FDA briefly suspends IRB's ability to do expedited reviews
Restrictions lifted after company changes SOPs
The FDA briefly suspended the ability of an independent IRB to conduct expedited reviews after raising concerns over the conduct of one such review.
Coast IRB, a Colorado Springs, CO-based IRB, was unable to conduct expedited reviews for a little more than two months after being issued a warning letter by the FDA. The company's ability to conduct expedited reviews was reinstated in May, after Coast made changes to its standard operating procedures for expedited reviews.
The initial FDA warning letter was issued March 11 following an inspection of the company last year. The letter states that Coast did not follow FDA regulations in its approval of a recruitment advertisement for a Phase 1 multicenter clinical trial.
The FDA warning letter states that Coast's IRB had met three times to consider the advertisement, first approving the ad with changes, then disapproving the sponsor's resubmitted ad on the grounds that it was coercive. The warning letter states that after the IRB's decision, the then-chief executive officer appointed a new member to the board and instructed him to conduct an expedited review of the advertisement.
The warning letter states that the expedited review of the ad was inappropriate, since the new member lacked the necessary experience to carry out an expedited review and had not been designated by the IRB chairperson. In addition, the warning letter states that the advertisement did not qualify for expedited review under federal regulations, and that Coast did not follow written procedures for keeping IRB members advised about the expedited review.
On April 22 Coast sent a response to the FDA, naming Gary Smith as the new president and CEO of the company. In that letter, Smith also details a number of changes to Coast IRB's expedited review procedures:
- clarifying that such reviews only will be carried out for studies involving no more than minimal risk or to make minor changes to previously approved studies, in accordance with federal regulations;
- restating that only the IRB chairperson or an experienced reviewer designated by the chairperson can carry out expedited reviews;
- explicitly prohibiting expedited review of matters that previously had been disapproved or approved with changes by the full IRB; and
- better communication with IRB members about expedited reviews and improved minute-taking at IRB meetings.
The FDA responded to these changes May 21 by removing the suspension of Coast's ability to conduct expedited review.
Smith says the company is continuing to improve its processes and has applied for accreditation with the Association for the Accreditation of Human Research Protection Programs.
The FDA briefly suspended the ability of an independent IRB to conduct expedited reviews after raising concerns over the conduct of one such review.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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