Draft Revised Human Immunodeficiency Virus (HIV) Organ Policy Equity Act Safeguards and Research Criteria for Transplantation of Organs Infected With HIV

The HOPE Act requires the Secretary of Health and Human Services (the Secretary) to develop and publish criteria for research involving the transplantation of organs from donors with HIV to recipients with HIV. In 2015, the National Institutes of Health (NIH), and the U.S. Department of Health and Human Services (HHS) published research criteria applicable to such transplants, which have been in effect for all transplants involving organs from donors with HIV as authorized by the HOPE Act. As amended in an HHS final rule published elsewhere in this issue of the Federal Register, the Secretary determined that participation in clinical research should no longer be a requirement for the transplantation of kidneys and livers from donors with HIV to recipients with HIV and amended the HHS regulations governing the operation of the Organ Procurement and Transplantation Network (OPTN) to reflect this determination. As a result, HOPE Act transplants involving kidneys and livers from donors with HIV no longer need to comply with the research criteria. Given this regulatory change, NIH proposes to delete aspects of the research criteria that are specific to kidney and liver transplantation. NIH proposes additional changes to the research criteria based on its review of scientific evidence and in consideration of prior public feedback concerning the criteria, including comments provided in the recent rulemaking procedure that modified the OPTN regulations. NIH invites the public to submit comments regarding the proposed changes to the research criteria.