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Report on Organ Donor Intervention Research Released Today

Oct 10, 2017

Opportunities for Organ Donor Intervention Research: Saving Lives by Increasing the Quality and Quantity of Organs for Transplantation, a new report from the National Academies of Sciences, Engineering, and Medicine, examines supply and demand in the U.S. organ transplantation system and assesses ethical, regulatory, policy, and operational issues relevant to organ donation and participation in organ donor intervention research.

The Committee on Issues in Organ Donor Intervention Research examined gaps, barriers, and opportunities for clinical research involving deceased donors with the aim of increasing the quality and quantity of organs donated for transplantation. The American Society of Transplant Surgeons is a sponsor of the study and was the first to announce funding for the project.

The committee has recommended the establishment of a national oversight body supported by a dedicated IRB to evaluate, enable, and ensure safety in donor intervention research. Among the committee’s recommendations are template language for all U.S. organ donor registries to explain organ donation options; standardized talking points for communicating with donor surrogates and families about organ donor intervention research; the coordination of all U.S. organ donor registries into a single national registry accessible to OPOs; clarification of legal guidance on donor research followed by transplantation; development of a protocol for informed consent for recipients’ participation in organ donor intervention research; and the development of tools to enable the implementation, tracking, and analysis of organ donor intervention research to improve transplant outcomes.

This work is timely in that progress in donor management through research will help save more lives through transplantation. ASTS members Sandy Feng, MD, PhD, and Peter L. Abt, MD, whose foresight and engagement contributed to the genesis of these efforts, stated that the report was “comprehensive, balanced, thoughtful, and yet practical.” The document “strongly affirms the importance and necessity of donor intervention research, delineated the obstacles, and articulated a path to ensure the safe and ethical conduct of these trials. The report unambiguously mandated the organ donation and transplant community to embark on this path.” They also noted that the recommendations, if enacted, will broadly improve the efficiency of organ donation and transplantation processes, thereby yielding benefits that extend beyond donor intervention research.

Members of the committee that conducted the study and wrote the report will present their findings and recommendations and answer questions during a public webinar beginning at 2 p.m. EDT on Thursday, Oct. 19. You can register for the webinar here.

Findings from the report will also be presented during a session at the ASTS 18th Annual State of the Art Winter Symposium January 11-14, 2018, in Miami.

More information, including the complete report, is available here.