Final Human Immunodeficiency Virus (HIV) Organ Policy Equity (HOPE) Act Safeguar

[Clark]

https://www.federalregister.gov/articles/2015/11/25/2015-30172/final-human-immunodeficiency-virus-hiv-organ-policy-equity-hope-act-safeguards-and-research-criteria

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

A Notice by DEPARTMENT OF HEALTH AND HUMAN SERVICES and National Institutes of Health on 11/25/2015

SUMMARY
The U.S. Department of Health and Human Services (HHS), through the National Institutes of Health (NIH), announces the publication of Final Safeguards and Research Criteria for transplantation of HIV-positive donor organs in HIV-positive recipients. All such transplants must occur under an institutional review board (IRB)-approved research protocol that is compliant with federal regulations governing human subjects' research. The goal of this research is to increase knowledge about the safety, efficacy, and effectiveness of solid organ transplantation (SOT) utilizing HIV-positive donors in HIV-positive recipients.
A summary of public comments on the previously published Draft Safeguards and Research Criteria and HHS' responses follow, as well as the Final Safeguards and Research Criteria.

…

Living Donors
Several commenters stated that HIV-infected living donors may be at long-term risk for renal and/or liver disease and therefore their centers would not use HIV-infected living donors. Another commenter felt it was premature to embark on living HIV-positive donors without prior experience with deceased HIV-positive donors and recommended a staged approach. The Hope Act (2013) does not include any language addressing the use of living HIV-infected donors.
The long-term risks of living organ donation to the donor might be greater for those infected with HIV than for those who are not. At the same time, the desire to donate an organ, (e.g., to save or prolong a life) is strong, and evaluation of the risks and benefits of such a decision is personal and unique to a given donor/recipient pair. Evidence for the safety of organ donation by an HIV-infected individual will only be generated by clinical research. HHS has included living donors in these Safeguards and Research Criteria so that, if investigators choose to pursue this line of research, that research can be conducted with appropriate informed consent, safeguards, and rigor.
The decision to participate in HIV-positive to HIV-positive clinical research is made freely, based on informed consent in the absence of coercion. The health care team must provide a rigorous, transparent education and informed consent process that describes alternatives, risks, potential benefits, unknowns, and the need for long-term follow-up. These discussions must address how research-related injuries are managed and paid for, and must specifically include the present uncertainties about the outcomes for both HIV-positive living donors and the recipients of HIV-positive organs. Participation of knowledgeable, independent advocates for both the HIV-positive recipient and the HIV-positive donor is required by these Safeguards and Research Criteria.
…