Device sponsors need to consider more than an institutional review board’s (IRB) registration with the Health and Human Services (HHS) Office for Human Research Protections (OHRP) when choosing a board to oversee their clinical trials. OHRP registration is not a guarantee that the IRB has the appropriate competence or expertise to review a particular research project, OHRP says in a clarification posted recently on its website.
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.