Joining Someone Else’s Research Project? Check Their Ethics Protocol!

Posted confidentially on the author’s behalf by the ethics blog editors

This post is a reflection on the role that IRBs and other institutional gatekeepers can play in protecting informants and researchers from unethical actions committed in the course of large research projects. It tells the (highly condensed) true story of a team project focused on helping refugees resettled in the U.S. Unsurprisingly, a project with such progressive, socially ambitious goals attracted researchers from several subfields of anthropology, including a couple of graduate students from the department where the project was hosted. A recently arrived refugee worked as a research assistant on the project to liaison with the refugee population.

As an anthropologist hired in as a postdoc to work on the project, I began to feel that some things were “off” when I observed that the refugee who worked for the project was never invited to the team meetings or given a key to the office. After getting to know the person working in this role, I learned that s/he was being paid hourly, barely above minimum wage, and had no health insurance or benefits of any kind. Soon, the uncomfortable feeling of finding myself working for a project that was “all talk and no show” turned into something much worse when researchers on the team were asked by the project director to do things that we felt were serious violations of anthropological ethics. Highly sensitive personal data were being collected, handled, and stored in the most careless way. Informed consent was barely an afterthought. During the months I worked for the project, I witnessed how disrespectfully the project director treated the one refugee employed on the project. In the employee’s own words, s/he felt better and freer at the refugee camp than working for this project! I also noticed that the observations we had made were manipulated at community events and professional meetings. The project director once admitted knowing that the project was “way out of compliance”. But all that seemed to matter to the director was that we appeared to be making progress so the grant could be renewed.

While I worried about the unprofessional and unethical ways in which we were being pushed to conduct research, I also feared being fired. Like others working on the project, my contract was “at will,” and everyone who expressed the slightest difference of opinion to the project director was threatened with being let go. To complicate things even further, the project was being conducted at the same institution where the project director had received their PhD, which made me, as a relative newcomer, wonder if such practices were supported (if not fostered) by that department. Hence I had to ask myself: who can I report to in this institution that will not automatically disregard my testimony?

My first instinct was to take these matters directly to the project’s advisory board. I was extremely lucky to get guidance from my mentors at my alma mater, whom I asked for help. They advised me not to go to the advisory board, as they may have had conflicting interests (for example, the project director’s dissertation advisor was a member of that board). So I contacted the university’s office of research compliance and IRB instead. Upon reviewing the documentation presented, the compliance director and the IRB immediately opened an investigation on the project. After interviewing several team members, the IRB decided to shut down the project until further notice. In addition to the problematic way in which the research was being carried out, I learned that no researchers (other than the project director) were even mentioned in the IRB protocol; hence none of us were technically authorized to be doing this research in the first place. In retrospect, I am shocked at how naive I was, not asking to see copies of the IRB protocol before starting to work on the project. A few months later our contracts were up. Needless to say, the grant was not renewed.

In this situation, the refugees we were working with were vulnerable, but so were the researchers, who found themselves with their backs against the wall: doing research the project director’s way, or “the highway.” What I would like to underscore is that it was the IRB and the university’s research compliance office, not the anthropology department, who were the ones to tell the project director that research could not be conducted in that way. By suspending the project and seizing all the data collected by the team, the IRB not only effectively protected participants’ rights, it also protected the researchers from being pushed to engage in unethical practices. Ironically, it also protected us from having to publish the data that we had collected. As bad as it is for a postdoc not having any publications to show for a year’s work—especially while on the job market—it is better than publishing something that would later have to be retracted.

We sometimes think of anthropologists as sympathetic saints who know more than their IRBs about “research with human subjects” and who would not, by the very nature of their professional commitments, violate the rights of participants in their research. But the fact is that such violations have happened in the past and continue to happen today. It is good and necessary, if at times tedious, to have to show someone that our work complies with federal regulations and the ethical guidelines those regulations aim to implement. Finally, a word of caution to anthropologists moving into postdoctoral positions: never embark on a project without first checking with the project director about their approach to research ethics. Ask to see the ethics protocol. It may be an awkward thing to ask at the time, but it is better than finding out later that you are implicated in an unethical project that renders all your professional efforts totally worthless.

Update on Proposed Revisions to The Common Rule

The Council on Governmental Relations recently published an article overviewing their “comprehensive review and analysis of 2,186 public comments on the Obama administration’s 2015 Notice of Proposed Rulemaking (NPRM) for revising the ‘Federal Policy for the Protection of Human Subjects,’ better known as the ‘Common Rule.'” Anthropologists, including the American Anthropological Association, were active during this public comment period (see our previous posts on this topic). This piece indicates that public comments on proposed changes to the Common Rule were overwhelmingly negative. This piece summarizes key critiques of the proposed changes offered in the larger document. Here is a link to the article and a link to the the comprehensive review.

 

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).

Fieldwork Safety and IRB Detachment

Emily Channell

Doctoral Candidate at CUNY

echannell@gradcenter.cuny.edu

In the fall of 2014, three months after returning from fieldwork in Ukraine, I was required to submit a “Continuing Review Form” for my university’s IRB. After spending several months the year before arguing with the IRB about what forms needed to include participants’ acceptance of being photographed and what an “official” translation would mean before they would approve my research, I was frustrated to read the questions on the Continuing Review.

“Have there been any unanticipated events, protocol violations, adverse events, subject complaints and/or DSMB reports since the last continuing review that have not already been reported to the IRB?” “Has any new information come to light that might affect the risk/benefit ratio of the study?”

These questions seemed absurd in the context of what I experienced during my fieldwork. About two months into my stay in Ukraine, mass mobilizations of hundreds of thousands of people began in Kyiv, the capital and my research base. The mobilizations and a protest camp continued until my research ended in June of the next year. In January 2014, people began to be killed and to disappear from hospital beds. In February, nearly 100 people were shot and killed by militarized police forces, whose provenance is still uncertain. Representatives from the US Embassy met with me and other state-funded grantees, attempting to convince us to leave the country (admitting only in March that they could not require us to evacuate under any circumstances). My fieldwork — and whether I would finish with enough legitimate “data” to write something at the end of it — was rife with uncertainties that mirrored the feelings of my local friends who participated in my research project. At home, those in my program watching from afar sent comments like, “How exciting!” and “I wish something like that would happen in my field site, it’s not that interesting here.”

My experience forced me to consider ethics in research in ways that I never anticipated. I spent months trying to figure out my relationship with the protests in Ukraine themselves and whether it was possible to engage with protesters in a critical way without endangering myself and others around me. This included attempts to obtain “research materials” in a way that did not put participants in and supporters of my research at risk. As an American citizen, I was forced to consider leaving the country under the guise of a relatively official evacuation, leaving my friends behind to face whatever came their way — and I was lucky to have the privilege to make the choice to stay despite my government’s recommendations. When I did return to the US at the end of my grant period, I was asked to sum up my experience to others who had peripherally observed what had happened. In this context, when I received the IRB’s request for a Continuing Review that was so detached from everything I had experienced, I was angry. If they cared so much about whether someone wanted to have their photo taken, couldn’t they at least bother to ask if all the people who helped me with my research were still alive?

The realities of ethnographic research — which, I suspect, most practitioners know — is that what happens on the ground often looks completely different than what was proposed in a grant or IRB application. Before I left the US, my advisor told me to keep my eyes open for everything, and that my final project would look nothing like what I thought (I don’t think even she knew how right she would be). Knowing this, it was extremely hard to take seriously the details expected in my IRB application, because “risk” and “benefit” are terms that are contextually fluid in ways that IRBs do not recognize. In my application, I presented my research in what I felt was an extremely detached and even falsified way, knowing that my field experience would not fit the stagnant outlines expected from the IRB.

When the protests in Kyiv began, I quickly dove into the mobilizations with my Ukrainian friends, who are largely leftist and feminist activists. From the beginning, these people were attacked and harassed during the protests, which were being touted by Western media either as the true representation of democracy in Ukraine or as a neo-fascist takeover. Of course, the reality was infinitely more complex. As days and weeks went by, it became very unclear to me what might happen next not only to my research but also to my friends, who ensured my safety throughout the protests while also constantly helping me find ways to continue my research in the context of uncertainty. While other Western observers and participants posted constant updates on social media, I felt it was more important for me to keep quiet. In this way, I felt I could continue doing research without calling attention to myself or to my friends, who faced danger not only from the governing regime (which targeted all protesters) but from the growing presence of radical right-wing nationalists (who found this a convenient opportunity to continue targeting leftist and feminist activists with attacks and harassment).

When I returned, transitioning back into academic life while the country I had been living in went to war was extremely challenging, a feeling that was exacerbated when I received the IRB’s request for Continuing Review. I didn’t know how to answer questions like whether anything had happened to impact the “risks” and “benefits” of my research. I had just spent eight months terrified that every person I knew in Ukraine would die or be kidnapped. I didn’t know how to translate this into Review Board language when “risk” meant death or bodily harm and “benefit” was meaningless. Even now, as I am writing my dissertation, I find every person who reads any part of it asking about my relationship with my “informants.” I was unable to remain detached or “objective” in this context; I came to love the people in Ukraine who participated in my research not just because they were kind enough to help me. They took me in, offered me escape from the city center, explained things I couldn’t understand, sent me away from the mayhem when they knew it was getting too dangerous, and called me when something significant happened. Our relationships were not framed by “risk” and “benefit” but by sharing an experience that I hope happens only once in our lifetimes.

As anthropologists, the circumstances of our research are largely out of our control, and in part, this is what makes our research so essential. We should be able to respond to rapidly changing contexts in order to understand them better and to help others comprehend them. After my experience, I firmly believe that my research is better than it would have been if I had not allowed my relationships with my interlocutors to cross over into friendship. I began to frame my research and writing around the goal of presenting the mobilizations honestly (rather than with some sort of pretense of objectivity). They were complicated, as I observed as many ugly interactions as I participated in beautiful, positive actions and initiatives. Only by placing my trust in people who were willing to treat me as a friend was I able to engage with this complexity. Ultimately, this is reciprocity. Portraying these events in an honest way is all my friends have asked of me in return for their ensuring my well-being.

I am still unsure if I behaved “ethically” according to the IRB’s standards. When I submitted my Continuing Review form, I glossed over their questions because I did not feel the IRB was concerned about my personal quandaries, only if I had done research in a “safe” way (“safe” here in terms of IRB-established “risks” and “benefits,” not concerning the personal safety of my friends). The IRB isn’t concerned with whether my research actually contributes to a better understanding of a complex situation (a point which is reflected throughout the AAA Statement of Ethics), which leaves me questioning how the IRB helps us do better research if it can’t understand why we are doing research in the first place. While I was lucky that my department and my advisor were fully supportive of the ways my research changed and my responses to those changes in the field, structures like the IRB do not equip researchers at all for the realities of ethnographic fieldwork, which can lead us into a false sense of preparedness. I recognize that IRB approval is a requirement for research among humans, but I propose that methods courses and other pre-research requirements in doctoral programs focus more on the AAA Statement of Ethics, a more flexible and appropriate guideline for anthropology.

Ultimately, these forms and approvals remove us from what is really important about ethics and anthropological research: people on the ground who make it happen. As anthropologists, we should know that our first concern has to be the safety and well-being of those generous people, both in the field and when we leave it. Only when we are honest with ourselves about the nature of our relationships with those people can we truly understand our own investment in our research and what it will mean for those who supported us.  

IRB Federal Regulations Update

As explained earlier, the US federal regulations that govern IRBs are being overhauled top to bottom. (You can access the “Notice of Proposed Rulemaking”, or NPRM, here). This overhaul is consequential for all anthropological research. A period of public comment on the proposed  changes closes at 5 p.m. on December 7, 2015. (Additional information about the NPRM, including instructions on how to submit comments, can be found here, where you’ll also find the the federal Office for Human Research Protection’s summary of the proposed changes; the IRB professional association, Public Responsibility in Medicine and Research, has produced a longer chart comparing the current and proposed regulations which may be helpful as well.)

All anthropologists are encouraged to review the NPRM and submit comments that reflect your interests!

In addition, anthropologists Rena Lederman and Lise Dobrin will submit comments on behalf of the AAA, and they seek your opinions and advice on what the AAA comment should look like. They especially seek feedback on the following five questions (all page references are to the text in the first link above). While these are by no means the only proposals in the NPRM that would affect anthropological research, they represent areas about which Lederman and Dobin especially welcome advice, discussion, and examples. Please send your responses to lederman@princeton.edu and dobrin@virginia.edu by December 1, 2015!

  1. The NPRM proposes to “exclude” from review oral history, journalism, biography, and forms of historical studies that focus directly on specific individuals (section _.101(b)(1)(ii); see NPRM p. 53946-8). Are there certain kinds of anthropological research that should be included in this category? (Note that “exclusion” is a new category, signifying that it would be entirely outside of IRB jurisdiction: unlike current “exemption”, IRBs would not need to be consulted at all about these forms of investigation.)
  1. The NPRM proposes to “exclude” from review research involving the use of educational tests, survey procedures, interview procedures, or public behavior observation, as long as the information is not individually identifiable, OR as long as a disclosure of responses could not reasonably place persons at risk (section _.101(b)(2); see NPRM p. 53950-1). In what ways (and for what reasons) do you think anthropological research fits this category of exclusion?
  1. The NPRM proposes that the Department of Health and Human Services further develop its list of research activities that present “no more than minimal risk” to human subjects (section _.110 and _.102(j); see NPRM p. 53985-6). Which broad categories of anthropological research do you think should be included on such a list?
  1. The NPRM proposes to “exempt” from review research that involves “benign interventions,” that is, encounters in which an adult provides verbal or written responses (which may even be recorded) that are “brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects,” and not “offensive or embarrassing.” This exemption would be allowed so long as the individuals responding cannot be identified, or so long as disclosure of the responses “would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation.” This exemption would be allowed even in cases of “authorized deception,” where subjects are prospectively informed that they may be misled about the nature or purposes of the research (section _.104(d)(3) and _.104(e)(1); see NPRM p. 53960). To what extent does anthropological research fit this proposed exemption?
  1. The NPRM proposes to change the definition of “human subjects” research to include all research with biospecimens, whether or not they are identified. What this means is that any “secondary” use of biospecimens (that is, work with banked specimens collected by others in research or nonresearch settings) will require researchers to obtain permission from the individual sources of those biospecimens: the NPRM proposes that this be done through some form of blanket consent for “future unspecified use,” obtained at the time of collection (section _.102(e) and _.101(b)(3)(i); see NPRM p. 53942-6). Would such a change impact anthropological research, and if so, how?

Proposed Federal Changes to the Common Rule

 

Anthropologists’ Input Needed!  Proposed Federal Changes to the Common Rule (IRB Regulations) Are Finally Published and Await Public Comment

 

On Tuesday, September 8, 2015 the U.S. Department of Health and Human Services (HHS), along with several other federal agencies, published its long-awaited proposal for a dramatic overhaul of the federal regulations for the protection of human subjects (http://www.gpo.gov/fdsys/pkg/FR-2015-09-08/pdf/2015-21756.pdf). Appearing in the Federal Register, this proposal takes the form of a “Notice of Proposed Rulemaking” or NPRM. Publication of an NPRM is a key stage in the process by which U.S. federal regulations are developed and implemented, during which federal agencies solicit public commentary from interested individuals and organizations. The comment period on this NPRM closes 5 pm, December 7, after which HHS administrators will begin the multi-year process of finalizing the new rules.

 

Anthropological research is heavily impacted by IRB regulations. This NPRM public commentary period is an opportunity for anthropologists to make our voices heard to persuade HHS to implement changes that acknowledge the intellectual value and ethical character of our discipline’s scholarship. In 2011, when HHS published an earlier version of these proposed changes for public comment, Rena Lederman (Princeton University) and Lise Dobrin (University of Virginia) authored the American Anthropological Association’s response, after soliciting advice and input from AAA sections and members. You can read that 2011 response here:  http://www.aaanet.org/issues/policy-advocacy/protecting-human-subjects.cfm

 

Lederman and Dobrin have agreed to draft the AAA’s commentary on the NPRM as well, and they need your input for the comment to represent members’ concerns. You are encouraged to study the NPRM, a detailed and intricately argued document. Please send your analyses and reflections concerning its implications for anthropological work across all subfields directly to Lederman (lederman@princeton.edu) and Dobrin (ld4n@virginia.edu), and/or to the AAA’s Ethics blog. Individual anthropologists and anthropological organizations may also send comments directly to HHS (information about how to do that is contained in the NPRM, p. 53933, at the Federal Register link above).

 

While anthropologists have been writing about the impacts of IRB regulations on ethnographic research ever since those regulations were introduced in the 1970s, this NPRM is brand new and there are no substantive anthropological responses as yet. While HHS has disseminated a summary highlighting what it construes as the NPRM’s most significant elements; and while other responses and analyses