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Update: IOM Donor Management Research Study

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David P. Nelson, MD
Integris Baptist Medical Center
Oklahoma City, OK, USA

As previously reported in Links, two HRSA funded donor management research consensus conferences were held in Crystal City, November 2014 and Philadelphia, May 2015 to define barriers to donor management research and explore their possible solutions. The conferences recommended that a national oversight board be developed to assess ethical and scientific merit and provide safety monitoring for these studies and observed that the existing network of regulations which safeguards us from human research abuse is a misfit for donor related research in the complex context of organ allocation. In response to efforts of the consensus conferences and others the Institute of Medicine (now National Academy Medicine) has initiated a study to "examine the ethical, policy, regulatory, and operational issues relevant to the conduct of research involving deceased organ donors...that aims to increase the quality and quantity of donated organs".

A criteria for IOM committee membership for this project was that the member not be currently active in transplantation or procurement. This criteria was established to avoid bias or conflict of interest in the work of the committee. However, input from the transplant and procurement communities is invited, specifically sought as needed, and actively engaged in scheduled public sessions of the committee with invited speakers from these communities. The first of these public sessions occurred at the National Academy of Sciences building in Washington DC on September 29 when representatives of the sponsoring organizations shared their perspectives and hopes with the committee.

The IOM committee has 12 members, 7 of whom are physicians, two are attorneys and 2 are former transplanters. Membership includes representation from the OPO community, pediatrics, one of the physicians is a liver transplant recipient, another physician is former Surgeon General of United States and there is significant representation from the ethics community. The two former transplanters are abdominal surgeon William Marks from Seattle and cardiologist Jim Young from the Cleveland clinic.

The chair of the committee is James Childress PhD who is emeritus Prof. of Ethics and Religious Studies at the University of Virginia. He is author of several textbooks on biomedical ethics, former chair of the National Task Force on Organ Transplantation, has served on the UNOS board of directors and the UNOS ethics committee. He was a member of the presidentially appointed National Bioethics Advisory Commission, he is a member of the National Academy of Medicine and has chaired several studies by the Academies.

Academies staff Study Directors are Cathy Liverman and Sarah Domnitz. The study sponsors are the Laura and John Arnold Foundation, American Association for the Study of Liver Diseases, American Society of Transplant Surgeons, American Society of Transplantation, The Association of Organ Procurement Organizations, the Gift of Life Donor Program, National Kidney Foundation, National Heart Lung and Blood Institute, the National Institute of Allergy and Infectious Diseases, the National Institute of Diabetes and Digestive and Kidney Diseases, and the Transplantation Society. Additional agencies and organizations may potentially later co-sponsor the project.

The next public session at the National Academy is December 15 when the following 6 panel presentations will occur: 1) impact of research on organ donation recovery and transplantation; 2) barriers, opportunities, and lessens learned from organ donor intervention research; 3) future approaches to organ donor intervention research study design; 4) federal perspectives on organ donor intervention research; 5) public awareness and public trust; and 6) ethical and legal considerations. Speakers will include Dave Klassen from UNOS, Bert Kasiski of SRTR, Jim Gleason of TRIO and former UNOS Pres. Tim Pruett.

The ISHLT is providing the IOM project with outcome metrics developed by the Heart and Lung Scientific Councils intended to address the potential for unmonitored adverse effects of donor research occurring to organs not primarily targeted by a study (e.g. a kidney study having unexpected cardiac or pulmonary consequences). The metrics were a charge to professional transplant societies by the HRSA's Donor Management Task Force in 2011. ■

Disclosure Statement: The author has no conflicts of interest to disclose.

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