A Trimmer PRIM&R

In my previous posting, I detailed the ways that the composition of PRIM&R's board and the operations of its conferences fail to match its stated mission, and I suggested what it would take for PRIM&R to live up to its claim to serve "the full array of individuals and organizations involved in biomedical and social science/behavioral/educational research." The other option, of course, would be for it to scale back its ambitions to serving merely "the full array of individuals and organizations involved in biomedical research," a noble task and one that its biomedical membership is far better equipped to handle.

PRIM&R's adopting this approach would mean recognizing that current regulations were written with biomedical research in mind and have never suited social science. It should therefore use its prestige to advocate broader exemptions from federal regulation for non-biomedical research. Such exemptions might exclude from IRB review:

* Research involving survey or interview procedures, where the subjects are legally competent, and where the investigator identifies himself/herself, and states that he/she is conducting a research survey or interview

* Research involving the observation (including observation by participants) of public behavior in places where there is no recognized expectation of privacy.

and

* Research involving the observation (including observation by participants) of public behavior in places where there is a recognized expectation of privacy, except where all of the following conditions exist:

(i) Observation are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects,

(ii) the observations recorded about the individual, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability, and

(iii) the research deals with sensitive aspects of the subject's own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol.

I fear that Dr. Cohen will reject such proposed exemptions, taking them as evidence that I have "no interest in making IRB review work better for researchers, but only in eliminating IRB review for [my] research." Before he does so, let me point out that these exemptions are not my creations, but those of a joint subcommittee of the American Association of University Professors' Committee A on Academic Freedom and Tenure and Committee R on Government Relations. They were published as a report on Regulations Governing Research on Human Subjects, Academe, December 1981, 358-370.

A member of the subcommittee, and a signatory to the recommendations, was Sanford Chodosh, MD, the founder of PRIM&R.