The wait is over for investigators anticipating criteria for conducting research related to solid organ transplantation from one HIV-infected person to another. HHS developed and published the criteria—as mandated in the HIV Organ Policy Equity (HOPE) Act*—in the Federal Register. See the November 25, 2015 notice.
Representatives from NIAID, the National Institute of Diabetes and Digestive and Kidney Diseases, and CDC developed the criteria with input from other federal agencies, transplantation experts, and HIV medical professionals.
- Provide the framework for clinical studies of organ transplantation from HIV-infected donors to HIV-infected recipients to begin in the U.S. as early as 2016
- Aim to ensure that research in HIV-positive to HIV-positive organ transplantation is conducted safely and will provide a basis for evaluating the safety and effectiveness of this intervention
- Cover six broad categories:
- Donor eligibility
- Recipient eligibility
- Transplant hospital criteria
- Organ procurement organization responsibilities
- Prevention of inadvertent transmission of HIV
- Required outcome measures
Find criteria details in the Final HOPE Act Safeguards and Research Criteria for Transplantation of Organs Infected With HIV.
For additional background information, see the November 25, 2015 NIAID Bulletin.
*The HIV Organ Policy Equity (HOPE) Act was signed into law on November 21, 2013, and allows scientists to carry out research into organ donations from one HIV-infected person to another. Before the HOPE Act became law, organ transplantation from HIV-positive people was illegal in the U.S.