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Posted by on Mar 31, 2009

Who’s Reviewing the Reviewers?

The system created to review and monitor clinical trials involving humans is vulnerable to “unethical manipulation,” and government officials admit they don’t assess whether some parts of the system are adequate or even factual.

In a recent investigation of the Institutional Review Board (IRB) system, the Government Accountability Office (GAO) created a fake company with a fake review board, received approval to test a nonexistent medical device, and falsified documents—all with the approval of federal agencies.

An IRB is an entity formally designated to review and monitor research involving human subjects. IRBs have traditionally been part of large research universities, but private companies have started playing a greater role in creating IRBs to oversee clinical trials. The Department of Health and Human Services’ Office for Human Research Protections and the Food and Drug Administration are responsible for overseeing the IRB system.

In its undercover investigation, GAO created a “bogus” company and IRB. It appeared so real that a private research company contacted the GAO’s IRB about reviewing its surgical procedures. In addition, GAO filed an assurance statement with HHS, promising to protect human subjects. That HHS assurance application, which was approved, would have allowed the fake company to receive HHS research funding. And the last part of the investigation? GAO was able to get approval from an actual IRB to test a fake medical device.

In response to GAO’s investigation, the director of the Office of Human Research Protections said when reviewing assurance applications, HHS does not consider whether the IRBs listed are “adequate” nor does it review applications to determine whether the information is true.

The results of GAO’s investigation were presented recently in testimony before the House Subcommittee on Oversight and Investigations, Committee on Energy and Commerce.

To read the full GAO report, click here.



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