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

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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.