Columbia University Grants Oral History Exclusion

Mary Marshall Clark, director of Columbia University's Oral History Research Office, has announced on H-Oralhist that the university yesterday approved a new policy on IRB review of oral history research. The policy notes that

Oral history interviews, that only document specific historical events or the experiences of individuals or communities over different time periods would not constitute "human subjects research" as they would not support or lead to the development of a hypothesis in a manner that would have predictive value. The collection of such information, like journalism, is generally considered to be a biography, documentary, or a historical record of the individual's life or experience; or of historical events. Oral history interviews of individuals is not usually intended to be scientific or to produce generalizable information and hence is not usually considered 'research' in accordance with the federal regulations or CU policy. Therefore, such oral history activities should not be submitted to the CU IRB for review.

Still covered by IRB jurisdiction are psychological studies that borrow some oral history techniques to test hypotheses. An example might be Kim T. Buehlman, John M. Gottman, and Lynn Fainsilber Katz, "How a Couple Views Their Past Predicts Their Future: Predicting Divorce from an Oral History Interview," Journal of Family Psychology 5 (March/June 1992): 295-318.

I hope Columbia will prove a model for other universities; in lumine tuo videbimus lumen.

American Historical Association Asks for Oral History Exclusion

In its response to OHRP's solicitation of comments on its 1998 guidance, the American Historical Association asked that "'oral history' . . . be removed from category 7 and explicitly removed from IRB review." The AHA blog, AHA Today, reports the request and posts the full text of the association's letter to OHRP.

Law & Society Review, continued

As I noted earlier, the December 2007 issue of Law & Society Review features five items concerning IRBs and the social sciences.

Malcolm M. Feeley, "Legality, Social Research, and the Challenge of Institutional Review Boards"

The section on IRBs begins with Malcolm M. Feeley's 2006 presidential address to the Law & Society Association. Feeley presents an impassioned critique of IRBs, complaining, "in the name of minimizing risks, IRBs subject researchers to petty tyranny. Graduate students and junior scholars are particularly likely to be caught in their web—and for them IRB tyranny is often more than petty. Senior scholars are generally more adept at avoidance, evasion, and adaptation, but they too are hardly exempt from this tyranny. A number of prominent social scientists, including some members of this Association, know all too well the harms of running afoul of campus IRBs. . . Entire research areas and methodologies are in jeopardy, insofar as the difficulties of obtaining IRB approval affect research priorities for funding agencies and universities' willingness to support researchers.”

Feeley then raises a number of specific problems, such as the ill fit between the beneficence encoded in regulation and the kind of social research that aspires to produce "tarnished reputations and forced resignations" of evil-doers.

To remedy this situation, Feely proposes three modes of action:

1. "Join [IRBs]; subvert them—or at least curtail them. Serve on them and do all you possibly can to facilitate the research of your colleagues rather than act as a censor."

2. Follow Richard Schweder's call to get your university to apply federal regulations only to federally funded research.

3. "Ask about estimates of how much actual harm to subjects in social science research has been prevented by IRB actions. And ask for documentation."

I am a bit skeptical about the first suggestion, for two reasons. First, few universities have IRBs strictly for the social sciences. This means that a sociologist, anthropologist, political scientist, or historian would spend most of her time on an IRB reviewing (or abstaining from reviewing) psychological experiments. That's an unfair price to pay to have some power over one's own research. Second, it assumes that IRBs are run by IRB members. As Caroline H. Bledsoe et al. report in "Regulating Creativity: Research and Survival in the IRB Iron Cage," the size of human protections staffs has ballooned in recent years. If the staff have the real power, IRB members will have little chance to facilitate research.

Laura Stark, "Victims in Our Own Minds? IRBs in Myth and Practice."

The first comment is Laura Stark's. It draws in part on Stark's 2006 Princeton dissertation, "Morality in Science: How Research Is Evaluated in the Age of Human Subjects Regulation." I am glad to learn of this work, and I hope to comment on it in a later post.

Stark suggests trying to improve, rather than restrict, IRBs, because “ethics review in some form is here to stay because of institutional inertia, and [because of her] belief as a potential research subject that ethics review is not an entirely bad idea, even for social scientists.” She advocates "changing local practices to suit the local research community, rather than refining federal regulations."

One intriguing example is the establishment of "IRB subcommittees, which can review lower-risk studies [and] have moved ethics review into academic departments. In so doing, these subcommittees of faculty members (who presumably understand the methods in question) have taken over the task of evaluating low-risk studies from board administrators." This sounds a lot like the departmental review that the AAUP suggested as an alternative to IRB control, and like the Macquarie model I described in August. I hope that Stark will publicize the name of the university that uses such subcommittees, so that it can better serve as an example to others. Stark does not explain why this model is appropriate only for low-risk studies. It seems to me the higher the risk, the more reason to have research reviewed by people who understand its methods.

Significantly, neither in her article nor in her dissertation does Stark take up Feeley's challenge to document cases in which IRBs have prevented actual harm to participants in social science research. Her research offers important insights about how IRBs reach decisions, but no evidence that those decisions do more good than harm, or that they are consistent with norms of academic freedom.

Finally, Stark claims, "the social science victim narrative—by which I mean the story that human subjects regulations were not meant to apply to us—is pervasive among academics, and it is particularly central to qualitative researchers as a justification for their criticisms of IRBs. Yet this victim narrative does not stand up to historical scrutiny, as I have shown." Yes and no. Stark's use of the passive voice (were not meant to apply) is telling; the question is who meant the regulations to apply to social scientists, and who did not. I am working on a full-scale history of the imposition of human subjects regulations on the social scientists, and I can tell Stark that more scrutiny will complicate her story.

Robert Dingwall, "Turn off the oxygen …"

The second comment is Robert Dingwall's "Turn off the oxygen …," the oxygen here referring to the legitimacy granted to IRBs by university faculty.

Dingwall is skeptical of legal challenges, given the cost, the possibility of failure, and the fact that the First Amendment only applies to the United States (Dingwall works in the UK.) He argues instead that “if we can show that ethical regulation does not actually contribute to a better society, but to a waste of public funds, serious information deficits for citizens, and long-term economic and, hence, political decline, then we may have identified a set of arguments that might lead to a more skeptical approach to the self-serving claims of the philosopher kings who sustain that system.” For example, we must continue to document ethical wrongs like the insistence by a British medical journal that two historians falsify the names of their oral history narrators, despite the wishes of most of the narrators to be named. [Graham Smith and Malcolm Nicolson, "Re-expressing the Division of British Medicine under the NHS: The Importance of Locality in General Practitioners' Oral Histories," Social Science & Medicine 64 (2007): 938–48.] I hope Professor Dingwall has a chance to read Scott Atran's essay, "Research Police – How a University IRB Thwarts Understanding of Terrorism," posted on this blog in May. It is an excellent example of the way that IRB interference can disrupt vitally important work.

Jack Katz, "Toward a Natural History of Ethical Censorship"

The third comment, by Jack Katz, is the most shocking, for it is the most thoroughly documented. (It even cites this blog, thanks.) Katz lists several cases, all recent, in which IRBs have derailed potentially important social research. Unlike the 2006 AAUP report, he gives names, universities, dates and citations for most of his horror stories. Among them:

* "In Utah, Brigham Young University's IRB blocked an inquiry into the attitudes of homosexual Mormons on their church. When the same anonymous questionnaire study design was transferred to another researcher, the IRB at Idaho State University found the study unproblematic."

* "A proposed study of university admissions practices [was] blocked by an IRB at a Cal State campus. The study had the potential to reveal illegal behavior, namely affirmative action, which was prohibited when Proposition 209 became California law."

* "At UCLA, a labor institute developed a white paper lamenting the health benefits that Indian casinos offered their (largely Mexican and Filipino) workers. Despite the university's support for the labor institute when anti-union legislators at the state capitol have sought to eliminate its funding, publication was banned by the IRB after a complaint by an advocate for Indian tribes that the study had not gone through IRB review."

Stark would have us believe that "the local character of board review does not mean that IRB decisions are wrong so much as that they are idiosyncratic." But Katz shows that IRBs' idiosyncracies can be hard to distinguish from viewpoint-based censorship.

In contrast to these identifiable harms, Katz finds "no historical evidence that the social science and humanistic research now pre-reviewed by IRBs ever harmed subjects significantly, much less in ways that could not be redressed through post hoc remedies." I don't think I would go quite this far, given Carole Gaar Johnson's description of the harms caused to the residents of "Plainville" by the inept anonymization of their town ("Risks in the Publication of Fieldwork," in Joan E. Sieber, ed., The Ethics of Social Research: Fieldwork, Regulation, and Publication (New York: Springer, 1982). But the rarity of such cases means we should weigh IRB review against other methods of prevention, such as departmental review of projects or better certification of researchers.

Katz reiterates his call, previously set forth in the American Ethnologist, for a "culture of legality," in which IRBs would be forced to explain their decisions and "publicly disseminate proposed rules before they take the force of law." He believes that "were IRBs to recognize formally that they cannot properly demand the impossible, were they to invite public discussion of policy alternatives, and were they to open their files to public oversight, they would fundamentally alter the trajectory of institutional development by forcing confrontation with the central value choices currently ignored in the evolution of ethical research culture."

But what do we do when we confront those value choices? We get statements like Stuart Plattner's: “no one should ever be hurt just because they were involved in a research project, if at all possible," a position clearly at odds with Katz's applause for "the American tradition of critical social research." (Plattner, “Human Subjects Protection and Cultural Anthropology,” Anthropological Quarterly, 2003) The problem with IRBs' value choices is not that they are hidden, but that they are often wrong. The Belmont Report is the most public and widely cited rule used by IRBs, and it is a terrible guide for the kind of critical research Feeley and Katz want done.

Feeley, "Response to Comments"

The most interesting part of Feeley's response comes at the very end. Noting that, with the AAUP's encouragement, some universities have ceased promising to review all human subjects research in favor of the regulatory minimum of federally funded research, he points out that we will soon know if the lack of IRB review of social science at those universities yields a flood of unethical research. "If there are few reports of negative consequences . . . they might encourage national officials to rethink the need for such an expansive regulatory system . . . On the other hand, if opt-out results in increased problems, the findings might help convince Katz, Dingwall, me, and still others of the value of IRBs." This strikes me a very fair bet, and the experiment can't begin soon enough.

My Comments to OHRP

As I noted in November, OHRP is soliciting comments on proposed changes to its 1998 guidance on expedited review. Below are the comments I submitted today. I thank Rob Townsend of the American Historical Association for his help in revision.

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Comments on Proposed to Categories of Research That May Be Reviewed by the Institutional Review Board Through an Expedited Review Procedure

To the Office of Human Research Protections:

The Federal Register of 26 October 2007 states that “OHRP is requesting comments on the entire expedited review list that was last published in the Federal Register on November 9, 1998 (63 FR 60364) to determine if other changes are needed.” I would like to recommend that “oral history” be removed from this list, and that OHRP make an unambiguous statement that oral history does not constitute human subjects research as defined in 45 CFR 46.

I believe that other historians and the American Historical Association will submit comments describing the harm done to historical scholarship by well-meaning but inexpert IRBs. Since I have spent much of 2007 researching the history of IRB review of the social sciences, I think I can be most helpful by explaining the historical significance of the inclusion of oral history in the 1998 guidance. Put simply, the 1998 guidance unintentionally overturned half a century of oral history practice and a quarter century or more of federal policy toward oral history.

While I hope to learn more about the origins of the 1998 guidance, I have found nothing to suggest that its authors anticipated the results it has had. I hope that as it reconsiders this guidance, OHRP will do so with more information and deliberation. To this end, I offer the following brief account of the current regulations, and I would be happy to elaborate on any of these points if asked.

1. CONGRESS DID NOT INTEND TO REQUIRE IRB REVIEW OF ORAL HISTORY

Today’s regulations for human subjects research draw their authority from two sets of congressional hearings. The first, the 1965 Special Inquiry on Invasion of Privacy, conducted by the House Committee on Government Operations, concerned itself with “a number of invasion-of-privacy matters” including “psychological testing of Federal employees and job applicants, electronic eavesdropping, mail covers, trash snooping, peepholes in Government buildings, the farm census questionnaire, and whether confidentiality is properly guarded in income-tax returns and Federal investigative and employment files.” [1] The second, the Senate Subcommittee on Health’s 1973 hearings on human experimentation, focused almost exclusively on medical research. [2] The only non-medical research the Senate investigated were behavioral experiments, such as B. F. Skinner’s “research in to the modification of behavior by the use of positive and negative rewards and conditioning.” [3] It was out of concern about this sort of behavior modification that that Congress included “behavioral research” in the National Research Act (93-348). [4]

At no point in either set of hearings, in subsequent reports, or in legislation did Congress concern itself with anything resembling oral history. Congress has never required IRB review of oral history research by its own staff or by the Library of Congress.

2. THE NATIONAL COMMISSION DID NOT INTEND TO REQUIRE IRB REVIEW OF ORAL HISTORY

As OHRP’s website notes, the current regulations were intended to effect the recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. But the National Commission never intended to require IRB review of oral history research. Oral history is not mentioned in any of its publications. In the course of my research I have spoken with the two leading authors of the commission’s IRB report (Bradford Gray and Barbara Mishkin) and two of the leading authors of the Belmont Report (Tom Beauchamp and Albert Jonsen). All assured me that they had no intention of imposing IRB oversight on oral history.

3. THE AUTHORS OF 45 CFR 46 DID NOT INTEND TO REQUIRE IRB REVIEW OF ORAL HISTORY

In 1978 and 1979, officials at the Department of Health, Education, and Welfare (later the Department of Health and Human Services) worked to translate the commission’s recommendations into a revised version of 45 CFR 46. Within the department, there was considerable debate between the Office of General Counsel, which did not believe that federal law provided for IRB oversight of any social science research, and officials of the health agencies, which sought broader coverage. But even the health agencies agreed to exempt “product and marketing research, historical research, journalistic research, studies on organizations, public opinion polls and management evaluations where the potential for invasion of privacy is absent or minimal.” [5] In a careful review of NIH records of the period, I have found no document by any of the authors of the 1974 or 1981 regulations even hinting that oral history should be subject to review. Nor have I found any mention of oral history in the debates leading up to the 1991 revisions that produced the current regulations.

4. THE 1998 GUIDANCE WAS AN EFFORT TO RESTRAIN OVERZEALOUS IRBs

While all of this was going on, oral history had proceeded in federally supported institutions since at least 1948 and the founding of Columbia University’s Oral History Research Office. Thus, over the course of thirty years, from the Public Health Service’s first policies on extramural research in 1965, through the passage of the National Research Act in 1974, and through three versions of 45 CFR 46, oral historians had continued their work undisturbed by IRBs or OPRR, and without provoking any ethical scandals worthy of federal attention.

In the 1990s, however, some university IRBs began insisting on their jurisdiction over oral history. In 1995, for example, the University of Delaware threatened to reject a doctoral dissertation because its author had not sought IRB approval for oral history interviews. [6] Historians at the university had long conducted such interviews without IRB supervision.

In response to the interference by university IRBs, historians sought common ground with regulators and IRBs, based on their shared concern with ethical research. [7] As part of this effort, in 1998 the Oral History Association (with the endorsement of the American Studies Association and the American Historical Association) asked OPRR to make oral history projects eligible for expedited review procedures. [8] In the 1998 guidance now being reconsidered, OPRR agreed to this request, noting that “research on oral history has been included in response to approximately six comments,” presumably including the Oral History Association comment. [9]

5. THE 1998 GUIDANCE HAD THE PERVERSE EFFECT OF RATIFYING THE BEHAVIOR IT SOUGHT TO RESTRAIN
Yet instead of improving relations between IRBs and historians, the inclusion of oral history in the 1998 guidance has disrupted oral history research throughout the United States, since IRBs have taken the list as evidence that OPRR wants oral history to be reviewed. For example, the CITI Program, a widely used training system for IRBs and researchers, claims erroneously that “the regulations specifically refer to interviews, oral history, focus groups, and other qualitative methods.” [10] And Northwestern University’s IRB claims that “Federal guidance defines social and behavioral science methodologies as those that include research on individual or group characteristics or behavior . . . or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies,” using the language of the 1998 guidance. [11] My impression is that many IRBs have taken a similar position, interpreting the 1998 guidance as a list of activities that should be reviewed.

In response to such misinterpretation of the guidance, the Oral History Association and the American Historical Association have asked OHRP to return to the regulatory situation of the 1970s and 1980s, in which no one considered oral history to be subject to federal regulation. In 2003, in response to such requests, OHRP stated that “oral history interviewing activities, in general, are not designed to contribute to generalizable knowledge and, therefore, do not involve research as defined by Department of Health and Human Services (HHS) regulations at 45 CFR 46.102(d) and do not need to be reviewed by an institutional review board (IRB).” [12]

As it stands, then, OHRP takes contradictory positions on the applicability of 45 CFR 46 to oral history interviewing. The 1998 guidance suggests that oral history can be subject to mandatory review, while the 2003 letter suggests that “in general” it is not. This contradictory guidance has contributed to the unhappiness of historians and IRB members across the country.

CONCLUSION: OHRP SHOULD REPLACE THE 1998 GUIDANCE WITH GUIDANCE CONSISTENT WITH FEDERAL LAW AND REGULATION

The 1998 guidance constituted a radical break with previous policy and a decision of lasting importance. Yet unlike the bulk of human subjects regulations and guidance, the current guidance concerning oral history is not based on the will of Congress or the findings of any federal commission. It was based on the request of historians’ professional organizations, but since 2003 those same organizations have sought a very different policy.

The inclusion of oral history in the 1998 guidance was a well-intentioned effort, but it has proven harmful to ethical scholarship. With the reconsideration of the guidance, OHRP has a splendid opportunity to return to the original intent of Congress and the National Commission by unambiguously excluding oral history from review.

NOTES

[1] U.S. House of Representatives, Committee on Government Operations, Special Inquiry on Invasion of Privacy (89th Cong., 1st sess., 1965), 5.
[2] U.S. Senate, Quality of Health Care—Human Experimentation, 1973: Hearings before the Subcommittee on Health of the Committee on Labor and Public Welfare, Part 3 (93d Cong., 1st sess., 1973).
[3] U.S. Senate, National Research Service Award Act (S. Report. 93-381, 93d Cong., 1st sess., 1973), 15.
[4] Sharland Trotter, “Strict Regulations Proposed for Human Experimentation,” APA Monitor 5 (February 1974), 8.
[5] Gerald L. Klerman, Administrator, to Assistant Secretary for Health and Surgeon General, 30 March 1979, FRC box 78, Res 3-1-B Proposed Policy Protections Human Subjects 1978-79, RG 443, National Archives.
[6] Donald A. Ritchie, Doing Oral History: A Practical Guide (New York: Oxford University Press, 2003), 196.
[7] Linda Shopes, “Remarks before President's National Bioethics Advisory Commission,” 6 April 2000, http://www.oah.org/pubs/nl/2000may/bioethics.html (20 December 2007).
[8] Linda Shopes, President, and Rebecca Sharpless, Executive Secretary, Oral History Association, to Office for Protection from Research Risks, 2 March 1998, copy in author’s possession.
[9] Federal Register, November 9, 1998 (Volume 63, Number 216), pp. 60364-60367, http://www.hhs.gov/ohrp/humansubjects/guidance/63fr60364.htm (18 December 2007).
[10] Lorna Hicks, “Defining Research with Human Subjects,” CITI Program, https://www.citiprogram.org (30 October 2006).
[11] Northwestern University, “Schools, Departments and Programs Served by Panel E of the Institutional Review Board,” http://www.northwestern.edu/research/OPRS/irb/training/docs/panelEReviews.doc (18 December 2007).
[12] Michael Carome to Linda Shopes and Donald Ritchie, 22 September 2003, http://grants.nih.gov/grants/policy/hs/Oral_History.doc (20 December 2007).

Law & Society Review

John Mueller has kindly alerted me to the December 2007 issue of Law & Society Review, which includes five items concerning IRBs. I will read and comment on them as time permits.

Readers interested in legal analysis of IRBs should also consult Philip Hamburger's "'Ingenious Argument' or a Serious Constitutional Problem? A Comment on Professor Epstein's Paper," a follow-up to the Northwestern Law Review special issue.