Lack of Whistleblower Protections Impacts Reports of Noncompliance

Mary Buckley


Aegis Compliance & Ethics, LLP

Lack of Whistleblower Protections Impacts Reports of Noncompliance

A report from the HHS Office of Inspector General (“OIG”) indicates that complainants often refrain from reporting information about alleged noncompliance with protections for human subjects to the Office for Human Research Protections (“OHRP”), because the agency lacks the authority to offer whistleblower protections. Information about alleged misconduct provided to OHRP officials does not qualify as a “protected disclosure” from which a complainant can receive whistleblower protections. Those with information regarding noncompliance with human subject protections, however, can disclose such allegations to other regulatory agencies and receive protections from those agencies. In its report, the OIG requests that OHRP make greater efforts to inform potential complainants of ways to receive whistleblower protections and asks that HHS consider the appropriateness of whistleblower protections for such complainants.

Overview of Whistleblower Protections

Whistleblower protections ensure that workforce members reporting compliance concerns receive job security or other similar assurances when they choose to report alleged misconduct. A workforce member may receive whistleblower protections if an HHS contractor, sub-contractor, grantee, or sub-grantee takes “prohibited employment action” (i.e. retaliation) against him or her for making a protected disclosure. A protected disclosure is defined as:

  1. A disclosure of information that the workforce member “reasonably believes is evidence of a substantial and specific danger to public health or safety, or a violation of law, rule, or regulation related to the HHS contract or grant,” and
  2. A disclosure made to “specific individual and entities, such as the OIG, the official of the grant-awarding agency (e.g. the National Institutes of Health) that is responsible for grant oversight and management; or a relevant employee of the contractor, sub-contractor, grantee, or sub-grantee who has the responsibility to investigate employee misconduct.”

If a workforce member who makes a protected disclosure is subject to prohibited employment action, he or she may file a complaint with the OIG and receive a variety of forms of compensation for such action, provided he or she can prove that she made a protected disclosure, and the employer had knowledge of the disclosure and took prohibited action against the workforce member because of that disclosure.

OIG Report Findings

The results of the OIG’s investigation into the impact of OHRP’s lack of authority to offer whistleblower protections were telling. OHRP indicated that it receives requests for whistleblower protections and at times, complainants refrain from reporting instances of noncompliance because of OHRP’s lack of authority to offer such protections. The OIG sampled five compliance evaluations to understand the effect that whistleblower protections, or lack thereof, has on workforce member reports of noncompliance. The OIG found that in four out of the five compliance evaluations reviewed, workforce members feared retaliation in response to reporting human subject protection violations. In every evaluation, the complainants communicated their concerns to OHRP, despite fearing retaliation. It is important to remember, however, that the OIG’s investigation could not account for reports of noncompliance with human subject protections that workforce members never actually made due to fear of reprisal.

Recommended Action

As a result of its findings, the OIG recommends that OHRP inform complainants of how they can potentially obtain protections by either 1) reporting alleged noncompliance to another agency, 2) OIG or the HHS agency awarding research grants, and 3) by posting on websites and including the information in routine outreach to research institutions. OIG also requests that HHS review the adequacy of whistleblower protections. This could help HHS determine whether it should seek a legislative change that enables OHRP and other HHS entities that are not responsible for contract or grant oversight management to receive protected disclosures and thereby offer whistleblower protections to those seeking them.

Impact on Research Institutions

The OIG’s report reflects the importance of cultures of compliance within research institutions. Not only is it imperative for institutions to have channels of communication so that workforce members feel empowered to voice suspected instances of noncompliance, but institutions must also implement policies and training that reflects non-tolerance for any retaliation against a workforce member for voicing such concerns.


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