Opportunities for
Organ Donor
Intervention Research
SAVING LIVES BY IMPROVING THE QUALITY AND
QUANTITY OF ORGANS FOR TRANSPLANTATION
Committee on Issues in Organ Donor Intervention Research
James F. Childress, Sarah Domnitz, and Catharyn T. Liverman, Editors
Board on Health Sciences Policy
Health and Medicine Division
A Consensus Study Report of
THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu
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This activity was supported by contracts between the National Academy of Sciences and the American Association for the Study of Liver Diseases, American Society of Transplant Surgeons, American Society of Transplantation, Association of Organ Procurement Organizations, Gift of Life Donor Program, Health Resources & Services Administration (Contract No. HHSH250201500001I), Laura and John Arnold Foundation, National Institutes of Health (National Heart, Lung, and Blood Institute; National Institute of Allergy and Infectious Diseases; National Institute of Diabetes and Digestive and Kidney Diseases) (Contract No. HHSN26300092), National Kidney Foundation, OneLegacy Foundation, and The Transplantation Society. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.
International Standard Book Number-13: 978-0-309-46487-1
International Standard Book Number-10: 0-309-46487-0
Digital Object Identifier: https://doi.org/10.17226/24884
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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2017. Opportunities for organ donor intervention research: Saving lives by improving the quality and quantity of organs for transplantation. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/24884.
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COMMITTEE ON ISSUES IN ORGAN DONOR INTERVENTION RESEARCH
JAMES F. CHILDRESS (Chair), University Professor Emeritus and John Allen Hollingsworth Professor of Ethics Emeritus, University of Virginia
DIANA L. CLARK (Retired), President and CEO, LifeCenter Northwest, Indianapolis, Indiana
I. GLENN COHEN, Professor of Law, Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics, Harvard Law School
MICHELE BRATCHER GOODWIN, Chancellor’s Professor of Law, Director, Center for Biotechnology and Global Health Policy, University of California, Irvine, School of Law
JONATHAN KIMMELMAN, Associate Professor of Biomedical Ethics, Experimental Medicine, Social Studies of Medicine, McGill University
WILLIAM H. MARKS (Retired), Robert B. McMillen Chair and Chief, Organ Transplantation and the Laboratory for Transplantation Biology, Swedish Medical Center, Seattle, Washington
KENNETH MORITSUGU (Retired), RADM, U.S. Public Health Service, First Samurai Consulting, Great Falls, Virginia
GLENN F. PIERCE (Retired), Chief Medical Officer of Hematology, Biogen, La Jolla, California
LAINIE FRIEDMAN ROSS, Carolyn and Matthew Bucksbaum Professor of Clinical Ethics, Professor, Departments of Pediatrics, Medicine, and Surgery, The University of Chicago
ROBERT D. TRUOG, Frances Glessner Lee Professor of Medical Ethics, Anaesthesia, and Pediatrics, and Director, Center for Bioethics, Harvard Medical School and Boston Children’s Hospital
PETER A. UBEL, Madge and Dennis T. McLawhorn University Professor of Business, Public Policy, and Medicine, Fuqua School of Business, Duke University
JAMES B. YOUNG, Professor of Medicine and Executive Dean, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio
Study Staff
CATHARYN T. LIVERMAN, Study Director
SARAH DOMNITZ, Study Director (through June 2017)
TRACY LUSTIG, Senior Program Officer (from July 2017)
KATIE LAWALL, Senior Program Assistant
OLIVIA YOST, Research Associate
ANDREW M. POPE, Director, Board on Health Sciences Policy
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Reviewers
This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process.
We thank the following individuals for their review of this report:
ALEX CAPRON, University of Southern California
DAVID CARTIER, cHealthWorks
SANDY FENG, University of California, San Francisco
JIM GLEASON, Transplant Recipients International Organization
SCOTT HALPERN, University of Pennsylvania
KATE HEFFERNAN, Verrill Dana, LLP
MARYL JOHNSON, University of Wisconsin
JEFFREY KAHN, Johns Hopkins University
HOWARD K. KOH, Harvard T.H. Chan School of Public Health
JACK LYNCH, Gift of Hope Organ & Tissue Donor Network
JOHN MAGEE, University of Michigan Transplant Center
JEFF ORLOWSKI, LifeShare Transplant Donor Services of Oklahoma
ALVIN E. ROTH, Stanford University
LAURA SIMINOFF, Temple University
LORRAINE WARE, Vanderbilt University Medical Center
Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before its release. The review of this report was overseen by Enriqueta C. Bond, Wellcome Fund, and Philip J. Cook, Duke University. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies.
Preface
Organ transplantation, a procedure that saves lives and improves quality of life, is made possible in the United States solely by the public’s generous gifts of organs. For deceased organ donation, this means that individuals during their lifetimes graciously decided to be organ donors or that their grieving families made that decision. Making the most of these gifts for current and future transplant recipients is the goal of organ donor intervention research.
Donor intervention research examines the use of various medications, procedures, or other interventions that might improve the quality of donated organs or increase the number of organs that are suitable for transplantation. Such research is unique in that the outcomes of an intervention performed in one individual, the deceased donor, may directly affect and be assessed in another individual, the transplant recipient. The very brief timeframe in which this research must be conducted (to maintain organ viability and ensure transport to the recipient) and the fact that organs from a single donor may go to multiple recipients in different transplant centers throughout the United States add to the complexities of this research. These factors also heighten the need for an ethics-based framework with strong oversight mechanisms that can facilitate this research and, at the same time, respect donors’ wishes and protect research participants.
The organ donation and transplantation system is built on public trust, and maintaining that trust is crucial to sustaining this system. Throughout this Consensus Study Report, the details of this system and the potential for research to improve the system are discussed from the perspectives of organ donors and recipients alike. The committee recommends a set of actions to
ensure that this research goes forward in a manner that supports trust, fairness, and respect for persons in organ donation and transplantation.
This report benefited immensely from the input and insights of many individuals and organizations. The committee appreciates the sponsors’ support for this study and their work in bringing this important topic to the forefront of efforts to further the field of organ transplantation. Many individuals generously provided time and expertise to the committee as invited workshop and conference call speakers, and the committee greatly appreciates their significant contributions. The reviewers also provided insightful comments that strengthened this report.
It was my great privilege to chair this National Academies of Sciences, Engineering, and Medicine study. From the first meeting through the final report’s publication, each committee member brought commitment, energy, and intellectual curiosity and rigor to this effort. The members devoted countless hours to this task and were a great pleasure to work with and learn from. The committee was supported by an energetic and knowledgeable staff that made sure that all aspects of this complex topic were thoroughly discussed and documented.
This report seeks to enable organ donor intervention research to move forward, within appropriate ethical, legal, and regulatory limits, in order to save more lives, to improve the quality of lives, and to fully honor the gifts of organs for both current and future transplant recipients.
James F. Childress, Chair
Committee on Issues in Organ Donor Intervention Research
Contents
The Potential of Organ Donor Intervention Research
Overview of Organ Donation and Transplantation
Distinguishing Research from Quality Improvement Studies
Challenges and Opportunities in Organ Donor Intervention Research
3 LEGAL, REGULATORY, AND POLICY FRAMEWORKS FOR ORGAN DONATION AND RESEARCH PARTICIPATION
Deceased Organ Donor Intervention Research Studies: Examples
Organ Donation: Improving Transparency and Public Trust in the Process of Authorizing Donation
Recipients of Research Organs: Improving Consent and Ensuring Protections
4 RESEARCH APPROVAL, IMPLEMENTATION, AND OVERSIGHT: ENSURING QUALITY AND TRUST
Centralized Management of Deceased Organ Donor Intervention Research: Background and Rationale
Framework for Centralized Management
Donor Research Oversight Committee
Single IRB for Organ Donor Intervention Research
Structure and Operations for Centralized Management of Organ Donor Intervention Research
