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) while the latter is basically a participant-controlled interaction (the researcher is responsive to his/her hosts’ agendas of activities, topics, and the like). This means that fieldworkers’ honest answers in response to [questions intended to establish exemption] would not enable them to meet the regulatory criteria for the exemption. This runs counter to the spirit of the NPRM proposal as we read it. We therefore ask that if the proposal to exempt low-risk research through interactions is adopted as described in the NPRM, “participant observation” be specifically listed among the activities that count as “low risk” for purposes of the exemption.


On the notion of “generalizability” as establishing a need for ethical oversight:

Reference to “generalizability” points to the heart of the problems inhering in the Common Rule definition of “research”. “Generalization” raises distinctive ethical problems within biomedicine as a result of the slippage between a doctor’s commitment to provide individual patients with personal care and the doctor-researcher’s commitment to socially-beneficial generalizing research. But it does not usefully diagnose a need for regulation across the board.


On the likelihood and severity of risk not greater than what is “ordinarily encountered in daily life” as a regulatory criterion:

Because researchers engaged in participant observation and ethnographic fieldwork interact with participants in the course of daily life on those persons’ own terms as a matter of methodological principle and because researchers do so without deception as a matter of ethical principle – that is, because they do not remove participants from their daily lives in order to engage in research or otherwise engage in research manipulations – these standard anthropological methods are consistent with the spirit of “minimal risk”, that is, they involve a “probability and magnitude of harm or discomfort” that is not greater that what is “ordinarily encountered in daily life”. Indeed, participant observation and ethnographic fieldwork more nearly approximate daily life than do any of the other activities currently listed on the OHRP expedited list, such as “surveys”, “interviews”, and “focus groups”. For that reason, we favor “excluding” participant observation/ethnographic fieldwork from the Common Rule.


On the need to determine confidentiality requirements on a case-by-case basis:

[W]hile anthropologists appreciate the importance of keeping data confidential when appropriate, it is not the case that information (e.g., stories or recorded texts) shared with investigators by participants in anthropological research should always be kept confidential along the lines of protected health information. To the contrary, one important purpose of anthropological research is to document knowledge for future use, whether by members of the community being investigated or by future researchers. The insistence on adherence to any privacy safeguards irrespective of the situation of research (including the wishes of the participants) runs counter to the context-sensitivity required for the ethical conduct of anthropological research, and in fact contradicts the AAA Statement on Ethics, which calls upon anthropologists to balance the protection of research participants and their communities with the careful preservation and judicious dissemination of their research records.


On the NPRM proposal to exempt low-risk research from IRB oversight:

We believe that anthropology’s most distinctive method of research, participant observation – if it does not fall completely within categories of “excluded” activity – falls within [the category of activities deemed “exempt”]: it involves the collection of information through open-ended interactions with participants in ways that are, as a matter of methodological principle, not under the researcher’s control but responsive to constraints imposed by study participants in their own daily life contexts. Because this exemption would support anthropologists’ ability to apply their professionally- and experientially-honed ethical judgment in an active, responsive, and situation-specific way as their research unfolds, the AAA supports this proposal, which decreases the burden on researchers to seek administrative review from those who have less knowledge about the risks to participants than they themselves do, while simultaneously diminishing (or at least not increasing) the risks associated with the research.


In response to the NPRM proposals about obtaining and documenting informed consent:

Among the proposals made in this section is one that would allow “a waiver of the requirement for a signed consent form if the subjects are members of a distinct cultural group or community for whom signing documents is not the norm” (FR 53977, 54055). The AAA supports this provision enthusiastically. Consent needs to be tailored to the social and cultural context of the research community if it is to be meaningfully informed. Yet despite the diversity of cultural settings in which anthropological work takes place, anthropologists frequently find themselves called upon by their IRBs to document consent in ways that make no sense to their study participants. In such situations signing consent forms offers the participants little in terms of protections, and unnecessarily burdens researchers who are caught between the expectations of their IRBs and the perspectives of their study populations. Moreover, the standard IRB-driven requirement for documentation of consent can interfere with rapport (that is, following local norms of relationship-building), a methodological prerequisite for effective ethnographic fieldwork.

We encourage Common Rule revisions to go even further, and explicitly recognize the need for “emergent” consent in the case of participant observation, where understandings of the research questions, and hence the potential risks and benefits of the research, develop dialogically (in culturally- appropriate encounters, usually by means of conversation) not only for participants but for researchers over the course of their interaction. For this reason, even when it is obtained orally, consent in anthropological fieldwork cannot be construed as an “event”, like listening to a script and agreeing to some or all of its terms.


On the awkwardness of continuing review for much anthropological research:

The NPRM proposes to eliminate the requirement of annual continuing reviews for “minimal risk” studies, i.e., those that qualify for expedited review. The NPRM also proposes to eliminate review of such minimal risk research once it has proceeded beyond data “collection” to data “analysis”, unless justification is given for why continuing review is called for. The AAA strongly supports these proposals, which help clarify the application of the Common Rule to anthropological research. It is standard practice for anthropologists to reflect on, analyze, and write about their field research experiences for years and even decades beyond the actual research encounters with study participants. This disciplinary norm makes it difficult or impossible for fieldworkers to identify a point at which their studies have ended.


On the category of “vulnerable populations”:

We applaud the NPRM’s proposal to clarify reference to “vulnerable populations” such that the consideration of relevance is specifically vulnerability to coercion. Categorizations of persons into a priori types cannot always be successfully applied across the board and apart from context; indeed, even reference to “children” must take into account local cultural conditions (e.g., the relevant distinction may be ritually initiated vs. uninitiated boys). The Common Rule specification of “vulnerable populations” may make sense in most situations in the U.S., but not in other settings where social categories may differ. Moreover, as is often emphasized by disability advocates, there is no reason to assume that being assigned to a given category of persons—those “physically disabled”, those “economically or educationally disadvantaged”, or any other group—necessarily puts individuals at risk of harm when those individuals engage in any area of life, research included. Indeed, the operative concerns—as the NPRM proposals attempt to acknowledge—are (1) the Belmont principle of Justice which calls for equitable opportunity to participate in research, and (2) the necessity for IRBs “to give consideration to [board] membership expertise” when they evaluate protocols involving study populations with which Americans are not generally familiar (CFR p.53989).