by organ, and are determined in part by recipient characteristics and in part by donor characteristics.127 VCA grafts were finally recognized as organs by the U.S. Department of Health and Human Services in July 2013. While this allows the allocation to be managed under OPTN, allocation protocols for facial and upper extremity grafts have yet to be developed and implemented.128 Currently, procurement for SOT and for VCA differs in several ways for a number of reasons, but primarily because the request for faces and limbs has not been fully integrated into the procurement system for solid organs.129 Suggestions for integration have been made, and focus on concerns

125Helga Kuhse and Peter Singer, “What is Bioethics? A Historical Introduction,” A Companion to Bioethics. 2nd ed. Oxford, UK: Blackwell Publishers, 2009: 2. 126John F. Neylan et al., “The Allocation of Cadaver Kidneys for Transplantation in the United States: Consensus and Controversy,” Journal of the American Society of Nephrology 10 (1999): 2237. 127J.M. Smith et al., “Kidney, Pancreas and Liver Allocation and Distribution in the United States,” American Journal of Transplantation 12, no. 12 (2012): 3192–3199. 128Siemionow, Gharb and Rampazzo, 633; Weissenbacher et al., 641. Schneeberger, Morelon and Landin provide a comparison of allocation of VCAs in the U.S. and Europe, 1088–1091. One proposed approach to identifying appropriate candidates for facial transplants may be found in Chad Gordon et al., “The Cleveland Clinic FACES Score: a Preliminary Assessment Tool for Identifying the Optimal Face Transplant Candidate,” Journal of Craniofacial Surgery 20 (2009): 1969–1974. 129McDiarmid, 665–671; Chong and Pruett, 1370–1372; Neha Datta et al., “Procurement Strategies for Combined Multiorgan and Composite Tissues for Transplantation,” Current Opinion in Organ Transplantation 20, no. 2 (2015): 121–126. 2.4 Similarities and Differences in VCA and SOT 27 about requests for VCA graft donations having a negative impact on the willingness of donors and donor families to donate solid organs. One common recommendation has been that requests for VCA grafts not take place until consent for solid organ donation has been obtained.130 Unlike VCA, solid organ transplants are considered standard therapy for certain disease states, and may therefore be covered by insurance or government funding. Because of this, SOTs are available to a far greater number of people. For example, according to OPTN, over 350,000 kidney transplants, 126,000 liver transplants and 57,000 heart transplants have taken place in the United States alone.131 By contrast, the total number of facial and upper extremity VCAs worldwide is approximately 200.132 Finally, SOTs are undertaken with the expectation that they will improve both the quality of life and the longevity of the patient, whereas VCAs are focused on quality of life only.133 This is true even for kidney and pancreas transplants, though they are occasionally described as focused on quality of life rather than the preservation or extension of life.134 There is ample evidence that those receiving kidney transplants live longer than those who remain on the waiting list.135 Pancreas transplantation also shows clear survival beneﬁts over remaining on the list.136

130Rahmel, 174. 131Organ Procurement and Transplantation Network Data, U.S. Department of Health and Human Services, Accessed March 7, 2014. http://optn.transplant.hrsa.gov/latestData/rptData.asp. 132International Registry for Hand and Composite Tissue Transplantation, Accessed March 20, 2014. https://www.handregistry.com/irhctt.php. Londono, Gorantla and Badylak, 2015. 133Sayegh and Carpenter, 2762–2765; Ortega, 17–24. 134Hautz et al., 3504; V.C. Lees and S.J. McCabe, “The Rationale for Hand Transplantation,” Transplantation 74, no. 6 (2002): 749. Weissenbacher et al., 641, make a distinction between “life-saving” (heart, lung and liver) and “life-prolonging,” (kidney and pancreas), but note that VCAs are neither life-saving nor life-prolonging. 135Stephen P. McDonald and Graeme R. Russ, “Survival of recipients of cadaveric kidney transplants compared to those receiving dialysis treatment in Australia and New Zealand, 1991– 2001,” Nephrology Dialysis Transplantation 17 (2002): 2212; Susan M. Samuel et al., “Survival in Pediatric Dialysis and Transplant Patients,” Clinical Journal of the American Society of Nephrology 6 (2011): 1094–1099; M. Tonelli et al., “Systematic Review: Kidney Transplantation Compared with Dialysis in Clinically Relevant Outcomes,” American Journal of Transplantation 11 (2011): 2095–2103. 136David van Dellen et al., “Mortality in diabetes: transplantation is associated with signiﬁcant survival beneﬁt,” Nephrology Dialysis Transplantation 28, no. 5 (2013): 1315–1322; Angelika C. Gruessner, “2011 Update on Pancreas Transplantation: Comprehensive Trend Analysis of 25,000 Cases Followed Up Over the Course of Twenty-Four Years at the International Pancreas Transplant Registry (IPTR),” The Review of Diabetic Studies 8, no. 1 (2011): 6–16; Rainier W.G. Gruessner, David E.R. Sutherland and Angelika C. Gruessner, “Mortality Assessment for Pancreas Transplants,” American Journal of Transplantation 4, no. 12 (2004): 2018–2026. 28 2 Vascularized Composite Allotransplantation

2.4.3 Unique Features of Vascularized Composite Allotransplantation

Given the brief clinical history of VCA, it is to be expected that many policies and procedures related to the practice are still in the process of formation and stan- dardization.137 At the time of this writing, upper extremity transplantation has taken place at fewer than twenty transplant centers,138 while fewer than thirty facial transplants have been attempted.139 As noted earlier, systems of procurement and allocation protocols are still being developed, with current procurement and allocation aptly described by Rahmel as “ad hoc arrangements… similar to the situation in the early days of solid organ transplantation”.140 Likewise still in the process of development are methods for identifying good candidates and determination of the best methods for supporting graft recipients.141 Debate continues about when it is most appropriate to offer VCA, since patients approached too soon may not have had the opportunity to adjust to their deﬁcit as well as they might, while waiting longer may subject them to several painful surgeries or other treatments that would otherwise not be necessary.142 Even the technical sequence of the surgery itself is not yet fully established or agreed upon among the various surgeons and centers.143 Those forms of VCA which involve skin are signiﬁcantly different from SOT in three distinct ways. First, while both VCA and SOT recipients must contend with the psychological task of accepting the body part(s) of another as their own, the visible nature of grafts that include skin make the task both more urgent and less avoidable. Not only are the grafts involved in face and upper extremity transplants visible, but they are also tactile, both to the recipient and others. Visual and tactile encounters with the grafts are common both in clinical care and in activities of daily living, providing frequent reminders of the graft’s existence and eliciting concern

137Diaz-Siso et al., 335. 138Kumnig, Jowsey and DiMartini, 188. 139Kathy L. Coffman and Maria Z. Siemionow, “Ethics of Facial Transplantation Revisited,” Current Opinion in Organ Transplantation 19 (2014): 181. 140Rahmel, 178. 141Coffman and Siemionow, 184; Kumnig, Jowsey and DiMartini, 189–190; Tintle et al., “Hand Transplantation,” 2; 7; Siemionow and Ozturk, 255; Shores, Imbriglia and Lee, 1866; Foroohar et al., 405; 407–408; Errico, Metcalfe and Platt; Evans, 154; Klapheke et al., 453–457; Shores, 539. 142Coffman and Siemionow, 182. The first emergency face transplant was reported in 2015 for a patient for whom other means of restoration were not feasible. The coincidental availability of a donor made this possible, and the outcome (especially the psychological outcome) will be watched carefully. Adam Majewski et al., “The First Immediate Face Transplant in the World,” Annals of Surgery, 263, no. 3 (2016): e36–e39. 143Petruzzo and Dubernard, 248. 2.4 Similarities and Differences in VCA and SOT 29 over how others may experience the graft and the recipient of the graft.144 As a consequence of the psychological challenges, both for the patient and close family members, substantial psychological and psychiatric support must be provided, particularly in the first post-surgical year.145 The second way in which skin-involved VCA grafts differ from SOT grafts is in the immunological role of the skin. Of the components of a VCA graft, the skin is the most likely to be the site of acute rejection, followed by muscle, bone, cartilage and nerves.146 The presence of skin is thought to account for the much higher rate of acute rejection in upper extremity and facial VCAs, when compared to SOT. Ravindra et al., report that 85% of hand transplant recipients and almost 55% of face transplant recipients have episodes of acute rejection in the first year, compared to less than 15% of kidney transplant recipients.147 The skin involved in VCA is also helpful, however, in identifying signs of acute rejection. Whereas the identification of acute rejection in SOT requires more complex analysis, such as elevation of creatinine in kidney transplants or reduced ejection fractions in heart transplants, the skin of VCA grafts demonstrates inflammatory responses for which patients themselves can monitor. Occasionally, skin inflammation in VCA recipients may be the result of something other than acute rejection and there is a need for better diagnosis and treatment of acute rejection in the field of VCA.148 Still, the high degree of immunogenicity of skin allows it to serve a generally reliable sentinel function.149 Thus, while the rate of acute rejection episodes appears to be considerably higher in VCA, as compared to SOT, rejection episodes in VCA have tended to be more quickly identified and successfully treated. Some give credit to this sentinel function of skin for the fact that chronic rejection for immunosuppressant-compliant patients has been rare in VCA, compared to SOT.150 Others, however, have questioned this connection, noting that chronic rejection in VCA can occur without changes to the skin and they have recommended routine

144Evans, 154; Errico, Metcalfe and Platt; Foroohar, 407; Kumnig, Jowsey and DiMartini, 189– 193; Coffman and Siemionow, 184.; Morris et al., 117; Lengele, 508. 145Roche et al., 6. 146MacKay, Nacke, and Posner, 81. While traditionally thought to bemore antigenic than other tissues, Fadi Issa argues that skin is actually no more antigenic but more susceptible to rejection for other reasons. See “Vascularized composite allograft-specific characteristics of immune responses,” Transplant International Epub (2016), doi:10.1111/tri.12765. 147Ravindra et al., 1. 148Sebastian Fischer et al., “Acute Rejection in Vascularized Composite Allotransplantation,” Current Opinion in Organ Transplantation 19 (2014): 532; 541. 149Alexander et al., 62. 150Siemionow, Gharb and Rampazzo, 634–636; Errico, Metcalfe and Platt; Murphy, Zuker, and Borschel, 1451; Diaz-Siso et al., 333–335; Foroohar et al., 408; Shores, Imbriglia and Lee, 1863: Tintle et al., “Hand Transplantation,” 4–5; Evans, 153. 30 2 Vascularized Composite Allotransplantation biopsies to rule out chronic rejection whether or not signs of acute rejection are seen.151 The third way in which VCAs involving skin are different from SOTs is that the pigmentation, size, age and gender of the donor become far more relevant. Matching donor and recipient in SOT and VCA considers blood type and HLA, but in visible VCA matching must also consider how the facial graft or limb will look cosmetically, as this may influence the patient’s ability to psychologically accept the graft. Such considerations must be kept in mind by the procurement staff and the suitability of a donor match is typically evaluated by the surgical team before the donation is accepted.152 Because vascularized composite allotransplantation involves the transplantation of multiple tissue types (e.g., skin, fat, muscle, bone, nerves, ligaments, etc.) as a single unit, it differs from solid organ transplantation which is concerned with a unit that is predominantly one type of tissue. This is significant because, as Zor points out, various tissue types show “different functional and immunologic characteristics”.153 Success in VCA requires all the tissue types to be tolerated immunologi- cally and all to regain some degree of function in the recipient. VCA transplant recipients tend to be healthier overall than recipients of SOT. VCA candidates often suffer from psychological as well as physical injuries, but do not have the metabolic or physiological deficits that make others candidates for SOT.154 The fact that VCA recipients have been both healthier and younger on the whole than SOT recipients has likely contributed significantly to fewer and less severe complications being experienced in VCA recipients than in SOT recipients.155 While they may be considered less than ideal, alternative treatments do exist for VCA candidates. Autologous flaps, tissue expansion, standard skin grafting and artificial dermal xenografts exist as alternatives for the repair of facial defects.156 It should be noted that non-VCA treatment for major facial tissue defects typically involves multiple surgeries which take place over an extended period of time and

151Gerhard S. Mundinger and Cinthia B. Drachenberg, “Chronic Rejections in Vascularized Composite Allografts,” Current Opinion in Organ Transplantation 19 (2014): 313. 152Cendales, Rahmel and Pruett, 1087; Cetrulo, Jr. and Kovach, 235; Jorge A. Galvez et al., “Assessment and Planning for a Pediatric Bilateral Hand Transplant Using 3-dimensional Modeling: Case Report,” Journal of Hand Surgery (America) 41 (2016): 341. 153Zor, 157. 154Kumnig, Jowsey and DiMartini, 189; Coffman and Siemionow, 181–182; Tintle et al., “Hand Transplantation,” 7; Hautz et al., 3505; Weissenbacher et al., 641; Siemionow, Ghard and Rampazzo, 638; Murphy, Zuker, and Borschel, 1451; Foroohar et al., 408; Shores, Imbriglia and Lee, 1865. 155Pushpakumar et al., 955; Barker et al., “Research and Events,” 239; Shores, Imbriglia and Lee, 1863; Foroohar et al., 408. 156Coffman and Siemionow, 182; Zor, 156. 2.4 Similarities and Differences in VCA and SOT 31 still yield cosmetic and functional results that may be considered inferior to what is possible with VCA.157 For upper extremity VCA candidates, prostheses are an obvious and common alternative. Prostheses are fitted following the necessary residual limb reconstruction and sufficient time for healing of the soft tissue. Short-term rehabilitation follows,158 including both training in the use of the prosthesis and psychological support. Despite the discomfort and other limitations often associated with upper extremity prostheses, they permit good motor function with far less risk and cost than VCA.159 Current research in prosthetics holds out the promise of restoring sensation as well as motor function.160 However, as prosthetics become more sophisticated, the difference in costs between prostheses and VCA is likely to be significantly reduced. Attitudes toward VCA and SOT are also dissimilar. This is true of physicians as well as of the general public. Physicians remain somewhat skeptical of the field of VCA, although some improvement is being seen.161 With regard to SOT, physicians show a much higher willingness to register as donors than do members of the general population.162 By contrast, the general population is much more willing to consider face transplants than are burn and plastic surgeons involved in facial reconstruction.163

157Louis L. Nguyen et al., “Cost Analysis of Conventional Face Reconstruction versus Face Transplantation for Large Tissue Defects,” Plastic and Reconstructive Surgery Journal 135, no. 1 (2015): 260. Experience has shown that face transplant recipients, while not requiring the number or extent of surgeries of those treated with traditional means, do require “numerous revisions.” Laurent Lantieri et al., “Face Transplant: Long-term follow-up and results of a prospective open study,” Lancet, 388 (2016): 1405. 158Salminger et al., report an average of a mere 10–20 h of therapy in total for prostheses. 159Hautz et al., 3505; Tintle et al., “Hand Transplantation,” 6; Errico, Metcalfe and Platt; Klapheke et al., 457; Pribaz and Caterson, 99–107; Jensen et al., 2127; Chang and Mathes, 553–554; Salminger et al., 2. 160Brian T. Carlsen, Pat Prigge and Jennifer Peterson, “Upper Extremity Limb Loss: Functional Restoration From Prosthesis and Targeted Re-innervation to Transplantation,” Journal of Hand Therapy, epub ahead of print (2013): 1–8; Raspopovic et al. Experts anticipate substantial improvements in both control and sensory feedback will become available in the near future. See Dario Farina and Sebastian Amsüss, “Reﬂections on the present and future of upper limb prostheses,” Expert Review of Medical Devices 13, no. 4 (2016): 321–324 and Wendy K. Dean and Simon G. Talbot, “Vascularized Composite Allotransplantation (VCA) at a Crossroad: Adopting Lessons From Technology Innovation to Novel Clinical Applications,” Transplantation, Epub ahead of Print (2016), doi:10.1097/TP.0000000000001610. 161Mathes et al., 812; A.A. Bertrand et al., “Changing Attitudes toward Hand Allotransplantation Among North American Hand Surgeons,” Annals of Plastic Surgery May 2014 Supplement: S55–S60. 162Amer A. Alkhatib et al., “Physicians’ Attitude Toward Organ Donation and Transplantation in the USA,” Clinical Transplantation 28 (2014): 149; Jason Siegel, “To Be an Organ Donor, Speciﬁc Attitudes Trump General Support, Study Finds,” American Psychological Association, Accessed January 15, 2015. http://www.apa.org/news/press/releases/2014/04/organ-donor.aspx. 163David W. Mathes, Neil Kumar and Emilia Ploplys, “A Survey of North American Burn and Plastic Surgeons on Their Current Attitudes Toward Facial Transplantation,” Journal of the American College of Surgeons 208, no. 6 (2009): 1054–1055; David B. Sarwer et al., “Attitudes 32 2 Vascularized Composite Allotransplantation

A comparative international study of attitudes toward donation and toward accepting a facial graft demonstrated substantial differences between “western” countries (U.S., United Kingdom, France, Australia and Brazil) and “eastern” countries (Iraq, Japan, Singapore, Taiwan and Korea). Overall, the respondents from the “western” countries indicated more willingness to both donate and accept facial grafts.164 In a recent U.S. study undertaken to compare the willingness of the general public to donate or receive either a VCA graft or an SOT graft, there was a consistent pattern of greater reluctance regarding both donation and reception when VCA was under consideration. 85% were willing to receive a kidney, while only 60% were willing to receive a hand and just 50% were willing to receive a facial transplant. Attitudes toward donation also differed signiﬁcantly when comparing VCA and SOT. More than 75% were willing to donate kidneys, livers and hearts upon death, but only 55% were willing to donate a hand and 44% were willing to donate a face.165 The support for insurance or government programs as sources of payment was also lower for VCA than for SOT.166 A difference between VCA and SOT with particularly profound ethical implications is that while SOT is directed at preserving and extending life, and has been demonstrated to do so, VCA is aimed at improving quality of life and, due to the risks associated with surgery and prolonged use of immunosuppressants, carries a signiﬁcant risk of shortening the patient’s life.167 Susceptibility to various infections is one risk associated with conventional immunosuppression. Indeed, in spite of prophylaxis, the majority of VCA recipients have developed at least one opportunistic infection, whether viral, bacterial or fungal.168 Still other risks of immunosuppression include metabolic changes leading to renal compromise or diabetes mellitus, hypertension, gastrointestinal problems, and an increased

(Footnote 163 continued) Toward Vascularized Composite Allotransplantation of the Hands and Face in an Urban Population,” Vascularized Composite Allotransplantation 1, no. 1–2(2014): 25–28. It is acknowledged that these comparisons sometimes depend on willingness to donate, contrasted with willingness to receive. While there is nearly always a discrepancy between the rates, with willingness to donate generally lagging behind willingness to receive, in this instance this only emphasizes the disparity between physicians and the general public. 164Pearlie W.W. Tan et al., “Cultural Perspectives in Facial Allotransplantation,” Eplasty 12 (2012): 344–353. 165Sarwer et al., 25–27. Compare to Rafael Denadai et al., “Public’s Knowledge and Attitudes Toward Vascularized Composite Allotransplantation and Donation,” Aesthetic and Plastic Surgery 40 (2016): 301–308. 166Sarwer et al., 28. Compare to Sabine Wöhlke, Julia Inthorn and Silke Schicktanz, “The Role of Body Concepts for Donation Willingness. Insights from a Survey with German Medical and Economics Students,” in Organ Transplantation in a Time of Donor Shortage, Ralf J. Fox, Galia Assadi and Georg Marckmann, eds., Dordrecht: Springer, 2016: 27–49. 167Hautz et al., 3504–3509; Evans, 154–159; Shores, Imbriglia and Lee, 1865; Breidenbach et al., 1046; Siemionow and Ozturk, 256; Dickenson and Hakim, 513; Murphy, Zuker and Borschel, 6; Kumnig, Jowsey and DiMartini, 190; Coffman and Siemionow, 184–185. 168Pomahac, Gobble and Schneeberger, 11. 2.4 Similarities and Differences in VCA and SOT 33 likelihood of developing certain cancers, particularly non-Hodgkin lymphoma, Kaposi’s sarcoma, nonmelanoma skin cancers, anogenital cancers and Hodgkin lymphoma.169 A ﬁnal difference between VCA and SOT, which also has considerable ethical import, is that unlike kidneys, hearts, lungs or livers which begin to function almost immediately following transplantation, meaningful functional recovery in VCA requires intensive and time-consuming therapy.170 While thermalgesic and dis- criminatory sensitivity develop more or less spontaneously within the ﬁrst six months, motoricity is recovered over a far longer period, and only with physiotherapy which begins quite soon after surgery.171 As Kumnig, Jowsey and DiMartini note, this therapy may yield little immediate functional or sensory improvement, thereby causing discouragement in patients.172 Compliance with both immunosuppressive medication and with rehabilitation has been problematic for some VCA patients, perhaps as a result of such discouragement.173 One factor in the length of time it takes for motor function and sensation to recover is the slow progress of reinnervation.174 Pomahac, Gobble and Schneeberger report nerve regeneration in upper extremity transplantation taking from six to nine months in transplants near the wrist level, and increasingly longer as the site of attachment moves further up the extremity. Various aspects of sensory and motor reinnervation develop over time in both facial and upper extremity transplants and fall short of complete restoration.175

169Coffman and Siemionow, 182–183; Hautz et al. 3506–3507; Weissenbacher et al., 641–642; Tintle et al., 4–6 “Hand Transplantation,”; Errico, Metcalfe and Platt; Siemionow, Gharb and Rampazzo, 634–638; Shores, Imbriglia and Lee, 1864–1865; Siemionow and Ozturk, 256; Evans, 153–154; Diaz-Siso et al., 335; O’Neill and Godden, 444; Pomahac, Gobble and Schneeberger, 12; Edwards and Mathes, 120; Wo, Bueno and Pomahac, 619. The small cell lung cancer which caused the death of the first face transplant patient may or may not have been caused by immunosuppression. It is more likely the result of her heavy smoking, but the cause cannot be scientifically proven one way or the other. 170Tintle et al., “Hand Transplantation,” 6; Amer et al., 42; Murphy, Zuker and Borschel, 4; Dubernard et al., 2459; Ericka Bueno et al., “Rehabilitation following hand transplantation,” Hand 9 (2014): 9; 14; Shores, Brandacher and Lee. 171Lengele, “Current Concepts,” 515. 172Kumnig, Jowsey and DiMartini, 189. 173Pomahac, Gobble and Schneeberger, 11; Alexandra Sifferlin, “‘I can do absolutely nothing’: The first American with a double hand transplant wants them removed,” Time Magazine online at http://time.com/4419959/double-hand-transplant-surgery/. Accessed January 31, 2017. 174Siemionow, Gharb and Rampazzo, 634; Shores, Imbriglia and Lee, 1863–1864; Foroohar et al., 408; Petruzzo and Dubernard, 413; Dubernard et al., 2453–2454; Petruzzo et al., 237; Shanmugarajah, Hettiaratchy and Butler, 294–295; Breidenbach et al., 1039; Herzberg et al., 116; Hodges, Chesher and Feranda, 389–392; Dixon et al., 152–170; Infante-Cossio et al., e268; Ninkovic et al., 459–460. 175Pomahac, Gobble and Schneeberger, 5–6; M. Ninkovic et al., “Assessing the Outcome of Hand and Forearm Allotransplantation Using the Action Research Arm Test,” American Journal of Physical Medicine and Rehabilitation, 94, no. 3 (2015): 219–221. 34 2 Vascularized Composite Allotransplantation

The slow progress of nerve regeneration is a major factor in the decision by most upper extremity VCA programs to focus on below-the-elbow transplantation, and in the limited interest thus far in attempting lower extremity transplants.176 Promising work is being conducted, primarily in non-human models, on strategies to promote more rapid nerve regeneration. Schwann cells are a major focus, but mesenchymal and stromal cells are also being investigated as resources to promote nerve repair. Induced pluripotent stem cell-derived Schwann cells have the added advantage of being native to the recipient and thus not causing a rejection response. Schwann cells are otherwise highly immunogenic.177 If nerve regeneration can occur more rapidly, recipients may be encouraged by the progress and compliance with medication and therapy regimens may improve.

2.5 Practical and Ethical Concerns in the Field of Vascularized Composite Transplantation

The practical and ethical concerns associated with VCA are frequently related. Procedural, technical and medical issues raise ethical concerns, and the resolution of those issues would alleviate many of the concerns. For example, significant reduction in the risk and burden profile would lessen the concern that has arisen from subjecting patients to those risks and burdens in a surgery that is not necessary to preserve or extend life.178 While the prospects of such improvements can and should raise hope, they cannot be used to justify the practice of human vascularized composite allotransplantation now. Justification for the practice today depends on the conditions now existing. What follows is a survey of the practical and ethical concerns, as they exist at present.

2.5.1 Immunological Concerns

2.5.1.1 Rejection and the Potential for Graft Loss

Rejection of transplanted tissue is a central concern of transplantation generally, though the nature, frequency and extent of rejection vary according to the kind of

176Saami Khalifian et al., “Stem Cell-Based Approaches to Improve Nerve Regeneration: Potential Implications for Reconstructive Transplantation?” Archivum Immunologiae et Therapia Experimentalis 63 (2015): 16. 177Khalfian et al., “Stem Cell-Based Approaches,” 15–16. 178Breidenbach et al., 1046; Evans, 153–154; Weissenbacher et al., 642; Hautz et al., 3509; Siemionow, Gharb and Rampazzo, 637–638; Shores, Imbriglia and Lee, 1862–1863; Tintle et al., “Hand Transplantation,” 5–7; Ravindra et al., 1244–1245; Ravindra, Xu and Ilstadt, 3501; Errico, Metcalfe and Platt. 2.5 Practical and Ethical Concerns in the Field of Vascularized … 35 organ or tissue that is transplanted.179 As discussed above, it was not until the first effective immunosuppressants were developed that solid organ transplantation became feasible. Because of the high level of immunogenicity of skin, the feasibility of VCA involving skin did not occur until second and third generation immunosuppressants became available.180 Rejection may be hyperacute, acute or chronic. Hyperacute rejection appears minutes to hours following anastomosis. Acute rejection takes place days to months after transplantation. Chronic rejection is a slowly developing condition that damages the allograft by means of vasculopathy and fibrosis, leading to loss of function.181 The first line of defense against rejection is blood-type and HLA matching of donor and recipient, but complete matches are seldom feasible.182 Even with good adherence in the use of immunosuppression, rejection may still take place. In VCA, there have been high rates of acute rejection, especially within the first year.183 Lantieri calls it “almost inevitable”.184 In upper extremity transplantation, one source reports 85% of recipients experience at least one episode of acute rejection, while 56% experience more than one episode.185 Acute rejection in upper extremity and facial VCA typically manifests as a rash on the skin and, in the case of facial transplants, the mucosa of the mouth and nose.186 These acute rejection episodes have been quickly identified, due to the sentinel role of the skin, and have responded well to treatment, typically resolving within a short time without apparent lasting damage to the graft tissue.187 Early detection, by simple visual inspection or by means of dermoscopy, is most likely a reason for good results of treatment for acute rejection, and the generally good health of VCA patients may also factor in.188

179Heinrich and Marcangelo, 401; Hautz et al., 3506–3507; Anil Seetharam, Venkataswarup Tiriveehi and T. Mohanakumar, “Alloimmunity and Autoimmunity in Chronic Rejection,” Current Opionion in Organ Transplantation 15, no. 4 (2010): 531–536. 180Amer et al., 40. 181Ali Inal, “Immunology of Liver Transplantation,” Experimental and Clinical Transplantation 12 (2014) Suppl. 1: 3–4; Leonard et al., 269. 182Heeger and Dinavahi, 376; Ninkovic et al., 455. 183Barker et al., 239; Diaz-Siso et al., 333–334; Petruzzo and Dubernard, 248; Petruzzo et al., 810; Siemionow and Ozturk, 256; Weissenbacher et al., 643; Lantieri, 253; Lantieri et al., 372. 184Lantieri, 253. 185MacKay, Nacke and Posner, 81. 186Karim A. Sarhane et al., “A Critical Analysis of Rejection in Vascularized Composite Allotransplantation: Clinical, Cellular and Molecular Aspects, Current Challenges, and Novel Concepts,” Frontiers in Immunology 4 (2013): 2; Ravindra et al., 2. 187Lengele, 511–515; Yi and Guo, 177; Shanmugarajah, Hettiaratchy and Butler, 295; Pomahac, Gobble and Schneeberger, 10. 188Ashlin J. Alexander et al., “Arguing the Ethics of Facial Transplantation,” Archives of Facial Plastic Surgery 12, no. 1 (2010): 62; Grazyna Kaminska-Winciorek et al., “Dermoscopy in Near-full Facial Transplantation,” Journal of the American Academy of Dermatology 72, no. 1 (2015): S19–S21. 36 2 Vascularized Composite Allotransplantation

Chronic rejection in SOT is manifested by vasculopathy and fibrosis, with the organ function declining.189 In several cases of human upper extremity VCA there have been signs of chronic rejection, which often leads to graft loss in SOT.190 Signs of chronic rejection have also been present in nonhuman primate VCA models, despite the use of immunosuppressants.191 Still, chronic rejection in VCA is rare, compared to the rates seen in SOT. However, the evidence for chronic rejection is uneven, with centers such as Lyon and Innsbruck reporting none, while the University of Louisville Hand Transplant Program reported evidence in five of six recipients at one point, including one case that led to graft loss.192 The overall low rate of chronic rejection may be attributed to the relatively short history of VCA, and there is some expectation that chronic rejection will develop eventually in most VCA grafts.193 Thus far, graft loss has occurred in six upper extremity transplants in the U.S. and Europe, with four of the six being necessary because of rejection. Seven upper extremity transplants have had to be amputated in China, but problems with the availability of immunosuppression are thought to account for this.194 Graft loss would inflict additional burdens and risks upon both upper extremity and face transplant patients.195 There would be the necessary surgery to remove the graft, with risks related to anesthesia and a heightened potential for post-surgical infections. Upper extremity patients who rejected the graft and required amputation would need time to heal before they could be fitted anew with prosthetic limbs, creating a period of increased dependency on others.196 For recipients of facial transplants, graft loss would be even more devastating.197 Whereas the upper extremity patient who lost a graft might reasonably be assumed to be able to return to essentially the same condition he or she was in prior to transplant, several have noted the strong possibility that loss of a facial transplant graft would leave patients even worse off than they were before transplant.198 This would certainly be true for those who have undergone total rather than partial face transplantation, and must be weighed against the possibility that a total face

189Inal, 8. 190Barker et al., 240; Murphy, Zuker and Borschel, 1451; Ravindra et al., 2; Lees and McCabe, 751; Tintle et al., “Hand Transplantation,” 5; Shores, Imbriglia and Lee, 1862–1863; Shanmugarajah, Hettiaratchy and Butler, 295. 191Mundinger and Drachenberg, 311. 192Mundinger and Drachenberg, 310. 193Pomahac, Gobble and Schneeberger, 10; Morelon, Kanitakis and Petruzzo, 857. 194MacKay, Nacke and Posner, 82. 195Morris et al., 119; Lees and McCabe, 750; Kalliainen, 550; Hautz et al., 3507. 196Petruzzo and Dubernard, 249–250; Shores, Imbriglia and Lee, 1864. 197Siemionow and Ozturk, 257. 198Edwards and Mathes, 119; Kalliainen, 551; Strong, 1115; Agich, 135–136; Coffman and Siemionow, 182; Murphy, Zuker and Borschel, 1450; Strong, 1115–1116; Edwards and Mathes, 119. 2.5 Practical and Ethical Concerns in the Field of Vascularized … 37 transplant may give a better functional and esthetic outcome.199 Facial graft loss would require multiple procedures to repair the wound and would yield a less satisfactory outcome than pre-transplant interventions.200 Concerns have increased about chronic rejection in facial allotransplantation since the ﬁrst report of ﬁndings in 2015.201

2.5.1.2 Immunosuppression

Because rejection interferes with graft function and can lead to graft loss, immunosuppression is implemented. Immunosuppression typically takes place in three stages: the induction phase, the maintenance phase, and the rescue phase. The induction phase prepares the recipient to receive foreign tissue, which will otherwise provoke a major immune reaction. Induction involves high doses of immunosuppressives. Due to the undesirable side effects of the immunosuppressants, particularly at higher doses, the effort is made as soon as possible after surgery to shift to a lower dose maintenance phase. When there are signs of rejection, a return to higher dose immunosuppression for a limited time constitutes the rescue phase.202 Immunosuppression regimens in both SOT and VCA vary because research has yet to clearly identify best practices, even in renal transplantation, the form of SOT with the longest history and greatest number of transplants attempted. Most often, however, a combination of an induction antibody, calcineurin inhibitor, an antiproliferative drug and a steroid is used.203 Commonly used immunosuppression in VCA includes rituximab, tacrolimus, mycophenolate mofetil and prednisolone.204 Medications are usually taken orally or intravenously but topical application is also used, especially in acute rejection where skin is involved, and

199J.P. Barrett, “From Partial to Full-Face Transplantation: Total Ablation and Restoration, A Change in the Reconstructive Paradigm,” International Journal of Surgery 12, no. 2 (2014): 109– 112. 200O’Neill and Godden, 444. 201Palmina Petruzzo et al., “Clinicopathological Findings of Chronic Rejection in a Face Grafted Patient,” Transplantation 99, no. 12 (2015): 2644–2650; Mundinger and Drachenberg, 312. 202Zor, 160; Aditi Gupta, Sean Kumer and Bruce Kaplan, “Novel Immunosuppressive Strategies for Composite Tissue Allografts,” Current Opinion in Organ Transplantation 19 (2014): 554. 203Iain A.M. MacPhee and Teun van Gelder, “Immunosuppression,” ed. by Iain MacPhee and Jiri Fronek, The Handbook of Renal and Pancreatic Transplantation, Hoboken: Wiley-Blackwell, 2012: 243; Shanmugarajah, Hettiaratchy and Butler, 295; Chad R. Gordon et al., 310; Ravindra et al.; Murphy, Zuker and Borschel; Diaz-Siso et al., 331–333; MacKay, Nacke and Posner, 80. 204Morelon, Kanitakis and Petruzzo, 858; Leonard et al., 268; Siemionow and Ozturk, 256; Leonard, Kurtz and Centrulo, Jr., 645–646; Murphy, Zuker and Borschel, 3; Tintle et al., “Hand Transplantation,” 3–4; Infante-Cossio et al., e268; Lantieri, 253; Lengele, 511; Shores, Imbriglia and Lee, 1862–1863; Hautz et al., “World Experience,” 429; Breidenbach et al., 1045; Schuind et al., 375; Leonard et al., 268; Karoline Edtinger et al., “Current Status of Vascularized Composite Tissue Allotransplantation,” Burns and Trauma 2, no. 2 (2014): 54–55; Khalifan et al., “Facial Transplantation,” 2153. 38 2 Vascularized Composite Allotransplantation this therapy has proven effective.205 Other forms of immunosuppression used in VCA include irradiation of the graft, extracorporeal photopheresis, IgC infusion and donor iliac crest bone marrow cell infusion.206 While useful for preventing or delaying rejection, immunosuppression does carry with it substantial risk of complications, such as opportunistic infections, malignancies, new onset diabetes after transplant, nephrotoxicity, hypertension, neurotoxicity and other problems.207 Some of these, either singularly or in combination, may in time lead to the death of the recipient. A recent study out of Poland showed signiﬁcant pathological changes in cardiac structures in a small sample of hand transplant recipients. These changes included arterial wall changes and endothelial dysfunction. The researchers concluded that hand transplantation puts recipients at higher risk for cardiovascular disease.208 Research continues into ways to avoid, withdraw or minimize immunosuppression, so that side effects may be avoided or lessened, with a focus on single agent maintenance therapy and steroid-free immunosuppression.209 Still, at present withdrawal of immunosuppressive therapy predictably results in the loss of the graft.210 While the side effects of the immunosuppressants used in VCA are predominantly negative, there is an important exception. Calcineurin inhibitors (CNIs) interfere with the function of an enzyme that is involved in T-cell production. The two CNIs employed in transplant immunosuppression are ciclosporin and tacrolimus. Tacrolimus is the more popular of the two, despite the fact that it is more likely to contribute to the development of diabetes post-transplant.211 Tacrolimus is

205Siemionow and Ozturk, 256; Yi and Guo, 178; Petruzzo and Dubernard (2011), 248; Leonard et al., 268. 206Saami Khaliﬁan et al., “Facial Transplantation,” 2153. Kaufman et al., “Immunobiology in VCA,” suggest that vascularized bone marrow offers “prolonged survival” of grafts in animal models, though the mechanism is not yet proven. 207MacPhee and van Gelder, 254; Leonard et al., 270; Tintle et al., “Hand Transplantation,” 4; Lantieri, 252; Bohdan Pomahac et al., “Three Patients with Full Facial Transplantation,” The New England Journal of Medicine 366, no. 8 (February 23, 2012): 719–721; Yi and Guo, 177; Lantieri, 252; Shanmugarajah, Hettiaratchy and Butler, 295; Barker et al., “Research and Events,” 240; Lantieri et al., 375; Siemionow and Ozturk, 256; Lengele, 517; T. Hautz et al., “How Reconstructive Transplantation is Different,” 3508; Shores, Imbriglia and Lee, 1864; Hautz et al., “World Experience,” 429; Foroohar et al., 406; Petruzzo and Dubernard (2011), 249; 252; Edwards and Mathes, 120; Harriet O’Neill and Daryl Godden, “Ethical Issues of Facial Transplantation,” British Journal of Oral and Maxillofacial Surgery 47 (2009): 444; Chang and Mathes, 554; Alexander et al., 61; Morelon, Kanitakis and Petruzzo, 858; Errico, Metcalfe and Platt; Roche et al. 8. 208M. Boratynska et al., “Impact of Immunosuppression Treatment on the Cardiovascular System in Patients After Hand Transplantation,” Transplantation Proceedings 46 (2014): 2890–2893. 209Siemionow and Ozturk, 257; Siemionow, Gharb and Rampazzo, 637. 210Heeger and Dinahavi, 376; Ravindra, Xu and Ilstadt, 3501; Shores, Imbriglia and Lee, 1865; Pomahac et al., 715; Breidenbach et al., 1046; Ninkovic et al., 455; Foroohar et al., 406–407; J.E. Janis et al., “Management of Steroid-resistant Late Acute Cellular Rejection Following Face Transplantation: A Case Report,” Transplantation Proceedings 47 (2015): 224–225. 211MacPhee and van Gelder, 251–255, Smeets et al. 2.5 Practical and Ethical Concerns in the Field of Vascularized … 39 particularly popular with VCA transplant teams because in addition to suppressing the mechanisms of rejection, it also promotes more rapid nerve regeneration.212 When the side effects of tacrolimus on the renal system are judged too great or there are signs of vasculopathy, a switch may be made to sirolimus. Sirolimus is not a CNI but has a similar suppressive effect.213

2.5.1.3 Tolerance Induction

Minimization of the use of immunosuppression, in order to lessen the toxic side effects, will continue to be a focus in both VCA and SOT. Ideally, transplant teams would like to eliminate the need for immunosuppression altogether.214 One avenue to minimization and perhaps even the elimination of immunosuppressants is tolerance induction.215 Heeger and Dinahavi define tolerance as a state in which “the immune system does not respond to the transplant but is otherwise fully functional in the absence of immunosuppression”.216 Ravindra et al., are correct in saying that if and when tolerance induction in humans is accomplished, it will be “transformational” for the field of transplantation.217 This is especially true for VCA, since the procedure does not offer the benefit of extending life, as in the case of SOT. Some have even described tolerance induction as “a necessity for wider application of” certain forms of VCA.218 A variety of means of inducing tolerance have been imagined and several are being studied. It has been hoped that the inclusion of bone in some VCAs might prompt chimerism, or a hybrid immune system, as currently takes place with bone marrow transplantation. Some have gone further by using donor bone marrow infusion with VCA patients in an attempt to produce tolerance. While tolerance per se has not been achieved, it has permitted low dose tacrolimus monotherapy.219 Such infusions carry their own risks, however, including graft versus host disease.220 Huang et al., list several other possible methods of inducing tolerance,

212Siemionow, Gharb and Rampazzo, 1885; Dwyer et al., 286; Morelon, Kanitakis and Petruzzo, 858. 213Petruzzo et al., “First Human Face Transplant,” 240. 214Wang et al., “Role of Donor-Speciﬁc Regulatory T Cells in Long-Term Acceptance of Rat Hind Limb Allograft,” PLOS One 7, no. 8 (2013): 1–2. 215Pushpakumar, 956; Lantieri, 253; Shanmugarajah, Hettiaratchy and Butler, 296; Lengele, 514– 515; Heeger and Dinavahi, 385; Huang et al.; Murphy, Zuker and Borschel; Edtinger et al., 56–57. 216Heeger and Dinahavi, 385. 217Ravindra et al., 4. Errico, Metcalfe and Platt describe it as “the holy grail of transplantation surgery”. 218Maria Koulmanda et al., “Hand Transplants and the Mandate for Tolerance,” Current Opinion in Transplantation 19, no. 6 (2014): 546. 219Leonard et al., 270; Ravindra et al., 6; Tintle et al., “Hand Transplantation,” 5. 220Leonard et al., 5; Lantieri, 253; Leonard, Kurtz and Cetrulo, 647; Ravindra, Xu and Ilstadt, 3501. 40 2 Vascularized Composite Allotransplantation including T-cell depletion, costimulation blockade and the infusion of mesenchymal stem cells from the donor or even from a third party.221 Some animal studies have shown promise. Work with both small animals (mice and rats) and large animals (canines, swine and non-human primates) continues. An immunoablative approach, in which the recipient undergoes bone marrow transplantation, has produced chimeric tolerance in some animal models.222 Thus far, however, tolerance induction in VCA has repeatedly been achieved in small animals, but far less often in larger ones.223 There have been SOT patients who have demonstrated spontaneous tolerance. A number of the very early renal transplant recipients maintained their grafts after ceasing immunosuppression, in one case for as long as thirty years. A liver recipient with apparent tolerance has retained the transplant for sixteen years, immunosuppressive-free. In 1992, donor leukocyte chimerism was detected in the kidney transplant patients who had demonstrated spontaneous tolerance.224 Yet, while the animal research is promising and the instances of human graft tolerance in some SOT recipients are suggestive, routine induction of tolerance in human SOT or VCA remains elusive.

2.5.2 Psycho-Social Issues

2.5.2.1 Patient Motivation

The nature and extent of motivation for undergoing VCA is assessed as part of the screening process. For facial transplant candidates, motivations are often grounded in both functional limitations and aesthetic concerns. A desire to be able to eat and breathe normally, to regain olfactory sensation, and to be able to communicate with facial expression is often voiced, as is the desire for aesthetic restoration that will

221Huang et al., 3–4. See also Ravindra et al., 4–8. 222Heeger and Dinahavi, 385. 223Ravindra et al., 3–4; Leonard et al., 5. Success has been seen in human renal transplant patients, according to Leonard et al., 270. Signs of progress are being seen quite recently, however. See D.A. Leonard et al., “Vascularized Composite Allograft Tolerance Across MHC Barriers in a Large Animal Model,” American Journal of Transplantation 14, no. 2 (2014): 343–355; R. Jindal et al., “Spontaneous Resolution of Acute Rejection and Tolerance Induction with IL-2 Fusion Protein in Vascularized Composite Allotransplantation,” American Journal of Transplantation 15, no. 5 (2015): 1231–1240. 224Wallace et al.; Starzl and Barker, 6–10; Sheng-Li Wu and Cheng-En Pan, “Tolerance and Chimerism and Allogeneic Bone Marrow/Stem Cell Transplantation in Liver Transplantation,” World Journal of Gastroenterology 19, no. 36 (2013): 5981–5982; Starzl et al., “The Future of Transplantation: With Particular Reference to Chimerism and Xenotransplantation,” Transplant Proceedings 29 (1997): 19–20. 2.5 Practical and Ethical Concerns in the Field of Vascularized … 41 allow for more normal social interaction.225 For some upper extremity transplant candidates, motivation may be focused on gaining the ability to perform occupational tasks or activities of daily living. For others, the chief motivation is based in aesthetic or bodily integrity concerns, or a desire for sensation.226 Martin Klapheke and colleagues found that a number of individuals who had experienced upper extremity loss had continued to participate in a wide range of physical activities, from scuba diving and martial arts to sewing and playing a guitar, yet these persons still expressed interest in upper extremity transplantation.227 However, others who by reason of the extent of defect would be candidates for VCA are not interested, even before they are made aware of the burdens and risks involved.228 Most persons using upper extremity prostheses are not fully satisﬁed with them. Common complaints include the weight, the functional limitations, and especially the lack of sensation, with thirty percent of upper limb amputees rejecting the use of prostheses, with the rate of prosthesis rejection increasing as the level of amputation becomes more proximal.229 Nonetheless, dissatisfaction with prostheses does not translate directly into a willingness to undergo VCA. It remains unclear why some with major facial defects or missing limbs are motivated to pursue VCA while others are not. Some people ﬁnd conventional methods of reconstruction acceptable and are able to adapt well physically and psychologically, while others of equal or lesser defect do not.230 The subjective perception of the defect and its effect on quality of life seem to matter more than an objective evaluation of the extent of the defect.231

225Christine Wo, Ericka Bueno and BohdanPomahac, “Facial transplantation: worth the risks? A look at the evolution of indications over the last decade,” Current Opinion in Organ Transplantation 20:6 (2015): 615–616; Alexander et al., 61; Petruzzo and Dubernard, 251–252; Kalliainen, 549. 226Kumnig, Jowsey and DiMartini, 189: Hautz et al., “World Experience,” 425; Ninkovic et al., 463. Salminger et al., point out that unilateral amputees tend to be motivated primarily by psychological issues, while bilateral amputees are more interested in improved functionality. 227Klapheke et al., 455. 228Alexander et al., 61. 229Tintle et al., “Hand Transplantation,” 1; Jenson et al., 2127; Klapheke et al. 455–456; Hautz et al. 3505. Tintle et al., “Traumatic and Trauma-Related Amputation,” 2939–2940, note that transradial amputees reject prostheses only 20% of the time or less. 230Barker et al., 71; Nichola Rumsey, “Psychological Aspects of Face Transplantation: Read the Small Print Carefully,” The American Journal of Bioethics 4, no. 3 (2004): 22; Furr et al., 561; Gardiner et al., “Differential Judgements About Disﬁgurement: The Role of Location, Age and Gender in Decisions Made by Observers,” Journal of Plastic, Reconstructive and Aesthetic Surgery 63 (2010): 73–74. 231O’Neill and Godden, 444; Edwards and Mathes, 114, Evans, 154; Eileen Bradbury, “Meeting the Psychological Needs of Patients with Facial Disﬁgurement,” British Journal of Oral and Maxillofacial Surgery 50 (2012): 194; Clarke and Butler, 1090; Hurlburt, RA148–RA151; Henry, 280. 42 2 Vascularized Composite Allotransplantation

Subjective evaluations may also change over time.232 Renshaw et al., contend that for those whose defect is the result of trauma, distance in time from the traumatic event may play a significant role in the level of motivation. They cite research that indicates people are more willing to take risks to erase a loss than they are to achieve a gain. When the traumatic event is recent, a person is more likely to view VCA as a means to erase the loss. After time passes, however, and the person makes some adaptations, he or she is more likely to view VCA as a means to gain a better life.233 Based on this analysis, it may be wise to allow time following injury for the individual with the defect to find a stable level of motivation.234 That the degree of defect does not seem to be determinative suggests that repair of the defect by means of VCA may not be the only way to address and potentially remedy the suffering that motivates individuals to accept the burdens and risks associated with VCA. Research is available regarding the factors that contribute to the ability to adapt and possible methods for promoting adaptation and acceptance, and this research should be more fully integrated into VCA research programs.235 A number of models and methods have proven helpful to some patients with visible difference, either through attempts to desensitize the disfigured person to the reactions of others or through the development of new social skills, or some combination of both approaches. As Norman and Moss note, while further research into the efficacy of various methods is needed, “the techniques themselves are still important”.236 Organizations, such as Changing Faces in the United Kingdom and similar groups elsewhere, may have resources and experience that can be considered in the process of informing candidates for VCA of their alternative treatment options.237 Also, in light of the fact that degree of defect does not correlate with motivation, some have expressed concern that motivation may at times verge on desperation, and thus compromise the ability of the VCA candidate to fully understand and

232Morris et al., 115. 233Renshaw et al., 864. 234Hautz et al., “World Experience,” 426. See also M. Dumont, L. Sann and A. Gazarian, “Bilateral hand transplantation: Supporting the patient’s choice,” Journal of Plastic, Reconstructive and Aesthetic Surgery 70:2 (2017): 148–49. 235Nichola Rumsey and Diana Harcourt, “Body Image and Disfigurement: Issues and Interventions,” Body Image 1 (2004): 83–97; Alyson Bessell and Timothy P. Moss, “Evaluating the Effectiveness of Psychosocial Interventions for Individuals with Visible Differences: A Systematic Review of the Empirical Literature,” Body Image 4 (2007): 227–238; Bradbury, 193– 196; Morris et al., 115; Clarke and Butler, 1090–1091; Cassandra S. Crawford, “Body Image, Prostheses, Phantom Limbs,” Body and Society, epub ahead of print (2014): doi:10.1177/ 1357034X14522102; A. Norman and T.P. Moss, “Psychosocial interventions for adults with visible differences: a systematic review,” Peerj Preprints 2:e617v1 (2014). Accessed January 15, 2015. http://dx.doi.org/10.7287/peerj.preprints.617v1. 236Norman and Moss. 237Information about Changing Faces is available at https://www.changingfaces.org.uk/Home. 2.5 Practical and Ethical Concerns in the Field of Vascularized … 43 rationally weigh the information provided about the procedure, particularly the information regarding benefits, burdens and risks.238 As Bradbury puts it, patients may listen “through a filter of hope and distress”.239 The powerful emotions that may be experienced by those who learn of the VCA option have been described in the literature.240 Motivation levels that are extreme do raise concern. Coffman and Siemionow report that ideal patients are less socially avoidant and tend to believe that disfigurement does not inevitably preclude happiness.241

2.5.2.2 Identity

Upper extremity and facial VCA have raised concern and debate over the psychological impact of the transfer of visible tissue and its effect on the recipient’s sense of identity. While more of the concern and debate has centered on facial transplantation, and reasonably so given the greater link between personal identity and the face,242 upper extremity transplantation must also wrestle with the implications of “what it means to… wear and use someone else’s hand”.243 Both limbs and faces which are transplanted are readily recognizable as “other”.244 The role of identity, or more precisely the patient’s ability to identify with the donor limb, came to the fore early in the history of clinical limb transplantation. The ﬁrst recipient of a hand eventually asked for it to be removed, claiming a sense of alienation from it.245 It has since become clear that integrating the graft into one’s sense of self is no easy task. It involves adjustment over time that is mediated in part through the patient’s interaction with others and with objects.246 Psychological screening to determine whether or not a candidate is likely to be able to integrate the donor limb into his or her sense of self has become standard.247 Most problems with

238R. Huxtable and J. Woodley, “Gaining face or losing face? Framing the Debate on Face Transplants,” Bioethics 19 (2005): 510–513. See also the response from Kiwanuka et al., 1563– 1564; and Freeman and Jaoude, 77–78; Strong, 13; Coffman and Siemionow, 182; Diane Perpich, “Vulnerability and the Ethics of Facial Tissue Transplantation.” Journal of Bioethical Inquiry 7, no. 2 (2010): 175–176. 239Bradbury, 195. 240Klapheke et al., 455. 241Coffman and Siemionow, 374. See also Furr et al., 562–563. 242Francoise Baylis, “A Face is Not Just Like a Hand,” The American Journal of Bioethics 4, no. 3 (2004): 30–32. 243Kumnig, Jowsey and DiMartini, 189. 244Lengele, 518; Catsanos, Rogers and Lotz. See also Jenny Slatman, Our Strange Body: Philosophical Reflections on Identity and Medical Interventions (Amsterdam: Amsterdam University Press, 2015): esp. 76–82 and 110–114. 245Jenny Slatman and Guy Widdershoven, “Hand Transplants and Bodily Integrity,” Body and Society 16, no. 3 (2010): 69–92; Errico, Metcalfe and Platt. 246Errico, Metcalfe and Platt; Crawford, 20. 247Chang and Mathes, 556–557. 44 2 Vascularized Composite Allotransplantation the ability to identify with the engrafted limbs occur early on, before there is significant return of sensation or motor function. Improvement in function promotes acceptance of the limb as part of the subject, rather than as an object. As time passes and function develops, identification improves and in hand transplantation overall it has been excellent.248 Kiwanuka et al., in their excellent review of the history of ethical debate related to facial VCA, note that much of the early concern regarding face transplantation had to do with the prospect of identity transfer between the donor and recipient.249 One commentator even suggested that facial transplantation would simply be “to replace one disfigurement by another”.250 The level of concern in this area has decreased substantially with clinical experience, as the degree of resemblance between donor and recipient has not been great.251 Adaptation to the facial graft and identification with the graft has been very good overall.252 Part of the reason may be that recipients typically feel they have lost their former identity through the defect and have been alienated from their disfigured pre-transplant faces in this respect. Thus, though the graft is not a restoration of the original face, it is a restoration of a face and replaces the identity that was lost.253 Slatman and Widdershoven insightfully observe that the process of identification with the graft is “not merely subjective, but rather intersubjective.” That is to say, the patient’s ability to identify with the graft is determined in part by the response to the graft by others, especially those in close relationship with the recipient. Loved ones also must adjust to the transplant, which may play an essential role in the expression of intimacy, such as a kiss from the lips of a facial graft or a caress with the hands of an upper extremity transplant.254 Assessments of social support in the process of screening candidates need to assess not merely the level of general

248Chang and Mathes, 556–557; Amer et al., Pomahac, Gobble and Schneeberger, 11; Kumni, Jowsey and DiMrtini, 191; Breidenbach et al., 1043–1044; Klapheke et al., 456. 249Murphy, Zuker and Borschel, 1450. 250Kay Toombs, cited in Freeman and Jaoude, 79. 251Kiwanuka et al., 1558–1563; Shanmugarajah, Hettiaratchy, and Butler, 295; Evans, 154; Siemionow, Gharb and Rampazzo, 636; Bueno, Diaz-Siso and Pomahac, 1576; Edwards and Mathes, 117; Alexander et al., 62; Agich and Siemionow, 707–708. 252Yi and Guo, 178; Infante-Cossio et al., e269. 253Barker et al., “Patient Expectations,” 71; Johnson and Corsten; O’Neill and Godden, 444; Barker et al., “Research and Events,” 243. For a compelling description of the experience of alienation from the body both pre- and post-transplant, see Jean-Luc Nancy, “The Intruder,” in Corpus: Perspectives in Continental Philosophy, Richard A. Rand, trans., Bronx: Fordham University Press, 2008: 161–170. For a treatment of the essay, see Perpich, 178–180. 254Donna Dickenson and Guy Widdershoven, “Ethical Issues in Limb Transplants,” Bioethics, 15, no. 2 (2001): 122–123; Slatman and Widdershoven, 74–75; 87–88; Crawford, 2; Kumnig and Jowsey-Gregoire, 93. Fay Bound Alberti also notes the signiﬁcance of intersubjectivity in the experience of the ﬁrst face transplant recipient. “From Face/Off to the face race: the case of Isabelle Dinoire and the future of the face transplant,” Journal of Medical Humanities Online First (2016), doi:10.1136/medhum-2016-011113. 2.5 Practical and Ethical Concerns in the Field of Vascularized … 45 support but also the capacity of those in the support system to accept the graft and interact with the patient and graft after engraftment.

2.5.2.3 Patient Selection

Patient screening and selection is widely regarded as critical to the success of VCA.255 Candidates must qualify in terms of the extent of the defect and the degree to which it is amenable to transplant, as well as on the basis of psychological stability, appropriate motivation, cognitive function, compliance history, attitude toward risk and social support.256 Jaimie T. Shores gives a very thorough description of the screening for hand transplant candidates at the Johns Hopkins University School of Medicine program. He begins with the initial contact from the patient, describes the initial visit and subsequent screening visit, lists screening test panels and consultations, and describes the psychiatric, psychological and social screening.257 Chad R. Gordon et al., outline their “FACES” tool for selecting face transplant candidates at the Cleveland Clinic, offering both inclusion and exclusion criteria.258 Various methods are used at different institutions to determine whether or not candidates are qualiﬁed, in part due to limited research into which factors are good predictors of outcome.259 In 2014, the Chauvet Workgroup, composed of specialists in surgery, medicine, psychiatry, psychology, social work and ethics, was formed to address the question of what factors should be considered in screening and what weight should be given to various factors in light of outcomes thus far.260 Up to this time, screening and evaluation have eliminated a large percentage of interested candidates. Chang and Mathes report that the Louisville program inter- viewed 213 candidates and approved only nine, while an Italian program approved

255Agich and Siemionow, 708–709; Edwards and Mathes, 114; Johnson and Corsten, 275; Bueno, Diaz-Siso and Pomahac, 1573–1574; Kiwanuka et al., 1563–1564; Pomahac, Gobble and Schneeberger, 5; Gordon et al., 312; Kaufman et al., 653; l. Allen Furr et al., “Psychosocial Implications of Disfigurement and the Future of Human Face Transplantation,” Plastic and Reconstructive Surgery 120, no. 2 (2007): 563; Bohdan Pomahac et al., “Facial Transplantation and Immunosuppressed Patients: A New Frontier in Reconstructive Surgery,” Transplantation 85, no. 12 (2008):1694; Hautz et al., “Update on Innsbruck Program,” 425; S. Khalifian et al., “Facial Transplant,” 2160. 256Edwards and Mathes, 114–115; Klapheke et al., 453–457; Breidenbach et al., 1041; 1046; Chang and Mathes, 558; Samuel Taylor-Alexander, “On Face Transplantation,” Anthropology Today 29, no. 1 (2013): 13–16; Shores, Imbriglia and Lee, 1865; Renshaw et al., 865; Losee, Fletcher and Gorantla, 261–263; Wo, Bueno and Pomahac, 617. 257Jaimie T. Shores, “Recipient Screening and Selection: Who is the Right Candidate for Hand Transplantation,” Hand Clinics 27 (2011): 539–543. 258Chad R. Gordon et al., 1969–1974. 259Kumnig, Jowsey and DiMartini, 190.; Gordon et al., 312. 260Jowsey-Gregoire et al. 46 2 Vascularized Composite Allotransplantation only four out of more than five hundred.261 Psychosocial characteristics sought in candidates include assertiveness, excellent social support, a strong sense of self, optimism, self-awareness and conscientiousness.262 Physical characteristics sought include the absence of chronic infections, active cancers, serious coronary artery disease and various metabolic diseases.263 In upper extremity VCA, tissue loss through sharp amputations are preferred to those from crush injuries, and more distal amputations are preferred to more proximal ones.264 In face transplantation especially, it is appropriate to also assess the patient for sufficient reconstructive options in the event of graft failure.265 Patients are selected very carefully for a number of reasons. First, the surgery and subsequent rehabilitation are demanding and the failure to adhere to the physiotherapeutic or immunosuppressant regimens will result in very poor outcomes, including failures in which grafts will need to be removed.266 Second, donor tissues seldom become available, represent a significant sacrifice on the part of donor families, and thus should be allocated only to recipients who give strong evidence that they will honor the sacrifice of the donor family through effort and adherence.267 Finally, in a relatively new area of research, early failures can do great harm to the prospects of the field.268

2.5.2.4 Psychological Consequences of Graft Loss

VCA patients are always susceptible to graft loss, due to chronic rejection, infection or other causes. Thus far, there has been only one total graft loss and one partial graft loss in facial transplantation, though there have been several total losses in upper extremity transplantation.269 It has even been recommended, with regard to upper extremity transplants, that prospective patients be advised of the “possibility in the long run of chronic rejection of hands that would be theirs only

261Chang and Mathes, 557. 262Furr et al., 563; Coffman and Siemionow, “ Psychological Outcomes,” 374; Pushpakumar et al., 954; Lantieri, 251; Tintle et al., “Hand Transplantation,” 2; Hautz et al., “How Reconstructive Transplantation is Different,” 3505. For psychological contraindications, see Coffman and Siemionow, “Ethics of Facial Transplantation Revisited,” Psychosomatics 54, no. 4 (2013): 185; Lantieri, 251; N. Roche et al., “Long-term multifunctional outcome and risks of face vascularized composite allotransplantation,” 2045. 263Losee, Fletcher and Gorantla, 260–261; Shores, 541–542. 264MacKay, Nacke and Posner, 77. 265Coffman and Siemionow, “Psychological Outcomes,” 374; Vercler, 379–380. 266Edwards and Mathes, 115; Bueno, Diaz-Siso and Pomahac, 1575; Evans, 153; Shanmugarajah, Hettiaratchy and Butler, 296; Salminger et al., 4. 267Bueno et al., 256; Weissenbacher et al., 641. 268Shores, 539; Siemionow, Gharb and Rampazzo, 638; Dean and Talbot. 269Siemionow, Gharb and Rampazzo, 633–639; Pomahac, Gobble and Schneeberger, 11; Siemionow and Ozturk, 254; Clarke and Butler, 1097; Tintle et al., “Hand Transplantation,” 5; E. Morelon et al., “Face Transplantation: Partial Graft Loss of the First Case Ten Years Later”. 2.5 Practical and Ethical Concerns in the Field of Vascularized … 47 temporarily”.270 While loss of upper extremities would certainly have negative psychological effects upon the patient, these would be somewhat mitigated by the relatively straightforward reconstructive options and the existence of a return to prostheses use as an option. The loss of a facial graft, however, would likely have a far more profound psychological impact.271 Loss of the graft would return patients to a state of disﬁgurement and functional limitations equal to or greater than that experience after the original trauma or at the worst point of the disease process that led them to seek out the surgery. Reconstruction after the loss of a facial graft, if possible, would be difﬁcult, requiring multiple surgeries.272 Psychological impact after facial graft loss would also tend to be greater than that after upper extremity graft loss because the face plays a much larger role in one’s sense of identity and in the manner one presents one’s self to the world.273

2.5.3 Procurement and Allocation Concerns

In both Europe and the United States, regulations for the procurement and allocation of organs differ from those regarding tissues.274 As noted earlier, this has influenced the transition in name for the field from composite tissue allotransplantation to vascularized composite allotransplantation.275 In the United States, VCAs have been redefined as organs and the process is underway to develop regulations for procurement and allocation under the oversight of the Organ Procurement and Transplantation Network.276 VCA grafts are also treated as organs by law in France.277 Because the retrieval of upper extremity and facial grafts is much more disfiguring for donors than the retrieval of solid organs, it is anticipated that the strict enforcement of first person consent rules as they apply to solid organs will not be appropriate for these new grafts.278 There is concern that a procurement approach which is too aggressive might decrease overall organ donation levels.279 The small

270Dumont, Sann and Gazarian, 148. 271Zor, 161. 272Lantieri et al., 376; Siemionow and Ozturk, 257; Edwards and Mathes, 119. 273Baylis, 31; Agich and Siemionow, 708; O’Neill and Godden, 443–444; Alexander et al., 62–63; Perpich, 173–178; F. Svenaeus, “Organ Transplantation and Personal Identity: How Does Loss and Change of Organs Affect the Self?” Journal of Medicine and Philosophy 37, no. 2 (2012): 154. 274Schneeberger, Morelon and Landin, 1088–1089. 275See note 38. 276McDiarmid, 665–666. The recognition of VCA grafts as organs was recommended by many, including Cendales, Rahmel and Pruett, 1086. 277Cendales, Rahmel and Pruett, 1086. 278McDiarmid, 667–668; Lantieri et al., 375. 279Chong and Pruett, 1371. 48 2 Vascularized Composite Allotransplantation number of approved candidates for facial and upper extremity VCAs at this time has made the development of regional or national allocation systems impractical, but if the scale of VCA were to increase greatly, such systems would become workable and valuable.280 Another concern related to procurement is the necessarily disfiguring effect of graft recovery. While both facial and upper extremity graft recovery is disfiguring for the donor, the recovery of facial grafts is far more disfiguring. In facial VCA, some attempt to restore the donor face for viewing by next-of-kin or simply out of respect for the dignity of the donor has become standard. In some countries it is even a legal requirement.281 Most attempts to restore donor faces have consisted of the creation of a mask by fairly traditional means, using acrylic resins or silicone and the skills of a maxillofacial prosthetics technician or an anaplastologist to match skin color. New methods involving digital imaging and 3-D printing are being explored and are likely to play a larger role in the future.282

2.5.4 Financial Costs

The ﬁnancial cost associated with facial and upper extremity VCAs is substantial, though it has received little attention in the literature.283 A full accounting must consider not only the costs of the surgery itself but also the costs involved in screening both accepted and rejected candidates, costs incurred in procurement of the graft, the costs of post-surgical therapy which may last for years, lost work, the cost of immunosuppressants for the remainder of the patient’s life unless the graft is removed, and the cost of treating the side effects of immunosuppression, such as diabetes and hypertension.284 Success in the effort to induce tolerance could have a major effect on costs, since the cost of immunosuppressants is estimated to be over half the total.285

280Kiwanuka et al., 1566; Weissenbacher et al., 641; Evans, 152; Cendales, Rahmel and Pruett, 1087. 281Gerald T. Grant et al., “Restoration of the Donor Face After Facial Allotransplantation: Digital Manufacturing Techniques,” Annals of Plastic Surgery 72, no. 6 (2014): 720. 282Grant et al., 720–724. Galvez et al., 343, report the use of 3-D modeling and printing for replacing the limbs of the pediatric donor of hands in a surgery which took place in 2015. 283Gaoussou Toure et al., “Facial Transplantation: A Comprehensive Review of the Literature,” Journal of Oral and Maxillofacial Surgery 64 (2006): 790; Siemionow, Gharb and Rampazzo, 636–637. In addition, this author’s own extensive research identiﬁed only one primary source regarding the cost of hand transplantation. 284Chang and Mathes, 557; Kevin C. Chung et al., “An Economic Analysis of Hand Transplantation in the United States,” Plastic and Reconstructive Surgery 125, no. 2 (2010): 591– 593; Tintle et al., “Hand Transplantation,” 6. 285Chung et al., 593. 2.5 Practical and Ethical Concerns in the Field of Vascularized … 49

Chung et al., estimated the estimated the lifetime costs of a single hand transplant to be $528,293 and the cost of a bilateral transplant to be $529,315. This may be compared to costs for treatment by means of prostheses at $20,653 and $41,305.286 Siemionow, Gharb and Rampazzo offer a much lower ﬁgure for the cost of facial transplantation, though it is not clear whether their accounting includes everything that Chung et al., included in their accounting of the costs of upper extremity transplants. Siemionow, Gharb and Rampazzo do note a differential in cost for face transplants between the United States and Europe, with European costs being roughly seventy-nine percent of U.S. costs.287 Some attempt has been made to evaluate the value of facial and upper extremity VCA in terms of expense per quality-adjusted life years (QALYs) . However, given that the economic costs remain uncertain, these attempts are subject to criticism. The evaluations are also subject to criticism because the quality of life measure was based on estimates by a survey of medical students who were not representative of the general population, and certainly not of the persons bearing defects which would make them potential candidates for VCA.288 More focused work on assessing the effect of VCA on quality of life is needed.289 Currently the ﬁnancial costs of VCA are not imposed on the patient or the patient’s insurance. Institutions performing the procedure have carried the cost, aided by research grants and other sources of income.290 Should facial or upper extremity transplant programs continue, there is a concern over whether insurance companies or government health care systems will be willing to bear the expense.291 Indications thus far have been that this is unlikely. A recent attempt to get a hand transplant covered in Switzerland was denied by a Swiss health technology assessment.292 If insurance companies or governments do not bear the cost, facial and upper extremity VCA would almost certainly continue to be rare.

286Chung et al., “Economic Analysis,” 593. In response to the original article by Chung et al., one correspondent argued that they had severely underestimated the lifetime costs of hand transplantation. See Matthew J. Concannon, “Discussion: An Economic Analysis of Hand Transplantation in the United States,” Plastic and Reconstructive Surgery 125, no. 2 (2010): 599– 600. 287Siemionow, Gharb and Rampazzo, 636. 288Chang and Mathes, 557–558; Tintle et al., “Hand Transplantation,” 7; Shores, Imbriglia and Lee, 1865; Errico, Metcalfe and Platt; Edwards and Mathes, 121. 289Mario A. Aycart et al., “Quality of Life after Face Transplantation: Outcomes, Assessment Tools, and Future Directions,” Plastic and Reconstructive Surgery 139:1 (2017): 194–203. 290Edwards and Mathes, 121; Shores, Imbriglia and Lee, 1865. 291Edwards and Mathes, 121; Errico, Metcalfe and Platt; Shores, Imbriglia and Lee, 1865; Tintle et al., “Hand Transplantation,” 6–7; Siemionow and Ozturk, 257; Coffman and Siemionow, 186. 292U. Brugger et al., “The Health Technology Assessment of the Compulsory Accident Insurance Scheme of Hand Transplantation in Switzerland,” The Journal of Hand Surgery (2014). Accessed January 9, 2014. http://jhs.sagepub.com.authenticate.library.duq.edu/content/early/2014/11/14/ 1753193414559463.full.pdf+html. 50 2 Vascularized Composite Allotransplantation

2.5.5 Ethical Issues

There is a growing body of literature focusing on the ethics of facial and upper extremity VCAs, including in recent years some featuring a broad discussion of multiple ethical issues293 and one article by Kiwanuka et al., examining the history of the ethical debate in facial transplantation.294 A large number of other articles focus on one or two ethical features of VCA, typically discussing either upper extremity or facial VCA, but seldom both. In 2008, Chung et al., undertook a review of ethical principles in plastic surgery literature, which included a number of articles concerning face transplantation. While the scope of their review did not extend to bioethics journals,295 what they discovered regarding the treatment of ethics in facial transplantation is intriguing. In all, they found less than one percent of all the plastic surgery literature was composed of articles clearly focused on ethics. Of a mere 110 articles they found, twenty dealt with ethics in facial transplantation specifically. Chung et al., then identified major and minor themes in these articles according to the four principles of Beauchamp and Childress. Of interest is that in all 110 articles, they identified respect for autonomy as the most common major theme, appearing more than twice as often as any other; however, when only the articles concerned with face transplantation are considered, beneficence and non-maleficence together appear as the major theme more than twice as often as respect for autonomy. Also of interest is that the principle of justice appears only once in the facial VCA ethical literature they review, and then only as a minor theme.296 The account of the evolution of the ethical debate by Kiwanuka et al., also involved a literature review of 110 articles and analyzed them by theme, though not using the four principles of Beauchamp and Childress as their guide. Nonetheless, interpretation of their analysis would suggest a similar distribution with regard to emphasis: beneficence and non-maleficence first, then respect for autonomy and finally justice.297 What follows is an exploration of ethical themes in relation to facial and upper extremity VCA. This exploration will consider the four principles of respect for autonomy, beneficence, non-maleficence and justice, as well as two additional principles, vulnerability and dignity. As noted above, the practical concerns in VCA are deeply intertwined with the ethical concerns, and this will be demonstrated below.

293Kalliainen; Edwards and Mathes; Errico, Metcalf and Platt; Chang and Mathes; Coffman and Siemionow, Wiggins et al., Johnson and Corsten; Doumit et al. 294Kiwanuka et al., passim. 295The author of this dissertation was able to identify fourteen additional articles addressing the ethics of VCA within the time frame surveyed by Chung et al., and twenty-seven more since. Time constraints prevented the analysis of these articles according to bioethical themes. The article by Toure et al., shows that discussion of VCA in bioethics journals was quite robust as of 2006; 790. 296Kevin C. Chung et al., “A Systematic Review of Ethical Principles in the Plastic Surgery Literature,” Plastic and Reconstructive Surgery 124, no. 5 (2009): 1711–1718. 297Kiwanuka et al., 1559–1565. 2.5 Practical and Ethical Concerns in the Field of Vascularized … 51

2.5.5.1 Justice

In bioethics, the principle of justice is primarily concerned with distributive justice, or “fair, equitable and appropriate distribution”298 of scarce goods and services. With regard to facial and upper extremity VCA, this would be related to patient selection, to the allocation of upper extremity and facial donations, and to discussions of the expense of the treatment, including cost/beneﬁt determination. Indeed, there has been considerable debate around these issues. At this point, since no formal procedure for allocation of upper extremity or facial tissue donations has been implemented, allocation takes place at the level of the medical center and is essentially the same as patient selection and matching when a graft becomes available.299 A synopsis of the debate may be derived from reading the earlier sections on patient selection and on procurement and allocation. At the core of this aspect of justice in VCA is the idea that it is fair, equitable and appropriate to allocate the donor tissue to those who have a clear, compelling need and who are deemed most likely to maintain the graft through psychological acceptance and adherence to immunosuppression and to maximize the functionality through consistent participation in physiotherapy.300 The second major aspect of justice discussed in the bioethics literature concerns the costs in light of limited resources for health care overall. VCA may be tech- nically feasible and yet not be a just use of scarce resources. Discussions of the economic dimensions of VCA and cost/beneﬁt analyses, including the use of QALYs, appear in several articles.301 Evans reports that this aspect of justice is a concern expressed by some members of VCA medical teams.302 The article by Chung et al., is devoted solely to an economic analysis of hand transplantation, but its conclusions have been questioned.303

298Beauchamp and Childress, Principles of Biomedical Ethics, 241. 299Carmen Paradis et al., “Ethical Considerations in the First American Face Transplant,” Plastic and Reconstructive Surgery 126, no. 3 (2010): 900–901. 300Agich and Siemionow, 708–709; Barker et al., “Research and Events,” 241; Losee, Fletcher and Gorantla, 260–264; Vercler, 80; Siemionow and Gordon, 1232–1235; Siemionow, “Ethical Considerations,” 157–159; Cendales, Rahmel and Pruett, 1086; Coffman and Siemionow, 185– 186; Shores, Imbriglia and Lee, 1865–1866; Freeman and Jaoude, 80; Lantieri, 252. Dean and Talbot have made the interesting argument that nonadherence among the early VCA recipients may have been a consequence of the “risk-tolerant innovator” personality style which led these persons to pursue the treatment in the ﬁrst place. 301Tintle et al., “Hand Transplantation,” 6–7; Siemionow, Gharb and Rampazzo, 636–637; Lantieri, 252; Shores, Imbriglia and Lee, 1865; Kallianen, 549; Chang and Mathes, 557–558; Errico, Metcalfe and Platt, 3; Edwards and Mathes, 120–121; Coffman and Siemionow, 186; Freeman and Jaoude, 80; Kiwanuka et al., 1565. 302Linda A. Evans, “Experiences of Healthcare Team Members Involved in Facial Transplant Surgery and Patient Care,” Nursing Research 62, no. 6 (2013): 379. 303Chung et al., “An Economic Analysis,” passim; Concannon, 599–600. 52 2 Vascularized Composite Allotransplantation

Early in 2015, research appeared claiming that a QALY calculation, based on survey results from a small number of unilateral amputees, showed that there was no preference toward hand transplantation given the current risk profile.304 Yet with the small sample and the failure to include bilateral amputees, this study does not present an especially strong case against upper extremity VCA. Further research is needed to resolve the uncertainty over costs and benefits, and progress in the field of VCA or in the field of prosthetics may alter the balance significantly.305 With regard to facial VCA, the difference in cost between VCA and conventional treatments is less extreme. Conventional face reconstruction for persons with major tissue deficits involves a series of operations over the course of many months or even years. The cumulative cost can be comparable to the costs associated with facial VCA, and the outcome far less satisfactory both cosmetically and functionally. Furthermore, as experience is gained, the cost of VCA is likely to come down, as has been the case with other new procedures, including forms of solid organ transplantation.306

2.5.5.2 Beneﬁcence and Non-maleﬁcence

As Chung et al., observed in their review of plastic surgery literature concerned with ethics, the themes of beneficence and non-maleficence have a tendency to appear together.307 Beneficence refers to the duty of those in health care to act in ways that lead to benefits for the patient.308 Non-maleficence may be described as the “obligation not to inflict harm on others”.309 Clearly, both principles may be applied to the evaluation of a single act. The ethical debate regarding facial and upper extremity VCA up to this point has been dominated by the consideration of these two ethical themes.310 Risk/benefit analyses, which are efforts to determine whether the good accomplished outweighs the burdens (harms) and risks imposed, are routine in articles on VCA, even those

304Noor Alolabi et al., “The Utility of Hand Transplantation in Hand Amputee Patients,” The Journal of Hand Surgery (American) 40 (2015): 8–14. 305Kalliainen, 549; Erika D. Sears and Kevin C. Chung, “Commentary on ‘The Utility of Hand Transplantation in Hand Amputee Patients,” The Journal of Hand Surgery (American) 40 (2015): 15. 306Julian Joseph Pribaz and Edward J. Caterson, “Evolution and Limitations of Conventional Autologous Reconstruction of the Head and Neck,” The Journal of Craniofacial Surgery 24, no. 1 (2013): 99; Nguyen et al., 260–265. 307Chung et al., “Systematic Review,” 1714. 308Beauchamp and Childress, 197–199. 309Beauchamp and Childress, 149. 310See notes 222 and 223. 2.5 Practical and Ethical Concerns in the Field of Vascularized … 53 that are not primarily focused on ethics.311 In the review of 110 articles by Kiwanuka et al., they claim that risks and benefits are discussed explicitly in 64.5% of the articles. However, an evaluation of the other “core issues” they found suggests that several of them are concerned with risk/benefit analysis even if they do not use that language. For example, articles that discuss immunosuppression, transplant failure, quality of life, the importance of the face, or that disfigured people cannot live normal lives, address key concerns in the risk/benefit analysis.312 For our purposes, the consideration of burdens, risks and benefits in regard to the ethical principles of beneficence and non-maleficence will draw on a number of specific issues raised in the literature: patient selection, immunosuppression and its side effects, psychological and identity concerns, program quality, privacy concerns, and harm to donors. Each of these is a factor in determining whether VCA can be justified in light of the ethical obligations to benefit patients and to refrain from doing harm. Patient selection, as we have seen, is also relevant to the ethical principle of justice, inasmuch as it is concerned with allocating the graft and the institutional resources to patients in a way that is appropriate and fair. It is relevant to the ethical principles of beneficence and non-maleficence because patients subjected to the burdens and risks of the surgery and subsequent immunosuppression and therapy must be those who are reasonably expected to benefit. In part, this means that an effort should be made to assure that they have the psychological and social resources to persist in the physiotherapy, psychotherapy and immunosuppression required to maximize the function and longevity of the graft.313 The first hand transplant may have failed because insufficient attention was given to the recipient’s psychological condition. Dickenson and Widdershoven note that he had previously rejected his replanted arm, denying that it was “really his,” and later ceased adhering to his immunosuppression regime when he came to feel the same way about his allograft.314 Post-transplant psychiatric disorders are not infrequent in upper extremity recipients, often leading to non-adherence with physiotherapy, immunosuppression or both. In some cases, the non-adherence has led to graft loss.315

311A more accurate term would be burdens and risks versus benefits, since patients face both certain burdens and merely probable risks in their pursuit of benefits. Since this way of expressing the calculations involved in determining the ethical justification is not yet widely used, we will continue to employ the traditional term, risk/benefit. 312Kiwanuka et al., 1561. 313Tintle et al., “Hand Transplantation,” 2; Chang and Mathes, 556–557; Losee, Fletcher and Gorantla, 261–263; Renshaw et al., 865; Agich, 133–134. 314Dickenson and Widdershoven, 116. 315Tintle et al., “Hand Transplantation,” 5; Errico, Metcalfe and Platt, Kumnig and Jowsey-Gregoire, 94; Jowsey-Gregoire et al. According to Siemionow and Ozturk, 257, multiple losses of upper extremity grafts in China were the result of lack of immunosuppression, but the fault may not have been the patients’, as it was only provided for a short time by the authorities. 54 2 Vascularized Composite Allotransplantation

The risks and harms associated with immunosuppression are perhaps the most discussed issue in connection with beneficence and non-maleficence in VCA. The risks include greater susceptibility to opportunistic infections, metabolic disturbances that may lead to co-morbidities such as renal failure or post-transplant development of diabetes, an increased risk of malignancies, cardiovascular problems and the possibility that patient longevity will be decreased by the treatment.316 These are obviously substantial risks, and require a high likelihood of substantial benefits in order for VCA to be ethically justified. The arguments which claim the benefits are indeed substantial frequently note that facial and upper extremity VCA offers both functional and cosmetic benefits. Successful upper extremity transplants not only provide more natural-looking limbs but also limbs which, after therapy, can be superior to prostheses in their function.317 Facial transplant recipients, as stated above, may obtain restoration of olfaction, and the ability to eat, breathe and communicate more naturally.318 In addition, as Agich points out, without facial transplantation, patients face the alternative of “multiple burdensome reconstructive procedures and a life of social isolation”.319 Psychological effects and consequences for patient identity also figure promi- nently in discussions of the risk/benefit ratio. Early on, concern over identity transfer in facial transplantation was common.320 This has subsided with clinical experience showing that recipients do not resemble the donors to a significant degree. The inability of upper extremity transplant patients to identify with the graft was also discussed as a risk, particularly in light of the failure of the first hand transplant patient to do so. For upper extremity patients since, this does not seem to have been a major problem. In reply to those who have argued that the psychological risks of transplant were too high, several have replied that the psychological suffering associated with disfigurement must also be considered.321 In fact, psychological follow-up of facial transplant recipients have shown improvement in anxiety and depression levels and increases in the perception of quality of life.322 Chang and Mathes, assert that upper

316See note 146. 317Errico, Metcalfe and Platt; Tintle et al., “Hand Transplantation,” 6. 318Lengele, 508; Losee, Fletcher and Gorantla, 260; Edgar, 126; 129; Pomahac, Gobble and Schneeberger, 5–6; Kalliainen, 549. 319Agich, 136. 320Kiwanuka et al., 1559. 321Kiwanuka et al., 1565; Coffman and Siemionow, “Ethics Revisited,” 184; Kalliainen, 549–550; Wiggins et al., 5; Errico, Metcalfe and Platt; Agich, 133–134; O’Neill and Godden, 444; Swindell, 449-452; Evans, “Historical Overview,” 154; Agich and Siemionow, 25–27; Alexander et al., 61; Losee, Fletcher and Gorantla, 260; Hurlburt, RA148. 322Coffman and Siemionow, “Face Transplantations: Psychological Outcomes,” 372–378. 2.5 Practical and Ethical Concerns in the Field of Vascularized … 55 extremity transplantation has improved patients’ body image.323 Furr et al., provide a thorough description of the psychological implications of disfigurement, noting that facial disfiguration in particular tends to become “a master status and leads to prejudice and discrimination, stereotyping and, frequently, social isolation”.324 Paradis et al., give an excellent description of how the functional impediments of disfigurement could have a troubling psychological impact.325 Program quality is given attention in a number of articles. The connection between program quality and the principles of beneficence and non-maleficence is that unless transplant programs are of sufficient quality, they may expose patients to excessive and unnecessary risks.326 The need for sufficient program quality was first advanced as part of the justification for VCA by the University of Louisville team as it began developing its program. Elements of program quality include the skill and experience of the team, the ethical climate of the institution and public and professional discussion and evaluation.327 Agich, in commenting on the Louisville approach, emphasizes that the skill of the team must refer to all members of the team, not just those directly involved in the surgical procedures.328 The research of Zhu et al., which looked at failure rates in facial VCA, lends some support for the claim that program quality is essential to the success, and thus the ethical justification, of VCA.329 Privacy and confidentiality concerns also raise the issue of potential harm to recipients, donors and their families, and thus must be considered under the principle of non-maleficence. Concern for confidentiality in bioethics reaches back to its earliest days, where it is a component of the Hippocratic Oath.330 It also appears in the first code of ethics published by the American Medical Association in 1847, and continues to appear in contemporary codes such as the Declaration of Geneva.331 However, the privacy of upper extremity and facial graft recipients has proven almost impossible to fully protect. Upper extremity and facial VCA procedures have elicited intense media interest, which was anticipated. Despite efforts to keep information about the recipient and donor of the first facial transplant private, the names of both the recipient and donor

323Chang and Mathes, 555. 324Furr et al., 560–564. See also Johnson and Corsten, 276; and Edgar, 130. 325Paradis et al., 896–897. 326Kalliainen, 551. 327Wiggins et al., 7–10; Barker et al., “Research and Events,” 241–242. 328Agich, 132–133. 329Hainan Zhu et al., “Perioperative Risk Factors for Vascularized Composite Allotransplantation: A Systematic Review and Proposal of Identity-Defining VCA,” Microsurgery 34, no. 3 (2013): 242. 330As cited in Albert R. Jonsen, Mark Siegler and William Winslade, Clinical Ethics: A Practical Approach to Ethical Decisions in Clinical Medicine 7th Edition, New York: McGraw Hill Medical, 2010: 174. 331J. Bell et al., 1847 AMA Code of Ethics. Accessed October 5, 2011. http://www.ama-assn.org/ resources/doc/ethics/1847code.pdf; Veatch, Haddad and English, 277–278. 56 2 Vascularized Composite Allotransplantation quickly appeared in the press.332 Given the level of public interest, a number of considerations must be taken in VCA with regard to patient privacy and confidentiality. First, patient selection must consider the likelihood of the patient’s identity and images being exposed. As Furr et al., put it, candidates “must be persons of sufficient confidence and composure to withstand the attention”.333 Second, informed consent and patient education before surgery should address the high probability that the recipient will be the subject of widespread media attention.334 Third, care should be taken to prepare the transplant team, ancillary services and others in the institution for the task of dealing with the media onslaught and for protecting the privacy of the recipient, the donor and their families to the highest degree possible.335 Protecting privacy can be challenging not only due to the curiosity of the media but also because publicity may have perceived benefits to the institutions and the staff involved in performing these revolutionary procedures.336 Evans, in her description of health care team members involved in a facial transplant, says they were aware that the procedure generated “good will and good press” for the institution. Even so, she states, they were conscious of the risk to patient privacy and felt the attention was “intrusive”.337 Samuel Taylor-Alexander expresses concern for both privacy and patient well-being by raising the issue of nationalism and national pride as motives driving the development of some VCA programs.338 Special concern over the potential harm to pediatric patients has been discussed by Doumit et al., in response to the announcement that Boston Children’s Hospital has established the first pediatric hand transplantation program. Doumit and colleagues were concerned about the inclusion of pediatric patients on several grounds. They noted that children are at higher risk for post-transplant malignancies, and that VCA in children will likely be complicated by the effects of immunosuppression on growth of the graft while increasing the risk of fractures. They also envisioned problems with rejection and graft loss due to the well-established propensity of

332Lengele et al., “Facing Up is an Act of Dignity: Lessons in Elegance Addressed to the Polemicists of the First Human Face Transplant,” Plastic and Reconstructive Surgery Journal 120, no. 3 (2007): 803. 333Furr et al., 563. 334Agich and Sieminow, 708–709; Paradis et al., 898; Lamparello et al., 285. 335Agich, 135; Coffman and Siemionow, 183. 336V.C. Lees and S.J. McCabe, “The Rationale for Hand Transplantation,” Transplantation 74, no. 6(2002): 750–751; Evangelos Sarantopoulos, “Is the Medical Community Adequately Prepared for Future Challenges in Facial Transplantation?” Anaplastology 4:153 (2015), doi:10.4172/2161- 1173.1000153. 337L. Evans, “Experiences of Health Care Team Members Involved in Facial Transplant Surgery and Patient Care,” Nursing Research 62, no. 6 (2013): 379. 338Taylor-Alexander, “On Face Transplantation,” 13–16; Samuel Taylor-Alexander, “Bioethics in the Making: ‘Ideal Patients’ and the Beginnings of Face Transplant Surgery in Mexico,” Science as Culture 23, no. 1 (2014): 27–50. 2.5 Practical and Ethical Concerns in the Field of Vascularized … 57 adolescents to struggle with adherence to the immunosuppressive regimen in solid organ transplantation. Similar non-adherence in the physiotherapy regimen required in upper extremity VCA would severely limit the functional success of grafts.339 As it happened, the first pediatric hand transplant requiring immunosuppression took place in 2015 and was performed on an 8-year-old child who was already receiving immunosuppression as a result of an earlier kidney transplant.340 The final topic of relevance to non-maleficence is concern for donors and donor families in VCA. The recipient and his or her family are a primary focus of concern, but donors and their families can also be wronged and harmed.341 This may have implications for donor consent, and some have questioned whether consent for facial donation should ever be allowed solely on the basis of substituted judgment, or whether it should always require first person consent as well.342 Concern about possible psychological harm to donor families has also contributed to the standard practice of some form of cosmetic restoration for donors after graft retrieval.343

2.5.5.3 Autonomy

The term autonomy was coined by the ancient Greeks as a way of describing certain city-states and distinguishing them from other cities or regions. An autonomous city-state was one that was self-governing. This political meaning of “autonomy” remained the primary meaning until the eighteenth century.344 In that century, Immanuel Kant used the term in his moral philosophy. Drawing in part on the works of Jean-Jacques Rousseau,345 Kant set out to establish a moral philosophy

339Doumit et al. See also Alexandre Marchac et al., “Ethical Issues in Pediatric Face Transplantation: Should we Perform Face Transplantation in Children?” Plastic and Reconstructive Surgery 138:2 (2016): 452. 340Harshad G. Gurnaney et al., “Anesthetic management of the first pediatric bilateral hand transplant,” Canadian Journal of Anasthesia 63 (2016); Galvez et al., 343. Two other pediatric VCAs have been reported, but took place with the donor being an identical twin of the recipient, thus obviating the need for immunosuppression. See B. Gander et al., “Composite Tissue Allotransplantation of the hand and face: a new frontier in transplant and reconstructive surgery,” Transplant International 19:11 (2006): 870, and R.M. Zuker et al., “First Successful lower-extremity transplantation: technique and functional result,” Journal of Reconstructive Microsurgery 22:4 (2006): 239–244. 341Siemionow and Ozturk, 256. 342Freeman and Jaoude, 80. 343Lantieri, 252; Edwards and Mathes, 117. 344Beauchamp and Childress, 103–104. 345Rousseau himself did not use the term, “autonomy,” but he did speak of moral freedom as “obedience to the law one prescribes to oneself,” which is quite close conceptually to Kant’s “autonomy.” See Iain Brassington, “The Concept of Autonomy and Its Role in Kantian Ethics,” Cambridge Quarterly of Healthcare Ethics 21 (2012): 173–174. 58 2 Vascularized Composite Allotransplantation grounded solely in reason. For Kant, autonomy of the will referred to the capacity of the will to be moved by reason alone, and not by other forces, either from within the person or from outside the person.346 As shall be shown in a subsequent chapter of this book, Kant’s notion of autonomy is influential upon but not identical with the concept of autonomy in contemporary health care ethics. Beauchamp and Childress, who have done the most to promote the concept of respect for autonomy as one of the pillars of bioethics, acknowledge their debt to both Kant and to nineteenth century philosopher John Stuart Mill and his notion of liberty. Drawing on these sources, Beauchamp and Childress contend that respect for autonomy implies that persons with decisional capacity ought to be provided with sufficient information so that they may choose for themselves which treatments they do or do not want.347 In the United States, where the writings of Beauchamp and Childress are most influential, autonomy serves almost exclusively as a justification for informed consent. In Europe, however, the role of autonomy is broader. Jacob Dahl Rentdorff, in his review of basic ethical principles in European bioethics and biolaw, offers five “important meanings of autonomy.” Rentdorff, quoting Paul Ricouer, asserts that the European understanding of autonomy “is based on the vision of ‘the good life for and with the other in just institutions’”.348 The VCA literature that addresses ethics tends to adhere to the understanding of autonomy associated with Beauchamp and Childress, discussing autonomy only in terms of informed consent.349 Some express concern that the desperation of potential candidates may undermine their capacity to give consent.350 The findings of Barker et al., that people are willing to accept more risk for a face transplant than for several other kinds of transplants could be taken as evidence of this desperation.351 Others argue, however, that a blanket disqualification smacks of paternalism.352 Kalliainen draws parallels between the interests of VCA candidates in therapy that bears significant risks and the interests of people infected with HIV in

346Mark Piper, “Autonomy, Normative,” Internet Encyclopedia of Philosophy: A Peer Reviewed Academic Resource. Accessed February 23, 2012. http://www.iep.utm.edu/aut-norm/#H1. 347Beauchamp and Childress, 103–104. 348Jacob Dahl Rentdorff, “Basic Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability—Towards a Foundation of Bioethics and Biolaw,” Medicine, Health Care and Philosophy 5 (2002): 236. 349Kalliainen, 548; Johnsen and Corsten, 275; Coffman and Siemionow, 182–183; Chang and Mathes, 555. 350Huxtable and Woodley, 510–513; Strong, 13. Dickenson and Widdershoven, 117–118, provide a notable exception, giving a more European approach in their interpretive and deliberative models of the doctor-patient relationship. 351Barker et al., “Investigation of Risk Acceptance in Facial Transplantation,” Plastic and Reconstructive Surgery 118, no. 3 (2006): 663–670. 352Hurlburt, RA149; Chang and Mathes, 556; Johnsen and Corsten, 275–277; Katrina A. Bramstedt, “Informed Consent for Facial Transplantation,” in The Know-How of Face Transplantation, Maria Siemionow, ed. (New York: Springer, 2011), 255; Agich, 134; Freeman and Jaoude, 78. 2.5 Practical and Ethical Concerns in the Field of Vascularized … 59 the early 1990s who some felt at the time should not be exposed to the risks of largely untried experimental therapies.353 In addition, VCA advocates note that vulnerability and distress are characteristic of many people who are asked for consent in the medical setting.354 Proponents of facial and upper extremity VCA contend that those who might not be able to rationally weigh the burdens, risks and benefits of the proposed treatment would be identified in the process of screening, and that it would be unethical to make the treatment unavailable to others who would be capable of giving voluntary consent.355 A second objection to the possibility of informed consent in VCA is based on the extremely limited information available. Consent cannot be informed, it is argued, when so little information is available.356 The counterargument given is that sufficient information is available from animal studies, human solid organ transplants and limb replantation. However, Agich and Renshaw et al., do argue that special attention must be given in VCA to assessing patient understanding of the information offered.357 Furthermore, VCA advocates contend, to demand more information than is available for VCA is unreasonable, and such a high standard would have a chilling effect on a great deal of beneficial medical research.358 In the words of Hurlburt, “Following [this] line of reasoning, it may be the case that all new forms of surgery… may be such that informed consent cannot be obtained”.359 As in all research, it is assumed that there is information not yet known, and this fact can and should be revealed to candidates.360

2.5.5.4 Dignity

Having addressed the standard quartet of bioethical principles explicated in multiple editions of Beauchamp and Childress’ Principles of Biomedical Ethics, one could

353Kalliainen, 548. 354Kalliainen, 548. 355Chang and Mathes, 558; Barker et al., “Ethical Considerations,” 106; Renshaw et al., 863–864. 356Powell, 111; Beth A. Preminger and Joseph J. Fins, “Face Transplantation: An Extraordinary Case with Lessons for Ordinary Practice,” Plastic and Reconstructive Surgery 118, no. 4 (2006): 1074; Hurlburt, RA149; Chang and Mathes, 555; Peter Clark, “Face transplantation: Part II—An Ethical Perspective,” Medical Science Monitor 11, no. 2 (2005): RA41–RA47; Alexander et al., 62; Renshaw et al., 861–862; Tobin et al., 1394. 357Agich, 134; Renshaw et al., 866. Paradis et al., offer an extended description of the informed consent process for the first face transplant in the United States, 898–899. 358Shores, Imbriglia and Lee, 1863; Siegler, 2779–2782; Barker et al., “Research and Events,” 243; Morris et al., 119; Barker et al., “Ethical Considerations,” 108; Siemionow and Gordon, 1234; Clarke and Butler, 1091; Hurlburt, RA149–RA150; Alexander et al., 62; Pomahac et al., 1696. 359Hurlburt, RA149. 360Edwards and Mathes, 116. 60 2 Vascularized Composite Allotransplantation argue that we have treated the topic of ethics in relation to VCA sufficiently. After all, principlism is the dominant approach to bioethics and Beauchamp and Childress are its leading purveyors.361 Yet there are both other approaches and other principles worth considering. Of special value in the consideration VCA, given its high stakes for patients and its still-experimental status, are the principles of respect for human dignity and human vulnerability. Dignity and vulnerability are ethical principles more commonly associated with bioethics outside the United States.362 Our discussion will treat dignity first, while vulnerability will be examined in the next section. The appropriateness and usefulness of dignity as a principle has been the subject of much dispute. Wolfhart Pannenberg asserts that dignity is something “that none of us has by merit, that none of us can receive from others, and that no one can take from us”.363 At the heart of the idea of human dignity, according to Ronald Dworkin, is the supposition that “there are ways of treating a [human being] that are inconsistent with recognizing him as a full member of the human community, and… that such treatment is profoundly unjust”.364 Some give dignity the leading role in bioethics.365 Others, however, have argued that the understanding of dignity is insufficiently precise, while yet others have argued that its functions are already accounted for in other principles.366 It is also considered suspect by some because of its historical association with religion and

361R. Gillon, “Ethics Needs Principles—Four Can Encompass the Rest—and Respect for Autonomy Should Be ‘First Among Equals,’” Journal of Medical Ethics, 29 (2003): 307–312; Henk ten Have, “Foundationalism and Principles,” in The Sage Handbook of Health Care Ethics, ed. by Chadwick, ten Have and Meslin, 21–24. 362Rentdorff, 237–238; R.E. Ashcroft, “Making Sense of Dignity,” Journal of Medical Ethics 31 (2005): 679; Leon Kass, “Defending Human Dignity,” accessed April 10, 2014. http://www.aei. org/files/2007/02/05/20070206_DefendingHumanDignity1.pdf. See “Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin,” Strasbourg (2002), online at https://rm.coe.int/CoERMPublicCommonSearch Services/DisplayDCTMContent?documentId=0900001680081562. Accessed Januray 31, 2017. 363Wolfhart Pannenberg, Systematic Theology, Vol. 2, New York: Bloomsbury Publishing, 1991: 177. 364Dworkin, as quoted in Daniel P. Sulmasy, “Death, Dignity and the Theory of Value,” accessed April 12, 2014. http://www.ethical-perspectives.be/viewpic.php?TABLE=EP&ID=53. 365Daniel P. Sulmasy, “More than Sparrows, Less than Angels: The Christian Meaning of Death with Dignity,” in Living Well and Dying Faithfully: Christian Practices in End-of-Life Care, ed. by John Swinton and Richard Payne. Grand Rapids: Eerdmans, 2009: 226–236; Charles Foster, Human Dignity in Bioethics and Law, Portland: Hart Publishing, 2011: 19–21. 366Alasdair Cochrane, “Undignified Bioethics,” Bioethics 24, no. 5 (2010): 234; Daniel P. Sulmasy, “The Varieties of Human Dignity: A Logical and Conceptual Analysis,” Medicine, Health Care and Philosophy 16 (2013): 937; Roberto Andorno, “The Dual Role of Human Dignity in Bioethics,” Medicine, Health Care and Philosophy 16, no. 4 (2013): 967–968; Charles Foster, “Human Dignity in Bioethics and Law,” Journal of Medical Ethics, epub ahead of print, (2013), doi:10.1136/medethics-2013-101339; Ashcroft, 679; David Badcott and Carlo Leget, “In Pursuit of Human Dignity,” Medicine, Healthcare and Philosophy 16, no. 4 (2013): 933. 2.5 Practical and Ethical Concerns in the Field of Vascularized … 61 its present popularity with those who tend to be conservative in their ethics.367 In fairness, it may be noted that the principles of respect for autonomy and justice are also subject to criticism on theoretical, cultural and political grounds.368 Furthermore, the criticisms of dignity as a principle in bioethics have been ably answered by a number of authors who, while admitting that the use of dignity in bioethics can at times exhibit these flaws, assert that the principle of dignity is capable of better when properly understood.369 Rentdorff gives a particularly robust definition of dignity as it should be used in bioethics.370 The term has its origins in ancient Rome among the Stoics. Leget notes that dignity had two meanings for Cicero.371 The first referred to public recognition of the special status of particular persons. A recognition of dignity called for behaviors that demonstrated respect for the status. For example, gestures of deference might be made by one of inferior status. Yet the bearer of the status was also expected to behave in certain ways consistent with the dignity he or she happened to bear, i.e., to behave in a dignified manner.372 The second meaning for Cicero was “the intrinsic and characteristic quality by which humans are distinct from other beings”.373 To put it another way, Cicero universalized the concept of dignity, claiming that all humans held a special status in comparison to other things in the world (animals, plants, etc.), and that this special status both deserved recognition from other humans and imposed special expectations upon all persons to act in ways which were appropriate to their inherent dignity.374

367Ashcroft, 680, claims that Kass “asserts that traditional morality is coherent with what dignity requires.” Sulmasy notes the predominance of dignity in the vocabulary of Church after the second Vatican Council, claiming that, “in Gaudium et Spes, almost every other word is ‘dignity’ [and] the decree on religious freedom is entitled Dignitas Humanae.” Daniel P. Sulmasy, “Death with Dignity: What Does It Mean?” Josephinium Journal of Theology 4, no. 1 (1997): 18; Cochrane, 236–237; Immaculada De Melo-Martin, “An Undigniﬁed Bioethics: There is No Method in this Madness,” Bioethics 26, no. 4 (2012): 224; Andorno, “Dual Role,” 967. 368There are profound tensions between those who approach autonomy from a Kantian perspective and those whose interpretation leans more toward Mill and negative liberty. As for justice, the point of view taken by Robert Nozick and associates is at odds with that taken by Rawls and others. 369De mello-Martin, passim; Andorno, “Dual Role,” passim; Carlo Leget, “Analyzing Dignity: A Perspective from the Ethics of Care,” Medicine, Health Care and Ethics 16 (2013): 945–952; Sulmasy, passim; Foster; Edlund, M., L. Lindwall, I.V. Post, and U.A. Lindstrom, “Concept determination of human dignity,” Nursing Ethics 20, no. 8 (2013): 851–860. 370Rentdorff, 237. 371Leget, 946. See also Roberto Andorno, “Human Dignity and Human Rights,” in H.A.M.J. ten Have and B. Gordijn, eds, Handbook of Global Bioethics, Dordrecht: Springer Science, 2013: 46. 372John Kleinig and Nicholas G. Evans, “Human Flourishing, Human Dignity and Human Rights,” Law and Philosophy 32 (2012): 550. 373Leget, 946. 374Kleinig and Evans, 548–552. 62 2 Vascularized Composite Allotransplantation

Stoic thought was influential in post-Constantinian Christian thought, which linked the idea of dignity to the teaching that humans are made in the image of God.375 The notion was further developed in the Renaissance by Gianozzo Manetti and Giovanni Pico della Mirandola, who saw the capacity of humans to pursue transformation as the basis of dignity.376 Dignity was later explored by Kant, who linked it to autonomy, calling autonomy the basis of dignity.377 According to Kant, all things have either “a price or a dignity.” Things with a price can be replaced by an equivalent, while things having dignity have no true equivalent and are irreplaceable.378 In more modern times, as van der Graaf and van Delden note, a link has been forged between unconditional dignity and human rights. Particularly after the Second World War, this emphasis is strengthened.379 Others have linked dignity to human flourishing, personhood and vulnerability.380 Much of the current debate about dignity and its appropriateness in bioethical debate is due to the fact that the idea of dignity remains fluid, if not amorphous. One scholar calls it, “intangible, yet luminous ….a vague though powerful concept”.381 The concept becomes considerably less vague when clarified by sorting out different uses or versions. Andorno observes that dignity plays very different roles in bioethics in relation to policy formation and patient care. In the former case, it is more general and better grasped by descriptions of what it forbids rather than by descriptions of what it allows or encourages. In the latter case, it calls for close attention to the vulnerabilities of a particular patient in a specific setting.382 Daniel Sulmasy speaks of “varieties of human dignity,” distinguishing three: intrinsic, attributed and inflorescent. Intrinsic dignity refers to that “worth, stature or value human beings have simply because they are human”; attributed dignity is that conferred upon one by one or more others; and inflorescent dignity refers to the dignity attached to a manner of living that reflects or leads to human flourishing.383 Leget offers another tripartite description, with the terms subjective dignity, social and relational dignity and intrinsic dignity. Leget’s intrinsic dignity is similar to Sulmasy’s variety of the same name. Subjective dignity refers to an individual’s sense of worth or honor, which may or may not be grounded in objective reality.

375Leget, 946; Andorno, “Human Dignity,” 46–47. 376Kleinig and Evans, 551. 377Andorno, “Human Dignity,” 47; Leget, 946–947. 378Kleinig and Evans, 553. 379Rieke van der Graaf and Johannes J.M. van Delden, “Clarifying Appeals to Dignity in Medical Ethics From An Historical Perspective,” Bioethics 23, no. 3 (2009): 157. 380Kleinig and Evans, 556–564; Haugen, 2208–213; David N. Weisstub and David C. Thomasma, “Human Dignity, Vulnerability, Personhood,” in Personhood and Health Care, ed. by David C. Thomasma, David N. Weisstub and Christian Herve, Dordrecht: Springer, 2001: 320–331. 381Rhonda Gay Hartman, “The Face of Dignity: Principled Oversight of Biomedical Innovation,” Santa Clara Law Review 47 (2007): 55; 60. 382Andorno, “Dual Role,” passim. 383Sulmasy, “Varieties,” 938. 2.5 Practical and Ethical Concerns in the Field of Vascularized … 63

Social and relational dignity is that sense of dignity conferred by the actions and expressions of others.384 Lennart Nordenfelt’s description of four kinds of dignity has also been influential. He calls inherent or intrinsic dignity by the German term, “Menschenwürde.” In addition, he lists the dignity of merit, the dignity of moral stature and the dignity of identity. Dignity of merit refers to the dignity associated with rank or title, i.e., royalty, an elected official, a member of the clergy or a physician. The dignity of moral stature refers to the dignity attached to the character and conduct of one who is above reproach. Nordenfelt’s treatment of the dignity of identity is significant for patient care, inasmuch as it is concerned with the patient’s subjective sense of dignity.385 Especially useful to bioethics is Rentdorff’s description of seven functions of dignity. Rentdorff holds that dignity points to the special standing of humans in the universe, requires respect for the moral agency of individuals, rejects the notion that humans may be “commercialized” or assigned a monetary value, and expresses the idea that human beings are capable of shaping their own destinies. Dignity also functions to draw attention to a consideration of the effect of decisions or actions on self-esteem, restricts behavior that is uncivilized, and opposes treatment of others that is regarded as degrading.386 Also important to bioethics is an aspect of dignity which is perhaps implied in Rentdorff’s description of the seven functions, but not made explicit. Respect for the moral agency of individuals does not only mean respect for their right to make decisions, but also holding them responsible for their decisions and actions. Indifference to the content of decisions which have been made is not respect for dignity; holding persons accountable is.387 While the principle of dignity holds promise for the ethical analysis of upper extremity and facial VCA, it has received little sustained attention in the literature. Dignity is frequently referred to as being associated with bodily integrity, with the implication that it might be restored to recipients through successful VCA treatment.388 Concern about the psychological effects of disfigurement, disability and VCA reflect concern about subjective and social and relational (or attributed) dignity. Nordenfelt’s description of the dignity of identity specifically mentions

384Leget, 948–949. 385Lennart Nordenfelt, “The Varieties of Dignity,” Health Care Analysis 12, no. 2 (2004): 69–81. 386Rentdorff, 237. 387Christopher Kaczor, A Defense of Dignity: Creating Life, Destroying Life, and Protecting the Rights of Conscience, Notre Dame: University of Notre Dame Press, 2013, 67. Holding an individual accountable assumes of course that he or she has the capacity and information necessary to make a rational, informed decision. That respect is demonstrated in holding people accountable is shown in part by a consideration of those we do not hold morally accountable: small children, those with major intellectual deficits, the elderly with dementia, etc. 388Freeman and Jaoude, 79; Furr et al., 559–562; Agich and Siemionow, 708–709; Dickenson and Widdershoven, 119–124; Coffman and Siemionow, 184; Slatman and Widdershoven, 75–77; John A. Roberston, “Face Transplants: Enriching the Debate,” The American Journal of Bioethics 4, no. 3 (2004): 32–33. 64 2 Vascularized Composite Allotransplantation disfigurement and disability.389 Concern with dignity also appears in discussions of the necessary disfigurement of the donor, and efforts at cosmetic reconstruction of the donor after the retrieval of the grafts.390 Protection of the privacy and confidentiality of the donor, recipient and their families may also be seen as a means of respecting the dignity of those involved.391 One major treatment of the theme of dignity in relation to facial VCA is found in a lengthy law review article by Rhonda Gay Hartman. Hartman argues that dignity should be the primary guide in determining whether and when facial VCA is appropriate.392 She discusses the dignity of donors,393 and concludes that reconstructive facial VCA can indeed promote patient dignity in some situations.394

2.5.5.5 Vulnerability

The English word “vulnerability” is derived from the Latin vulnus, which means “wound”.395 Wounded persons are generally less capable than the unwounded of protecting themselves from additional harm. Some have linked vulnerability with autonomy, suggesting that “with reduced autonomy comes increased vulnerability”.396 This view has some merit, but is too narrow as a deﬁnition. While limited autonomy is one source of vulnerability, there are certainly other reasons why individuals or groups may not be in a position to protect themselves. Vulnerability as an idea in modern bioethics goes back at least as far as the Nuremburg Code, where the call for consent should be understood to reﬂect concern about vulnerable persons as research subjects.397 Vulnerability entered the vocabulary of ethical codes with the Belmont Report, and has since been included in major international statements on bioethics as the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, the 2005 UNESCO

389Nordenfelt, 76–77. 390Lantieri, 252; Edwards and Mathes, 117; Coffman and Siemionow, 184. 391Agich, 135. 392Hartman, 80–91. 393Hartman, 66–68. 394Hartman, 77. 395Online Etymology Dictionary. Accessed January 15, 2014. http://www.etymonline.com/index. php?term=vulnerable. See also M. Therese Lysaught, “Vulnerability within the Body of Christ: Anointing of the Sick and Theological Anthropology,” in Health and Human Flourishing: Religion, Medicine and Moral Anthropology, Roberto Dell’oro and Carol R. Taylor, eds., Washington, D.C.: Georgetown University Press, 2006: 162. 396Hans Morten Haugen, “Inclusive and Relevant Language: The Use of the Concepts of Autonomy, Dignity and Vulnerability in Different Contexts,” Medicine, Health Care and Philosophy 13 (2010): 203. 397Margaret Meek Lange, Wendy Rogers and Susan Dodds, “Vulnerability in Research Ethics: A Way Forward,” Bioethics 27, no. 6 (2013): 334; Wendy Rogers, Catriona Mackenzie, and Susan Dodds; “Why Bioethics Needs a Concept of Vulnerability,” The International Journal of Feminist Approaches to Bioethics, 5, no. 2 (2012): 14. 2.5 Practical and Ethical Concerns in the Field of Vascularized … 65

Universal Declaration on Bioethics and Human Rights and the 2008 version of the Declaration of Helsinki. The Belmont Report is a product of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was established in the United States in 1974 with the passage of the National Research Act. The eleven members of the commission met for four days in February 1976 and produced a document that identified the ethical principles the commission felt should guide research with human subjects. The report attempts to set the boundaries between medical practice and medical research, delineate three basic principles (respect for person, beneficence and justice), and provide applications of the principles to research. It is under the heading of “Applications,” sub-section, “Selection of Subjects,” that vulnerability is mentioned. Specifically, concern is expressed over certain groups that might become targets for the recruitment of research subjects. Members of groups “such as racial minorities, the economically disadvantaged, the very sick, and the institutionalized” are considered potentially “vulnerable subjects”.398 Despite its origin in Belmont, the concept of vulnerability in bioethics has been more readily embraced internationally than it has in the United States. Beauchamp and Childress, the authors of the dominant American text in bioethics, begin to discuss vulnerability only in the sixth edition of their Principles of Biomedical Ethics.399 It is explored there in their chapter on “Moral Status,” where the authors address the issue of vulnerable populations over the course of a few pages.400 The term does not appear in the index or table of contents of Gert, Culver and Clouser’s Bioethics: A Systematic Approach401 or Veatch, Haddad and English’s Case Studies in Biomedical Ethics.402 In contrast, the concept of vulnerability is quite extensively developed in two international bioethical resources. The CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects appeared in 2002. CIOMS, the Council for International Organizations of Medical Sciences, worked with the World Health Organization to develop this revision of earlier versions of international ethical guidelines for medical research.403 The CIOMS Guidelines address

398The Belmont Report, Accessed January 31, 2014. http://www.hhs.gov/ohrp/humansubjects/ guidance/belmont.html. 399Haugen, 208. 400Beauchamp and Childress, 89–91. It seems likely that Beauchamp and Childress would consider the issues related to respect for vulnerability adequately addressed by their principles of respect for autonomy and justice. 401Bernard Gert, Charles M. Culver and K. Danner Clouser, Bioethics: A Systematic Approach 2nd Edition, New York: Oxford University Press, 2006. 402Robert M. Veatch, Amy M. Haddad and Dan C. English, New York: Oxford University Press, 2010. 403CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, 7–10; Accessed January 31, 2014. http://www.cioms.ch/publications/layout_guide2002.pdf. 66 2 Vascularized Composite Allotransplantation vulnerability directly in Guideline 13, which states: “Special justiﬁcation is required for inviting vulnerable individuals to serve as research subjects and, if they are selected, the means of protecting their rights and welfare must be strictly applied”.404 Just three years after the publication of the CIOMS Guidelines, UNESCO (United Nations Educational Scientiﬁc and Cultural Organization) published its Universal Declaration on Bioethics and Human Rights. Included therein is Article 8, which states:

In applying and advancing scientific knowledge, medical practice and associated technologies, human vulnerability should be taken into account. Individuals and groups of special vulnerability should be protected and the personal integrity of such individuals respected.405 The meaning of the article was set forth at length in the 2011 The Principle of Respect for Human Vulnerability and Personal Integrity: Report of the International Bioethics Committee. This latter document, in addition to providing a general introduction to the concept of vulnerability and an attempt to define the ‘determinants of ‘special vulnerability,’ offers a series of examples in place of a propositional definition.406 In the 2008 update of the Declaration of Helsinki, vulnerability is addressed in articles 9 and 17. Approved at the 59th meeting of the World Medical Association, which took place in Seoul, Korea, the 2008 version is the sixth revision of the original statement created at the Helsinki meeting in 1964. Article 9 states: “Some research populations are particularly vulnerable and need special protection. These include those who cannot give or refuse consent for themselves and those who may be vulnerable to coercion or undue influence”.407 In turn, Article 17 adds:

Medical research involving a disadvantaged or vulnerable population or community is only justiﬁed if the research is responsive to the health needs and priorities of this population or community and if there is a reasonable likelihood that this population or community stands to beneﬁt from the results of the research.408

404CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, 64. 405UNESCO Universal Declaration on Bioethics and Human Rights, accessed January 31, 2014. http://unesdoc.unesco.org/images/0014/001461/146180e.pdf. 406The Principle of Respect for Human Vulnerability and Personal Integrity: Report of the International Bioethics Committee. Accessed January 25, 2014. http://unesdoc.unesco.org/images/ 0021/002194/219494E.pdf. Article 7 notes that “attempts to deﬁne vulnerability in general risk drawing the concept too widely or too narrowly, thereby triggering disputes rather than resolving them”. 4072008 Declaration of Helsinki, 2. Accessed February 1, 2008. http://www.wma.net/en/ 30publications/10policies/b3/17c.pdf. 4082008 Declaration of Helsinki,3. 2.5 Practical and Ethical Concerns in the Field of Vascularized … 67

In comparing the three international statements, it becomes clear that each uses substantially the same language to describe vulnerability and the obligations which respect for vulnerability entails.409 As stated earlier, to be vulnerable is to be situated in such a way that one is, in one or more ways, unable to adequately defend against encroachments upon one’s person or interests. Given that the concern about vulnerability in bioethics was generated by historical occasions in which vulnerable persons were harmed, it is not surprising that vulnerability in bioethics carries a clear negative connotation. While acknowledging that vulnerability is universal, bioethics has focused its attention on groups and individuals who are especially vulnerable. Thus, vulnerability tends to be regarded in bioethics as an unfortunate and perhaps unjust condition, and the associated moral obligations tend to focus on either protecting the vulnerable or empowering them so they might be able to protect themselves.410 Special vulnerability, then, is seen to have certain “moral implications,” such as requiring extra justification for including vulnerable persons in research, offering special protections after vulnerable subjects are enrolled in research, and engaging vulnerable persons in research only when the research can be reasonably expected to benefit the subjects themselves or others similarly situated.411 It is possible, however, to appreciate the continuity between ordinary and extraordinary vulnerability and to employ such an appreciation in the development of approaches to addressing conditions of special vulnerability. Such appreciation and approaches have been developed by Christian theologians, including William C. Placher,412 Ellen F. Davis413 and Kristine A. Culp,414 but may also be found in secular sources.415 These broader understandings of vulnerability will play a significant role in the construction of our concept of covenant consent later on.

409Samia A. Hurst claims the European deﬁnitions tend to be much broader than those developed elsewhere, particularly in the United States. See Hurst, “Vulnerability in Research and Health Care; Describing the Elephant in the Room?” Bioethics 22, no. 4 (2008): 191–192. 410See especially Articles 1–21 of The Principle of Respect for Human Vulnerability and Personal Integrity: Report of the International Bioethics Committee. 411Henk ten Have, “The Principle of Vulnerability in the UNESCO Declaration on Bioethics and Human Rights,” in Religious Perspectives on Human Vulnerability in Bioethics, Joseph Tham, Alberto Garcia and Gonzalo Miranda, eds., Dordrecht: Springer, 2014: 26. 412William C. Placher, Narratives of a Vulnerable God: Christ, Theology and Scripture, Louisville: Westminster John Knox Press, 1994. 413Ellen F. Davis, “Vulnerability, the Condition of Covenant,” in The Art of Reading Scripture, Ellen F. Davis and Richard B. Hays, eds., Grand Rapids: William B. Eerdmans Publishing Company, 2003: 277–293. 414Kristine A. Culp, Vulnerability and Glory: A Theological Account, Louisville: Westminster John Knox Press, 2010. 415Margaretha Strandmark K., “Ill Health is Powerlessness: A Phenomenological Study About Worthlessness, Limitations and Suffering,” Scandinavian Journal of Caring Sciences 18 (2004): 138–142; Bettina Stenbock-Hult and Anneli Sarvimäki, “The Meaning of Vulnerability to Nurses Caring for Older People,” Nursing Ethics 18, no. 1 (2011): 31–32; Robyn Bluhm, “Vulnerability, Health and Illness,” The International Journal of Feminist Approaches to Bioethics 5, no. 68 2 Vascularized Composite Allotransplantation

At this point, however, it is necessary to offer grounds for claiming that candidates for VCA may be regarded as being especially vulnerable. In the absence of clear, widely accepted criteria for what constitutes special vulnerability, the case must be made by assembling indicators from multiple sources. First, we will turn to the entry on vulnerability in the Sage Handbook of Health Care Ethics. Drawing upon the work of Kipnis, the authors offer a list of six categories of special vulnerability. From these six categories, at least two are potentially applicable to potential VCA candidates. These would include “medical vulnerability” and “social vulnerability”.416 Medical vulnerability applies to candidates for VCA because it refers to persons who are so seriously ill or injured that they may be attracted to research protocols by unrealistic expectations. As Philip Nickel points out, “In general, research subjects tend to underestimate the level of risk or impact associated with participation in biomedical research,” while overestimating the likelihood of potential benefits. Subjects do so, Nickel claims, because of the effects of “‘motivated bias,’ i.e., errors based on a desire to believe something is true”.417 Given that those drawn to VCA tend to be those who have been unable to adapt to their disfigurement or disability, while others of equal or greater injury do adapt, the question is raised whether VCA inadvertently targets the most desperate among the disabled and disfigured who are also the most vulnerable.418 Social vulnerability applies to candidates for VCA whose condition has led to social isolation. Facial defects often lead to such isolation.419 Upper extremity defects may also cause isolation, as a result of their effect of the individual’s self-image or because the functional consequences of the defect exclude the individual from certain activities.420 A sense of social isolation may also be created by the increased level of dependency that occurs as a result of a defect. Loss of independence due to disability has been associated with a decrease in psychological well-being and subjective estimates of quality of life, a limitation of employment opportunities, and social stigma or marginalization. Persons with disabilities frequently “report giving up established ways of doing things, and

(Footnote 415 continued) 2 (2012): 155–157; Catriona Mackenzie, “The Importance of Relational Autonomy and Capabilities for an Ethics of Vulnerability,” in Vulnerability: New Essays in Ethics and Feminist Philosophy, Catriona Mackenzie, Wendy Rogers and Susan Dodds, eds., New York: Oxford University Press, 2014: 33–59. 416Agamoni Ganguli-Mitra and Nikola Biller-Andorno, “Vulnerability in Healthcare and Research Ethics,” Sage Handbook of Healthcare Ethics, ed. by Chadwick, ten Have and Meslin, 240–241. 417Philip J. Nickel, “Vulnerable Populations in Research: The Case of the Seriously Ill,” Theoretical Medicine and Bioethics 27 (2006): 256. Rumsey, 22–23; Bradbury, 194. 418Rumsey, 22–23; Bradbury, 194. 419Schenk, 411; Strong, 13; Rumsey, 22–23; Svenaeus, 144; 193–196; Bradbury, 193–196; Strandmark K., 142. 420Examples would be the loss of the ability to continue one’s career, certain activities of daily living or familiar leisure activities. 2.5 Practical and Ethical Concerns in the Field of Vascularized … 69 forgoing numerous activities, plans and goals.” Various factors have been identified as playing a role in the subjective perception of dependence, including not only an individual’s pre-existing coping skills, but the “cultural norms and societal values” to which the individual has been exposed.421 When facial defects are of such a nature as to prevent normal eating or even normal breathing, and when upper extremity defects render persons unable (perhaps temporarily) to drive, feed themselves, etc., a state of dependency may be created which individuals may be so anxious to escape that they are willing to take greater than normal risks. Desperate individuals may also become prone to overestimating the potential benefits of proposed treatments.422 The afore-mentioned Report of the International Bioethics Committee of UNESCO423 offers a number of examples of vulnerability in both straightforward healthcare and in research. Though none of these examples mentions VCA, they are by the authors’ own stated intention meant to be “neither exhaustive nor pre- scriptive,” but rather a means of “paving the way for a broader reflection…”.424 Among the examples that may be seen as reflecting the condition of potential candidates for VCA are the examples of “social vulnerability,”“premature applications of technology,” and “unexpected risks.” Social vulnerability in the report is substantially the same as social vulnerability described above. VCA could be regarded as a premature application of technology, given that the issues related to immunosuppression are not yet resolved sufficiently to justify exposing persons without a life-threatening condition to their toxic effects. VCA candidates could also be considered especially vulnerable because the “full risks of participation” are not known but are expected to be substantial, based on existing experience with SOT.425 Both Diane Perpich and Rhonda Gay Hartman deal specifically with the implications of facial disfigurement for establishing a condition of special vulnerability. Perpich points out the obvious “link between the face and personal identity”

421Monique A.M. Gignac ansd Cheryl Cott, “A Conceptual Model of Independence and Dependence for Adults with Chronic Physical Illness and Disability,” Social Science and Medicine 47, no. 6 (1998): 739; 745–747. 422Eva Feder Kittay, “The Ethics of Care, Dependency and Disability,” Ratio Juris 24, no. 1 (2011): 55; Bradbury, 193; Svenaeus, 155; Rumsey, 22; Schenk, 411–412; Nickel, 256; Eileen Bradbury artfully remarks that patients who have received information about treatment burdens, risks and possible benefits “may have been listening through a filter of hope and distress.” Bradbury, 195. 423The Principle of Respect for Human Vulnerability and Personal Integrity: Report of the International Bioethics Committee. Accessed January 25, 2014. http://unesdoc.unesco.org/images/ 0021/002194/219494E.pdf. 424The Principle of Respect for Human Vulnerability and Personal Integrity: Report of the International Bioethics Committee, Introductory Remarks. 425The Principle of Respect for Human Vulnerability and Personal Integrity: Report of the International Bioethics Committee. See also S.A.M. McLean, “Respect for Human Vulnerability and Personal Integrity,” Handbook of Global Bioethics, ed. by H.A.M.J. ten Have and Bert Gordijn, Dordrecht: Springer Science & Business, 2014: 112. 70 2 Vascularized Composite Allotransplantation which makes facial defects especially devastating and the promise of a transplant especially enticing.426 Perpich points out that functional limitations, such as the “inability to perform everyday actions such as eating or drinking, smiling or frowning” interfere with social interaction and deprive persons of vital social support.427 Thus, candidates for facial VCA are especially vulnerable, according to Perpich, and require a level of consideration, compassion and care beyond that otherwise expected in health care.428 Rhonda Gay Hartman is more concerned with dignity than vulnerability, but the two are clearly related, as she acknowledges429 and the UNESCO IBC Report on Respect for Vulnerability and Personal Integrity asserts explicitly.430 Y. Michael Barilan sees vulnerability as “a derivative concept” grounded in “human dignity and human solidarity”.431 While granting that facial transplantation appears to offer “inestimable relief… for disfigured persons,”432 Hartman is cautious. She worries that “patient desperation and despair” will impede proper consent.433 Hartman also raises the issue of social vulnerability as a result of disfigurement, which may contribute to patient desperation.434 Social isolation, caused either by fear of rejection or the actual experience of it, can lead to feelings of hopelessness. She concludes that respect for human dignity and efforts to promote dignity are the best way to respond to the condition of vulnerability in the disfigured.435 In light of the preceding discussion of categories and examples of special vulnerability, along with the review of the articles by Perpich and Hartman, it seems reasonable to conclude that candidates for facial and upper extremity VCA may be regarded as especially vulnerable. The consequence of regarding VCA candidates in this way is that they are therefore to be afforded special consideration, special protection and special support.436 That special consideration, special protection and special support may take several forms. In a later chapter, it will be argued that covenant consent is one possible form this special consideration, protection and support can take.

426Perpich, 173–176. 427Perpich, 176. 428Perpich, 183–184. 429Hartman, 59. 430The Principle of Respect for Human Vulnerability and Personal Integrity: Report of the International Bioethics Committee. 431Y. Michael Barilan, “Reﬂections on Human Vulnerability and the Rabbinic Perspective on Medical Ethics,” in Religious Perspectives on Human Vulnerability in Bioethics, 93. 432Hartman, 64; 76. 433Hartman, 72–74. 434Hartman, 75. 435Hartman, 90. 436Strandmark K., 141–142; Perpich, 184; McLean, 106; Schenk, 413–414; Bradbury, 195–196; Hurst, 196–197; Rogers, Mackenzie, and Dodds, 24–26; Lange, Rogers and Dodds, 337. 2.6 Conclusion 71

2.6 Conclusion

This chapter has reviewed the historical background, origins and development of the practice of human vascularized composite allotransplantation of upper extremities and facial tissue. It has shown that technical skills and insights developed in the fields of solid organ transplantation, limb replantation and face replantation following partial or total avulsion have laid the groundwork for the development of upper extremity and facial VCA. The most significant among these technical skills and insights were the development of vascular and nerve anasto- moses, microsurgical techniques, and a deeper understanding of the processes of immunological rejection. The development of VCA as a realistic clinical option had to wait, however, on the development of more effective and less toxic immunosuppressive agents and protocols. As better immunosuppression was developed and implemented in SOT, VCA began to be seriously considered again. The potential for successful VCA was demonstrated first in an animal model. Eventually, the first human VCAs were attempted. The first upper extremity transplant after the development of improved immunosuppression was attempted by Dubernard in 1998. Seven years later, Dubernard assisted Devauchelle in the first face transplant. Since those pioneering efforts, many more surgeries of both types have been performed in several centers around the world. Despite generally good results thus far, a number of practical issues remain to be addressed in order to make the transition from small scale, experimental VCA to larger scale, routine clinical VCA. Among the issues are advances in tolerance induction, improvements in patient selection, the development of means to speed nerve regeneration and the establishment of best practices in rehabilitation and physiotherapy.437 As facial and upper extremity VCA began on an experimental basis, it has been subject to close ethical scrutiny. The ethical issues raised by VCA are intertwined with some of the practical concerns, including especially the burden and risk to benefit ratio. The consideration of the burden and risk to benefit ratio must take into account the substantial negative side effects of immunosuppression, the potential for graft loss and what that might mean for recipients, the substantial duration and intensity of post-surgical physiotherapy, and psychological concerns. A general survey of the ethical debate thus far was presented, organized by ethical principles. These principles included respect for autonomy, beneficence, non-maleficence, justice, dignity and vulnerability. The purpose of this chapter is to provide the first part of the foundation for an attempt to argue for the justification of a new form of consent, called covenant consent, for VCA procedures. The following two chapters will continue to build the

437Ralf Smeets et al., L. Scott Levin, “Monograph on Hand Transplantation,” Techniques in Hand & Upper Extremity Surgery 17, no. 4 (2013): 207. 72 2 Vascularized Composite Allotransplantation foundation by exploring the history, development and current debate surrounding consent in bioethics and by examining the concept of covenant from its historical origins in the ancient near east through its development and applications in late twentieth and early twenty-ﬁrst century bioethics. A thorough knowledge of all three subjects or areas is necessary before moving on to a description and justiﬁ- cation of covenant consent for VCA. Chapter 3 The Ethics of Consent

Abstract The right of informed consent, grounded in the principle of respect for autonomy, has come to be seen by many as the central element in contemporary Western bioethics. This chapter will introduce the history and development of the role of consent in healthcare, from Pre-Enlightenment developments and Post-Medieval inﬂuences through the philosophical contributions of ﬁgures such as Immanuel Kant and John Stuart Mill. A review of nineteenth and twentieth century developments in consent for healthcare and research will feature legal cases, troubling research practices and shifting cultural values. The legal cases include Schloendorff v. Society of New York Hospitals, Salgo v. Leland Stanford Jr. University Board of Trustees and Canterbury v. Spence. Troubling research practices will include the infamous Nazi atrocities, the revelations of Henry Beecher regarding research in the 1960s and the Tuskegee Syphilis Study. Various codes of ethics which were created in response to the troubling research practices will also be examined, including the Nuremburg Code, the Declaration of Helsinki, the Belmont Report and the UNESCO Universal Declaration on Bioethics and Human Rights. Following the description of the history of consent, the predominant contemporary model of informed consent presented by Beauchamp and Childress will be described, and various critiques will be offered, including those of Franklin G. Miller and Alan Wertheimer, Robert Veatch, Y. Michael Barilan, and Rebecca Kukla. Finally, the inadequacy of the standard formulation for particular treatment forms and contexts will be examined.

3.1 History and Development of the Role of Consent in Health Care

The concept of consent has a long history and the term bears a range of meanings. Consent plays a central role in a number of contexts, including political, social, legal and medical ones. In political contexts, consent of the governed is recognized by many as a necessary condition for the legitimacy of the government. In social and legal contexts, consent is understood to create entitlements and obligations

© Springer International Publishing AG 2017 73 J.L. Benedict, A Revised Consent Model for the Transplantation of Face and Upper Limbs: Covenant Consent, International Library of Ethics, Law, and the New Medicine 73, DOI 10.1007/978-3-319-56400-5_3 74 3 The Ethics of Consent between persons.1 These entitlements and obligations may be created for simple contractual relationships or more intimate personal relationships like marriage. Consent also has special meanings within the context of health care. An exploration of these meanings is the primary purpose of this chapter. Consent is widely recognized as a key pillar in the structure of contemporary ethics for both standard medical practice and scientific research involving human subjects. While there are numerous and vigorous debates over the precise definitions, relative value, proper foundations, and reasonable limits of consent, there is a general affirmation of the responsibility of physicians and researchers to enable and obtain consent and a corollary right of patients or subjects (or their surrogates) to give or withhold consent.2 In fact, the embrace of consent in health care and research has reached the point where one leading bioethicist has described the “autonomous choice” of patients or subjects as a “benchmark (of) moral adequacy”.3 Despite its predominance in contemporary bioethics, consent has not always held such a high place in medical care or research. This is especially true if one has in mind the kind of autonomous informed consent advocated at present by main- stream bioethicists.4 While consent as understood and practiced in health care and research today is relatively new, it is the result of a long process of development which must be examined in order to fully appreciate what consent means today. The modern concept of consent in health care and research has its origins in certain philosophical and political ideas found in antiquity. These ideas were passed along and later developed by influential thinkers in the Renaissance and Enlightenment periods, then further developed by philosophers of the eighteenth, nineteenth and twentieth centuries. Application of the notion of consent to health care and research does appear now and then before the middle of the twentieth century, but the major emphasis on consent and serious attempts to define its

1David Johnston, “A History of Consent in Western Thought,” in The Ethics of Consent: Theory and Practice ed. by Franklin G. Miller and Alan Wertheimer, New York: Oxford University Press, 2010: 25–26. 2This is clearly the opinion of the many contributors to The Ethics of Consent: Theory and Practice. See also Tom L. Beauchamp and Ruth R. Faden, “Informed Consent,” in The Encyclopedia of Bioethics 3rd edition, ed. by Stephen G. Post, New York: Thomson Gale, 2003: 1271–1276; Vilhjalmur Arnason, Hongwen Li and Yali Cong, “Informed Consent,” in The Sage Handbook of Health Care Ethics, ed. by Ruth Chadwick. Henk ten Have and Erik M. Meslin, Los Angeles: Sage, 2011, 106–116. 3Tom L. Beauchamp in Miller and Wertheimer, 58. 4Prominent examples of such autonomous consent are described by Tom L. Beauchamp and James F. Childress in Principles of Biomedical Ethics 6th edition, New York: Oxford University Press, 2009: 117–134; Franklin G. Miller, “Consent to Clinical Research,” in Miller and Wertheimer, 375–404; Robert M. Veatch, Amy M. Haddad, and Dan C. English, “Consent and the Right to Refuse Treatment,” in Case Studies in Biomedical Ethics New York: Oxford University Press, 2010: 366–388; Bernard Gert, Charles M. Culver and K. Danner Clouser, Bioethics: A Systematic Approach, 2nd Edition, New York: Oxford University Press, 2006: 191–236; Jay Katz, “Reﬂections on Informed Consent: 40 Years After Its Birth,” Journal of the American College of Surgeons 186:4 (1998): 466–474. 3.1 History and Development of the Role of Consent in Health Care 75 properties in the context of health care and research take place only after that point. What follows is an exploration of the development of the concept of consent from its origins in ancient Greece to its modern role as a normative expectation in physician-patient and researcher-subject relationships in health care.

3.1.1 Pre-enlightenment Developments

We find in the writings of Aristotle from the 4th century B. C. E. some of the groundwork for the concept of consent. According to David Johnston, Aristotle departed from his teacher Plato regarding the importance of consent. Plato felt that the maintenance of order was more important than consent in legitimizing action. Aristotle, on the other hand, insisted that social relations are ideally based on mutual consent. The particular social relations Aristotle had in mind were focused on the exchange of goods and services generally, and Aristotle thought these exchanges ought to be voluntary.5 This idea was picked up and developed with great enthusiasm roughly two thousand years later by Adam Smith.6 Even Aristotle’s view, however, most likely assumed a social context in which one’s most fundamental rights and obligations were grounded in relationships (i.e., kinship) that one did not choose. As can be seen from Greek literature, in comparison to one’s obligations grounded in kinship, those obligations freely consented to are, in the words of one scholar, “insignificant and unreliable”.7 The Romans also promoted consensual transactions, often in the form of contracts both formal and informal.8 It must be noted, however, that both the Greeks and the Romans operated out of a cultural perspective that excluded many people from the status necessary to enter into consensual transactions. Slavery, which was widespread especially in the Roman period, provides one example. Women and children were likewise not eligible to enter into many transactions independently, and non-citizens had fewer rights generally than citizens. In short, adult male citizens were the most likely to expect and to be given the right to consent.9 Autonomy, which is generally recognized as the philosophical basis for the modern concept of consent, also originated in ancient Greece. The word “autonomy” is a portmanteau; that is, a composite of two Greek words: autos meaning “self,” and nomos meaning “rule” or “law”. Autonomy was first a political term used to distinguish certain territories or political entities, such as city-states. City-states were considered autonomous if they were self-governing, while

5David Johnston, “A History of Consent in Western Thought,” in Miller and Wertheimer, 35–40. 6Johnston, 46–47. 7Johnston, 36. 8Johnston, 40–42. 9Johnston, 45. 76 3 The Ethics of Consent city-states or territories which were controlled by an outside power were not regarded as autonomous.10 Claims, demands and promises of autonomy played a substantial role in disputes among the city-states in ancient Greece. For example, a promise of autonomy could be used to motivate colonies to participate in wars against one’s foes.11 The political meaning of “autonomy” remained its primary meaning until the eighteenth century, when Immanuel Kant, a German philosopher, appropriated the term for his moral philosophy, so that it could be a description of a person as well as of a political entity. Kant’s notion of autonomy drew inspiration and some content from the work of the philosopher Jean-Jacques Rousseau. Rousseau did not use the term, “autonomy,” but he did speak of moral freedom as “obedience to the law one prescribes to oneself,” which is quite close to Kant’s concept of autonomy.12 Though the modern concept of consent in health care and research would require the contribution of Kant’s notion of autonomy, it would be wrong to think no form of consent was operational prior to Kant. In fact, there is evidence that consent played some role in medical care even in Greco-Roman times. Dalla-Vorgia et al., argue persuasively that some instances of consent may be identiﬁed in Hippocrates’ recommendation that the patient’s cooperation be sought and in what they call early “defensive medicine” in the time of Alexander the Great and the later Byzantine era.13 Steven H. Miles argues even more ardently that we misread the Hippocratic tradition when we conclude consent was unknown or merely tangential to it.14 Despite the presence in ancient medicine of something recognizable as consent, the consent which existed was quite different from the fully informed, voluntary consent which has become standard in the twenty-ﬁrst century.15 Practically

10Willard Gaylin and Bruce Jennings, The Perversion of Autonomy: Coercion and Constraints in a Liberal Society, Washington DC: Georgetown University Press, 2003: 28; Mogens Herman Hansen, “The ‘Autonomous City State’: Ancient Fact or Modern Fiction?” in Studies in the Ancient Greek Polis, ed. by Mogens Herman Hansen and Kurt A. Raaflaub, Stuttgart: F. Steiner Verlag, 1995: 21–22. 11John V. A. Fine, The Ancient Greeks: A Critical History, Cambridge: Belknap Press, 1985: 578– 584. 12Mark Piper, “Autonomy: Normative,” Internet Encyclopedia of Philosophy: A Peer-Reviewed Academic Resource, accessed February 23, 2012 at http://www.iep.utm.edu/aut-norm/#H1. See also Iain Brassington, “The Concept of Autonomy and its Role in Kantian Ethics,” Cambridge Quarterly of Healthcare Ethics 21 (2012): 173–174. 13P. Dalla-Vorgia et al., “Is Consent in Medicine a Concept Only of Modern Times?” Journal of Medical Ethics 27 (2001): 59–61. 14Steven H. Miles, “The Art of Medicine: Hippocrates and Informed Consent,” The Lancet 374 (2009): 1322–1323. 15Johnston, 40; Ruth Faden and Tom Beauchamp, A History and Theory of Informed Consent, New York: Oxford, 1986: 61–62; Robert Veatch, “Three Theories of Informed Consent: The Philosophical Foundations and Policy Implications,” in The Belmont Report—Ethical Principles and Guidelines for the Protection of Human Subjects of Research, pp. 26–1–26–66. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (Washington, DC: U.S. Government Printing Office, U.S. Department of HEW), DHEW Publication No. (OS) 78-0014: 26–8. 3.1 History and Development of the Role of Consent in Health Care 77 speaking, consent for treatment was implied when one sought out a physician and continuing consent was embodied in continuing cooperation in the course of treatment. Presumably, provided one was not a slave, a child or a criminal, one retained the right to refuse or demand an end to treatment. Thus, while consent may sometimes have been sought, primarily for practical reasons (patient cooperation), there was no expectation that consent or refusal needed to be informed. At times, physicians were even encouraged to withhold information from their patients.16 According to Faden and Beauchamp, the withholding of information was justified by a perspective that prioritized beneficence and non-maleficence over autonomy.17 The primary obligation of physicians in the Hippocratic tradition was to benefit patients and prevent harm to them.18 Given this primary obligation, a request for some kind of consent might be allowed or even encouraged if it contributed to the goals of benefitting and/or protecting the patient. However, if patient consent was deemed immaterial to patient benefit or protection, consent was not necessary. Further, if information that might be provided before consent was thought to cause harm to the patient, the physician was to heed the primary obligation to prevent harm and thus withhold the information. In the Encyclopedia of Bioethics, Beauchamp and Faden describe information disclosure from the Hippocratic perspective “as a matter of prudence and discretion”.19 A small remnant of this belief remains in the form of the “therapeutic privilege”. Therapeutic privilege is the name given to the legal doctrine which holds that physicians may under special conditions withhold information from patients that one would otherwise disclose. Withholding the information is justified under the doctrine of therapeutic privilege when, in the physician’s medical judgment, providing that information would be likely to cause serious harm to an emotionally fragile patient.20

16Encyclopedia of Bioethics, s.v., “Informed Consent”; Jonathan D. Moreno, Arthur L. Caplan, and Paul Root Wolpe, “Informed Consent,” Encyclopedia of Applied Ethics, v. 2 (San Diego: Academic Press, Inc., 1998), 691; Faden and Beauchamp, 61–63; Tauber, 64; Veatch, Haddad, and English, 115–116. The widespread use of some form of the Hippocratic Oath in modern times may obscure the fact that Hippocratic ideas were unpopular in ancient times and largely ignored for centuries thereafter. 17Faden and Beauchamp, 62. 18As Faden and Beauchamp, 62–63, point out, the Hippocratic was a minority perspective in Greece and did not become dominant in the West until sometime after the rise of Christianity. The health care ethics which were actually dominant in ancient Greece were probably more amenable to patient autonomy and consent, at least on the part of patients who were free adult males. Plato, however, had a rather extreme communitarian approach to the understanding of a physician’s ethical obligations. See Jose Miola, “The Need for Informed Consent: Lessons from the Ancient Greeks,” Cambridge Quarterly of Healthcare Ethics 15 (2006): 155–157. 19Tom Beauchamp and Ruth Faden, “Informed Consent: I. History of Informed Consent,” in The Encyclopedia of Bioethics, 3rd Edition, ed. by Stephen G. Post, New York: Macmillan Reference, 2004: v. 3, 1271. 20Beauchamp and Childress, 124–125; Veatch, Haddad and English, 368–369; Kate Hodkinson, “The Need to Know—Therapeutic Privilege: A Way Forward,” Health Care Analysis 21, no. 2 (2013): 105–129; C. Richard, Y. Lajeunesse and M. T. Lussier, “Therapeutic Privilege: Between 78 3 The Ethics of Consent

Relatively little is known about consent practices in late antiquity and the early Middle Ages. Some have cited the “hold harmless document” (pro corpore mor- tuoto) used by 14th century physicians in Italy, France and Middle East as a forerunner of informed consent. However, as it provided little more than a general warning that there could be a negative outcome and was designed to protect the physician rather than to empower the patient, it can be argued that it has little to do with informed consent as it came to be understood in the 20th century and afterwards.21 Faden and Beauchamp claim that Christian physicians followed Hippocratic traditions in this period, but the evidence they cite comes from the mid-to-late segment of the Middle Ages.22 Veatch and Mason observe that many monks and secular clergy took up the practice of medicine, particularly after Constantine’s conversion, but that there is little evidence of any substantial connection between Hippocratic ethics and the Christian practice of medicine prior to the ninth century.23 Darrel Amundsen, a leading scholar on the history of medicine and its relation to Christianity, states that an overt tension existed between Christianity and medicine generally from late antiquity through the early Middle Ages.24 Amundsen’s view is supported by the textual evidence, or the absence thereof. The Hippocratic oath is seldom mentioned in the Christian literature of late antiquity. Of the two clear instances in which the Hippocratic Oath is mentioned during late antiquity, only one suggests that some apprentice physicians were taking it. The other mention of the oath takes place in a discussion of the ethical obligations of clergy. In that instance, clergy are called to observe the same standards of confidentiality expected of physicians according to the oath.25 Only in the ninth century, as new interest in Hippocrates and the oath was mediated through Arabic medicine and learning which increasingly influenced the Christian world, did Hippocratic values begin to have a greater influence on Christian medical practitioners.26 From this point forward, as Faden and

(Footnote 20 continued) the Ethics of Lying and the Practice of Truth,” Journal of Medical Ethics, 36, no. 6 (June 2010): 353–357; Faden and Beauchamp, 74; Moreno, Caplan and Wolpe, 689. 21Wouter K. G. Leclercq et al., “A Review of Surgical Informed Consent: Past, Present, and Future. A Quest to Help Patients Make Better Decisions,” World Journal of Surgery 34 (2010): 1407. 22Faden and Beauchamp, 63–64. 23Robert M. Veatch and Carol G. Mason, “Hippocratic versus Judeo-Christian Medical Ethics: Principles in Conﬂict,” Journal of Religious Ethics 15, no. 1 (1987): 87–88. 24Darrel Amundsen, “Casuistry and Professional Obligations: The Regulation of Physicians by the Court of Conscience in the Late Middle Ages,” Transactions and Studies of the College of Physicians of Philadelphia 3, no. 1 (1981): 96. 25Carlos R. Galvao-Sobrinho, “Hippocratic Ideals, Medical Ethics and the Practice of Medicine in the Early Middle Ages: The Legacy of the Hippocratic Oath,” Journal of the History of Medicine and Allied Sciences, 51 (1996): 440–442. 26Albert R. Jonsen, A Short History of Medical Ethics, New York: Oxford University Press, 2008: 18–19. 3.1 History and Development of the Role of Consent in Health Care 79

Beauchamp contend, the Hippocratic emphasis on beneﬁcence predominates and there is even the development of a Christian version of the oath.27 Informing the patient in the late Middle Ages was discussed primarily in relation to terminal illness rather than treatment. Even so, it is clear that withholding the information was sometimes acceptable, on the grounds of benevolence. Revealing the information that a patient is likely to die soon is recommended when it will encourage and allow the patient to set his or her spiritual or temporal affairs in order, and failing to reveal such a prognosis to a patient whom the physician believes is in a state of mortal sin is itself a mortal sin.28 Beneﬁcence was clearly the primary concern in these practices. Patient autonomy or a patient’s right to information were not compelling reasons to provide information.

3.1.2 The Inﬂuence of Post-medieval Philosophy

Important developments in the history of consent took place during the period of the Renaissance and Enlightenment, even though those developments would not lead to major changes in the normative expectations regarding consent in the health care setting until the middle of the twentieth century, long after they had come to be applied to consent in other areas of life. The changing attitude toward the importance of consent is amply reflected in the philosophical endeavors of Hobbes, Locke, Rousseau and Kant. It was Hobbes, first and foremost, who advanced the notion that the political legitimacy of rulers required the consent of those governed. Hobbes also promoted the importance of consent in other areas of human relations. In fact, Hobbes extended the argument that legitimacy of authority required consent even to the relationship between a parent and child.29 John Locke employed Hobbes’ notion of the necessity of consent in order to argue for democracy.30 Rousseau, as noted above, spoke of moral freedom in a way that Kant later took up and described as “autonomy”.31 Immanuel Kant, an 18th century German philosopher, drew upon the resources of Hobbes, Locke and Rousseau in the course of developing his own understanding of the nature and role of autonomy, which stressed in particular its moral or ethical significance. Kant set out to develop a moral philosophy grounded solely in reason which could thus be universally valid. For Kant autonomy of the will refers to the capacity of the will to be moved by one’s reason alone, apart from other forces or

27Faden and Beauchamp, 63–64. See also Johnston, 43. 28Amundsen, 103–104. 29Johnston, 45–47. 30John Dunn, Locke: A Very Short Introduction, New York: Oxford University Press, 2003: 27–65. 31See note 8. 80 3 The Ethics of Consent influences. Those other forces or influences might originate within the person as urges, impulses, instincts or reflexes, or from outside the person in the form of coercion or manipulation by other people. In fact, Kant was as concerned about inner forces other than reason as he was about coercion by other people, recognizing that humans are susceptible to being “enslaved by inner forces that in our better moments we would not endorse and that can make us act as beasts do”.32 Thus, Kant regarded acts as truly moral only when they arose from one’s reason alone.33 Kant’sreflection on the nature of pure practical reason led him to two basic principles. The first is the famous “categorical imperative,” which holds that acts are morally justified only when they are based on rules that one could reasonably will to be universal laws. The second of Kant’s core moral principles is that one should never treat people (including one’s self) as merely means to an end, but always also as ends. In short, we must always treat others as subjects rather than as mere objects. So for Kant, freedom from coercion or manipulation is a necessary but not sufficient condition for a person’s acts to be considered autonomous.34 In order to be truly autonomous, one’s acts must be as free from non-rational internal influence as they were from external influence. Respect for autonomy is widely recognized as a core principle and the basis for informed consent in contemporary healthcare ethics, and no one has done more to promote and refine the concept of respect for autonomy than Tom Beauchamp and James Childress in the several editions of their Principles of Biomedical Ethics.35 Beauchamp and Childress credit Kant for some of the content of their concept of autonomy, but admit that it owes as much or perhaps more to the notion of individual liberty found in the philosophy of nineteenth century British philosopher, John Stuart Mill.36 Whereas Kant’s moral acts were constrained by the categorical imperative, Mill as a consequentialist insisted that individual freedom should be constrained only by foreseeable and unjustifiable harm to others. Mill, like Kant, built upon ideas found earlier in both Hobbes and Locke. It can even be argued that Mill’s position is closer to Hobbes and Locke than is that of Kant. As a leading example, like Mill, both Hobbes and Locke understood liberty primarily as the absence of external constraints.37

32Grant Gillett, “Autonomy and Selﬁshness,” The Lancet 372 (2008): 1214. 33Charles Foster, “The Art of Medicine: Autonomy Should Chair, Not Rule,” The Lancet 375 (2010): 368–369. 34Brassington, 168. 35The most recent edition is the 7th. Tom Beauchamp and James Childress, Principles of Biomedical Ethics, 7th Edition, New York: Oxford University Press, 2012. Material in this dissertation will be drawn from the 6th edition (2009), as the material on autonomy and informed consent was not signiﬁcantly changed in the 7th. 36Beauchamp and Childress, Principles of Biomedical Ethics, 6th edition, 103–104. 37Tuija Takala, “Concepts of ‘Person’ and ‘Liberty’ and Their Implications for Our Fading Notions of Autonomy,” Journal of Medical Ethics 33, no. 4 (2007): 227. 3.1 History and Development of the Role of Consent in Health Care 81

For Mill, the liberty of persons to make choices was paramount. In On Liberty, one of his major works, Mill makes his case that individuals should be free to make decisions as long as those decisions and the actions which proceed from them do not infringe on the rights or well-being of others without their consent. Mill holds that others have no right to interfere, even if the choice seems likely or even certain to harm the individual who is making it.38 For Mill, the freedom to make one’s own choices is necessary because “each person is the most reasonable custodian and deﬁner of his or her own interests and objectives”.39 Mill’s concept of liberty has both positive and negative aspects. On the one hand, providing liberty may require that certain conditions be established so that individuals have the opportunity and ability to make choices. On the other hand, the negative aspect of liberty is simply the obligation to refrain from acts that would interfere with others’ pursuit of their own goals. Negative liberty has often been emphasized by later authors,40 but both aspects are present in the contemporary concept of consent in health care. Health care, however, was relatively slow to take up this emphasis on liberty.41

3.1.3 Building on the Philosophical Foundation

The lingering inﬂuence of the Hippocratic commitment to prioritizing beneﬁcence over autonomy is strongly evident in eighteenth and nineteenth century medicine. Faden and Beauchamp point out that Benjamin Rush, a leading American physician and thinker of the period, maintained a Hippocratic orientation despite his clear commitment to the importance of autonomy and self-determination in other aspects of life, especially politics. After all, Rush was a signer of the Declaration of Independence, by which the people who later formed the United States asserted their political autonomy from England. In his medical practice, Rush did promote a

38John Stuart Mill, On Liberty, New York: Simon and Shuster, 2012: 19. 39Bruce Jennings, “Autonomy,” in The Oxford Handbook of Bioethics, ed. by Bonnie Steinbock, New York: Oxford University Press, 2009: 83. 40For example, Isaiah Berlin, “Two Concepts of Liberty,” in Liberty: Incorporating Four Essays on Liberty, 2nd Edition, ed. by Henry Hardy, New York: Oxford University Press, 2006: 157–217. 41Tauber, 71–75; Dolgin, 99–100; Hana Osman, “History and Development of the Doctrine of Informed Consent,” The International Electronic Journal of Health Education, 4 (2001): 41–42; “The Right and Wrong of Making Experiments on Human Beings,” Journal of the American Medical Association, 67, no. 19 (November 4, 1916): 1372–1373; G. Herranz, “Some Christian Contributions to the Ethics of Biomedical Research: A Historical Perspective,” in Ethics of Biomedical Research in A Christian Vision: Proceedings of the Ninth Assembly of the Pontifical Academy for Life, ed. by Juan De Dios Vial Correa and Elio Sgreccia, (Vatican City: Libreria Editrice Vaticana, 2003), 126–141. 82 3 The Ethics of Consent greater sharing of information with patients than was typical, but his interest was not in creating conditions for proper informed consent but to increase the likelihood of patient compliance and cooperation. Rush also supported the use of deception when necessary to benefit patients.42 In 1803 Thomas Percival, an English physician, author, and an advocate for public health and the regulation of child labor, published Medical Ethics: or a Code of institutes and precepts, adapted to the professional interests physicians and surgeons, which contained an attitude toward patient autonomy and consent similar to that of Rush. Percival also recommended benevolent deception, particularly when needed to supply hope to discouraged or despondent patients. Percival’s views were highly influential in the first Code of Ethics of the American Medical Association, which appeared in 1847.43 The first chapter of the 1847 Code of Ethics, which addresses the “duties of physicians to their patients and the obligations of patients to their physicians,” is clearly influenced by traditional Hippocratic values. The physician is urged to protect confidentiality as a matter of honor, not only during the course of treatment but beyond it. The notion of withholding information in order to spare the patient suffering is also endorsed. In a section warning physicians against making “gloomy prognostications,” physicians are reminded that “the life of a sick person can be shortened not only by the acts, but also by the words or manner of the physician”. Nowhere in the description of the duties of the physician is any mention made of the right of a patient to consent or of patient autonomy.44 G. Herranz identifies some evidence of a concern for consent in what he calls “the practically ignored” nineteenth century Morale Medicale, which was a Roman Catholic school of thought devoted to the ethical practice of health care. While the Morale Medicale, including one of its prominent spokespersons, Georges Surbled, grounded respect for the dignity and freedom of the individual in the imago dei,it seems likely that this connection was the result of an attempt to integrate and harmonize certain aspects of theology with secular philosophy. Nonetheless, Surbled’s advocacy for subjects’ rights and consent in research is robust. Surbled warned against exploitation of research subjects by asserting, “The patient can never be used as a cheap object for experimentation”. More positively, Surbled stated, “Every man has the right to be respected in his body… So it is not permitted to the doctor to experiment on man without his formal consent”.45

42Faden and Beauchamp, 64–65. 43Beauchamp and Faden, Encyclopedia of Bioethics, 1272. 441847 Code of Ethics of the American Medical Association, Accessed July 23, 2013. http://www. ama-assn.org/ama/pub/about-ama/our-history/history-ama-ethics.page? 45Herranz, 135–137. It is interesting to note that this insistence on the right of every man to be respected in his body, which appears in 1905, sounds very similar to Justice Cardozo’s assertion, “Every human being of adult years and sound mind shall have the right to determine what shall be done with his own body.” See note 54. 3.1 History and Development of the Role of Consent in Health Care 83

Grzegorz Mazur contends that Surbled’s approach offers a viable alternative to secular autonomy as a basis for contemporary informed consent, particularly in Catholic health care.46 Despite the strong evidence for this approach to respect for patients and the importance of consent in one small part of nineteenth century French medicine, it seems doubtful that it played any significant role in the development of the modern concept of consent in health care. The understanding of consent that has become predominant in the last half century or so instead resulted from the convergence of several factors, the first of which was the popularity of the philosophical ideas of Kant and Mill, as described above. These ideas were in wide circulation, both in the United States and in Europe during the early twentieth century, and provided the basis for thinking about human rights generally. The convergence of the ideas of Kant and Mill with historical, social and legal developments is treated in greater detail below. Given the wide scale of research on subjects without their consent which later took place under the Nazis, it may be seen as ironic that the first clear recognition of informed consent as normative in medical research (both therapeutic and non-therapeutic) came from Germany.47 As early as 1891, the Prussian Minister of the Interior ordered that prison inmates not be given tuberculin for treatment of tuberculosis against their will. In 1900, the Prussian minister for religious, educational and medical affairs became aware of research on syphilis. The research was being conducted by Albert Neisser, who had discovered gonococcus. In the research on syphilis, patients who had been admitted to the hospital for other medical concerns were intentionally infected, without the patients being either informed or asked for consent. The minister for religious, educational and medical affairs, following a court ruling against Neisser and at the urging of the Prussian parliament, issued regulations insisting on disclosure of information and clear consent.48 In 1931, the national Reich Ministry issued regulations, again in response to research with catastrophic results. In this instance, a vaccine trial led to the deaths of seventy-seven children out of a total of two hundred and fifty who were vaccinated. The vaccine in question, the Bacille Calmette-Guerin (BCG) vaccine against

46Grzegorz Mazur, O. P., Informed Consent, Proxy Consent, and Catholic Bioethics, Dordrecht: Springer, 2012: 9–13. Mazur also notes the existence of legal contracts between patients and physicians from the 14th through the 17th century, which though they may not be based on informed consent as presently understood, do indicate some degree of concern for consent. 47Jochen Vollmann and Rolf Winau, “Informed Consent in Human Experimentation Before the Nuremburg Code,” BMJ 313 (1996): 1445–1447; Hans-Martin Sass, “Reichsrundschreiben 1931: Pre-Nuremburg German Regulations Concerning New Therapy and Human Experimentation,” The Journal of Medicine and Philosophy 8 (1983): 99–111; Paul Weindling, “The Origins of Informed Consent: The International Scientific Commission on Medical War Crimes, and The Nuremburg Code,” Bulletin of the History of Medicine 75 (2001): 41–42; Jay Katz, “The Nuremburg Code and the Nuremburg Trial: A Reappraisal,” JAMA 276, no. 20 (11/27/1996): 1663. 48Vollman and Winau, 1445. 84 3 The Ethics of Consent tuberculosis, had been safely administered to over one hundred thousand infants between 1924 and 1928. However, in 1930 a director of the Lübeck General Hospital, and the chief medical officer of the Lübeck Health Department created a program for administering the vaccine to newborns that had a tragic result. In addition to the seventy-seven children who died, another one hundred and thirty-five were infected but recovered.49 In response to this tragedy, in 1931 the Reichsrundschreiben concerning new therapy and human experimentation declared that henceforth “innovative therapies” could only be employed after information had been provided and either the patient or the patient’s legal guardian had “unambiguously consented”.50 Similarly high standards of consent for human experimentation did not appear outside of Germany until after the war, and the development of informed consent as a norm in the United States came much later, as the result of the confluence of several legal cases, revelations of troubling research practices and significant social change.

3.1.3.1 Legal Cases

In the words of David J. Rothman, “the idea (of informed consent) was born in a court”.51 Certainly courts do not operate in isolation from their surrounding societies and are heavily influenced by social change. Still, courts have most definitely played a central role in the establishment and clarification of informed consent in health care. Notions of a right to self-determination, which were growing in popularity from the mid-eighteenth century on, altered expectations and made patients more willing to challenge their physicians, including at times in courts of law, for the right to make choices about treatment. Several cases with some relation to consent appear prior to the twentieth century. In 1767 the English case of Slater v. Baker and Stapleton heard testimony from physicians that a request for consent was customary for procedures like that performed on the patient (breaking a leg in order to reset it). The court found in favor of the patient who had sued on the grounds that consent had not been requested.52 However, the decision is thought by some to have turned as much on the fact that the procedure was inappropriate as on the fact that consent had not been requested. Had the treatment been considered ordinary and appropriate, the absence of a request for consent may not have been sufficient grounds for finding in favor of the plaintiff.53

49Simona Luca and Traian Mihaescu, “History of BCG Vaccine,” Maedica: A Journal of Clinical Medicine 8, no. 1 (2013): 55. 50Weindling, 41; Sass, 99–107. 51David J. Rothman, “The Origins and Consequences of Patient Autonomy: A 25-year Retrospective,” Health Care Analysis 9, no. 3 (2001): 256. 52Dennis J. Mazur, “Inﬂuence of the Law on Risk and Informed Consent,” BMJ 327 (2003): 731. 53George J. Annas, “Doctors, Patients and Lawyers—Two Centuries of Health Law,” New England Journal of Medicine 367 (2012): 446; Margaret Mayberry and John Mayberry, Consent in Clinical Practice, London: Radcliffe Medical Press, 2003: 33–34. 3.1 History and Development of the Role of Consent in Health Care 85

In 1871, a New York state court found a duty of physicians to inform patients of departures from standard practice. In the case of Carpenter v. Blake, the treatment of a dislocated elbow by “unorthodox means” was deemed negligent, and the failure to inform the patient of the nature and consequences of the procedure was the key point. Consent only entered the case with regard to whether or not the patient consented to the cessation of treatment.54 The issue of consent was also raised, though certainly not fully addressed, in the Wells v. World Dispensary Medical Association case of 1890, a case in which the doctor was sued for using a ruse in order to convince a woman to undergo surgery.55 A series of four cases in the early 20th century created a ﬁrmer basis for informed consent.56 In Mohr v. Williams, the Supreme Court of Minnesota found that consent must be explicit, and not merely implied by the patient’s decision to consult a physician for treatment. In Pratt v. Davis, the Illinois Supreme Court denied the physician’s claim that the patient was incompetent to give consent because she was an epileptic. In Rolater v. Strain, the court ruled against a physician who removed a bone from the patient’s foot after the patient had only consented to having the infected foot drained. The Supreme Court of Oklahoma found the patient had a right to carefully limit consent.57 The last of the series is the case often credited with a major role in the development of the practice of informed consent, and occurred nearly a quarter century after Wells. In Schloendorff v. Society of New York Hospitals, a surgeon performed an operation against the clearly stated wishes of the patient, Mary Gamble Schloendorff, who had consented only to an examination while under ether. Schloendorff had entered the hospital with rather vague complaints, described in court documents as a “disorder of the stomach”. During a physical examination, her doctor discovered a lump which he considered suspicious. Mary Schloendorff agreed to allow a colleague of the doctor to examine the lump while she was under sedation, but claimed that she had stated plainly that she did not wish to have surgery. The colleague was a surgeon, and once Mrs. Schloendorff was sedated, he proceeded to remove the ﬁbroid tumor which had been attached to her uterus and the uterus itself.58 The court concluded that Mary Schloendorff’s rights had been violated, with Justice Benjamin Cardozo opining, “Every human being of adult years and sound mind shall have the right to determine what shall be done with his own body”.59

54Faden and Beauchamp, 117–118. 55Faden and Beauchamp, 118–119. 56Faden and Beauchamp, 120–123. 57Michelle Wandler, “The History of the Informed Consent Requirement in United States Federal Policy,” Harvard Law School Third Year Paper, Accessed January 27, 2015. http://dash.harvard. edu/handle/1/8852197. 58Paul A. Lombardo, “Phantom Tumors and Hysterical Women: Revising Our View of the Schloendorff Case,” The Journal of Law, Medicine and Ethics 33, no. 4 (2005): 791–796. 59Douglas S. T. Green and Ronald MacKenzie, “Nuances of Informed Consent: The Paradigm of Regional Anesthesia,” HSS Journal 3, no. 1 (2007): 115; Steven Joffe and Robert D. Truog, 86 3 The Ethics of Consent

However, for Mrs. Schloendorff the acknowledgement of such a right was of little consequence. She in fact lost the case because the court found that hospitals which provided care to the needy enjoyed charitable immunity. Underlying such immunity was the fear that hospitals would otherwise limit their provision of care for the needy out of concern over liability. The immunity of the hospital was upheld in spite of the fact that Mary Schloendorff herself was not a charity case, and she was charged for the court costs of nearly three hundred dollars.60 A number of other cases concerned with consent followed. In the words of Beauchamp and Faden, during this era “the behavior of physicians was often egregious, and the courts did not shrink from using…sweeping principles to denounce it”.61 In the 1929 case, Hawkins v. McGee, concerning a skin graft, the court recognized a special burden is placed upon health care practitioners over and above what is required in normal contract negotiations. McGee, the physician, performed a skin graft using skin from the patient’s chest to repair a scarred hand. The result was that Mr. Hawkins was left with a hairy palm. McGee had simply promised a “one hundred percent good hand,” without further comment on possible side effects or complications.62 The court determined that the physician with expertise must provide careful, clear and comprehensible information to the patient, and not mere general assurances.63 In Bang v. Charles T. Miller Hospital,a Minnesota case from 1955, it was established that patients have the right to be informed of very likely or inevitable results of surgery. Mr. Bang consented to the surgery but he was not informed of the high probability that he would be sterile after a transurethral prostatectomy and won his case against the hospital.64 The term “informed consent” ﬁrst appears in a legal proceeding in the 1957 case, Salgo v. Leland Stanford Jr. University Board of Trustees.65 Martin Salgo sustained paralysis following a procedure in which paralysis was a known risk, although the risk of paralysis was not disclosed to Mr. Salgo. The court found a duty to inform the patient of known risks and ruled that consent was not valid apart from the

(Footnote 59 continued) “Consent to Medical Care: The Importance of Fiduciary Context,” in The Ethics of Consent, Miller and Wertheimer, 348. 60Lombardo, 792–795. 61Beauchamp and Faden, “Informed Consent,” Encyclopedia of Bioethics, 1273. 62Hawkins v. McGee Case Brief, Accessed January 27, 2015. http://www.4lawschool.com/ contracts/mcgee.shtml. 63Y. Michael Barilan, “Informed Consent: Between Waiver and Excellence in Responsible Deliberation,” Medicine, Health Care and Philosophy 13 (2010): 89–90; Rob Atkinson, “Medicine and Law as Model Professions: The Heart of the Matter (and How We Have Missed It),” Health Matrix 22, no. 2 (2012): 358–359. 64Peter M. Murray, “The History of Informed Consent,” The Iowa Orthopaedic Journal,10 (1990): 105. 65Jonathan D. Moreno, Arthur L. Caplan and Paul Root Wolpe note an earlier use in a 1947 letter regarding experimentation with radioactive material. “Informed Consent,” in Encyclopedia of Applied Ethics, v. 2, ed. by Dan Callahan, Peter Singer and Ruth Chadwick, Waltham: Academic Press, 1998: 693. 3.1 History and Development of the Role of Consent in Health Care 87 provision of “any facts which are necessary to form the basis of an intelligent consent”.66 From Salgo forward, the disclosure of risks, benefits and alternatives prior to obtaining consent was expected. More precise parameters of informed consent were worked out over the next decade and a half in American courts, culminating in Canterbury v. Spence.In Canterbury, the patient suffered paralysis as the result of a post-surgical fall. While the risk of paralysis associated with that type of surgery was only one percent, the court held the physician responsible for not disclosing the information, finding that the lack of this information made it impossible for the patient to exercise true self-determination.67 Canterbury is seen as creating a new standard of disclosure, replacing the “professional practice standard,” which refers to what level of disclosure is customary among physicians in the area where the treatment is taking place. Canterbury called for a standard based instead on what a reasonable patient might wish to know.68 Similar developments took place in English jurisprudence. Bolam v. Friern Hospital Management Committee in 1957 concerned a patient injured in the course of electro-convulsive therapy. The court found information disclosure prior to consent to be sufficient if it is done in a manner acceptable to other responsible practitioners.69 In 1985, Sidaway v. Governors of Bethlem Royal Hospital reas- serted a professional practice standard in the case of a patient who became para- plegic following an operation for cervical cord decompression. As the risk of paraplegia was less than one percent, it was not customary for physicians to include a warning of the possibility prior to consent.70 In 1998, the case of Pearce and Another v. United Bristol Healthcare NHS Trust, concerning whether a woman should have been informed of the risk of stillbirth in continuing a pregnancy beyond 42 weeks, some have seen the creation of a prudent patient standard.71 There is not full agreement on the standard of disclosure, either in Great Britain or in the United States. In fact, disclosure standards vary by state in the United

66Faden and Beauchamp, 125–127; Janet L. Dolgin, “The Legal Development of the Informed Consent Doctrine: Past and Present,” Cambridge Quarterly of Healthcare Ethics 19 (2010): 98–99; Moreno, Caplan and Wolpe, 693–694. 67Janet L. Dolgin and Lois L. Shepherd, Bioethics and the Law, New York: Aspen Publishers, 2005: 52–58. 68Faden and Beauchamp, 133–138; Dolgin, 100–101; Beauchamp and Faden, “Informed Consent,” 1275; Murray. 106. 69M. Valimaki et al., Patient’s Autonomy, Privacy and Informed Consent (Biomedical and Health Research, V. 40) Amsterdam: IOS Press, 2000: 38; Alasdair Maclean, “From Sidaway to Pearce and Beyond: Is the Legal Regulation of Consent Better Following a Quarter Century of Judicial Scrutiny?” Medical Law Review 20, no. 1 (2012): 108. 70Maclean, “From Sidaway to Pearce,” 113. 71M. Brazier and J. Miola, “Bye-bye Bolam: a Medical Litigation Revolution?” Medical Law Review 8, no. 1 (2000): 85; Ash Samanta and Jo Samanta, “Legal Standard of Care: A Shift from the Traditional Bolam Test,” Clinical Medicine 3 (2003): 445–446. 88 3 The Ethics of Consent

States.72 Nonetheless, there is a well-established legal obligation to disclose information and to obtain clear, voluntary consent from patients with decisional capacity, or from the surrogate of a patient lacking such capacity, for nearly all forms of treatment or research.

3.1.3.2 Troubling Research Practices

The second major factor in the development of the modern normative expectation of informed consent is the revelation of troubling research practices. It has already been shown that such revelations led to the German Reichsrundschreiben concerning new therapy and experimentation in 1931. While there were certainly concerns about unethical research prior to this,73 the Reichsrundschreiben of 1931 appears to be the first effort by a governmental or quasi-governmental authority to establish guidelines requiring something like informed consent for research. The next major revelation was of the horrifying research conducted under the Nazis during the Second World War. Studies conducted on prisoners in concentration camps without consent included prolonged exposure to freezing tempera- tures and low pressure, bone grafting to test the efficacy of sulfa drugs, exposure to poisonous gas, and exposure to various contagious diseases to discover how different “races” responded.74 These and other horrifying atrocities came to light and were addressed in the post-war Nuremberg military trials. What was discovered eventually led to the publication of the Nuremburg Code.75 The first article of the Code boldly asserts, “The voluntary consent of the human subject is absolutely essential”.76 A lengthy paragraph follows, defining what voluntary consent is and is not. The definition insists that the subject of research must be informed of:

72Thaddeus Mason Pope, “Legal Brieﬁng: Informed Consent,” The Journal of Clinical Ethics 21, no. 1 (2010): 72. 73Herranz, 128–129; David J. Rothman, “To the Editor,” JAMA 277, no. 9 (1997): 709. 74“Nazi Medical Experiments,” Holocaust Encyclopedia, Washington DC: The United States Holocaust Memorial Museum, 2014. Accessed January 7, 2015. http://www.ushmm.org/wlc/en/ article.php?ModuleId=10005168. 75Herranz, 127–128; Florencia Luna, “Research in Developing Countries,” Oxford Handbook of Bioethics, ed. by Bonnie Steinbock, New York: Oxford University Press, 2007: 622; Jonsen, Birth of Bioethics, 133–138; Franklin G. Miller, “Consent to Clinical Research,” in Miller and Wertheimer, 375–376; Robert M. Veatch, Hippocratic, Religious, and Secular Medical Ethics: The Points of Conﬂict, Washington DC: Georgetown University Press, 2012: 64–66; Neil C. Manson and Onora O’Neill, Rethinking Informed Consent in Bioethics, Cambridge: Cambridge University Press, 2007: 2–4. For the text of the Code, see The Nuremberg Code. Accessed December 7, 2012. http://www.hhs.gov/ohrp/archive/nurcode.html. For a thorough historical account of the development of the Code, see Weindling, passim. 76Nuremberg Code at http://www.hhs.gov/ohrp/archive/nurcode.html. 3.1 History and Development of the Role of Consent in Health Care 89

the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person, which may possibly come from his participation in the experiment.77 The definition also speaks to the voluntary nature of acceptable consent. In the words of Manson and O’Neill, it “forbids research that is based on overwhelming or undermining the will, or on forcing the body”.78 The Nuremberg Code was soon followed by other declarations, reports and statements addressing ethics in research and later the ethics of clinical care.79 The World Medical Association approved “Principles for those in Research and Experimentation” in 1954 and the first version of the Declaration of Helsinki a nearly decade later.80 The Declaration of Helsinki distinguished therapeutic research, in which some benefit is expected to accrue to the subject, from non-therapeutic research, in which there is no expectation of benefit, and called for stricter consent requirements for the latter.81 Several years after the Declaration of Helsinki appeared, the (United States) National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research produced The Belmont Report. The framers of that document included only two ethicists, Albert Jonsen and Karen Lebacqz. The rest of the commissioners were physicians, lawyers, professors in other fields or administrators of organizations. However, the commissioners did seek input from several additional ethicists, including Alasdair MacIntyre, James Childress, LeRoy Walters, and Robert Veatch.82 The commissioners believed they were exploring “the ethical foundations for human research more deeply” than their predecessors at Nuremberg or Helsinki.83 Their goal was to produce a superior document to guide research in the United States. Belmont grounds consent requirements in the ethical principle of “Respect for Persons,” one aspect of which is respect for autonomy and self-determination. Belmont then addresses and attempts to define informed consent specifically, stressing the provision of information, consideration of the subject’s comprehension of that information, and subject voluntariness.84

77Nuremberg Code at http://www.hhs.gov/ohrp/archive/nurcode.html. 78Manson and O’Neill, 4. See also Veatch, Hippocratic, Religious and Secular Medical Ethics, 66. 79For a thorough account of the development of these statements and the distinctions between them, see G. Mazur, 13–52. 80Jonsen, Birth of Bioethics, 136. 81Moreno, Caplan and Wolpe, 692–693. 82Albert R. Jonsen, “On the Origins and Future of the Belmont Report,” in Belmont Revisited: Ethical Principles for Research with Human Subjects, ed. by James F. Childress, Eric M. Meslin and Harold T. Shapiro, Washington DC: Georgetown University Press, 2005: 3–4. 83Jonsen, “On the Origins and Future of the Belmont Report,” 3. 84See The Belmont Report, Accessed December 7, 2012. http://www.hhs.gov/ohrp/humansubjects/ guidance/belmont.html. 90 3 The Ethics of Consent

A few years prior to Belmont, the American Hospital Association produced its “Patient Bill of Rights,” which included an emphasis on the patient’s right to a wide range of information about proposed treatments and the personnel involved in treatment, and the right to decide about treatment alternatives without coercion.85 This document extended the expectations regarding consent for subjects of research to patients undergoing clinical treatment. It has since been replaced by “The Patient Care Partnership,” which continues to insist that patients have the right to information and self-determination in medical decision-making.86 More than a half century after the publication of the Nuremberg Code, its concern for protecting research subjects and their rights continued to be voiced. One finds, for example, continued recognition of the importance of informed consent in the 1997 “Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine”. This statement anchors informed consent in respect for human dignity as well as in regard for human rights and freedoms.87 One also finds the legacy of Nuremburg reflected in the UNESCO Universal Declaration on Bioethics and Human Rights, which was published in 2005. Donald Evans notes the link between Nuremberg and the UNESCO Declaration.88 Article six of the Declaration, which is devoted to consent, calls for “prior, free and informed consent of the person concerned, based on adequate information”.89 In describing the application of the article, Regine Kollek employs the elements of consent set forth by Beauchamp and Childress, which shall be described in greater detail below.90 While the Nuremberg Code inspired these several other declarations, reports and statements, it did not bring a quick end to egregious research practices. Research continued in which subjects were exposed to serious risks and harms without their prior knowledge or consent.91 Henry Beecher drew attention to the problem, particularly within the United States, with his 1966 article in The New England Journal of Medicine, “Ethics and Clinical Research”. In the article, he described the ethical

85“The Patient Bill of Rights,” Accessed May 2, 2014. http://184.80.193.37/consumerinfo/ hospitalguide/patients/consumer_help/bill_of_rights.htm. 86“The Patient Care Partnership”. Accessed May 2, 2014. http://www.aha.org/content/00-10/pcp_ english_030730.pdf. 87“Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine,” Council of Europe, online at http://conventions.coe.int/Treaty/en/Treaties/Html/164.htm. Accessed May 23, 2014. 88Donald Evans, “Article 5: Autonomy and Individual Responsibility,” The UNESCO Universal Declaration on Bioethics and Human Rights: Background, Principles and Application, ed. by Henk A. M. J. ten Have and Michele S. Jean, Paris: UNESCO, 2009: 112. 89Regine Kollek, “Article 6: Consent,” in The UNESCO Universal Declaration, 123. 90Kollek, 131–132. 91Beauchamp and Faden, 1275; Jonsen, Birth of Bioethics, 137: Luna, 622–623; Jay Katz, “The Nuremberg Code and the Nuremberg Trial: A Reappraisal,” JAMA 276, no. 20 (1996): 1665– 1666. 3.1 History and Development of the Role of Consent in Health Care 91 lapses in a number of studies published in prominent journals, naming the absence of fully informed consent as one of the leading problems. Examples of unethical research offered by Beecher in the article include studies in which a known effective treatment was withheld without the subject’s knowledge or consent, removal of the thymus during unrelated surgery without knowledge or consent, and the administration of toxic substances which caused mental disturbances in patients suffering from cirrhosis of the liver, again without the subjects’ knowledge or consent. Beecher had his doubts that fully informed consent was possible in many cases, and placed greater faith in “a truly responsible investigator” (emphasis in the original). Even so, he considered fully informed consent a goal for which researchers should strive.92 While Beecher’s revelations precipitated a strong reaction within the guild, the public revelation of the shocking details of the Tuskegee Syphilis Study created a greater reaction among the general populace and contributed significantly to the call for the formation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The National Commission eventually published the Belmont Report, which has been described above. The Tuskegee study was conducted over forty years by the United States Public Health Service, with the expressed aim to investigate racial differences in the nature and course of untreated syphilis. The subjects were over four hundred poor African Americans from Alabama, who were recruited by an African-American public health nurse employed by the Public Health Service. The subjects were never informed that they had syphilis, never given any guidance in how to avoid spreading the illness and never provided treatment even though effective treatment was available. More than one hundred of these subjects ultimately died from syphilis or complications of syphilis.93 Gisell Corbie-Smith, in reflecting on the lessons learned as well as the lingering consequences of Tuskegee, reached the same conclusion as Beecher: “fully informed consent is an ideal difficult to realize”. Smith notes another lesson from Tuskegee regarding consent: trust can be counter-productive. Patients and subjects may be too ready to “relinquish” autonomy and follow the advice or recommendation of a trusted clinician.94

92Henry K. Beecher, “Ethics and Clinical Research,” The New England Journal of Medicine 274, no. 24 (1966): 1354–1360. See also Jay Katz, “‘Ethics and Clinical Research’ Revisited: A Tribute to Henry Beecher,” Hastings Center Report 23 (1993): 31–39 and Franklin G. Miller, “Homage to Henry Beecher (1904–1976),” Perspectives in Biology and Medicine 55, no. 2 (2012): 218–220. 93Giselle Corbie-Smith, “The Continuing Legacy of the Tuskegee Syphilis Study: Considerations for Clinical Investigation,” The American Journal of the Medical Sciences 317 (1999): 5–8; John J. Gillon, “More Subject and Less Human: The Pain-Filled Journey of Human Subjects Protection…And Some Differences in the United States and the European Union,” Medical Law International 7 (2005): 65–66. 94Corbie-Smith, 7. 92 3 The Ethics of Consent

3.1.3.3 Social Change

Several scholars have noted the importance of social changes, specifically the several movements which promoted the recognition of equal rights, in providing a context for the emergence of informed consent as both a normative expectation and a legal requirement. The same decades which saw the rise of bioethics and its emphasis on patient autonomy also saw major movements promoting civil rights for racial minorities in the United States, women’s rights, and rights movements for other groups.95 At the same time, there was a general shift away from blind trust of anyone who might be in a position of authority, from parents to governmental officials. Janet Dolgin describes the core of the social change in this period as “the generalization of individualist values”.96 Dolgin contrasts traditional social relationships, in which hierarchy and loyalty are leading values, with most contemporary social relationships in which the values of the marketplace predominate. The values of the marketplace, says Dolgin, are predicated upon an understanding of the relationship in which those who enter it are “putatively equal and essentially fungible”. Further, in marketplace relationships, the relationship itself is thought to last only so long as is necessary for the fulfillment of the terms of the exchange of goods or services.97 Patients become consumers when marketplace values are applied to health care.98 Subjects become independent contractors, especially in non-therapeutic research for which some compensation is provided. In therapeutic research, like VCA, subjects may be seen as both consumers and independent contractors. Bruce Jennings, in describing the “cultural context” in which bioethics and its emphasis on autonomy has arisen, suggests that the dominant characteristic of the period is an insistence on “moral freedom”. Quoting sociologist Alan Wolfe, he defines moral freedom as the idea that “individuals should determine for themselves what it means to live a good and virtuous life”.99 Informed consent is an important step in this direction, and away from the tradition of physician paternalism. However, Robert Veatch asserts that informed consent is only an intermediate step, and that the natural progression would lead to a new arrangement between physician and patient in which the patient is not presented with a recommendation, as is the case in informed consent, but simply with a list of options from which to choose on the basis of his or her own values.100

95Rothman, 256; Robert D. Truog, “Patients and Doctors—The Evolution of a Relationship,” The New England Journal of Medicine 366, no. 7 (2012): 581. 96Dolgin, 99. 97Dolgin, 99. 98Nan D. Hunter, “Rights Talk and Patient Subjectivity: The Role of Autonomy, Equality and Participation Norms,” Wake Forest Law Review 45 (2010): 101. 99Jennings, “Autonomy” 79. 100This is the argument made in Veatch’s Patient, Heal Thyself: How the New Medicine Puts the Patient In Charge, New York: Oxford University Press, 2009. 3.2 The Current Understanding of Consent 93

3.2 The Current Understanding of Consent

3.2.1 The Dominant Formulation

As shall be discussed below, there are several different ways in which consent is understood within contemporary bioethics, but there is also a clearly dominant model. That dominant model is the one crafted by Tom Beauchamp and James Childress, and described in detail in their Principles of Biomedical Ethics, now in its seventh edition.101 Childress, of the University of Virginia, and Beauchamp, of Georgetown University, anchor informed consent in their principle of respect for autonomy, one of four core principles they employ to address ethical questions in health care.102 As suggested earlier, their understanding of autonomy rests rather more heavily on Mill’s notion of liberty than on Kant’s concept of autonomy.103 The dominance of Beauchamp and Childress’ formulation can be attributed in part to its early appearance and in part to the detail with which it has been described. The authors set forth seven elements of informed consent, and divide those seven elements into three groupings: threshold elements, information elements and consent elements. Threshold elements are the competence of the patient or subject and the voluntariness of the consent. Information elements include the disclosure of information, the recommendation of a plan and some attempt at determining the understanding of the information by the patient or subject. The consent elements include both the decision and the act of authorization. Beauchamp and Childress go into detail about each element.104 One important elaboration Beauchamp and Childress provide is the identiﬁcation of different standards of information disclosure, which include the professional practice standard, the reasonable person standard and the subjective standard. The professional practice standard requires the care provider to supply the information a similarly situated care provider would supply to a similar patient. The reasonable person standard holds the care provider responsible for providing all the information that a hypothetical “reasonable patient” might ﬁnd valuable in making a decision. The subjective standard extends the responsibility of the care provider to

101Beauchamp and Childress, Principles of Biomedical Ethics, 7th Edition, New York: Oxford University Press (2012). 102Originally there were three principles. Beauchamp’s involvement in crafting the Belmont Report at the same time he and Childress were working on the first edition of their Principles led to the inclusion of three principles in Belmont. One notable difference is that in Belmont, the first principle is respect for persons, whereas in Beauchamp and Childress’ work it was respect for autonomy. See T. L. Beauchamp, “The Origins and Evolution of the Belmont Report” in Belmont Revisited, Childress, Meslin and Shapiro, eds, 12. For commentary on the shift from respect for persons to respect for autonomy, see M. T. Lysaught, “Respect: or, How Respect for Persons Became Respect for Autonomy,” The Journal of Medicine and Philosophy 29, no. 6 (2004): 665– 680. 103Beauchamp and Childress, Principles, 6th Edition, 103–104. 104Beauchamp and Childress, Principles, 6th Edition, 117–135. 94 3 The Ethics of Consent include the provision of any information they have reason to believe would be of interest to that particular patient.105 The first two standards—the professional practice standard and the reasonable person standard—are closely aligned with legal standards in various states of the United States. The popularity of the dominant formulation is also due in part to its utility in modern societies where there is a “lack of shared objective morality”.106 If we are indeed and irrevocably “moral strangers,”107 then an understanding of autonomy which supports practices of informed consent that stress negative liberty, or the freedom to do as one pleases without external interference, is extremely useful. It is designed to enable peaceful co-existence in spite of diversity. Furthermore, for members of a diverse society who highly value individualism and self-expression, it is also “enormously appealing”.108 Despite or perhaps due to its dominance, the Beauchamp and Childress approach to consent has attracted a number of challenges. Some challenges address particular elements while others question the foundation, arguing that Beauchamp and Childress have defined autonomy in such a way that their whole approach to consent is distorted. At any rate, the concept of consent is not settled and important work on the subject is continuing.109

3.2.2 Critiques and Alternatives

A major critique of the dominant approach comes from Franklin G. Miller and Alan Wertheimer. Miller and Wertheimer describe Beauchamp and Childress’“autonomous authorization” approach as having “serious practical and theoretical difﬁculties”. Among these difﬁculties are the fact that consent as autonomous authorization is based on an understanding of consent that is quite different from the basis of consent in contexts other than health care. A second concern of Miller and Wertheimer is that consent as autonomous authorization fails to fully respect the need of those who seek consent to be able to determine when they may proceed.110 Miller and Wertheimer believe that the autonomous authorization approach places undue burdens on those seeking consent, and recommend instead a “fair transaction” or “moral transformation” model of consent. That model, they say, should focus on whether the transaction between physician and patient, or researcher and subject, renders morally permissible action that would otherwise be

105Beauchamp and Childress, Principles, 122–123. See also Moreno, Caplan and Wolpe, 689. 106Takala, 228. 107H. Tristam Engelhardt developed the notion of “moral strangers” in The Foundations of Bioethics, 2nd Edition, New York: Oxford University Press, 1996. See especially 3–15. 108Jennings, “Autonomy,” 78. 109Moreno, Caplan and Wolpe, 687–688. 110Miller and Wertheimer, “Preface,” in The Ethics of Consent,80–81. 3.2 The Current Understanding of Consent 95 impermissible.111 The point of view they ﬁnd most important is that of the disin- terested observer of the transaction, rather than that of the patient or subject. The adequacy of consent depends, in their view, on contextual features, including the level of risk involved. Depending on the context, expectations regarding the extent of disclosure, the competence of the patient or subject, and the degree of voluntariness may vary considerably.112 Miller and Wertheimer believe an adequate approach to consent must recognize the validity of consent even “when we want to enter into agreements without clearly or substantially understanding their terms”.113 However, they do believe that in research, the therapeutic misconception must be addressed.114 Miller and Wertheimer’s ideas about consent seem to echo Robert Nozick’s idea of distributive justice, i.e., that the distribution of power and other resources is just if it has been arrived at through transactions that were not fraudulent or coerced.115 What matters for Miller and Wertheimer is that patients or subjects are treated fairly, whether or not they in fact understand or receive full disclosure.116 Consent is a contract, and clarity regarding what each party can expect of the other is at the heart of that contract.117 In general, the requirements for valid consent recommended by Miller and Wertheimer are less rigorous than those recommended by Beauchamp and Childress, though Miller and Wertheimer contend that this difference may not yield as great an effect in practice as it does in theory.118 A second alternative to the dominant formulation of consent is that of Bernard Gert, Charles M. Culver and K. Danner Clouser. This trio of scholars developed their own systematic approach to bioethics, ﬁrst published 1997 and updated in

111Franklin G. Miller and Alan Wertheimer, “The Fair Transaction Model of Informed Consent,” Kennedy Institute of Ethics Journal 21:3 (2011): 203. 112Miller and Wertheimer, “Preface,” 95–105. 113Miller and Wertheimer, “Fair Transaction,” 205. 114Miller and Wertheimer, “Preface,” 103–104. 115See Robert Nozick, Anarchy, State and Utopia, 2nd Edition, New York: Basic Books, 2013: 149–231. Miller and Wertheimer make no mention of Nozick, but do suggest that their views are compatible with Rawls, whose understanding of distributive justice Nozick opposed. Miller and Wertheimer are only able to suggest a connection to Rawls by ignoring the concern Rawls had for power imbalances, to which he referred in his emphasis on the least advantaged. Essentially, Miller and Wertheimer argue that people in Rawl’s “original position” would come up with Nozick’s theory rather than Rawls’! See Alan Wertheimer, “Voluntary Consent: Why a Value-Neutral Concept Won’t Work,” Journal of Medicine and Philosophy 37, no. 3 (2012): 223; and Miller and Wertheimer, “Preface,” 98. 116Miller and Wertheimer, “The Fair Transaction,” 208–210; 214; Miller and Wertheimer, “Preface,” 103. 117N. G. Messer sees the understanding of consent as a contract as the result of autonomy being regarded as the key concept within a principlist system of bioethics. “Patient-professional Relationships and Informed Consent,” Postgraduate Medical Journal 80 (2004): 277. 118Miller and Wertheimer, “The Fair Transaction,” 214. 96 3 The Ethics of Consent

2006.119 Gert, Culver and Clouser argue that bioethics ought to be based not on some esoteric approach to morality, but rather on “common morality,” an informal public system which can be understood by all to whom it applies. Explanations for why an action is right or wrong should be grounded in principles which are already familiar to the average person.120 Gert, Culver and Clouser offer a list of ten brief moral rules, none more than five words in length. They admit there may be conditions under which the rules may be broken, but contend that any violation of a moral rule requires justification. Justification usually involves the appeal to one or more of the remaining moral rules.121 The moral rule which provides the foundation for informed consent in their system is the rule which says, “Do not deprive (others) of freedom”. Gert, Culver and Clouser deal with matters related to consent in three consecutive chapters of Bioethics: A Systematic Approach. In chapter eight, they describe the many kinds of information that physicians need in order to practice well and that patients may need to make decisions about their care. Some of this knowledge concerns probabilities. Understanding probabilities is important to them because they argue that patients or subjects cannot be considered informed if they merely know a certain risk or potential benefit exists; they must also have some idea how likely it is that they will experience the benefit or suffer the harm of which there is a risk. Gert, Culver and Clouser claim that many physicians currently practicing do not pursue such knowledge and may not understand it well when it is presented. If the physicians themselves do not understand it, then they obviously cannot explain it to their patients or subjects, rendering adequate consent impossible.122 Chapter nine of their book is more explicitly concerned with consent. There, the three scholars propose that valid consent requires “adequate information, competence and the absence of coercion,” and explore each in some detail.123 Chapter ten is perhaps the most unusual. It argues for the justification of paternalism in a number of contexts. The justifications they offer tend to be consequentialist in nature.124 The approach to consent of Gert, Culver and Clouser differs from the dominant formulation in at least two ways. First, they differ in terms of foundation: the moral rule, “Do not deprive of freedom,” rather than the principle of respect for autonomy. The degree of difference in this case is debatable. It would not be unreasonable to see it as more semantic than substantive. Second, they differ in terms of the practical application, with a greater emphasis being placed on the

119Bernard Gert, Charles M. Culver and K. Danner Clouser, Bioethics: A Return to Fundamentals, New York: Oxford University Press, 1997; Bioethics: A Systematic Approach, New York: Oxford University Press, 2006. 120Gert, Culver, Clouser, Bioethics: A Systematic Approach,22–26. 121Gert, Culver, Clouser, Bioethics: A Systematic Approach,36–39. 122Gert, Culver, Clouser, Bioethics: A Systematic Approach, 191–212. 123Gert, Culver, Clouser, Bioethics: A Systematic Approach, 213–236. 124Gert, Culver, Clouser, Bioethics: A Systematic Approach, 237–282. 3.2 The Current Understanding of Consent 97 quality of information. This seems to be the greatest challenge they offer to the dominant formulation of informed consent and to its normal practice. Robert Veatch challenges the dominant formulation of informed consent by rejecting the fourth element of Beauchamp and Childress, which involves the recommendation of a plan. Veatch is generally a proponent of greater patient autonomy, and is wary of the way in which a patient’s options might be limited or the patient’s choice too strongly influenced by a recommendation. Some support for Veatch’s position may come from a recent study which indicated patients are extremely reluctant to disagree with those providing their health care.125 Veatch goes so far as to speak of abandoning informed consent, because physicians are not able to judge what is in a particular patient’s best interests. Rather than a recommendation, Veatch feels the patient should simply be offered a menu of choices with their accompanying harms, risks and potential benefits.126 Howard Brody critiques the dominant approach to informed consent by noting it fails to adequately address the disparities in power between patients and subjects on the one hand and physicians and researchers on the other. This critique seems equally applicable, if not more so, to Miller and Wertheimer’s fair transaction approach. Brody contends that the principle of respect for autonomy, while intended to resolve the problem of an imbalance of power, does not in fact do so. The standard approach to autonomy tends to view the world in ways that privilege those who see themselves primarily as rational individuals with well-defined individual interests. In other words, it privileges those with a worldview typical of well-educated Caucasian males in developed western societies.127 As Brody sees it, informed consent grounded in this standard approach based on autonomy asks those who do not see themselves or the world in this way to consider and make decisions in a way that fundamentally fails to take into account all their values. Yet another major challenge to Beauchamp and Childress comes from Neil C. Manson and Onora O’Neill, who call for a rethinking of informed consent. They are concerned that the dominant approach treats information and its transfer simplis- tically. They call for a recognition that information and the transfer of information always take place in a given context, and the nature of that context determines the

125Jared R. Adams et al., “Communicating with Physicians About Medical Decisions: A Reluctance to Disagree,” Archives of Internal Medicine 172, no. 15 (2012): 1185. 126Veatch, Patient, Heal Thyself, especially 33–42, 51–56 and 91–102. It should be noted that Veatch, in this instance, is addressing consent in clinical care, not consent in research. One can extrapolate from his argument, however, how he might feel about therapeutic research such as VCA. 127Howard Brody, The Future of Bioethics, New York: Oxford University Press, 2009: 110–115. Foster has similar concerns, “Autonomy Should Chair, Not Rule,” 368–369; as does Tom Koch in “Bioethics as Ideology,” Journal of Medicine and Philosophy 31 (2006): 253. Rothman, “Origins and Consequences,” 257, argues that the dominant formulation “presumes…a ‘hyper-rational’ patient who, in disembodied, abstract, coldly analytic and bloodless fashion, calculates the advantages and disadvantages…”. 98 3 The Ethics of Consent meaning and relevance of the information, as well as the possibility for the information to be successfully transferred.128 In place of the dominant approach, they call for understanding informed consent as a waiver, granting permission to others to do what would otherwise be ethically unacceptable or legally impermissible.129 Manson and O’Neill go so far as to claim that consent is not “ethically fundamental,”130 a claim rebutted in a 2010 review by Y. Michael Barilan of Manson and O’Neill’s book, Rethinking Informed Consent.131 Barilan’s own perspective on informed consent will be treated in detail below. Y. Michael Barilan is also critical of the dominant formulation of informed consent. First, he sees Beauchamp and Childress’ definition of autonomy as inadequate.132 Second, he sees their conceptual approach to informed consent as too heavily shaped by its origins, which have emphasized protection from abuse and harm. Barilan argues that a more adequate formulation of informed consent should be grounded in reflection on its role and functions in more typical health care treatment and research settings.133 Barilan is critical of “codes of ethics,” seeing them as legalistic and minimalistic. He contends that health care practices, including the practice of obtaining informed consent, are better when guided and shaped by virtue ethics, which are “excellence-oriented,” rather than by codes, which he feels tend to set too low a bar.134 Barilan is especially troubled by the reduction of informed consent to non-interference with any choice made by “free, adequately informed, and mentally competent persons”.135 He contends that genuine respect for persons often includes non-coercive attempts to persuade them. Informed consent is ideally the product of mutual deliberation, in which all parties seek to understand one another and are open to being persuaded.136 Barilan sees respect for autonomy as too flimsy a foundation for consent, unless it is acknowledged that respect for autonomy is always intertwined with and dependent upon “respect for human dignity, the virtue of prudence, and the attitudes of charity and humility”.137 Consent is therefore as much about respecting human dignity as it is about avoiding abuse or

128Neil C. Manson and Onora O’Neill, Rethinking Informed Consent in Bioethics, Cambridge: Cambridge University Press, 2007: 26–49. 129Manson and O’Neill, 72–77. 130Manson and O’Neill, 78. 131Y. Michael Barilan, “Informed Consent: Between Waiver and Excellence in Responsible Deliberation,” Medicine, Health Care and Philosophy 13 (2010): 89–95. 132Y. M. Barilan, “Respect for Personal Autonomy, Human Dignity, and the Problems of Self-Directedness and Botched Autonomy,” Journal of Medicine and Philosophy 36 (2011): 497, 512. 133Barilan, “Informed Consent,” 92. 134Y. M. Barilan and M. Brusa, “Deliberation at the Hub of Medical Education,” Medicine, Health Care and Philosophy, 16, no. 1 (2013): 5. 135Barilan, “Respect for Personal Autonomy,” 497. 136Barilan, “Persuasion as Respect for Persons,” 21. 137Barilan, “Respect for Personal Autonomy,” 502. 3.2 The Current Understanding of Consent 99 manipulation.138 Barilan’s position is not far removed from that of Thomasma and Pelligrino, who assert there has been an overemphasis on autonomy, at the expense of other values.139 Grzegorz Mazur contends that the dominant formulation of informed consent is lacking in three critical respects. First, it provides no role for virtue or moral character in informed consent. Second, it is not concerned with the formation of conscience. Third, it does not address the importance of integrity. Mazur’s concern seems to be that the dominant formulation operates without reference to the content of the consent, but only with the procedural elements and the conditions under which informed consent is carried out.140 Mazur favors an alternative foundation for informed consent which he draws from Roman Catholic teachings and traditions. His justiﬁcation of informed consent relies on a foundation of justice, love and equality before God, values which are equally binding on both the patient and the health care professional, regardless of the difference in status or power between them.141 Several bioethicists feel “shared decision-making” is a better descriptor than informed consent, when it comes to what ought to take place in health care. There is evidence that greater patient involvement in decision-making leads to improved outcomes.142 Practitioners often embrace the ideal of shared decision making, but consider its use somewhat impractical, noting many barriers: time constraints, patients lacking interest, and a dearth of tools to facilitate the process.143 Some practitioners and policy makers exhibit concern that shared decisions may increase demand for “unnecessary, costly or harmful procedures”.144 The effective implementation of shared decision making requires addressing the concerns of professional care providers, developing resources to support patient participation, and training both the professionals and the patients to participate in shared decision making.145 For Moulton and King, shared medical decision-making is “a process of communication”. Patients and care providers exchange information, with the care

138Barilan, “Informed Consent,” 94. 139David C. Thomasma and Edmund D. Pelligrino, “Autonomy and Trust in the Clinical Encounter: Reflections from a Theological Perspective,” in Theological Analyses of the Clinical Encounter, Gerald P. McKenny and J. R. Sande, eds, Dordrecht: Springer, 1993: 70. 140G. Mazur, 70–71. 141G. Mazur, 7–9. 142France Legare et al., “Patients’ Perceptions of Sharing in Decisions,” The Patient 5, no. 1 (2012): 2; Michael J. Barry and Susan Edgman-Levitan, “Shared Decision Making—The Pinnacle of Patient-Centered Care,” New England Journal of Medicine 366, no. 9 (2012): 781. 143Glyn Elwyn et al., “Option Grids: Shared Decision Making Made Easier,” Patient Education and Counseling 90 (2013): 208. 144Legare et al., 3. 145Barry and Levitan, 781; Legare et al., 14; Thomas Bodenheimer et al., “Patient Self-management of Chronic Disease in Primary Care,” JAMA 288, no. 19 (2002): 2474. 100 3 The Ethics of Consent provider supplying information about risks and benefits of treatment alternatives, while the patient supplies information about his or her values and life situation that bear upon the decision to be made.146 William Sieber and Robert Kaplan likewise call for shared medical decision making, which takes seriously the values and experiences of the patient or subject, and assert that this approach is far more likely to promote adherence than informed consent which focuses on providing information but not on gathering information or receiving any back.147 France Légaré, describing several models of the physician-patient relationship and their effects on decision-making, claims that shared decision-making is a “negotiation process” which has implications for the nature of the clinical encounter prior to the actual decision. These include the development of a therapeutic alliance grounded in empathy, eliciting the patient’s understanding of the illness, the physician’s description of the illness in laymen’s terms, and the open acknowledgement of differences in understanding between the patient and physician. Légaré also notes that shared decision-making is especially important in the context of “clinical uncertainty where a ‘good’ decision might lead to an undesirable outcome”.148 Jones, McCullough and Richman advise a form of shared decision-making in their article, “Comprehensive Primer of Surgical Consent”. They feel that consent is an element in a larger therapeutic alliance with the patient, and this alliance requires an awareness of the patient’s values and belief systems. It also requires that patients be encouraged to ask questions, and that the care provider should ask questions intended to elicit the patient’s values.149 Pip Creswell and Jean Gilmore assert that consent must consist of the formation of a “partnership” with the patient or subject, which implies a commitment to support the patient or subject and assessment of the continuing validity of the consent throughout treatment or research.150 Wade et al., have explored how specific practices may encourage shared decision making. They studied the effects of different strategies used in recruitment appointments for randomized controlled trials. They found that when recruiters controlled and dominated the agenda of these appointments, potential subjects were more passive and less likely to demonstrate understanding or to express concerns. On the other hand, when recruiters employed a strategy that used open questions,

146Benjamin Moulton and Jaime S. King, “Aligning Ethics with Medical Decision-Making: The Quest for Informed Patient Choice,” Journal of Law, Medicine and Ethics 38, no. 1 (2010): 89. 147William J. Sieber and Robert M. Kaplan, “Informed Adherence: The Need for Shared Medical Decision Making,” Controlled Clinical Trials 21 (2000): 234S–237S. 148France Légaré, “Models of Physician-Patient Relationship,” in Encyclopedia of Medical Decision Making, ed. by Michael W. Kattan, Thousand Oaks: Sage Publications, 2009: 775–776. 149James W. Jones, Lawrence B. McCullough and Bruce W. Richman, “A Comprehensive Primer of Surgical Informed Consent,” Surgical Clinics of North America 87 (2007): 90–912. 150Pip Cresswell and Jean Gilmour, “The Informed Consent Process in Randomised Controlled Trials: A Nurse-led Process,” Nursing Praxis in New Zealand 30, no. 1 (2014): 22–23. 3.2 The Current Understanding of Consent 101 pauses and a willingness to allow the potential subjects to lead the conversation, the potential subjects asked more questions, more readily expressed concerns, and demonstrated better comprehension.151 Alasdair Maclean contends at length for a richer understanding of informed consent, an understanding which includes the acknowledgement that consent “raises issues of liberty, power, control and responsibility”.152 Like others, Maclean sees shared medical decision-making as the means “of achieving a more meaningful consent”. Without the genuine engagement between persons that is a part of shared decision-making, informed consent may be “abandoning patients to their decisions”.153 Arthur Caplan sees this same problem unfolding in certain situations, observing that it can leave “too many competent and able patients…unsure, guilty, bereft, floundering or angry”.154 Whitney, McGuire and McCullough recommend shared decision making in cases of uncertainty, where two or more reasonable alternatives exist, while holding that in other cases informed consent or even simple consent may be sufficient. For them, shared decision making “involves an exchange of ideas” and “collaboration,” and they counsel that physicians should empower patients.155 Priscilla Alderson and Christopher Goodey take a more descriptive approach to consent and point out that it is “understood differently by various disciplines and professions, and also in various theoretical models”.156 They distinguish between real consent, constructed consent, functionalist consent, critical theory and post-modern choice, while noting critiques of these various models. Real consent and critical theory come close to the dominant model of Beauchamp and Childress, emphasizing information exchange and authorization, as well as the protections of patients or subjects and physicians or researchers. Socially constructed consent recognizes that consent is often, and perhaps ideally, a process involving interaction and the development of trust between care provider and patient or subject. Thus, it bears a resemblance to shared decision-making. Further, according to Alderson and Goodey, socially constructed consent acknowledges the web of relationships in which patients and subjects find themselves, and believes that these relationships can contribute positively to decision-making. Functionalist consent is, according to Alderson and Goodey, “a polite ceremony,” or formality in which the net effect is to

151Julia Wade et al., “It’s Not Just What You Say, It’s Also How You Say It: Opening the ‘Black Box’ of Informed Consent Appointments in Randomized Controlled Trials,” Social Science and Medicine 68 (2009): 2018–2028. 152Alasdair Maclean, Autonomy, Informed Consent and Medical Law: A Relational Challenge (Cambridge Law, Medicine and Ethics) Cambridge: Cambridge University Press, 2013: 9. 153Maclean, Autonomy, Informed Consent and Medical Law, 129. 154Arthur L. Caplan, “Why Autonomy Needs Help,” Journal of Medical Ethics epub ahead of print, doi:10.1136/medethics-2012-100492. 155Simon N. Whitney, Amy L. McGuire and Laurence B. McCullough, “A Typology of Shared Decision Making, Informed Consent, and Simple Consent,” Annals of Internal Medicine 140, no. 1 (2004): 54–59. 156Priscilla Alderson and Christopher Goodey, “Theories of Consent,” BMJ 317 (1998): 1313. 102 3 The Ethics of Consent transfer responsibility from physician or researcher to patient or subject. Finally, post-modern choice recognizes that much health care in developed societies is not treatment of disease or injury that is urgent and life threatening, but for conditions that are minor and allow for the consideration of personal preferences. Under these conditions, patients assume the role of consumer. Post-modern choice approximates Veatch’s perspective, in which patients simply choose from options based on their values, much as they expect to do as consumers in other aspects of life.157 Kaufert and O’Neil also take a more descriptive approach to consent, and recognize it as a process for developing trust between parties who differ significantly in terms of power and perhaps culture. Informed consents may be viewed as rituals, which they define as “formal, repetitive behaviors which express and renew basic cultural values and define social relationships”.158 Ideally, the ritual ameliorates a sense of powerlessness often felt by the patient or subject.159 Y. Michael Barilan also appreciates the value of the formal elements of informed consent as rituals. By making explicit the “implicit contract” between doctor and patient or researcher and subject, the ritual of consent impresses upon all parties the importance of reflection and deliberation, as well as the value of information. Further, the ritual of informed consent may make patients and subjects aware of their power at a time when they may be feeling powerless or especially vulnerable, while reawakening the physician’s or researcher’s conscience to the seriousness of the obligations he or she bears, both to the patient or subject and to the norms and institutions of scientific medicine. The ritual of informed consent may even be a means of drawing attention to and strengthening the “therapeutic alliance” between the parties.160

3.3 A More Fundamental Critique

Despite its critics, the model of informed consent offered by Beauchamp and Childress remains dominant. Accounting for this dominance is not difﬁcult. As noted previously, it has three signiﬁcant advantages over its competitors. First, it has a much longer history than its alternatives, originating nearly forty years ago, just as modern bioethics was beginning with the founding of institutions and journals.161 Second, from the start it has been integrated into a more comprehensive

157Alderson and Goodey, 1313–1315. 158Joseph M. Kaufert and John D. O’Neil, “Biomedical Rituals and Informed Consent,” in Social Science Perspectives on Medical Ethics, ed. by George Weisz, Dordrecht: Kluwer Academic Publishers, 1990: 43. 159Kaufert and O’Neil, 59. 160Barilan, “Informed Consent: Between Waiver and Excellence,” 93–94. 161The Hastings Center began in 1969, the Kennedy Institute in 1971, and the Society for Health and Human Values in 1970, while the first issue of the Hastings Center Report appeared in 1971. See Jonsen, The Birth of Bioethics,20–27. While the first edition of Principles and Biomedical 3.3 A More Fundamental Critique 103 presentation of health care ethics and described in detail, with the precision of that detail increasing through the several revised editions of Principles of Biomedical Ethics. Third, it offers a way to avoid certain conflicts in a diverse society. In addition to these advantages, it must be conceded that the model of informed consent functions reasonably well as a standard approach; that is, it adequately supports good practices in the majority of situations in which consent ought to be sought in the health care context. Even so, it does have limitations and these limitations become apparent in certain special circumstances. The limitations result from the historical and philosophical origins of the concept. Within the context existing at the time of the formation of the concept, this dominant model of consent attempted to answer the most pressing questions, i.e., how can the rights of patients and research subjects be protected; how can gross ethical violations, like those found in the Nazi experiments and the Tuskegee research, be avoided; and how can patients and research subjects clearly convey legal permission to physicians and researchers. Other questions were not considered and thus other possible functions of and approaches to consent were not developed. To more fully appreciate the nature and scope of the limitations, it is necessary to explore more thoroughly the historical and philosophical origins of the dominant model and to look at certain contexts in which it does not serve patients, subjects, physicians or researchers well. Insights from themes touched on by Wibren van der Burg, Y. Michael Barilan and Rebecca Kukla will be central in the exploration and examination.162

3.3.1 Historical Origins

As noted earlier in this chapter, the three primary factors which led to the development of the current concept of informed consent were the revelation of troubling research practices, social change emphasizing human rights, and a series of legal cases. Each of these was substantially if not predominantly concerned with law. The development and reﬁnement of the legal doctrine of informed consent occurred primarily through case law. Troubling research practices both generated statutory laws and often led to victims seeking redress through civil suits. Finally, the various

(Footnote 161 continued) Ethics did not appear until 1979, Beauchamp and Childress were working on the manuscript in the mid-1970’s, at the same time Beauchamp was working on the Belmont Report. See Tom L. Beauchamp in Belmont Revisited, ed. by Childress, Meslin and Shapiro, 13. 162Barilan, “Informed Consent,” 94; Barilan and Brusa, passim; Rebecca Kukla, “How Do Patients Know?” The Hastings Center Report 37 (2007): 29–31; Rebecca Kukla, “Communicating Consent,” Hastings Center Report 39, no. 3 (May–June 2009): 46–47; Rebecca Kukla, “Conscientious Autonomy: Displacing Decisions in Health Care,” Hastings Center Report 35, no. 2 (2005): 37–38; Wibren van der Burg, “Law and Bioethics” in A Companion to Bioethics, 2nd Edition, ed. by Helga Kuhse and Peter Singer, Oxford: Wiley-Blackwell, 2012: 56–64. 104 3 The Ethics of Consent rights movements (civil rights, women’s rights, etc.) frequently generated new statutory laws and regulations. Given the role of law in each of the factors that led to the development of the current concept of informed consent, it should come as no surprise that the concept of informed consent has been profoundly shaped by the perspective and role of law.163 Mark Rothstein points out that informed consent was an established legal doctrine before it was fully defined and accepted in medical ethics.164 Legal scholar Nan D. Hunter refers to the development of informed consent as “a species of tort” through “a slow accretion of references in state tort law”.165 Wibren van der Burg, writing in the second edition of A Companion to Bioethics, claims that law and ethics are more “strongly intertwined” in biomedicine than in any other field, and the work of bioethicists is “both oriented towards the law and influenced by the law”. He names informed consent as a leading example of a concept which has been developed through cooperation between lawyers and ethicists.166 Not all the effects of this close relationship between law and ethics have been salutary. As van der Burg acknowledges, “Legal styles of argument can influence the style of moral reasoning,” and “legal concepts sometimes influence the structure of moral debates”.167 In the case of informed consent in particular, it is not difficult to see that the dominant formulation has borrowed conceptual categories from law, speaking of “rules, principles, rights and procedures”.168 Further, van der Burg points out, the unfortunate consequence is that the resultant health care ethics tend to focus on “what is minimally necessary,” rather than on best practices.169 Joan H. Krause asserts that “the legal system offer(s) a highly imperfect mechanism for achieving ethical ideals,” and that it can in fact create “barriers”.170 As David Wendler and Jonathan E. Rackoff point out, even the signature requirement can become an impediment, as in those instances when it clashes with the cultural values or the reasonable fears of patients.171 When ethics appropriates not only some of the vocabulary but also the implied conceptual world of law, limits are imposed on what it is reasonable to expect of ethics. Conceptually, one of the main purposes of law is to protect us from one another and from violations of our person or our property by others. This requires

163Moreno, Caplan and Wolpe, 688–689; Hunter, 102. 164Rothstein, 75. 165Hunter, 104–105. 166Van der Burg, 56. 167Van der Burg, 61. 168Van der Burg, 62. 169Van der Burg, 62–63. 170Joan H. Krause, “Can Health Law Truly Become Patient Centered?” Wake Forest Law Review 45, no. 5 (2010): 1490. 171David Wendler and Jonathan E. Rackoff, “Informed Consent and Respecting Autonomy: What’s a signature got to do with it?” IRB: Ethics and Human Research 23, no. 3 (2001): 1–4. 3.3 A More Fundamental Critique 105 the demarcation of and emphasis upon boundaries (rights),172 which further incline us to think of others as actual or potential threats to our well-being. Law thus arouses our suspicions and subtly alienates us from each other, and ethics which are heavily influenced by law are bound to do the same.173 Under the influence of law, informed consent becomes more of a transaction, and often a merely formal one, rather than a process of shared discernment and decision.174 Informed consent becomes simply a means of protecting patients and subjects from unwanted treatment or research and “an essential constraint on the most powerful profession”.175 Such protections and constraint are important, of course. One must hope that informed consent so conceived has already prevented several instances in which great harms would have otherwise occurred. It is also plausible to expect that the legal requirement of informed consent will prevent future harms. The legal doctrine of informed consent should indeed emphasize rights, boundaries and protection.176 However, the ethical concept need not always have the same emphasis as the legal doctrine.177 In fact, Y. Michael Barilan argues that the protection of patients and subjects, while important, is far from the “sole justification for the universal practice of informed consent”. Rather, he argues, informed consent is an expression of respect for the dignity of persons and an attempt to “recruit the best level of cooperation”.178 There can be a much richer, less rigid and more sensitive understanding of consent when the ethical concept is sufficiently liberated from the context of conflict and law.179 This richer, less rigid and more sensitive understanding of consent is appropriate and beneficial in situations of clinical care and therapeutic research in which long-term engagement and cooperation are expected.180

3.3.2 Philosophical Origins

While the influence of the legal ethos on the formation of the concept and practice of informed consent has been quite profound, the concept and practice have also been heavily influenced by their philosophical foundation. Specifically, particular

172Hunter, 115. 173Jack Coulehan et al., “The Best Lack All Conviction: Biomedical Ethics, Professionalism and Social Responsibility,” Cambridge Quarterly of Healthcare Ethics 12 (2003): 23; Krause, 1491. 174Krause, 1492. 175Alderson and Goodey, 1314. 176Manson and O'Neill, 82; Kukla, “Conscientious Autonomy,” 35. 177Joffe and Truog, 367–368. 178Barilan, “Informed Consent: between waiver and excellence,” 93. 179Van der Burg, 63; Coulehan et al., “The Best Lack All Conviction,” 23. 180Grant Gillett and Simon Walker, “The Evolution of Informed Consent,” Journal of Law and Medicine 19, no. 4 (2012): 674. 106 3 The Ethics of Consent notions of autonomy have tended to hold sway, especially in the dominant formulation set forth by Beauchamp, Faden and Childress181 and carried further by others, such as Veatch.182 These notions form the basis of the position that “a competent and informed adult must always be free to…make his or her own choices in the light of his or her own preferences”.183 When autonomy is conceived solely as decisional freedom, and informed consent is understood as the procedure or process designed to protect autonomy thus understood, the outcome is predictable: informed consent becomes the means by which individuals deemed to have capacity are able to assert their wills without interference, regardless of foreseeable consequences of their choices unless one foresees that the consequences would include unjust harm to others. As Mill himself asserted, “the only purpose for which power can rightly be exercised over (another)…against his will, is to prevent harm to others”.184 Some see the influence of Millian liberty being too great in the dominant formulation. Bruce Jennings goes so far as to claim that “talk about ‘autonomy’ in bioethics is something of a misnomer” because the operative idea in the dominant formulation “is a version of Millian ‘liberty.’”185 According to Gillett, this version of autonomy becomes problematic because it is “compatible with selfishness,”186 and respect for autonomy means the decision of the patient or subject is not to be second-guessed.187 Respect for autonomy may therefore be used to endorse choices and acts which directly or indirectly undermine the common good, or even the good of the patient or subject. Alternative ways of thinking about autonomy can lead to alternative ways of thinking about the meaning and process of informed consent. One alternative would be to place a greater emphasis on Kant than Mill in one’s way of understanding autonomy. Onora O’Neill, for example, offers a neo-Kantian alternative which she calls “principled autonomy”.188 O’Neill contends that a concept of autonomy oriented to principles and obligations rather than to mere self-expression or assertion is better able to support “the maintenance and creation of trust,” which she sees as an essential value in health care.189 Rebecca Kukla may also be classified as a neo-Kantian in her thinking about how autonomy should function in health care ethics. She calls the dominant

181Beauchamp and Childress, Principles, 117–120; Faden and Beauchamp, A History and Theory of Informed Consent, 235–268. 182Veatch, Patient, Heal Thyself,57–64. 183Takala, 225. 184Mill, quoted in Jennings, “Autonomy,” 83–84. 185Jennings, “Autonomy,” 73. 186Gillett, “Autonomy and Selﬁshness,” 1214. 187Jennings, “Autonomy,” 74. 188Onora O’Neill, Autonomy and Trust in Bioethics, New York: Cambridge University Press, 2007: 16. 189O’Neill, 84–95. 3.3 A More Fundamental Critique 107 approach “inadequate,”190 in part because it is too narrow. The focus on autonomy as decisional freedom has led, according to Kukla, to a focus on the “punctuate decision—a decision made in response to a discrete choice that can be understood in isolation…”191 Bioethics therefore tends to restrict its thinking about autonomy solely to “discrete crises or choice points”.192 Instead of thinking of autonomy as individual decisional freedom, Kukla suggests it be thought of as “conscientious autonomy,” which for her is the notion that we ought to “act out of a commitment to diligently uphold principles…that we take as our own normative standards”.193 Further, Kukla points out that much of our health care is made up of “routine, on-going activities,” such as exercise, refraining from behaviors thought to damage health, and self-monitoring for signs of illness. We do not make discrete decisions to do these things each time we do them. Instead, we commit to them as an expression of our values and they become habitual.194 We cultivate these habits in part as a means of reaching goals we have chosen for ourselves and in part from a sense of accountability to others, including others in positions of medical authority.195 This blended accountability to self and others is what Kukla calls “conscientiousness” which “is inherently a virtue displayed over time”.196 Diego Gracia offers yet another neo-Kantian approach to understanding autonomy. He argues that the “proper moral meaning of the word” is one which leads to acts that are post-conventional, inner-directed and responsible.197 Gracia distinguishes his view from Kant’s by pointing out that his view focuses on acts while Kant’s is concerned with persons, but admits that otherwise they share much in common. Gracia points out that his view of autonomy is “compatible with agreements but not with obedience”. He also admits that it is such a high standard that truly autonomous actions are “rare, unusual and (even) exceptional for human beings”.198 Because of this, it cannot be used as legal requirement. However, it can and should be the ethical ideal that is sought, and the proper goal of ethics should be to form persons capable of it.199 In addition to Kantian critiques of the dominant formulation of autonomy, it may also be worthwhile to consider relational critiques, which are not entirely incompatible with Kant’s theory. Kant may insist that one’s morality ought to arise from reason alone, uncoerced by others. Even so, the conclusions he reaches about a

190Kukla, “Conscientious Autonomy,” 35. 191Kukla, “Conscientious Autonomy,” 35. 192Kukla, “Conscientious Autonomy,” 36. 193Kukla, “Conscientious Autonomy,” 38. 194Kukla, “Conscientious Autonomy,” 36–37. 195Kukla, “Conscientious Autonomy,” 37. 196Kukla, “Conscientious Autonomy,” 38–39. 197Diego Gracia, “The Many Faces of Autonomy,” Theoretical Medicine and Bioethics 33, no. 1 (2012): 57. 198Gracia, 62. 199Gracia, 57, 63. 108 3 The Ethics of Consent morality based in reason are always mindful of others. The categorical imperative calls upon us to act in ways we would desire others to act in the same situation, while to act morally, according to Kant is to treat others as ends, not means. Kantian thought regarding autonomy is thus clearly other regarding. As Gillett puts it, “(Kantian) autonomy, rightly construed, therefore results in action informed and motivated by the desire to be a responsible member of one’s moral community”.200 Yet a relational critique would ask for more than simple regard for others. It would call for us to disavow the notion that decisions or commitments are usually —or even should be—made from a position of “unencumbered independence”. Rather, it would require us to acknowledge that dependence, responsibility and collaboration are part of the more typical and appropriate context of decision and commitment making.201 Indeed, scholars from feminist ethics and from the ethics of care perspective contend that the “liberal understanding of autonomy,” by assuming individuals to exist and operate out of a strict self-concept of individuality and self-sufficiency, significantly misrepresents the actual human condition of the vast majority of people. They call for an account of autonomy that is able to integrate notions of “relationality, interdependence and…vulnerability” and which values “dignity, trust, authenticity, and integrity”.202 Catriona Mackenzie has provided a thorough account of her version of relational autonomy, which she claims is better suited to addressing both philosophical and practical problems with respect for autonomy in the health care setting. Contra Veatch and others who would ground the requirement of respect for autonomy in epistemic humility, Mackenzie recommends grounding it in a recognition that autonomy is a social construct. Normative authority over one’s own life is a good to be promoted, but it must be acknowledged that an individual’s sense of self is “developed and sustained intersubjectively”.203 When this is acknowledged, it becomes possible to recognize and respond to situations in which the desires and values of a person “may have arisen from oppressive social relationships”.204 The acknowledgment of the relational aspect of autonomy also implies that respect for autonomy requires efforts to promote autonomy by providing the social structure (i.e., justice conditions) and interpersonal support necessary for the person to develop “self-respect, self-trust and self-esteem”.205 Y. Michael Barilan argues that the definition of autonomy by Beauchamp and Childress “seems to fit voluntariness, not autonomy,” and thus provides little help in cases where patients have capacity but “demonstrate no consistent pattern of

200Gillett, “Autonomy and Selﬁshness,” 1215. 201Kukla, “How Do Patients Know?”, 29; John Christman, “Relational Autonomy, Liberal Individualism and the Social Construction of Selves,” Philosophical Studies 117 (2004): 143–147. 202Rita M. Struhkamp, “Patient Autonomy: The View From the Kitchen,” Medicine, Health Care and Philosophy 8 (2005): 105. 203Catriona Mackenzie, “Relational Autonomy, Normative Authority and Perfectionism,” Journal of Social Philosophy 39, no. 4 (2008): 514–526. 204Mackenzie, “Relational Autonomy,” 513. 205Mackenzie, 525. 3.3 A More Fundamental Critique 109 aiming at some good”.206 In another article, Barilan and Moshe Weintraub also critique the dominant understanding of autonomy from a relational perspective. They aver that “people are dependent on social interaction in order to construct their autonomy and secure it”.207 For Barilan and Weintraub, one implication of such a view is that physicians have an obligation to attempt to persuade patients to accept medical advice, but only with a “non-coercive attitude” and a willingness “to be persuaded while trying to persuade”.208 They contend that by means of “creative and sincere interpersonal engagement” one both demonstrates respect for autonomy and enhances the other’s ability to choose autonomously.209 For Barilan, genuine autonomy is “self-governance that is sincerely interactive with some other people” and “open to deliberation, to ‘reason-giving,’ and to persuasion”.210 Given that humans are inherently social, thrive in non-oppressive relationships of mutual responsibility, and often value those relationships and the others in them as much or more than they value themselves, it should not be a surprise that a liberal individualistic concept of autonomy will strike many “as arrogant, grimly isolating or misguided”.211 Relational approaches to understanding autonomy offer an alternative that is more appropriate to many health care settings in which consent is sought, because relational autonomy better accounts for those situations in which persons may want or even need others to help them reach a decision and to carry that decision through. Further, relational understandings of autonomy remind us that while manipulation and coercion constitute disrespect, non-interference does not necessarily constitute respect; it may simply be an expression of indifference.212

3.3.3 Atypical Contexts

The ﬂaws or weaknesses in the dominant approach to informed consent in health care, which are derived in part from the concept’s close association and long shared history with law and in part from a philosophical foundation which emphasizes individualism and liberty over connectedness and responsibility, do not always cause the dominant approach to be inadequate. As stated earlier, the standard

206Y. Michael Barilan, “Respect for Personal Autonomy, Human Dignity, and the Problems of Self-Directedness and Botched Autonomy,” Journal of Medicine and Philosophy 36 (2011): 497. 207Y. Michael Barilan and Moshe Weintraub, “Persuasion as Respect for Persons: An Alternative View of Autonomy and of the Limits of Discourse,” Journal of Medicine and Philosophy 26, no. 1 (2001): 22. 208Barilan and Weintraub, 20. 209Barilan and Weintraub, 21. 210Barilan, “Respect for Personal Autonomy,” 500. 211Arthur Caplan, “Why Autonomy Needs Help,” Journal of Medical Ethics 40, no. 5 (2014): 301. 212Barilan and Weintraub, 20; Caplan, “Why Autonomy Needs Help,” 201–302; Jennings, “Autonomy” in The Oxford Handbook of Bioethics,86–88. 110 3 The Ethics of Consent approach to seeking and providing informed consent is sufﬁcient in most circumstances. This is so because the standard approach assumes conditions which are not uncommon in modern health care: an intervention which is relatively limited in duration and in which the patient or subject plays a predominantly passive role. Common surgeries, like appendectomies or cholecystectomies, would be examples. The information the surgeon is expected to supply is generally straightforward, while the risks and burdens are well established. Post-surgical requirements for patients involve mostly rest and the avoidance of certain strenuous activities, and most patients are able to return to normal activities within weeks or a few months at most. Under these conditions, the physician asking for consent seeks authorization to perform the surgery, and consent is essentially permission or authorization to do so.213 But some clinical treatment or therapeutic research may take place under very different conditions. For example, in emergency situations that arise with little or no warning, basic mental processing skills may falter in otherwise normal patients or surrogates. Proponents of interpreting medical encounters phenomenologically have emphasized this in their descriptions of the experience of illness.214 Allmark and Mason, who are not phenomenologists, found evidence of impaired mental processing skills under such conditions. They studied parents suddenly confronted with the need to give or withhold consent to participation in a randomized controlled trial involving total body hypothermia for their critically ill neonates. Allmark and Mason found problems among the parents in both competence and understanding. A number of the parents themselves later expressed doubts about the validity of their consent at the time it was given.215 Another example of atypical circumstances would be extended research protocols or therapeutic programs which demand a great deal of time, energy and commitment from patients or subjects and in which the risks and/or burdens are substantial. In these circumstances, more may be required than a simple act of authorization-seeking and permission-giving at the outset. It would be more ﬁtting to understand consent in such circumstances as entering into a partnership, rather than as simply seeking and receiving permission. Grant Gillett calls on medical professionals to see themselves as guides, especially when the course of treatment is long and arduous. As he puts it, patients are “on a journey and have strayed from their chosen path…into the wasteland of illness and disease”. Consent that extends through time brings physician or researcher and patient or subject together as partners.216

213Beauchamp and Childress, 119. 214Richard J. Baron, “An Introduction to Medical Phenomenology: I Can’t Hear You While I’m Listening,” Annals of Internal Medicine 103 (1985): 609–610. 215P. Allmark and S. Mason, “Improving the Quality of Consent to Randomized Controlled Trials by Using Continuous Consent and Clinician Training in the Consent Process,” Journal of Medical Ethics 32, no. 8 (2006): 439–443. 216Gillett, “The Evolution of Informed Consent,” 674. 3.3 A More Fundamental Critique 111

Furthermore, in extended treatment or research, taking antecedent consent to be sufficient does not reflect what we know to be true about patients and subjects. First, subjects and patients may not fully understand or appreciate the treatment or research protocol until after they have experienced it. Their initial expectations may be confirmed or confounded. If their expectations are confounded, they have obtained new information and some would argue that a renewal of their consent is advisable.217 Second, under stressful and urgent conditions at the outset of treatment or therapeutic research, it may be especially difficult for patients or surrogates to find the mental focus or have the time to deliberate as they might wish to.218 Third, patients and subjects simply forget the information on which their consent is to be based.219 Patients can even be aware that they have forgotten, and want the information, but be reluctant to ask for it.220 This raises questions about the legitimacy of their consent for present and future treatment and may also diminish their rate of compliance or adherence.221 One way of addressing concerns about patient or subject forgetfulness or changes in protocol during lengthy research is through the practice of “re-consenting”. This practice is generally a simple repetition of the original consent procedure, noting changes if any and again requiring a signature on a new consent form.222 This practice is particularly appropriate in instances of significant material changes in the research protocol.223 Another way to address the concerns raised by patient or subject “forgetfulness” and new information obtained through the actual experience of research or treatment is to incorporate into research protocols or care plans “periodic and informal discussions” during which participants would be given the opportunity and encouragement to ask questions.224 This is preferable to a periodic repetition of the full original consent disclosure and formal consent signing, according to Helgesson and Ericksson, who argue that full repetition or re-consenting may convey

217Dave Wendler and Jonathan Rackoff, “Consent for Continuing Research Participation: What It Is and When It Should be Obtained,” IRB: Ethics and Human Research 24, no. 3 (2002): 2. 218Allmark and Mason, 442–443. 219Kristen J. Prentice et al., “Maintaining Informed Consent during Lengthy Research Protocols,” IRB: Ethics and Human Research 29, no. 6 (2007): 1. 220Smith et al., “Empirical Evaluation of the Need for ‘On-Going Consent’ in Clinical Research.” AIDS 25 (2011): 109. 221Joffe and Truog, 350–356; Gert Helgesson and Stefan Eriksson, “Does Informed Consent Have an Expiry Date? A Critical Reappraisal of Informed Consent as a Process, Cambridge Quarterly of Healthcare Ethics 20 (2011): 90. 222Mary-Rose Meuller and Susan Instone, “Beyond the Informed Consent Procedure: Continuing Consent in Human Research,” Ciencia & Saude Coletiva 13, no. 2 (2008): 384–385. 223Wendler and Rackoff, “Consent for Continuing Research,” 2–3. 224Smith et al., 111–112. 112 3 The Ethics of Consent disrespect toward subjects and encourage them to drop out of studies.225 Wendler and Rackoff call this “reaffirmation of willingness to participate”.226 Consent for lengthy or complex treatments or research may also take place in tiered, layered or staged models. Tiered models are appropriate in screening or testing which may provide more information than is desired at one time. The patient or subject can then select how much information to receive initially, while retaining the option to receive more at a later time. Layered consent understands that different patients or subjects may want different amounts of information. Basic information is shared with all, but individual patients or subjects may request additional “layers” of information at that point or later on. Staged consent is designed for complex and high stakes treatment proposals or research protocols. Staged consent is premised on the idea that in such situations, time is needed to absorb and reflect upon information and it is helpful to present the information in stages. It may also be that there are obvious steps in the protocol or treatment that can be consented to independently.227 Prentice et al., have identified six areas of knowledge which they claim must be maintained over the course of lengthy research protocols in order to “maintain valid consent”. These include several items of basic knowledge, beginning with the knowledge that one is participating in research and not simply receiving treatment as one would in standard medical care. Other areas of subject knowledge they consider essential are: (1) understanding that participation is voluntary and they have the right to withdraw; (2) understanding that withdrawal will not prevent them from receiving clinical care; (3) knowledge of the purpose or goal of the research; (4) knowledge of the risks involved in the research; and (5) knowledge of how standardized treatment in research differs from individualized clinical care.228 When treatment or research protocols are both lengthy and impose substantial demands on patients or subjects, the understanding of consent as permission-giving or authorization is even more substantially called into question. In these circumstances, consent is not simply allowing another to act after being informed of the likely consequences and possible risks. Consent to treatment or research that requires patients to be actively engaged in strenuous therapy, self-monitoring, and complex drug regimens, has more to do with the assumption of responsibility and entry into a long-term relationship than it does with simple permission-giving or authorization of another to act.229

225Helgesson and Ericksson, 87–89. 226Wendler and Rackoff, “Consent for Continuing Research,” 4. 227Eline M. Bunnik, A. Cecile J. W. Janssens and Maartje H. N. Schermer, “A Tired-Layered-Staged Model for Informed Consent in Personal Genome Testing,” European Journal of Human Genetics 21 (2013): 596–601. 228Prentice et al., 3–4. 229Kukla, “Conscientious Autonomy,” 36–40. 3.3 A More Fundamental Critique 113

3.3.4 Adapting Informed Consent for Treatment Contexts

The ethical requirement of informed consent for medical treatment and participation in research is well established and beyond dispute, but the theoretical foundation and practical applications of informed consent are still matters of debate. The multiple critiques of the dominant theoretical formulation of informed consent found above indicate substantial dissatisfaction with it and with its influence on actual practices. Most of the dissatisfaction is not with what the dominant approach does, but with what it fails to do. The values implicit in the dominant theoretical formulation of informed consent and the protections it offers are recognized as important. Even critics such as Thomasma and Pelligrino admit that “protection of the patient’s autonomy is a buffer against the most egregious insults”.230 Yet they and other critics contend a narrow focus on protecting patients’ autonomy over- looks other values and inadequately addresses the various actual conditions under which patients and subjects are called upon to arrive at their decisions and offer or refuse their consent. As discussed above, among the conditions worthy of consideration for their influence upon consent is the context and nature of treatment. Few would dispute that the consent process for a simple blood draw to check for anemia need not be as lengthy or in-depth as the consent process for participation in a randomized clinical trial for a new form of chemotherapy. Some researchers conducting long-term research have already adapted the consent process in recognition that subjects may be forgetful or that renewal of consent may improve compliance with the research regimen.231 Further adaptations to the understanding and practice of informed consent for specific treatment and research contexts may be undertaken in order to strengthen the ethical justification for the treatment or research. These adaptations should maintain the protections of the dominant approach, but incorporate a wider set of values and a more adequate conception of how persons best deliberate, choose and carry out their choices.

230Thomasma and Pelligrino, 70. 231Wendler and Rackoff, 1–6; Meuller and Instone, 381–389; Prentice et al., 1–6; Bunnik, Janssens and Schermer, 1–6. Chapter 4 The Meaning of Covenant

Abstract In order to construct the concept of “covenant consent,” a thorough exploration of the concept of covenant will be provided. The exploration will include a look at its origin and character in the ancient near east, a brief survey of its uses in general Jewish and Christian ethics and a review of some uses in healthcare ethics, focusing particularly on the work of Paul Ramsey and William F. May. Finally, some of the implications of the covenant concept for re-envisioning the care provider—patient relationship in healthcare will be suggested. The idea of covenant will be shown to derive from certain social and political arrangements made by Akkadians, Hittites and Israelites. Key elements of covenants in the ancient near east included an emphasis on loyalty, shame and honor, and what anthropologists have called “ﬁctive kinship.” Covenant terminology has been prominent in the ethics of Jewish and Christian scholars such as Louis E. Newman, Elliot Dorff, Daniel J. Elazar, Alan L. Mittleman, H. Richard Niebuhr, Joseph L. Allen and Perry Simspon Huesmann, while the use of covenant in healthcare ethics speciﬁcally has been associated with Ramsey and May. Finally, an effort will be made to show the relevance of the concept of covenant for care provider—patient relationships in general, and for consent in particular.

4.1 Introduction

If the process of informed consent is to be re-imagined so that it might be adapted for the special context of vascularized composite allotransplantation involving upper extremities and faces, it will be useful to draw on conceptual resources in addition to those found in the dominant approach to consent. Some of those resources may, of course, be drawn from the various critiques of the dominant approach to consent which were examined in the previous chapter. In addition, the polysemous and evocative concept of covenant has much to offer. The purpose of this present chapter is to explore the concept of covenant, from its origins as a term for a certain type of treaty in the ancient near east to its late twentieth and early twenty-ﬁrst century uses in health care ethics. In the course of

© Springer International Publishing AG 2017 115 J.L. Benedict, A Revised Consent Model for the Transplantation of Face and Upper Limbs: Covenant Consent, International Library of Ethics, Law, and the New Medicine 73, DOI 10.1007/978-3-319-56400-5_4 116 4 The Meaning of Covenant this exploration, special attention will be given to the role of covenant in Jewish and Christian ethics, to its use in bioethics generally, and more speciﬁcally to the use of the concept in bioethics as covenant terminology was introduced by Paul Ramsey and developed further by William F. May. The chapter will conclude with an attempt to describe some of the implications of employing the concept of covenant for re-thinking care provider/researcher-patient/subject relationships and the function of consent within these relationships.

4.2 Covenant in the Ancient Near East

4.2.1 Etymological Roots

The modern English word, “covenant” is traced by etymologists to the beginnings of the fourteenth century, and from there through the Old French to the Latin, convenire, meaning to come together or agree. Conceptually, “covenant” is originally a particular kind of agreement between humans or between humans and a divine ﬁgure. This type of agreement is designated in the Hebrew language by berith and in the Greek of the New Testament by diatheke. Some confusion arose due to the fact that the Old Latin translation of the Bible translated diatheke as testamentum, from which we get our modern word, “testament,” whereas Jerome translated the Hebrew berith as foedus or pactum, while in neither instance was some form of convenire utilized. Thus, it was made to seem that berith and diatheke were different ideas, and the connection of both to convenire or covenant was not made clear until the sixteenth century. Between 1525 and 1535, English scholar William Tyndale translated both the Old and New Testaments using “covenant” to translate both the Hebrew word, berith, and the Greek word, diatheke.1 The term berith appears in the Hebrew Bible 286 times, and is generally understood as a major theme of that text.2 The covenant (berith) concept is one that the Hebrews shared with others in the ancient near east. In fact, it is believed that the concept originated elsewhere under different names, speciﬁcally in the cultures and languages of the Hittites and the Akkadians. The Akkadians were rulers in Mesopotamia from 2350 to 2150 BCE,3 while the Hittites originated in Anatolia but controlled a substantial portion of the ancient near east from 1700 to approximately

1OED Online, s. v., “covenant,” OED Online version December 2012. Accessed February 1, 2013 at http://www.oed.com.authenticate.library.duq.edu/view/Entry/43328?rskey=JrAwto&result=1& isAdvanced=false#eid. See also s. v. “covenable,” http://www.oed.com.authenticate.library.duq. edu/view/Entry/43322#eid7888762. 2Erhard Gerstenberger, “Covenant and Commandment,” JBL 84, no. 1 (1965): 38; Max L. Stackhouse, Covenant & Commitments: Faith, Family and Economic Life, Louisville: Westminster John Knox Press, 1997: 140. 3J. N. Postgate, Early Mesopotamia: Society and Economy at the Dawn of History, New York: Routledge, 1992: 22. 4.2 Covenant in the Ancient Near East 117

1300 BCE.4 Covenant treaties were also enacted by the Assyrians, whose period of Empire overlaps that of the kings of Israel and Judah described in the Hebrew Bible.5 While there is not full agreement on the actual origins of the Hebrew berith, a preponderance of scholars believe it is derived from the Akkadian biritu, meaning “clasp” or “fetter.” The fact that the Hittite ishiul, which is associated with covenantal-type agreements, has a meaning similar to biritu lends credibility to this theory of the origin of berith.6 The earliest meaning of berith is a relationship imposed upon a weaker party by a stronger one, as in the case of vassal states which were bound by the berith to serve and pay tribute to a nation which had defeated them militarily or threatened an attack which could only be avoided by agreeing to the berith. Such relationships were established by formal treaties, known as suzerain-vassal treaties.7 The treaty (berith) was established between the rulers, but was binding upon their subjects as well. While created by imposition rather than mutual consent, this earliest form of berith nonetheless incorporated elements of reciprocity and called for loyalty on the part of both partners. Often the more powerful treaty partner granted substantial authority over local matters to the vassal.8 At the least, the more powerful partner promised to protect the vassal state from attack by others.9 Yonick calls this form of covenant “essentially a technique for imperial administration.”10 Yet, as Weinfeld

4John Haywood and Simon Hall, Penguin Historical Atlas of Ancient Civilizations, New York: Penguin Books, 2005: 36–38. 5David Noel Freedman, Allen Myers and Astrid Beck, eds., Eerdmans Dictionary of the Bible, s. v. “covenant,” Grand Rapids: Eerdmans Publishing, 2000: 291. 6M. Weinfeld, “berith” in Theological Dictionary of the Old Testament v. 2, Revised Edition, ed. by G. Johannes Botterweck and Helmer Ringgren, Grand Rapids: William B. Eerdmans Publishing Company, 1975: 266–269. According to Weinfeld, the Akkadian for covenant is riksu, but biritu is used in conjunction with it. See also John J. Hayes, “Covenant,” in Mercer Dictionary of the Bible, Macon: Mercer University Press, 1991: 177. 7Sandra Richter, “Covenants,” in The Eerdmans Companion to the Bible, ed. by Gordon D. Fee and Robert L. Hubbard Jr., Grand Rapids: William B. Eerdmans Publishing Company, 2011: 141–142; Weinfeld, 255; Niehaus notes that some believe that the notion of covenant originated in the family rather than in the political realm. Jeffrey J. Niehaus, “Covenant: An Idea in the Mind of God,” Journal of the Evangelical Theological Society 52, no. 2 (June 2009): 225–226; Elod Hodossy-Takacs, “The Concept of Covenant in the Ancient Near East and in Biblical Theology,” Studia Theologica Debrecinensis (2011): 21. 8Moshe Weinfeld, “Covenant Making in Anatolia and Mesoptamia,” Journal of the Ancient Near Eastern Society 22 (1993): 136. 9George E. Mendenhall and Gary A. Herion, “covenant,” in The Anchor Bible Dictionary v. 1, ed. by David Noel Freedman, (New York: Doubleday: 1992), 1181. Eerdmans Dictionary of the Bible,s.v.“covenant,” 291; Saul M. Olyan, “Honor, Shame and Covenant Relations in Ancient Israel and Its Environment,” JBL 115 (1996): 204–205; Daniel J. Elazar, Covenant and Polity in Biblical Israel, New Brunswick: Transaction Publishers, 1998: 69. 10A. Yonick, “Covenant (in the Bible)” in New Catholic Encyclopedia 2nd Edition, v. 4, Detroit: Gale, 2003: 325. 118 4 The Meaning of Covenant notes, there were alternative means of imperial administration which were far less concerned about any rights of, or services provided to, the vassal state.11 The covenant between God and the people of Israel established through Moses at Sinai demonstrates several of the basic features of the suzerain-vassal treaty, first delineated by Yugoslav scholar, V. Korosec, in 1931. Based on his study of Hittite material, Korosec distinguished between parity and suzerainty treaties and listed the features of each. Korosec was not concerned with biblical parallels, so the common features of the Hittite vassal-suzerain treaties and the Sinai covenant were left to be discovered and developed by George Mendenhall and others two decades later.12 The similarity is obvious and interesting, but since the term “covenant” came to be applied to more than human-divine or political relationships,13 these formal features are not always present. While loyalty and obligation were central to the concept of covenant, other terms also came to be associated with it. These terms include promise, gratitude, fellowship, honor, pledge, contract, grace, forgiveness, repentance, brotherhood, peace, love and friendship.14 The covenant central to Jewish identity, as represented in the Hebrew Bible, defined expectations for several aspects of life. Erhard Gerstenberger, a leading scholar of the covenant concept, has described the covenant as having “[s]tipula- tions concerning social, juridic and cultic conduct.”15 Acts or omissions in each of these areas could be viewed as fulfillment or violation of the covenant. Indeed, the Hebrew prophets often emphasize the social and juridic aspects over the cultic, as when Jeremiah accuses the people of violating the covenant for enslaving their fellow Judeans (Jeremiah 34) or when Micah contrasts the value of burnt offerings with the value of doing justice, loving kindness and walking humbly with God (Micah 6). Covenants include specific acts to be performed or avoided. Clearly, however, covenants involved more than formal obedience or the performance of tasks specified in advance, as in a modern contract. A covenant was generally understood as a personal relationship as well as a formal or legal one.16 Gottfried Quelle, in the Theological Dictionary of the New Testament, points out that on a number of

11Weinfeld, “Covenant Making,” 135–136. 12J. Alberto Soggin, Introduction to the Old Testament: From its Origins to the Closing of the Alexandrian Canon, Louisville: Westminster John Knox Press, 1980: 137–138; E. C. Lucas, “Covenant, Treaty and Prophecy,” Themelios 8, no. 1 (1982): 19–23. 13Weinfeld, 264; 270; Gerard Van Groningen, “Covenant,” in Baker Theological Dictionary of the Bible, ed. by Walter A. Elwell, Grand Rapids: Baker Books, 2000: 124; Hayes, 178; Richter, 288. 14Weinfeld, 256–257; Hayes, 177; J. A. Thompson, “The Significance of the Ancient Near Eastern Treaty Pattern,” Tyndale Bulletin 13 (1963): 6; Eerdman’s Dictionary of the Bible,s.v.“covenant,” 291; Richter, 141, includes the Hebrew term, hesed; Joseph L. Allen, Love and Conflict: A Covenantal Model of Christian Ethics, Nashville: Abingdon Press, 1984: 25. 15Gerstenberger, 38. 16Jacqueline E. Lapsley points out that “the Psalms testify to the potential for a poignant and sometimes anguished intimacy” in the ongoing covenant relationship between God and God’s people. “Friends with God? Moses and the Possibility of Covenantal Friendship,” Interpretation 58, no. 2 (April 2004): 119; Elazar, Covenant and Polity, 71. 4.2 Covenant in the Ancient Near East 119 occasions, covenant is “presented as the half-legal and half-sacral form of fellowship” between two or more humans.17 Elazar speaks of hesed, or covenant love, as the “operative mechanism” of all covenants, which prevented covenants from becoming mere contracts “narrowly interpreted by each partner for his benefit alone.” Rather, according to Elazar, hesed required each covenant participant to go “beyond the letter of the law.”18 Three types of berith may be identified in the Hebrew Bible. In addition to the imposed obligations of the vassal-suzerain treaty, a berith could also be an obligation freely assumed by one party with the intent of benefiting another. Such covenants are basically unilateral promises or pledges. The third type would be a mutual agreement to certain obligations intended to benefit all parties.19 Walter Brueggemann states that the central meaning of covenant in the history of Israel is the making “of mutual promises and commitments.”20 Van Groningen offers several examples of covenants involving mutual consent and the expectation of mutual benefit, including the covenants between Abimelech of Gerar and Isaac, Solomon and the Phoenician king Hiram, and the oath between David and Jonathan, son of Saul.21 Hayes mentions covenants between Abram and Abimelech and between Jacob and his father-in-law, Laban.22 Marriage was likewise understood as a covenant bond established for mutual benefit.23 In general, the term berith came to be applied to just about any binding agreement between two parties sealed by ritual or oath.24 The standard Hebrew terminology used to describe the establishment of a covenant was karath berith,to“cut a covenant.”25 This may have referred to the “cutting” of animals in sacrificial ceremonies which were part of covenant making, as is seen in Genesis 15, where God asks Abram to offer a sacrifice which involved

17Gottfried Quell, “diatheke,” Theological Dictionary of the New Testament, vol. II. Ed. by Gerhard Kittel; trans. by Geoffrey W. Bromiley, Grand Rapids: Eerdmans, 1964, 109. 18Elazar, Covenant and Polity, 71. 19Hayes, 178. Weinfeld calls the unilateral pledge type a promissory covenant and says it is modelled on the royal grant. He offers the example of the covenants with Abraham and David. See Weinfeld, 270–271. 20Walter Brueggemann, Reverberations of Faith: A Theological Handbook of Old Testament Themes, Louisville: Westminster John Knox Press, 2002: 37. 21Van Groningen, 124. 22Hayes, 179. 23Van Groningen, 124. It should be noted that in Biblical times, the parties directly involved in the making of a marriage covenant did not include the bride. Rather, her father and the groom made promises to each other. See James Benedict, “Neither Marriage Nor Giving in Marriage: Jesus, The Age to Come, and Gender Equality,” Brethren Life and Thought 57, no. 2 (2012): 25–27. 24Eerdman’s Dictionary of the Bible,s.v.“covenant,” 288. See also Ada Taggar-Cohen, “Biblical Covenant and Hittite išḫiul Reexamined,” Vetus Testamentum 61 (2011): 471–482. 25Weinfeld, 259–262, who also notes that similar expressions appear in Aramaic, Phoenician and Greek. 120 4 The Meaning of Covenant cutting a heifer, goat and ram in half, as part of a ceremony in which God afﬁrms covenant promises to Abram and Abram’s descendants. On the other hand, “to cut a covenant” may simply have been a manner of speaking, as in contemporary English, where we may speak of “cutting a deal.”26 One could also speak of “entering into” a covenant. Entry into a covenant was a serious matter, and partners to a covenant were expected to honor it even at great personal cost. Partners were called upon to “hold fast” to the covenant or “be true” to it with a “whole heart.”27 Failure to do so made one justly subject to judgment and criticism, as is shown in the proclamations of the Hebrew prophets against their people who have not kept their covenant promises or fulﬁlled their covenant obligations.28 Covenant remained an important concept beyond the time of the prophets. It was especially important to the Qumran community, as revealed in the Dead Sea Scrolls. Members of the Qumran community believed they alone followed the covenant as God intended.29 It plays a central role in the gospels, particularly in reference to the establishment of a “new covenant” by Jesus and is also present in the writings of the apostle Paul, who abandons the traditional understanding of covenant as expressed through obedience to the Mosaic code but retains the concept nonetheless.30 For Paul, the core of the gospel is God’s faithfulness to the covenant promises, in spite of human unfaithfulness.31 The covenant concept was passed down from Judaism, and from both Judaism and Christianity, to Islam, where it also plays a central role in the self-understanding of the religion. According to Frederick Mathewson Denny, in Islam the term is used in reference to both divine-human relationships and relationships between humans. Particularly in its use in reference to the divine-human relationship, Denny notes that the emphasis in Islam is more about obligation and obedience and less about forgiveness and mutuality, though mention of the latter elements is not entirely absent in the tradition.32

26Elazar, Covenant and Polity, 66, notes that sealing a covenant always involved some ritual act, but the act did not necessarily have to be a sacriﬁce. 27Weinfeld, 260–261. 28Allen, Love and Conﬂict,25–28; David Novak, “Natural Law, Halakah, and the Covenant,” in Contemporary Jewish Ethics and Morality: A Reader, ed. by Elliot N. Dorff and Louis E. Newman, New York: Oxford University Press, 1995: 48–49. 29Scott Hahn, “Covenant in the Old and New Testaments: Some Current Research (1994–2004),” Currents in Biblical Research 3:2 (2005): 280. 30Hahn, 280–285. 31J. C. Beker, “The Faithfulness of God and the Priority of Israel in Paul’s Letter to the Romans,” The Harvard Theological Review 79, no. 1–3 (1986): 10–16. 32Frederick Mathewson Denny, “Some Religio-Communal Terms and Concepts in the Qur’ān,” Numen 24 (1977): 47–59. 4.2 Covenant in the Ancient Near East 121

4.2.2 The Structure of Covenants

Formal political covenants, such as the vassal-suzerain treaties, tended to have clear structures, though that structure varied somewhat over time and between empires.33 The covenant between Yahweh and Israel at Mt. Sinai has often been analyzed in terms of these structures or formats, but there is disagreement over whether it more resembles the Akkadian or Hittite type.34 A list of some elements of the later Hittite type includes an historical prologue, stipulations, a provision for the deposit and periodic public reading of the written covenant, a listing of witnesses, and a rati- ﬁcation ritual or ceremony.35 As the element of provision for deposit and later public reading suggests, political covenants were always written, often inscribed in clay or on metal, or perhaps written on a scroll before being stored away securely.36 Hittite treaties of the covenant type were typically given a public reading before the citizens of the vassal state from one to four times each year.37 The recorded covenant was normally conﬁrmed by an oath and placed in a temple or other sacred place as a means of indicating that it was henceforth divinely sanctioned and would be divinely enforced.38 In effect, the deity became a third party or guarantor to a covenant between two or more humans.39 The substance of political covenants dealt with loyalty obligations, tribute payments, grants of land and authority, and often a promise of protection.40 Personal covenants between individuals did not necessarily involve such an elaborate structure, but generally included some small ritual gesture or oath. For example, twice in the Book of Genesis we hear of a pledge being made which involves one party placing his hand under the thigh of the other while making the pledge or promise.41 A shared meal between covenant partners might also be used to seal the covenant.42 The covenant established in the gospels of the New Testament between Jesus and his disciples originates in the setting of the meal which comes to be known as the “Last Supper.”

33For details on the differences, see Thompson, 2–3 and Weinfeld, “Covenant Making,” 135–136. 34Eerdman’s Dictionary of the Bible,s.v.“covenant,” 291. 35Mendenhall and Herion, 1180–1182; Thompson, 2. 36Weinfeld, 265; 274; Mendenhall and Herion, 1180–1182; Gary A. Anderson, 277; Gordon Wenham, “Covenants and Near Eastern Treaties,” in Zondervan Handbook to the Bible, ed. by David and Pat Alexander, Grand Rapids: Zondervan Publishing House, 1999, 211; Stackhouse, 145–146. 37Mendenhall and Herion, 1181. 38Mendenhall and Herion, 1181; Weinfeld, 256; (Mercer), 179; Bernhard W. Anderson, Oxford Companion to the Bible, ed. by Bruce M. Metzger and Michael D. Coogan, New York: Oxford University Press, 1993: 138; Taggar-Cohen, 485; Elazar, Covenant and Polity, 23. 39Hayes, 179. 40Taggar-Cohen, 483. 41See Genesis 24:2 and 47:29. 42Elazar, Covenant and Polity, 66. 122 4 The Meaning of Covenant

Gene M. Tucker argues for a clear distinction between covenant forms and contract forms in the Hebrew Bible. He notes that contracts, which are “private legal and economic agreements,” were agreements to participate in limited, clearly deﬁned transactions and were witnessed by outside parties. Covenants, by contrast, were commitments entered into by means of a solemn oath, including a provisional self-curse in the event that one did not fulﬁll the commitment. Human witnesses were not required for covenant making, as God was the witness.43

4.2.3 Covenants and Fictive Kinship

In the ancient near east, covenants commonly served as a means to establish deep and enduring personal relationships between parties where no bond of blood or marriage existed.44 Such relationships routinely employed family terms to communicate the nature and intensity of the bond.45 For example, Gerstenberger describes a covenant between Ramses II of Egypt and the Hittite Hattusili III which states, “You are my brother and I am your brother.”46 As Gary Stansell notes, while the Greeks idealized friendship (amacitia or philia), for the Israelites and others in the ancient near east, “family is the primary meaning which shapes and defines reality.”47 So to apply family terms to covenant relationships was to suggest covenants created obligations much greater than those created by ordinary agreements or contracts. Sandra Richter asserts, “… the ideological foundation of covenant-making was ‘fictive kinship.’”48 The understanding of covenant as the extension of kinship status to non-kin emerged earlier but has become dominant in biblical studies over the last two decades.49 In addition to Richter, the connection between the ancient near eastern concept of covenant and fictive kinship has been made by Stansell in his study of the David-Jonathan friendship and by Roth and Reuther in their study of covenants more generally.50 Franklin Moore Cross has also provided an

43Gene M. Tucker, “Covenant Forms and Contract Forms,” Vetus Testamentum 15, no. 4 (1965): 487–503. 44D. J. McCarthy, Treaty and Covenant (Rome: Pontifical Biblical Institute, 1982), 175. As cited in Niehaus, 226. 45James Nicholas Jumper, Honor and Shame in the Deuteronomic Covenant and the Deuteronomistic Presentation of the Davidic Covenant (Ph.D. dissertation, Harvard University, 2013), 128; Gerstenberger, 40. 46Gerstenberger, 41. 47Gary Stansell, “David and His Friends: Social-Scientific Perspectives on the David-Jonathan Friendship,” Biblical Theology Bulletin 41 (2011): 116. 48Richter, 141. 49Hahn, 263–270. 50Stansell, 118–119; Wolfgang Roth and Rosemary Radford Reuther, The Liberating Bond: Covenants—Biblical and Contemporary, New York: Friendship Press, 1978: 3–13. 4.2 Covenant in the Ancient Near East 123 important essay on the topic.51 Fictive kinship is a term which comes from anthropology, and refers to relationships in which the obligations and privileges associated with one’s kin by blood or marriage are transferred to others.52 Alternative terms referring to the same concept include chosen kin, self-ascribed kin, ritual kin and voluntary kin.53 The fictive kinship concept originated in the early kinship study of the late nineteenth century anthropologist, Lewis Henry Morgan. In Morgan’sinfluential Systems of Consanguinity and Affinity in the Human Family (1871), he observed that in addition to kinship by blood (consanguineal) or marriage (affinal) there were some who recognized and behaved toward one another as kin despite the absence of the usual kinship connections.54 Fictive kinship can be established more or less formally, but frequently involves a ritual.55 As a form of fictive kinship, the covenant relationship incorporates both expectations which can be specified at the time of covenant making and an attitude of trust and faithfulness which is prepared for the unexpected. It is a “flexible relationship” which is expected to endure even as conditions or the needs and capacities of the covenant partners change.56

4.2.4 The Role of Shame and Honor in Covenantal Relations

The power and importance of covenant as a basis for social relations in the ancient near east is well established; so too is the central role of shame and honor as factors shaping individual and group behavior. The connection between shame and honor and covenants in the ancient near east has been explored in detail by Saul Olyan and others.57 Shame and honor, like ﬁctive kinship, is a concept which has been developed most extensively within the ﬁeld of anthropology.

51Frank Moore Cross, From Epic to Canon: History and Literature in Ancient Israel, Baltimore: Johns Hopkins University Press, 1998: 3–21. 52Richard A. Wagner, “Fictive Kinship,” in International Encyclopedia of Marriage and Family, 2nd Ed., ed. by James J. Ponzetti, New York: Macmillan Reference, 2003: 671; Margaret K. Nelson, “Whither Fictive Kin? Or, What’s in a Name?” Journal of Family Issues 35, no. 2 (2014): 205. 53Dawn O. Braithwaite, et al., “Constructing Family: A Typology of Voluntary Kin,” Journal of Social and Personal Relationships, 27, no. 3 (2010): 290; “Kinship terminology,” Encyclopedia Britannica. Accessed June 27, 2014. http://www.britannica.com/EBchecked/topic/318924/ kinship-terminology#ref4090. 54Linda Stone, “Kinship” in International Encyclopedia of the Social Sciences, 2nd Ed., ed. by A. Darrity, Detroit: Macmillan Reference, 2008: 272; Carles A. Ibsen and Patricia Klobus, “Fictive Kin Term Use and Social Relationships: Alternative Interpretations,” Journal of Marriage and the Family 34, no. 4 (1972): 615. 55Nelson, 205. 56Roth and Reuther, 2. 57Olyan, 201–202; Jumper, 8–15. 124 4 The Meaning of Covenant

Anthropologists observe that some degree of concern about shame and honor exists in all cultures.58 However, certain cultures may be characterized as shame and honor cultures, meaning that in these cultures concern to acquire or maintain honor and to avoid shame are primary, pervasive or dominant values.59 Many ancient near eastern cultures are considered shame and honor cultures. In describing the importance of shame and honor in the ancient near east, James Nicholas Jumper says that “to lose honor was catastrophic. … [it] could be depicted as death.”60 On the other hand, to confer honor or restore honor that had been lost was a compassionate and sometimes heroic act. In the Judeo-Christian tradition acts and promises to confer honor or restore lost honor were characteristic of God.61 Failure to honor a covenant incurred shame. On the other hand, faithfulness to covenant, especially at signiﬁcant cost to one’s self, generated honor. Words or actions demonstrating disrespect for a covenant partner would be seen as covenant violations, inasmuch as they represented a breach of the duty to honor a covenant partner.62 Such violations are especially egregious if they become widely known, as shame and honor are assessed in the “public court of reputation.”63 Thus, concern for shame and honor strongly motivated covenant partners both to perform the tasks stipulated in the covenant and to treat one another with respect. It is worth noting that there is evidence that shame and honor concerns still have a powerful moti- vating effect, even in cultures that are not recognized as shame and honor cultures.64 Shame and honor promote cooperation, even in conditions where such cooperation is costly.

4.2.5 Durability and Flexibility

In contrast to contracts, which exist for the simple exchange of commodities or services and require clear limits and boundaries, covenants exist to transcend limits

58Halvor Moxnes, “Honor and Shame,” The Social Sciences and New Testament Interpretation, Peabody: Hendrickson Publishers, 1996: 19. 59Zeba Crook, “Honor, Shame, and Social Status Revisited,” JBL 128, no. 3 (2009): 592–594. See also F. Gerald Downing, “‘Honor’ Among Exegetes,” The Catholic Biblical Quarterly 61 (1999): 53–73. Downing claims that the world of the New Testament cannot be characterized in these terms, yet admits that shame and honor were important values which “could predominate.” (63). Downing is right in observing that Jesus and his followers in the New Testament do not adhere entirely to the existing standards of shame and honor, but it could be argued that rather than rejecting the concept, they simply attach shame and honor to different behaviors and relationships. 60Jumper, 119. See also 261–262. 61Jason Borges, “‘Dignified’: An Exegetical Soteriology of Divine Honour,” Scottish Journal of Theology 66, no. 1 (2013): 79–80. 62Olyan, 204–208. 63Crook, 593. 64Jennifer Jacquet, et al., “Could shame and honor save cooperation?” Communicative & Integrative Biology 5, no. 2 (2012): 209–213. 4.2 Covenant in the Ancient Near East 125 and create relationships that may involve the exchange of goods or services but cannot be reduced to exchange alone.65 Covenants create relationships that are expected to last. The provisions for periodic reading of the covenant and the understanding of marriage as one form of covenant both suggest that covenants were expected to endure. In several cases, loyalty to the covenant was expected to outlive the original parties to the covenant, as indicated by references to relationships between the descendants of the original parties to the covenant.66 Elazar goes so far as to claim that most covenants were intended to be of “unlimited duration.”67 This is clearly the case in the central divine-human covenant in the Hebrew Bible. As relationships expected to last, covenant relationships were by design flexible and durable.68 Covenants, being relationships which were personal enough to borrow kinship terms and to be concerned with shame and honor, could not endure without some degree of flexibility. Olyan observes that “covenant relations were never static.”69 Gerstenberger states that a covenant is “a living organism.”70 Covenants were entered into with the realization that the circumstances of one or both parties might change, and that change might require renegotiation of the specified responsibilities, rights and privileges within a context of a continuing commitment to honor and respect the covenant partner. The new terms of the covenant would often be acknowledged in a ritual or other ceremonial reaffirmation of the covenant relationship.71 Scholar Jaqueline Lapsley notes several dynamics in covenant relationships which enable them to be durable and flexible. While admitting that the covenant between God and the Israelites established at Sinai is central in the Hebrew Bible, Lapsley contends that the covenant friendship shared by Moses and God represents the ideal human-divine covenant.72 She identifies four features of the friendship which she argues were essential to it and made it resilient. These four features were “habit, reciprocity, self-assertion and … emotion.”73 As a matter of habit or routine, the relationship is sustained over time by consistent, repeated activities which simultaneously call to mind and renew the covenant. Reciprocity refers to the characteristic of covenants which places expectations or obligations on both parties to the covenant, even if they are not equal in status or power. The faithfulness of the partner of lower status and power must be reciprocated by the party of higher status. Furthermore, self-assertion is

65Gordon M. Freeman, “The Process of Covenant,” Publius 10, no. 4 (1980): 71–73. 66Gerstenberger, 43. 67Elazar, 23. 68Van Groningen, 138–139. 69Olyan, 208. 70Gerstenberger, 45. 71Olyan, 217. 72Lapsley, 117. 73Lapsley, 121. 126 4 The Meaning of Covenant allowed within the covenant relationship, as the covenant itself is a common good in which all parties to the covenant have an interest. Thus, any person involved in the covenant is justiﬁed in calling attention to the situation when his or her interests are being neglected. Finally, covenants are not simply abstract, rational agreements; they engage the whole person and permit the expression of a range of emotions.74

4.3 The Role of Covenant in Contemporary Religious Ethics

The covenant concept appears in the religious ethics of a number of scholars, both Jewish and Christian. Applications of the covenant ethic within these two related traditions extend from the general understanding of the role of humanity before God to speciﬁc applications of the concept to political and social institutions. Jewish and Christian scholars have also applied covenant ideas to health care ethics, as we will see in later sections.

4.3.1 Jewish Ethics

In light of the crucial role the concept of covenant plays in Jewish self-understanding and its pervasiveness in the Hebrew Bible, it is reasonable to expect the concept to play a major role in Jewish ethics. This expectation is not disappointed. A number of scholars describe covenant as central or foundational to Jewish ethics. A series of essays collected in the volume, Contemporary Jewish Ethics and Morality: A Reader, emphasizes the role of covenant. David Novak examines the relationship between covenant and natural law, and argues for the possibility of coherence between the concepts against many who contend that natural law is incompatible with Jewish thought.75 Elliot Dorff describes the covenant concept as “the transcendent thrust in Jewish law,” stressing the role of covenant in shaping a number of core values in Jewish life. These include the love of God as a motivation for obedience, promise keeping as the source of obligation, and the ultimate aim of universal peace.76 Louis E. Newman and Eugene Borowitz also examine the relevance of covenant for understanding Jewish morality, calling it “the primal

74Lapsley, 121–129. 75David Novak, “Natural Law, Halakah and the Covenant,” in Contemporary Jewish Ethics and Morality, Dorff and Newman, eds, 38–58. 76Elliot N. Dorff, “The Covenant: The Transcendant Thrust in Jewish Law,” in Contemporary Jewish Ethics and Morality, Dorff and Newman, eds, 59–78. 4.3 The Role of Covenant in Contemporary Religious Ethics 127 elemental ground of Jewish existence,” and emphasizing its implications for the treatment of others.77 In his 2009 dissertation, Jonathan Kadane Crane calls covenant “an ineluctable horizon from which a Jewish ethicist cannot escape when constructing a Jewish ethical argument.”78 Crane argues that how a particular Jewish ethicist conceives of the covenant determines his or her normative rhetoric, inasmuch as the manner of understanding covenant influences the “person’s assumptions about rightful authority, preferred reason and proper autonomy.”79 Crane demonstrates this by examining the covenant concepts of J. David Bleich, Elliot N. Dorff and Eugene Borowitz.80 Louis E. Newman also asserts the “centrality of covenant” in Jewish ethics in an article in the Journal of Law and Religion. For Newman, covenant refers to a relationship between God and the community of God’s people, a “relationship much like an interpersonal human relationship” involving “complex emotional ties and mutual responsibilities.”81 Newman develops the distinction between covenant and contract, in terms of origin, scope and duration. In the end, he recognizes contract as a more limited agreement. He demonstrates that while the Hebrew Bible sometimes speaks of the covenant in contractual terms, it also speaks of the covenant as more than a contract, in that it involves a relationship that is more holistic. Certain texts, he argues, make plain that the obligations which the community bears under the covenant cannot be reduced to mere obedience to commandments. It is not less than the actions it commands or forbids, but more.82 As Newman explains in a later essay, as a relationship, “it must be dynamic, and the demands that it makes cannot be fixed in advance or set in stone once and for all time.”83 Eugene Borowitz identifies five “premises for Jewish duty” that are influenced by the centrality of covenant in Jewish self-understanding. Included among the five premises is the idea that life under the covenant is inherently social, so that one cannot reach conclusions about one’s own ethical obligations without consideration of others with whom one stands under the covenant.84 Second, Borowitz notes that life in covenant “necessarily orients itself to the future.” Therefore, it is not enough

77Eugene Borowitz, “The Jewish Self,” in Contemporary Jewish Ethics and Morality, Dorff and Newman, eds, 106–117. 78Jonathan Kadane Crane, Rhetoric of Modern Jewish Ethics (Ph.D. dissertation, University of Toronto, 2009): 78. 79Crane, 137–138. 80Crane, 140–162. 81Louis E. Newman, “Covenant and Contract: A Framework for the Analysis of Jewish Ethics,” Journal of Law and Religion 9 (1991): 89–92. 82Newman, “Covenant and Contract,” 102–112. 83Newman in Dorff and Newman, 89. 84Eugene Borowitz, “The Jewish Self,” in Dorff and Newman, 109. 128 4 The Meaning of Covenant to obey commandments established in the past, or to respond to present circumstances without asking where one’s actions will lead.85 Alan L. Mittleman is yet another who places the concept of covenant at the heart of Jewish ethics. Mittleman identiﬁes covenant as the theme of key biblical narratives, and the covenant perspective as having shaped “all subsequent Jewish self-understanding.”86 Covenant, he contends, serves to “instantiate norms of respect, friendship, kindness, compassion and equity,” while blending the responsibility to perform stipulated duties with a more open-ended aspiration toward goodness.87 Indeed, for Mittleman, this is the genius of the covenant concept, that it is a way of holding together ethics as duty and ethics as virtue.88

4.3.2 Christian Ethics

Substantial use of the covenant concept took place in the work of several early Protestant Reformed theologians. The leading figure of the movement, John Calvin, may have been less important to the development of what came to be known as “covenant theology” than several others, such as Ulrich Zwingli, Zacharias Ursinus and Heinrich Bullinger. Covenant theology was a way of understanding the whole sweep of human history, in terms of the divine-human relationship which was constituted under covenants of works, grace and redemption.89 While more concerned with theology than ethics, covenant theology carried ethical implications, especially through its assumptions about the human capacity for moral behavior. The covenant concept has been more directly influential in Christian ethics over the last seventy-five years. Its influence in ethics is derived from its earlier use in the analysis of the political foundations of the United States. In 1954, H. Richard Niebuhr published an influential essay, “The Idea of Covenant and American Democracy.” In the essay, Niebuhr claimed that the covenant idea was “one of the greatest common patterns that guided men in the period when American democracy was formed….”90 Tracing the idea back through the Puritans to the Reformation figure, John Calvin, Niebuhr pointed to covenant as the foundation of the belief that “government should be not only by the consent of the people but with their participation in

85Borowitz, 112. 86Alan L. Mittleman, A Short History of Jewish Ethics: Conduct and Character in the Context of Covenant, Hoboken: Wiley-Blackwell, 2012: 8–9. 87Mittleman, 9–10. 88Mittleman, 4; 10; 21. 89Everett H. Emerson, “Calvin and Covenant Theology,” Church History 25, no. 2 (1956): 136–144. 90H. Richard Niebuhr, “The Idea of Covenant and American Democracy,” Church History 23, no. 2 (1954): 129. 4.3 The Role of Covenant in Contemporary Religious Ethics 129 it.”91 Promise-making and promise-keeping were at the heart of covenant, as Niebuhr understood the concept, and covenants differed from contracts which were entered into only “for the sake of gaining certain common advantages.”92 Covenants, on the other hand, involved a commitment to the relationship itself and to a greater cause, rather than merely to direct benefits for the partners. From a covenant perspective, therefore, “freedom does not lie in the liberty of choice, but in the ability to commit oneself for the future to a cause.”93 Niebuhr’sinfluence is seen in the work of a number of subsequent scholars who apply the covenant concept to ethics. One of the earliest examples of Niebuhr’s influence took place in two stages. Paul Ramsey, who would go on to become widely known for his work in medical ethics, was first a student of Niebuhr’sat Yale.94 In fact, it is possible that the concept of covenant and its importance in political life may have been something Niebuhr and Ramsey worked on together, as Ramsey’s article, “Elements of a Biblical Political Theory,” predates Niebuhr’s article on covenant and American democracy by five years. In this article, Ramsey delves into the biblical literature and language, but also compares what he finds to the political thought of Hobbes and Rousseau.95 The following year, Ramsey brought the covenant concept into ethics with the publication of his Basic Christian Ethics.96 His elaboration of the covenant theme in Basic Christian Ethics will be treated below in the section on Ramsey. Joseph L. Allen employs the covenant paradigm to provide the structure of his model of Christian ethics in Love and Conflict: A Covenantal Model of Christian Ethics. Allen acknowledges his debt to Niebuhr early on.97 Allen posits that to see ourselves in covenant relationship with others is to recognize that we are members of the “same moral community” and to “reject some contractual ideas,” including the idea that our rights and obligations are limited to what has been explicitly agreed.98 Covenant relationships are characterized instead by trusting and accepting trust.99 Furthermore, in contrast to contracts which are of limited and often strictly defined duration, covenants are designed to be “enduring,” and thus continuing faithfulness and loyalty are required.100

91Niebuhr, 132. 92Niebuhr, 134. 93Niebuhr, 133. 94Allen Verhey, “Paul Ramsey (1913–1988),” The Reformed Journal 38, no. 4 (1988): 2. 95Paul Ramsey, “Elements of a Biblical Political Theory,” The Journal of Religion 29, no. 4 (1949): 258–283. 96Paul Ramsey, Basic Christian Ethics, New York: Charles Scribner and Sons, 1950. 97Joseph L. Allen, Love and Conﬂict: A Covenantal Model of Christian Ethics, Nashville: Abingdon Press, 1984: 15. 98Allen, 16–17. 99Allen, 32–37. 100Allen, 38–39. 130 4 The Meaning of Covenant

From his belief that humans are made to establish and exist in covenantal relationships, Allen derives the notion that covenant love is “the basic moral standard,” which means that “we constantly stand responsible to and for other people under God.”101 The implications of this standard include that an effort must be made to meet the needs of all covenant participants and that one is obligated to seek reconciliation whenever alienation exists between covenant partners.102 Allen then applies his covenant understanding to moral conﬂicts and examines marriage, political community and the church as instances of contexts within which special covenants exist.103 Max Stackhouse takes a similar approach in applying the covenant concept to contemporary family life. He argues that covenant is a rich and dynamic notion which undergirds “the most creative and sustaining contemporary institutions,” allowing them to be “revised from within.” The covenant concept works, he says, because it manages to be “version of Christian ethics fair to all” and open to reform without being hierarchical. Further, it is capable of being understood and adapted by those who are not already committed to a covenantal faith tradition.104 Eric Mount, Jr. joins covenant with the concepts of community and the common good to form his version of Christian ethics. Covenant allows Mount to “locate the relational self in a “community of identity, promise and obligation with God and neighbor.”105 Though he applies his covenant thinking to more than politics, he does acknowledge his intellectual debt to Niebuhr.106 By means of covenantal thinking, Mount sees the possibility of holding together the often divergent impulses toward individual liberty and community solidarity which threaten to rend civil society.107 Perry Simpson Huesmann understands the value of the covenant concept in a similar way. Huesmann argues that the covenant concept is needed “to provide an alternative framework” necessary to overcome Western social disintegration.108 He sees covenant as a ﬁtting paradigm in light of the “ontological relationality” which conditions human existence. Covenant, in his understanding, encourages humans to imagine themselves “not [as] the autonomous individual of modernity, but [as] a covenanted person whose identity is rooted in relationality.”109 Covenant,

101Allen, 77. 102Allen, 78–80. 103Allen, 103–310. 104Stackhouse, 139–140. 105Eric Mount, Jr., Covenant, Community, and the Common Good: An Interpretation of Christian Ethics, Cleveland: The Pilgrim Press, 1999: 1. 106Mount, 15. 107Mount, 157. 108Perry Simspon Huesmann, Covenant as Ethical Commonwealth: Possibilities for Trust in an Age of Western Individualism and Disintegration, Milan: IPOC, 2010: 11. 109Huesmann, 62. 4.3 The Role of Covenant in Contemporary Religious Ethics 131

Huesmann asserts, encourages persons to “go beyond … the minimum” and enables “human ﬂourishing.”110

4.4 The Role of Covenant in Health Care Ethics

4.4.1 General Use of the Covenant Concept

Covenant has become a popular theme in healthcare ethics. It has been applied in a number of attempts to describe the nature of the moral obligations found in patient-health care provider interactions. As a Judeo-Christian concept, it appears most often in ethics associated with or originating in one of those traditions, but is not limited to religiously-based ethics. In explicitly Jewish health care ethics, the concept is employed by a number of scholars. Rabbi Irving Greenberg calls the covenantal model the “model of partnership” which inspires “self-limitation” on the part of care-providers.111 Jeff Levin, addressing the debate over health care reform in the United States, places covenant among a number of Jewish themes relevant to that discussion.112 Aaron Mackler, in his comparison of Jewish and Catholic bioethics, notes the importance of covenant as the context for the exercise of autonomy, from the perspective of the Reform tradition.113 Mackler admits, however, that Jews who lean more toward the Orthodox theological tradition would be less open to patient autonomy, and would argue that faithfulness to covenant is most appropriately expressed through adherence to halakah, or the legal codes found in the tradition.114 Paul Ramsey and William F. May are the two individuals who have done the most to promote the concept of covenant in health care ethics in the last seventy years, with May somewhat reliant on Ramsey but going into far greater detail. Both operate from a clear and openly declared Christian faith commitment. Before examining their contributions to the use of covenant terminology in health care ethics, however, the lesser contributions of others operating from a Christian perspective may be noted. James J. Rusthoven is reliant on Ramsey and May to some degree, but makes his own case for understanding care-provider/patient relationships as essentially covenantal. A covenant understanding, according to Rusthoven, calls forth ﬁdelity

110Huesmann, 139; 143. 111Rabbi Irving Greenberg, “A Covenantal Ethic of Medicine” in Jewish Values in Bioethics, ed. by Rabbi Levi Meier, New York: Human Sciences Press, 1986: 137–148. 112Jeff Levin, “Jewish Ethical Themes That Should Inform the National Healthcare Discussion: A Prolegomenon,” Journal of Religion and Health, 51, no. 3 (2012): 593. 113Aaron Mackler, Introduction to Jewish and Catholic Bioethics, Washington, D. C.: Georgetown University Press, 2003: 52–53. 114Mackler, 57. 132 4 The Meaning of Covenant on the part of the care-provider in light of the patient’s vulnerability.115 Clarke Cochran insists that Catholic health care has a special covenantal responsibility to incorporate the values of subsidiarity and solidarity in its outreach116 The late Edmund Pelligrino was another who embraced “covenant” as a term to express something essential about the ethical aspect of the medical encounter. Pelligrino contended that the physician who sees himself or herself as one in “a covenant of trust” is ethically superior to the physician who sees himself or herself primarily as scientist, mechanic, business person, or even servant of society. For Pelligrino, the covenant is a solemn promise that binds a particular physician to a particular patient, and carries with it both positive and negative obligations.117 Neil G. Messer has promoted the covenant theme as a key to creating and sustaining an appropriate physician-patient relationship. In a 1996 monograph, he declares his goal to be the articulation of “a Christian understanding of the doctor-patient relationship, rooted in the theology of covenant.”118 He cites May and Ramsey frequently in his presentation of several themes related to covenant. These themes include a pattern of initiative and response, commitment, inclusive- ness, affirming the worth of the covenant partner and faithfulness.119 Messer then discusses the relevance of the therapeutic covenant for consent, again drawing heavily on May and Ramsey.120 Use of the covenant concept by authors who are less explicitly religious can also be found. For example, covenant is identified as a theme in understanding the special nature of nursing care. Sue Coffey identifies three “attributes” of the nurse-patient relationship in cancer care which she contends are characteristic of covenantal relationships.121 First, she notes that nurse-patient relationships, as compared with other relationships experienced in the course of health care, tend to be more enduring. The endurance of the relationships may be due in part to the fact that the relationships also tend to be “dynamic, adaptive, growing and

115James J. Rusthoven. “Understanding Medical Relationships Through a Covenantal Ethical Perspective,” Perspectives on Science and Christian Faith 62, no. 1 (2010): 3–15. 116Clarke E. Cochran, “Pope Benedict XVI’s New Encyclical: Implications for Catholic Health Care,” Health Progress, 90, no. 5 (2009): 50–52. 117Edmund D. Pelligrino, “The Moral Foundations of the Patient-Physician Relationship: The Essence of Medical Ethics,” in Military Medical Ethics, v. 1, ed. by Thomas E. Beam and Linette R. Sparacino, Bethesda: Uniformed Services University of the Health Sciences, 2003: 3–21. 118Neil G. Messer, The Therapeutic Covenant, Grove Ethical Studies 103, Cambridge: Grove Books Limited, 1996: 3. 119Messer, The Therapeutic Covenant,8–10. 120Messer, The Therapeutic Covenant,13–23. Messer also published an article on covenant and informed consent eight years later, without significant change in his thinking about covenant or consent. See, “Professional-patient Relationships and Informed Consent,” Postgraduate Medical Journal 80 (2004): 277–283.. 121Sue Coffey, “The Nurse-Patient Relationship in Cancer Care as a Shared Covenant,” Advances in Nursing Science 29, no. 4 (2006): 311–314. 4.4 The Role of Covenant in Health Care Ethics 133 responsive.”122 Second, Coffey finds the nurse-patient relationship to be characterized by “caring benevolence,” and drawing on the values of “selflessness, compassion, humility, commitment, competence, honesty and trust.”123 Third, Coffey points to “contextually negotiated reciprocity” as a covenantal characteristic common to nurse-patient relationships. Though not equals, nurse and patient understand themselves as partners.124 Sylvia Käppeli is another who sees the nurse-patient relationship, especially in long-term and hospice care, as needing to be informed by the covenant concept in order to assure ethical practices. She believes caregiving as a business is likely to lead to poor care, and suggests that only as caregivers see themselves as being in covenant with patients will they find the emotional resources to provide quality care.125 Sally Gadow also writes about the role of covenant in nursing. Gadow holds that the “covenant of care,” which she defines as the “commitment to alleviating another’s vulnerability,” must always take precedence over efforts to cure. She calls care “the moral end,” and cure merely a “means to that end,” and concludes that “efforts to cure—outside the context of care—are unethical.”126 Joseph Fins finds the covenant concept useful in thinking about the ethics of advance care planning and surrogate decision making. Fins first argued in 1999 that “a covenantal view of the patient-proxy relationship” was superior to a contractual view. For Fins, a covenant is a relationship of trust that allows the covenant partner the use of his or her discretion. The ethical standards associated with proxy decision-making, such as substituted judgment or best interests, may be less helpful than simple trust in the judgment of one who has known the patient well and sincerely cares for the patient.127 A few years later, Fins worked with others to conduct empirical research to see how persons in patient-proxy pairs and others who had served as proxies for patients who had died felt about contractual and covenantal understandings of the proxy role. A contractual understanding was one in which the proxy’s “primary obligation was to promote the patient’s self-determination by adhering to prior wishes and instructions.” A covenantal understanding, by contrast, was one in

122Coffey, 313. 123Coffey, 313. 124Coffey, 314. 125Sylvia Käppeli, “Büdnis oder Vertrag? Eine Reflexion über zwei Paradigmen der Pflegenden Bezeihung,” Pflege 18, no. 187 (2005): 191–192. Ann Bradshaw shares some of Käpelli’s concerns, and also employs the notion of covenant as one way of addressing the special burdens of nursing. See “The Virtue of Nursing: the Covenant of Care,” Journal of Medical Ethics, 25 (1999): 477–481. 126Sally Gadow, “Covenant Without Cure: Letting Go and Holding On in Chronic Illness,” in The Ethics of Care and the Ethics of Cure: Synthesis in Chronicity, New York, N.Y: National League for Nursing, 1988: 6–11. 127Joseph J. Fins, “Commentary: From Contract to Covenant in Advance Care Planning,” Journal of Law, Medicine and Ethics 27, no. 1 (1999): 46–50. 134 4 The Meaning of Covenant which the proxy was given broader “discretionary authority.”128 The findings of the research indicated that, in practice, proxies tended to operate more from a covenantal stance, making “nuanced and contextually informed moral judgments.” It was further found that neither patients nor proxies considered deviation from patient’s prior wishes as necessarily a violation of patient autonomy, although patients were less willing to extend discretionary authority to proxies when the patient’s prior wishes were to forego life-sustaining treatment.129 Joan Cassell led a team that conducted research on the different approaches of surgeons and intensivists to the management of critically ill patients. In their findings, the researchers claimed that while intensivists seemed to operate out of a communitarian ethic concerned with the allocation of scarce resources, surgeons operated out of a “covenantal ethic” which was an unwavering commitment “to battle death on behalf of that patient.”130 The researchers credit William F. May as their source for the covenant concept, but it may be that they have understood it in a way somewhat different than May intended.131 Robert L. Fine also gave credit to May for the concept of covenant which Fine used in a brief essay on care for patients in chronic pain. Fine contrasts a contractual physician-patient relationship in which the patient is understood fundamentally as a consumer of goods and services with a relationship in which physician and patient are covenantal partners, working together in a dynamic and flexible way.132 Others share Fine’s concern with the increasing tendency, especially in the United States, to understand the patient as a consumer and to manage the patient’s relationship with care providers by means of a contract. Contractarian approaches emphasize rights and permissions, while neglecting compassion and trust, values more associated with covenantal relationships, according to Maureen Kelly.133 John Bruhn expresses similar concerns in an article about changes in the way medical care is delivered.134

128Joseph J. Fins, et al., “Contracts, Covenants and Advance Care Planning: An Empirical Study of the Moral Obligations of Patient and Proxy,” Journal of Pain and Symptom Management 29, no. 1 (2005): 56–57. 129Fins, et al., 64. 130Joan Cassell, et al., “Surgeons, Intensivists, and the Covenant of Care: Administrative Models and Values Affecting Care at the End of Life—Updated,” Critical Care Medicine 31, no. 5 (2003): 1551–1554. 131Cassell, et al., 1554. 132Robert L. Fine, “The Physician’s Covenant with Patients in Pain,” American Journal of Bioethics 10, no. 11 (2010): 23–24. 133Maureen Kelly, “Contractarianism and Bioethics,” in Encyclopedia of Bioethics, v. 1, 3rd Edition, ed. by Stephen G. Post, New York: Macmillan Reference, 2004: 526. 134John G. Bruhn, “The Lost Art of the Covenant: Trust as a Commodity in Health Care,” The Health Care Manager 24, no. 4 (2005): 311–319. 4.4 The Role of Covenant in Health Care Ethics 135

4.4.2 Paul Ramsey

Paul Ramsey, a professor of Christian Ethics at Princeton, introduced the concept of covenant to the discussion of ethics in his Basic Christian Ethics, published in 1950, and carried it over into his work on medical ethics some two decades later. Ramsey was mentored by H. Richard Niebuhr,135 and influenced intellectually by neo-orthodox theologians such as Anders Nygren and Karl Barth,136 as well as by existentialist thinkers Kierkegaard, Sartre, and Dostoyevsky.137 At the time Ramsey was called upon to address issues in medical ethics in the Beecher Lectures at Yale, he was already well-known. His Basic Christian Ethics had been a Religious Book Club selection and had become a standard text in American Protestant seminaries.138 Further, he had gained notoriety by writing on the topic of just war during the turbulent decade in which the United States was engaged in armed conflict in Vietnam.139 Among his peers, Ramsey was known not only as a profound thinker who was thoroughly familiar with a wide variety of sources, but also as “formidably disputatious, occasionally pontifical, (and) a master polemicist given to hyperbole.”140 The 1969 Lyman Beecher Lectures at Yale continued a tradition stretching back to the 19th century. However, the tradition of having a notable theologian address the faculty and students of the Divinity School was altered for Ramsey. The 1969 lectures were co-sponsored by the School of Medicine and included not only the lectures but also a number of seminars led by other scholars to discuss and debate Ramsey’s lectures. Ramsey had prepared himself to deliver the lectures by securing a grant from the Joseph P. Kennedy Foundation which allowed him to shadow the scientists and physicians at the Georgetown University Hospital for two seme- sters.141 The lectures Ramsey subsequently gave at Yale focused on four topics which were at the time emerging as issues of contention: organ donation and

135William F. May, “The Patient as Person: Beyond Ramsey’s Beecher Lectures,” in Paul Ramsey, The patient as person: explorations in medical ethics, Second Edition, New Haven: Yale University Press, 2002: xli. See also Paul Ramsey and Kenneth L. Vaux, “An Interview with Paul Ramsey,” in Covenants of Life: Contemporary Medical Ethics in Light of the Thought of Paul Ramsey, ed. by Kenneth L. Vaux, Sara Vaux and Mark Stenberg, Dordrecht: Kluwer Academic Publishers, 2002: 247. 136David H. Smith, “Covenant-Centered Ethics: The Theological Context of Paul Ramsey’s Medical Ethics,” in Covenants of Life,3. 137Kenneth Vaux and Mark Stenberg, “Discerning Stewardship: Contemporary Philosophy and the Legacy of Paul Ramsey’s Medical Ethics,” in Covenants of Life, 21. 138Adam Edward Hollowell, “Revising Basic Christian Ethics: Rethinking Paul Ramsey’s Early Contributions to Moral Theology,” Studies in Christian Ethics 23, no. 3 (2010): 269. 139Lisa Sowle Cahill, “Paul Ramsey: Covenant Fidelity in Medical Ethics,” The Journal of Religion 55, no. 4 (1975): 471. 140Ronald A. Carson, “Paul Ramsey’s Ethic of Covenant Fidelity,” in Covenants of Life, 10. 141Albert R. Jonsen, “The Structure of an Ethical Revolution: Paul Ramsey, The Beecher Lectures and the Birth of Bioethics,” in Patient as Person, Second edition, xvii–xix. 136 4 The Meaning of Covenant transplantation, the new criteria for the determination of death, withdrawing or withholding treatment from dying persons, and ethical standards for medical experimentation. When the lectures were published the following year as Patient as Person,afifth chapter addressing the issue of the allocation of scarce medical resources was included.142 In his preface for Patient as Person, Ramsey was quick to introduce the concept of covenant and to declare it central to his ethics. Those in a covenant relationship with one another owe one another faithfulness or loyalty, which Ramsey associates with “justice, fairness, … hesed, agape, and charity.”143 He declares his “chief aim” to be the exploration of “the meaning of care, to find the actions and abstentions that come from adherence to covenant.”144 While he introduces the concept of covenant in the preface, he does not elaborate on it greatly nor does he revisit it often in subsequent chapters. He appears to assume a degree of familiarity with his earlier work in Basic Christian Ethics. In Basic Christian Ethics, Ramsey had asserted the notion of the “righteousness of God as the Bible’s main theme,” and the foundation for ethics. However, he quickly linked the concept of covenant to the righteousness of God by defining the divine righteousness as “[God’s] steadfast faithfulness to the covenant he makes with [humans].”145 After exploring the semantic field surrounding the term covenant, Ramsey declared that “God’s righteousness becomes the plumb line for measuring the rightness of human relationships.”146 That is to say, the obligations which humans have toward other humans are based in covenant, a relationship of promised loyalty, reflecting the promised loyalty of God in the covenant with humanity which is fully realized in Jesus Christ. Agape love, the love which responds in self-giving to the needs of the other, is central to this loyalty. Care for the vulnerable is therefore an obligation.147 Because covenant love is responsive, the requirements cannot be fully stipulated in advance. Covenant love is thus dynamic.148 In the words of Ronald Carson, Ramsey’s notion of covenant imagines “commitment that reaches beyond the spoken and spelled out (and) envelops or encompasses the people so related.”149 Beyond the preface of Patient as Person, Ramsey explicitly invokes the covenant concept primarily in his discussion of consent for medical research. Consent, says Ramsey, “expresses or establishes” a relationship of covenant fidelity in which researcher and subject become “joint adventurers in a common cause.” The consent

142Jonsen, “The Structure of an Ethical Revolution,” in Patient as Person, xx. 143Ramsey, Patient as Person, Second Edition, xlv. 144Ramsey, Patient as Person, Second Edition, xlv. 145Paul Ramsey, Basic Christian Ethics,2. 146Ramsey, Basic Christian Ethics, 5. See also 367–68; 370; 376; and K. L. Vaux and M. Stenberg, “Discerning Stewardship,” in Vaux, Vaux and Stenberg, 27. 147Ramsey, Basic Christian Ethics,12–14. 148Ramsey, Basic Christian Ethics,1–132. 149Carson, “Paul Ramsey’s Ethic,” in Covenants of Life, 10. 4.4 The Role of Covenant in Health Care Ethics 137 he has in mind must be “reasonably free and adequately informed,” and ideally continuous or on-going.150 As long as the patient is capable of giving consent, research or treatment without consent would violate the pledge of loyalty inherent in covenant relations. As Albert Jonsen notes, Ramsey’sinfluence on the development of bioethics has been profound. Yet, in order for his insights to be transferred into the more secular approach which came to dominate the field, they had to be shorn of their more explicitly religious language. So, for example, Ramsey’s emphasis on the “sanctity of the individual” became concern for the dignity of persons, and his understanding of the obligation of covenant fidelity was reduced to a simple insistence on informed consent.151 Nonetheless, the concept of covenant did not disappear entirely from bioethics, as demonstrated by the variety of uses noted in the previous section. Further, the concept was taken up and elaborated by William F. May, once a student of Ramsey, and later himself a major figure in bioethics.152

4.4.3 William F. May

William F. May has had a long and distinguished career in ethics generally, with a concentration in health care ethics.153 May, as noted above, was an undergraduate student of Paul Ramsey. May went on to earn his Ph.D. at Yale before teaching at Smith College for fourteen years. He moved from Smith College to Indiana University, where he established the religion department, then to the Kennedy Institute at Georgetown University and later to Southern Methodist University. Following retirement from SMU, he became a Senior Fellow at the Institute for Practical Ethics and Public Life at the University of Virginia. May was a founding fellow of the Hastings Center for Bioethics and served a term on the President’s Council on Bioethics.154 While he has also written about professional ethics outside of health care and on political ethics,155 May is best known for his contributions to health care ethics,

150Ramsey, Patient as Person, Second Edition, 6. 151Jonsen, “The Structure of an Ethical Revolution,” in Patient as Person, xxiii. 152William F. May, The Patient as Person: Beyond Ramsey’s Beecher Lectures,” in Paul Ramsey, The Patient as Person, xxix. Many of May’s own contributions to bioethics will be noted in the section to follow. 153An excellent summary of May’s career and influence is found in Paul Lauritzen, “Covenant Keeper: William F. May & The Crisis of Bioethics,” Commonweal 140, no. 3 (2013): 10–15. 154Lauritzen, 11–14; “William May,” Accessed August 10, 2014. https://bioethicsarchive. georgetown.edu/pcbe/about/may.html; “Institute for Practical Ethics and Public Life,” Accessed August 10, 2014. http://www.virginia.edu/ipe/peopleFellows.html. 155See William F. May, Beleaguered Rulers: The Public Obligations of the Professional, Louisville: Wsetminster John Knox Press, 2001 and Testing the National Covenant: Fears and Appetites in American Politics, Washington, D. C.: Georgetown University Press, 2011. 138 4 The Meaning of Covenant beginning with his essay, “The Sacral Power of Death in Contemporary Experience.”156 In 1975, May introduced the covenant concept in an article entitled, “Code, Covenant, Contract or Philanthropy,” which appeared in Hastings Center Report. After developing his understanding of covenant as a way to “conceptualize professional ethics,” May contrasts it with the concepts of code, philanthropy and contract. He emphasizes the continuity and contrast with contract, concluding that he is inclined “to accept covenant as the most inclusive and satisfying model for framing questions of professional obligation.”157 May developed the concept of covenant further in his 1983 book, The Physician’s Covenant. There, covenant becomes an “image” which serves as a “corrective lens,” helping one see more clearly one’s role so that one may then define one’s tasks.158 May understands the physician “covenanter” as “a bonded partner in the pursuit of health.”159 May identifies four elements essential to the covenant concept. First, covenant begins with a gift from one party which provides the basis of the relationship. The gift is not part of a quid pro quo. It is not expected to be repaid; it may not even be possible to do so. The appropriate response of the other party is gratitude.160 On the basis of this foundation, then, a covenant may be formed through an exchange of promises, the second element. The promises are both specific and general, naming certain duties while “enjoining a comprehensive fidelity that extends beyond particulars to unforeseen and unforeseeable contingencies.”161 The third element is the dynamic process of covenant-keeping over time, and the fourth element is some ritual or rituals by which the meaning of covenant is revisited and the covenant reaffirmed.162 After returning to and expanding upon the covenant concept in The Physician’s Covenant, May took a detour into reflection on the experience of illness and health care encounters from the perspective of the patient in The Patient’s Ordeal.163 The Patient’s Ordeal does not explicitly mention covenant, focusing instead on the phenomenology of illness, much as May had explored the phenomenology of dying in “The Sacral Power of Death in Contemporary Experience.” May returned to the concept of covenant and made it central in Testing the Medical Covenant: Active Euthanasia and Health Care Reform (1996), in “Testing the Medical Covenant:

156William F. May, “The Sacral Power of Death in Contemporary Experience,” Social Research 39, no. 3 (1972): 463–488. 157William F. May, “Code, Covenant, Contract or Philanthropy,” Hastings Center Report 5 (1975): 29–38. It is curious that, in his ten references for the article, May does not include Paul Ramsey, even though the connections seem obvious. May does acknowledge Ramsey in notes to The Physician’s Covenant, 239; 241. 158May, Physician’s Covenant,4–7. 159May, Physician’s Covenant,8. 160May, Physician’s Covenant, 114–116. 161May, Physician’s Covenant, 113. 162May, Physician’s Covenant, 115. 163William F. May, The Patient’s Ordeal, Bloomington: Indiana University Press, 1991. 4.4 The Role of Covenant in Health Care Ethics 139

Caring for Patients with Advanced Dementia,” (2012) and in Testing the National Covenant: Fears and Appetites in American Politics (2011).164 While these later works do apply the concept to specific issues, they do not particularly develop further the concept itself. In The Physician’s Covenant, where May describes his understanding of covenant in the greatest detail, he revisits the categories of code, contract and philanthropy as well. May contends that the essential indebtedness of the physician prevents the physician from acting merely as a philanthropist,165 and a focus on code supports an understanding of the physician as technician which May contends can contribute to a failure to appreciate the humanity of the patient.166 This leaves the concepts of contract and covenant as the chief competing images.167 May acknowledges certain advantages to treating the health care encounter as a contractual transaction. Physician as contractor “breaks with more authoritarian models,” encourages respect for the dignity and autonomy of the patient, provides legal protections, and encourages collaboration based on self-interest.168 May does not wish to forfeit these advantages entirely, but feels that the covenant concept can include the benefits of contract while mitigating the disadvantages. Further, he sees covenant as being more adequate in light of the actual conditions under which health care takes place, likely drawing on insights similar to those found in The Patient’s Ordeal. These conditions include the vulnerability of the patient, the substantial power differential which exists between physician and patient in the health care setting, concern for others, and the unpredictability of future needs.169 May believes the physician’s primary covenant is with the profession of medicine, and covenants with individual patients are secondary to it. This is important because, as May recognizes, physicians (like their patients) tend to participate in multiple covenantal relationships simultaneously. In those cases where the demands of one covenant conflict with the demands of another, some priority must be established.170 In this way, May begins to address the broader implications of the covenant concept for the conduct of health care, including at the institutional and system level.171

164William F. May, Testing the Medical Covenant, Grand Rapids: William B. Eerdmans, 1996; “Testing the Medical Covenant: Caring for Patients with Advanced Dementia,” Journal of Law Medicine and Ethics 40, no. 1 (2012): 45–50; Testing the National Covenant: Fears and Appetites in American Politics, Washington, D. C.: Georgetown University Press, 2011. 165May, “Code, Covenant, Contract, or Philanthropy,” 31–32. 166May, Physician’s Covenant, 108–111. 167May, “Code, Covenant, Contract or Philanthropy,” 33; Testing the Medical Covenant,6–9; “Testing the Medical Covenant,” 45; The Physician’s Covenant, 124–136. 168May, Physician’s Covenant, 124–126. 169May, Physician’s Covenant, 126–136; Testing the Medical Covenant,9. 170May, “Code, Covenant, Contract or Philanthropy,” 36. 171May, Physician’s Covenant, 182–234; “The Medical Covenant: An Ethics of Obligation or Virtue?” in Theological Analyses, ed. by McKenney and Sande. 140 4 The Meaning of Covenant

William F. May writes self-consciously and unapologetically as a virtue ethicist, focusing on issues of identity and moral formation rather than on the establishment of principles or the direct resolution of concrete ethical dilemmas. He admits that the focus on principles, which has become dominant in health care ethics, is better suited for the resolution of such dilemmas. Still, he sees an ethics of principles meant to guide action as merely necessary, not sufficient. He believes that without attention to matters of identity and character, an ethics of principles will not be able to restrain the powerful from taking advantage in forming contracts with the vulnerable persons who present themselves for treatment.172 May’s articulation of the covenant concept and his description of its implications for health care have not been above criticism. Some feel it is all too amorphous, failing to be useful in defining specific obligations.173 Others argue that distrust, rather than trust, characterizes post-modern life, and thus people will tend to prefer the protections of autonomy to the comforts of covenant.174 John Evans characterizes the kind of work May does as “cultural bioethics,” as compared to “public policy bioethics,” and is concerned that the two are so disparate that calling both “bioethics” creates confusion.175 Ron Hamel contends that May’s approach to covenant, while ostensibly about mutual obligations, says too little about the obligations of patients to those who provide their care.176

4.5 Covenant and Care Provider—Patient Relationships

In the present chapter, the covenant concept has been examined and analyzed from a number of perspectives. The etymological roots of the word, “covenant,” have been identiﬁed, noting the Akkadian and Hittite terms which informed the Hebrew “berith,” which was later translated into the Latin testamentum, foedus or pactum. These, in turn, were translated as “covenant” by Tyndale when he produced his English translation in the 16th century.177

172William F. May, Physician’s Covenant, 131–136; 148–149; “The Medical Covenant: An Ethics of Obligation or Virtue?” in Theological Analyses, ed. by McKenney and Sande, 32. 173Ron Hamel, “Uses, Abuses and Promises of the Covenant Model,” in Theological Analyses, 23. See also criticisms by Jerome Groopman, Joel Feinberg and the late K. Danner Clouser in Lauritzen, 14–15. 174Ed Dubose, “Trust in the Clinical Encounter: Implications for a Covenant Model,” in Theological Analyses,45–66. 175John Evans, The History and Future of Bioethics: A Sociologist’s View, New York: Oxford University Press, 2014: xxxiii–xliv. 176Hamel, in Theological Analyses, 24. 177OED Online, s. v., “covenant,” OED Online version December 2012. Accessed February 1, 2013 at http://www.oed.com.authenticate.library.duq.edu/view/Entry/43328?rskey=JrAwto&res ult=1&isAdvanced=false#eid. See also s. v. “covenable,” http://www.oed.com.authenticate.lib rary.duq.edu/view/Entry/43322#eid7888762. 4.5 Covenant and Care Provider—Patient Relationships 141

The historical origins of the concept in political arrangements found in the ancient near east have also been described. The earliest forms of covenant appear to have been arrangements made between a dominant ruler and a less powerful ruler, either following a military conquest or in lieu of one. In return for loyalty and material tribute, the dominant ruler offered protection and delegated authority. Israel borrowed the concept as one metaphor for the relationship between God and its kings, a relationship understood to be both formal and personal. In Hebrew thought, covenant also came to be used to describe a number of close personal relationships, including marriage and friendship. Relationships understood as covenantal were generally those expected to perdure over time, requiring a significant degree of flexibility.178 Several examples of the use of the covenant concept in contemporary ethics, both Jewish and Christian, have been identified and analyzed. It has been demonstrated that the covenant concept has been found useful in describing a variety of political and social relationships and that often distinctions between covenantal arrangements and contractual arrangements have been emphasized.179 Finally, the use of the covenant concept in health care ethics has been noted, with special emphasis on the pioneering work of Paul Ramsey180 and the later, more in-depth investigation and application by William F. May.181 With this background, it is now possible to begin to construct a fresh argument for the use of the covenant concept to describe the care provider—patient or researcher—subject relationship. In doing so, we are extending the work of William F. May, who seeks to employ concepts and images as “lenses” through which situations or circumstances may be viewed more clearly.182 While not all care provider—patient or researcher—subject interactions or relationships will need to be understood as covenantal, the application of the covenant concept to such relationships will illumine certain features that may turn out to be both fitting and useful in particular contexts. What follows is a listing, description and brief analysis of several implications of the use of the covenant concept to describe care provider—patient or researcher— subject interactions and relationships. The list is not necessarily exhaustive, but it is intended to be broad and deep enough to demonstrate that the covenant concept can function well as a central symbol in health care ethics generally, as well as specifically in the ethics of consent in certain situations and for certain treatment regimens.

178Richter, 141–144; Olyan, 201–218; Weinfeld, 266–269; Van Groningen, 124–132; Lapsley, 117–129. 179Crane, 140–162; Newman, 89–112; Mittleman, 8–21, Niebuhr, 129–134; Ramsey, “Elements of a Biblical Political Theory,” 258–283; Allen, 16–37; Stackhouse, 136–160; Mount, 80–160; Huesmann, 61–140. 180Ramsey, Patient as Person,1–10. 181May, The Physician’s Covenant,4–8; 113–116; “Code, Covenant, Contract or Philanthropy,” 29–38; “Testing the Medical Covenant: Caring for Patients with Advanced Dementia,” 45–50. 182For this reason, May describes the task of ethics as “corrective vision.” See The Physician’s Covenant,1–2. 142 4 The Meaning of Covenant

4.5.1 Reciprocity, Loyalty and Disparities in Power

Covenantal relationships contain elements of reciprocity and ask loyalty of all parties to the covenant, even when there is a disparity in power. Howard Brody credits the practitioners of feminist ethics for helping us to recognize the existence and effects of power disparities between care providers and patients.183 Care providers often possess knowledge and access to resources which the patient desper- ately wants or needs. Further, social conventions support special respect for care providers and researchers as professionals. Thus, patients approaching care providers are generally well aware that they are in a vulnerable, dependent position. Deferential behavior on the part of patients is common. The practice of informed consent is thought to be a remedy of sorts for the disparity in power between care providers and patients or researchers and subjects.184 Robert Veatch goes so far as to claim that informed choice, rather than traditional consent, actually “puts the patient in charge.”185 Yet Veatch’s ideal of informed choice seems improbable, if not entirely unrealistic, in many circumstances. Patients and subjects often treat consent as a formality required for them to receive care or participate in the research, and believe the purpose of consent is to protect the care provider or researcher rather than the patient or subject. Meanwhile, features of research in various fields make it difficult, if not impossible, to provide the full scope of information traditionally associated with informed consent.186 In addition, experienced care providers and researchers are well aware of their ability to have a substantial influence on the decision of a patient or potential subject, whether they consider such influence reasonable persuasion, a legitimate nudge or an unethical “shove.”187 Consent remains important and when it is properly designed and practiced, it can offer substantial benefits to care providers or researchers and to patients or subjects. However, it is unlikely to be able to fully mitigate the consequences of the power disparity in most therapeutic and research encounters in health care.

183Brody, The Future of Bioethics, 105–116. Brody does not speak of researchers and subjects speciﬁcally, but his argument seems applicable, particularly when the research is therapeutic in nature. 184Brody, 110–116. 185Veatch, Patient, Heal Thyself, especially 103–134. 186Gail E. Henderson, “Is Informed Consent Broken?” The American Journal of the Medical Sciences 342, no. 4 (2011): 267–272. 187Shlomo Cohen, “Nudging and Informed Consent,” The American Journal of Bioethics 13, no. 6 (2013): 3–11; Charles Douglas and Emily Proudfoot, “Nudging and the Complicated Real Life of ‘Informed Consent’,” The American Journal of Bioethics 13, no. 6 (2013): 16–17; Barilan and Weintraub, 13–33; Kukla, “Conscientious Autonomy,” 34–37. 4.5 Covenant and Care Provider—Patient Relationships 143

The covenant concept may be helpful in thinking about interactions in health care precisely because it does not depend on conditions of equality between the parties. Indeed, as we have seen, in its origins it described relationships in which the distribution of power was decidedly unequal.188 Nonetheless, covenant was not a term for the use of power by a stronger party in order to simply impose its will on a weaker party. Especially as it came to be appropriated by Israel, covenant was an instrument for describing or creating a relationship—a kind of partnership in which both parties had obligations and both parties received benefits. It eventually came to refer to relationships in which admittedly unequal parties could work together toward a shared goal.189 Partners in covenant are expected to exhibit loyalty to both the shared goal and to one another. Failure to exhibit loyalty is a violation of the covenant, even when it does not directly interfere with progress toward the shared goal. Honor or shame may be imputed to persons on the basis of their loyalty or lack thereof. Personal loyalty and progress toward the shared goal tend to be mutually reinforcing.190 Covenants also assume reciprocity.191 Messer describes this as a “pattern of initiative and response.”192 One implication of the reciprocity that is expected in covenantal relationships is that there is a sense of ongoing negotiations. Should conditions change for either party, it is permissible for that party to approach the other for a reconsideration of the terms of the relationship going forward. Covenants are flexible. A second implication of the reciprocity which is an essential part of the covenant concept is that covenants are in some ways better adapted to human nature. Research in economics, game theory, and social psychology shows that people seldom act from a strict, rational, self-interested perspective. Instead, people often act in ways described as reciprocal. As Fehr and Gächter put it, “Reciprocity means that in response to friendly actions, people are frequently much nicer and more cooperative than predicted by the self-interest model ….”193 Such reciprocity tends to facilitate conditions in which relationships can flourish. By incorporating reciprocity as an expectation, the covenant concept is therefore well-suited to the way in which people often behave, particularly when they anticipate repeated or ongoing interaction.

188Weinfeld, 255; Richter, 141–142; Elazar, Covenant and Polity, 70. 189Elazar, Covenant and Polity in Biblical Israel, 69. 190Richter, 141–144; Olyan, 201–218; Jumper, 8–15. 191Lapsley’s description of the reciprocity in the relationship between God and Moses is very much to the point. See 121–123. 192Messer, The Therapeutic Covenant,5. 193Ernst Fehr and Simon Gächter, “Fairness and Retaliation: The Economics of Reciprocity,” Journal of Economic Perspectives 14, no. 3 (2000): 159. 144 4 The Meaning of Covenant

4.5.2 Covenantal Relationships: Accompanying Characteristics

Along with an emphasis on loyalty and reciprocity, the covenant concept bears several other characteristics which are important to notice. First, covenantal relationships do not pretend to be merely legal or contractual. Rather, they are deeply personal and ask participants to exhibit fidelity to one another and to the relationship itself. The legal and contractual paradigm on which the standard approach to consent tends to be founded is appropriate for the episodic exchange of goods or services between persons who may be strangers to one another. The emphasis in that paradigm is on rights and on a strict definition and limitation of obligations. It is possible in many contractual exchanges that the parties never meet, or even know one another’s identities. So long as the terms of the contract are fulfilled by all parties, the contractual arrangement may be considered a success. In a contract relationship, the other party is essentially the means to obtain that which is desired. If that which is desired could be obtained as easily or as cheaply without the involvement of the other, nothing would be lost in so doing. Covenantal relationships, on the other hand, are by nature deeply personal. Covenants do more than merely structure an exchange of goods or services. Covenants create, structure and maintain relationships in which an ongoing exchange of goods or services may take place. These relationships are more than mere conduits; they have meaning and value to the parties involved beyond their role in facilitating exchanges. The good or service desired cannot be separated from the relationship with the covenant partner with whom one is engaged. As several scholars have argued, covenantal relationships are virtually familial at times, establishing fictive kinship.194 Second, while covenantal relations do include some specifications, they also retain an openness to the unknown and a significant degree of flexibility. Covenants include commitments to do certain things or to refrain from doing certain things. In that sense, they involve some specified expectations of the partners to the covenant. In early political covenants, such specifications might include the payment of tribute and the grant of limited authority over a region or people.195 The detailed law codes associated with the Sinai covenant are an example of detailed specifications.196 Yet even in the case of the Sinai covenant, the specifications of the law code do not exhaust the expectations placed upon covenant partners.197 Newman points to the combination of fixed expectations and flexibility within covenant by

194Richter, 141; Stansell, 118–119; Roth and Reuther, 3–13. 195Taggar-Cohen, 483. 196Messer, The Therapeutic Covenant,5. 197See, for example, the more general “great” commandment following the Decalogue in Deuteronomy 5–6: 5. 4.5 Covenant and Care Provider—Patient Relationships 145 describing it as both contract and relationship, noting that the demands placed on one by a (personal) relationship “cannot be fixed in advance.”198 In later, more personal covenants, like those involving friendship or marriage, there could still be specified expectations regarding dowries, labor or care for descendants.199 Yet, inasmuch as covenants create, structure and maintain relationships which are expected to endure, the specifications are not fixed to the degree that they would be in a contract. Depending upon the nature of changing circumstances, the expectations of covenant partners might be modified, curtailed, or expanded. Many of the words associated with the covenant concept support this dynamic understanding of covenant obligation. Words like “honor,”“peace,” “love,”“friendship,” and “loyalty”200 convey a sense of a serious commitment, yet one in which at least some particular responsibilities only become evident as context develops. In the words of Roth and Reuther, a covenant is “a flexible relationship where trust and faithfulness to each other determine the action of the partners.”201 Third, covenantal relationships are structured so as to be long term and durable. Covenants create relationships that are expected to last. The early political covenants frequently included provisions for periodic public reading and rituals for reaffirmation of covenants, clearly indicating that the covenant was to extend over a considerable period of time. Such relationships might last as long as the original covenant partners were living, or even longer.202 At any rate, covenants are not relationships designed to expire once their stipulations are fulfilled. Rather, actions which honor the covenant deepen the covenant relationship and strengthen its bonds. As Jacqueline Lapsley states, covenants anticipate “regular encounters that form habitual practice.”203 It is precisely because covenantal relationships are expected to last that loyalty and faithfulness are central to the covenant concept. Loyalty and faithfulness are demonstrated over time through words and deeds that may be recognized as a fulfillment of prior pledges, especially when the pledges are serious yet open-ended.204

198Newman, in Contemporary Jewish Ethics and Morality, Dorff and Newman, 89. See also Borowitz, 112. 199For specifications in marriage covenants, one might consider the agreements regarding Rachel and Leah made by Jacob and Laban in Genesis 29: 15–30. For friendship, the relationship between David and Jonathan provides an example of the pledge to care for descendants, later fulfilled in the care shown to Mephibosheth, 1 Samuel 18–20; 2 Samuel 9. 200Weinfeld, 256–257; (Mercer) 177; Eerdman’s Dictionary of the Bible,s.v.“covenant,” 291; Richter, 141, includes the Hebrew term, hesed; Allen, 25. 201Roth and Reuther, 2. Alan Mittleman would support this claim. See Mittleman, 9–10. Paul Ramsey picks up this notion, especially in his Basic Christian Ethics, as does William F. May in The Physician’s Covenant, 113. 202Elazar, Covenant and Polity, 23. 203Lapsley, 121. 204One may think of pledges to love, to honor, or to pursue justice as open-ended, in that the words and actions that express faithfulness or loyalty to the covenant partner in light of such pledges must be defined contextually in future unforeseen and perhaps unforeseeable situations. 146 4 The Meaning of Covenant

Fourth, covenantal relationships create a new moral community in which partners are committed to working together toward a common end. A covenant creates, structures and sustains a moral community to which all partners to the covenant belong.205 The covenantal relationship itself becomes a good to be supported and protected by faithfulness and loyalty. The description of covenantal relations as ﬁctive kinship implies the formation of deep bonds which facilitate the pursuit of shared goals.206 Covenants, by creating moral communities, establish mutual accountability. Within a moral community, members accept moral responsibility to, and sometimes for, each other.207 One’s covenant partners do not just matter instrumentally, but as persons to be respected and valued beyond their utility.208 At the same time, each member of the moral community created by means of a covenant is called upon to contribute as they are able to the ends or goals of the covenant.209

4.5.3 A Covenant Approach to Care Provider—Patient Relations

A covenantal approach to care provider—patient relationships in health care, whether standard care or care in the context of therapeutic research, addresses several weaknesses of a contractualist approach. Contractarianism in bioethics began as reaction against longstanding patterns of physician paternalism.210 Given the egregious abuses that took place, as noted in the earlier chapter on consent, a reaction against physician paternalism is understandable and legitimate. Patients and research subjects do deserve the greater control over decisions affecting them in therapy and research. Thus, contractarian values have an important place in bioethics. However, contracts have limits and weaknesses within certain contexts, including some contexts within health care delivery and research.211 William F. May, who has provided the most extensive argument for the role of covenant in bioethical thought, has noted several of the limitations or weaknesses of contracts. May notes, for example, the paradox that contractualism inspires a reduction of “professional obligation to self-interested minimalism,”212 while (within the litigious context of modern American health care) also inspiring the

205Elazar, Covenant and Polity, 64. 206Richter, 141; Elazar, Covenant and Polity, 66; 69. 207Allen, 37. 208Allen, 38; 46. 209Elazar, Covenant and Polity, 69. 210Kelly, 524, who credits Howard Brody for this observation. 211Allen, 17; Kelly, 526–527. 212May, The Physician’s Covenant, 126. 4.5 Covenant and Care Provider—Patient Relationships 147

“peculiar maximalism” of defensive medicine.213 In either case, the best interests of the patient or the wellbeing of the research subject are secondary and instrumental to the physician’s or researcher’s self-interest. Contractualism also is limited by the fact that it requires specifications that are not always possible, or a listing of possible side effects or complications that is so lengthy that it becomes difficult for the patient to fully grasp or appreciate.214 Gert, Culver and Clouser point out that simply listing of possible risks is not especially helpful without some attempt to assess and communicate the probabilities of each.215 Unfortunately, both parties—the physicians or researchers and the patients or research subjects—often have difficulty understanding the statistical probabilities. This limits the value of such specifications primarily to the legal protection of the physician or researcher.216 Contractualism also suffers limits because the very requirement of specification of rights and obligations necessary for enforcement of the contract tends to prevent the proper evolution of expectations and alternatives as circumstances change. In contrast, as May notes, covenants have a “gratuitous, growing edge to them.”217 That is, they are designed to account for change, to anticipate and accommodate the “ebb and flow”218 which is characteristic of human relationships generally and the often unpredictable course of therapy and research specifically. Finally, contractualism under the conditions of power disparity naturally gives an advantage to the more powerful or least vulnerable party to the contract. Given the strength of their bargaining position, one must depend on the more powerful parties to limit themselves appropriately and to offer protections for the more vulnerable parties. However, it is not always clear why they should do so.219 Covenants, which create, structure and maintain relationships which are understood to matter beyond their utility, incline partners to respect and care for each other in a way that encourages benevolent action or restraint beyond what the original agreement might require.220 Properly constructed and implemented, a covenant approach to the relationship between care provider/researchers and patient/subjects is able to address several of the weaknesses and limitations of a contractualist approach while maintaining a number of important values and protections associated with contracts. Covenantal relations place serious obligations on all parties to the covenant, to which persons

213May, The Physician’s Covenant, 131. 214May, The Physician’s Covenant, 127. 215Bernard Gert, Charles M. Culver, and K. Danner Clouser, Bioethics: A Systematic Approach, 2nd Edition, New York: Oxford University Press, 2006: 199–236. 216Gert, Culver and Clouser, 191–212, observe that some research shows that physicians themselves often draw the wrong conclusions from statements of probability. 217May, The Physician’s Covenant, 128. 218Newman, “Covenant and Contract,” 92; 97. 219May, The Physician’s Covenant, 133–136, addresses this concern in response to the claims of Veatch, who argues in favor of contract. 220Allen, 38. 148 4 The Meaning of Covenant can expect to be held accountable. Covenantal relations allow for the speciﬁcation of obligations, burdens and risks, insofar as it is possible to do so, while also allowing for the evolution of obligations over time, as burdens are encountered and risks are manifested. Covenantal relations may take place between parties equal in power, but are also adaptable to situations in which there is a disparity in power, as is often the case in illness generally and in cases of severe illness in particular. Illness “creates vulnerability … and a consequent inequality in the medical relationship.”221 In such situations, the vulnerability of the less powerful party is acknowledged and the responsibilities of the more powerful party are assessed accordingly. Ana Maria Pineda goes so far as to assert that:

“covenant’s most foundational truth is that it exists precisely because of the vulnerability of the relationship. It is the need and weakness of the [patient] that requires more from the [professional] than the establishment of an equal relationship.”222 It is true that covenantal relations demand more of the parties than do contractual relations. More time and effort will be required to establish covenantal relations, to maintain them, and often to fulﬁll the broader set of obligations associated with them. As such, covenantal relations may be neither necessary nor desirable for most routine health care or many instances of health care research. Yet when therapy or research involves multiple interactions over a long period of time, substantial burdens and risks, signiﬁcant long-term demands upon the patient or subject, and considerable uncertainty with regard to the ultimate success of the intervention, the advantages of covenant relations become evident. When the advantages of covenant relations become evident, the task of re-imagining consent in covenantal terms becomes appropriate.

221G. Kevin Donovan, “The Physician-Patient Relationship,” in The Health Care Professional as Friend and Healer: Building on the Work of Edmund D. Pelligrino, ed. by David C. Thomasma and Judith Lee Kissell, Washington, D. C.: Georgetown University Press, 2000: 18. 222Ana Maria Pineda, “Covenanting with the Powerless: Strangers, Widows and Orphans,” Fordham Law Review 66 (1998): 1179. Chapter 5 Covenant Consent

Abstract This chapter will argue for the adaptation of the consent process for vascularized composite allotransplantation research involving the transplant of faces and upper extremities. This adaptation of the consent process will reﬂect the particular nature of VCA as a form of therapeutic research which takes place over a long period of time, exposes the vulnerable subject to great risks and burdens, requires intensive long-term active participation of the recipient and raises the issue of the recipient’s dignity and vulnerability in a special way. It will incorporate several of the insights offered by various critics of the current standard approach to consent. Finally, at the heart of this adaptation will be a reimagining of consent in covenantal terms. This will involve reimagining the researcher/subject and physician/patient relationship. In place of the more typical professional distance and emotional detachment on the part of researchers or physicians, covenant consent will require “compassionate solidarity.”

5.1 Introduction

The ﬁeld of vascularized composite allotransplantation continues to expand, albeit slowly, more than two decades after the French team led by Jean-Michael Dubernard transplanted a forearm on to a 48 year old male recipient, and despite the disappointing outcome of that initial attempt.1 While not all medical centers or teams involved in VCA have been faithful or timely in reporting their attempts and outcomes to the International Registry on Hand and Composite Tissue Transplantation, it is likely that the total number of patients who have undergone

1K.V. Ravindra et al., “Composite Tissue Transplantation: A Rapidly Advancing Field,” Transplantation Proceedings 40, no. 5 (2008): 1237–1248; Maria Siemionow, Bahar Bassiri Gharb and Antonio Rampazzo, “Successes and Lessons Learned After More Than a Decade of Upper Extremity and Face Transplantation,” Current Opinion in Organ Transplantation 18, no. 6 (2013): 633–639; J.R. Diaz-Siso et al., “Vascularized Composite Tissue Allotransplantation— State of the Art,” Clinical Transplantation, 27, no. 3 (2013): 330–337.

© Springer International Publishing AG 2017 149 J.L. Benedict, A Revised Consent Model for the Transplantation of Face and Upper Limbs: Covenant Consent, International Library of Ethics, Law, and the New Medicine 73, DOI 10.1007/978-3-319-56400-5_5 150 5 Covenant Consent face and upper extremity VCAs, as of mid-year 2016, is nearing two hundred.2 A number of technical and other challenges still inhibit the broader acceptance and practice of VCA, including issues surrounding funding, procurement and allocation, patient selection, adherence, psychological acceptance, and the negative consequences of long-term immunosuppression. Yet, in spite of these very substantial challenges, the effort to expand VCA continues and there are indications it is being met with greater acceptance.3 Alongside the technical challenges which may be inhibiting the growth of the field of face and upper extremity VCA are a number of ethical challenges. As noted in an earlier chapter, several of these ethical challenges are closely tied to the technical challenges. Naturally, questions of justice are implicated in the issues of procurement, allocation and patient selection. Concern about beneficence and non-maleficence are clearly raised by the risks and burdens that accompany the long-term use of immunosuppression, especially for conditions that are not life-threatening. Due regard for the dignity and vulnerability of patients comes into question when we consider the significance of bodily integrity, and the special role of the face in interpersonal relations and one’s sense of self. Also relevant to questions of dignity and vulnerability is the unavoidable wide publicity that so far attends the practice of facial and upper extremity transplants. Ethical challenges related to respect for autonomy with regard to VCA have tended to focus on the ability of patients/subjects to give appropriate consent. Some have expressed concern about the possible desperation of potential candidates,4 while others have pointed to the problem caused for consent by the paucity of information available about risks and other aspects of the treatment.5 Both of these

2Ricardo Londono, Vijay S. Gorantla, and Stephen F. Badylak, “Emerging Implications for Extracellular Matrix-based Technologies in Vascularized Composite Allotransplantation,” Stem Cells International, epub (2015), doi:10.1155/2016/1541823; Bohdan Pomahac, Ryan M. Gobble and Stefan Schneeberger, “Facial and Hand Allotransplantation,” Cold Spring Harbor Perspectives in Medicine, epub ahead of print, accessed 22 Mar. 2014 at http:// perspectivesinmedicine.org/content/early/2014/01/28/cshperspect.a015651.full.pdf+html. 3A.A. Bertrand et al., “Changing Attitudes Toward Hand Allotransplantation Among North American Hand Surgeons,” Annals of Plastic Surgery May 2014 Supplement: S55–S60; Gaby Doumit et al., “Pediatric Vascularized Composite Allotransplantation,” Annals of Plastic Surgery, epub ahead of print, July 2014; Jacques Balayla has joined his voice to others calling for public funding of uterine transplantation. See “Public Funding for Uterine Transplantation,” JME Online First, doi:10.1136/medethics-2015-103232. 4R. Huxtable and J. Woodley, “Gaining Face or Losing Face? Framing the Debate on Face Transplants,” Bioethics 19 (2005): 510–513; Carson Strong, “Should We Be Putting a Good Face on Facial Transplantation?” American Journal of Bioethics 4, no. 3 (2004): 13. 5K. Shanmugarajah, S. Hettiaratchy and Peter E.M. Butler, “Facial Transplantation,” Current Opinion in Otolaryngology and Head and Neck Surgery 20, no. 4 (2012): 294–295; Jaime T. Shores, Joseph E. Imbriglia, and W.P. Andrew Lee, “The Current State of Hand Transplantation,” Journal of Hand Surgery 36A (November 2011): 1864–1865; T. Hautz et al., “World Experience After More Than A Decade of Clinical Hand Transplantation: Update on the Innsbruck Program,” Hand Clinics 27 (2011): 428; Warren C. Breidenbach et al., “Outcomes of the First Two American Hand Transplants at 8 and 6 Years Posttransplant,” Journal of Hand Surgery, 33A (September 5.1 Introduction 151 concerns about the ability of persons to consent have been answered with fairly standard rebuttals. The gist of these rebuttals has been that if the level of desperation and the lack of information associated with VCA make consent impossible, then any number of common therapeutic interventions and much other therapeutic research would also have to be excluded on the same ethical grounds.6 The point made in the rebuttals is accurate, but not adequate. It is true that patients or their surrogates are often anxious and desperate when consent is sought in various health care settings. It is also true that it is in the very nature of research that one lacks information which, were it available, one might ﬁnd useful in determining whether or not to participate. And it is true that existing forms and processes of consent have been, and continue to be, used in such contexts. However, it may be argued that consent sought and granted under such conditions at present is less than it should be. It is certainly obvious from the many criticisms of the dominant approach to consent that many feel the consent process can be improved.7 At any rate, the argument that the consent processes currently in use must be considered adequate for new treatments or research because they have been used for other forms of treatment or research is far from compelling. It is the intent of this chapter to argue for an adaptation of the consent process for vascularized composite allotransplantation research involving the transplant of faces and upper extremities. This adaptation of the consent process will reﬂect the particular nature of VCA as a form of therapeutic research which takes place over a long period of time, exposes the vulnerable subject to great risks and burdens,

(Footnote 5 continued) 2008): 1039; G. Brandacher et al., “The Innsbruck Hand Transplant Program: Update at 8 Years After the First Transplant,” Transplantation Proceedings 41 (2009): 493. 6Michael Hurlburt, “Facial Transplantation: Understanding the Interests of Patients,” Medical Science Monitor 12, no. 8 (2007): RA149; L. Kallianen, “Supporting Facial Transplantation with the Pillars of Bioethics,” Journal of Reconstructive Microsurgery 26, no. 8 (2010): 548; Jeff Chang and David W. Mathes, “Ethical, Financial, and Policy Considerations in Hand Transplantation,” Hand Clinics 27, no. 4 (2011): 558; Katrina A. Bramstedt, “Informed Consent for Facial Transplantation,” in The Know-How of Face Transplantation, ed. by Maria Siemionow, (New York: Springer, 2011), 255. 7See especially Y.M. Barilan, “Respect for Personal Autonomy, Human Dignity, and the Problems of Self-Directedness and Botched Autonomy,” Journal of Medicine and Philosophy 36, no. 5 (2011): 496–515; Rebecca Kukla, “Communicating Consent,” Hastings Center Report 39, no. 3 (2009): 45–47 and “Conscientious Autonomy: Displacing Decisions in Health Care,” Hastings Center Report 35, no. 2 (2005): 34–44; Robert Veatch, Patient, Heal Thyself: How the New Medicine Puts The Patient in Charge, Oxford: Oxford University Press, 2009; Grzegorz Mazur, Informed Consent, Proxy Consent, and Catholic Bioethics for the Good Of The Subject, Dordrecht: Springer, 2012; Benjamin Moulton and Jaime S. King, “Aligning Ethics With Medical Decision-Making: The Quest For Informed Patient Choice,” The Journal of Law, Medicine & Ethics 38, no. 1 (2010): 85–97; Alisdair MacLean, Autonomy, Informed Consent and Medical Law: A Relational Challenge, Cambridge, UK: Cambridge University Press, 2009; P. Alderson and C. Goodey, “Theories in Health Care and Research: Theories of Consent,” BMJ 317, no. 7168 (1998): 1313–1315; for a legal perspective, see Thaddeus Mason Pope and Melinda Hexum, “Legal Briefing: Shared Decision Making and Patient Decision Aids,” Journal of Clinical Ethics 24, no. 1 (2013): 70. 152 5 Covenant Consent requires intensive long-term active participation of the recipient and raises the issue of the recipient’s dignity and vulnerability in a special way. It will incorporate several of the insights offered by various critics of the current standard approach to consent. Finally, at the heart of this adaptation will be a reimagining of consent in covenantal terms. Reimagining consent in covenantal terms will involve reimagining the researcher/subject and physician/patient relationship. In place of the more typical professional distance and emotional detachment on the part of researchers or physicians, covenant consent will require “compassionate solidarity.”8 For the subject or patient, there will also be different expectations and responsibilities. As Karen Lebacqz puts it in her reflection on the characteristics of the virtuous patient, “being responsible… puts flesh on the bones of the ‘covenant’ or ‘partnership’ between patient and physician.”9 Instead of simple, largely passive compliance, patients will be expected to acknowledge and accept that their consent is a commitment to fulfill their responsibility to engage in long-term physiotherapy, maintain the immunosuppressant regimen, and communicate concerns, frustrations and questions they may have.10 Further, subjects or patients will be expected to commit themselves to ongoing dialogue which is “open, respectful and frequent.”11 Consent, therefore, will not be understood as a punctuate decision12 in the past tense, i.e., the subject has (or has not) consented. Rather, the focus will be on the present and on-going relationship or therapeutic alliance within which the subject and the researcher are consenting partners. In order to provide justification for covenant consent for vascularized composite allotransplantation of faces and upper extremities, it will be necessary to show that such an adaptation is both warranted and feasible, and that the covenant concept is a useful resource for the adaptation because of the particular nature of VCA. This justification will take place in three steps. First, it will be demonstrated that informed consent is a dynamic concept and evolving practice, which has already been adapted to various other contexts of health care and research. Second, a number of particular aspects of vascularized composite allotransplantation of faces and upper extremities will be shown to be inadequately addressed by the standard, antecedent approach to informed consent. Third, it will be argued that the aspects of VCA which are inadequately addressed by standard,

8Jack Coulehan, “Compassionate Solidarity: Suffering, Poetry, and Medicine,” Perspectives in Biology and Medicine 52, no. 4 (Autumn 2009): 597–598. 9Karen Lebacqz, “The Virtuous Patient,” in Virtue and Medicine: Explorations in the Character of Medicine, ed. by Earl E. Shelp, Dordrecht: D. Reidel Publishing Company, 1985: 282. 10A more traditional approach to patient responsibilities in research is found in David B. Resnik and Elizabeth Ness, “Participants’ Responsibilities in Clinical Research,” Journal of Medical Ethics 38, no. 12 (2012): 746–750. What is proposed as part of covenant consent would not exclude any of the responsibilities they list, but would approach those responsibilities from a different perspective. 11Tineke A. Abma et al., “Inter-ethics: Towards an Interactive and Interdependent Bioethics,” Bioethics 24, no. 5 (2010): 250. 12Kukla, “Conscientious Autonomy,” 35. 5.1 Introduction 153 antecedent informed consent are more adequately addressed by a consent process shaped by the themes and values of the covenant concept. Following the ethical justiﬁcation of covenant consent for VCA, a brief description of how such a consent process might be formulated and implemented will be offered.

5.2 Informed Consent: Dynamic and Evolving

It seems likely that nearly all care providers and most patients in modern Western healthcare systems are aware, to some degree, of the concept of informed consent. As outlined in an earlier chapter, the modern concept of informed consent which arose in the twentieth century as an interest in protecting patients and research subjects was fueled by revelations of Nazi abuses,13 other troubling research practices,14 and a number of legal cases involving patients who suffered negative outcomes without being adequately informed of the risks in advance.15 The concurrent rise in emphasis on individual rights also contributed significantly to the demand for the choices implied in the idea of informed consent.16 Yet, despite a widespread awareness of the concept and frequent efforts to apply it in one fashion or another, neither the theoretical underpinnings nor the practical applications of informed consent are fixed or agreed upon. Nearly sixty years after the term, “informed consent,” first appeared in a California legal proceeding,17 the concept

13Robert M. Veatch, Hippocratic, Religious, and Secular Medical Ethics: The Points of Conflict, Washington, D.C.: Georgetown University Press, 2012: 64–66; Neil C. Manson and Onora O’Neill, Rethinking Informed Consent in Bioethics, Cambridge: Cambridge University Press, 2007: 2–4. For the text of the Code, see The Nuremberg Code. Accessed December 7, 2012. http:// www.hhs.gov/ohrp/archive/nurcode.html. 14Henry K. Beecher, “Ethics and Clinical Research,” The New England Journal of Medicine 274, no. 24 (1966): 1354–1360. See also Jay Katz, “‘Ethics and Clinical Research’ Revisited: A Tribute to Henry Beecher,” Hastings Center Report 23 (1993): 31–39 and Franklin G. Miller, “Homage to Henry Beecher (1904–1976),” Perspectives in Biology and Medicine 55, no. 2 (2012): 218–220; Giselle Corbie-Smith, “The Continuing Legacy of the Tuskegee Syphilis Study: Considerations for Clinical Investigation,” The American Journal of the Medical Sciences 317 (1999): 5–8; John J. Gillon, “More Subject and Less Human: The Pain-Filled Journey of Human Subjects Protection… And Some Differences in the United States and the European Union,” Medical Law International 7 (2005): 65–66. 15Steven Joffe and Robert D. Truog, “Consent to Medical Care: The Importance of Fiduciary Context,” in The Ethics of Consent, ed. by Miller and Wertheimer, 348; Janet L. Dolgin, “The Legal Development of the Informed Consent Doctrine: Past and Present,” Cambridge Quarterly of Healthcare Ethics 19 (2010): 98–99; Janet L. Dolgin and Lois L. Shepherd, Bioethics and the Law, New York: Aspen Publishers, 2005: 52–58. 16Nan D. Hunter, “Rights Talk and Patient Subjectivity: The Role of Autonomy, Equality and Participation Norms,” Wake Forest Law Review 45 (2010): 101; Dolgin, 99; Robert D. Truog, “Patients and Doctors—The Evolution of a Relationship,” The New England Journal of Medicine 366, no. 7 (2012): 581. 17Salgo v. Leland Stanford Jr. University Board of Trustees. 154 5 Covenant Consent and the practices associated with it remain dynamic, subject to adaptation, and in need of improvement. In terms of consent practices, research has shown that they are unevenly and inconsistently employed. As one of several examples, Dafydd Loughran noted that in one study of surgical consent in the United Kingdom, physicians seeking consent for a surgery that carried a 14% risk of mortality (more than 1 in 8) documented mention of that risk in a mere 28% of cases.18 Jukic et al., found physicians routinely overestimate patients’ understanding of the informed consent process.19 Other studies have found physicians do a very poor job of identifying patient preferences in preference sensitive treatment situations.20 Constantine A. Mathous and associates note that the practice of obtaining consent for medical procedures is uneven, with certain procedures (bronchoscopy, GI endoscopy) more likely to take place after informed consent than others (Foley catheterization, nasogastric intu- bation).21 Leclercq et al., in a study of informed consent practice in the Netherlands, observed the same inconsistency in whether or not consent was sought.22 In a study of nearly two dozen hospitals throughout Europe with regard to the nature of informed consent practices for similar research, written informed consent was required at 12 hospitals, oral consent was sufficient at 10, and one hospital conducted the research without consent. Significant differences in the amount of information provided to research subjects was also found.23 In addition to what appear to be serious and potentially unethical inconsistencies in consent practices, there are also differences in consent practices that are reasonably justified by considerations of the context of treatment and the capacity of the patient or subject. Beauchamp and Childress describe and justify variations such as express consent, implicit consent, presumed consent, and surrogate consent.24 Others have described how consent practice should be adapted for pediatric patients

18Dafydd Loughran, “Surgical Consent: the World’s Largest Chinese Whisper? A Review of Current Surgical Consent Practices,” Journal of Medical Ethics Published Online First; accessed September 28, 2014, doi:10.1136/medethics-2013-101931. 19Marko Jukic et al., “Physicians overestimate patients’ knowledge of the process of informed consent: a cross-sectional study,” Medicinski Glasnik 8, no. 1 (2011): 39–45. 20A. Mulley, C. Trimble and G. Elwyn, Patients’ Preferences Matter: Stop the Silent Misdiagnosis, London: King’s Fund, 2012: 13–14. 21Constantine A. Mathous et al., “Informed Consent for Medical Procedures,” Chest 124, no. 5 (2003): 1978–1984. 22Wouter K.G. Leclercq et al., “A Survey of the Current Practice of the Informed Consent Process in General Surgery in the Netherlands,” Patient Safety in Surgery 7, no. 4 (2013). See also Leclercq et al., “A Review of Surgical Informed Consent: Past, Present, and Future. A Quest to Help Patients Make Better Decisions,” World Journal of Surgery, 34 (2010): 1406–1415. 23Ulrike M. Stamer et al., “Ethical Procedures and Patient Consent Differ in Europe,” European Journal of Anesthesiology 32 (2015): 126–131. 24Beauchamp and Childress, Principles of Biomedical Ethics 6th Edition, 107–110; 135–140. 5.2 Informed Consent: Dynamic and Evolving 155 and patients with dementia.25 Adaptations of the information provision aspect of informed consent include a trend toward greater use of patient decision aids, driven both by demonstrations of their effectiveness and by legislation, including the Affordable Care Act in the United States.26 Recognition of the inadequacy of consent practices for particular forms of treatment has led to the development of special adaptations of the consent process. As discussed in the earlier chapter devoted to the theory and practice of consent, lengthy and complex interventions—either in standard therapy or in research—may call for consent that is tiered, layered or staged. In these models of consent, information disclosure does not take place all at one time, but in layers or stages and at a pace that may be patient or subject-driven.27 In some cases, the earlier choices made by patients or subjects may dictate the amount and content of information they receive in later stages.28 There may be several reasons for the diverse and irregular practices associated with seeking and obtaining informed consent in both clinical care and research. Gail Henderson points to failures to appreciate cultural differences, an emphasis on the form rather than the process, failures to fully grasp the differences between treatment and research and ﬂawed enforcement of standards.29 Others point to a lack of training and a lack of appreciation on the part of researchers, care providers, research subjects and patients for the value of appropriate consent.30 Yet others note

25Maria De Lourdes Levy, Victor Larcher and Ronald Kurz, “Informed Consent/Assent in Children: Statement of the Ethics Working Group of the Confederation of European Specialists in Paediatrics,” European Journal of Pediatrics 162 (2003): 629; K. Jane Lee et al., “Assent for Treatment: Clinician Knowledge, Attitudes and Practice,” Pediatrics 118 (2006): 723–724; Paul Baines, “Assent for Children’s Participation in Research is Incoherent and Wrong,” Archives of Disease in Childhood 96 (2011): 960–962; Susan Slaughter et al., “Consent and Assent to Participate in Research From People with Dementia,” Nursing Ethics 14, no. 1 (2007): 32–33; Statement of the Alzheimer’s Association on Protection of Participants in Research, Accessed April 4, 2013. http://www.alz.org/about_us_statements.asp. 26Pope and Hexum, “Legal Briefing: Shared Decision Making and Patient Decision Aids,” 70–73. 27Kristen J. Prentice et al., “Maintaining Informed Consent Validity During Lengthy Research Protocols,” IRB: Ethics and Human Research 29, no. 6 (2007): 1–6. 28Eline M. Bunnik, A. Cecile J.W. Janssens, and Maartje H.N. Schermer, “A Tiered-Layered-Staged Model for Informed Consent in Personal Genome Testing,” European Journal of Human Genetics (2012): 1–6; A.L. Angiolillo et al., “Staged Informed Consent for a Randomized Clinical Trial in Childhood Leukemia: Impact on the Consent Process,” Pediatric Blood Cancer 42 (2004): 433–437; P. Allmark and S. Mason, “Improving the Quality of Consent to Randomised Controlled Trials by Using Continuous Consent and Clinician Training in the Consent Process,” Journal of Medical Ethics 32, no. 8 (2006): 439–443. 29Gail E. Henderson, “Is Informed Consent Broken?” The American Journal of the Medical Sciences 342, no. 4 (2011): 267–269. See also Daniel K. Sokol, “Let’s Stop Consenting Patients,” BMJ Published Online First; accessed September 27, 2014, doi:10.1136/bmj.g2192. 30Leclercq et al., “A Review,” 1406; 1411; Leclercq et al., “A Survey”; Mathous et al., 1980– 1981; Jukic et al., 43–44. 156 5 Covenant Consent the absence of clear definitions of what constitutes adequate consent or even when formal consent is required.31 Diverse consent practices for the same or similar procedures may indeed raise ethical concerns, but it would be both absurd and highly impractical to require a single, one-size-fits-all consent process for all procedures, regardless of context. It is entirely reasonable and consistent with various theoretical foundations of consent that consent for a digital prostate exam as part of a routine check-up need not be as complex or as thoroughly documented as consent for a non-emergency, experimental, high risk surgery. Rebecca Kukla points out that consent in health care does not always need to take the form of propositional speech acts; it can, and often does, take place through “embodied interactions.”32 Further diversity in practice may result from informed consent being both a legal requirement and an ethical standard, with each field taking one or more different approaches to understanding the concept. Informed consent was not first developed as an abstract philosophical concept. Rather, informed consent emerged and evolved in response to specific events and new situations. The Nuremburg Code, for example, is directed at research practices, not clinical care,33 and yet despite the Code’s clear instructions regarding informed consent, research without informed consent continued to be conducted for decades even by otherwise responsible and respected institutions and agencies.34 The Nuremburg Code was followed by the first Declaration of Helsinki, in 1964. It was in the Declaration of Helsinki that the distinction between therapeutic and non-therapeutic research was made.35 In the development of the Belmont Report of 1979, there was conscious effort to improve and expand upon Nuremburg and Helsinki.36 Belmont explicitly grounds consent in a principle of respect for persons, while emphasizing information, comprehension and voluntariness.37 Both Beauchamp and Childress had significant roles in the drafting of the Belmont Report, so one should not be surprised to see a strong resemblance between their concept of informed consent as it is presented in their later works, including

31Manthous et al. 1982, notes that the Joint Commission does not list what procedures require informed consent, nor are state statutes much help. Jukic et al., 43; Loughran, “Surgical Consent.” Leclercq et al., “A Review,” notes that physicians in the Netherlands are not strictly required to obtain written consent, 1410. 32Kukla “Communicating Consent,” 45–47. 33The Nuremberg Code. Accessed December 7, 2012. http://www.hhs.gov/ohrp/archive/nurcode. html. 34Beecher, “Ethics and Clinical Research,” 1354–1360; Corbie-Smith, 5–8; Gillon, “More Subject and Less Human,” 65–66. 35Jonathan D. Moreno, Arthur L. Caplan, and Paul Root Wolpe, “Informed Consent,” Encyclopedia of Applied Ethics, v. 2 (San Diego: Academic Press, Inc., 1998), 692–693. 36Albert R. Jonsen, “On the Origins and Future of the Belmont Report,” in Belmont Revisited: Ethical Principles for Research with Human Subjects, ed. by James F. Childress, Eric M. Meslin and Harold T. Shapiro, Washington, D.C.: Georgetown University Press, 2005: 3. 37See The Belmont Report, accessed December 7, 2012. http://www.hhs.gov/ohrp/humansubjects/ guidance/belmont.html. 5.2 Informed Consent: Dynamic and Evolving 157

Principles of Biomedical Ethics, and the concept of informed consent found in the Belmont Report.38 The development of informed consent for clinical treatment was driven more by legal cases than by codes, reports or declarations. From Schloendorff 39 through Salgo40 to Canterbury,41 one may trace the evolution of the legal definition of informed consent, particularly with regard to the standard of disclosure. Yet, while one may trace that evolution historically, it has not resulted in a single clear concept of adequate informed consent. In fact, the standard of disclosure still varies from place to place, with the various states of the U. S. more or less equally divided between those requiring a professional practice standard and those requiring a reasonable person standard.42 The initial development of informed consent as an ethical concept depended on codes, declarations, reports and legal cases, each reflecting and responding to particular circumstances. Only when Tom Beauchamp and James Childress published the first edition of their Principles of Biomedical Ethics was there a major effort to provide a more complete or universal foundation.43 Yet even the attempt by Beauchamp and Childress to formalize and systematize the theoretical underpinnings of informed consent did not end the process of development. That the concept and practice of informed consent in healthcare continues to be dynamic and to evolve is evidenced both by changes over time in the approach of Beauchamp and Childress and by the many challenges and alternatives to the approach of Beauchamp and Childress which have been put forward by others. Even in the most recent (7th) edition of Principles of Biomedical Ethics, Beauchamp and Childress expand their coverage of theories of autonomy and address new questions about the ability of patients or subjects to process information.44 Meanwhile, challenges, alternatives and modifications have been offered by scholars such as Franklin Miller and Alan Wertheimer,45 Bernard Gert, Charles Culver and K. Danner Clouser,46

38See Albert R. Jonsen, “On the Origins and Future of the Belmont Report,” and Tom L. Beauchamp, “The Origins and Evolution of the Belmont Report,” in Belmont Revisited,3–11 and 12–26. 39Joffe and Truog, 348. 40Dolgin, 98–99. 41Dolgin, 100–101. 42Thaddeus Mason Pope, “Legal Briefing: Informed Consent,” The Journal of Clinical Ethics 21, no. 1 (2010): 72; Thaddeus Mason Pope and Melinda Hexum, “Legal Briefing: Informed Consent in the Clinical Context,” The Journal of Clinical Ethics 25, no. 2 (2014): 153. 43That first edition appeared in 1977. 44Tom L. Beauchamp and James F. Childress, Principles of Biomedical Ethics, 7th Edition, New York: Oxford University Press, 2012. 45Franklin G. Miller and Alan Wertheimer, “Preface to a Theory of Consent Transactions: Beyond Valid Consent,” in The Ethics of Consent, ed. by Miller and Wertheimer, New York: Oxford University Press, 2010: 79–106. 46Bernard Gert, Charles M. Culver, and K. Danner Clouser, Bioethics: A Systematic Approach, 2nd Edition, New York: Oxford University Press: 2006: 99–128 and 191–238. 158 5 Covenant Consent

Robert Veatch,47 Neil Manson and Onora O’Neill,48 Y. Michael Barilan,49 Rebecca Kukla50 and others.51 Miller and Wertheimer, for example, contend that the standard approach of Beauchamp and Childress is too demanding upon care providers or researchers. They advocate instead for a “fair transaction” model which would permit consent to take place when patients might wish “to enter into agreements without clearly or substantially understanding the terms.” Miller and Wertheimer have in mind consent to low risk/high benefit treatment and feel it is unreasonable and unnecessarily burdensome on both patients/subjects and care providers/researchers to require the level of disclosure and confirmation of understanding demanded by the model of Beauchamp and Childress.52 Gert, Culver and Clouser, on the other hand, suggest that the level of information provided is often inadequate, particularly when the risks of an intervention are merely listed without any attempt to describe how likely particular undesirable outcomes are to occur, or how likely it is that the patient will realize the benefits sought.53 Robert Veatch, as noted previously, takes issue with the assumed practice of a physician recommendation in the standard model of informed consent. He challenges the practice on epistemological grounds, i.e., how it is possible for the physician or other care provider to know what will benefit patients? Veatch

47Robert Veatch, Patient, Heal Thyself: How the New Medicine Puts the Patient In Charge, New York: Oxford University Press, 2009. 48Neil C. Manson and Onora O’Neill, Rethinking Informed Consent in Bioethics, Cambridge: Cambridge University Press, 2007. 49Y. Michael Barilan, “Informed Consent: Between Waiver and Excellence in Responsible Deliberation,” Medicine, Health Care and Philosophy 13 (2010): 89–95; “Respect for Personal Autonomy, Human Dignity, and the Problems of Self-Directedness and Botched Autonomy,” Journal of Medicine and Philosophy 36 (2011): 496–515; Moshe Weintraub and Y. Michael Barilan, “Persuasion as Respect for Persons: An Alternative View of Autonomy and of the Limits of Discourse,” The Journal of Medicine and Philosophy 26, no. 1 (2001): 13–34. 50Rebecca Kukla, “Conscientious Autonomy: Displacing Decisions in Health Care,” Hastings Center Report 35, no. 2 (2005): 34–44; “Communicating Consent,” 45–47. 51Arthur L. Caplan, “Why Autonomy Needs Help,” Journal of Medical Ethics 40.5 (2014): 301– 302; Willard Gaylin, and Bruce Jennings, The Perversion of Autonomy: The Proper Uses of Coercion and Constraints in a Liberal Society, New York: Free Press, 1996; Grant Gillett and Simon Walker, “The Evolution of Informed Consent,” Journal of Law and Medicine 19, no. 4 (2012): 673–677; Grzegorz Mazur, Informed Consent, Proxy Consent, and Catholic Bioethics for the Good of the Subject, Dordrecht: Springer, 2012; Benjamin Moulton and Jaime S. King, “Aligning Ethics With Medical Decision-Making: The Quest For Informed Patient Choice,” The Journal of Law, Medicine & Ethics 38, no. 1 (2010): 85–97; Mary-Rose Mueller and Susan Instone, “Beyond the Informed Consent Procedure: Continuing Consent in Human Research.” Ciência & Saúde Coletiva 13, no. 2 (2008): 381–389; Dave Wendler and Jonathan Rackoff, “Consent for Continuing Research Participation,” IRB: Ethics and Human Research 24, no. 3 (2002): 1–6. 52Franklin G. Miller and Alan Wertheimer, “The Fair Transaction Model of Informed Consent,” Kennedy Institute of Ethics Journal 21, no. 3 (2011): 201–218. 53Gert, Culver and Clouser, 99–128 and 191–238. 5.2 Informed Consent: Dynamic and Evolving 159 contends that physicians are trained only in medicine and therefore can at most know what will benefit their patients medically. However, since patients are often willing to trade off medical benefits for other aspects of well-being, the physician is in no position to say what is in the patient’s best interests more generally. Veatch is primarily interested in applying this adaptation to consent for clinical care, but does explore some possible implications for research.54 Neil C. Manson and Onora O’Neill go so far as to suggest that consent is not “ethically fundamental.”55 They argue that insisting precisely on the full application of all the requirements of the standard model would render a great deal of contemporary consent practices invalid. They prefer a model which sees consent as essentially a waiver or a giving of permission, which would allow persons giving consent to waive their right to some or all information regarding risks and burdens under certain conditions.56 Rebecca Kukla is concerned that informed consent is misunderstood when it is conceived of as simple self-determination derived from decisions in response to discrete choices. Kukla argues that if genuine autonomy is the foundation of informed consent, then we can know little about whether or not the patient or subject is acting autonomously from the fact that they made a specific choice at one point in time. If, as Kukla contends, autonomy is self-government, then it will be reflected in “on-going practices” and “authentic adherence to principles over time,” rather than in “punctuate decisions.”57 She acknowledges that there may be some forms of treatment for which a simple “punctuate decision” is sufficient consent. However, she argues that in other instances, “patients need to do more than assent to care in order for care to happen: they must enact the care by regulating and disciplining their own practices appropriately.”58 Using pre-natal care as an example, Kukla points out how genuine consent must be informed, of course, but is demonstrated not merely by signing a form but by adopting certain habits and routines. Consent, in her view, is about more than patient choice. It is also about mutual responsibility, accountability and self-management.59 Kukla does not dismiss the value or importance of the conventional process of disclosure leading to the signing of consent forms, but understands the value of the act of signing forms as a “ritual” which inclines the parties to an attitude that will support consent going forward.60 Y. Michael Barilan has a similar opinion of the value of the formal process of signing a consent form, which he also describes as a ritual. Barilan believes that the ritual can impact the consciences of those who sign it and “strengthen the

54Veatch, Patient, Heal Thyself,33–42; 57-6491-110 and 209–218. 55Manson and O’Neill, 78. 56Manson and O’Neill, 26–96. 57Kukla, “Conscientious Autonomy,” 35–36. 58Kukla, “Conscientious Autonomy,” 38. 59Kukla, “Conscientious Autonomy,” 37. 60Kukla, “Communicating Consent,” 47. 160 5 Covenant Consent therapeutic alliance.”61 He also agrees with Kukla that informed consent implies a willingness to participate actively in whatever treatment is proposed.62 Yet Barilan focuses as much on the process that leads up to the ritual of signing the form as Kukla does on what follows it. Barilan contends that the “moral root” of informed consent is “the structure of sincere and responsible dialogical deliberation in the doctor-patient relationship.”63 He is concerned that an over-emphasis on negative liberty has led to practices that actually fail to respect the autonomy of patients and subjects. He suggests that “the noblest respect” that can be shown toward the autonomy of the patient or subject is to engage the person in a serious conversation which challenges the patient or subject to articulate the reasons for the decision they are making.64 Challenges are appropriate even when the patient is inclined to defer to the physician or researcher’s judgment, because it is important for patients or subjects to be part of a “cooperative process” in which they take ownership.65 Barilan is also critical of Beauchamp and Childress’ concepts of autonomy and informed consent. He claims that their definition of autonomous action “seems to fit voluntariness, not autonomy.”66 His concern is similar to that of Kukla, in that he believes discrete choices by persons with decisional capacity may be nonetheless “capricious, careless [and] self-destructive,”67 and such acts do not reflect any meaningful attempt to be self-governing, i.e., autonomous. Autonomy, according to Barilan, is present and to be respected in “persons disposed to the development and pursuance of coherent, non-predatory, and rich life plans.”68 Thus, there is a dia- logic element to autonomy. Persons should be able to give reasons for their decisions which make sense in light of their espoused system of values. Respect for autonomy, says Barilan, is an “attitude of care and support (neighborly love)” for persons who demonstrate autonomy.69 Barilan admits that biolaw calls for us to respect decisions “made by free, competent and adequately informed persons of legal age,” regardless of whether or not they demonstrate authentic autonomy, but points out that acknowledging the right to negative liberty does not require our “active help and sustenance” of their decisions.70 The preceding review of criticisms of the standard approach to informed consent is not exhaustive. Debates over various features of informed consent, at the level of

61Barilan, “Informed Consent: Between Waiver and Excellence,” 93. 62Barilan, “Informed Consent: Between Waiver and Excellence,” 94. 63Barilan, “Informed Consent: Between Waiver and Excellence,” 93. 64Barilan, “Persuasion as Respect for Persons,” 14. 65Barilan, “Informed Consent: Between Waiver and Excellence,” 21–22. 66Barilan, “Respect for Personal Autonomy,” 497. 67Barilan, “Respect for Personal Autonomy,” 497. 68Barilan, “Respect for Personal Autonomy,” 499. Compare Dickenson and Widdershoven, 118, where they describe autonomy as “moral self-development” by means of “dialogue.” 69Barilan, “Respect for Personal Autonomy,” 512. 70Barilan, “Respect for Personal Autonomy,” 512. 5.2 Informed Consent: Dynamic and Evolving 161 theory or practice or both, are exceedingly common. The point being made here is not that the standard approach of Beauchamp and Childress lacks merit or that all (or even most) current informed consent practice is inadequate or unethical. It is, rather, that the concept is far from settled, despite the dominance of the standard theory and approach, and that the ethical adequacy of consent is determined at least in part by the form of treatment to be undertaken and the context within which the treatment will take place.

5.3 Incongruity: VCA and Standard Antecedent Consent

Turning now to vascularized composite allotransplantation specifically, the task at hand is to explore how the ways in which this form of therapeutic research differs from other forms of treatment and research call into question the appropriateness of the standard approach to consent. Rather than compare VCA to a wide variety of standard treatments for common conditions, a sustained comparison between VCA and treatments which have provided the technical and theoretical foundations for VCA will be offered. It will be argued that VCA differs sufficiently even from these closely related treatments, so that VCA may require an approach to consent that goes beyond that which is normally employed for these related treatments. As it was described in an earlier chapter, vascularized composite allotransplantation is itself a composite of sorts. In order to accomplish its goals, it joins surgical techniques, immunological modification and physiotherapy protocols originally developed and used in other treatments. Micro-surgical methods, especially the anastomic suturing of small vascular structures and nerves, are essential to the success of VCA, but were originally applied to surgery on the inner ear and the eye.71 Developments in immuno-modulation or immunosuppression originated and were developed for decades in the field of solid organ transplantation, prior to the beginning of the modern era of vascularized composite allotransplantation.72 The physiotherapy involved in upper extremity and facial VCA is modeled on that provided to individuals who have had upper limb replantation, facial replantation,

71Tsu-Min Tsai, Juan M. Breyer, and Joao B. Pannatoni, “History of Microsurgeries: Curiosities from the Sixties and Seventies,” Microsurgery 33, no. 2 (2013): 85; Susumu Tamai, “History of Microsurgery,” Plastic and Reconstructive Surgery Journal 124, no. 6 (2009): 282e–285e; Mininder S. Kocher, “History of Replantation: From Miracle to Microsurgery,” World Journal of Surgery 19 (1995): 462–467. 72Howard, Cornell and Cochran, 7; Bergan, 6; Mohamed H. Sayegh and Charles B. Carpenter, “Transplantation 50 Years Later—Progress, Challenges and Promises,” New England Journal of Medicine 351, no. 26 (2004): 2761–2762; Peter K. Linden, “History of Solid Organ Transplantation and Organ Donation,” Critical Care Clinics 25, no. 1 (2009): 169–170; Alexis Bergan, “Ancient Myth, Modern Reality: A Brief History of Transplantation,” The Journal of Biocommunication 24, no. 4 (1997): 6; Francisco Ortega, “Organ Transplantation in the 21st Century,” in Stem Cell Transplantation, ed. by Carlos Lopez-Larrea, Antonio Lopez-Vasquez and Beatriz Suarez-Alverez, New York: Springer Science, 2012: 22–24. 162 5 Covenant Consent or to those who have contracted whole or partial paralysis of the face, due to traumatic injury.73 Yet, while many elements of facial and upper extremity VCA are derived from other health care interventions, when these elements are brought together they create a new complex, risk-filled, burdensome and sustained treatment which requires its own ethical justification. That justification, in turn, may require standards and practices other than those required for the justification of the interventions which have provided the technical basis for VCA. Among those standards and practices may be an approach to consent that goes beyond the standard antecedent model.74 A comparison of VCA to some of the treatments from which VCA has borrowed technical aspects may help to clarify how VCA is substantively, significantly and sufficiently different to require its own justification. The immunosuppression required for the prevention of chronic rejection and the reversal of acute rejection is admittedly similar to that used in solid organ transplantation.75 The similar immunosuppressive protocols naturally carry similar burdens and risks, including increased infection risk, the development of diabetes, kidney damage, and possible malignancies.76 Yet it is important to note that while solid organ transplant recipients undertake the risks and burdens of their treatment in order to extend their lives, the toxic side effects of immunosuppression are likely to produce the opposite consequence for recipients of facial and upper extremity transplants.77 In short,

73Cleveland Clinic, “Frontiers in Rehabilitation, 2010–2011,” accessed October 16, 2014. https:// my.clevelandclinic.org/ccf/media/ﬁles/Neurological_Institute/Frontiers-In-Rehab-2010-2011.pdf; Pamela L. Dixon et al., “Physical Medicine and Rehabilitation in Face Transplantation,” in The Know-How of Face Transplantation, ed. by Maria Siemionow, New York: Springer, 2011: 152–170; Ericka Bueno et al., “Rehabilitation Following Hand Transplantation,” Hand 9 (2014): 9–15; Bradon J. Wilhelmi et al., “First Successful Replantation of Face and Scalp with Single-Artery Repair: Model for Face and Scalp Transplantation,” Annals of Plastic Surgery 50, no. 5 (2003): 535–540. 74Donna Dickenson and Guy Widdershoven have suggested that inadequacy of consent played a role in the failure of the ﬁrst limb transplant at Lyon. See “Ethical Issues in Limb Transplants,” Bioethics 15, no. 2 (2001): 117. 75T. Hautz et al., “How Reconstructive Transplantation is Different from Organ Transplantation— and How It Is Not,” Transplant Proceedings 43, no. 9 (2011): 3507–3509; Cavadas, Pedro C., Javier Ibanez, and Alessandro Thione, “Secondary Surgery for Functional Improvement After Hand Transplantation,” Annals of Plastic Surgery 67, no. 4 (2011): 421–422; Peter Morris, Andrew Bradley, Len Doyal, Michael Earley, Patricia Hagen, Martin Milling, and Nichola Rumsey, “Face Transplantation: A Review of the Technical, Immunological, Psychological and Clinical Issues with Recommendations for Good Practice,” Transplantation 83, no. 2 (2007): 109–128. 76G.J. Agich and Maria Siemionow, “Until They Have Faces: The Ethics of Facial Allograft Transplantation,” Journal of Medical Ethics 31, no. 12 (2005): 707–709. 77Faith Zor, “Facial Vascularized Composite Tissue Allotransplantation,” Gulhane Medical Journal 55 (2013): 160; Stephen P. McDonald and Graeme R. Russ, “Survival of Recipients of Cadaveric Kidney Transplants Compared to Those Receiving Dialysis Treatment in Australia and New Zealand, 1991–2001,” Nephrology Dialysis Transplantation 17 (2002): 2212; Susan M. Samuel et al., “Survival in Pediatric Dialysis and Transplant Patients,” Clinical Journal of the 5.3 Incongruity: VCA and Standard Antecedent Consent 163

VCA recipients are likely to die sooner than they would if they did not undergo the transplant procedure, and to suffer from debilitating side effects of immunosuppression which they would have avoided had they not opted for the intervention. This has been acknowledged by the advocates for and practitioners of VCA, and drives the many efforts to develop less toxic immunosuppressive protocols or to achieve tolerance without the use of standard immunosuppressive medicines.78 Clearly, there is a substantial difference between the decision to submit to major surgery and life-long immunosuppression in order both to extend one’s life and improve the quality of one’s life, as with SOT, and the decision to submit to major surgery and life-long immunosuppression in order to improve some aspects of one’s quality of life while subjecting one’s self to the toxicity of immunosuppression and likely shortening one’s life as part of the bargain. A second critical difference between SOT and VCA, despite their many shared characteristics, is the need for extensive physiotherapy in order to regain function in VCA.79 Significant levels of function must occur in SOT very quickly or the transplant is a failure, and in many cases the recipient will not survive. Fortunately, simple blood flow is often sufficient to produce adequate function in SOT. In VCA, however, the tissues may survive due to sufficient blood flow, but nerve regeneration is required before the recipient can begin to establish sensation and the voluntary control necessary for functionality.80 Rehabilitation protocols tend to be both demanding and lengthy, and VCA patients must often endure a significant period of time when they may be less independent and have a lesser quality of life than they had pre-surgically.81 Patients may find the burdens of physiotherapy discouraging, and this can affect compliance with both the therapy and the use of immunosuppressives.82

(Footnote 77 continued) American Society of Nephrology 6 (2011): 1094–1099; M. Tonelli et al., “Systematic Review: Kidney Transplantation Compared with Dialysis in Clinically Relevant Outcomes,” American Journal of Transplantation 11 (2011): 2095–2103; Donna Dickenson and Nadey S. Hakim, “Ethical Issues in Limb Transplants,” Postgraduate Medical Journal 75 (1999): 513. 78Shanmugarajah, Hettiaratchy, and Butler, 296; L. Lantieri, “Face Transplant: A paradigm change in facial reconstruction,” Journal of Craniofacial Surgery 23, no. 1 (2012): 253. 79Scott M. Tintle et al., “Hand Transplantation,” JBJS Reviews 2:1 (2014): 6; Hatem Amer et al., “Hand Transplantation,” Minnesota Medicine 94, no. 5 (2011): 42; Blake D. Murphy, Ronald M. Zuker, and Gregory H. Borschel, “Vascularized Composite Allotransplantation: An Update on Medical and Surgical Progress and Remaining Challenges,” Journal of Plastic, Reconstructive & Aesthetic Surgery 66, no. 11 (2013): 1452. 80Jaimie T. Shores, Joseph E. Imbriglia, and W.P. Andrew Lee, “The Current State of Hand Transplantation,” The Journal of Hand Surgery 36, no. 11 (2011): 1863–1864; Siemionow, Gharb, and Rampazzo, 634; Shanmugarajah, Hettiaratchy, and Butler, 294–295. 81Martin Kumnig, Sheila G. Jowsey and Andrea F. DiMartini, “Psychological Aspects of Hand Transplantation,” Current Opinion in Organ Transplantation 19, no. 2 (2014): 189–190. 82Pomahac, Gobble and Schneeberger. Accessed March 22, 2014. http://perspectivesinmedicine. org/content/early/2014/01/28/cshperspect.a015651.full.pdf+html. 164 5 Covenant Consent

The visible and tactile nature of VCA and the publicity surrounding individual cases also distinguishes it from SOT. Solid organ transplantation does, of course, create visible scars, but these are normally covered by clothing, so that neither the recipient nor others are routinely confronted with them. In upper extremity and facial VCA, by contrast, the grafts are regularly in view of the recipient and others, and subject to tactile sensation. Recipients are thus continually reminded that the tissue of another has been attached to their bodies.83 Whereas SOT has become so common that recipients often receive little or no publicity when they receive their graft, the recipients of VCA grafts are routinely subjected to intense media attention. In fact, the potential recipient’s ability to cope with this attention is considered in the process of screening.84 In light of the physiotherapy requirements and the psychological factors of visible and tactile grafts, the burdens associated with VCA should be seen as much greater than those associated with SOT. Another important distinction that may be made between SOT and VCA relates to concern for respecting human dignity. Again, because VCA grafts are visible and because recipients must endure media scrutiny, special consideration must be given to the effect of the treatment on the patient’s subjective, social and relational dignity.85 It is possible to imagine both positive and negative consequences for the dignity of the recipient in VCA. On the positive side, VCA may provide functional and aesthetic improvements which allow the recipient to become far more independent and more socially active. Disﬁgurement may be experienced as an assault on the dignity of the person, which is countered by the physical restoration of VCA. On the negative side, the dignity of some recipients may be challenged by the loss of privacy that follows from publicity and by the psychological burden of “wear- ing” another person’s tissue. Limb replantation and face replantation are similar to upper extremity and facial VCA in the use of microsurgical techniques and in the rehabilitation needed to restore function post-surgically.86 Both replantation and VCA lead to less than ideal esthetic and functional results. In upper extremity replantation and VCA, the use of

83Evans, 154; Kumnig, Jowsey and DiMartini, 189–193; B. Lengele, 508; Kathy L. Coffman and Maria Z. Siemionow, “Ethics of Facial Transplantation Revisited,” Current Opinion in Organ Transplantation 19 (2014): 184. 84B. Lengele et al., “Facing Up is an Act of Dignity: Lessons in Elegance Addressed to the Polemicists of the First Human Face Transplant,” Plastic and Reconstructive Surgery Journal 120, no. 3 (2007): 803; V.C. Lees and S.J. McCabe, “The Rationale for Hand Transplantation,” Transplantation 74, no. 6(2002): 750; Linda A. Evans, “Experiences of Healthcare Team Members Involved in Facial Transplant Surgery and Patient Care,” Nursing Research 62, no. 6 (2013): 379. 85Lennart Nordenfelt, “The Varieties of Dignity,” Health Care Analysis 12, no. 2 (2004): 69–81; Jacob Dahl Rentdorff, “Basic Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability—Towards a Foundation of Bioethics and Biolaw,” Medicine Health Care and Philosophy 5 (2002): 235–244; Rhonda Gay Hartman, “The Face of Dignity: Principled Oversight of Biomedical Innovation,” Santa Clara Law Review 47 (2007): 55–91. 86Susumu Tamai, “History of Microsurgery,” Plastic and Reconstructive Surgery 124 (2009): e290–e291; Wilhemi et al., 538. 5.3 Incongruity: VCA and Standard Antecedent Consent 165 prosthetics is an alternative for both. In many cases, VCA is actually the simpler surgery on a technical level because the graft is generally more complete than the autologous tissue that has suffered trauma. Conditions leading to the need for replantation also often require significant debridement and have higher rates of post-surgical infection.87 Yet even when there is little tissue loss and infection risks are minimalized in replantation, there remains an important difference between replantation and VCA. As has been noted previously, VCA requires the use of immunosuppressive therapy with its attendant burdens and risks, including the burden of life-long self-monitoring for signs of rejection. Adding these burdens and risks to those of the surgery and rehabilitation obviously alters the ratio of burdens and risks to benefits. Since the benefits of replantation and VCA are roughly the same, attention must be given to ameliorating the risks or burdens in order to provide the same level of justification for VCA as for replantation. In addition, it can be argued that VCA candidates and recipients are in some respects more vulnerable than candidates or recipients of either solid organ transplants or various replants. Several aspects of vulnerability that may be associated with VCA are shared with other conditions or treatments, but in VCA these several aspects are brought together, increasing vulnerability beyond that seen in separate but related conditions and treatments. Social exclusion due to their disfigurement and the dependence upon others even for aspects of self-care may result in such desperation that VCA candidates will have difficulty rationally weighing burdens and risks against benefits.88 It may also incline them to develop unrealistic expectations, as if the surgery and therapy could return them fully to the physical condition they were in prior to trauma or disease.89 Vulnerability of VCA candidates or recipients is likewise exacerbated by the relatively small number of VCA programs. Knowing their options are severely limited, potential candidates for VCA are more likely to feel heavily dependent on approval and acceptance by members of the treatment team and less likely to question the authority of the team.90 In sum, vascularized composite allotransplantation of faces and upper extremities creates an unusual constellation of conditions. First, VCA involves a degree of foreseeable risks and burdens not often seen in treatments which are not intended to

87Pedro C. Cavadas, “Salvage of Replanted Upper Extremities with Major Soft-Tissue Complications,” Journal of Plastic, Reconstructive & Aesthetic Surgery 60 (2007): 769–775. 88Ganguli-Mitra and Biller-Andorno, 241; Eileen Bradbury, “Meeting the Psychological Needs of Patients with Facial Disfigurement,” British Journal of Oral and Maxillofacial Surgery 50 (2012): 193; 195; Frederik Svenaeus, “Organ Transplantation and Personal Identity: How Does Loss and Change of Organs Affect the Self?” Journal of Medicine and Philosophy 37 (2012): 155; Rumsey, 22–23; Strong, 13. 89Philip J. Nickel, “Vulnerable Populations in Research: The Case of the Seriously Ill,” Theoretical Medicine and Bioethics 27 (2006): 256. 90Agamoni Ganguli-Mitra, and Nikola Biller-Andorno, “Vulnerability in Healthcare and Research Ethics,” In The SAGE Handbook of Health Care Ethics. London: SAGE Publications, 2011: 240; Wendy Rogers, Catriona Mackenzie, and Susan Dodds, “Why Bioethics Needs a Concept of Vulnerability,” International Journal of Feminist Approaches to Bioethics 5, no. 2 (2012): 15. 166 5 Covenant Consent extend the life of the patient or subject. This point is only accentuated by the fact that one of the major risks is an actual shortening of life, due to the toxicity of the immunosuppressants necessary to maintain the viability of the graft. Second, VCA is an unusually lengthy and demanding treatment. According to Lamparello et al., it begins with “a long, exhaustive evaluation process followed by a waiting period of uncertain duration and, quite possibly, high anxiety.”91 Should the candidate be chosen and a donor found, the lengthy and arduous selection process and waiting period are then followed by the surgery itself and a significant amount of time in which he or she is actually more dependent on others than prior to the surgery. Beyond these burdens, the recipient faces literally years of intensive therapy, medical monitoring, and self-monitoring for signs of rejection. In the likely event that one or more serious side-effect of immunosuppressive use should develop, the recipient will be required to address that condition by taking even more medicines and possibly by enduring dialysis or further surgery. Third, VCA both appeals to persons who tend to be especially vulnerable and can create conditions of special vulnerability for those who have the opportunity to undergo the treatment. In particular, candidates for facial and upper extremity VCA may be regarded as especially vulnerable on both medical and social grounds.92 Some contend that all persons for whom research and health care are mixed should be regarded as especially vulnerable.93 Further, given that those attracted to VCA are those who have not been able to adapt to their disfigurement or disability, while others have been able to adapt to equal or greater disfigurement or disability, it is possible to argue that those attracted are more vulnerable because they are less resilient or possess inferior coping skills. This may create a tendency for these especially vulnerable persons to overestimate the potential benefits while under- estimating the extent of the burdens and the likelihood of the risks.94 Social vulnerability is characteristic of VCA candidates due to the socially isolating conditions in which disfigured and disabled persons often find themselves.95 When the disability results in substantial dependency upon others for the accomplishment of activities of daily living, such as feeding, dressing, bathing or using a toilet, the person may become extremely anxious to escape the condition of dependency, and thus extremely vulnerable to offers to participate in research or

91Brooke M. Lamparello et al., “Face Time: Educating Face Transplant Candidates,” Eplasty 13 (2013): 284. 92Ganguli-Mitra and Biller-Andorno, 240–241. 93Samia A. Hurst, “Vulnerability in Research and Health Care: Describing the Elephant in the Room?” Bioethics 22:4 (2008): 193. 94Nickel, 256; Nichola Rumsey, “Psychological Aspects of Face Transplantation: Read the Small Print Carefully,” The American Journal of Bioethics 4, no. 3 (2004): 22–23; Bradbury, 194. 95David P. Schenk, “Ethical Considerations in the Treatment of Head and Neck Cancer,” Cancer Control 9, no. 5 (2002): 411; Strong, 13; Rumsey, 22–23; Svenaeus, 144; Bradbury, 193–196; Margaretha Strandmark K., “Ill Health is Powerlessness: A Phenomenological Study about Worthlessness, Limitations and Suffering,” Scandinavian Journal of Caring Sciences 18 (2004): 142. 5.3 Incongruity: VCA and Standard Antecedent Consent 167 treatment that holds out some hope of ameliorating the dependency.96 Eileen Bradbury artfully remarks that patients who have received information about treatment burdens, risks and possible benefits “may have been listening through a filter of hope and distress.”97 The special vulnerability of VCA recipients is not confined to the pre-surgical stage. Given the significant publicity that attends VCA and its implications for the privacy expectations of recipients as well as donor families,98 recipients may find themselves burdened and stressed by attention far beyond what they have previously experienced or could have anticipated. Coupled with the fact that such publicity may be considered desirable and even beneficial by the treatment team and/or its parent institution,99 candidates and recipients may be vulnerable to pressures to undergo the procedure and to participate in publicity events. Even if not conscious or intentional on the part of the treatment team, these pressures could be significant.100 In addition, the great deal that is unknown, especially about long-term consequences of VCA, creates a special vulnerability related to unexpected risks,101 and an obligation on the part of the treatment team to do more to enable the subject to choose autonomously and to follow through with whatever choice is made.102 Conditions of special vulnerability do not foreclose the possibility that treatment is ethical or that consent may be valid. However, conditions of special vulnerability do create an ethical obligation to give candidates and recipients of treatment or participants in research special consideration, special protection and special support.103 In the words of S.A.M. McLean, for those who are especially vulnerable, “the basic rules of law and professional guidelines offer insufficient protection.”104

96Eva Feder Kittay, “The Ethics of Care, Dependency and Disability,” Ratio Juris 24, no. 1 (2011): 55; Diane Perpich, “Vulnerability and the Ethics of Facial Tissue Transplantation,” Journal of Bioethical Inquiry 7, no. 2 (2010): 173–184; Hartman, 72–75; Bradbury, 193; Svenaeus, 155; Rumsey, 22; Schenk, 411–412; Nickel, 256. 97Bradbury, 195. 98Lees and McCabe, 750–751; Samuel Taylor-Alexander, “Bioethics in the Making: ‘Ideal Patients’ and the Beginnings of Face Transplant Surgery in Mexico,” Science as Culture 23, no. 1 (2014): 27–50; L. Evans, “Experiences of Health Care Team,” Nursing Research, 379. 99Evans, “Experiences of Health Team Members,” 379–380; Lees and McCabe, 750–751. 100Hurst, 201. 101The Principle of Respect for Human Vulnerability and Personal Integrity: Report of the International Bioethics Committee: 22; 33. Accessed January 25, 2014. http://unesdoc.unesco.org/ images/0021/002194/219494E.pdf. 102S.A.M. McLean, “Respect for Human Vulnerability and Personal Integrity,” Handbook of Global Bioethics, ed. by H.A.M.J. ten Have and Bert Gordijn, Dordrecht: Springer Science & Business, 2014: 112. 103Strandmark K., 141–142; Perpich, 184; 106; Schenk, 413–414; Bradbury, 195–196; Hurst, 196–197; McLean, 106; Rogers, Mackenzie, and Dodds, 24–26; Margaret Meek Lange, Wendy Rogers and Susan Dodds, “Vulnerability in Research Ethics: A Way Forward,” Bioethics 27, no. 6 (2013): 337. 104McLean, 110. 168 5 Covenant Consent

In particular, special vulnerability calls into question the standard approach to consent, according to Marianna Fotaki, who states

good care is not a matter of making well-argued individual choices but is something that grows out of collaborative and continuing attempts to attune knowledge and technologies to diseased bodies and complex lives.105 In light of the special vulnerability of VCA candidates an recipients, the nature of the treatment including the burdens, risks, duration of physiotherapy, and the requirement of intensive participation by the recipient of a graft, it is appropriate to question whether simple, antecedent informed consent is adequate. Regardless of whether one chooses to understand consent primarily as permission giving,106 autonomous authorization,107 fair transaction,108 waiver,109 patient choice110 or even shared decision making,111 a consent process that takes place solely prior to the surgical intervention and focuses primarily on disclosure and voluntariness at a single point in time seems ill-matched to the needs of the patient and to the nature and extent of the treatment.112 The standard approach to consent assumes a context in which the treatment for which consent is sought takes place over a relatively short period of time. Typically, the proposed intervention takes from a few seconds to several hours, perhaps followed by a recuperation of a few weeks or months. Furthermore, the standard approach to consent assumes that risks, burdens and beneﬁts and the likelihood of each are fairly well known and reasonably easy to communicate and understand. Finally, the standard approach assumes a context in which the patient’s role in said

105Marianna Fotaki, “Is Patient Choice the Future of Health Care Systems?” International Journal of Health Policy and Management 1, no. 2 (2013): 122. 106Gert, Culver and Clouser, 89; Terenia Brosnam and Michael Perry, “‘Informed’ Consent in Adult Patients: Can We Achieve a Gold Standard?” British Journal of Oral and Maxillofacial Surgery 47 (2009): 186. 107Tom L. Beauchamp, “Autonomy and Consent,” in The Ethics of Consent: Theory and Practice, ed. by Franklin G. Miller and Alan Wertheimer, (New York: Oxford University Press, 2010), 57– 58; Steven Joffe and Robert D. Truog, “Consent to Medical Care: The Importance of Fiduciary Context,” in Miller and Wertheimer, 350. 108Franklin G. Miller and Alan Wertheimer, “Preface to a Theory of Consent Transactions: Beyond Valid Consent,” in Miller and Wertheimer, 79–106; Franklin G. Miller and Alan Wertheimer, “The Fair Transaction Model,” 201–218; Alan Wertheimer, “Voluntary Consent: Why A Value-Neutral Concept Won’t Work,” Journal of Medicine and Philosophy 37, no. 3 (June 2012): 4. 109Manson and O’Neill, 68–96. 110Veatch, Patient, Heal Thyself,91–110. 111Jaime S. King and Benjamin Moulton, “Rethinking Informed Consent: The Case for Shared Medical Decision-Making,” American Journal of Law and Medicine 32 (2006): 429–501; William J. Sieber and Robert M. Kaplan, “Informed Adherence: The Need for Shared Medical Decision Making,” Controlled Clinical Trials 21 (2000): 234S–240S. 112The Chauvet Workgroup has acknowledged as much, at least indirectly. See Sheila G. Jowsey-Gregoire et al., “The Chauvet 2014 Meeting Report: Psychiatric and Psychosocial Evaluation and Outcomes of Upper Extremity Grafted Patients,” Transplantation Epub ahead of print, 2015, http://dx.doi.org/10.1097/TP.0000000000001013. 5.3 Incongruity: VCA and Standard Antecedent Consent 169 treatment is primarily passive; that is, the patient consents to be acted upon by the physician or other care provider. Some element of compliance with short-term physiotherapy or the taking of post-surgical antibiotics, for example, may be involved, but nothing on the scale of that which is required for a satisfactory outcome in VCA. In VCA, treatment extends over years, as extensive physiotherapy is required for optimal results113 and monitoring for signs of rejection may continue for the remainder of the patient’s life. VCA also expects more of the patient. In order for VCA to succeed, cooperation and effort over the long term are required from transplant recipients, both in terms of physiotherapy and in terms of surveillance for signs of rejection. What is asked of patients undergoing VCA is far more than permission, authorization, approval of a transaction or even a shared decision. What is asked of patients is long-term active cooperation or collaboration. A reasonable hope of success requires a recipient who is able and willing to be what Paul Ramsey had in mind when he argued that researcher and subject should be “joint adventurers in a common cause.”114 When one combines the necessity of long-term patient cooperation in the course of treatment with the signiﬁcant level of risk and burdens (both physical and psychological)115 involved in VCA, simple antecedent consent which is centered around authorization, permission giving, or some other sort of punctuate decision-making116 is revealed as inadequate.

5.4 The Concept of Covenant as a Resource

In place of simple antecedent consent, for which patient or subject competence and voluntariness are sufﬁcient preconditions and information disclosure and non- coercion are the main responsibilities of the one seeking consent,117 it is possible to imagine consent that is less like a transaction and more like the formation and

113Shanmugarajah, Hettiaratchy, and Butler, 294–295; Shores, Imbriglia, and Lee, 1864–1865; G. R. Brandacher et al., “The Innsbruck Hand Transplant Program: Update at 8 Years After the First Transplant,” Transplantation Proceedings 41 (2009): 493; Breidenbach et al., “Outcomes,” 1039. 114Paul Ramsey, Patient as Person, 2nd Edition, New Haven: Yale University Press, 2002: 6. 115Bohdan Pomahac et al., “Three Patients with Full Facial Transplantation,” The New England Journal of Medicine 366, no. 8 (February 23, 2012): 719–721; Harriet O’Neill and Daryl Godden, “Ethical Issues of Facial Transplantation,” British Journal of Oral and Maxillofacial Surgery 47 (2009): 444; Jeff Chang and David W. Mathes, “Ethical, Financial and Policy Considerations in Hand Transplantation,” Hand Clinics 27 (2011): 554; J.S. Swindell, “Facial Allograft Transplantation, Personal Identity and Subjectivity,” Journal of Medical Ethics 33, no. 8 (2007): 450–451; L. Allen Furr et al., “Psychosocial Implications of Disfigurement and the Future of Human Face Transplantation,” Plastic and Reconstructive Surgery 120, no. 2 (2007): 560; L. Lantieri et al., “Feasibility, Reproducibility, Risks and Benefits of Face Transplantation: A Prospective Study of Outcomes,” American Journal of Transplantation 11 (2011): 376. 116Kukla, “Conscientious Autonomy,” 35. 117Beauchamp and Childress, Principles of Biomedical Ethics, 6th edition, 120. 170 5 Covenant Consent maintenance of an abiding cooperative human relationship. For the task of imagining consent as the creation of a cooperative human relationship, the concept of covenant is a particularly rich resource. From its ancient origins to it various prior uses in health care ethics, covenant has exhibited several themes and emphases that are especially fitting for thinking about consent in the context of VCA. If one were to consider only the earliest forms of covenant, the concept would appear to be a most unlikely candidate for a conceptual foundation for any modern practice of informed consent. In its Akkadian and Hittite forms (biritu and ishiul, respectively), it referred to a political arrangement created by imposition, following military conquest or the threat of conquest.118 Fundamentally coercive, these forms of covenant are antithetical to modern informed consent, which must be voluntary. As it passed into the Hebrew culture as berith, some have argued that covenant was at first still not voluntary. According to this argument, while not imposed by conquest per se, the berith between God and the Hebrew people was not a mutual agreement, but rather a condition established by divine election. The Hebrew people were chosen for the covenant. While they could (and, according to the Hebrew Bible, did) violate it, they did not in any real sense need to accept it in order for it to be in force.119 Others would contend that the Hebrew berith with God was in fact consensual, if not at first at least later on as the tradition developed. And it is clear that the term implies mutual consent as it is applied to various human-human relationships, including friendships and marriages. In its New Testament uses (diatheke), covenant is also clearly consensual. An adherent to the new Christian movement must respond to the invitation offered in order to become a member of the movement, and demonstrate consent through the ritual of baptism.120 Yet, even in its earliest forms, covenant contains elements that are relevant for a reimagining of consent. While the suzerain would impose the covenant upon the

118M. Weinfeld, “berith” in Theological Dictionary of the Old Testament v. 2, Revised Edition, ed. by G. Johannes Botterweck and Helmer Ringgren, Grand Rapids: William B. Eerdmans Publishing Company, 1975: 266–269; John J. Hayes, “Covenant,” in Mercer Dictionary of the Bible, Macon: Mercer University Press, 1991: 177; Sandra Richter, “Covenants,” in The Eerdmans Companion to the Bible, ed. by Gordon D. Fee and Robert L. Hubbard Jr., Grand Rapids: William B. Eerdmans Publishing Company, 2011: 141–142; Jeffrey J. Niehaus, “Covenant: An Idea in the Mind of God,” Journal of the Evangelical Theological Society 52, no. 2 (June 2009): 225–226; Moshe Weinfeld, “Covenant Making in Anatolia and Mesopotamia,” Journal of the Ancient Near Eastern Society 22 (1993): 136. 119J. Alberto Soggin, Introduction to the Old Testament: From its Origins to the Closing of The Alexandrian Canon, Louisville: Westminster John Knox Press, 1980: 137–138; E.C. Lucas, “Covenant, Treaty and Prophecy,” Themelios 8, no. 1 (1982): 19–23; Daniel J. Elazar, Covenant and Polity in Biblical Israel, New Brunswick: Transaction Publishers, 1998: 71. 120Hayes, 178; Weinfeld calls the unilateral pledge type a promissory covenant and says it is modelled on the royal grant. He offers the example of the covenants with Abraham and David. See Weinfeld, Theological Dictionary of the Old Testament, 270–271; Walter Brueggemann, Reverberations of Faith: A Theological Handbook of Old Testament Themes, Louisville: Westminster John Knox Press, 2002: 37; Gerard Van Groningen, “Covenant,” in Baker Theological Dictionary of the Bible, ed. by Walter A. Elwell, Grand Rapids: Baker Books, 2000: 124. 5.4 The Concept of Covenant as a Resource 171 vassal, the covenant would nonetheless establish responsibilities and rights for both. The covenant treaty would spell out not only what was expected of the vassal, but also what the suzerain promised to provide to the vassal. So the covenant involved the exchange of mutual promises. Such an exchange of promises remains part of the covenant concept as it evolves.121 The earliest covenants were also understood as both legal agreements and as personal relationships.122 They were more than contracts through which each party pursued its own interests. They were relationships in which matters of shame, honor and dignity mattered as much or more than the performance of the prescribed duties.123 As personal relationships, they also exhibited a degree of flexibility often absent from strict contracts. They were expected to last, and did last, sometimes for more than one generation. If the circumstances of either or both partners changed, renegotiation was possible within the relationship structure. Further, because covenants were expected to last, a provision was often made for periodic renewal and reading of the covenant.124 In the Jewish and early Christian context, the emphasis on covenant as a close personal relationship is supported by the semantic field that develops around the term. Terms like promise, gratitude, fellowship, honor, pledge, contract, grace, forgiveness, repentance, brotherhood, peace, love and friendship come to be associated with covenant.125 The covenant creates bonds that are much stronger than those needed for the simple exchange of goods and services. Covenant creates bonds that are comparable to those which exist between members of a family (fictive kinship).126

121George E. Mendenhall and Gary A. Herion, “covenant,” in The Anchor Bible Dictionary v. 1, ed. by David Noel Freedman, (New York: Doubleday: 1992), 1181. Eerdmans Dictionary of the Bible,s.v.“covenant,” 291; Saul M. Olyan, “Honor, Shame and Covenant Relations in Ancient Israel and Its Environment,” JBL 115 (1996): 204–205; Elazar, Covenant and Polity, 69; Weinfeld, “Covenant Making,” 135–136. 122Jacqueline E. Lapsley, “Friends with God? Moses and the Possibility of Covenantal Friendship,” Interpretation 58, no. 2 (April 2004): 119; Elazar, Covenant and Polity, 71. 123Olyan, 201–202; James Nicholas Jumper, Honor and Shame in the Deuteronomic Covenant and the Deuteronomistic Presentation of the Davidic Covenant (Ph.D. dissertation, Harvard University, 2013), 8–15; Zeba Crook, “Honor, Shame, and Social Status Revisited,” JBL 128, no. 3 (2009): 592–594; F. Gerald Downing, “‘Honor’ Among Exegetes,” The Catholic Biblical Quarterly 61 (1999): 53–73. 124Eerdman’s Dictionary of the Bible,s.v.“covenant,” 291; J.A. Thompson, “The Significance of the Ancient Near Eastern Treaty Pattern,” Tyndale Bulletin 13 (1963): 2; Mendenhall and Herion, 1180–1182; Weinfeld, Theological Dictionary of the Old Testament, 265; 274; Gordon Wenham, “Covenants and Near Eastern Treaties,” in Zondervan Handbook to the Bible, ed. by David and Pat Alexander, Grand Rapids: Zondervan Publishing House, 1999, 211. 125Weinfeld, Theological Dictionary of the Old Testament, 256–257; Hayes, 177; Thompson, 6; Eerdman’s Dictionary of the Bible,s.v.“covenant,” 291; Richter, 141, includes the Hebrew term, hesed; Joseph L. Allen, Love and Conflict: A Covenantal Model of Christian Ethics, Nashville: Abingdon Press, 1984: 25. 126Jumper, 128; Gary Stansell, “David and His Friends: Social-Scientific Perspectives on the David-Jonathan Friendship,” Biblical Theology Bulletin 41 (2011): 116. 172 5 Covenant Consent

In agreeing to a covenant, covenant partners promise loyalty and take on commitments to act in ways that will contribute to the well-being of the other. The Hebrew term hesed, which is frequently associated with berith (covenant), has been variously translated as loyalty, devotion, loving-kindness or mercy.127 The term is used more often to describe God than humans, and frequently in the context of God’s redemptive activity, whether past, present or promised. It is reasonable to suggest that God’s interest in and commitment to the well-being of the objects of hesed is at the heart of that term, and by extension may be seen as essential within covenant.128 Likewise, in the Greek of the New Testament, the term oikodomeo (to edify, to build up) expresses the responsibility which members of the community of the new covenant have toward one another.129 That is, to be in covenant is to will and work toward the well-being of those with whom one is in covenant. From the Akkadian, Hittite, Hebrew and early Christian sources, we may construct a simple definition of covenant: a lasting personal relationship initiated by an exchange of promises, characterized by loyalty and a commitment to the well-being of the covenant partner, involving specified responsibilities yet flexible and open to renegotiation as necessary. Though not employing this specificdefinition, several persons have already found the covenant concept useful in thinking about ethics generally130 and health care ethics particularly.131 Those who adopt the covenant concept as a key to thinking about ethics more generally focus on several of the covenant themes we have already noted. Covenant

127Harold M. Kamsler, “Hesed—Mercy or Loyalty?” Jewish Bible Quarterly 27, no. 3 (1999): 184; Robert B. Chisolm, Jr., “The Word Hesed in the Hebrew Bible: A Review,” Bibliotheca Sacra 153 (1996): 494. 128James A. Montgomery says hesed “means the moral relation lying between two parties that is entailed in, but lies beyond, the concrete legal requirements, as in the relations between parent and child… man and wife, host and guest or client.” This is extremely similar to the covenant concept argued for in this chapter. See “Hebrew Hesed and Greek Charis,” Harvard Theological Review 32, no. 2 (1939): 98. See also Chisolm, Jr., 495. 129James L. Benedict, “The Language of Edification in 1 Corinthians and End-of-Life Decision Making,” Brethren Life and Thought 41 (1996): 20–22. 130Louis E. Newman, “Covenant and Contract: A Framework for the Analysis of Jewish Ethics,” Journal of Law and Religion 9 (1991): 89–92; Alan L. Mittleman, A Short History of Jewish Ethics: Conduct and Character in the Context of Covenant, Hoboken: Wiley-Blackwell, 2012; H. Richard Niebuhr, “The Idea of Covenant and American Democracy,” Church History 23, no. 2 (1954): 126–135; Eric Mount, Jr., Covenant, Community, and the Common Good: An Interpretation of Christian Ethics, Cleveland: The Pilgrim Press, 1999; Perry Simpson Huesmann, Covenant as Ethical Commonwealth: Possibilities for Trust in an Age of Western Individualism and Disintegration, Milan: IPOC, 2010; Allen, Love and Conflict. 131Rabbi Irving Greenberg, “A Covenantal Ethic of Medicine” in Jewish Values in Bioethics, ed. by Rabbi Levi Meier, New York: Human Sciences Press, 1986: 137–148; Neil G. Messer, The Therapeutic Covenant, Grove Ethical Studies 103, Cambridge: Grove Books Limited, 1996; William F. May, “Code, Covenant, Contract, or Philanthropy,” Hastings Center Report 5, no. 6 (1975): 29–38; Paul Ramsey, Patient as Person Second Edition, New Haven: Yale University Press, 2002; William F. May, The Physician’s Covenant Second Edition, Louisville: Westminster John Knox Press, 2000. 5.4 The Concept of Covenant as a Resource 173 thinking, they observe, focuses on relationships of actual persons rather than on abstract rights or obligations.132 Perry Simpson Huessmann even argues that thinking about persons solely as autonomous individuals with rights divinely endowed and obligations freely chosen is fundamentally misleading since humans are by nature “rooted in relationality.”133 Those who apply the concept of covenant in ethics more generally also emphasize the flexibility and dynamism of covenants, especially their openness to the progressive and unpredictable nature of life.134 They see this flexibility as one of the main ways in which covenants can be distinguished from and operate better than contracts.135 Another feature of covenant appreciated by those employing the term in general ethics is the call within covenant to participatory involvement in an enduring commitment.136 Applications of the covenant concept in health care ethics have likewise lifted up features noted above. Several accounts of the role of covenant in health care ethics emphasize the focus on a relationship involving mutuality and solidarity.137 Ramsey, whose importance in promoting the use of the covenant concept in health care ethics is matched only by that of William F. May, emphasized fidelity as a critical theme of covenant.138 Others subsequently picked up on the theme of fidelity as well.139 A number of authors in the field stress the dynamic adaptability of the covenant relationship, while contrasting it with the rigidity and other

132Newman, 89–92; Eugene Borowitz, “The Jewish Self,” Contemporary Jewish Ethics and Morality: A Reader, ed. by Elliot Dorff and Louis Newman, New York: Oxford University Press, 1999: 109; Allen, 77; Mount, Jr., 1. 133Huesmann, 62. 134Newman in Dorff and Newman, 89; Mittleman, 8–10; Eugene Borowitz, “The Jewish Self,” in Dorff and Newman, 112; Allen, 16–17; Max L. Stackhouse, Covenant & Commitments: Faith, Family and Economic Life, Louisville: Westminster John Knox Press, 1997: 139–140. 135Newman, “Covenant and Contract,” 102–112; Niebuhr, 134; Allen, 16–17; Huesmann, 139; 143. 136Niebuhr, 132–133; Allen, 38–39. 137Rabbi Irving Greenberg, “A Covenantal Ethic of Medicine” in Jewish Values in Bioethics, ed. by Rabbi Levi Meier, New York: Human Sciences Press, 1986: 137–148; Sue Coffey, “The Nurse-Patient Relationship in Cancer Care as a Shared Covenant,” Advances in Nursing Science 29, no. 4 (2006): 311–314; Clarke E. Cochran, “Pope Benedict XVI’s New Encyclical: Implications for Catholic Health Care,” Health Progress, 90, no. 5 (2009): 50–52; Robert L. Fine, “The Physician’s Covenant With Patients in Pain,” American Journal of Bioethics 10, no. 11 (2010): 23–24; Ramsey, Patient as Person, Second Edition, 6; May, Physician’s Covenant,8. 138Ramsey, Patient as Person, Second Edition, xlv. 139Edmund D. Pelligrino, “The Moral Foundations of the Patient-Physician Relationship: The Essence of Medical Ethics,” in Military Medical Ethics, v. 1, ed. by Thomas E. Beam and Linette R. Sparacino, Bethesda: Uniformed Services University of the Health Sciences, 2003: 3–21; James J. Rusthoven. “Understanding Medical Relationships through a Covenantal Ethical Perspective,” Perspectives on Science and Christian Faith 62, no. 1 (2010): 3–15; Messer, Therapeutic Covenant,8–10. 174 5 Covenant Consent limitations of a contractual understanding of the patient-care provider or subject- researcher relationship.140 Finally, a few individuals working with the concept of covenant in health care ethics claim it has special meaning as a commitment to alleviate the vulnerability of the covenant partner.141 Among the distinctive features of covenant are several that commend themselves as elements in the construction of an understanding of consent appropriate for vascularized composite allotransplantation of faces and upper extremities. Compared to standard antecedent informed consent, covenant consent better addresses the duration of treatment involved in VCA, the substantial known burdens and considerable uncertainty regarding risks, the need for long-term active participation by the recipient of the graft, and the special concerns about dignity and vulnerability which arise in the context of VCA.

5.4.1 Covenant Consent and the Duration of Treatment in VCA

The treatment process in VCA, beginning with screening and continuing through surgery, post-surgical hospitalization and inpatient rehabilitation, outpatient rehabilitation, life-long monitoring for signs of rejection and treatment for side effects of the immunotherapy regimen, lasts for many years. Indeed, the hope of both patients and care providers is that the patient and graft will survive for decades. Consent for VCA, therefore, is not simply authorization or permission-giving for the medical staff to perform a surgery. Rather, it is the agreement to enter into a long-term cooperative relationship. A covenantal understanding of consent implies that consent is a mutual commitment or exchange of promises intended to create and sustain a cooperative relationship over time. Because of its focus on consent as a long-term relationship rather than simply as an antecedent event or process, covenant consent may be better at recognizing the continuing responsibility to inform and support patients even after consent documents are signed. In research on the experiences of patients and families who were

140Coffey, 313; Joseph J. Fins, “Commentary: From Contract to Covenant in Advance Care Planning,” Journal of Law, Medicine and Ethics 27, no. 1 (1999): 46–50; Fine, 23–24; Maureen Kelly, “Contractarianism and Bioethics,” in Encyclopedia of Bioethics, v. 1, 3rd Edition, ed. by Stephen G. Post, New York: Macmillan Reference, 2004: 526; John G. Bruhn, “The Lost Art of the Covenant: Trust as a Commodity in Health Care,” The Health Care Manager 24, no. 4 (2005): 311–319; May, “Code, Covenant, Contract or Philanthropy,” 29–38; Ronald Carson, “Paul Ramsey’s Ethic of Covenant Fidelity,” in Covenants of Life: Contemporary Medical Ethics in Light of the Thought of Paul Ramsey, ed. by Kenneth L. Vaux, Sara Vaux and Mark Stenberg, Dordrecht: Kluwer Academic Publishers, 2002: 10; May, Physician’s Covenant, 113–115; May, Testing the Medical Covenant,9. 141Ramsey, Basic Christian Ethics,12–14; Sally Gadow, “Covenant without Cure: Letting Go and Holding on in Chronic Illness,” NLN Publications 15 (1988): 6–11; May, Physician’s Covenant, 126–136; Testing the Medical Covenant,9. 5.4 The Concept of Covenant as a Resource 175 involved in new clinical procedures, Kathryn Ehrich, Luke Cowie and Jane Sandall found that many patients and family members felt the information provided prior to the procedures was clear and there were ample opportunities to ask questions at that point. However, “post-procedure information follow-up was often reported as lacking.”142 It seems likely that the resulting frustration could inhibit cooperation, which is so important in VCA. By recognizing the continuous nature of consent, a covenant consent paradigm should actively encourage questions and dialogue both before and after the surgical procedure. Another important feature of covenant consent which enables it to create and sustain long-term cooperation is its shared emphasis on both the medical goal(s) of the treatment and the relationship itself. Successful long-term cooperation is seldom sustained by aligned self-interests alone. Part of the reason that aligned self-interests alone are often unable to motivate long-term cooperation is that the self-interests of two or more parties rarely remain fully aligned over long periods of time. In addition, the desire of all parties to uphold the commitments they have made may waver as time passes, due to changes in circumstances or simply due to fatigue. Under such conditions, continuing cooperation may still be supported by the bonds of loyalty or ﬁdelity to a covenant partner.143 One is motivated by one’s desire to preserve the relationship and to act honorably within it, even when the actions required would otherwise be too burdensome. In this way covenant consent, with its emphasis on the formation and maintenance of a durable human relationship, is well-suited to the nature of VCA treatment.

5.4.2 Covenant Consent and the Burdens and Risks of VCA

Covenant consent is also superior to standard antecedent informed consent in the context of VCA in light of the substantial known burdens and significant uncertainty regarding risks. In standard antecedent informed consent, information regarding various risks, burdens and anticipated benefits is to be provided prior to and as a basis for the patient’s decision to authorize treatment. In covenant consent, consideration of risks and burdens plays a larger role. Patients who consent to VCA are consenting not only to a lengthy surgery with its own substantial profile of risks

142Kathryn Ehrich, Luke Cowie and Jane Sandall, “Expect the Unexpected: Patients’ and Families’ Expectations and Experiences of New Clinical Procedures,” Health Expectations, 2013 epub ahead of print, Accessed October 11, 2014. http://onlinelibrary.wiley.com.authenticate.library.duq. edu/doi/10.1111/hex.12065/pdf. 143Susanne Dibbelt et al., point out that the quality of relationship between care provider and patient correlates positively with superior outcomes in rehabilitation. “Patient-doctor Interaction in Rehabilitation: The Relationship Between Perceived Interaction Quality and Long-Term Treatment Results,” Patient Education and Counseling 76 (2009): 334. John M. Kelley et al., found a similar result in a systematic review of patient-clinician relationships more generally. “The Influence of the Patient-Clinician Relationship on Healthcare Outcomes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials,” PLOS One 9, no. 4 (2014): 5–6. 176 5 Covenant Consent and the burdens of recovery, but also to a period of increased dependency post-surgically, the arduous rehabilitation regimen, the responsibility to faithfully maintain the immunosuppressive regimen and monitor for signs of rejection, and the high risk of side effects of immunosuppression, including the possibility that the lives of patients will be shortened as a result. In a sense, the individual who consents to VCA is consenting to take on a complex chronic illness. While the benefits graft recipients seek to obtain in exchange for agreeing to bear the burdens and endure the risks of VCA are themselves substantial, the degree of sacrifice and risk required of patients calls for more than a simple quid pro quo agreement. Covenant consent, by incorporating a concern for shame and honor, allows for the recipient’s sacrifices and risks to be acknowledged and calls upon care providers to honor those sacrifices and risks with due respect, by recognizing recipients as genuine “joint adventurers”144 in VCA research. As joint adventurers, recipients are understood as participants rather than simply as patients.145

5.4.3 Covenant Consent and Long-Term Active Participation by the Recipient in VCA

Covenant consent is also more fitting than simple antecedent informed consent in the context of VCA due to the importance in VCA of the patient’s active participation over a long period of time. As noted earlier, standard antecedent informed consent is adequate and appropriate for the typical health care intervention in which the patient’s role is primarily passive. In situations where little is asked of the patient beyond granting permission and accepting risk, consent understood as permission-giving, authorization or waiver is sufficient. Yet, where more is expected, a focus only on antecedent consent should be regarded as unethical. If one knows or has strong reasons to suspect that the individual giving such consent will not actually be able to carry through with the commitments or bear the burdens involved in the proposed course of treatment, then it is unethical to request or accept such consent. Nor would it be ethical to seek or accept simple antecedent consent without the means or intention to provide the support necessary for the patient or subject to carry through the commitments or bear the burdens. In VCA, where treatment success depends on the active participation of the patient in long-term physical therapy, immunosuppression use, and self-monitoring, consent must be more robust. The nature and form of consent requested ought to reflect what is actually being asked of the patient. If what is being asked is simply permission to act upon the patient, then consent is appropriately permission. But if what is being asked is both permission to act upon the patient and for the patient to

144The term is originally Ramsey’s. Patient as Person, Second Edition, 6. 145Katherine N. Moore, “Compliance or Collaboration? The Meaning for the Patient,” Nursing Ethics 2, no. 1 (1995): 71. 5.4 The Concept of Covenant as a Resource 177 actively participate in significant ways for a substantial amount of time, then one is really asking the patient to enter into the kind of cooperative relationship that may be described as covenantal. Covenant consent invites and supports the patients’ commitment, as opposed to mere compliance. This is an important distinction which is highly relevant to VCA. Cooperation with and active participation in the treatment is variously called compliance, adherence or concordance. While distinctions are made between these various forms of cooperation,146 each tends to focus on rational processes grounded in self-interest. Patient cooperation with and active participation in the treatment is a significant issue in health care generally,147 and transplantation specifically.148 One estimate of the total direct and indirect costs of medication non-adherence alone is between $100 and $300 billion annually in the United States, and over one hundred factors have been associated with non-adherence.149 Cooperation with and active participation in the treatment has been an area of concern thus far in VCA as well.150 Failure to cooperate in treatment has been addressed primarily by urging stronger emphasis on the quality of screening for

146Lawrence R. Brawley and S. Nicole Culos-Reed, “Studying Adherence to Therapeutic Regimens: Overview, Theories, Recommendations,” Controlled Clinical Trials 21 (2000): 157S. 147Jeffrey K. Aronson, “Compliance, Concordance, Adherence,” British Journal of Clinical Pharmacology, 63, no. 4 (2007): 383–384; K. Khair, “Compliance, Concordance and Adherence: What Are We Talking About?,” Haemophilia 20, no. 5 (2014): 601–603; C. Wahl et al., “Concordance, Compliance and Adherence in Healthcare: Closing Gaps and Improving Outcomes,” Healthcare Quarterly 8, no. 1 (2005): 65–70; Allan Zuckoff, “‘Why Won’tMy Patients Do What’s Good for Them?’ Motivational Interviewing and Treatment Adherence,” Surgery for Obesity and Related Diseases 8 (2012): 514–521; Mark Lassleben, Matthew J. Cullen and Andrew J. Wilson, “Compliance by Collaboration: Effectively Addressing Problems of Treatment Adherence,” Australian Family Physician 28, no. 8 (1999): 850–853; Mohammadreza Hojat et al., “Patient Perceptions of Physician Empathy, Satisfaction with Physician, Interpersonal Trust and Compliance,” International Journal of Medical Education (2010): 83–87. 148E.M. Fredericks et al., “Post-transplant Adjustment—The Later Years,” Pediatric Transplantation 18 (2014): 682–683; M. Serper et al., “Medication Misuse, Non-adherence, and Clinical Outcomes among Liver Transplant Recipients,” Liver Transplantation, 2014, epub ahead of print. Accessed November 13, 2014. http://onlinelibrary.wiley.com.authenticate.library.duq. edu/doi/10.1002/lt.24023/pdf; F.L. Weng et al., “Prevalence and Correlates of Medication Non-Adherence Among Kidney Transplant Recipients More Than 6 Months Post-Transplant: A Cross-Sectional Study,” BMC Nephrology 14 (2013): 261–270; Joseph E. Losee, Derek R. Fletcher and Vijay S. Gorantla, “Human Facial Allotransplantation: Patient Selection and Pertinent Considerations,” Journal of Craniofacial Surgery 23, no. 1 (2012): 263. 149Hayden B. Bosworth et al., “Medication Adherence: A Call to Action,” American Heart Journal 162, no. 3 (2011): 412–415. 150A.A. Bertrand et al., “Changing Attitudes Toward Hand Allotransplantation among North American Hand Surgeons,” Annals of Plastic Surgery, 72, Supplement no. 1 (2014): S56–60; Lamparello et al., 282–283; Maria Siemionow, Faith Zor, and Chad Gordon, “Face, Upper Extremity, and Concomitant Transplantation: Potential Concerns and Challenges Ahead,” Plastic and Reconstructive Surgery 126, no. 1 (2010): 312; Martin M. Klapheke et al., “Psychiatric Assessment of Candidates for Hand Transplantation,” Microsurgery 20 (2000): 453–457. 178 5 Covenant Consent prospective patients.151 The unstated assumption in this approach to addressing the problem is, as Katherine Moore puts it, that “the locus of the problem of non- compliance is the patient.”152 Patient cooperation is understood as simply a function of characteristics which pre-exist in the patient. Proper screening, it is hoped, will identify those patients who have the “right stuff.”153 When such patients, in the course of standard antecedent informed consent, determine that the anticipated benefits of VCA outweigh the burdens and risks, they are expected to grant permission to proceed and thereafter comply. By contrast, covenant consent assumes that cooperation is a function both of characteristics which pre-exist in the patient and of the quality of the relationship the patient has with others, including the care team. Covenant consent sees active patient cooperation as a manifestation of commitment. The difference between commitment and compliance has been discussed at length in the fields of social psychology,154 human resources management155 and occupational safety.156 Compliance is cooperation driven by self-interest. An individual may or may not find direct value or meaning in the requested action, but will comply in order to get something else he or she wants. Commitment, on the other hand, is when an individual has internalized shared goals and values and so is motivated to act by those goals and values, and not merely by the promise of an extrinsic reward.157 Kenneth G. Brown of the University of Iowa aptly observes that compliance is adequate in most “day-to-day interactions.”158 Yet in order for compliance-based cooperation to continue over time, the salience of the positive or negative

151Losee, Fletcher and Gorantla, 263; Christina L. Kaufman et al., “Monitoring and Long-term Outcomes in Vascularized Composite Allotransplantation,” Current Opinion in Organ Transplantation 18, no. 6 (2013): 653. 152Moore, 72. 153Klapheke et al., 454–457, provide a list of these characteristics. To their credit, they also note that one characteristic that ought to be identified in candidates is “the ability to form a therapeutic working relationship with the treatment team.” 154Jean-Leon Beauvois, Marc Bungerty and Pascale Mariette, “Forced Compliance: Commitment to Compliance and Commitment to Activity,” European Journal of Social Psychology 25 (1995): 17–26. 155Ed Emde, “Why Go for Compliance When You Need Commitment?” Journal for Quality and Participation 20, no. 1 (1997): 30–33; Karlene Kerfoot and Steven L. Wantz, “Compliance Leadership: The 17th Century Model That Doesn’t Work,” Urologic Nursing 25, no. 2 (2005): 131–133. 156E. Scott Geller and Bob Veazie, “From Compliance to Commitment: Comparing BBS to AC4P,” Professional Safety (2014): 44–50; John W. Wells, Jr., “Commitment, Ethics and Compliance,” Professional Safety (2013): 62–68. 157Charles O’Reilly III and Jennifer Chatman, “Organizational Commitment and Psychological Attachment: The Effects of Compliance, Identification, and Internalization on Prosocial Behavior,” Journal of Applied Psychology 71, no. 3 (1986): 493. The authors trace the origin of the distinction to a 1958 article by H.C. Kelman, which spoke of compliance, identification and internalization. 158Kenneth G. Brown, Influence: Mastering Life’s Most Powerful Skill: Course Guidebook, Chantilly: The Teaching Company, 2013: 4. 5.4 The Concept of Covenant as a Resource 179 reinforcement (promised reward or threatened punishment) must be maintained.159 This is quite difficult to accomplish. Cooperation motivated by commitment, on the other hand, tends to be more stable, since commitment is based on internalized values. Commitment must also be reinforced, of course, but it is reinforced as much by positive interaction with those who share the commitment as it is by explicit revisiting of the content of the commitment and the reasons for it. Covenant consent seeks to create and sustain affective commitment on the part of both the care team and the graft recipient. Affective commitment is created in and through relationships in which patients receive emotional support, instrumental support, information and affirmation.160 While compliance is generally grounded in conscious reasoning, commitment engages emotion as well. The role of emotion in motivation is well established, with some research pointing to specific brain structures that are implicated in both emotion and motivation.161 According to Petra Gelhaus, “Current findings in neuroscience underline the importance of affective intentional states and their irreducibility to merely cognitive ones.”162 In an interesting study on the impact of commitment, Heiner Evanschitzky, Christian Brock and Markus Blut found that “affective commitment” inclined study participants to complain more while simultaneously rendering them more loyal. It is believed that the higher rate of complaints reflected the desire of participants to improve the process precisely because they were more committed to it.163 In covenant consent, the formation of a significant relationship with an affective dimension is assumed, increasing the possibility that the motivation for cooperation will be based in an affective commitment.

5.4.4 Covenant Consent and the Role of Dignity and Vulnerability in VCA

The value of covenant consent is also evident when one considers the special concerns about dignity and vulnerability that arise in the context of VCA. In an

159Lassleben, Cullen and Wilson, 851. 160Marie A. Chisolm-Burns, Christina A. Spivey and Scott E. Wilks, “Social Support and Immunosuppressive Therapy Adherence among Adult Renal Transplant Recipients,” Clinical Transplantation 24, no. 3 (2010): 313. 161Rudolph N. Cardinal et al., “Emotion and Motivation: The Role of the Amygdala, Ventral Striatum, and Prefrontal Cortex,” Nueroscience and Biobehavioral Reviews 26 (2002): 321–352; Tim Dalgleish, “The Emotional Brain,” Nature Reviews Neuroscience 5 (2005): 582–588; Larry C. Bernard et al., “An Evolutionary Theory of Human Motivation,” Genetic, Social, and General Psychology Monographs 131, no. 2 (2005): 138–139; 147–148. 162Petra Gelhaus, “The Desired Moral Attitude of the Physician: (II) Compassion,” Medicine, Health Care and Philosophy 15 (2012): 398. 163Heiner Evanschitzky, Christian Brock, and Markus Blut, “Will You Tolerate This? The Impact of Affective Commitment on Complaint Intention and Postrecovery Behavior,” Journal of Service Research 14, no. 4 (2011): 410–419. 180 5 Covenant Consent earlier chapter, some of the ways in which dignity and vulnerability become special concerns in VCA were described. According to Dworkin, violations of dignity occur when people are treated in ways “that are inconsistent with recognizing [a person] as a full member of the human community.”164 Concerns about dignity are raised by the practices (conscious and unconscious) of avoidance and exclusion often experienced by the disfigured and disabled persons who are candidates for face and upper extremity VCA. It may be argued that VCA aims at restoring dignity.165 Yet, as is sometimes the case, in our eagerness to “fix” others, we sometimes offend their dignity in unintended ways. Full dignity is only preserved by an approach that is sensitive to the many ways an individual’s sense of being recognized as a “full member of the human community” may be undermined. For example, VCA necessarily causes recipients to experience a significant period of greater dependence early in recovery. This involves the experience of loss of control over one’s body, one’s environment and perhaps one’s emotions as well.166 Even beyond the period of greater dependence, the requirements to engage in physiotherapy and maintain the immunosuppressive regimen, along with the unavoidable publicity, can make it seem as if the recipient’s life has been consumed by VCA.167 A partial remedy, at least, is to not only assure that the recipient is fully informed before being asked to consent and that the decision to undergo surgery is completely voluntary, but also to make every effort to treat the recipient as a genuine partner throughout the process, from screening on. Dignity is more than the freedom to choose for one’s self; it also includes being respected and regarded as a valued person who, as such, is in some ways responsible to others for the choices he or she makes.168 Furthermore, inasmuch as covenant consent inclines participants to see each other as partners, it calls attention to the sacrifices and risks undertaken by graft recipients, and the courage and persistence they bring to the work of

164Dworkin, as quoted in Daniel P. Sulmasy, “Death, Dignity and the Theory of Value.” Accessed April 12, 2014. http://www.ethical-perspectives.be/viewpic.php?TABLE=EP&ID=53. 165Michael Freeman and Pauline Abou Jaoude, “Justifying Surgery’s Last Taboo: The Ethics of Face Transplants,” Journal of Medical Ethics 33 (2007): 79; L.A. Furr et al., “Psychosocial Implications of Disfigurement and the Future of Human Face Transplantation,” Plastic and Reconstructive Surgery, 120, no. 2 (2007): 559–562; G.J. Agich and M. Siemionow, “Until They Have Faces: The Ethics of Facial Allograft Transplantation,” Journal of Medical Ethics 31, no. 12 (2005): 707–708; Jenny Slatman and Guy Widdershoven, “Hand Transplants and Bodily Integrity,” Body and Society 16, no. 3 (2010): 75–77. 166Kumnig and Jowsey-Gregoire, 96; Isabelle Aujoulat, Olivier Luminet and Alain Duccache, “The Perspective of Patients on Their Experience of Powerlessness” Qualitative Health Research, 17, no. 6 (2007): 776–779. 167An article in GQ on face transplant recipient Richard Norris suggests that this may have happened to him. See Jeanne Marie Laskas, “The New Face of Richard Norris,” GQ July 2014. Accessed September 15, 2014. http://www.gq.com/news-politics/newsmakers/201408/richard- norris. 168Jack Coulehan, “‘They Wouldn’t Pay Attention’: Death without Dignity,” American Journal of Hospice and Palliative Medicine 22, no. 5 (2005): 341–342. 5.4 The Concept of Covenant as a Resource 181 physiotherapy and other aspects of post-surgical self-care. These sacrifices and risks deserve to be acknowledged as heroic. As William F. May puts it, “the heavy burden of heroism in medicine falls not on the physician but on the patient(s)… as they face… an extraordinarily long and heavy responsibility of chronic care.”169 The dignity of patients which is acknowledged under covenant consent is, according to Sulmasy’s taxonomy, not merely the “inherent,” but also the “inflorescent.” The courage and persistence of the recipient of the graft are evidence of his or her commitment to ways of being in the world which support human flourishing, and so deserve respect. Thus, covenant consent, with its concern for matters of shame and honor, helps promote respect for the dignity of all persons involved. Along with dignity, the vulnerability of graft recipients is also a concern in VCA. Both disfigurement and disability may create conditions of special vulnerability, particularly to the degree that they create dependence on others and social isolation. Further, to the extent that VCA candidates are sufficiently motivated to undertake the burdens and risks associated with the treatment while it is still considered experimental, some may argue that they are necessarily (or at least highly likely to be) in a state of special vulnerability.170 Desperate for relief and severely limited in their options for treatment, potential recipients may be susceptible to unreasonable expectations and unable to fully appreciate or adequately consider the information provided regarding burdens and risks. Regarding candidates for VCA as being especially vulnerable does not dis- qualify them outright. However, it does imply that they ought to be afforded special consideration, protection and support.171 Covenant consent is one form that such special consideration, protection and support may take. Covenant consent achieves this by engaging recipients (both potential and actual) at a deeper level (solidarity), working to empower them at every step along the way by seeking their input and feedback, and by understanding consent to be an on-going, dynamic condition

169William F. May, The Patient’s Ordeal, Bloomington: Indiana University Press, 1991: 3. 170Philip J. Nickel, “Vulnerable Populations in Research: The Case of the Seriously Ill,” Theoretical Medicine and Bioethics 27 (2006): 256; Nichola Rumsey, “Psychological Aspects of Face Transplantation: Read the Small Print Carefully,” The American Journal of Bioethics 4, no. 3 (2004): 22–23; Eileen Bradbury, “Meeting the Psychological Needs of Patients with Facial Disfigurement,” British Journal of Oral and Maxillofacial Surgery 50 (2012): 194; Dearbhail Bracken-Roche et al., “Disclosure, Consent, and the Exercise of Patient Autonomy in Surgical Innovation: A Systematic Content Analysis of the Conceptual Literature,” Accountability in Research, 21 (2014): 336; 341. 171Margaretha Strandmark K., “Ill health is powerlessness: a phenomenological study about worthlessness, limitations and suffering,” Scandinavian Journal of Caring Sciences 18 (2004): 141–142; Diane Perpich, “Vulnerability and the Ethics of Facial Tissue Transplantation.” Journal of Bioethical Inquiry 7, no. 2 (2010): 184; Wendy Rogers, Catriona Mackenzie, and Susan Dodds; “Why Bioethics Needs a Concept of Vulnerability,” The International Journal of Feminist Approaches to Bioethics, 5, no. 2 (2012): 24–26. 182 5 Covenant Consent initiated by the exchange of promises.172 By this means, a covenant approach aims at “alleviating another’s vulnerability.”173 Yet only some kinds of vulnerability can be alleviated, and only some of the time. Under many conditions of vulnerability, one is faced with a choice between the paralysis of fear and the possibility of liberation via trust, while recognizing that to trust makes one vulnerable also. Therefore, it is not always the case that it is best for us to avoid or escape all forms of vulnerability. The concept of covenant actually invites us to reconsider the typical way vulnerability is understood in health care ethics. Thus far in health care ethics, vulnerability has primarily been understood as a negative and undesirable condition to be avoided whenever possible. From a covenant perspective, however, vulnerability may be understood as an inevitable and universal condition which indicates susceptibility both to further harm and to growth and improvement.174 As Kristine Culp puts it, one is vulnerable “to transformation as well as to devastation.”175 Indeed, both aspects of vulnerability are involved when one agrees to accept a facial or upper extremity VCA. From the covenant perspective, the goal of completely escaping the condition of vulnerability is both unrealistic and harmful. Not only is vulnerability “intrinsic to being creatures who are interdependent,”176 but our attempts to avoid vulnerability entirely generally lead to the avoidance of the very relationships through which we are able to flourish. Furthermore, to enter a covenant is to make one’s self vulnerable,177 since one’s partner in covenant can always violate the covenant in some way. Nonetheless, we enter covenants because of their rich possibilities for growth and fulfillment. Thus, the special vulnerability of patients and research subjects may be seen as the opportunity to do good as well as an indicator of heightened susceptibility to harm.

5.5 Covenant Consent for VCA

So far in this chapter, three points have been argued. First, it has been argued that the concept of consent in health care is not ﬁxed and remains open to adaptation. Second, it has been argued that standard antecedent informed consent, based solely

172Bracken-Roche et al., 343. McLean, 105, notes that Article 8 of the UNESCO Declaration of Bioethics and Human Rights explicitly names a “duty to promote solidarity” as an element of respect for human vulnerability in the context of health care treatment and research. 173Gadow, 6–7. 174William C. Placher, Narratives of a Vulnerable God: Christ, Theology and Scripture, Louisville: Westminster John Knox Press, 1994: 19. 175Kristine A. Culp, Vulnerability and Glory: A Theological Account, Louisville: Westminster John Knox Press, 2010: 3; 16. 176Culp, 4. 177Ellen F. Davis, “Vulnerability, The Condition of Covenant,” in The Art of Reading Scripture, ed. by Ellen F. Davis and Richard B. Hays, Grand Rapids: William B. Eerdmans Publishing Company, 2003: 278. 5.5 Covenant Consent for VCA 183 on information, understanding, and voluntariness, is ill-suited to the nature of treatment involved in vascularized composite allotransplantation of faces and upper extremities. And third, it has been argued that the concept of covenant is a rich resource for re-imagining or adapting consent for VCA. The next step is to describe in some detail what form such a re-imagining or adaptation of consent would take, both theoretically and practically.

5.5.1 Re-imagining Consent in Covenantal Terms

Consent in covenantal terms, or covenant consent, is a long-term, cooperative and purposeful relationship between two or more persons, founded on mutual respect and expressed through compassionate solidarity. The respect that forms the foundation of covenant consent, and continues throughout the duration of the relationship, requires full disclosure of pertinent information by all parties prior to the formal initiation of the covenant consent. The formal initiation of covenant consent involves promises of ﬁdelity and commitments both to the medical goals and to the well-being of the relationship itself. The proper functioning of covenant consent is evidenced in words and deeds (including sustained practices) that express compassionate solidarity. This basic theoretical formulation of covenant consent as a long-term, cooperative and personal relationship does not render irrelevant the various elements of the standard antecedent approach to informed consent. Rather, the elements of the standard approach must be included in and integrated into this new approach. Covenant consent requires the same amount of information (or more) to be provided in advance to persons from whom consent is being sought, and requires the same level of effort to demonstrate that the one consenting understands the information provided. Covenant consent also requires the care providers to determine that potential recipients have decisional capacity. Covenant consent likewise requires all participants to enter the covenant voluntarily. Covenant consent also has a place for the consent form as a legal document, with all its protections for both care providers and patients. In fact, from the perspective of covenant consent, the signing of the form may serve the ritual purpose suggested by Kukla178 and Barilan.179 The form and its signing may play roughly the same role with regard to the relationship in which consent exists over time as a marriage license and its signing play in the covenant of marriage. In both cases, the ritual in which the signing takes place is very signiﬁcant as an initiation into the relationship as a covenant. Nonetheless, the form and its signing are not to be confused with the totality of the covenant relationship. The form and its signing signal and bear witness to the intention to enter into and remain in covenant, but the covenant itself

178Kukla, “Communicating Consent,” 47. 179Barilan, “Informed Consent: Between Waiver and Excellence,” 93. 184 5 Covenant Consent is something which must be practiced and supported over time by appropriate words and actions on the part of the covenant partners. Two fundamental assumptions undergird this concept of covenant consent. The first is that persons are fundamentally relational.180 That is to say, humans only flourish in and through relationships, and the relationships themselves are a human good worth pursuing and protecting. By emphasizing relationships, attention is drawn to responsibilities as well as to rights. Ways of thinking about what humans are which lose sight of the role of relationships are seriously deficient. For example, to think of a person primarily in mechanistic terms, as medicine is sometimes prone to do,181 is to distort one’s approach to life in a way that is sure to have wide-ranging negative implications for the relationships in which one inevitably finds one’s self. Likewise, to imagine persons primarily as individuals who are motivated by self-interest and who interact only because of their interest in goods or services is certain to have a profound impact upon one’s expectations of self and others. Both ways of thinking about what it means to be human—to think in mechanistic terms or to think in individualistic terms—obscure that fundamental relational aspect which motivates so much human behavior and gives meaning to our ethics.182 Remembering that we as humans are fundamentally relational is especially important in a consideration of consent because it reminds us that our relationships influence both the decisions we make and how likely we are to live up to the commitments we take on. In the process that leads to (and from) the formal act of consent, we never simply operate out of stable pre-existing values or ideas. Rather, we construct and revise our values and ideas through our interactions with others.183 Our relationships essentially create and sustain our ability and willingness to make and keep promises. The second fundamental assumption undergirding this concept of covenant consent is that what one seeks in situations where covenant consent is appropriate, is not simply a patient, subject or provider of medical services, but rather a partner or “joint adventurer.”184 Because one is looking for a partner rather than a patient or a service provider, one must ask more than whether the needs or the skills of the person in question fit abstract criteria. One must also focus on what sort of person the other is and whether one can expect to be successful in entering into a long-term relationship with such a person, i.e., what kind of partner this other person will be

180Henk ten Have’s way of putting it is that “we are primarily social beings.”“Images of Man in Philosophy of Medicine,” in Critical Reflections on Medical Ethics: Advances in Bioethics Volume 4, ed. by Rem B. Edwards and Edward Bittar, Stamford: JAI Press, 1998: 190; Jack Coulehan, “The Best Lack All Conviction: Biomedical Ethics, Professionalism and Social Responsibility,” Cambridge Quarterly of Healthcare Ethics 12 (2003): 24. 181ten Have, 185: Coulehan, “The Best Lack All Conviction,” 35. 182ten Have, 190. 183France Legare, “Models of Physician-Patient Relationship,” in Encyclopedia of Medical Decision Making, Thousand Oaks: SAGE Publications, 2009: 775. 184Ramsey, Patient as Person, Second Edition, 6. 5.5 Covenant Consent for VCA 185 and what kind of partner one will be able to be to that person. After all, if one’s intention is to enter into a long-term relationship of compassionate solidarity, one must think in personal, relational ways. To suggest that covenant consent requires a long-term, cooperative relationship of compassionate solidarity does not imply that the care provider/researcher and patient/subject need to become “friends” in the way that one often thinks of friends. While covenant friendships are possible,185 covenant is a broader category within which a number of different types of relationships may be initiated and maintained. Acknowledging that some may argue that friendship is a fitting description for the ideal relationship between physicians and their patients under particular conditions, F. Daniel Davis has challenged the idea of friendship as an ideal for the patient-physician relationship.186 While admitting that certain motivations and virtues associated with friendship play an important role in the physician-patient relationship, Davis employs the description of friendship in Aristotle’s Nichomachean Ethics to show that friendship implies characteristics (equality of moral obligation and freedom to enter or dissolve the relationship) which do not always pertain to patients and physicians in the context of health care.187 One may question whether Aristotle’s model is appropriate, since it is based on an abstract ideal that is seldom fully realized in human relationships. One may also critique Davis’ argument for tending toward a view of the physician as benefactor, which has been shown by William F. May to be a deficient image in its own right.188 Yet Davis’ point that friendship is often an unrealistic and unnecessary goal for the patient-physician relationship can be accepted without affecting the possibility of covenant consent. Covenants require neither equality between the participants nor even absolute freedom to dissolve the relationship at any time. At this point it must be conceded that covenant consent as a long-term, cooperative, purposeful relationship characterized by compassionate solidarity will be challenging in light of some of the existing values and structures of modern Western health care. There is ample evidence that patients want more personal, compassionate care and that such care improves both satisfaction and objective outcomes.189 Patients are seeking care that incorporates greater respect, continuity,

185The friendship covenant of David and Jonathan is an early example, found in the Hebrew Bible. 186F. Daniel Davis, “Friendship as an Ideal for the Patient-Physician Relationship: A Critique and an Alternative,” in The Health Care Professional as Friend and Healer: Building on the Work of Edmund D. Pelligrino, Washington, D.C.: Georgetown University Press, 2000: 24–34. 187Davis, 29–31. 188May, The Physician’s Covenant, 117–124. 189Melanie Neumann et al., “Physician Empathy: Deﬁnition, Outcome-Relevance and Its Measurement in Patient Care and Medical Education,” GMS Zeitschrift für Medizinische Ausbildung 29, no. 1 (2012): 2–3; Stewart W. Mercer, “Practitioner Empathy, Patient Enablement and Health Outcomes of Patients Attending the Glasgow Homeopathic Hospital: A Retrospective and Prospective Comparison,” Wiener Medizinische Wochenschrift 155, no. 21–22 (2005): 501; Dibbelt et al., 328; 334; Simone Steinhausen et al., “Physician Empathy and Subjective Evaluation of Medical Treatment Outcome in Trauma Surgery Patients,” Patient Education and Counseling 186 5 Covenant Consent attention, and empathy.190 There is also evidence that care delivered compassion- ately enhances the perceived well-being of care providers.191 Nonetheless, the treatment actually delivered to patients often lacks in personal caring. One study found that physicians “responded empathically” only about ten percent of the time,192 while a survey in the United States revealed that only slightly more than half of patients and physicians felt the health care system routinely provided “good levels of compassionate care.”193 Some responsibility for the lack of compassionate care may be placed upon the training care providers receive. Mannion suggests that “traditional pedagogic methods in medicine and nursing… teach health professionals to maintain an emotional distance from patients.”194 Howard Spiro contrasts empathy with equa- nimity, his name for the emotional distance which is widely encountered in health care.195 Jack Coulehan gives that emotional distance another name: “detached concern,”196 a term he borrows from Renee C. Fox, a sociologist whose career focused on investigations into medicine, medical training, and medical ethics.197 According to Coulehan, this attitude “devalues subjectivity, emotion, relationship and solidarity.”198 The rationale for “detached concern,” according to Coulehan, is that it protects the care provider “from being overwhelmed and paralyzed by pain and suffering,” and protects the patient by preventing those providing care from being unduly inﬂuenced in their judgments by emotion.199 This message is conveyed to care

(Footnote 189 continued) 95 (2014): 53; 58; Russell Mannion, “Enabling Compassionate Healthcare: Perils, Prospects and Perspectives,” International Journal of Health Policy and Management 2, no. 3 (2014): 115. 190Gelhaus 400–408; s. Joffe et al., “What Do Patients Value in Their Hospital Care? An Empirical Perspective on Autonomy in Bioethics,” Journal of Medical Ethics 29 (2003): 103. 191Ezequiel Gleichgerrcht and Jean Decety, “The Relationship Between Different Facets of Empathy, Pain Perception and Compassion Fatigue Among Physicians,” Frontiers in Behavioral Neuroscience 8 (2014): Article 243, 1; 7. 192Gleichgerrcht and Decety, Article 243, 2. 193Mannion, 115. 194Mannion, 116, Coulehan, “The Best Lack All Conviction,” 21. 195Howard Spiro, “Empathy: An Introduction,” in Empathy and the Practice of Medicine, ed. by Howard Spiro, Mary G. McCrea Curnen, Enid Peschel and Deborah St. James, New Haven: Yale University Press, 1993: 2–3. 196Jack Coulehan, “Compassionate Solidarity: Suffering, Poetry, and Medicine,” Perspectives on Biology and Medicine 52, no. 4 (2009): 600. 197Renee C. Fox, “Training for ‘Detached Concern’ in Medical Students,” In Harold I. Leif et al., The Psychological Basis of Medical Practice. New York: Harper and Row, 1963: 12–35. 198Coulehan, “Compassionate Solidarity,” 585. Clearly, in light of the values we have associated with covenant consent, this makes it difficult or even impossible for the detached care provider to engage in covenant consent. 199Coulehan, “Compassionate Solidarity,” 592; Jodi Halpern, “Empathy and Patient-Physician Conflicts,” Journal of General Internal Medicine 22, no. 5 (2007): 696. 5.5 Covenant Consent for VCA 187 providers in their training.200 As Coulehan states, “While the explicit curriculum focuses on empathy, communication, relief of suffering, trust [and] fidelity,…these values are largely pushed aside by… objectivity, detachment, self-interest and distrust.”201 It has been claimed that even the teaching of ethics in medical school can reinforce the attitude of detached concern.202 The structure developed for the delivery of healthcare also makes it more difficult to provide compassionate care. The fragmentation of health care into subspecialties means the patient deals with many more care providers than was the case previously, making it more difficult to establish a truly trusting relationship with any of them.203 Mannion points to staffing levels, incentives based on business models and the complex bureaucracy of modern health care as factors that work against compassionate care.204 Others see structural issues, such as payment systems, risk management and care which is directed by strict protocols and heavily reliant on technology.205 Despite the challenge some of the existing values and structures pose to the formation and maintenance of covenant consent, it remains possible under certain conditions. In particular, some aspects of the processes associated vascularized composite allotransplantation of faces and upper extremities lend themselves to the establishment and maintenance of covenant consent. VCA involves repeated contacts over a long period of time, which provides the opportunity for both care providers and graft recipients to form the kind of in-depth relationship or partnership which covenant consent requires. While, as Evans has pointed out, VCA patients interact with a large team of health care professionals,206 the leader(s) of the team may take a major role in the formation of the covenant consent and the team as a whole may be aware of and involved in the sense of covenant partnership. Further, as a special research enterprise, VCA appears to encourage what Evans calls an “esprit de corps.”207 If the graft recipient is able to perceive himself or herself as part of that team and experience the “esprit de corps,” it would certainly provide some of the affective motivation which is associated with covenant consent.

200David A. Landis. “Physician, Distinguish Thyself: Conﬂict and Covenant in a Physician’s Moral Development,” Perspectives in Biology and Medicine 36, no. 4 (1993): 629–630. 201Jack Coulehan, “Today’s Professionalism: Engaging the Mind, But Not the Heart,” Academic Medicine 80, no. 10 (2005): 894. 202Coulehan, “The Best Lack All Conviction,” 23. 203Shimon M. Glick, “The Empathic Physician,” Empathy and the Practice of Medicine, ed. by Howard Spiro et al., 87–88. 204Mannion, 116. 205Joffe et al., 106; Dennis Hollinger, “Curing, Caring and Beyond: Reﬂections for a Clinical Ethic,” Ethics and Medicine, 19, no. 1 (2003): 47; Jenny Firth-Cozens and Jocelyn Cornwell, The Point of Care: Enabling Compassionate Care in Acute Hospital Settings, London: The Kings Fund, 2009: 8. 206Evans, “Experiences of Healthcare Team Members,” Nursing Research, 372–374. 207Evans, “Experiences of Healthcare Team Members,” Nursing Research, 377–379. 188 5 Covenant Consent

5.5.2 Creating a Structure and Process for Covenant Consent

The conceptual understanding of covenant consent as a long-term, cooperative and purposeful relationship between two or more persons, founded on mutual respect and expressed through compassionate solidarity provides a foundation for changes in practices as well as in theory. Change does not come easily in health care. This is especially true when multidisciplinary teams are involved and the change involves signiﬁcant challenges to traditional or existing ways of thinking and acting.208 Therefore, in order for the concept of covenant consent to move from theory into practice, some structure must be developed and some process implemented. At this point, some key elements of those structures and processes may be named and described, while acknowledging that both structure and process will likely need to be reﬁned as experience in using covenant consent accumulates. First among the elements necessary for the implementation of covenant consent for vascularized composite allotransplantation of faces and upper extremities is the commitment of core team leaders to the concept.209 As long as VCA remains therapeutic research, this would naturally include the principle investigator. Yet, inasmuch as VCA involves a multidisciplinary team, it should also include leaders of the various disciplinary or professional groups, from surgical and medical staff through nursing, physical therapy, occupational therapy, social work, and psychology or psychiatry staff.210 As the leaders embrace the covenant consent concept with “energy, enthusiasm and hopefulness,” the likelihood that others will also embrace it increases substantially.211

208Carol VanDeusen Lukas et al., “Transformational Change in Health Care Systems: An Organizational Model,” Health Care Management Review 32, no. 4 (2007): 310–311; 318–319; Trish Reay et al., “Legitimizing New Practices in Primary Health Care,” Health Care Management Review 38, no. 1 (2013): 10. 209Lukas et al., 315; William K. Bleser et al., “Strategies for Achieving Whole-Practice Engagement and Buy-into the Patient-Centered Medical Home,” Annals of Family Medicine 12, no. 1 (2014): 40–41; Vanessa May and Hazel Burke, “Realities Toolkit #11: Practical Considerations for Leading and Working on a Mixed Methods Project,” Educational and Social Research Council Research Methods, Accessed December 17, 2014. http://eprints.ncrm.ac.uk/1320/1/11-toolkit-mixed- method-working.pdf; Alicia O’Cathain, Elizabeth Murphy and Jon Nicholl, “Multidisciplinary, Interdisciplinary or Dysfunctional? Team Working in Mixed-Methods Research,” Qualitative Health Research 18, no. 11 (2008): 1582–1583; Danielle D’Amour and Ivy Oandasan, “Interprofessionality as the Field of Interprofessional Practice and Interprofessional Education: An Emerging Concept,” Journal of Interprofessional Care Supplement 1 (2005): 13–14. 210Samia Chreim et al., “Change Agency in a Primary Health Care Context: The Case of Distributed Leadership,” Health Care Management Review 35, no. 2 (2010): 188; 198. Jowsey-Gregoire et al., suggest that the hand therapist in upper extremity transplantation may be the individual who forms the most intense and durable relationship with the patient, and thus may need support from other members of the team. 211Michael Fullan, Leading in a Culture of Change, Revised Edition, New York: John Wiley and Sons, 2007: 5–6. 5.5 Covenant Consent for VCA 189

A second element necessary for the successful implementation of covenant consent is training, both for key members of the care team and for potential VCA recipients. As Legare et al., found with the implementation of programs of shared decision-making, the most effective are those programs which combine training of health professionals with training and resources for patients.212 This training would include orientation to the concept, emphasizing both how and why covenant consent would be employed. There should be descriptions of the ways covenant consent would differ from standard consent protocols, and an explanation of how the elements of standard consent, including the signing of a consent form, would be incorporated within the covenant consent process. The importance of scheduling regular opportunities for conversations about the quality of the researcher-subject relationship should be emphasized. A third element necessary for the successful implementation of covenant consent is careful attention to vocabulary. Care must be taken to employ the term covenant consent and associated language, such as partnership, mutuality, cooperation and commitment. These terms may replace others which are commonly used, such as adherence, compliance, patient or subject, and physician orders. While covenant consent must be expressed in concrete acts of compassionate solidarity as well as in language, language is critical. The importance of a shared vocabulary which supports the perspective and goals of covenant consent cannot be over-emphasized.213 Of particular signiﬁcance is the term “partner,” rather than patient or subject. Much has been written about partnership with those who receive treatment in clinical care or as part of therapeutic research. Important themes in this discussion include empowerment, cooperation and responsibility.214 Ideally, the three themes are mutually reinforcing; patients who are empowered are in the long run more likely to cooperate and assume responsibility, while patients who are denied empowerment are more likely to be uncooperative or resist assuming responsibility. In research settings, recipients of care as partners can bring insights from their experiential knowledge,215 and can help shape research design and inﬂuence analysis. Some have seen the potential for recipients of care as research advisors.216

212Legare, et al., 14. 213Sarita Verma, Margo Paterson, and Jennifer Medves, “Core Competencies for Health Care Professionals: What Medicine, Nursing, Occupational Therapy and Physiotherapy Share,” Journal of Allied Health 35, no. 2 (2006): 110; 114; O’Cathain, Murphy and Nicholl, 1575. 214Mae H. Gallant, Marcia C. Beaulieu, and Franco A. Carnevale, “Partnership: an Analysis of the Concept within the Nurse-Client Relationship,” Journal of Advanced Nursing 40, no. 2 (2002): 152–153. 215J. Francisca Caron-Flinterman, Jacqueline E.W. Broerse and Joske F.G. Bunders, “The Experiential Knowledge of Patients: A New Resource for Biomedical Research?” Social Science and Medicine 60 (2005): 2575–2584. 216Tineke Abma, Christi J. Nierse, and Guy A.M. Widdershoven, “Patients as Partners in Responsive Research: Methodological Notions for Collaborations in Mixed Research Teams,” Qualitative Health Research 19, no. 3 (2009): 401–403. While some have seen beneﬁts, there is still overt and covert resistance. See Janneke E. Elberse, J. Francisca Caron-Flinterman and 190 5 Covenant Consent

The terms “patient” and “subject” present particular semantic problems when there is an expectation of substantial, long-term patient participation. “Patient,” as Deber et al., observe “carries connotations of passivity and deference to physicians.”“Subject” is associated with being acted upon and observed, but not otherwise involved in research. “Partner” implies one who shares in both the risk and the work.217 This is quite obviously the case in VCA, as it has been described in this and earlier chapters. The success of VCA is heavily dependent on the recipient behaving as a partner rather than as a mere subject or patient. Recipients of care in the more traditional clinical setting have shown a slight preference for being referred to as patients, when considering alternatives such as consumer, client, survivor or partner. Their primary objections were to the terms consumer and client, which recast the relationship into market language. This raised concern because of the implication that care providers, as “sellers” were acting out of self-interest rather than in the interest of the “consumer.”218 However, while there was a demonstrated preference for the term “patient” in traditional acute clinical encounters, research into chronic conditions shows that the partnership label has been embraced by many in that context. Further, the partnership of recipients of care in research has demonstrated benefits.219 In vascularized composite allotransplantation of faces and upper extremities as therapeutic research, the language of partnership is especially fitting. VCA recipients reap substantial benefits, but are not restored to full health even after years of physiotherapy. Due to the side effects of the immunosuppressants and the need to regularly monitor for signs of rejection, VCA recipients are in several ways similar to individuals with chronic illness. As research has shown, for patients with chronic illness approaches to patient care which emphasize patient participation and a sense of partnership tend to lead to greater patient satisfaction, increased adherence and better outcomes.220 The language of partnership is also appropriate for VCA for several other reasons. First, it honors the risks and burdens the graft recipients take on not only for

(Footnote 216 continued) Jaqueline E.W. Broerse, “Patient-expert Partnerships in Research: How to Stimulate Inclusion of Patient Perspectives,” Health Expectations 14 (2010): 225–237. 217Raisa B. Deber et al., “Patient, Consumer, Client or Customer: What Do People Want to Be Called?” Health Expectations 8 (2005): 346–347. 218Deber et al., 350; C.W. Ritchie, D. Hayes and D.J. Ames, “Patient or Client? The Opinions of People Attending a Psychiatric Clinic,” Psychiatric Bulletin 24 (2000): 447–450. 219Sarah Hewlett et al., “Patients and Professionals as Research Partners: Challenges, Practicalities, and Beneﬁts,” Arthritis and Rheumatism 55, no. 4 (2006): 679; Abma, Nierse and Widdershoven, 403. 220Philippe Karazivan et al., “The Patient-as-Partner Approach in Health Care: A Conceptual Framework for a Necessary Transition,” Academic Medicine, 2015 epub ahead of print. Accessed February 3, 2015. doi: 10.1097/ACM.0000000000000603; Traber Davis Giardina, “Patient Access to Medical Records and Healthcare Outcomes: A Systematic Review,” Journal of the American Medical Informatics Association 21 (2014): 739–740; Thomas Bodenheimer et al., “Patient Self-management of Chronic Disease in Primary Care,” JAMA 288, no. 19 (2002): 247–2474. 5.5 Covenant Consent for VCA 191 their own potential beneﬁt but to assist the medical team in its efforts to create a new therapeutic option for persons similarly situated. Second, it gives recognition to the fact that the success of the treatment depends as much upon the active participation of the recipient in physiotherapy, maintenance of immunosuppression and self-monitoring for signs of rejection as it does on the technical skills of the treatment team. Third, it invites frequent and open communication between the recipient and the medical team, including the possibility of (re)negotiation. Such communication is likely to increase the degree to which recipients will be willing to assume a full share of responsibility for the course of treatment. Fourth, it can ameliorate some of the sense of vulnerability recipients experience221 and demonstrate respect for the dignity of patients, since it recognizes them as persons able to contribute in important ways.222 To insure that the covenant consent concept becomes operational in VCA involving faces and upper extremities, the commitment to the concept and its associated vocabulary ought to be thoroughly integrated not only into the collegial interactions of the team, but also and especially into interactions with recipients at all points in the process. The concept and its vocabulary should be present in graft recipient recruitment and screening materials, as well as in the materials and conversations directly associated with the consent forms. Use of the concept and vocabulary should also be maintained after surgery when the full weight of partnership is experienced in the burdens and demands placed upon the recipient. Embracing covenant consent is more than embracing a vocabulary, of course. Simply calling a graft recipient a “partner” does not make him or her one. Cooperation, respect and compassionate solidarity must be expressed through concrete practices as well. Some important practices for actualizing the partnership include providing regular opportunities for the recipient to express feelings or provide feedback about the relationship as well as about his or her physical or mental state. Periodically the recipients should also be asked for feedback on what aspects of the process have been especially challenging for them, how so, and what they think might be done differently. By seeking recipient advice, one demonstrates respect and may gather valuable information for use in the selection, consent process and treatment of later graft recipients. Because VCA involves patient interaction with a large number of health care professionals in a variety of specialized roles, it is advisable to create a small team of persons with whom the graft recipient will meet more regularly as primary covenant partners. These meetings may coincide with other elements of treatment,

221Rumsey, 22–23; Hartman, 75; Perpich, 173–176; Bradbury, 194. 222Coulehan, “They Wouldn’t Pay Attention,” 341–342; Barilan, “Respect for Personal Autonomy,” 502. Ann Gallagher argues persuasively that dignity need not apply only to those possessing decisional capacity and thus able to choose or act autonomously, but that for those who do possess decisional capacity, respect for their dignity does include a willingness to hold them accountable for their choices and actions. See “Dignity and Respect for Dignity—Two Key Health Professional Values: Implications for Nursing Practice,” Nursing Ethics 11, no. 6 (2004): 591–593. 192 5 Covenant Consent but should also focus explicitly on the partnership, the exchange of feedback and emotional support. This team should include persons who are recognized as leaders within the larger treatment team. Another important practice would be the provision of contact information, so that the recipient can get in touch directly with core team leaders without going through intermediaries. Access sends an important message about how seriously the recipient is taken as a partner. A third practice for promoting partnership is some form of increased access of patients to records or physician notes. In one study, despite physician’s concerns about “disruption of workflow” and frequent contacts from anxious patients, the implementation of programs giving patients access to physicians’ notes did not lead to such problems. Instead, in many instances, it led to little or no negative impact on physician’s schedules and “an increased sense of control, greater understanding of their medical issues, improved recall of their plans for care, and better preparation for future visits” on the part of patients.223 A fourth valuable practice for promoting partnership is the creation of a ritual around the signing of the consent form. Core team leaders should be present at this ritual and participate in it. Just as the potential recipient commits himself or herself to the course of treatment, so the core team members may commit themselves not only to providing quality care but also to engaging with the recipient as a true partner going forward. The suggestions offered above for creating a structure and process for covenant consent are deliberately brief and general. They are presented in this way in recognition of some of the factors that appear to influence the acceptance of innovation and change in modern health care systems. First, simple innovations diffuse more rapidly than complicated ones.224 Covenant consent, while it challenges prevailing notions of what constitutes adequate consent, is not in itself a complicated idea nor does it necessarily involve multiple complex changes to existing practices. Second, it is recognized that innovations in health care typically undergo change as they spread.225 As teams involved in VCA adopt covenant consent, the general description of the suggested structure and processes invites them to adapt the concept to their context and to integrate it with their existing practices. Indeed, it is anticipated that individuals involved in VCA programs may find many elements or emphases of covenant consent consistent with existing ideas and practices.226 The substantial success thus far in VCA involving faces and upper extremities is likely due in part to the members of the clinical team intuitively embracing the values implicit in covenant consent. Still, the formal adoption of

223Tom Delbanco et al., “Inviting Patients to Read Their Doctors’ Notes: A Quasi-experimental Study and a Look Ahead,” Annals of Internal Medicine 157, no. 7 (2012): 467–469. 224Donald M. Berwick, “Disseminating Innovations in Health Care,” JAMA 289, no. 15 (2003): 1971. 225Berwick, 1971. 226Christina L. Kaufman, Executive Director of the Christine M. Kleinert Institute for Hand and Microsurgery, suggests this is the case. E-mail message to author, September 4, 2012. 5.5 Covenant Consent for VCA 193 covenant consent holds forth prospects for real improvements. The formal adoption of covenant consent will reinforce certain existing practices by providing a theoretical foundation for them, while making associated attitudes and practices more consistent than they might otherwise be. By making explicit the commitment to consent in VCA as a long-term cooperative partnership, the adoption of covenant consent will also provide a standard against which current practices may be evaluated and in light of which they may be altered. Chapter 6 Conclusion

Abstract This chapter is a summary and review of the argument made throughout the book. The argument is that the particular risks and burdens associated with vascularized composite allotransplantation (VCA) of facial tissue and upper extremities necessitates modifications to the standard understanding and practice of informed consent, and that those modifications can be helpfully guided by the concept of covenant. VCA arose in part because major tissue deficits of the face or upper extremities deprive persons of at least some of their ability to control the world, to savor the world, and to reveal themselves to others. The possibility of alleviating these forms of suffering provides a powerful motivation for developing treatment. Yet, in order to be successful, such treatment requires more than technical intervention by healthcare specialists. It also requires the commitment and efforts of the recipients and their circle of support. In order to facilitate this commitment and sustained effort, it is useful to focus on the formation and maintenance of a robust therapeutic relationship. The process of forming and maintaining this kind of relationship is what the book describes as covenant consent.

6.1 Summary and Restatement

Vascularized composite allotransplantation of faces and upper extremities is intended to offer a signiﬁcant improvement in quality of life for a select group of patients. In order to do so, it requires tremendous skill and dedication from a large and diverse group of health care professionals.1 Successful VCA of faces and upper extremities also requires courageous, dedicated and cooperative graft recipients. Only when dedicated, highly skilled medical teams enter a therapeutic partnership with courageous, dedicated and cooperative recipients can the full potential of VCA be realized.

1Linda A. Evans, The Experience of Health Care Team Members Involved in Facial Transplant Surgery and Patient Care: A Dissertation, University of Massachusetts Medical School Graduate School of Nursing 2012: 13; 17–18.

© Springer International Publishing AG 2017 195 J.L. Benedict, A Revised Consent Model for the Transplantation of Face and Upper Limbs: Covenant Consent, International Library of Ethics, Law, and the New Medicine 73, DOI 10.1007/978-3-319-56400-5_6 196 6 Conclusion

A series of medical developments in the 20th century laid the foundation for VCA. Over a period of several decades, beginning a little more than a century ago, the necessary surgical skills and understanding of physiological processes were developed.2 During the middle decades of the twentieth century, the first successful programs for transplantation of organs began to appear and major advances were made in the replantation of upper extremities and facial tissue.3 This set the stage for facial and upper extremity VCA, and prompted new non-human research. However, it was not until the development of newer, more effective and less toxic immunosuppression that clinical applications of VCA to humans became feasible.4 From the start, serious ethical questions were raised about VCA. The severe facial disfigurement and the absence of portions of the upper extremities that make one a candidate for VCA are conditions which are not in themselves life-threatening.5 Yet, in order to avoid rejection and the loss of the graft, immunosuppressant use is required. Even the more effective and less toxic immunosuppression protocols that have made VCA feasible carry with them substantial risks and burdens. These include significant risk of metabolic illnesses, greater susceptibility to a number of infections, and an increased risk of malignancies.6 It is probable that at least some of those who receive VCA grafts will have their lives shortened as a result, and many will have to contend with new onset

2Anastomosis of blood vessels and nerves, microsurgical techniques, and refinements in the understanding of the immune response were perhaps most critical. See D. Schultheiss and J. Denil, “History of the Microscope and Development of Microsurgery: A Revolution for Reproductive Tract Surgery,” Andrologia 34 (2002): 238; Richard J. Howard, Danielle L. Cornell, and Larry Cochran, “History of Deceased Organ Donation, Transplantation, and Organ Procurement Organizations,” Progress in Transplantation 22, no. 1 (2012): 7; Peter K. Linden, “History Of Solid Organ Transplantation And Organ Donation,” Critical Care Clinics 25, no. 1 (2009): 165– 184; Thomas Schlich, “The Origins of Organ Transplantation,” The Lancet 378, no. 9800 (2011): 1372–1373; Thomas E. Starzl and Clyde Barker, “The Origin of Clinical Organ Transplantation Revisited,” JAMA 301, no. 19 (2009): 2041. 3Mohamed H. Sayegh and Charles B. Carpenter, “Transplantation 50 Years Later—Progress, Challenges and Promises,” New England Journal of Medicine 351, no. 26 (2004): 2761; Alexandros Beris, et al., “Digit and Hand Replantation,” Archives of Orthopaedic and Trauma Surgery, 130, no. 9 (2010): 1141; Roni Prucz and Jeffrey Friedrich, “Upper Extremity Replantation: Current Concepts,” Plastic and Reconstructive Surgery Journal 133, no. 2 (2014): 333. 4Brendan J. MacKay, Eliot Nacke and Martin Posner, “Hand Transplantation: A Review,” Bulletin of the Hospital for Joint Diseases 72, no. 1 (2014): 76–77; Scott M. Tintle, Benjamin K. Potter, River M. Elliot, and L. Scott Levin, “Hand Transplantation,” JBJS Reviews 2, no. 1 (2014): 2; Abtin Foroohar, et al., “The History and Evolution of Hand Transplantation,” Hand Clinics 27, no. 4 (2011): 406. 5Francisco Ortega, “Organ Transplantation in the 21st Century,” in Stem Cell Transplantation. New York: Springer Science + Business Media, 2012: 17–24; Sayegh and Carpenter, 2762–2765. 6Palmina Petruzzo, et al., “First Human Face Transplantation: Years Outcomes,” Transplantation 93, no. 2 (2012): 236–240; Sayegh and Carpenter, 2762; Ortega, 22–24; Gaby Doumit, et al., “Pediatric Vascularized Composite Allotransplantation,” Annals of Plastic Surgery, epub ahead of print, July 2014; G. J. Agich and Maria Z. Siemionow, “Until They Have Faces: The Ethics of Facial Allograft Transplantation,” Journal of Medical Ethics 31, no. 12 (2005): 707–709. 6.1 Summary and Restatement 197 diabetes after transplant, nephrotoxicity, hypertension, neurotoxicity and other conditions they might otherwise have avoided.7 Much of the ethical concern has been centered around these burdens and risks, and whether it is appropriate to expose persons to them in the course of treatment that is not required to preserve life. While it is true that the conditions that make one a candidate for upper extremity or facial VCA are not life-threatening, they are undeniably a source of profound suffering for those who must contend with such major tissue deficits. They may not be life-abbreviating, but they are life-limiting in that they severely limit the ability of the person to live fully. The degree of suffering associated with them explains why so many express a willingness to take on the risks and to make the sacrifices necessary to receive a graft.8 While the subjective experience of suffering in candidates for facial or upper extremity VCA does not seem to be fully correlated with the objective degree of defect,9 the nature of this suffering strikes at several elements of what some might consider necessary to make life worth living. In addition to the suffering that comes from social isolation, lost opportunities and dependency, there is the suffering which results from a sense of alienation from one’s own body. The contours of that suffering resemble those William F. May has ascribed to the phenomenological experience of those who are contemplating the loss of their body/flesh as death approaches.10 Major tissue deficits of the face or upper extremities deprive persons of at least some of their ability to control the world, to savor the world, and to reveal themselves to others. The loss of significant ability to control the physical environment is obvious when portions of one’s upper extremities are absent. Prostheses may restore some of the ability to manipulate objects in one’s surroundings, but VCA promises a much higher level of functioning.11 Facial defects impair one’s ability to control food, drink or even saliva in one’s mouth, and may prevent the normal intake of air, requiring tracheotomy. Facial VCA has been able to restore these very basic functions.

7Bohdan Pomahac, et al., “Three Patients with Full Facial Transplantation,” The New England Journal of Medicine 366, no. 8 (February 23, 2012): 719–721; Harriet O'Neill and Daryl Godden, “Ethical Issues of Facial Transplantation,” British Journal of Oral and Maxillofacial Surgery 47 (2009): 444; Tintle, et al., “Hand Transplantation,” 4. 8Jeff Chang and David W. Mathes, “Ethical, Financial and Policy Considerations in Hand Transplantation,” Hand Clinics 27 (2011): 557. 9Nichola Rumsey, “Psychological Aspects of Face Transplantation: Read the Small Print Carefully,” The American Journal of Bioethics 4, no. 3 (2004): 22–23; Eileen Bradbury, “Meeting the Psychological Needs of Patients with Facial Disﬁgurement,” British Journal of Oral and Maxillofacial Surgery 50 (2012): 194. 10William F. May, “The Sacral Power of Death in Contemporary Experience,” in On Moral Medicine, 3rd Edition, ed. by M. Therese Lysaught, Joseph Kotva, Stephen E. Lammers and Allen Verhey, Grand Rapids: William B. Eerdmans Publishing Company, 2012: 1036–1037. 11Scott M. Tintle, et al., “Hand Transplantation,” Journal of Bone and Joint Surgery 2, no. 1 (2014): 6. 198 6 Conclusion

Major tissue deficits of the face or upper extremities also compromise the ability of persons to savor the world around them. When facial defects prevent a person from taking nourishment by mouth, that person is deprived of the experience of flavors. When there is major damage to the nose and nasal cavity, one loses the capacity to perceive the aroma of food, the perfume of flowers and other scents. Major facial defects also deprive persons of the simple but profound pleasure associated with being able to give or receive a kiss. With the loss of upper extremities, one is deprived of a primary means through which we typically experience tactile sensation. This desire for sensation plays a large role in the high level of dissatisfaction with the current generation of prostheses and is a significant element of motivation for those who are interested in VCA.12 Major tissue deficits of the face or upper extremities also interfere with the ability of persons to reveal themselves to others. With major facial defects, the ability to speak clearly (or at all) can be lost. Even when speech is retained, the ability to use facial expressions to convey emphasis and other subtle meanings is often absent. Without hands or arms, the ability to make gestures, to point or to express one’s self through sign language is lost. So, too, is the ability to embrace another or to shake hands in greeting naturally. Compounding the loss of the ability to reveal one’s self in the ways that one would like to is the sense that one’s defects are on display and can become the object of unwanted scrutiny. Others may have trouble seeing past one’s defects to the person and what he or she is trying to reveal or express. Even for the individual bearing the defect, the nature of one’s attention to the body is changed. Whereas in health one normally acts without thinking about one’s body, one’s broken body requires attention. One is given frequent reminders of the limitations one has. The body may even become strange to the person, self and yet not self, the damaged part “an intruder,” as philosopher Jean-Luc Nancy has put it.13 Given the extent of suffering that may accompany major tissue deficits of the face or upper extremities, the promise of relief through VCA is obviously welcome. As noted in earlier chapters, outcomes thus far have been good overall. Numbers are still limited to around a hundred upper extremity recipients and around thirty facial tissue recipients, and the long-term outlook is still unclear, as only a few surviving grafts are more than a decade old. However, while VCA does not produce full restoration, dramatic improvements in both function and cosmesis are typical, and levels of recipient satisfaction are high.14 The ability of vascularized composite

12Tintle, et al., 1; M. M. Klapheke, et al., “Psychiatric assessment of candidates for hand transplantation,” Microsurgery 20, no. 8 (2000): 455–456. 13Jean-Luc Nancy, “The Intruder,” in Corpus, Richard A. Rand, trans., New York: Fordham University Press, 2008: 161–180. 14Jaime T. Shores, Gerald Brandacher and W. P. Andrew Lee, “Worldwide Update of Hand Transplantation,” Plastic and Reconstructive Surgery, epub ahead of print, November 2014; Ralf Smeets, et al., “Face Transplantation: On the Verge of Becoming Clinical Routine?” Biomed Research International (2014). Accessed January 9, 2015 at http://www.hindawi.com/journals/ bmri/2014/907272/; Brendan J. MacKay, Elliot Nacke and Martin Posner, “Hand Transplantation: 6.1 Summary and Restatement 199 allotransplantation of upper extremities and facial tissue to significantly improve form and function following major tissue loss is now well established. Nonetheless, major concerns remain about the practice of facial and upper extremity VCA. These concerns are both practical and ethical. Practical concerns include the development of systems of procurement and allocation, issues surrounding rejection and the undesirable consequences of the use of immunosuppressants, a perceived need for better methods of screening potential recipients, and questions about the coverage of costs. Ethical concerns are related to the practical concerns. Concerns about allocation and costs are related to concerns about justice. Concerns about rejection, the potential for graft loss, and undesirable consequences of immune-suppressants raise questions about the risk/burden versus benefit balance, and thus the principles of beneficence and non-maleficence. Some concern about respect for autonomy has been raised by those who would argue too little is known about long-term outcomes for recipients to give truly informed consent. The ethical principle of respect for dignity is naturally implicated in a treatment that involves visible anatomical structures, and those involving the face in particular. Meanwhile, the ethical principle which calls for extra protections of those who may be regarded as especially vulnerable may be relevant to facial and upper extremity VCA inasmuch as the potential candidates for such treatment tend to experience some degree of disability and social marginalization which may predispose them to take greater risks and to overestimate potential benefits. At the same time, VCA candidates could also be considered especially vulnerable because the full risks of participation are not known but are expected to be substantial. This book has attempted to identify and address an additional ethical concern, namely the ethical adequacy of the standard approach to informed consent in the context of VCA. It has been argued that the standard approach to consent fails to take into consideration forms of treatment in which the duration of treatment is lengthy rather than brief, in which the patient is expected to play a highly active rather than primarily passive role, and in which quite vulnerable patients are asked to take on significant burdens and risks while long-term outcomes are still largely unknown. Under such conditions, simple antecedent consent ought to be regarded as ethically inadequate. Simple antecedent consent is appropriate for situations in which consent essentially represents permission giving, authorization, waiver or choice. However, when consent represents an agreement to enter into and sustain a long-term therapeutic alliance, the theoretical foundations and the normal processes associated with simple antecedent consent are no longer fitting. In order to account for the factors which make vascularized composite allotransplantation of faces and upper extremities atypical, some more appropriate

(Footnote 14 continued) A Review,” Bulletin of the Hospital for Joint Diseases 72, no. 1 (2014): 83–84; S, Khalifian, et al., “Facial Transplantation: The First 9 Years,” The Lancet 384 (2014) 2158-2160; S. Fischer, et al., “Functional Outcomes of Face Transplantation,” American Journal of Transplantation 15 (2015): 220–223. 200 6 Conclusion approach to consent must be imagined. What has been proposed in this work is a re-imagining of consent which employs the concept of covenant as a central resource. While the essential elements of standard consent have been maintained in this new approach, important emphases associated with the covenant concept have been added. Above all, consent is no longer regarded as a singular event or a simple transaction. Instead, it is understood as an ongoing relationship which may be formally initiated by an event but which must be supported and sustained over time by the covenant participants. Covenant, as was shown, originated as a concept in the ancient near east. While the earliest forms of covenant were political, and often involved a more powerful and a less powerful partner, a covenant was “an alternative to complete subjuga- tion.”15 As such, it recognized the dignity of the less powerful partner, assigning that partner certain rights and assigning the more powerful partner certain responsibilities. Later, particularly within the Hebrew tradition, the concept of covenant came to be applied as well to relationships of parties more equal in status, such as friendships. Ancient covenants were relationships intended to endure, and required both the performance of specified duties and behavior which manifested respect for the covenant partner. Words or actions which were disrespectful or brought dishonor upon one’s partner were violations of covenant, even if the specified duties were adequately carried out.16 Covenants were also flexible and open to re-negotiation, as long as the fundamental nature of the relationship was maintained.17 The covenant concept has been appropriated for use in both Jewish and Christian ethics more generally, and in bioethics specifically. In ethics, the covenant concept is often contrasted with the idea of contract. Whereas contracts are concerned primarily with the exchange of goods or services, covenants are concerned equally with the performance of specified duties and with the quality and persistence of the relationship itself. Covenants exist to create and sustain relationships. An exchange of goods or services may take place within those relationships, but the relationships have a value and meaning that goes beyond any such exchange.18 The embrace of the covenant concept in bioethics or health care ethics began with Paul Ramsey19 and has been most substantially developed by William F.

15Gordon M. Freeman, “The Process of Covenant,” Publius 10, no. 4 (1980): 74. 16Saul M. Olyan, “Honor, Shame and Covenant Relations in Ancient Israel and Its Environment,” JBL 115 (1996): 204–208. 17Freeman, 77–78; Olyan, 217; Jacqueline Lapsley, “Friends with God? Moses and the Possibility of Covenantal Friendship,” Interpretation 58, no. 2 (April 2004): 121. 18H. Richard Niebuhr, “The Idea of Covenant and American Democracy,” Church History 23, no. 2 (1954): 129–134; Louis E. Newman, “Covenant and Contract: A Framework for the Analysis of Jewish Ethics,” Journal of Law and Religion 9 (1991): 89–92; 102–112; Joseph L. Allen, Love and Conﬂict: A Covenantal Model of Christian Ethics, Nashville: Abingdon Press, 1984: 16–17; 32–39. 19Paul Ramsey, Patient as Person, Second Edition, New Haven: Yale University Press, 2002: xlv. 6.1 Summary and Restatement 201

May,20 but covenant has also appealed to several others.21 Much of the appeal has had to do with the contrast between covenant and contract, and the desire to avoid ways of thinking about health care as a commodity. Understanding the provision and utilization of health care through a covenantal lens is seen to support the development of human partnerships in the pursuit of health-related goals. It permits the creation, structuring and maintenance of relationships which are capable of adaptation as circumstances, including the needs and resources of the partners, change. A covenant basis for health care is also believed to be more appropriate, given the essentially social nature of persons and the particular needs of especially vulnerable persons.22 It is possible, of course, to argue that covenant consent is needed for VCA while admitting standard antecedent consent is sufficient for most routine treatments and most research. Covenant consent would be impractical and unnecessary in many situations. The basic elements of standard antecedent consent, including the provision of information, concern for patient or subject competence and freedom from coercion, and the requirement of some explicit act signifying permission or authorization is necessary always, and often sufficient. Yet it is possible to imagine conditions in which these emphases of standard antecedent consent, while still necessary, would not be sufficient. The argument here is that this is the case when one considers VCA of faces and upper extremities. Because more is required of and more is risked by those who agree to receive facial or upper extremity grafts, more must be required of the theory and practices of consent. Covenant consent does more than standard antecedent consent. Covenant consent provides a basis for a partnership between the recipient of the VCA graft and the care team. Partnership, as noted in earlier chapters, conveys a number of benefits, including improvements in patient satisfaction, health behaviors and

20William F. May, “Code, Covenant, Contract, or Philanthropy,” Hastings Center Report 5, no. 6 (1975): 29–38; Testing the Medical Covenant: Active Euthanasia and Health Care Reform, Grand Rapids, Mich.: William B. Eerdmans Pub. Co., 1996; The Physician’s Covenant, Second Edition, Louisville: Westminster John Knox Press, 2000: esp. 112–234. 21Edmund D. Pelligrino, “The Moral Foundations of the Patient-Physician Relationship: The Essence of Medical Ethics,” in Military Medical Ethics, v. 1, ed. by Thomas E. Beam and Linette R. Sparacino, Bethesda: Uniformed Services University of the Health Sciences, 2003: 3–21; Sally Gadow, “Covenant without Cure: Letting Go and Holding On in Chronic Illness.” In The Ethics of Care and the Ethics of Cure: Synthesis in Chronicity, New York, N.Y: National League for Nursing, 1988: 5–14; Neil G. Messer, The Therapeutic Covenant, Grove Ethical Studies 103, Cambridge: Grove Books Limited, 1996. 22G. Kevin Donovan, “The Physician-Patient Relationship,” in The Health Care Professional as Friend and Healer: Building on the Work of Edmund D. Pelligrino, ed. by David C. Thomasma and Judith Lee Kissell, Washington, D. C.: Georgetown University Press, 2000: 18; Ana Maria Pineda, “Covenanting with the Powerless: Strangers, Widows and Orphans,” Fordham Law Review 66 (1998): 1179. 202 6 Conclusion communication with health care providers.23 Partnership also honors the risks and burdens borne by recipients, and recognizes the beneﬁts which may accrue to others because these persons were willing to become involved in the research at the early stage. Covenant consent supports the lengthy process of rehabilitation and lifelong self-monitoring for signs of rejection by understanding consent as the entry into a durable, lasting relationship which must be sustained and periodically renewed. It permits and even encourages the partners to engage in regular, open dialogue and occasional renegotiation. It enables the partners to continue to teach one another and to adapt to change. By emphasizing the relationship itself, as well as decisions about the course of treatment, covenant consent acknowledges that consent—especially consent which must be maintained over time—is the product of more than a logical analysis of information. Consent under such conditions is more than a rational selection from among reasonable options; it is a commitment which must be carried into the future. One’s approach to such consent should not only facilitate reaching a decision but also prepare one to see the decision through. This implies that consent should be an affective commitment as well as a rational choice. Furthermore, inasmuch as humans are inherently social, we tend to do best at keeping commitments when we share these commitments with others. Thus, when in covenant consent the commitment of the potential recipient of VCA is met and matched by a commitment by the members of the care team to be partners to the recipient, the possibility of success is enhanced. Whereas covenant consent might seem unrealistic under the conditions typical of most modern health care and health research, the special conditions associated with VCA are more conducive to the formation and maintenance of covenantal partnerships. Contemporary health care is notoriously fragmented into sub-specialties, many patients have accepted a more passive role, and many professional care givers lack training for engaging in genuine therapeutic partnerships with their patients.24 In VCA, however, the necessity of careful screening and repeated contacts over a long period of time create a context in which covenant consent is possible. Patient selection already focuses on choosing candidates who demonstrate social and

23Traber Davis Giardina, et al., “Patient Access to Medical Records and Healthcare Outcomes: A Systematic Review,” Journal of the American Medical Informatics Association, 21 (2014): 737; Thomas Bodenheimer, et al., “Patient Self-management of Chronic Disease in Primary Care,” JAMA 288, no. 19 (2002): 2470–2474; Philippe Karazivan, et al., “The Patient-as-Partner Approach in Health Care: A Conceptual Framework for a Necessary Transition,” Academic Medicine 2015, epub ahead of print. doi:10.1097/ACM.0000000000000603. 24Bodenheimer, et al., 2474; Legare, et al., 14; Michael J. Barry and Susan Edgman-Levitan, “Shared Decision Making—The Pinnacle of Patient-Centered Care,” The New England Journal of Medicine 366, no. 9 (2012): 781; Shimon M. Glick, “The Empathic Physician,” Empathy and the Practice of Medicine, ed. by Howard Spiro, et al., New Haven: Yale University Press, 1996: 87– 88; Russell Mannion, “Enabling Compassionate Healthcare: Perils, Prospects and Perspectives,” International Journal of Health Policy and Management 2:3 (2014): 116. 6.1 Summary and Restatement 203 emotional stability,25 and these are certainly characteristics which contribute to the ability to form and sustain the kind of therapeutic partnership imagined in covenant consent. Screening procedures might be developed to focus even more directly on the capacity of the potential recipient to participate in covenant consent. While VCA does require patient interaction with care providers from several subspecialties, there are repeated encounters throughout the process with some, including the core team leaders. Additionally, it would be possible to designate a small group of three to five persons from the care team as key covenant partners and schedule regular meetings between them and the recipient. The meetings could be more frequent at the outset, and less frequent as the recipient returns to a more independent status. In order for covenant consent to become operational in VCA, both health care professionals and potential recipients must be given a basic introduction to the concept and some training in how this will affect the treatment protocol. Leaders of the care team must commit to the concept and the kinds of interaction with recipients that are associated with the concept. The vocabulary of covenant consent, particularly the terms “partnership,”“mutuality,”“cooperation,”“compassionate solidarity” and “commitment,” should be embraced and replace terms like “adherence,”“compliance,”“physician orders”“professional distance” and “emotional detachment.” Graft recipients should also be given more direct access to care providers and the notes and records concerning their cases. Finally, the signing of the consent form required by law should be incorporated into a “ritual” that promotes an understanding of the act as a commitment to a long-term, cooperative and purposeful relationship between two or more persons, founded on mutual respect and expressed through compassionate solidarity. Covenant consent is needed for VCA because it more adequately describes what is being asked of recipients and what is necessary for the treatment to succeed. It is also needed because it appropriately honors the recipients by understanding them as active partners rather than as passive patients, and as people assuming major burdens and risks while contributing meaningfully to the development of the field. The employment of covenant consent significantly strengthens the ethical justification for vascularized composite allotransplantation of faces and upper extremities by acknowledging what is actually required of patients and by creating a structure through which they are supported in carrying out their commitment through the long, arduous period of rehabilitation and beyond.

25Jaime T. Shores, “Recipient Screening and Selection: Who is the Right Candidate for Hand Transplantation,” Hand Clinics 27 (2011): 539–543; Chad Gordon, et al., “The Cleveland Clinic FACES Score: A Preliminary Assessment Tool for Identifying the Optimal Face Transplant Candidate,” The Journal of Craniofacial Surgery 20, no. 6 (2009): 1969–1970. Erratum to: A Revised Consent Model for the Transplantation of Face and Upper Limbs: Covenant Consent

Erratum to: J.L. Benedict, A Revised Consent Model for the Transplantation of Face and Upper Limbs: Covenant Consent, International Library of Ethics, Law, and the New Medicine, DOI 10.1007/978-3-319-56400-5

In the original version of the book, the incorrect volume number “Vol 126” has to be changed to “Vol 73”. The erratum book has been updated with the change.

The updated original online version for this book can be found at http://dx.doi.org/10.1007/978-3-319-56400-5

© Springer International Publishing AG 2017 E1 J.L. Benedict, A Revised Consent Model for the Transplantation of Face and Upper Limbs: Covenant Consent, International Library of Ethics, Law, and the New Medicine 73, DOI 10.1007/978-3-319-56400-5_7 Bibliography

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A CIOMS International Ethical Guidelines for Adherence, 24, 25, 35, 46, 51, 57, 100, 111, Biomedical Research Involving Human 131, 136, 150, 159, 177, 189, 190, 203 Subjects, 64, 65 Affective commitment, 179, 202 1847 Code of Ethics, 82 Akkadians, 115, 116 Commitment of core team leaders, 188 Allocation, 14, 25, 26, 28, 47, 48, 51, 134, 136, Compassionate solidarity, 149, 152, 183, 185, 150, 199 188, 189, 191, 203 Amputation, 15, 17, 24, 36, 41, 46 Compliance, 33, 34, 45, 82, 111, 113, 152, Anastomosis, 9, 13–15, 25, 35 163, 169, 177–179, 189, 203 Aristotle, 75, 185 Composite Tissue Allotransplantation (CTA), Attitudes toward VCA and SOT, 31, 32 16, 47 Autonomy, 50, 57, 58, 62, 64, 75–77, 79–83, Consent 91–94, 97–99, 106–109, 113, 127, 131, autonomous authorization, 5, 94, 168 134, 139, 140, 157, 159, 160 covenant consent, 1, 6, 7, 9, 67, 70, 72, 149, 152, 153, 174–176, 178, 179, B 181–185, 187–189, 192, 193, 201–203 Basic Christian Ethics, 129, 135, 136 fair transaction, 5, 94, 97, 158, 168 Beauchamp, Tom, 80, 93, 157 informed consent, 5, 56, 58, 59, 73, 74, 78, Beecher, Henry, 73, 90 82–85, 87, 88, 90–92, 96–99, 101–106, Belmont Report, 64, 65, 73, 89, 91, 156, 157 113, 115, 152–158, 160, 168, 175, 183, Beneﬁcence, 50, 52–55, 65, 71, 77, 79, 81, 199 150, 199 permission giving, 5, 168, 169, 199 Berith, 116, 117, 119, 140, 170, 172 shared decision making, 99–101, 168 Bilateral transplant, 49 standard antecedent, 161, 162, 174–176, Bone marrow transplantation, 39, 40 178, 182, 183, 201 Burdens and Risks, 1, 5, 9, 36, 41–43, 53, 148, waiver of responsibility, 5 162, 165, 178, 181, 197, 199, 203 Consent form, 111, 159, 183, 189, 191, 192, Butler, Peter, 21 203 Contractualism, 146, 147 C Cosmas, St., 11 Calcineurin inhibitor, 37, 38 Covenant and Care Provider—Patient Carrel, Alexis, 11, 12, 14 Relationships, 140 Changing faces, 42 Covenant and contract, 127, 201 Chauvet Workgroup, 45 Covenant in Christian ethics, 116 Chi’ao, Pien, 11 Covenant in health care ethics, 131, 173, 174 Childress, James, 80, 89, 93, 157 Covenant in Jewish ethics, 116, 127 Chimerism, 39, 40 Cyclosporine, 15, 16, 18 Cicero, 61

© Springer International Publishing AG 2017 253 J.L. Benedict, A Revised Consent Model for the Transplantation of Face and Upper Limbs: Covenant Consent, International Library of Ethics, Law, and the New Medicine 73, DOI 10.1007/978-3-319-56400-5 254 Index

D Islam, 120 Damian, St., 11 Israel, 115, 117–119, 121, 122, 125, 141, 143 Declaration of Geneva, 55 Declaration of Helsinki, 65, 66, 73, 89, 156 J Degree of defect, 42, 197 Jaboulay, Mathieu, 11 Detached concern, 186, 187 Justice, 50, 51, 53, 61, 65, 71, 95, 99, 108, 118, Diabetes, 17, 25, 32, 38, 48, 54, 162, 197 136, 150, 199 Dignity, 48, 50, 59–64, 70, 71, 82, 90, 98, 105, 108, 137, 139, 149, 150, 152, 164, 171, K 174, 179–181, 191, 199, 200 Kant, Immanuel, 57, 73, 76, 79 Disparities in power, 97, 142, 148 Kidney dialysis, 14 Donor consent, 25, 57 Kidney transplantation, 26 Dubernard, Jean-Michael, 18, 21, 149 Kocher, Theodor, 11 Durability and ﬂexibility, 124 Kukla, Rebecca, 73, 103, 106, 156, 158, 159 Duvauchelle, Bernard, 21 L E Liberty, 58, 80, 81, 93, 94, 101, 106, 109, 129, Earle Peacock, Jr., 16 130, 160 Ethics and law, 104, 105 Life-limiting, 197 Limb replantation, 5, 9, 10, 13, 14, 59, 71, 161, F 164 Face transplant, 1, 15, 20–22, 29, 31, 36, Liver transplantation, 14, 27, 33, 35, 40, 177 44–46, 49, 50, 58, 71 Longevity, 27, 53, 54 partial, 36 Loyalty, 92, 115, 117, 118, 121, 125, 129, 136, total, 37 137, 141–146, 172, 175 Facial defects, 10, 20, 30, 41, 68–70, 197, 198 Lung transplantation, 14, 33 Fictive kinship, 115, 122, 123, 144, 146, 171 Lydston, Frank, 12 Financial costs, 48, 49 Lymphoproliferative disorder, 24 Friern, Bolam v. Hospital Management Committee, 87 M Malignancy, 25, 38, 54, 56, 162, 196 G Malt, Ronald A., 15 Graft loss, 36, 37, 46, 47, 53, 56, 71, 199 Matching, 25, 30, 35, 51 Graft versus host disease, 39 May, William F., 115, 116, 131, 134, 137, 140, 141, 146, 173, 181, 185, 197, 201 H Medawar, Peter, 13 Halstead, William Stewart, 14 Merrill, John, 14 Heart transplantation, 11, 14, 27, 29, 33 Michael Barilan, Y., 70, 73, 98, 102, 103, 105, Hippocratic Oath, 55, 78 108, 158, 159 Hittites, 115, 116 Microsurgery, 9, 12, 15 Mill, John Stuart, 58, 73, 80 I Morale Medicale, 82 Identity transfer, 44, 54 Motor function, 23, 31, 33, 44 Immunogenicity of skin, 16, 29, 35 Murray, Joseph, 14 Immunological concerns, 34 Mycophenolate mofetil, 15, 16, 37 Immunomodulation, 15 Immunosuppression, 9, 15, 17, 22, 24, 32, N 35–40, 48, 51, 53, 54, 57, 69, 71, 150, National Organ Transplant Act, 26 161–163, 176, 191, 196 Nazi atrocities, 73 Induced tolerance, 15 Negative liberty, 81, 94, 160 Infection risk, 25, 162, 165 Non-maleﬁcence, 50, 52–55, 57, 71, 77, 150, International Hand Registry, 19 199 International Registry on Hand and Composite Nordenfelt, Lennart, 63 Tissue Transplantation (IRHCTT), 19, 149 Nozick, Robert, 95 Index 255

Nuremburg Code, 64, 73, 88, 156 Reciprocity, 117, 125, 133, 142–144 Nylen, Carl Olof, 12 Reconstructive transplantation, 15 Rehabilitation, 31, 33, 46, 71, 163–165, 174, O 176, 202, 203 Organ Procurement and Transplantation Reichsrundschreiben, 84, 88 Network (OPTN), 26, 27 Reinnervation, 33 Other VCA Rejection abdominal wall, 24 acute, 22, 29, 30, 35, 37, 162 esophagus, 24 chronic, 24, 29, 30, 35–37, 46, 162 larynx, 24 hyperacute, 35 lower extremity, 24 Renal compromise, 32 penis, 24 Renegotiation, 125, 171, 172, 202 tongue, 24 Rentdorff, Jacob Dahl, 58 uterus, 23 Respect for autonomy, 50, 58, 61, 71, 73, 80, vascularized knees, 24 89, 93, 96–98, 106, 108, 109, 150, 160, 199 Richard Niebuhr, H., 115, 128, 135 P Ritual, 102, 119, 121, 123, 125, 138, 145, 159, Patient as Person, 136 160, 170, 183, 192, 203 Patient Bill of Rights, 90 Rituximab, 37 Patient cooperation, 77, 169, 177, 178 Royal College of Surgeons, 21 Patient decision aids, 155 Rush, Benjamin, 81 Patient motivation, 40 Patient selection, 45, 51, 53, 56, 71, 150, 202 S Pearce and Another v. United Bristol Salgo v. Leland Stanford Jr. University Board Healthcare NHS Trust, 87 of Trustees, 73, 86 Pediatric VCA, 57 Samhita, Sushutra, 10 Percival, Thomas, 82 Schloendorff v. Society of New York Perritt, Richard A., 12 Hospitals, 73, 85 Physiotherapy, 5, 6, 15, 33, 51, 53, 57, 71, 152, Sensitivity, 23, 33 161, 163, 164, 168, 169, 180, 181, 190, 191 Sentinel function of skin, 29 Plato, 75 Shame and honor, 115, 123–125, 176, 181 Prednisolone, 37 Sidaway v. Governors of Bethlem Royal Principles of Biomedical Ethics, 59, 65, 80, 93, Hospital, 87 103, 157 Solid Organ Transplantation (SOT), 5, 9, 10, Privacy and conﬁdentiality, 55, 56, 64 14–16, 18, 25–33, 35–37, 39, 40, 52, 57, Procurement, 14, 16, 26, 28, 30, 47, 48, 51, 69, 71, 161–164 150, 199 Spence, Canterbury v., 73, 87 Prosthetics, 31, 48, 52, 165 Standards of information disclosure Psychological consequences of graft loss, 46 professional practice standard, 87, 93, 94, Psycho-social issues, 40 157 reasonable person standard, 93, 94, 157 Q subjective standard, 93 Quality-adjusted life years (QALYs), 49, 51 Stanley, L.L., 12 Quality of life, 14, 27, 32, 41, 49, 53, 54, 68, 163, 195 T Tacrolimus, 15, 18, 37–39 R Physician’s Covenant, The, 138, 139 Ramsey, Paul, 115, 116, 129, 131, 135, 137, Therapeutic alliance, 6, 100, 102, 152, 160, 141, 169, 200 199 Rat hind limb transplantation, 18 Therapeutic privilege, 77 Recipient satisfaction, 198 Training, 31, 99, 155, 186, 187, 189, 202, 203 256 Index

Transplantation of bone, 10 V Transplantation of teeth, 10, 11 Vascularized Composite Allotransplantation Transplantation of testicles, 12 (VCA), 1–3, 5–7, 9, 10, 13, 15–19, 21, Trephination, 11 24–59, 63, 64, 68–71, 92, 115, 149–152, Tuskegee Syphilis Study, 73, 91 161–170, 174–177, 179–183, 187–192, 195–199, 201–203 U Vasculopathy, 35, 36, 39 UNESCO Universal Declaration on Bioethics Vassal-suzerain treaty, 119 and Human Rights, 65, 73, 90 Visible difference, 42 United Network for Organ Sharing (UNOS), Vocabulary, 64, 104, 189, 191, 203 26 Voronoff, Serge, 12 Upper extremity transplant, 9, 15, 17–19, 28, Voronoy, Yury, 13 33, 35, 36, 41, 43, 44, 46, 49, 54, 55, 71, Vulnerability, 6, 50, 59, 60, 62, 64–71, 108, 150, 162 132, 133, 139, 148–150, 152, 165–168, 174, 179, 181, 182, 191