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.
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.”  The second, the Senate Subcommittee on Health’s 1973 hearings on human experimentation, focused almost exclusively on medical research.  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.”  It was out of concern about this sort of behavior modification that that Congress included “behavioral research” in the National Research Act (93-348). 
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.”  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.  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.  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.  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. 
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.”  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.  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).” 
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.
 U.S. House of Representatives, Committee on Government Operations, Special Inquiry on Invasion of Privacy (89th Cong., 1st sess., 1965), 5.
 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).
 U.S. Senate, National Research Service Award Act (S. Report. 93-381, 93d Cong., 1st sess., 1973), 15.
 Sharland Trotter, “Strict Regulations Proposed for Human Experimentation,” APA Monitor 5 (February 1974), 8.
 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.
 Donald A. Ritchie, Doing Oral History: A Practical Guide (New York: Oxford University Press, 2003), 196.
 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).
 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.
 Federal Register, November 9, 1998 (Volume 63, Number 216), pp. 60364-60367, http://www.hhs.gov/ohrp/humansubjects/guidance/63fr60364.htm (18 December 2007).
 Lorna Hicks, “Defining Research with Human Subjects,” CITI Program, https://www.citiprogram.org (30 October 2006).
 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).
 Michael Carome to Linda Shopes and Donald Ritchie, 22 September 2003, http://grants.nih.gov/grants/policy/hs/Oral_History.doc (20 December 2007).