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October 25, 2006


Dean C. Rowan

If I read it correctly, Virginia's definition of human research specifies a limitation: "Human research shall not be deemed to include research exempt from federal research regulation pursuant to 45 C.F.R. § 46.101(b)." Among the variety of exemptions in (b) is "Research involving the use of . . . survey procedures, interview procedures or observation of public behavior. . . ." Exceptions to this exemption are provided to prevent damage--from publicizing names of survey respondents, for example--to subjects of this kind of research as well.

So, it appears that political pollsters are safe. In any case, and even if my cursory reading of the statute and regulation is incorrect, an apt elaboration of the problem identified in this post--the failure of a FA challenge to have arisen against what appears to be a state restriction on speech--is Frederick Schauer's The Boundaries of the First Amendment: A Preliminary Exploration of Constitutional Salience, 117 Harv. L. Rev. 1765 (2004). There, Schauer discusses the range of regulated behaviors involving speech that simply do not (yet) command FA attention. He also discusses the "magnetism" of the FA, and its potential usefulness as a defense against charges of violations of regulations such as Virginia's. The upshot is that "nondoctrinal" factors (i.e., cultural, social, symbolic factors and the like) can help us to account for why it is sometimes acceptable (so far...) to regulate speech we would otherwise imagine protected.

Rebecca Tushnet

I think Schauer's work is great; I'm using it heavily as I try to think through why advertising law hasn't really felt the First Amendment's sting yet. I'm not sure that anything in his theory suggests that Va's law would be safe if it were interpreted to cover historical-type research; the fact of the matter is that it's simply unlikely to be enforced at all. I should note that the exemptions to which you refer have not stopped university IRBs from insisting that their authority covers history, sociology, psychology, and so on, and claiming justification in the federal regulations. That's not to say they're right -- indeed, they seem quite wrong -- but their imperialism within institutions is pretty stunning.

Dean C. Rowan

The Schauer piece in fact suggests that the law would succumb to the FA once it is perceived to have fallen under the FA's purview. The FA's "magnetisim" generates a good deal of extra-doctrinal force, according to Schauer.

I gather a fear of some sort of liability prods the imperialist universities to cover their collegial butts. As you point out, there are less restrictive -- and less expensive -- means to do this than more bureaucracy embodied in review boards and their attendant procedures. Why don't they retreat in the face of those costs?

Rebecca Tushnet

I think it's a matter of power within the university. Once the IRB
exists, it tries to expand its mandate. And once it gets the idea that
someone other than the researcher should be reviewing research
protocols to protect subjects, it's easy enough to expand that to other
areas. The problem is when the specific means of protecting research
subjects useful for medical research get generalized to areas where "do
no harm" is not the rule, like the writing of history. The IRBs do have
a reasonable story -- it's bad to hurt people unnecessarily -- but they
don't usually have sufficient representation from nonmedical
specialties to modify their requirements for specific fields.

Jerry Menikoff

I don't claim to be a First Amendment scholar, but I do know a bit about how we regulate the world of IRBs. Many of the complaints relating to what IRBs are doing with regard to social science research stem from institutions and their IRBs not understanding the rules. In my non-FA-expert opinion, if the rules are applied correctly, the system actually provides minimal hindrance to the conduct of non-medical research, and those minimal effects are extremely unlikely to lead to FA problems.

In any event, for more on this question (including from people who are FA experts), you might want to check out the output from the conference that took place at Northwestern University back in April, Censorship and Institutional Review Boards. Conference co-organizer Philip Hamburger started the whole thing going by having earlier written a paper claiming that the system does indeed violate the FA. The full set of papers from the conference is going to be published in February 2007 in Volume 101, Issue 2, of the Northwestern University Law Review. I know that Jim Weinstein's paper, for one, will deal with Schauer's views (and Weinstein concludes there isn't a substantial FA problem).

By the way, at least in the world of medical research, there are good reasons to think that the protections being afforded research subjects are not as strong as they should be. I describe this in a recent book, What the Doctor Didn't Say: The Hidden Truth about Medical Research (Oxford 2006). Richard Epstein, who provided a blurb, found the state of affairs described in the book to be "disturbing."

Rebecca Tushnet

Thanks for the comments -- excellent points all, though I note that First Amendment jurisprudence cares about implementation as well as theory. That's the source of a number of speech-protective doctrines that require us to err against regulation, which we wouldn't need to do if regulators could reliably sort truth from falsity, dangerous speech from nondangerous speech, etc.

I look forward to reading the conference papers.

I absolutely agree that medical research is a different animal, which is yet another reason for IRBs not to apply the same standards across the board.

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