At a congressional hearing the Government Accountability Office (GAO) revealed failings in the institutional review board process that left it “vulnerable to unethical manipulation,” which prompted calls for the system to be reformed.
The US Food and Drug Administration (FDA) has now responded to the GAO investigation by issuing a warning letter to Coast based on the alleged failings heard by Congress.
In response Coast has suspended the approval of new studies and the recruitment of new patients to on-going studies, when they are subject to the requirements of 21 CFR Part 56.
Coast has said it will respond to the FDA with a corrective plan before April 29 and has already taken action in the wake of the GAO investigation, replacing its current chair and detailing 12 specific improvements.
These form part of the “immediate and sweeping reforms” Coast is initiating in an attempt to prevent a “recurrence of the vulnerabilities ... brought to light in the investigation”.
A 30-day internal audit of procedures has been launched “to review every aspect of Coast IRB, to reinvent the company and make it stronger”. Coast has hired a consulting firm to assist it with the review.
FDA highlights five alleged violations
The warning letter to Coast details allegations of five “serious violations” of FDA regulations that present a “risk to the rights and welfare of human research subjects”.
These include: failure to determine that risks to subjects are minimised; failure to ensure that the basic elements of informed consent are present in the form; and failure to demonstrate it can asses the acceptability of research in light of regulations, laws and standards.
The complete warning letter can be viewed here.