Ethical Issues in Transnational Eye Banking
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REVIEW Ethical Issues in Transnational Eye Banking Dominique E. Martin, PhD, MBBS, BA (Hons),* Richard Kelly, MD, BBiomed,† Gary L. A. Jones, BSc (Econ),‡ Heather Machin, RN, MBA,§ and Graeme A. Pollock, PhD, MPH, BSc (Hons)¶ discussion of issues relating to tissue-derived products and Purpose: To review ethical issues that may arise in the setting of musculoskeletal tissue banking, rather than eye banking transnational eye banking activities, such as when exporting or specifically.2,5 As recognized in the recent World Health importing corneal tissue for transplantation. Organization (WHO) Initiative on MPHOs, which aims “to Methods: A principle-based normative analysis of potential common support the development of global consensus on guiding dilemmas in transnational eye banking activities was performed. ethical principles for the donation and management of [MPHOs],”6 a number of ethical concerns are common to Results: Transnational activities in eye banking, like those in other all MPHOs, including ocular tissues used in transplanta- fields involving procurement and use of medical products of human tion.1,7 Common concerns associated with transnational origin, may present a number of ethical issues for policy makers and movement of MPHOs include national self-sufficiency, donor professionals. Key ethical concerns include the potential impact of autonomy, equity in resource distribution, and care of donors export or import activities on self-sufficiency of corneal tissue supply and recipients.1 In this article, we briefly review several within exporting and importing countries; potential disclosure ethical issues that may be associated with transnational eye requirements when obtaining consent or authorization for ocular banking activities, using the example of importation and tissue donation when donations may be exported; and difficulties exportation of corneas for transplantation. inherent in assuring equity in the allocation of tissues available for In 2012, an estimated 11% of corneal transplants export and in establishing and respecting standards of safety and performed worldwide used imported tissue, with 27 countries quality across different jurisdictions. wholly dependent and 43 countries partially dependent on imported tissue.4 Eight percent of corneal tissue procured Conclusions: Further analysis of specific ethical issues in eye annually was reportedly exported, primarily from the United banking is necessary to inform development of guidelines and other States, which accounted for 85% of corneal exports, Sri governance tools that will assist policy makers and professionals to Lanka (9%), and Italy (3%).4 Thus, of the 116 countries support ethical practice. currently active in corneal transplantation, at least 70 of these Key Words: ethics, eye banking, corneal transplantation are directly involved in transnational eye banking activities.4 Although such transnational eye banking activities may be (Cornea 2017;36:252–257) a rare occurrence or represent a small proportion of activity for many eye banks, for others, the export or import of corneas may substantially influence their capacity to meet the thical issues concerning the transnational movement of transplant needs of the population they serve. In reviewing medical products of human origin (MPHOs) such as E ethical dilemmas that may arise in the setting of import or organs, gametes, and blood products have been extensively – export of corneas, we lay the foundations for further ethical explored in the academic literature in recent decades.1 3 In analysis of global eye banking activities, which is necessary contrast, issues related to the transnational movement of to inform the development of guidelines for governance of human ocular tissues such as corneas have received little 6 attention, despite a significant volume of global activity.4 MPHOs such as those being prepared by the WHO. To our Corneas are usually referenced only in the context of broader knowledge, there are no analyses dedicated to the ethics of eye banking activities in the extant peer-reviewed literature. Throughout the text, we highlight recommendations for Received for publication May 22, 2016; revision received October 6, 2016; practice grounded in our analysis, which we summarize in accepted October 9, 2016. Published online ahead of print December 1, Boxes 1–4. 2016. From the *School of Medicine, Deakin University, Geelong, Australia; †St Vincent’s Hospital, Melbourne, Australia; ‡Veneto Eye Bank Foundation, Box 1. Recommendations for promoting self-sufficiency Zelarino-Venice, Italy; §Lions Eye Donation Service, Centre for Eye Research With the exception of transnational eye banking Australia, Royal Victorian Eye and Ear Hospital; and ¶Ophthalmology, Department of Surgery, University of Melbourne, Melbourne, Australia. activities involving a reciprocal exchange of tissues and/or The authors have no funding or conflicts of interest to disclose. collaboration in the pursuit of regional self-sufficiency, Reprints: Dominique E. Martin, PhD, MBBS, BA (Hons), Geelong Waurn import or export activities should be designed as temporary Ponds Campus, Locked Bag 20000, Geelong 3220, Australia (e-mail: strategies that are implemented in conjunction with, rather [email protected]). 8 Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved. than as substitutes for, eye bank development programs. 252 | www.corneajrnl.com Cornea Volume 36, Number 2, February 2017 Copyright Ó 2016 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. Cornea Volume 36, Number 2, February 2017 Ethical Issues in Transnational Eye Banking 1. Export activities should be conditional on the exis- the Eye Banking association of Australia and New tence of a feasible “exit plan” outlining steps for the Zealand.9 These principles should be reviewed to development of local infrastructure and resources ensure that they are fit for the purpose and required to provide services in the long-term; or; consistently applied to local and transnational 2. If local eye bank service development is considered activities. Consultation of an ethicist and relevant unfeasible in the long term, for example, because of stakeholders will assist in development of guide- a low population, then a long-term plan for meeting lines to support ethical policy and practice. patient needs should be elaborated. 2. Checklists identifying requirements or expectations of import or export activities should be developed. These may include items such as • Code of ethics to be followed; • Required documentation such as evidence of Box 2. Recommendations for promoting autonomy legislation governing procurement, import or 1. Donation decision makers should routinely be export, and use of human tissues as well as informed of the possibility that donated tissue may consent forms, and of accreditation by an appro- be exported if there is no suitable local recipient. priate licensing body; details of operating systems 2. Information about regional or international tissue and standards, etc; fi • Mechanisms for reporting of outcomes; sharing programs and the bene ts of export activi- • ties, etc, should also be made available to donation Fees and charges. decision makers. 3. Potential recipients of corneal tissue should routinely be informed that their transplant will involve use of a product of human origin, and, where this possibility exists, that it may be obtained from tissue donated in POTENTIAL ETHICAL CONCERNS IN THE a foreign country. CONTEXTOFEXPORTANDIMPORTOFCORNEAS Self-Sufficiency in Donation and Transplantation fi Box 3. Recommendations for assuring quality and safety Self-suf ciency in corneal transplantation refers to the Before engaging in import or export of corneal goal of meeting needs for transplantation within a given tissues, both sending and receiving agencies or individuals population using transplant services and corneal tissue 1 fi should confirm: obtained from within that population. Self-suf ciency in 1. The procurement of corneal tissues in a manner that many MPHOs such as blood or organs is commonly pursued respects donors and the integrity of donation at the national level, but regional collaboration often occurs to decision making; ensure that smaller populations can together meet their needs for transfusion or transplantation in a timely manner.1,10 2. The necessary written authorization from relevant fi health authorities for the export, import, and/or Economies and ef ciencies of scale in procurement and application of these tissues; processing systems as well as distribution networks may be 3. The availability of professionals who are suitably better achieved through regular or ad hoc subnational or qualified and legally authorized to use the supranational collaborations, in which donor tissue is shared, imported tissue; which involves potential export and import of tissue by all 4. That recipient health services are adequately equip- collaborating partners as required. Australia, for example, has ped with operating rooms and staff responsible for a cooperative relationship with New Zealand in which postoperative follow-up; resources such as organs or corneas for transplantation are 5. Mechanisms for traceability and reporting of out- shared between both countries to meet urgent needs and fi 11 comes of tissue use. ensure that available resources are used ef ciently. Although controversial in the context of some MPHOs such as plasma-derived products,12 the pursuit of self-sufficiency in other MPHOs