The Department of Health and Human Services (HHS) is taking measures to protect whistleblowers who express concern about human research trials, agreeing with a government watchdog report that the current system has a chilling effect due to “fear of reprisal.”1
“We concur with the recommendations in the report,” Don Wright, MD, MPH, acting assistant secretary of HHS, wrote in a letter to the Office of Inspector General (OIG).
The HHS Office for Human Research Protections (OHRP) “will inform complainants of how they can potentially obtain whistleblower protections by concurrently reporting their allegations of noncompliance with human subject research protections to entities such as OIG or the HHS-awarding agency,” Wright wrote in the letter. “This information will be posted on OHRP’s website for complainants to potentially obtain whistleblower protections.”
OIG reported that complainants about human research may include the subjects in the trial, employees of a research facility, and other advocates for safe and ethical trials.
“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,” OIG reported. “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. For such complainants, information regarding whistleblower protections may encourage disclosures of noncompliance.”
While the report did not give specific examples, an OIG representative provided IRB Advisor with descriptions of some of the incidents reviewed in making the recommendations, summarized as follows:
- A complainant provides several examples of noncompliance, particularly with cancer research trials. The allegations include the research is not reviewed by the IRB, researchers are not following IRB procedures/paperwork submissions, and the IRB has no protocols for the reporting of adverse events.
- Complainant on a medical center nursing staff that assists with neurosurgeries alleges that when patients sign up for a particular research study, the surgeon delays surgery a few weeks in order to obtain the appropriate research equipment for the surgery. The nurse believes this is not in the best interest of the patients. Other nurses have voiced concerns, but were reassigned.
- A resident in the ophthalmology service of a large hospital alleges children and adults are enrolled in research that is not IRB-approved. Research involves injection of chemotherapy to treat retinoblastomas and there have been adverse events. Many research participants do not speak English, informed consent is inadequate, and consent forms are not provided in the participant’s native language. Complainant is not comfortable complaining and does not want retaliation.
- Complainant is a student-athlete with a university scholarship and needs to be cautious because allegations could affect his situation and career. He alleges that students do not have a choice about whether to participate in athletic testing research. The coach is in the room during the informed consent process and the student alleges that the research has blanket IRB approval, meaning that additional testing can be included without additional consent. The researchers are coaches as well as teachers, so students feel that refusing to participate may result in poor grades and/or a loss of their scholarships.
Step Up Protections
While those seem to be valid concerns, the problem arises in reporting the incidents in a protected manner that would ease fears of retribution.
“Under certain circumstances, employees at research institutions with HHS-funded grants or contracts may be entitled to relief commonly called ‘whistleblower protections,’” the OIG report states. “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 the employee’s disclosure to be considered protected, according to OIG, the complainant must believe there is evidence of a “substantial and specific danger” to health and safety, or a violation of law or regulation described in the HHS contract. However, a “disclosure to officials of a regulatory oversight agency such as OHRP does not qualify as a ‘protected disclosure’ for the purposes of whistleblower protections.”
Nevertheless, whistleblower protections may be available if complainants disclose such noncompliance to other entities, such as OIG or the HHS grant-awarding agency.
“Providing information about these available whistleblower protections could encourage complainants to come forward and thus help OHRP identify actual or potential problems,” OIG recommended. “OHRP should post this information prominently on its website and include it in routine outreach to research institutions.”
In addition, OIG offered to provide assistance to OHRP via its Whistleblower Protection Ombudsman on how potential complainants can make a protected disclosure.
“OHRP should coordinate with the HHS grant-awarding agencies to ensure that they relay to OHRP any allegations they receive,” OIG recommended.
Wright wrote in the letter that these actions will be taken. “We will notify HHS grant-awarding agencies of this process and request that they relay to OHRP any allegations of noncompliance with HHS regulations at 45 CFR Part 46,” Wright stated. “[W]e will ask HHS leadership to consider the adequacy of the proposed whistleblower protections for complainants in making disclosures about human subject protection to OHRP. We agree that elevating this issue could help HHS determine whether it should seek a legislative change that enables the OHRP and other HHS entities that are not responsible for contract and oversight management to receive protected disclosures.”
- Office of Health and Human Services. Office of Inspector General. OHRP Should Inform Potential Complainants of How They Can Seek Whistleblower Protections. OEI-01-15-00351. September 2017. Available at: http://bit.ly/2wYkRs5. Accessed Oct. 10, 2017.