Author's note: As historians may know, research projects involving oral history interviews may be subject to prospective review, according to the terms of Title 45, Part 46 of the Code of Federal Regulations, Protection of Human Subjects (commonly referred to as 45 CFR 46). 45 CFR 46 codifies two key principles: that "human subjects" of research must give their informed consent prior to participation in the research, and that protocols for ethical treatment of these human subjects, including for their informed consent, must be reviewed before the research begins by an independent body, referred to as an Institutional Review Board (IRB). 45 CFR 46 is applicable only to research funded by the 17 federal agencies that have adopted the regulations; however—and this is key for historians, who are generally not funded by any of these 17 agencies—many universities have filed multiple project agreements with regulatory authorities, by which they agree that all research conducted under their auspices be subject to review by a campus IRB according to the terms of 45 CFR 46.¹

The current regulations were designed to protect people from unwittingly subjecting themselves to harmful scientific and medical experiments. Applied to oral history interviews and other forms of nonscientific research, they present numerous, serious difficulties, especially because many IRBs are constituted entirely of medical and behavioral scientists, who have little understanding of the principles and protocols of humanistic inquiry. On April 6, 2000, I outlined these difficulties at a meeting of the National Bioethics Advisory Commission (NBAC), a presidential commission charged with advising and recommending policy to the White House and other government entities about bioethical issues arising from human subjects research. The NBAC is currently reviewing the terms of 45 CFR 46 and the functioning of IRBs. I spoke before it as part of a panel of social scientists and humanities scholars charged with both describing the nature of human subjects research in our various disciplines and addressing the appropriateness of the current regulatory system. The full text of my remarks appears below. (These comments and those of my copanelists appear on the NBAC website, http://www.bioethics.org.)

My comments before the NBAC were considerably informed by historians' responses to a survey circulated by the American Association of University Professors (AAUP), which last fall convened a working group of representatives from several professional associations, including the AHA, to investigate ways in which 45 CFR 46 is being applied to work in our disciplines and, in particular, to consider if it presents a threat to academic freedom.² I am representing the AHA on this group. The AAUP plans to issue a report sometime within the next year, to be reviewed by the associations represented on the working group and, pending their approval, promulgated widely.

I believe my comments before the NBAC were well received. Eric Meslin, its executive director, subsequently told me that the commission had never before heard from a historian nor considered the implications of the regulations for our work. At one point I was asked what I might substitute for the current system of review. I responded that review of research protocols for oral history should take place among peers at the departmental level, according to the professional standards articulated in the Oral History Association's (OHA) "Principles and Standards and Evaluation Guidelines" and the AHA's "Statement on Interviewing for Historical Documentation."³ Such a practice, I believe, would guard against the unethical treatment of human beings while not violating historians' professional practices nor jeopardizing free inquiry.

45 CFR 46 is proving inadequate on several grounds and the explosion of both genetic research and privately funded biomedical research is creating considerable debate over current regulations at the national level. It is an opportune moment for historians to raise our concerns, stay abreast of the debates surrounding the regulation of human subjects research, and take appropriate action in our own interests. I welcome the thoughts of AHA members; you may contact me at lshopes@aol.com.

Remarks before the National Bioethics Advisory Commission April 6, 2000

Good morning. Thank you for the opportunity to speak to you today about the concerns of professional historians regarding current regulations governing research involving human subjects.

For historians, "human subjects" research means oral history, that is, preplanned, open-ended, in-depth, and generally tape-recorded interviews with men and women whose first-hand experiences are deemed of some historical significance. The term oral history itself is maddeningly imprecise: it refers to both the process of interviewing and the recorded interview, in both its taped and transcribed forms. Although the transmission of knowledge about the past through the spoken word is probably the oldest way in which humans have learned about history, historians generally consider oral history as originating with the work of the historian Allan Nevins at Columbia University in the 1940s. It was Nevins who first initiated a systematic, disciplined effort to record on tape, preserve, and make available for future research individual recollections considered to be of historical significance.

Historians generally conduct interviews for one of two reasons: to develop an archives of primary source material for future scholarly work, or as research for their own scholarly project. A good example of the former is that initiated by Nevins and now continued at Columbia's Oral History Research Office; a good example of the latter are the interviews with former southern textile mill workers conducted by Jacqueline Hall and her colleagues at the University of North Carolina that resulted in the award-winning book, Like a Family: The Making of a Southern Cotton Mill World. There is considerable overlap between these two approaches to oral history, in that scholars conducting interviews for their own research are encouraged to place the completed interviews in an archives or public repository so that others can build upon, and also interrogate, their research. Moreover, some scholars don't conduct interviews themselves, but draw deeply from extant archival collections. Many historians also use oral history in their teaching, assigning students to interview family members about the Great Depression, for example, or, more recently, about the 1960s. Historians also use interviews in the production of films, radio programs, museum exhibitions, and other sorts of nonprint, public forms of historical presentations.

For historians, oral history is a way of getting at information and insights not otherwise available in the extant record. For many of us, it is also a way to integrate the experiences and the voices of the historiographically—if the not the historically—silent into our accounts of the past. I think it is important to state that for historians, oral history is not understood as research on human subjects, but rather research with other human beings: an oral history interview is an interactive process, in which the questions of the historian/interviewer elicit the responses of the narrator, which in turn influence the historian's subsequent questions. Historians view oral history as a unique kind of primary source: the quality of the interview depends as much on the methodology employed and the relationship between interviewer and narrator as it does on the significance of the events being recalled and the sharpness of the narrator's memory.

Recognizing the need for sound methodology and professional standards, including careful attention to the ethics of the unique human relationship that is an interview, in 1968 the Oral History Association codified, through a lengthy deliberative process, a set of principles and protocols to guide work in oral history. These were expanded in 1979, and revised in 1989–90 and again in 1998–99 to take into account new concerns and new developments in the field. This document, commonly referred to as the Evaluation Guidelines, defines a set of responsibilities interviewers have to narrators, to the public, to the profession, and to sponsoring institutions. It seeks to encourage recorded interviews that are as accurate, complete, thoughtful, and usable as possible, and to discourage the misuse of oral history. The American Historical Association, in consultation with OHA, has developed a briefer "Statement on Interviewing for Historical Documentation," directed specifically to those using oral history for their own scholarly projects.

Which gets me now to 45 CFR 46 and historians' relationships with campus Institutional Review Boards. For years both OHA and AHA had intermittently been receiving complaints from members who had been experiencing difficulties with their campus IRBs. As a result, in September 1997, I, as president-elect of OHA, along with the then president and another colleague, met with Gary Ellis, Thomas Puglisi, and Michele Russell-Einhorn of the National Institute of Health's Office for Protection from Research Risks. The meeting was both cordial and informational. We needed to learn more about the federal regulations governing research involving human subjects and the functioning of IRBs; we believed OPRR needed to learn about the professional standards governing historical research, including especially oral history. At that meeting Dr. Puglisi stated that the OHA's Evaluation Guidelines are "not incompatible" with the federal regulations governing human subjects research. Both OHA and AHA guidelines urge those planning to conduct oral history interviews to meet with potential narrators prior to the interview to discuss the nature of the project, the types of questions interviewers will ask, and the anticipated uses of the collected material. Both require narrators to sign a legal release form that addresses copyright, access, identification of narrators, and disposition of tapes and transcripts. Both specifically advise historians to "be cognizant of and comply with all laws, regulations, and institutional policies applicable to their research activities," and further recommend that "before beginning any research that may include oral history interviewing, historians should contact their IRBs for policies and regulations governing the use of human subjects in research projects." In 1997–98 the Oral History Association sent copies of both its own and AHA's guidelines to directors of graduate studies in history and American Studies at universities around the country and apprised them of the need for historians to contact their IRB prior to undertaking oral history research. Historians do not dispute the importance of high ethical standards governing research that involves human beings, the review of research protocols involving humans beings, and the principle of informed
consent.

That said, the biomedical and behaviorist frameworks within which 45 CFR 46 was developed have resulted in IRBs' evaluating oral history projects according to standards and protocols not appropriate for historical research, thereby calling into question the underlying assumption of peer review. This problem is exacerbated by the tendency for IRBs to be composed of people unfamiliar with methods of historical research. Thus, IRBs have asked historians how narrators would be recruited when, in fact, recruitment is not the issue. A request for an interview is based on the potential narrator's sometimes unique relationship to the person or topic under consideration. We have been asked what the consequences would be if a person refused to consent to an interview. Again, this simply isn't an issue in oral history research, unless, of course, one considers the consequence of not having a particular person's version of events on record, though obviously that's not what the regulations refer to. Historians report that they have been told by IRBs to submit detailed questionnaires prior to conducting any interviews, to maintain narrator anonymity both on tape and in their published work, and to either destroy their tapes or retain them in their private possession after their research project is completed. Each of these requests misconstrues oral history and violates fundamental standards of historical practice. An interview is an open-ended inquiry, generally structured around a set of biographical and broadly historical questions. It does not follow a rigid schedule of questions but is shaped by the interview exchange. While anonymity is an option in oral history, and indeed appropriate in some cases, anonymous sources lack credibility in most historical scholarship—the precise identity of an interviewee often matters, as a way of gauging that person's relationship to the topic under discussion and hence assessing the perspective from which he or she speaks. In fact, most narrators agree to retain their identity in archival collections and published scholarship. And although narrators can choose to restrict all or a portion of their interviews for a period of time, hoarding or destroying tapes contradicts a primary canon of historical research, namely that sources not only be cited, but also be available and accessible as a way of assessing the validity and integrity of the work that draws upon them. And most incredible to me, some historians report that IRBs have questioned their use of sources in the public record, including newspapers and manuscripts collections, as well as properly archived oral history interviews, simply because they deal with the activities of human beings! Some also question whether the current extensive and often bureaucratically complex review to which proposed oral history research projects are subjected, including even interviews assigned as a classroom project, is, in fact, appropriate for a research activity that generally presents the most minimal of risks to the narrator.

In March 1998, the OHA, in conjunction with the OAH and the AHA, corresponded with Institutional Review Boards at those institutions that had filed multiple project assurances with OPRR. This correspondence addressed areas where current review practices seemed at variance with established principles of historical research and recommended that, when feasible, historians be appointed to IRBs. IRBs were also provided with a copy of the OHA's Evaluation Guidelines. In many, perhaps most, cases historians have been able to clarify the issues and negotiate protocols for informed consent and for interviewing that satisfy their IRBs. And IRB review of oral history research has certainly been facilitated by the recent inclusion of oral history as a category of research that may enjoy an expedited review procedure, something the historical profession actively advocated. Nonetheless, in the spirit of peer review, I suspect many would find it more appropriate for oral history interviewing projects to be reviewed by historians, other scholars in the humanities disciplines, and qualitative researchers among social scientists, according to the terms of the OHA's Evaluation Guidelines.

For there is a deeper disjunction between the biomedical model of research on which current human subjects regulations are based and the research that historians and perhaps those in other humanities and social sciences disciplines engage in. This lack of fit is suggested by reports from some historians that they are requested by their IRB not to ask questions about certain sensitive subjects, such as an individual's criminal history or history of arrests. It is suggested by the current regulation that states "where appropriate, a statement that significant new findings developed during the course of the research, which may relate to the subject's willingness to continue participation, will be provided to the subject." It is suggested by the need to identify the "risks or discomforts" an interviewee may experience during the course of an interview. In all of this there is the possibility, or at least the hint, that, according to current regulations, controversial, difficult, or challenging topics cannot be addressed in historical research. The need to treat individual narrators with honesty and respect is not the issue here, nor is the need to apprise them of the nature and purpose of any interview. What is at issue is the notion of critical inquiry, inquiry that does challenge, that may be adversarial, that may even "expose," as interviews with Klansmen and women and with Nazi collaborators, for example, have done. Yet current regulations, interpreted narrowly, can have a chilling effect on historian's freedom to pursue difficult topics. Moreover, historians pursuing research on some twentieth-century topics may find they have acquired critical, if controversial information with profound consequences for public life; they may further determine that the public's need to know may have greater urgency than may be allowed for in current regulations. The boundaries of current regulations are admittedly unclear about these sorts of issues, but historians believe it is imperative that they not be used to hinder the recording of our recent past.

Notes

1. For a fuller discussion of the application of 45 CFR 46 to oral history, see Michael A. Gordon, "Historian and Review Boards," Perspectives (September 1997): 35–7.

2. The survey appeared in Perspectives, (March 2000): 40 and also on AHA's web site, www.historians.org. Readers' responses to the survey are still welcome.

3. The Oral History Association's Evaluation Guidelines are available at the OHA web site, http://www.dickinson.edu/organizations/oha/EvaluationGuidelines.html. AHA's "Statement on Interviewing for Historical Documentation" is available at http://www.historians.org/pubs/standard.htm#StatementonInterviewing.