Does the NPRM Exclude or Exempt Ethnography?

Though I could not attend the October 20 Public Town Hall Meeting on the Federal Policy for the Protection of Human Subjects (Common Rule) Notice of Proposed Rulemaking (NPRM), I’ve now watched the whole thing on YouTube. Much of the day was spent discussing procedures for biospecimens, which is outside the scope of this blog. But I was interested to see Julia Gorey of OHRP reply to questions that had been sent in by two anthropologists, Lise Dobrin, co-author of the American Anthropological Association’s 2011 comment on the ANPRM, and Edward Liebow, the AAA’s executive director. Gorey frankly admitted OHRP’s lack of expertise on ethnography but held out hope that ethnography may be exempt or even excluded under the NPRM’s proposals.

In Part 3 of the video recording, at minute 56, Gorey reads Dobin’s question:

DOBRIN (as read by Gorey): The NPRM provides a list of activities that are excluded on the grounds that they do not count as research. These include journalism, history, and biography. Among the reasons given for exclusion of these fields is that they focus on particular individuals and they are generally carried out by practitioners of disciplines that have their own codes of ethics. On what grounds was this exclusion made?

GOREY: The rationale here really hinges on the concept of generalizability. The line was what activities do or do not create generalizable knowledge. Ethnographic fieldwork, at least as we understand it, when we discussed it, generally involves drawing conclusions from groups or from communities, and not from individuals. However, no one from OHRP was willing to put forth themselves as an expert in the field of ethnography. So we would invite your comment on whether this or other fields of scholarship should be included in or outside of this exclusion.

The nasty thing about that last line is that in 2011, Dobrin already crafted a thoroughly reasoned, eloquent comment on the ANPRM, in which the AAA called for IRB review to be restricted to biomedical research and experiments that depend on deception. In drafting the NPRM, OHRP and other agencies ignored this suggestion without explanation. So it’s a bit insulting for Gorey to confess ignorance and then tell Dobrin to again spit into the wind.

Things get better at minute 59:35, when Gorey responds to Liebow:

LIEBOW (as read by Gorey): The NPRM makes no mention of ethnographic field work, that is, interactive activities such as conversation, open-ended interviewing, collection of life histories, participant observation in everyday settings, by means of which investigators seek to understand social and cultural particularities. Where does ethnographic fieldwork fit in, in the categories of review?

GOREY: This is a hard question to answer. It really depends on exactly what the activities are that are encompassed in that ethnographic fieldwork. There are certainly portions of it that could fit in the exclusion at 101.b.2.i. for research not involving interventions that also involve survey procedures, or interview procedures, or observations of public behavior. But it's also very likely that some of this research could be exempt under 101.e.1. [I think she must mean 104.e.1] for surveys or interviews if the subjects can be identified. Without knowing the specifics of really what's going on here, it's hard to be very granular in the response other to say there are different pigeonholes where the research could indeed fit.

If they dig deep enough in the NPRM’s provisions, the anthropologists may find their freedom.