The American Association of University Professors published a report on the IRB system in 2006. (The authors are Judith Jarvis Thomson, Catherine Elgin, David Hyman, Philip Rubin, and Jonathan Knight.)
The report leads with some horror stories. similar to the ones I collected. I especially liked the first one:
* A linguist seeking to study language development in a preliterate tribe was instructed by the IRB to have the subjects read and sign a consent form before the study could proceed.
* A political scientist who had bought a list of appropriate names for a survey of voting behavior was required by the IRB to get written informed consent from the subjects before mailing them the survey.
* A Caucasian PhD student, seeking to study career expectations in relation to ethnicity, was told by the IRB that African American PhD students could not be interviewed because it might be traumatic for them to be interviewed by the student.
* An experimental economist seeking to do a study of betting choices in college seniors was held up for many months while the IRB considered and reconsidered the risks inherent in the study.
* An IRB attempted to block publication of an English professor’s essay that drew on anecdotal information provided by students about their personal experiences with violence because the students, though not identified by name in the essay, might be distressed by reading the essay.
* A campus IRB attempted to deny an MA student her diploma because she did not obtain IRB approval for calling newspaper executives to ask for copies of printed material generally available to the public.
The report proposes two major changes to the current system:
* Exempting survey, interview, and observational studies from IRB review.
* Taking research that doesn’t use federal funds out of the IRB system. (It turns out that the law requires that institutions promise to protect all human subjects, but not to run all research through the IRB, and some big institutions, including Harvard, Princeton, Chicago, and Berkeley, have opted out.)
The report criticizes the lack of reviewability in the IRB process, but proposes no remedy.
Given the Hamburger article arguing that the IRB system consititutes an unconstitutional set of prior restraints on freedom of speech and of the press, it seems to me that a court challenge is a matter of who and when, not if.
But in many ways it would be better to win this one through the political process; if I were looking for an issue around which to mobilize what Don Price called “the scientific estate,” this would be the one. I don’t know who in Congress has any interest in the topic, but the key Executive Branch units seem to be the Office of Science and Technology Policy in the White House (which John Holdren now heads) and the Office of Information and Regulatory Affairs at OMB (which Cass Sunstein just took over).
Who’s in motion on this?