Emerging Ethical Challenges Raised by the Evolution of Vascularized Composite Allotransplantation

Background Despite early skepticism, the field of vascularized composite allotransplantation (VCA) has demonstrated feasibility. The ethics of VCA have moved past doubts about the morality of attempting such transplant to how to conduct them ethically. Methods Leaders of each program performing and/or evaluating VCA in the United States were invited to participate in a working group to assess the state and future of VCA ethics and policy. Four meetings were held over the course of 1 year to describe key challenges and potential solutions. Results Working group participants concluded that VCA holds great promise as treatment for patients with particular injuries or deficits, but the field faces unique challenges to adoption as standard of care, which can only be overcome by data sharing and standardization of evaluation and outcome metrics. Conclusions Adequate attention must be given to concerns including managing the uniquely intense physician-patient relationship, ethical patient selection, ensuring patients have adequate representation, informing and earning the trust of the public for donation, standardizing metrics for success, and fostering an environment of data sharing. These steps are critical to transitioning VCA from research to standard of care, and to its insurance coverage inclusion. Corresponding Author: Brendan Parent. brendan.parent@nyu.edu; 7 East 12th Street Suite 825b NY NY 10003 *List of members/contributors to NYU/Hopkins VCA ethics working group: Arthur L. Caplan, Jeffrey Kahn, Brendan Parent, WP Andrew Lee, Wendy Dean, Laura L. Kimberly, Bruce Gelb, James F. Childress, Eduardo D. Rodriguez, James McCartney, Nomi Levy-Carrick, Gerard MaGill, Hatem Amer, Rolph N Barth, Leslie Bernstein, Rosamond Rhodes, David B. Sarwer, Helen Irving, Simon Talbot, Kevin I Reid, Elisa J Gordon, Benjamin Chang, Lisa Kearns, James Benedict, Linda C. Cendales, Jeremy Sugarman Authorship All authors participated in working group meetings and drafting documents on assigned relevant topics. BP wrote the initial draft of this paper based on literature review, notes from working group meetings, and content in assigned documents. AC revised with significant feedback from LK, JK, WD, and BG. WPAL and EDR contributed to design and final revisions. Disclosure The authors of this manuscript declare no conflicts of interests. Funding Working group hosts received a gift from United Therapeutics to support travel and lodging for participants of working group meetings. Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.

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