IRB Caught in GAO Sting is Closing its DoorsApril 28, 2009
By William T. Koustas –
Earlier this month, FDA announced that Institutional Review Board (“IRB”) Coast IRB, LLC of Colorado Springs, Colorado (“Coast”) voluntarily agreed to stop reviewing new FDA-regulated studies and halt enrollment of new subjects in ongoing trials after FDA determined it committed several violations of laws and regulations in approving a fake research study during a U.S. Government Accountability Office ("GAO") undercover investigation.
In its investigation, GAO selected three independent IRBs to submit fake research protocols to that contained significant problems. The GAO created a fake medical device company, a fake medical device with no history and fake specifications and vague information about some aspects of the proposed study. Coast was the only one of the three IRBs to approve the fake study. FDA identified the following violations in its Warning Letter to Coast following the investigation:
- “The IRB failed to determine that risks to subjects are minimized.” 21 C.F.R. § 56.111(a)(1).
- “The IRB failed to determine that risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may be expected to result.” 21 C.F.R. § 56.111(a)(2).
- “The IRB failed to determine the applicability of 21 CFR Part 812 and failed to make a risk determination for the investigational device study.” 21 C.F.R. §§ 812.2(c)(2), 812.66, 812.20(a).
- “The IRB failed to ensure that basic elements of informed consent are included in the IRB-approved consent form.” 21 C.F.R. §§ 50.25(a)(2) and 56.109(b).
- “The IRB failed to demonstrate its ability to ascertain the acceptability of the proposed research in terms of regulations, applicable law, and standards of professional conduct and practice.” 21 C.F.R. § 56.107(a).
In light of these findings, several significant customers severed their relationship with Coast, leading the IRB to “cease future company operations.” FDA and Coast officials reportedly met in Colorado Springs on April 22nd to discuss ways to minimize the disruption for patients and sponsors involved in clinical trials reviewed by Coast. Approximately 300 ongoing studies and 3,000 investigators across the U.S. could be affected.