COPYRIGHT AND USE OF THIS THESIS This thesis must be used in accordance with the provisions of the Copyright Act 1968. Reproduction of material protected by copyright may be an infringement of copyright and copyright owners may be entitled to take legal action against persons who infringe their copyright. Section 51 (2) of the Copyright Act permits an authorized officer of a university library or archives to provide a copy (by communication or otherwise) of an unpublished thesis kept in the library or archives, to a person who satisfies the authorized officer that he or she requires the reproduction for the purposes of research or study. The Copyright Act grants the creator of a work a number of moral rights, specifically the right of attribution, the right against false attribution and the right of integrity. You may infringe the author’s moral rights if you: - fail to acknowledge the author of this thesis if you quote sections from the work - attribute this thesis to another author - subject this thesis to derogatory treatment which may prejudice the author’s reputation For further information contact the University’s Copyright Service. sydney.edu.au/copyright The Legal and Ethical Limits of Consent in High Risk Medical Interventions: An Empirical Study Camilla Louise Scanlan AAIMS BSc MBA MHL A thesis submitted in fulfilment of the requirements for the award of the degree of Doctor of Philosophy (Medicine) 2015 University of Sydney Page 1 of 429 Page 2 of 429 Page 3 of 429 ACKNOWLEDGEMENT I would like to confirm my profound and most sincere gratitude to my primary research supervisor, Professor Ian Kerridge who remained resolutely focused on the end goal regardless of the many challenges that life threw in the way. He seamlessly shifted between being guiding shepherd one moment, and tenacious sheep dog the next, according to the need, as he untiringly and resolutely kept my straying, wilful thoughts on track. In addition to Ian, I acknowledge the significant assistance provided by my auxiliary supervisors, Professor Cameron Stewart, Emeritus Professor Miles Little, and A/Professor Stacy Carter. Without their distinctive expertise and assistance in providing specific insights and knowledge at various stages, I could not have managed to complete this thesis. My thanks also go to A/Professor Christopher Jordens who participated in the concept and design of the empirical study. The empirical study was supported by an NHMRC Project Grant (457439), and I was funded by a CCRE Postgraduate Research Scholarship awarded by the Centre for Clinical Excellence in Infection and Bioethics in Haematological Malignancies (CCRE-IBHM). Without the support of Professor Ken Bradstock in providing me with access to patients and relevant healthcare professionals, the empirical phase of this study could not have been undertaken in the manner, and with the relative ease in which it was - I am very grateful to him. I thank my colleagues at the Centre for Values, Ethics and the Law in Medicine (VELiM), University of Sydney, for maintaining the culture of questioning, creative encouragement and collegiality that is unique to VELiM. I would also like to acknowledge [in alphabetical order] Dr Alison Butt, Dr Sue Firth, Dr Janet Martin, and Dr Carolyn Scott for their proofreading, and especially for their enduring encouragement in my pursuit of this endeavour. I am indebted to Professor Philip Crowe and Professor Michael Friedlander without whose assistance I could not have completed this thesis. Page 4 of 429 DEDICATION It is my great honour and privilege to dedicate this thesis to the participants in the empirical study, particularly the patients and their significant others who so readily shared their experiences with me during the most difficult times of their lives. I thank you all most sincerely. I wish also to dedicate this thesis in my small, but sincere way of thanking and ‘giving back’ to the transplant physicians and other members of the transplant team for their generous time and insights, and also those other healthcare professionals for ‘holding the fort’ so that their colleagues could participate in lengthy interviews for this study. Your individual and collective dedication to your patients is nothing short of inspiring. I salute you all. Page 5 of 429 Thesis synopsis That a person’s consent is required prior to any medical intervention, is now well established in law, ethics and medical practice, and is the most profound practical manifestation of respect for autonomy, or self-determination in medicine. For consent to be valid a number of conditions need to be satisfied; the person making the decision must have sufficient capacity (competence) to make the decision; they must have been provided with sufficient information about the proposed intervention and about relevant alternatives such that their decision is adequately informed; the decision must be appropriately and specifically authorized. While the person’s consent occupies the central legitimising feature of medical practice, little is known about how consent per se, or its elements, are conceptualised or actualised in high-risk medical settings. Aim The aim of this thesis was to develop a richer understanding of the process of consent to high- risk medical interventions. This issue was explored both theoretically (through the reflection on relevant literature) and empirically through study of the experience of consent in clinical practice. The exemplar of a high-risk medical treatment on which the empirical study was based, is allogeneic haematopoietic stem cell transplantation, referred to in this thesis as HSCT. Method This was a longitudinal qualitative study. Data was gathered from in-depth, semi-structured interviews with those people most intimately involved in the consent process (patients undergoing HSCT, their ‘significant others’, physicians performing HSCT, and other relevant healthcare professionals). Data was thematically analysed in terms of the elements of consent (which were explicitly explored during the interviews), and by reference to those additional concepts that emerged from Page 6 of 429 the participants’ narratives. The accounts provided by the participants were contrasted against contemporary understandings of consent drawn from the relevant empirical and philosophical literature. Findings The results of this study reveal that each one of the elements required for valid consent are challenged in high-risk medical settings. Capacity is often compromised, decisions are enmeshed in social obligations, information disclosure is comprehensive but inevitably limited, understanding is rarely tested and never privileged, and all decisions are made in the shadow of disease and mortality. But the results also reveal that consent remains an important process – not simply because it validates decision-making and manifests respect, but because it increases trust, and builds alliances that maximise adherence, and ensure ‘presence’. Conclusion While consent in medical practice is legally established and morally justified, its realisation in practice is extraordinarily difficult. This is never more so than in high-risk medical settings. In these situations it is necessary to recognize that consent cannot be understood simply by reference to the role it plays in law – but also by acknowledgment of its moral justification, social and relational contexts, and clinical utility. Page 7 of 429 Introduction and Organisation of thesis That a person’s consent is required prior to any medical intervention, is now well established in law, ethics and medical practice and is the most profound practical manifestation of respect for autonomy, or self-determination in medicine. For consent to be valid a number of conditions need to be satisfied; the person making the decision must have sufficient capacity (competence) to make the decision; they must have been provided with sufficient information about the proposed intervention and about relevant alternatives such that their decision is adequately informed; the decision must be appropriately and specifically authorized. A deficiency in any one of these elements would mean that the consent could be vitiated. While consent has remained a moral and legal cornerstone of medical practice, much has changed in the recent decades regarding how consent is conceptualized. Over the past two decades, in particular, profound critiques of the adequacy of consent have been articulated in the academic and professional literature. Many commentators have suggested that the accepted construction of consent is flawed,1 either in its conceptualisation, or it realisation, or both. Some have citied the lack of agreed definitions of the fundamental elements of consent, such as voluntariness and competence (capacity), and the lack of universal means of measuring or assessing such concepts in practice, leading some to question whether consent can ever be truly voluntary, or ‘informed’.2 Finally, both clinicians and scholars from the social sciences and humanities have noted that consent means different things to different people. Some consider consent to be synonymous with shared decision-making,3 others view it as fundamentally a rules- 1 Katz, J. 1977. Informed Consent-A Fairy Tale-Law's Vision. U. Pitt. L. Rev. , 39, 137.; Katz, J. 1994. Informed consent-must it remain a fairy tale. J. Contemp. Health L. & Pol'y, 10, 69, Jones, M. A. 1999b. Informed consent and other fairy stories. Med L Rev, 7, 103. 2 As Kennedy and Grubb point out in Medical Law, 2nd