Lederman, an anthropologist and sometime member of the Princeton University IRB, challenges the regulatory defintion of research: "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." She correctly notes that the definition was crafted to distinguish the practice of medicine from biomedical research. As she puts it,
U.S. human subjects research regulations (known since 1991 as the “Common Rule” but formally set in place in the early 1970s) derive from earlier National Institutes of Health guidelines based on specifically biomedical experience and ethical problematics. Their logic goes something like this: First, medical therapy is appropriately evaluated in terms of individual patient interests, because its central concern is the direct improvement of individual patient well-being. Second, medical research is appropriately evaluated in terms of society’s and science’s interests, because its central concern is the production of knowledge “generalizable” beyond individual cases. And third, although physical risks to persons are inherent in both medical research and therapy, the risks to individuals are qualitatively greater in research (where individual persons are not the central concern) than in therapy (where they are). Consequently, research needs special oversight. (312)
[It's worth noting that the research definition entered the regulations as a result of congressional mandate; the National Research Act of 1974 instructed the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to consider "the boundaries between biomedical or behavioral research involving human subjects and the accepted and routine practice of medicine." The result was the defintion of research now encoded in regulations.]
Lederman then explains that the boundaries between research and therapy remain fuzzy even for biomedical topics. A case study of an individual patient offers some contribution beyond therapy, but is it generalizable? What about quality improvement, like the Johns Hopkins checklist?
Finally, Lederman produces her "modest proposal":
If there are indeed other ways of knowing the world that are similarly entangled in the everyday but not yet benefiting from IRB oversight, doesn’t fairness dictate that all of these modes be surveilled in the same manner? What would happen if ethnographers made common cause—all in (or all out)—not just with ethnographically inclined sociologists, political scientists, religion scholars, and folklorists but also with urban planners, architects, engineers, literary and cultural studies scholars, and colleagues in college and university writing programs—all of whom are engaged in varieties of research-with-human-participants? (320)
She then goes on to note similarities between the methods of ethnographers and novelists, asking why the latter have not been swept into the IRB dragnet.
The problem with Lederman's self-described "parodic" comparison is that some regulators and IRBs are already enacting parody as policy. As Lederman notes, "IRBs are already involving themselves in the lives of writing teachers, journalists, and others who had not heard of “human subjects research” until their own work came under scrutiny." (324, n. 10)
Other countries have taken this further. The Australian National Statement on Ethical Conduct in Human Research (2007) observes that the British definition of human subjects research "could count poetry, painting and performing arts as research," then fails to offer a defintion of human subjects research that clearly excludes those endeavors. It then goes on to state that "the conduct of human research often has an impact on the lives of others who are not participants," raising the possibility that a novelist might violate Australia's ethical standards without even talking to anyone. (p. 8) More recently, in February 2008, a Canadian committee proposed adding a chapter on Research Involving Creative Practices to Canada's Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. The draft chapter suggests that some creative processes are outside the purview of ethics boards, but it does not make a good case for any review of creative work, except that "researchers from a wide range of disciplines" would feel cheated if artists got special treatment.
It's too late for reductio ad ridiculum; the ridiculous is at the gates.
Like Bosk's essay, Lederman's expresses frustration with IRB oversight of ethnography without clearly calling for an end to such oversight, much less offering a strategy to achieve that goal. She reports, offhand, that when oral historians seemed to have escaped IRB jurisdiction, the anthropologists she knew "were briefly thrilled, but there was no notable effort to follow suit." (318) Why this passivity? I am less interested in why ethnographers have not made common cause with novelists than in why they have not made common cause with themselves.