Facing FDA concerns about its ability to protect human subjects participating in clinical trials, Coast Institutional Review Board has voluntarily suspended the approval of new studies as well as the recruitment of new patients for ongoing studies.
These actions may involve up to 300 active trials conducted by 3,000 clinical investigators, the FDA announced yesterday. Studies that Coast IRB already has approved will be permitted to continue but no new patients will be enrolled.
Coast, which was recently the target of an undercover investigation by the Government Accountability Office, received a warning letter from the FDA outlining five “serious violations” and calling for reform.
Coast announced last week a 30-day suspension of the processing of new study submissions and has hired a consulting firm to audit its operations, SOPs and forms. Coast has said it will return to the FDA with a corrective action plan by the end of this month.