In a remarkable federal human subject research policy development, it appears that the U.S. Department of Health and Human Services (HHS) Secretary's Advisory Committee on Human Research Protections (SACHRP) has been disbanded. Formed in 2003, SACHRP was a federal advisory committee whose expert volunteers advised government agencies that regulate human subject research.
SACHRP provided advice and recommendations to HHS on a wide variety of cutting-edge human subject protection matters. Examples of recent SACHRP work product include guidance on decentralized clinical trials, research involving children and the use of artificial intelligence in human subject research.
SACHRP was scheduled to meet on March 19, 2025, but that meeting was canceled, and the SACHRP website shows no upcoming meetings.
SACHRP was part of the Office for Human Research Protections (OHRP) and also advised on OHRP policy. The overall impact on OHRP operations as a result of recent cuts to HHS remains unclear. Given that SACHRP was comprised entirely of volunteers, termination of this committee will have only a negligible impact on government expenditures – but the loss of this expert panel will immediately decrease sophisticated expertise on ethical and legal issues important to human subject research protections.
Holland & Knight attorneys familiar with the congressional and political landscape surrounding this issue will continue to monitor these developments, including ongoing legal challenges.
