A registered IRB can extend its federalwide assurance to a trial site, but the assurance doesn’t prove compliance, OHRP director Jerry Menikoff said.

OHRP provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the US Department of HHS. OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and behavioral research.