Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity Act
Summary

The Department of Health and Human Services HHS proposes to amend the regulations implementing the National Organ Transplant Act of 1984 as amended NOTA to remove clinical research and institutional review board IRB requirements research and IRB requirements for transplantation of kidney and livers from donors with human immunodeficiency virus HIV to recipients with HIV. As allowed by the HIV Organ Policy Equity HOPE Act the Secretary of HHS proposes to determine that participation in such clinical research should no longer be a requirement for transplantation of HIV positive kidneys and livers from donors with HIV to recipients with HIV. This proposed rule serves as publication of the Secretary's proposed determination and proposes to amend the regulations to reflect this determination. Consistent with NOTA and current regulatory requirements the Secretary's proposed determination and the proposed corresponding regulatory revision if finalized will necessitate that the Organ Procurement and Transplantation Network OPTN adopt and use standards of quality concerning kidneys and livers from donors with HIV as