IRB Stings & Accreditation
The IRB world has been rocked by the recent "stings" conducted by the Congressional Government Accountability Office (GAO) to investigate IRBs. This investigation was conducted at the behest of Congress because of concern over the adequacy of IRB review. Those who are not familiar with the results of the investigation should review the GAO and testimony from the hearings:
Although the focus of the hearings was on Independent IRBs and most of the attention has been on Coast IRB, the concerns raised by this investigation and these hearings apply to the whole field of human research protections. The best response to this investigation is accreditation. Accreditation not only raises the standards for what constitutes adequate IRB review, it provide helps ensure that organizations are meeting those standards. How would accreditation have addressed the GAO findings in this investigation?
1) Due diligence to verify information
The GAO faked 510(k) status of the device and the qualifications of PI. AAHRPP expects IRBs to obtain documentation of INDs, IDEs and 510(k) status. AAHRPP also expects organizations to have an ongoing quality assurance program, which should include audits and site visits.
2) Inadequate information to make determinations
The GAO selected IRBs that "...had less burdensome initial paperwork requirements than other IRBs for protocol submission" and "...designed our protocol so that it would contain vague information about certain aspects of our proposed study." AAHRPP expects detailed information in the protocol on all aspects of human subject protections, including subject populations, subject recruitment, consent process and safety monitoring. If the protocol requirements had been that detailed, the GAO could not have provided the information.
3) Lack of substantive IRB review
The GAO raised concerns that one IRB approved the protocol even though there were safety concerns. AAHRPP expects that all IRB review will be substantive and will address all of the regulatory criteria for approval for each review. This must be documented in the minutes with protocol-specific justification that the criteria have been met.
4) Inadequate federal oversight
The GAO was able to register a fake IRB and get an assurance for a fake medical device company. Beyond assuring that the minimum regulatory requirements have been met, OHRP is unable to review the quality of IRBs or research institutions. Accreditation will provide the accountability to help ensure that there is adequate IRB of human research.
The best protection that institutions and IRBs have against the kind of investigation conducted by the GAO (and, for that matter, against litigation) is accreditation. Not only will AAHRPP accreditation help ensure adequate IRB review, but organizations will be able to say, "We're doing it right and you don't have to take our word for it!"