Human Subject: An Investigational Memoir

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6. One Rule Fits All?

“Il est impossible que des hommes qui jugent les faits avec des idées si différentes, puissent jamais s'entendre; et comme il est impossible de satisfaire tout le monde, le savant ne doit avoir souci que de l'opinion des savants qui le comprennent, et ne tirer de règle de conduite que de sa propre conscience.”

When the National Research Act was passed in 1974, researchers in the social sciences and the humanities feared that regulatory bodies and institutional oversight committees would fail to make any distinction between medical and other types of research. In many cases it seems that their dire predictions have proven correct. Historians, anthropologists, political scientists, and journalists, all of whose research tends to consist mainly of surveys and interviewing, have all complained about having their research plans scrutinized according to the same standards as those applied to biomedical research.

As political scientist Ithiel de Sola Pool pointed out in a New York Times op-ed piece (Pool, 1979), the NRA regulations were promulgated to prevent the recurrence of scandals that involved purely biomedical research. There was no reason, he maintained, to apply the same rules to behavioral and social-science research. In the wake of the Belmont report, the rules were being amended to require institutional review of all research at institutions where any HHS-funded research was being done, and the definition of “human subject” was being expanded to mean anyone about whom data were acquired “through intervention or interaction with the individual” or about whom “identifiable private information” was obtained. Pool, calling the regulations “well-intentioned reform carelessly adopted,” contended that the new regulatory climate amounted to prior restraint on students’ and researchers’ freedom of expression.

A letter responding to Pool’s column maintained that “subjects cannot be expected to protect themselves against risks to psyche or dignity that they may not understand and cannot anticipate . . . ” The author was Arthur L. Caplan, a newly minted Ph.D. in history and philosophy of science, who was serving at that time as associate for the humanities at the Hastings Center. Since, according to its Web site (http://www.thehastingscenter.org/), the Hastings Center exists “to explore fundamental and emerging questions in medicine, health care, biotechnology,” it’s unclear why they ever needed an associate for the humanities. It’s clear, however, that he was unwilling to recognize any substantive distinction between biomedical research and the kind of research being done in the humanities and social sciences.

“Few if any studies are blocked by I.R.B.’s,” wrote Caplan. “At most, researchers are asked to modify their proposals . . . If there is any interference with free scientific inquiry, it occurs only to the extent to which an investigator fails to convince a sample of his or her colleagues as to the safety, efficacy and utility of conducting a given piece of research.” (Caplan, 1979) In fact, the IRB is unlikely to include in its membership anyone in the researcher’s general field, let alone any actual colleagues. And the weeks-long delay while proposals are reviewed and questions are asked and answered can effectively kill many academic research projects.

Since the 1970s, other critics of overzealous oversight have called the IRB process a threat to First Amendment rights. James Lindgren, a law professor at Northwestern University, likens the IRB system to England’s 17th century Star Chamber system. Under that system, he says, censorship was delegated to the universities, and one needed a license from the censors in order to publish a book. Compared to IRBs, he maintains, the Star Chamber was less intrusive, less insistent on changes, and “less prone to kill books than many IRBs are to kill most of the projects brought before them.” While the Star Chamber system merely restricted publication, IRBs can and do “prevent the development of knowledge before it can be published.” (Northwestern University, 2005)

The Court of Star Chamber was the judicial arm of the monarch’s Privy Council, which legislated in lieu of (or in addition to) Parliament. Apparently this court issued a decree in 1566 that essentially banned books that were critical of the government. Then in 1637 it issued a decree that suppressed seditious publications. (It’s strange that for 10 years people could advocate overthrowing the government, but they couldn’t criticize it.) I’m not sure that the court ever mandated any prior licensing, but at some point it did require publications to be licensed by, or registered with, the Stationers Company. The Star Chamber was abolished in 1641, and in 1643 there was a licensing order issued by Parliament. In all my research I found no evidence that the Star Chamber ever required publications to be licensed by a university. But I’ll take the word of Lindgren and others who get paid for knowing that sort of thing.

One particularly knowledgeable critic of the IRB system is Columbia University law professor Philip Hamburger, who decries, in an 85-page article supported by 191 footnotes, the “new, soft kind of censorship” exercised by IRBs at public and private institution. He believes that IRBs constitute a more insidious threat to civil liberties than the Star Chamber ever did. The licensing power granted to them, he maintains, undoubtedly violates the First Amendment, but the violations go largely unmentioned, and challenges to them are not taken seriously. He writes that “rather than aim at political or religious ends, this censorship aspires to be bureaucratic, and rather than threaten civil liberties, it attempts to protect them. . . . With this mild and moral tenor, the new censorship seems to slip past both political and constitutional barriers.” (Hamburger, 2005, p. 7)

I confess that I didn’t read all of Hamburger’s article, and I didn’t understand or remember much of what I did read. Two of his main points could very possibly be that the U.S. Supreme Court has weakened the Constitutional prohibition against licensing and that Congress is controlling research activities with its funding power. One thing I did manage to grasp was the fact that researchers who are brave enough to stand up to the IRBs and the feds usually base their argument on something other than the First Amendment.


In January 2002, an HHS-convened panel discussed the issue of research regulation in the social sciences and humanities (AAUP, 2002). Here are excerpts from two of the panelists' remarks:

“[H]istorians have reported that they have been told to submit detailed questionnaires for IRB review prior to conducting any interviews, to maintain narrators’ anonymity, and to destroy their tapes or retain them in their own possession after an interview. . . . Each of these requests violates a fundamental principle of historical research. . . . An oral history interview is an open-ended inquiry, structured around a set of topics but with ample room to follow the logic of the exchange. While anonymity is always an option in oral history, anonymous sources lack credibility in history."—Lisa Shopes, Historian, Pennsylvania Historical and Museum Commission

“Although our IRB manual says that the standards applied should be those prevalent in each individual field, in truth we are asked to meet biomedical standards that are often not carefully explicated or explained. . . . IRB leaders told us that they had no intention of interfering with freedom of the press, and that is why they were steering clear of our journalistic product. When we asked them about the application of press freedom to other kinds of academic work, we were told the courts would have to decide that issue."—Margaret A. Blanchard, William Rand Kenan Jr. Professor, School of Journalism and Mass Communication, University of North Carolina at Chapel Hill

In 2003 the American Historical Association and the Oral History Association attempted to prove that the federal regulations don’t apply to oral history, because oral history interviews do not contribute to “generalizable knowledge.” It appears that their attempt was at least partly successful, judging by the agreement reached with OHRP in 2004, which resulted in an official statement that “oral history interviewing activities, in general, are not designed to contribute to generalizable knowledge.” (http://www.historians.org/Perspectives/Issues/2004/0403/0403new1.cfm) However, if the interviewers plan to draw conclusions or develop policy based on the interviews they conduct, that would constitute research.

Zachary M. Schrag, an assistant professor of history at George Mason University, maintains the Institutional Review Blog (http://institutionalreviewblog.blogspot.com/) to “inform the debate” about IRB oversight of research in the humanities and social sciences. His blog assails the views of some prominent people in the field of human-subjects protection, but he often gives them space to respond to his criticisms. A favorite target in spring 2007 was the 30-year-old organization called Public Responsibility in Medicine and Research, which claims to serve “the full array of individuals and organizations involved in biomedical and social science/behavioral/educational research.” PRIM&R’s board, says Schrag, actually has little understanding of, or interest in, non-biomedical research. He suggests that PRIM&R narrow its focus to its true area of expertise and, at the same time, push for broader exemptions from federal regulation for research in the social sciences and humanities.

Harry Perlstadt, of Michigan State University, has proposed a “Researcher’s Bill of Rights” (Perlstadt, 2004). It includes this statement, which starts out defiant and resolute but tends to lose its teeth toward the end: “Researchers and evaluators shall have the same rights to associate with and observe people, ask questions, and publish the information they acquire as does any person whose rights of assembly, inquiry, and publication are protected by the First Amendment of the U.S. Constitution unless the receipt of funding for research specifically requires prior review and approval of research procedures.”

One writer, describing a two-year ordeal in which two psychologists were subjected to IRB overzealousness at their two institutions, characterized the modus operandi of IRBs as “keep the charges secret, keep changing the charges, keep the meetings secret, keep the accused in the dark.” Both “researchers” (they were doing no more research in this case than a journalist would in investigating a story) were eventually exonerated. (Tavris, 2002)

Citing examples of IRBs that have unreasonably stifled research in the social sciences and humanities, C K Gunsalus writes: “Several scholars are calling for changes to the institutional-review system that would exclude research from oversight unless it posed a risk of physical harm. That seems unrealistic: We have had 40 years of debate about regulating research, and the public has made it clear that it does not trust scholars alone to judge what may be harmful.” (Gunsalus, 2002)

I’m not sure which members of the public have made their feelings known about research regulation. Yes, there are a few outspoken research watchdogs, but most people aren’t even aware of the rules that are in place, much less how they’re being interpreted and applied.

As for the question of harm, while it may be unwise to limit regulatory oversight to those studies where the risks are purely physical, I think the National Science Foundation (2006) goes overboard in its proscriptions. In answer to the question “What sorts of harm can arise from social and behavioral science research?” it lists the following as “Harms that have the potential for serious effects, which IRBs should examine”:

How on earth can a researcher promise that no subjects will decide to behave unethically in the course of the research? The other harms could only occur if confidentiality is breached, so I don’t see how research could be riskier than any other circumstance where a person discloses personal information. In fact, it should be less risky, given the confidentiality and privacy rules in place. Finally, it seems a little wacky to call it “legal harm” when a person is brought to justice for committing a crime.

Most surveys, oral histories, etc., are exempt from review under the Common Rule, either because they pose little, if any, risk or because they aren’t research at all. But of course the researcher can’t determines whether an activity is exempt. At Big U, supposedly your department head makes that determination, but you still have to apply to InvestiGuard for a certificate of exemption. The application review process can take several weeks. By that time, especially if you're a student doing a course project, it may be too late to conduct your research.


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