Wednesday, May 13, 2009

A Horror Anthology

Mark Kleiman takes on IRBs at The Reality-Based Community. On April 14 he asked his readers for IRB horror stories, and on May 2 he posted some of the responses.

The saddest concerns a group of law students who wished "to send testers of different races in different styles of clothing to the restaurant over some period of time to test whether they enforced their dress code in a discriminatory manner." Law school administrators told them they would have to secure IRB approval. This discouraged the students, who did not want to go through the time and effort of the approval process.

This was not the intent of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. At its 15 April 1978 meeting, the commission discussed just such a scenario (pp. II-5 to II-21 of the transcript), and all the members seemed to agree that such testing for discrimination should not require IRB review. But, as I've noted before, the commission wrote a definition of human subjects research that plausibly includes a great deal of activity the commission did not seek to regulate. Thirty years later, justice suffers as a result of the commission's sloppiness.

NOTE: In honor of Professor Kleiman's search, I have gone back through this blog to add the "horror stories" tag to some posts that should have had it to begin with. Clicking on that tag now yields more than a dozen posts, with even more documented horror stories.


Anonymous said...

I have a horror story, but this is from the IRB side of things. I work for an IRB. We recently received a study funded by a federal agency (not NIH). The proposal clearly does not fit the definition of research as defined in the Common Rule, but could be classified as journalism. We wrote the investigator and told her that she did not need IRB review for her project. Almost immediately we heard from the funding agency accusing us of not doing our job. We provided the agency with our policy on the review of journalism, oral history and ethnography. However the agency is insisting on review. Unfortunately, because of the way the exempt and expedited categories are set up, it does not qualify for either. So this journalism project now needs full Board review. Gaining written informed consent would be inane and, while we can grant waivers of consent, there is absolutely no reason this project needs IRB review. So this is an illustration of how one IRB is trying to combat mission-creep and was thwarted by a federal agency.

Zachary M. Schrag said...

Thank you for this comment. I am sorry you feel unable to identify yourself or the agency involved.