Colorado-based institutional review board (IRB) Coast has launched what it describes as “immediate and sweeping” reforms of its management and operating procedures in an attempt to repair the damage from a hostile US Congressional hearing last month.

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.

Coast president and chief executive officer Dan Dueber, who testified at the hearing, said he had “taken the criticisms of the Subcommittee to heart, while accusing the media of distorting the facts of the matter. He acknowledged, though, that “across-the-board changes to procedures governing intake and evaluation of clinical trials are needed, both at Coast IRB and throughout the clinical trials system”.

In a post-hearing statement to the Subcommittee, Coast listed 12 initial measures it is instituting, from background checks on every clinical trial sponsor to hiring an expert consultant to revamp the company’s ethical review procedures, in an effort to “prevent recurrence of the vulnerabilities” exposed at the hearing.

“For Coast, this process of reform is not going to end,” Dueber commented. “We mean it to be continuous, making re-examination and improvement a dynamic, not a static condition.”

One of the first moves is a 30-day internal audit of procedures, started on 1 April with the help of a “nationally recognised” consulting firm. The aim is to “review every aspect of Coast IRB, to reinvent the company and make it stronger and, most importantly, to further protect the rights and welfare of subjects in clinical trials”, Coast said.

The company will be accepting study submissions on a case-by-case basis as it receives and implements the recommendations from this audit.

Among the other reforms are:

- Investigating all clinical trials currently under review to verify that the qualifications of all principal investigators are accurate and up-to-date, that identified trial sites are real, and that all government approval numbers and references are valid.

- Revising the company’s questionnaire for evaluating new clinical trials “to exceed industry standards”. Coast has hired an expert consultant in IRB administration and protocol reviews to develop the new questionnaire and define the standard operating procedures needed to validate questionnaire responses.
- Terminating the practice of guaranteeing 24- to 48-hour delivery of protocol submissions to the company’s review board.

- Requiring full board risk-assessments for all new studies, regardless of the product’s regulatory status.
- Removing the present board chair from that post and replacing her with someone who has not only a scientific background approved by the company’s expert consultant but also experience in the critical review of IRB administration.

- Having the company’s expert consultant participate as a witness in all review board meetings over the next three months and provide post-meeting critiques, with the authority to require additional board meetings tackling issues not deemed to be adequately addressed by the board.