The HIV Organ Policy Equity Act, enacted on November 21, 2013, will allow for the development and publication of criteria for research relating to transplantation of organs from donors infected with HIV into individuals who are infected with HIV before receiving such organ.
The OPTN’s Organ Procurement Organization Committee distributed an initial public comment proposal in 2014 to remove the prohibition on recovering and transplanting organs from HIV positive donors. A subsequent proposal to create an open variance was distributed in January 2015. It also outlined specific requirements for transplant hospitals and OPOs participating in the recovery and transplantation of HIV positive organs. Both proposals received overwhelming support, and the OPTN/UNOS Board of Directors approved the policy language in June 2015.
The National Institutes of Health, U.S. Department of Health and Human Services published a Federal Register notice on June 18, 2015 seeking public comment criteria for research involving the transplantation of organs from HIV-positive donors to HIV-positive candidates. The public comment period ends on Aug. 17, 2015 at 5:00 p.m. The criteria are being developed in accordance with the HIV Organ Policy Equity Act, also known as the HOPE Act. The goals of the proposed criteria are to ensure that research using organs from HIV-positive donors is conducted in ways that protect the safety of research participants and the general public and to ensure that the research results may be used to evaluate the safety of organ transplantation from HIV-positive donors to HIV-positive recipients.
What members need to do to participate?
- Once the NIH finalizes the research criteria (the deadline is Nov. 21, 2015), transplant programs can begin the IRB approval process based on the requirements outlined in the regulations. Transplant programs must notify the OPTN Contractor in writing that they have Hope Act IRB approval that meets all the requirements in the research criteria. The OPTN Contractor will document and track in the UNOS Membership Database when an active kidney or liver transplant program has Hope Act IRB approval to participate. If transplant programs lose HOPE Act IRB approval, they must notify the OPTN contractor in writing.
- Transplant programs with Hope Act IRB approval will be able to indicate in Waitlist, the HIV status/willingness of the candidate to accept an HIV positive kidney/liver. A second user must verify the HIV status/willingness of the candidate to accept an HIV positive kidney/liver as outlined in Policy 15.6 (Open Variance for the Recovery and Transplantation of Organs from HIV Positive Donors).
- On November 19, 2015, OPOs will be able to run liver and kidney matches for HIV positive donors. Only candidates from centers that have HOPE Act IRB approval and whose HIV status/willingness to accept an HIV positive kidney/liver has been verified by a second user will appear on HIV positive kidney and liver match runs.