Letter to the Director of the OHRP

Roy Rosenzweig, February 2006

Editor's Note: We print below the text of the letter written by Roy Rosenzweig, vice president of the AHA's Research Division, to Bernard Schwetz, director of the federal government's Office for Human Research Protections, seeking clarification of the government's policy on oral history research.

Dear Dr. Schwetz:

We are writing to reiterate our concerns about continuing, unresolved issues related to Institutional Review Board (IRB) review of historical research, particularly oral history interviewing. As you know, in September of 2003, the Office for Human Research Protections (OHRP) concurred with a policy statement developed by the American Historical Association (AHA) and the Oral History Association (OHA) excluding oral history, "in general," from IRB review on the grounds that the oral history methodology does not conform to the regulatory definition of research. To quote from this statement:

"Most oral history interviewing projects are not subject to the requirements of the Department of Health and Human Services (HHS) regulations for the protection of human subjects at 45 CFR part 46, subpart A, and can be excluded from institutional review board (IRB) oversight because they do not involve research as defined by the HHS regulations."

Later in the fall of 2003, however, in response to queries from local IRBs (cited at http://www.oprs.ucla.edu/human/NewsLetters/20031210.htm and elsewhere), OHRP developed further guidance for review of oral history, defining some forms of oral history interviewing as "research" and hence subject to IRB review and thereby obviating—or at best undercutting—the original policy statement.

This is troubling for several reasons. First, OHRP apparently did not consult with historians when it issued this guidance, for it demonstrates a considerable misapprehension about the nature and methodology of oral history. It makes distinctions among forms of oral history that do not conform to standard oral history practice. For example, OHRP guidance states that

"oral historians and qualitative investigators may want to create archives for the purpose of providing a resource for others to do research. Since the intent of the archive is to create a repository of information for other investigators to conduct research as defined by 34 CFR part 46, the creation of such an archive WOULD constitute research under 45 CFR 46.

This implies that some oral history interviews are not intended for archival deposit and use by others. However, oral history is by definition an archival practice. Historians insist that all interviews be archived because the only way we can interrogate and build upon each other's work is through equal access to the sources on which that work is built. Thus, all oral history interviews are recorded for posterity and intended to be part of the collective documentary record of our history, whatever the purpose for which they were originally conducted and used. This point is made quite explicitly in the original policy statement, which incorporates the OHA's definition of oral history as

"a method of gathering and preserving historical information through recorded interviews."

Second, OHRP's subsequent commentary on the policy statement attempts to distinguish between "open ended interviews that ONLY document a specific historical event or the experiences of individuals without an intent to draw conclusions or generalize findings;" and "systematic investigations involving open-ended interviews that are designed to develop or contribute to generalizable knowledge (e.g. designed to draw conclusions, inform policy or generalize findings." According to OHRP, the former do not conform to the regulatory definition of research and hence remain excluded from IRB review; the latter do conform to the regulatory definition and are subject to review. Yet this distinction makes little sense to historians: Interviews by definition document
specific events and individual experiences; even interviews with multiple individuals on a single subject retain their specificity and individuality. All interviews are also systematic, in that they proceed according to a well defined methodology. Most importantly, however, all interviews, whether conducted solely for archival purposes with no immediate research goal in mind or conducted in conjunction with a specific research project, can contribute to a generalized understanding of a given historical event or person. The point is that "generalized understanding" is different from "generalizable knowledge" in the regulatory sense of the term. This too is made explicit in the original policy statement:

It is primarily on the grounds that oral history interviews, in general, are not designed to contribute to "generalizable knowledge" that they are not subject to the requirements of the HHS regulations at 45 CFR part 46 and, therefore, can be excluded from IRB review. Although the HHS regulations do not define "generalizable knowledge," it is reasonable to assume that the term does not simply mean knowledge that lends itself to generalizations, which characterizes every form of scholarly inquiry and human communication. While historians reach for meaning that goes beyond the specific subject of their inquiry, unlike researchers in the biomedical and behavioral sciences they do not reach for generalizable principles of historical or social development, nor do they seek underlying principles or laws of nature that have predictive value and can be applied to other circumstances for the purpose of controlling outcomes. Historians explain a particular past; they do not create general explanations about all that has happened in the past, nor do they predict the future.

We expressed these concerns to the OHRP staff, and in a January 2004 teleconference with several members of OHRP staff, the authors of the original policy statement (Linda Shopes representing the AHA and Donald Ritchie representing the OHA), raised several objections to OHRP's efforts to refine that original statement. Following this telephone conversation, in an e-mail to Ms. Shopes and Dr. Ritchie dated January 8, 2004, Dr. Michael Carome of your staff

"reaffirmed its concurrence with your [i.e. AHA's and OAH's] policy statement that oral history interviewing activities in general, . . . 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)." Dr. Carome further stated that "OHRP recognizes that oral historians and members of the IRB community would like OHRP to consider issuing formal written guidance on oral history activities. OHRP will consider drafting such guidance in the future."

To date, this has not happened.

As a result, historians find themselves and their work in a very complex and contradictory position. Staff at the AHA surveyed the IRB policies published on the web sites of 152 research universities and 100 other colleges and universities with history departments this past summer. Only 11 of them mentioned one of the guidance statements from the OHRP—nine mention the September 2003 policy concurrence, seven mention the subsequent contradictory guidance from OHRP in fall 2003, and five mention the more recent reaffirmation from Michael Carome in January 2004. At the other institutions, at least among those that post their IRB policies, only 10 explicitly discuss the status of oral history, typically in the terms of the fall 2003 guidance. Among the rest it is mentioned at most in passing, as part of the general summary of research subject to expedited review. As a result, historians find themselves in a deeply troubled position. Through their professional associations they have been told they are excluded in most cases. Through their universities and Review Boards they have been provided with little if any guidance to the contrary. So in practice, we have begun to hear regularly from historians who find themselves charged with violating rules that are not clearly stated, which they fairly thought did not apply to them. Perhaps equally important, some find themselves bumping up against hard and fast rules on matters like source confidentiality that cut against the standards of our profession. As a result, historical work is being curtailed, suppressed, or done under a legal cloud because of conflicting policy statements from OHRP and inconsistent application at the college and university level.

In addition to concerns about contradictory statements from OHRP, and its apparent misapprehension about the nature of historical inquiry, historians continue to be deeply troubled by elements of the Common Rule that conflict with the essential canons of our practice. At times information in an interview, if made public, could indeed, in the language of 45 CFR 46,

"reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation."

Yet historians' deepest responsibility is to follow the evidence where it leads, to discern and make sense of the past in all its complexity; not necessarily to protect individuals. In this we are akin to journalists and unlike medical professionals, who are indeed enjoined to do no harm.

In light of this situation, we write to request that OHRP place these concerns before the Secretary's Advisory Committee on Human Subjects Protection, which is now reviewing the application of 45 CFR 46. We encourage them to consider formal adoption of the September 2003 agreement in the regulations. We believe that the original policy statement needs reaffirmation and that OHRP's subsequent commentary needs to be rescinded, insofar as it misrepresents the normal practice of oral history and contradicts OHRP's earlier action. We would be happy to discuss these matters further with you and members of your staff. Our point of contact on these issues is Robert B. Townsend, Assistant Director for Research at the AHA. He can be reached at (202) 544-2422 ext. 118 or by e-mail.

Sincerely,

Roy Rosenzweig,
Vice President for Research, American Historical Association,
Mark and Barbara Fried Professor of History & New Media, George Mason University