Executive Summary

The HIV Organ Policy Equity Act (HOPE Act), enacted on November 21, 2013, allows research to be conducted on the transplantation of organs from donors infected with HIV into individuals who are infected with HIV before receiving such organ. The legislation required the OPTN to revise its policies “not later than 2 years after the enactment” to allow this research to begin. The HOPE Act also states that “not later than 4 years after the date of enactment and annually thereafter, the Secretary shall review the results of scientific research in conjunction with the Organ Procurement and Transplant Network to determine whether the results warrant revision of the standards of quality.”

Though the OPTN/UNOS policies went into effect on November 21, 2015, creating a variance to permit the research to be conducted, the policy does not explicitly address how the OPTN will work with the Secretary to review the results of the research. OPTN/UNOS leadership discussed the OPTN’s role in this review, and recommended modifying the variance to require members participating in a HOPE Act research study to provide periodic reports from their data safety monitoring boards to the OPTN. On October 19, 2015, under the authority granted by OPTN/UNOS Bylaw 11.7: Emergency Actions, the OPTN/UNOS Executive Committee approved this requirement to meet the statutory deadline outlined in the HOPE Act. Bylaw 11:7 requires policies adopted as an emergency action “to be distributed for public comment no more than 6 months after approval.”