Kusserow on Compliance: OIG report on research compliance through OHRP

The OIG conducted a study of the Office of Human Research Protection (OHRP) at HHS in response to Congressional requests that raised questions about its independence. The request was for the OIG to review OHRP procedures and make recommendations to strengthen protections for human subjects and ensure OHRP’s independence. OHRP enforces compliance with HHS regulations for protecting human subjects. Its mission is to protect the rights of human subjects-individuals who volunteer to participate in research conducted or supported by the HHS. The OIG conducted a survey of research institutions that were the primary subjects of the compliance evaluations about their experiences with the OHRP. The OIG also reviewed documents from eight compliance evaluations that had been closed; and interviewed OHRP staff, other HHS officials, and individuals with expertise in protections for human subjects.

OIG findings regarding OHRP

The OIG found that OHRP:

  • evidenced carrying out its compliance activities independently from agencies funding the research and the institutions conducting the research;
  • made decisions on how to use resources, resulting in fewer compliance evaluations, while increasing its use of other mechanisms in response to allegations;
  • determined the scope of its evaluations and what methods to employ;
  • was able to access the information it needed to conduct its compliance evaluations;
  • maintained documentation on its determinations;
  • may be limited in its ability to act independently due to its role, placement within HHS, and the way its budget is set may limit; and
  • may have the appearance of limited oversight and independence due to the practice of not reporting publicly on all of its compliance activities.

OIG Recommendations to HHS

The OIG recommended that HHS:

  1. issue guidance that clarifies OHRP’s role;
  2. re-evaluate OHRP’s position within HHS;
  3. evaluate sufficiency of OHRP’s resources;
  4. consider ways to elevate the prominence of OHRP’s budget (e.g. having a separate line item in the President’s budget);
  5. foster a shared understanding for OHRP’s independence by considering seeking statutory authority for OHRP’s independence; and
  6. post on OHRP’s website: (a) a description of its approach to oversight and (b) data (in aggregate) regarding its compliance activities.

 

 

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

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Copyright © 2017 Strategic Management Services, LLC. Published with permission.