Human subject protections in clinical research: OHRP and whistle blower protections

As we reported in a prior publication, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently published a report entitled “OHRP Generally Conducted Its Compliance Activities Independently, But Changes Would Strengthen Its Independence.” In that report, the OIG found that the Office of Human Research Protections (OHRP) generally carried out its compliance activities for protecting human subjects independently, but it made suggestions for how to improve OHRP’s oversight activities. Following up on that report, the OIG recently published a “companion” report to the July 2017 report discussing the implications of the fact that OHRP does not provide information on whistleblower protections to complainants who disclose alleged noncompliance with protections of human subjects.

OHRP is the federal agency charged with receiving and responding to alleged violations of protections for human subjects in research conducted or supported by HHS. If OHRP identifies noncompliance with regulations, either through a for-cause compliance evaluation or through direct contact with the research institution involved, OHRP can take a variety of actions, including requiring the institution to take corrective action, restricting or suspending research at the institution, or even recommending that an institution or investigator be debarred from receiving federal funds for research. 

Employees of research institutions, including researchers and study coordinators with inside knowledge, can help identify noncompliance earlier than other complainants or OHRP’s own oversight activities. OHRP, therefore, relies on information from these complainants in ensuring protection for human subject volunteers in HHS-supported research.  

Protections for these insider-complainants, or whistleblowers, from retaliation such as demotion, suspension or termination is available in some circumstances when an HHS contractor, subcontractor, grantee or subgrantee takes a prohibited employment action against an employee for making a “protected disclosure.” Available protections for whistleblowers include job restoration, reversal of suspension, back pay, and reasonable and foreseeable damages such as medical costs and attorney fees.  OIG’s latest report focuses on the fact that reporting suspected noncompliance to OHRP is not considered a “protected disclosure” that would shield a complainant from retaliation. For an employee’s disclosure to be considered protected, it must meet each of the following criteria:

1. The disclosure is information that the employee 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.
2. The complainant’s employer must have knowledge of the complainant’s protected disclosure.
3. The disclosure must be made to specific individuals and entities, such as the OIG, the officials of the grant-awarding agency (such as the National Institutes of Health (NIH)) who are responsible for grant oversight and management; or a relevant employee of the contractor, subcontractor, grantee or subgrantee who has the responsibility to investigate employee misconduct.

The issue noted by the OIG is that disclosures to OHRP and other regulatory oversight agencies do not qualify as “protected disclosures” for the purposes of whistleblower protections. nd when a complainant discloses an instance of possible noncompliance to OHRP, OHRP does not inform complainants of how they can potentially obtain whistleblower protections by reporting their allegations to the OIG or the HHS grant-awarding agency even when the complainant expresses concerns about fear of reprisal. As a result, some instances of noncompliance may go unreported due to fear of retaliation, which may hamper OHRP’s effectiveness if allegations of potential noncompliance are not reported due to this fear. To address this, the OIG recommended that OHRP: (1) inform potential complainants of how they can seek whistleblower protections by reporting their allegations of noncompliance to the OIG or the HHS awarding agency, (2) post information about how to obtain whistleblower protection prominently on the OHRP website, and (3) include information about obtaining whistleblower protections in routine outreach to research institutions. The OIG also recommended that HHS consider the adequacy of whistleblower protections for complainants who make disclosures to OHRP to determine whether HHS should seek legislative change to enable OHRP to receive protected disclosures.

While this OIG report highlights a potential gap in the system that is intended to protect whistleblowers and encourage individuals to report instances of possible noncompliance, it also should serve as a reminder to institutions where HHS-supported research is performed (including research funded by NIH) that compliance programs should extend to clinical research taking place in their facilities. Research institutions should ensure that individuals working in areas where clinical research is performed are aware of how to report suspected instances of noncompliance internally through a disclosure hotline or to the compliance office. Failure to prevent and detect possible noncompliance with applicable laws affecting protection of human subjects in clinical research, as well as billing compliance with respect to clinical research trials, could subject an institution to substantial penalties.