The U.S. Department of Health and Human Services (“HHS”) and the National Institutes of Health (“NIH”) have recently announced significant updates to the implementation of the HIV Organ Policy Equity (“HOPE”) Act (42 U.S.C. § 274f-5). These changes, published in the Federal Register on November 27, 2024, and December 30, 2024, mark a pivotal shift in organ transplantation policy by eliminating the requirement for institutional review board (“IRB”) approved research protocols and compliance with HHS research standards for kidney and liver transplants from donors with HIV. Additionally, they streamline the research criteria for all other organ transplants involving patients with HIV. These updates are designed to increase the availability of organs and improve equity in transplantation for recipients with HIV.
Background
Enacted in 2013, the HOPE Act established a framework for organ transplants from donors with HIV to recipients also living with HIV, provided that the recipients participated in an IRB-approved research protocol. Subsequently, the NIH issued its Final Revised Human Immunodeficiency Virus (HIV) Organ Policy Equity Act Safeguards and Research Criteria for the Transplantation of Organs from Donors with HIV (referred to as the “Research Criteria”) on November 25, 2015, which outlined safeguards to protect both donors and recipients under the HOPE Act.
The HOPE Act gave HHS, in consultation with the Organ Procurement and Transplantation Network (“OPTN”), the authority to waive clinical research requirements for the transplantation of organs from donors with HIV to recipients with HIV based on scientific evidence. Recent scientific studies, including a recent NIH and HHS-funded research study demonstrating the noninferiority of kidney transplants from HIV-positive donors, led Secretary Becerra to conclude that IRB and research requirements for kidney and liver transplants were unnecessary.
In a final rule published on November 27, 2024 (“Final Rule”), HHS removed the condition that kidney and liver transplants conducted under the HOPE Act occur exclusively within an IRB-approved research protocol. Accordingly, transplant programs may now perform kidney and liver transplants from donors and recipients with HIV without needing to first obtain IRB approval, as long as standard OPTN safety and quality measures are followed. This regulatory shift aligns with ongoing initiatives to expand the total number of eligible organ donors, reduce average wait times for organ transplant and maximize the use of transplantable organs.
In announcing the Final Rule, Secretary Becerra remarked, “This rule removes unnecessary barriers to kidney and liver transplants, expanding the organ donor pool and improving outcomes for transplant recipients with HIV.” By eliminating the research requirement, HHS anticipates that access to kidney and liver transplants for individuals with HIV will improve as more transplant centers will be eligible to participate in HOPE Act procedures.
Revisions to Research Criteria for All Other HOPE Act Transplants
Following the publication of the HHS Final Rule, the NIH released a complementary update to its Research Criteria on December 30, 2024. This update removes certain requirements specific to kidney and liver transplants and re-focuses the Research Criteria on transplants involving other organs, such as hearts and lungs.
The revised Research Criteria eliminates several previous requirements, including the following:
- Transplant Program Experience: The requirement for transplant programs to demonstrate organ-specific transplant experience from a donor without HIV to a recipient with HIV has been removed from the Research Criteria; however, transplant programs must still demonstrate that they maintain a program for the care of patients with HIV and include an individual with HIV program expertise on the transplant team.
- Pre-Implementation Biopsies: NIH has also removed the requirement for mandatory pre-implantation donor organ biopsies. Although such pre-implementation biopsies are typically performed for kidneys and livers, they are not routinely performed for other donor organs.
- CD4+T-Cell Count Requirements: The requirement for minimum threshold CD4+T-Cell counts for recipients when all other eligibility criteria are met, has been removed.
- Advocacy Requirements: The requirement that donors and recipients with HIV each have an independent advocate, beyond standard site practices, has been eliminated. The NIH noted in the revised Research Criteria that the current OPTN policy already requires that all living donors have an independent advocate. As such, many commentators viewed this additional requirement as redundant and a potential barrier for HIV patients seeking organ transplants.
Additionally, the NIH updated the Research Criteria to include several new data elements and outcome measures. They also adopted person-first language to reduce stigma, replacing phrases like “HIV-infected organs” with “organs from donors with HIV.” This change reflects a broader effort to use more inclusive and respectful terminology in clinical and regulatory settings.
It is important to note that the Research Criteria still apply to multiple organ transplants if the transplant of any of the organs remains subject to the revised criteria. For example, a dual heart-kidney transplant from a donor with HIV would still need to be conducted under an IRB-approved protocol and in accordance with the HHS research regulations, as well as the Research Criteria, since the Secretary of HHS has not removed the clinical research requirements for heart transplants occurring under the HOPE Act.
Practical Takeaways
- Kidney and liver transplants from donors with HIV to recipients with HIV can now proceed without the administrative burden of research protocols, simplifying processes and accelerating timelines for the transplant of such organs. These updates present a critical opportunity for Organ Procurement Organizations (“OPOs”) and transplant programs to expand access to kidney and liver transplants for patients living with HIV.
- OPOs and transplant programs should update internal guidelines, staff training and patient communication materials to reflect the new regulatory landscape and ensure compliance with the revised standards.
- For organs other than kidneys and livers, IRB oversight and compliance with research regulations and the NIH Research Criteria are still required. As such, transplant centers engaging in heart and lung transplants under the HOPE Act should ensure their research protocols align with OPTN policies and the updated NIH Research Criteria.
By embracing these regulatory changes, OPOs and transplant centers can contribute to reducing organ shortages and enhancing equity in transplantation, ultimately improving outcomes for individuals living with HIV.
If you have any questions or would like additional information on this topic, please contact:
- Liza Brooks at (248) 457-7852 or lbrooks@hallrender.com;
- Lori Wink at (414) 721-0456 or lwink@hallrender.com;
- Megan Culp at (317) 429-3644 or mculp@hallrender.com;
- An additional member of Hall Render’s Transplant & Organ Procurement service line; or
- Your primary Hall Render contact.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
