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Suggested Citation:"Front Matter." 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: 10.17226/24884.
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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

images

THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu

Suggested Citation:"Front Matter." 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: 10.17226/24884.
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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001

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

Additional copies of this publication are available for sale from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu.

Copyright 2017 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

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.

Suggested Citation:"Front Matter." 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: 10.17226/24884.
×

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The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president.

The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. C. D. Mote, Jr., is president.

The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president.

The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine.

Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org.

Suggested Citation:"Front Matter." 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: 10.17226/24884.
×

Image

Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task.

Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies.

For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo.

Suggested Citation:"Front Matter." 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: 10.17226/24884.
×

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

Suggested Citation:"Front Matter." 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: 10.17226/24884.
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Suggested Citation:"Front Matter." 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: 10.17226/24884.
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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

Page viii Cite
Suggested Citation:"Front Matter." 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: 10.17226/24884.
×

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.

Suggested Citation:"Front Matter." 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: 10.17226/24884.
×

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

Suggested Citation:"Front Matter." 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: 10.17226/24884.
×

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

Suggested Citation:"Front Matter." 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: 10.17226/24884.
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Suggested Citation:"Front Matter." 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: 10.17226/24884.
×
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Suggested Citation:"Front Matter." 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: 10.17226/24884.
×
Page R3
Suggested Citation:"Front Matter." 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: 10.17226/24884.
×
Page R4
Suggested Citation:"Front Matter." 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: 10.17226/24884.
×
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Suggested Citation:"Front Matter." 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: 10.17226/24884.
×
Page R6
Suggested Citation:"Front Matter." 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: 10.17226/24884.
×
Page R7
Page viii Cite
Suggested Citation:"Front Matter." 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: 10.17226/24884.
×
Page R8
Suggested Citation:"Front Matter." 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: 10.17226/24884.
×
Page R9
Suggested Citation:"Front Matter." 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: 10.17226/24884.
×
Page R10
Suggested Citation:"Front Matter." 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: 10.17226/24884.
×
Page R11
Suggested Citation:"Front Matter." 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: 10.17226/24884.
×
Page R12
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The organ donation and transplantation system strives to honor the gift of donated organs by fully using those organs to save and improve the quality of the lives of their recipients. However, there are not enough donated organs to meet the demand and some donated organs may not be recovered, some recovered organs may not be transplanted, and some transplanted organs may not function adequately.

Organ donor intervention research can test and assess interventions (e.g., medications, devices, and donor management protocols) to maintain or improve organ quality prior to, during, and following transplantation. The intervention is administered either while the organ is still in the deceased donor or after it is recovered from the donor but before it is transplanted into a recipient. Organ donor intervention research presents new challenges to the organ donation and transplantation community because of ethical questions about who should be considered a human subject in a research study, whose permission and oversight are needed, and how to ensure that such research does not threaten the equitable distribution of a scarce and valuable resource.

Opportunities for Organ Donor Intervention Research focuses on the ethical, legal, regulatory, policy, and organizational issues relevant to the conduct of research in the United States involving deceased organ donors. This report provides recommendations for how to conduct organ donor intervention research in a manner that maintains high ethical standards, that ensures dignity and respect for deceased organ donors and their families, that provides transparency and information for transplant candidates who might receive a research organ, and that supports and sustains the public’s trust in the process of organ donation and transplantation.

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