Caught in a Congressional sting operation last year, Colorado Springs, CO-based Coast IRB has been asked by the FDA to stop some of the work it does in approving clinical trial designs and overseeing patient safety guidelines. And the agency says that the sudden voluntary halt could affect some 300 trials and 3,000 researchers working for biopharma and medical device developers.
The Government Accountability Office ran the sting last year, setting up a fake trial of a fake product to test how for-profit review boards do their work supervising such studies. Two other IRBs declined to approve the fake study but Coast did approve it, according to a report in the Wall Street Journal.
The FDA asked Coast IRB to stop some elements of its work "due to serious concerns the FDA has about Coast's ability to protect human subjects." The agency went on to say that the company could resume its work once the agency was satisfied that the company is meeting safety standards.
In testimony to lawmakers, Coast Chief Executive Dan Dueber called the sting illegal entrapment. Coast announced recently that it was suspending new trial work for 30 days and beginning a trial audit using an outside firm.
- read the report in the Wall Street Journal