Clarification – HOPE Act IRB protocols and individual IRB candidate applicability

Published on: Wednesday, May 14, 2025

In response to a recent HRSA directive, the Organ Procurement and Transplantation Network (OPTN) will soon consider adoption of revised policies and requirements for transplantation under the HIV Organ Policy Equity (HOPE) Act for liver, kidney and combined liver-kidney candidates.

While these revisions are expected to be approved and implemented soon, the current HOPE Act provisions in OPTN policy continue to apply to transplant programs wishing to use organs from donors with HIV to treat candidates living with HIV. These provisions are specifically addressed in OPTN Policy 15.7: Open Variance for the Recovery and Transplantation of Organs from HIV Positive Donors.

• These requirements apply even if the transplant program has a single transplant candidate, or a small group of candidates, who may qualify for transplantation under the HOPE Act.
• If the program intends to list and treat only a single candidate, the OPTN will accept an institutional review board (IRB) for a single candidate, as long as all other standards are met.
• There is no specific restriction on pediatric candidates, so an IRB that includes provisions for pediatric candidates is acceptable as long as all other standards are met.

What you need to know

Transplant programs are still responsible for ensuring that until IRB approval is granted, non-approved candidates do not receive access to organs from donors with HIV. In addition, programs with an IRB but seeking any additional patient or program-level approval must provide updated approval documentation to the OPTN.

The program must have two separate providers from the institution separately and independently affirm on the candidate’s record that the candidate is living with HIV and is willing to accept an organ from a donor with at least one positive HIV test. If the patient is not of legal age of consent, the patient’s legal guardian must consent. Programs are responsible for ensuring approvers only approve candidates with IRB approval.

In addition, the same OPTN policies and processes to mitigate risk of unintentional HIV transmission will apply regardless of whether the IRB addresses a single candidate or multiple candidates. These requirements are addressed in the following policies:

• OPTN Policy 2.7: HIV Screening of Potential Deceased Donors
• OPTN Policy 2.9: Required Deceased Donor Infectious Disease Testing
• OPTN Policy 5.4.E: Allocation to Candidates Not on the Match Run
• OPTN Policy 15.2: Candidate Pre-Transplant Infectious Disease Reporting and Testing Requirements
• OPTN Policy 15.3: Informed Consent of Transmissible Disease Risk
• OPTN Policy 15.7: Open Variance for the Recovery and Transplantation of Organs from HIV Positive Donors

How long will the current requirements be in place?

These requirements will remain in place until the expected implementation of updated policies and standards. Among the key items expected to change would be the elimination of IRB requirements for kidney or liver transplant candidates. IRBs would still be required for transplant of any other organ type.

Additional resources and information

The HOPE Act resource page on the OPTN website contains current information about the process and requirements, as well as Frequently Asked Questions. It will be updated with additions and changes as approved to meet the HRSA directive.

You may also reach out to member.questions@unos.org for additional information or clarification.