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Suggested Citation:"Appendix B: Committee Biographical Sketches." 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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B

Committee Biographical Sketches

James F. Childress, Ph.D. (Chair), has been a University Professor, the John Allen Hollingsworth Professor of Ethics, and a professor of religious studies at the University of Virginia, where he is now an emeritus professor. Dr. Childress has previously served as the Joseph P. Kennedy, Sr., Professor of Christian Ethics at the Kennedy Institute of Ethics at Georgetown University and as a visiting professor at The University of Chicago Divinity School and Princeton University. In 1990 he was named Professor of the Year in the Commonwealth of Virginia by the Council for the Advancement and Support of Education, and in 2002 he received the University of Virginia’s highest honor, the Thomas Jefferson Award. In spring 2010 he held the Maguire Chair in American History and Ethics at the Library of Congress. Dr. Childress is the author of numerous articles and several books in several areas of ethics, including Principles of Biomedical Ethics (with Tom Beauchamp), now in its seventh edition and translated into several languages. Dr. Childress was vice chair of the national Task Force on Organ Transplantation, and he also has served on the board of directors of the United Network for Organ Sharing (UNOS), the UNOS Ethics Committee, the Recombinant DNA Advisory Committee, the Human Gene Therapy Subcommittee, the Biomedical Ethics Advisory Committee, and several data and safety monitoring boards for National Institutes of Health clinical trials. He was a member of the presidentially appointed National Bioethics Advisory Commission (1996–2001). Dr. Childress is a member of the National Academy of Medicine, and he has chaired several studies at the National Academies of Sciences, Engineering, and Medicine. His current research focuses on public bioethics, on public health ethics, and on

Suggested Citation:"Appendix B: Committee Biographical Sketches." 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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just-war theory and practice. Dr. Childress received his B.A. from Guilford College, his B.D. from Yale Divinity School, and his M.A. and Ph.D. from Yale University.

Diana L. Clark, R.N., M.H.A., retired as the president and chief executive officer of LifeCenter Northwest, the federally designated organ procurement organization (OPO) for the Pacific Northwest. LifeCenter Northwest was accountable for a large and regionally diverse area, serving Washington, Idaho, Montana, and Alaska. This OPO service area presented unique challenges for very remote population centers. Ms. Clark previously served as the first executive director, chief executive officer, and chairperson of the board for the Indiana Organ Procurement Organization. She was the first woman elected as the president of the Association of Organ Procurement Organizations. Throughout her career, Ms. Clark was effective in management, program development, and leadership in health care at Methodist Hospital of Indiana. At the time, Methodist Hospital was the 13th largest private hospital in the United States and the first private teaching hospital to perform heart transplants, which Ms. Clark obtained program approval for and directed for several years. During her career, Ms. Clark served in several capacities, including vice president, directly accountable to the hospital president. In these capacities she had accountability for diverse areas in health care—including transplantation, organ procurement, medical education, medical and nursing research, allied health, and community health centers. Ms. Clark is the co-author of the section on donation and transplantation in two editions of Mosby’s Critical Care Nursing textbook. This is the most widely used critical care textbook for nursing.

I. Glenn Cohen, J.D., is a professor of law at Harvard Law School and faculty director of Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. Professor Cohen’s current projects relate to big data, health information technologies, mobile health, reproduction/reproductive technology, research ethics, organ transplantation, rationing in law and medicine, health policy, U.S. Food and Drug Administration law, translational medicine, and medical tourism—the travel of patients who are residents of one country, the home country, to another country, the destination country, for medical treatment. Prior to becoming a professor he served as a law clerk to Judge Michael Boudin of the U.S. Court of Appeals for the First Circuit and as a lawyer for U.S. Department of Justice, Civil Division, Appellate Staff, where he handled litigation in the Courts of Appeals and (in conjunction with the Solicitor General’s Office) in the U.S. Supreme Court. In his spare time he still litigates, having coauthored an amicus brief in the U.S. Supreme Court for leading gene scientist Eric Lander in Association of Molecular Pathology v. Myriad, concerning

Suggested Citation:"Appendix B: Committee Biographical Sketches." 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.
×

whether human genes are patent-eligible subject matter. Most recently he submitted an amicus brief to the U.S. Supreme Court in Whole Women’s Health v. Hellerstedt (the Texas abortion case, on behalf of himself, Melissa Murray, and B. Jessie Hill). Professor Cohen was selected as a Radcliffe Institute Fellow for the 2012–2013 year and by the Greenwall Foundation to receive a Faculty Scholar Award in Bioethics. He is also a fellow at the Hastings Center, the leading bioethics think tank in the United States. He leads the Ethics and Law initiative as part of the multi-million dollar National Institutes of Health (NIH)-funded Harvard Catalyst, the Harvard Clinical and Translational Science Center program. He is also one of three editors-in-chief of the Journal of Law and the Biosciences, a peer-reviewed journal, and serves on the editorial board for the American Journal of Bioethics. He serves on the Steering Committee for Ethics for the Canadian Institutes of Health Research, the Canadian counterpart to NIH.

Michele Bratcher Goodwin, J.D., L.L.M., is a Chancellor’s Professor of Law at the University of California (UC), Irvine, with appointments at the School of Law; Program in Public Health; Department of Criminology, Law, and Society; Department of Gender and Sexuality Studies; and Center for Psychology and Law. She is the founder and director of the Center for Biotechnology and Global Health Policy at the UC Irvine School of Law and its internationally acclaimed Reproductive Justice Initiative. Professor Goodwin is one of the world’s leading authorities on the regulation of medicine, science, and biotechnology. Her publications include 5 books and more than 70 articles and book chapters on law’s regulation of the human body, including civil and criminal regulation of pregnancy and reproduction, reproductive technologies, human trafficking (for organs, sex, and marriage), and tissue and organ transplantation. She has been at the forefront of organ transplant discourse, including increasing the supply of organs for transplantation and achieving access across America’s many communities. Her recent works appear in or are forthcoming in the Harvard Law Review, California Law Review, Georgetown Law Review, Northwestern Law Review, and Texas Law Review, among others. Professor Goodwin’s scholarship defines new ways of thinking about supply, demand, and access to sophisticated medical technologies. Reviews of her work appear in the New England Journal of Medicine, Nature, Publishers Weekly, Law and Politics Book Review, Book News, and the Library Journal, among other periodicals. Her editorials and commentaries appear in the Los Angeles Times, The New York Times, Gene Watch, Christian Science Monitor, Politico, Cleveland Plain Dealer, Houston Chronicle, Chicago Sun Times, The Washington Post, AlterNet and Forbes magazine among others. She is a blogger for the Huffington Post and the Harvard Bill of Health. Professor Goodwin is also the president of the Defense for

Suggested Citation:"Appendix B: Committee Biographical Sketches." 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.
×

Children International U.S. affiliate and founder of the Institute for Global Child Advocacy. She is the former Everett Fraser Professor in Law at the University of Minnesota. She served as a visiting professor at The University of Chicago and as a visiting scholar at UC Berkeley and Columbia University Law School. Prior to law teaching, Professor Goodwin was a Gilder-Lehrman Post-Doctoral Fellow at Yale University.

Jonathan Kimmelman, Ph.D., holds a doctorate in molecular biophysics and biochemistry from Yale University and is an associate professor in biomedical ethics at McGill University, with a cross-appointment in experimental medicine. His research centers on the ethics of translational clinical research. He leads several funded projects investigating risk-benefit across the research trajectory, and he directs the Studies for Translation, Ethics, and Medicine (STREAM) Group. Major publications have appeared in journals, including Science, Lancet, BMJ, and PLOS Medicine. His book, Gene Transfer and the Ethics of First-in-Human Experiments (Cambridge Press, 2010), is the first full-length analysis of the ethics of translational clinical research and has been described as “set[ting] a new standard for bioethical scholarship that is at once scientifically well-grounded, politically astute, philosophically original, and a pleasure to read.” Dr. Kimmelman was the winner of the 2006 Maud Menten New Investigator Prize (Institute of Genetics), received a Canadian Institutes of Health Research New Investigator Salary Award in 2008, and was a Humboldt-Bessel Award Winner in 2014. He has served in numerous advisory capacities, including ethics committee chairs for the American Society of Gene and Cell Therapy (2008–2010) and the International Society of Stem Cell Research (2013–2016).

William H. Marks, M.D., Ph.D., FACS, M.H.A., recently retired from full time employment and currently works as an independent consultant. His immediate past position was executive medical director and global medical lead for transplantation at Alexion Pharmaceuticals (2010–2015). In that role he was responsible for the design and medical oversight of clinical research focused on exploring the safety and efficacy of terminal complement inhibition as a tool to facilitate organ transplantation in patients sensitized to their donors and to protect organs from organ preservation injury. Currently he is adjunct professor of natural products chemistry at the University of Illinois College of Pharmacy. Dr. Marks is a former national medical advisor for the Association of Organ Procurement Organizations and was a founding officer of the board for LifeCenter Northwest Organ Procurement Organization in Seattle, where he also served as medical director for 9 years. He chaired or served as a member of numerous national and local committees related to transplantation, authored more than 100 medical/scientific publications and has received several honors

Suggested Citation:"Appendix B: Committee Biographical Sketches." 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.
×

including the University of Illinois Margaret Wright Graduate College Distinguished Alumnus Award (2007). Dr. Marks received his B.S. and M.D. from Loyola University of Chicago in 1970 and 1977 respectively, his M.S. from the University of Illinois College of Pharmacy in 1973, his Ph.D. from the University of Lund, Sweden, in 1984, and his M.H.A. from University of Southern California, School of Policy Planning and Development in 2009. Dr. Marks did his general surgery residency and transplant fellowship at the University of Michigan. He held academic positions at the University of Michigan, Loyola University, and Yale University. In 1993 he founded the multidisciplinary program in organ transplantation and the laboratory for transplantation biology at the Swedish Medical Center where he held the Robert B. McMillen Chair in transplantation.

Kenneth Moritsugu, M.D., M.P.H., FACPM, is the chairman and chief executive officer of First Samurai Consulting, LLC. He served for 37 years as a career officer in the U.S. Public Health Service. He is a former Surgeon General of the United States (Acting) and has held several public health leadership positions with Johnson & Johnson, including WorldWide Chairman of the Johnson & Johnson Diabetes Institutes and Vice President for Global Professional Education and Strategic Relations for Johnson & Johnson’s Diabetes Solutions Companies. Board certified in preventative medicine, Rear Admiral Moritsugu earned a B.A. in classical languages from the University of Hawaii in 1967, an M.D. degree from The George Washington University in 1971, and an M.P.H. from the University of California, Berkeley, in 1975. He holds fellowships in the American College of Preventive Medicine, the Royal Society of Public Health, the Royal Society of Medicine, and the National Academy of Public Administration. He is an adjunct professor of global health at The George Washington University Milken School of Public Health and an adjunct associate professor of preventive medicine at the Uniformed Services University of the Health Sciences.

Glenn F. Pierce, M.D., Ph.D., is a retired biotech executive, volunteer, and biopharma consultant. Dr. Pierce currently serves on the World Federation of Hemophilia (WFH) board of directors and the National Hemophilia Foundation (U.S.) Medical and Scientific Advisory Council. He is an entrepreneur-in-residence at Third Rock Ventures and a board member of Global Blood Therapeutics and Voyager Therapeutics, as well as an advisor to biotechnology companies in the gene therapy and hematological space. Dr. Pierce retired in 2014 from Biogen, where he most recently led the Hematology, Cell and Gene Therapies division as senior vice president. He had overall research and development responsibiliity for hemophilia and hemoglobinopathies and led the development of extended half life FVIII and FIX Fc fusions as chief medical officer, hematology, culminating

Suggested Citation:"Appendix B: Committee Biographical Sketches." 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.
×

in regulatory approvals for both products in 2014. At Biogen, Dr. Pierce spearheaded the initiation of the Humanitarian Aid collaboration with WFH to donate 1 billion units of clotting factor to the low socioeconomic countries, and My Life Our Future, a population-wide genomic biobank initiative in the United States. Dr. Pierce has 30 years of experience in biotechnology research, development, and translation from the bench to the bedside in small and large, public and private biotech and biopharma firms, including Amgen, Avigen, Bayer Healthcare, and Biogen. He is the author of more than 150 scientific papers and holds numerous patents. For more than two decades Dr. Pierce served on the medical and scientific advisory council and the board of directors of the National Hemophilia Foundation (U.S.), where he also served as president of the board. Dr. Pierce served on the Blood Products Advisory Committee at the U.S. Food and Drug Administration and the Committee on Blood Safety and Availability at the U.S. Department of Health and Human Services. He received an M.D. and a Ph.D. in immunology, both from Case Western Reserve University in Cleveland, Ohio, and did his postgraduate training in pathology and hematology research at Washington University in St. Louis, Missouri. He lives in San Diego and focuses his free time on humanitarian aid training workshops in the developing world with WFH. Dr. Pierce was born with severe hemophilia A and was cured in 2008 following a liver transplant.

Lainie Friedman Ross, M.D., Ph.D., is the Carolyn and Matthew Bucksbaum Professor of Clinical Medical Ethics; a professor in the departments of pediatrics, medicine, and surgery at The University of Chicago; and the associate director of the MacLean Center for Clinical Medical Ethics. Dr. Ross has published two books on pediatric ethics: Children, Families and Health Care Decision Making (Oxford University Press, 1998) and Children in Medical Research: Access versus Protection (Oxford University Press, 2006), and she has co-authored two books with Robert M. Veatch (Transplantation Ethics, 2nd edition, Georgetown University Press, 2015; and Defining Death: The Case for Choice, Georgetown University Press, 2016). Dr. Ross has also published more than 150 articles in peer-reviewed journals in the areas of pediatric ethics, transplantation ethics, research ethics and genetics and ethics. Dr. Ross earned her A.B. from the Woodrow Wilson School of Public and International Affairs at Princeton University (1982), an M.D. from the University of Pennsylvania School of Medicine (1986), and a Ph.D. in philosophy from Yale University (1996). She did her pediatric residency at the Children’s Hospital of Philadelphia (1986–1988) and at Columbia University (1988–1989). Dr. Ross was a 2014 recipient of a John Simon Guggenheim Memorial Foundation Fellowship and the 2015 recipient of the William Bartholome Award in Ethical Excellence from the American Academy of Pediatrics.

Suggested Citation:"Appendix B: Committee Biographical Sketches." 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.
×

Robert D. Truog, M.D., is the Frances Glessner Lee Professor of Medical Ethics, Anaesthesia, and Pediatrics at Harvard Medical School, where he serves as director of the Center for Bioethics, leading teaching and academic initiatives across the medical school, including an undergraduate curriculum, master’s degree and fellowship programs, and a post-doctoral program for research scholars. He has practiced pediatric intensive care medicine at Boston Children’s Hospital for more than 30 years, including serving as chief of the division for more than a decade. He has published more than 250 articles and books in bioethics and related disciplines, including Talking with Patients and Families about Medical Error (Hopkins, 2010) and Death, Dying, and Organ Transplantation (Oxford, 2012). In 2013 he was honored with the Spinoza Chair at the University of Amsterdam.

Peter A. Ubel, M.D., is a physician and behavioral scientist whose research and writing explores the mixture of rational and irrational forces that affect our health, our happiness, and the way society functions. Dr. Ubel is the Madge and Dennis T. McLawhorn University Professor of Business, Public Policy and Medicine at Duke University. His research explores controversial issues about the role of values and preferences in health care decision making, from decisions at the bedside to policy decisions. He uses the tools of decision psychology and behavioral economics to explore topics like informed consent, shared decision making, and health care cost containment. His books include Pricing Life: Why It’s Time for Healthcare Rationing (MIT Press, 2000) and Free Market Madness: How Economics is at Odds with Human Nature—and Why it Matters (Harvard Business Press, 2009). His newest book, Critical Decisions (HarperCollins, 2012), explores the challenges of shared decision making between doctors and patients.

James B. Young, M.D., is a professor of medicine and the executive dean of the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University and chairman of the Endocrinology and Metabolism Institute. He also serves as a physician director of the Philanthropy Institute and holds the George and Linda Kaufman Chair in the Heart and Vascular Institute. He is a medical director of the Kaufman Center for Heart Failure, which he and a former surgical colleague established in 1998 at Cleveland Clinic. After joining Cleveland Clinic in 1995, Dr. Young was named head of heart failure and cardiac transplant medicine. He is an internationally recognized heart failure and heart transplant cardiologist with an interest in mechanical circulatory support devices. Dr. Young has participated in more than 150 clinical trials as an investigator and has served as the U.S. principal or co–principal investigator for many multicenter clinical trials. He has published more than 650 manuscripts and several textbooks. A member of many professional associations, Dr. Young served as a board

Suggested Citation:"Appendix B: Committee Biographical Sketches." 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.
×

member and past president of the International Society of Heart and Lung Transplantation and as a board member of the Heart Failure Society of America and the American Society of Transplantation. Dr. Young earned a B.A. with honors in biology from the University of Kansas, where he was a resident of Stephenson Scholarship Hall. He matriculated to Baylor College of Medicine in Houston, where he was awarded his medical degree cum laude and was elected to the Alpha Omega Alpha medical honor society. He completed his clinical training at Baylor Affiliated Hospitals. Dr. Young is a fellow of the American College of Cardiology, American College of Physicians, American Heart Association, and the European Society of Cardiology. He is a diplomat of the American Board of Internal Medicine and the sub-specialty Boards of Cardiovascular Disease and Advanced Heart Failure and Cardiac Transplantation.

Suggested Citation:"Appendix B: Committee Biographical Sketches." 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:"Appendix B: Committee Biographical Sketches." 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 152
Suggested Citation:"Appendix B: Committee Biographical Sketches." 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 153
Suggested Citation:"Appendix B: Committee Biographical Sketches." 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 154
Suggested Citation:"Appendix B: Committee Biographical Sketches." 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 155
Suggested Citation:"Appendix B: Committee Biographical Sketches." 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 156
Suggested Citation:"Appendix B: Committee Biographical Sketches." 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 157
Suggested Citation:"Appendix B: Committee Biographical Sketches." 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 158
Opportunities for Organ Donor Intervention Research: Saving Lives by Improving the Quality and Quantity of Organs for Transplantation Get This Book
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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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