IRB seals fate by approving fake protocol in federal sting.

IRB seals fate by approving fake protocol in federal sting

"To say this is just a problem of [some] IRBs is very naive."

A federal undercover investigation into possible vulnerabilities in the IRB review system has led to the closure of one independent IRB, and has left other IRBs wondering whether the due diligence they exercise is diligent enough.

Coast IRB, based in Colorado Springs, CO, announced in April that it would close its doors as soon as oversight of its protocols was transferred to other IRBs. Coast had been one of the targets of a General Accounting Office (GAO) sting, in which investigators submitted a phony protocol on behalf of a non-existent medical device company.

Two other independent IRBs had rejected the fake study of a post-surgical healing device for women, which had purposely included multiple characteristics of "significant risk" from existing FDA guidance, according to a GAO report on the investigation..sup.1Comments from those IRBs had called it "junk" and "the riskiest thing I've ever seen on this board," the report found. However, Coast IRB approved the study, said Gregory Kutz, managing director of forensic audits and special investigations for the GAO in Washington, DC.

The GAO investigators provided information to the FDA, which "determined that Coast IRB committed several violations of the laws and regulations intended to protect the rights and welfare of human research subjects in clinical trials and that the company failed to perform the robust review needed to approve a study," according to an FDA statement.

While criticizing the sting operation as illegal and unnecessary, Coast did voluntarily agree to stop accepting new studies and to put in place a number of improvements, including a new board chair, new members and new standard operating procedures. Shortly afterward, however, the company announced it would stop operating.