each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.
As Jeffrey Cohen has recently noted, this means that "researchers have the right under the regulations to have their research reviewed with the appropriate expertise and it is the Institutional Official's responsibility to ensure that the review is appropriate to the research."
Unfortunately, as I have documented in this blog, researchers in the social sciences and humanities are routinely denied that right. A nice illustration of this problem appears in the recently released RAND Corporation working paper, "Ethical Principles in Social-Behavioral Research on Terrorism: Probing the Parameters," September 2007. James R. Sayer of the University of Michigan's Behavioral Sciences Institutional Review Board describes the problem of reviewing research on terrorism. Presumably this includes the research described on this blog by Scott Atran.
Here is how that case, or perhaps a similar case, appeared to Sayer, whose own expertise concerns "the effects of hydrophobic and hydrophilic glass coatings, window tinting, and defrosters/defoggers on visual performance and driving behavior."
We’ve struggled with expertise, or rather the lack of expertise. Two years ago we sought assistance from a number of academic and private institutions to get reviewers to assist us in the evaluation of one particular protocol. And we found nobody. Maybe that’s because people really don’t want to assume that risk themselves. Maybe it’s because, from an academic standard perspective, I’m sure those of you who review IRB applications don’t get many really big feathers in your cap for doing it. And you’re certainly not going to get them for reviewing somebody outside of your institution. It’s gotten to the point that at the University of Michigan we are seriously considering putting together another board. That board would deal exclusively with international research. There’s enough of it going on that we could easily keep that board busy on a monthly basis. But we will still struggle with trying to find somebody that understands what the culture is like in rural provinces of China, in the Sudan. And as hard as we try, we can’t always adhere to what is the intent of the federal regulations in having the necessary expertise.
This is a nicely humble statement, recognizing the limitations of not only Michigan's IRBs but also the entire IRB process. At the end, Sayer admits that his IRB fails to meet the very requirement Cohen identifies. Yet that humility did not stop the Michigan IRB from delaying and interfering with Atran's research.
The problem is that the right to expert review comes with no enforcement mechanism. Cohen suggests appeals should be directed to the institutional official, but in many cases that is the very person who failed to appoint appropriate experts to the IRB. One would be appealing the violation to the violator. Beyond that official lies only OHRP. And on the day OHRP reprimands an institution for constituting an IRB with insufficient expertise in the social sciences and humanities, I will buy Dr. Cohen an ice cream.
Whether Atran should have sued the university for violating the federal regulations is a question I'll leave to the lawyers.
See also, "In Search of Expertise."