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The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently conducted a study on the Office of Human Research Protection’s (OHRP) independence in conducting research compliance activities. OHRP enforces compliance with HHS regulations for protecting human subjects in research. OHRP’s mission is to protect the rights of human subject volunteers that participate in HHS conducted or supported research. Previous congressional requests raised questions about OHRP’s independence, which led to the OIG’s study. Specifically, Congress requested the OIG to review OHRP procedures, and make recommendations to strengthen protections for human subjects and ensure OHRP’s independence.
The OIG surveyed research institutions that were the primary subjects of OHRP’s compliance evaluations about their experiences. The OIG also reviewed documents from eight closed compliance evaluations and interviewed OHRP staff, other HHS officials, and individuals with expertise in protections for human subjects.
The OIG reported the following findings:
- OHRP carried out its compliance activities independently from agencies funding the research and the institutions conducting the research;
- OHRP’s decisions on resource-utilization have resulted in fewer compliance evaluations, while increasing its use of other mechanisms in response to allegations;
- The OIG determined the scope of its evaluations and what methods to employ;
- The OIG was able to access the information it needed to conduct its compliance evaluations;
- OHRP maintained documentation on its determinations;
- OHRP’s role, placement within HHS, and its budget may limit or appear to limit its ability to act independently; and
- OHRP’s practice of not publicly reporting all of its compliance activities may give the appearance of limited oversight and independence.
The OIG requested that HHS:
- Issue guidance that clarifies OHRP’s role;
- Re-evaluate OHRP’s position within HHS;
- Evaluate the sufficiency of OHRP’s resources;
- Consider ways to elevate the prominence of OHRP’s budget;
- Foster a shared understanding for OHRP’s independence by potentially seeking statutory authority for OHRP’s independence; and
- Require OHRP to post on its website: (a) a description of OHRP’s approach to oversight; and (b) data (in aggregate) regarding OHRP’s compliance activities.
The OIG Report can be found at: https://oig.hhs.gov/oei/reports/oei-01-15-00350.pdf.