Monday, August 25, 2008

Can Satire Match IRB Reality? Comment on Lederman's "Modest Proposal"

The last entry in the PoLAR symposium for which I will offer comments is Rena Lederman's "Comparative 'Research': A Modest Proposal concerning the Object of Ethics Regulation."

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.

Tuesday, August 19, 2008

Oral History Association Plans Revised Guidelines

The Oral History Association has posted a call for suggestions for revision of its Principles and Standards. Oral historians who find themselves trying to explain their work to IRBs often rely on this statement, so it needs to be as clear as possible. I encourage concerned oral historians to join in the revision process.

Monday, August 18, 2008

Critiques of Consent Forms

Two items in the November 2007 PoLAR symposium question the utility of written consent forms. Both offer important insights about the difficulty of relying on written consent, though neither presents a persuasive alternative.

Wednesday, August 13, 2008

AHA Calls for Comments on Training

At AHA Today, the American Historical Association's blog, Rob Townsend calls for responses to OHRP's recent invitation to comment on training for IRBs. As Townsend notes, the very phrasing of OHRP's questions suggest a continued inability to remember that the office's policies have effects beyond medical research. On the other hand, he notes, some kind of training mandate is likely, so it would be best for historians not to remain silent.

Sunday, August 10, 2008

Reform or Revolution? Comment on Bosk, "The New Bureaucracies of Virtue"

Following the introduction, the first substantive piece in the PoLAR symposium is Charles L. Bosk, "The New Bureaucracies of Virtue or When Form Fails to Follow Function."

In the past, Bosk has advocated living with IRB review. As he wrote in 2004

Prospective review strikes me as generally one more inane bureaucratic requirement in one more bureaucratic set of procedures, ill-suited to accomplish the goals that it is intended to serve. Prospective review, flawed a process as it is, does not strike me as one social scientists should resist. After all, we agree with its general goals: that our informants should not be subject to untold risks, that they be treated with decency, that their confidentiality and anonymity be safeguarded, when feasible. Given this, we should not waste our energies resisting a process that has an enormous amount of both bureaucratic momentum and social consensus behind it. Instead, we should focus our energies on reforming and revising procedures; we should fix the system where it is broken.

[Charles Bosk, "The Ethnographer and the IRB: Comment on Kevin D. Haggerty,'"Ethics Creep: Governing Social Science Research in the Name of Ethics'," Qualitative Sociology 27 (December 2004), 417.]


But at some point in 2005 or 2006, an IRB seems to have really pissed him off. In this essay, he writes that "having now been on the receiving end of IRB objections that I find incomprehensible, I appreciate my colleagues' multiple frustrations." (204) He now seems to think the system is not merely broken, but so defectively designed that it cannot be repaired:

The presumption of prospective review—that our subjects are in need of protection— has embedded within it an insulting distrust of our integrity and motives. The insult inherent in a regulatory regime based on distrust deepens when the barriers the review system places between us and the doing of our research appear to protect powerful institutions from close scrutiny more than they guarantee the well-being of our research subjects. For me, the most serious defect of the current regulatory system is that the requirements of policy reduce and trivialize the domain of research ethics. In the process, our ability to conceptualize, discuss, and make sense of the ethical problems of ethnographic work is dulled. As we do our work, we face ethical dilemmas aplenty, almost none of which have to do with the dual mandate of prospective research review—the adequacy of the consent process, which is invariably reduced to concern about a "formal document" or potential risks to subjects. (194)


Bosk's essay is rich in ideas--too many, really, for an essay of this length. I will do my best to unpack them.

The New Bureaucracies of Virtue

Pity the poor blogger. When I started this blog, I expected to report on the occasional journal article on IRB review of the social sciences. Instead, I find that journals insist on publishing special symposium issues with several articles on the topic. Rather than sipping a beer I must down a six-pack.

In the coming weeks I plan to take on the November 2007 issue of PoLAR: Political and Legal Anthropology Review (Vol. 30, Number 2), which includes eight articles totally 147 pages, some of them based on an October 2006 symposium at Cornell. In their introduction to the symposium, organizers Marie-Andrée Jacob and Annelise Riles, write,

Although we certainly do not defend the current regulatory framework of research, we also wanted to press the pause button on the ambient criticism of IRBs and accompanying expressions of fears and anxieties about their impact on research and free speech. Instead, we wanted to trigger a discussion that would harness, among other things, these practical anxieties in the service of a larger theoretical and epistemological inquiry. (183)


As someone more interested in the practical than the theoretical or epistemological, I'm not sure this is my thing, but I'll do my best. And while I can't promise to comment on all the essays, here's the table of contents:

SYMPOSIUM: Papering Ethics, Documenting Consent: The New Bureaucracies of Virtue


  • Marie-Andrée Jacob and Annelise Riles, "The New Bureaucracies of Virtue: Introduction"

  • Charles L. Bosk, "The New Bureaucracies of Virtue or When Form Fails to Follow Function"

  • Amy Swiffen, "Research and Moral Law: Ethics and the Social Science Research Relation"

  • Jennifer Shannon, "Informed Consent: Documenting the Intersection of Bureaucratic Regulation and Ethnographic Practice"

  • Marie-Andrée Jacob, "Form-Made Persons: Consent Forms as Consent’s Blind Spot"

  • Stefan Sperling, "Knowledge Rites and the Right Not to Know"

  • Adriana Petryna, "Experimentality: On the Global Mobility and Regulation of Human Subjects Research"

  • Rena Lederman, "Comparative 'Research': A Modest Proposal concerning the Object of Ethics Regulation

Sunday, August 3, 2008

Social Scientists Debate Defense Department Funding

Today's Washington Post reports contrasting reactions to a Department of Defense plan to give $50 million in grants to social scientists to study such issues as China's military and political violence in the Islamic world. [Maria Glod, Military's Social Science Grants Raise Alarm," Washington Post, 3 August 2008]

Some anthropologists quoted in the story seem to reject any military sponsorship as unethical. David Price, whose book on anthropologists during World War II is on my reading list but not yet in my library, objects that the program "sets up sort of a Soviet system, or top-down system. If you look at the big picture, this will not make us smarter -- this will make us much more narrow. It will only look at problems Defense wants us to in a narrow way." By contrast, Rob Townsend of the American Historical Association notes that "hopefully, a project like Minerva will provide some historical perspective before, rather than after, it is needed."

The Post correctly explains that this debate is a replay of controversies in the 1960s, when the Pentagon and CIA sponsored studies of Latin America and Southeast Asia, including the infamous "Project Camelot." Throughout the 1960s and 70s, scholars struggled to find ways to lend their skills and insight to sound public policy without sacrificing their intellectual independence and integrity. Obviously, this is not an easy thing to do, and questions of sponsorship remain among the most difficult ethical problems faced by social scientists.

For a blog about IRBs, the salient point is the irrelevance of the Belmont Report to such questions. The authors of that report were steeped in the history of medical experimentation, and the report reflects their concerns about past abuses of poor ward patients, Nazi concentration camp prisoners, and the rural black men enrolled in the Tuskegee syphilis study. They knew nothing of Project Camelot, anthropology's "Thai affair," or less spectacular concerns about corporate sponsorship. As a result, the Belmont Report, while getting rather specific about such medical concerns as selection of subjects, says nothing about the conflicting duties to sponsors, subjects, and the truth. When applied to social science, the report gives the wrong answers to some questions, and no answers to others. And if anyone were to attempt to write a Belmont-style report on the ethics of social science, they would find various scholarly disciplines clashing over programs like this one.