In my earlier post (“Responses to comments…”), part of my responses somehow disappeared. Here’s the missing bit (and sorry for my post-incompetence!):

#3 on inconsistencies and a sneaky plan to heighten the contradictions: John McCreery raises an excellent question. It would be nice if consistency ruled: all researchers should face the same constraints, but they don’t. The irony here is that consistency is one of the core values of bureaucratic ethics management. Consistency is a recurrent refrain on many local IRBs (“…well, if we allow you guys to do away with written informed consent, then we’d have to allow everyone to…”) and it is a key theme at the national level as well.

Ironies aside, as I understand it, there’s an important, fatal flaw in your deliciously sneaky consistency argument: market researchers don’t depend on federal funds to do their work.

Strictly speaking, IRB oversight is only required for institutions (like most universities and colleges) that accept federal research funds. The federal human subject protections regulations (45 Code of Federal Regulations, Pt. 46) were nicknamed “the Common Rule” in 1991 when 17 federal agencies (like NIH) that fund human subjects research all signed on. Rick Shweder’s contribution to our November 2006 American Ethnologist Forum explains that universities and other institutions that accept federal research funds cannot get those funds unless they sign an “assurance” with the relevant funding agencies, or a general Federal Wide Assurance (FWA): documents that obligate them to have one or more local IRBs to review their employees’ research proposals.

Now, as Shweder’s article also explains, university and college IRBs only need to promise to review federally funded research. However, it seems that most of our institutions have gone beyond this minimum requirement and have checked a box on the FWA form that obligates them to review all research, not just federally funded research! (Folks all over the place are looking in to this situation at their institutions: I recommend that you make friends with someone in your institution’s counsel’s office and look in to it too!) In any case, over the past five or six years of IRB “hypervigilance” (the situation that prompted the AE Forum) boards have been jittery and have tended to review all research regardless of how it is funded, regardless of whether their FWA obligates them to do so or not.

Responding to John’s question about the existence of guidelines parallel to those on which IRBs are founded: I can think of one that, while still being at least partially academic, is interesting nonetheless. Check out the National Academy of Sciences “On Being a Scientist” booklet (available online at http://bob.nap.edu/readingroom/books/obas/ ), which concerns science research ethics very generally. This is another example of the inconsistencies mentioned above: unlike the IRB oversight of research with human participants, these general (mostly non-human participant research) guidelines are completely voluntary even tho the research is very likely to be federally funded!

#4 on the roots of the IRB problems in disciplinary ‘cultures of research’: Another terrific question! My responses to other folks’ questions contain bits and pieces of an answer to this one (as does my AE Forum paper). But a fuller response would be the paper I mention in my comment on #5 (below). My contribution to the Cornell conference was a paper entitled “Comparative ‘Research’: A Modest Proposal Concerning the Regulatory Object” (which I’ll be ready to make available in a few weeks). In my view, the problems go way, way beyond the IRB context and derive exactly from the “cultures of research” of which IRB members and the rest of us are part. My own long-term research has been all about disciplinarity and interdisciplinarity—that is, engagements like those cross-disciplinary discussions concerning methodology you mention. As I explained in my AE paper, IRB discourse is just one of my “fieldsites” (which include other places in which disciplinary practitioners bump up against one another, as well as fractious intra-disciplinary moments of ethical crisis). But it’s a fieldsite in which everyone is implicated and consequently of great interest. My AE paper unpacks the Common Rule “definition of research” a bit; and it also begins to address exactly the issues you identify concerning how ethnographic fieldwork is understood by folks from other disciplines (and vice versa). Check it out.

#5 on the relationship between IRB and intellectual property issues: If Michael Brown is still out there, what do you think about the relationship between IRB surveillance and the management of intellectual property contradictions?

Different institutional mechanisms are at play with respect to intellectual property and IRB controversies. For one thing, the IRB system exists outside of (or prior to) legal mechanisms for dealing with accusations about misrepresentation (libel laws), privacy, and the like. This is a huge issue: several of us refer to it in the AE Forum (and anyone interested in following this might also check outhttp://irbinfo.blogspot.com/ and follow references to Hamburger’s Supreme Court Review paper). In a paper that I wrote for a Cornell Law School-hosted conference on “Bureaucracies of Virtue”, I suggested that we’d be better off (and our informants no worse off) if our work were held to account in the same ways that the work of journalists and other writers are. As I understand the current situation, IRB reviews do not protect us or our institutions from lawsuits (that is, whether or not consent forms are involved, IRB reviews don’t prevent our interlocutors from suing us). As things stand, many critics see IRB reviews as constituting censorship-like prior review (arguably a kind of “prior restraint”, something that the First Amendment protects against).

In his comment on my earlier post, Kerim wrote that it would be interesting to see how IRB regulations work for “examples which are supposed to be paradigmatic” (medical research). I agree. Doing so really exposes the fundamental impotence of the rules (despite mighty efforts by droves of well-intentioned, clever rule-writers). While ethnographers and biomedical experimenters do face analogous disconnections between regulatory prescriptions and the inevitable surprises of actual research practice, exploring the problems that medical folks in particular face brings us back to the regulatory system’s “origin place”. It brings us back to the problem that the rules were meant to solve but never did.
I’ll summarize the argument—part of the forthcoming PoLAR article, “Comparative ‘Research’” (mentioned in earlier posts)—versions of which also appear less centrally in my 2006 AE paper.
I begin with the observation that there is no such thing as Research-in-general: there is no suite of ideals or traits shared by all the practices to which the term “research” usually refers. Instead, there are diverse, historically specific, socially organized ways of knowing the world, in shifting partial relations with one another, as well as ambivalent relations with particular non- and quasi-research activities (from journalism or travel writing to stage magic or, as we will see below, therapy).
Bureaucratic regulation cannot tolerate such incoherence. To control human-subjects research, variation must be bracketed so as to create a stable object with clear boundaries. Criteria must be found for deciding when instances of “research” begin and end, and for deciding what is and is not “research”.
However, research involving human beings persistently resists reductive objectification in the interest of consistency. This is true not just among the ornery humanistic social studies but also in biomedicine and other unambivalently science-identified fields whose research models fit the Common Rule definition.
So why bother? Why did “research” with human participants come to be viewed as in need of regulation (and therefore agonizing definition)?
The IRB definition of research was designed originally to provide a means of eradicating a potentially lethal ambiguity, specific to medical practice, concerning when “therapy” ends and “research” begins. This danger, publicized in the 1960s and early 1970s, is central to the history of the US federal regulations (for lots of bibliographic leads, see that November AE again).
But the design was flawed: the original ambiguity is still with us.
Human-subjects research regulations (45 CFR, Pt. 46, known as the Common Rule: see Chris Kelty’s Savage Mind 2/8/06, on which I hope to comment soon!)—formally set in place in the late 1970s/early 1980s—derive from earlier NIH guidelines that reflect specifically biomedical background assumptions. These assumptions go something like this:
1. Since it concerns directly improving the wellbeing of particular individuals, medical therapy is appropriately evaluated in terms of individual patient interests.
2. In contrast, since medical research concerns the production of knowledge “generalizable” beyond individual cases, it is appropriately evaluated in terms of the interests of science and society at large.
3. It follows that—since a concern for individuals isn’t inherent to the definition of “research” the way it is to the definition of “therapy”—even though physical risks to persons are associated with both medical therapy and research, the risks to individuals are qualitatively more serious in research
4. Consequently, “research” (in this sense) needs special oversight.
These specific background assumptions are evident in regulatory provisions that, firstly, limit risk/benefit calculi to research “emas distinguished from risks and benefits of therapies/em” and that, secondly, exclude from consideration the “long range effects of applying knowledge” (45 CFR 46.111[a][2]). “Research” is not “therapy”: not the emapplication/em of medical knowledge to individual persons (applications normally enabled when research results are published and made available to practicing physicians). The medical rationale of regulatory distinctions is just as evident in the definition of “human subject”, but I won’t discuss that here.
Now, while Common Rule regulations were applied widely to federally-financed non-biomedical research from the start, the idea of research-as-not-therapy does not translate readily outside of biomedicine. For example, cancer patients participating in clinical trials of new cancer therapies can compare the likelihood of a direct personal benefit from new knowledge against the risk of harm in the research process itself. In contrast, social research rarely promises practical payoffs to its participants. Its benefits tend to be indirect and its harms are located less in the research process than in its products.
Not only is research-as-not-therapy untranslatable across fields, but the regulatory definition did not even do away with the ambiguities within medical practice. Heroic efforts of clarification can be found in works that interpret the Common Rule for IRBs, like the IRB Guidebook (www.hhs.gov/ohrp/irb/irb_guidebook.htm). Nevertheless, to this day it continues to be a frequent topic of debate in IRB circles.
I’ll stop here for now. In the full length treatment of this argument, I offer an extended example of problem solving discussions among experienced biomedical IRB insiders concerning how the medical therapy/research distinction might be operationalized in particular cases. Such discussions—which happen all the time—demonstrate very clearly that it is effectively impossible in practice to distinguish clearly between when “therapy” ends and “research” begins: when innovations in the care of a particular patient with an unusual condition ought to be treated as research (worth publishing, in need of an IRB review). The regulations offer no solution to this problem.
More soon.