Coast IRB, a Colorado Springs, Colo.-based independent review board that reviews Food and Drug Administration-regulated clinical trials for the purpose of ensuring the safety and rights of enrolled participants, will voluntarily halt some of its clinical-trial oversight operations, according to an FDA news release.
The move came in response to a warning letter that Coast IRB received from the FDA on Tuesday. The letter referenced a fictitious medical-device clinical trial that the Government Accountability Office created and submitted to Coast and two other IRBs for review. Coast, according to the FDA, was the only IRB to approve the clinical trial. As a result, the agency found that Coast violated several laws, including not properly reviewing the trial and failing to protect the safety of potential trial participants.
Under the suspension agreement, Coast will cease reviewing new FDA-regulated studies. The company will also direct clinical investigators in on-going studies it approved to halt enrollment of new participants. The suspensions will remain in effect until Coast has taken acceptable corrective action, according to a news release.
