Jerry Goldman and Martin Katz published a rare empirical study of IRBs in the Journal of the American Medical Association in 1982. Here is a brief summary:
We submitted three flawed medical protocols with the expectations that the review boards would find the flaws evident in the proposals. But the boards, on the whole, did not find the flaws. Rather, they suggested changes that would, if approved, made bad research projects worse. This is the only major empirical study of IRBs and the findings have never been controverted with other evidence.
The paper can be found here. Professor Goldman may have already started a replication of this study with Dr. Lewis Smith. (Thanks to Steve Wasby for calling my attention to this paper.)
A better approach would be to overhal the 1974 law that created IRBs in the first place.
Posted by: James | 17 February 2009 at 12:07 AM
Years ago, I participated in a review meeting. Afterwards, the Chairman thanked me for my great service. He would let me know when I would be needed again.
I found the lawyer, the priest and the housewife to be reasonable. "Doc, once I give you my urine, it's yours," said the lawyer seeking to end the 1 hour debate on the property interest of patients' urines.
The doctors were the most nuts, picayune, and legalistic. They were also obstructing projects by competitors in their specialty. But, in a dilemna, they were the only ones who understood the proposal. Something happens to people on those committees.
Perhaps, doctors should review lawyer research. Lawyers should review medical research. If the proposal cannot be plainly explained to the lawyers, how is it going to be explained to the medical subjects?
Posted by: Supremacy Claus | 29 March 2006 at 09:03 PM
Perhaps because IRBs are not "human"? :)
Posted by: Mark Hall | 29 March 2006 at 08:21 PM
I was not able to find where these studies of IRB's were approved by an IRB.
Posted by: Supremacy Claus | 28 March 2006 at 08:53 PM
Several recent empirical studies of IRBs coming from large, multi-site medical studies, document considerable inconsistency among IRBs at different institutions that review the exact same protocol, as well as burden on researchers. For instance, researchers with one multi-site study reported that, out of 43 IRBs, 1 exempted the protocol, one rejected it as too risky, 10 gave expedited review, and the rest full review, with a wide variety of conflicting requirements. All of this took almost 5000 hours of staff time. Health Services Research 41:214 (Feb. 2006), at this link: http://www.blackwell-synergy.com/doi/abs/10.1111/j.1475-6773.2005.00458.x
See also:
http://www.blackwell-synergy.com/doi/abs/10.1111/j.1475-6773.2005.00354.x
http://www.blackwell-synergy.com/doi/abs/10.1111/j.1475-6773.2005.00353.x
Posted by: Mark Hall | 28 March 2006 at 06:10 PM