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OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would Strengthen Its Independence

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Protecting the rights of human subjects-individuals who volunteer to participate in research-is critical to ensuring their safety and public confidence in research conducted or supported by the Department of Health and Human Services (HHS). OHRP enforces compliance with HHS regulations for protecting human subjects. Congress and others have raised questions about OHRP's independence, and Congress requested that OIG review OHRP procedures and make recommendations to strengthen protections for human subjects and ensure OHRP's independence.


We analyzed data on OHRP's compliance activities for 2010 through 2015. We did a survey of research institutions that were the primary subjects of OHRP compliance evaluations about their experiences with OHRP. We also reviewed documents from eight compliance evaluations that had been closed. Finally, we interviewed OHRP staff, other HHS officials, and individuals with expertise in protections for human subjects.


OHRP appeared to carry out its compliance activities for protecting human subjects while maintaining its independence from the HHS agencies that fund the research and the institutions conducting the research. OHRP decided how to use its resources and, over time, initiated fewer compliance evaluations while increasing its use of other mechanisms in response to allegations. OHRP determined the scope of its evaluations and what methods to employ. Furthermore, OHRP was able-with some delays-to access the information it needed to conduct its compliance evaluations. Lastly, OHRP maintained its determinations. However, certain factors-varying interpretations of OHRP's role, its placement within HHS, and the way its budget is set- may limit or appear to limit OHRP's ability to act independently. In addition, OHRP's practice of not reporting publicly on all of its compliance activities may give the appearance of limited oversight and independence.


We recommend that HHS address factors that may limit OHRP's ability to operate independently. To accomplish this, HHS could (1) issue guidance that clarifies OHRP's role, (2) evaluate OHRP's position within HHS, and (3) evaluate the sufficiency of OHRP's resources and consider ways to elevate the prominence of its budget, such as including OHRP's budget as a line item in the President's budget. HHS should also foster a shared understanding for OHRP's independence by considering seeking statutory authority for OHRP's independence. We also recommend that OHRP post the following on its website: (a) a description of its approach to oversight and (b) data (in aggregate) regarding its compliance activities.