Status: Public Comment
Sponsoring Committee: Ad Hoc Disease Transmission Advisory Committee
Strategic Goal 1: Increase the number of transplants
Read the proposal (PDF; 1/2019)
Contact: Emily Ward
The HIV Organ Policy Equity Act was enacted on November 21, 2013, permitting use of organs from HIV- positive donors for transplantation into HIV-positive candidates under approved research protocols designed to evaluate the feasibility, effectiveness, and safety of such organ transplants. In November 2015, OPTN/UNOS policies for recovery and transplantation of HIV positive livers and kidneys to HIV-positive candidates were effective, in addition to final research requirements for program participation, published by the National Institutes of Health (NIH).
This proposal modifies the policies enacted by the OPTN/UNOS HOPE Act Variance to allow programs meeting the research and experience requirements to recover and transplant organs in addition to liver and kidney. Program participation requirements, including meeting minimum experience, operating under an approved Institutional Review Board (IRB), and adhering to the federal research protocol guidelines, remain unchanged.
No clinical outcomes that may threaten the safety of such transplants have been reported to the OPTN/UNOS since 2015. Expansion of the variance to include other organs besides kidney and liver has been requested by active program participants. Federal criteria do not limit the program to specific organ transplants, and explicitly encouraged future expansion of the program upon publishing research study participation criteria in November 2015.