HHS also faulted in GAO investigation.

HHS also faulted in GAO investigation

Questions raised after fake IRB registered

The General Accounting Office (GAO) report on the IRB system's vulnerabilities doesn't just criticize the individual IRBs targeted by the investigation.

It also faults the U.S. Department of Health and Human Services (HHS), which oversees the registration of IRBs and the issuance of federalwide assurances (FWAs), both of which investigators were able to obtain fraudulently for a fake IRB and fictitious medical device company.

In his report, Gregory Kutz, managing director of forensic audits and special investigations for the GAO in Washington, DC, described the process of registering the IRB through an online registration form, and then using that fake IRB on its application for a FWA for its medical device company. In neither case did HHS's Office for Human Research Protections (OHRP) verify the information in those applications.

"With an HHS-approved assurance, GAO's device company could have applied for federal funding for human subjects research," Kutz notes in the report.

Investigators created a Web site for their fake IRB and advertised in newspapers and online. They received one request from a real medical research company seeking to get approval to join an ongoing clinical trial.