Research Violations Stay in Dark Over Retaliation Fears

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By Jeannie Baumann

Informants who might report federal human research rule infractions are choosing not to do so because the HHS office overseeing those regulations can’t offer whistle-blower protections.

This inability highlights the limited legal authority provided to the HHS Office for Human Research Protections, according to a report by the HHS Office of Inspector General. The OHRP’s mission is ensuring billions of dollars in federally funded clinical trials and other human experiments take place under an ethical regulatory framework known as the Common Rule ( 45 C.F.R. 46).

The OIG already has made clear it wants the OHRP to be more independent from the agencies it regulates, particularly the National Institutes of Health.

“OHRP reported that it often gets requests from complainants for whistleblower protections, and sometimes complainants choose not to report suspected noncompliance because OHRP cannot offer such protections,” the OIG wrote in the report ( OEI-01-15-00351).

NIH, OIG Have Authority

Disclosures must be made to specific individuals and entities—such as the OIG, or the agency that awards or manages the grant--to be eligible for whistle-blower protections. That means a study coordinator could seek whistle-blower protection when reporting a Common Rule violation to the NIH or the OIG. But if the coordinator brought that same allegation directly to the OHRP—the office responsible for administering the Common Rule—whistle-blower protections can’t apply.

The OHRP often receives requests for whistle-blower protections from complainants, the report found. But four out of five compliance evaluations reviewed came from complainants who had a “fear of reprisal,” the OIG said.

Stephen Rosenfeld, executive board chairman of Quorum Review IRB, told Bloomberg BNA in a Sept. 20 email, “I suspect that it appears arbitrary, and perhaps surprising, to individuals reporting an issue that reporting to the NIH gives them whistleblower status but reporting to OHRP does not.” Quorum is a large commercial institutional review board based in Seattle.

F. Lisa Murtha, a Philadelphia-based consultant with nearly three decades of experience on research compliance issues, told Bloomberg BNA she agrees whistle-blowers may be disinclined to report wrongdoing since there are no protections for them through the OHRP.

“However, egregious fraud against the federal government would likely be reported to OIG by OHRP if those matters are reported by whistleblowers,” she wrote in a Sept. 20 email. “Moreover, serious and dangerous fraud in connection with human research protections violations may also be reported by OHRP to OIG if there was harm to research participants or danger to public safety.”

Legislative Action Needed

“OHRP’s effectiveness may be hampered if potential complainants at research institutions that conduct HHS-funded studies are unaware of whistle-blower protections that may be available to them,” the OIG report said. “This raises concerns that some instances of noncompliance may go unreported and unresolved.”

But the HHS doesn’t have the authority to change the OHRP’s eligibility unless Congress rewrites the whistle-blower provisions of the False Claims Act. Legislative change would be necessary to allow disclosure to officials of a regulatory oversight agency such as the OHRP to be considered a “protected disclosure” for the purposes of whistle-blower protections, an OIG spokeswoman told Bloomberg BNA.

Murtha, who is a senior managing director with Ankura Consulting and a member of Bloomberg BNA’s health-care advisory board, said a change in law is warranted.

“The government should make it as easy as possible for individuals to report wrongdoing to federal agencies including OHRP,” Murtha said. “If whistle-blowers know there are protections in place, they are definitely more likely to report wrongdoing.”

OIG Recommendations

The OIG recommended the OHRP inform potential complainants how they can seek whistle-blower protections. The watchdog office also advised the HHS to consider seeking a legislative change to enable the OHRP and other HHS entities to receive protected disclosures. Don Wright, assistant secretary for health for the HHS, which oversees the OHRP, concurred, according to the report.

The recommendation for new legislation raises a practical concern of who would be responsible for enforcing any new whistle-blower protections, Rosenfeld said. “If complainants to OHRP are given whistleblower status, and OHRP then has responsibility of enforcing the protections, the change must be accompanied by sufficient resources and staffing to support the added responsibility,” he said.

Rosenfeld, who is also the chairman of the HHS Secretary’s Advisory Committee on Human Research Protections, said he wasn’t sure if there was a SACHRP issue in the report. “The expertise of the committee may not be well suited to evaluation of such a legal/procedural issue,” Rosenfeld said.

Best Path Forward

“OHRP will work with OIG to determine the best path forward on this issue,” an HHS spokesperson told Bloomberg BNA in a Sept. 20 email.

The whistle-blower findings follow up on a July report in which the OIG called for the OHRP to have more independence from the Common Rule agencies.

“We found that OHRP appeared to independently carry out compliance activities for protecting human subjects but that certain factors may have limited or appear to limit OHRP’s ability to operate independently,” the OIG said about the July report.

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bna.com

To contact the editor responsible for this story: Randy Kubetin at RKubetin@bna.com

For More Information

The OIG report "OHRP Should Inform Potential Complainants of How They Can Seek Whistleblower Protections" is available at https://oig.hhs.gov/oei/reports/oei-01-15-00351.pdf.

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