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OHRP Should Inform Potential Complainants of How They Can Seek Whistleblower Protections


OHRP receives and responds to alleged violations of protections for human subjects in research conducted or supported by the Department of Health and Human Services (HHS). Employees of research institutions (e.g., researchers or study coordinators) with insider knowledge of the circumstances can help identify noncompliance in human subjects research earlier than other complainants or OHRP oversight activities. Such information allows OHRP to address any noncompliance, hold institutions accountable, minimize risk to human subject volunteers, and ensure public confidence in federally funded research. However, when employees are considering whether to disclose information about potential noncompliance, they may fear reprisal, such as demotion, suspension, or termination. Under certain circumstances, employees at research institutions with HHS-funded grants or contracts may be entitled to relief commonly called "whistleblower protections." Such protections may be available if an HHS contractor, subcontractor, grantee, or subgrantee takes a prohibited employment action (e.g., termination) against an employee for making a "protected disclosure." For complainants who fear reprisal, information regarding whistleblower protections may encourage disclosures of noncompliance.


We analyzed data on OHRP's compliance activities for 2000 through 2015. We reviewed OHRP's administrative files from eight closed compliance evaluations and an open incident report. Five of the eight compliance evaluations we reviewed were for-cause evaluations and included documentation of the complaint reported to OHRP. If the complainant requested whistleblower protections or reported concerns of retaliation that could adversely impact his or her career, we considered that to be evidence of fear of reprisal. Finally, we conducted interviews with OHRP staff, HHS officials outside of OHRP, and individuals with expertise in protections for human subjects.


OHRP reported that it often gets requests from complainants for whistleblower protections and that some complainants have chosen not to report suspected noncompliance to OHRP because it does not have the statutory authority to offer such protections. In addition, of the five closed OHRP compliance evaluations we reviewed that were prompted by complaints, four had evidence of a fear of reprisal.


We recommend that OHRP inform complainants of how they can potentially obtain whistleblower protections by reporting their allegations of noncompliance with human subject protections to entities such as OIG or the HHS agency that funds the research. OHRP should post this information prominently on its website and include it in routine outreach to research institutions. We also recommend that OHRP request that HHS consider the adequacy of whistleblower protections for complainants who make disclosures to OHRP about human subjects protections. Elevating this issue would prompt HHS to consider whether a broad review of whistleblower protections is appropriate and whether it should seek a legislative change that enables OHRP and other HHS entities to receive protected disclosures. The Office of the Assistant Secretary for Health concurred with our recommendations.