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:
http://energycommerce.house.gov/index.php?option=com_content&task=view&id=1552
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!"
