Institution Bulletin vol 4, issue 1
This spring will mark the fifth anniversary of the downfall of Coast IRB. In March 2009, it was announced that Coast IRB had fallen for a sting operation. Congress and the Government Accountability Office had sent several IRB’s
a sham medical device study for review. The study proposal had several flaws, including no device description, no preclinical data, questionable procedures and outdated investigator licensure documentation. Coast IRB’s board approved the study unanimously. Within weeks of disclosure of the sham, the FDA issued a warning letter and Coast chose to close its doors.
Many in the ethics community were not surprised. Coast IRB had never been accredited and had received a disturbing FDA Warning Letter the prior year. Disillusioned employees had been seeking work elsewhere.
Nevertheless, it’s worthwhile to take steps to ensure that your IRB – or the IRB to which you outsource – does not make this type of mistake. Factors to consider in assessing the strength of an IRB include accreditation status; quality of the IRB members; availability of regulatory support during Board meetings; documented separation of business interests and ethics review; and the organization’s commitment to quality assurance and compliance measures.
Quorum Review is committed to the highest standards in all these areas. When an institution is ready to use a central IRB, we are committed to supporting the institution with a high quality review, a strong regulatory team and multiple quality control and compliance processes. And to help support you and your ethics board, today’s newsletter describes new guidelines from SACHRP as well as Quorum’s ability to support international research. We look forward to an opportunity to work with you.
Cami Gearhart, CEO
Quorum Review IRB