AAA Comments on Notice of Proposed Rule Making for IRBs
Post authored by Lise Dobrin (University of Virginia)
Below are some excerpts from the 18-page comment submitted by the AAA to the Office of Human Research Protections on January 6, 2016, in response to the proposed changes in the “Common Rule”, the federal regulations that motivate the system of research ethics review that is implemented by IRBs. The AAA comment was authored on the AAA’s behalf by Rena Lederman (Princeton University) and Lise Dobrin (University of Virginia). An overview of the Notice of Proposed Rulemaking (NPRM) and the full text of the AAA’s response can be found here.
On the NPRM’s proposal to expand the definition of “human subject” to include even non-identified biospecimens:
The American Anthropological Association is in general accord with the principle of “autonomy” (or “respect for persons”) underlying this NPRM proposal to change the definition of Human Subject. Anthropologists and their study participants have objected to the reduction of biospecimens to “data” (i.e., values detachable from their sources); they have pointed out that blood, tissue samples and the like can come to stand for persons and be invested with specific social, cultural, and ritual values.
On the problematic omission of sociocultural anthropology’s signature methods from both the Common Rule and the proposed rule change:
Our first and most important general comment is that several of the proposed changes will deepen, rather than alleviate, ambiguity. This is especially true with respect to sociocultural anthropologists’ most characteristic research activity – “participant observation” (also referred to as “ethnographic fieldwork”, “fieldwork”, and similar terms) – which finds no place within the existing Common Rule at all. Insofar as the proposed changes likewise make no mention of participant observation, anthropologists and others who employ this approach—along with their IRBs—are left entirely in the dark. This situation promises to keep ethnographic field projects that rely on participant observation in “expedited” or “full board” categories when according to the logic behind the NPRM they should be “exempt” or “excluded”.
…
[A]nthropologists preparing to undertake “participant observation” do not understand themselves as conducting “interviews”. Instead, they are trained to appreciate that interviewing and participant observation are distinct (indeed methodologically opposed) activities: the former is an investigator-controlled interaction (the researcher asks a more or less predetermined set of questions keyed to his/her relatively well-defined research agenda)