Colorado-based institutional review board (IRB) Coast has agreed not to approve any new clinical studies regulated by the US Food and Drug Administration, nor to add any new subjects to ongoing FDA-regulated studies.
The action was taken in response to a warning letter from the US agency, which cited “serious concerns about the company’s ability to protect human subjects participating in clinical trials”. According to the FDA, Coast’s records indicate that the restrictions may affect some 300 active human research studies conducted by around 3,000 clinical investigators.
The agency will continue actively to monitor Coast and will “take appropriate action as necessary”, it added. The restrictions will stay in place “until the FDA is satisfied that Coast IRB has taken necessary corrective actions that bring it into compliance with FDA regulations designed to protect human research subjects”.
The IRB has informed clients that it is co-operating fully with the FDA and will provide the agency with a corrective action plan on or before 29 April 2009.
Only last week, Coast launched what it described as “immediate and sweeping” reforms of its management and operating procedures in an attempt to repair the damage from a hostile US Congressional hearing in March.
At the hearing on IRBs organised by the House Energy and Commerce Committee’s Oversight & Investigations Subcommittee, Coast was pilloried for having approved a trial protocol submitted for a fake and potentially dangerous medical device by a bogus company invented as part of a ‘sting’ operation by the US Government Accountability Office (GAO).
In evaluating the information provided by the GAO investigators, the FDA said, it determined that Coast had “violated several regulations intended to protect the rights and welfare of human research subjects in clinical trials and that the company failed to perform a robust review prior to approving the GAO study”.
Specifically, the agency noted, Coast failed to:
– Determine that the risks to participants in the bogus device trial were minimised.
– Determine that the risks to trial subjects were “reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may be expected to result”.
– Determine the applicability of 21 CFR Part 812 (the regulation that provides for investigational device exemptions in the US) or make a risk determination for the proposed device study .
– Ensure that basic elements of informed consent were included in the IRB’s approved consent form for the study.
– Demonstrate “its ability to ascertain the acceptability of the proposed research in terms of regulations, applicable law, and standards of professional conduct and practice”.
The FDA gave Coast 15 working days from the receipt of the warning letter to “notify the Agency of the specific actions you have taken or plan to take to bring Coast IRB into full compliance with FDA regulations”.
Clinical studies already approved by Coast will be allowed to continue because of the potential risk to enrollees and disruption to research if ongoing trials are abruptly terminated, the agency said.
