UIC IRB Asserts Power Over Oral History

By Zachary M. Schrag

The University of Illinois at Chicago’s Office for the Protection of Research Subjects (UIC-OPRS) recently announced a new policy, “IRB Review of Oral History and Other Social Science Projects,” along with an accompanying “Tip Sheet: IRB Review of Oral History and Other Social Science Projects.” The policy, which has been in effect since April 2008 but only appeared on office’s website in January, “requires that any research involving humans, including social science studies incorporating historical methodologies, oral history, biographical methodologies, or qualitative interviews, be submitted for a human subjects research determination” by UIC’s institutional review board, or IRB, the committee charged with enforcing federal regulations concerning human subjects research. Should the IRB decide that an oral history project meets the federal definition of human subjects research, it could potentially demand changes to the project, or even forbid it entirely.

Historians nationwide have long complained that IRBs make inappropriate demands, such as asking scholars to prepare detailed questionnaires in advance of an interview, destroy recordings, or avoid sensitive topics, all of which violate historians’ professional ethics. The new policy makes UIC the latest battleground in an ongoing struggle between oral historians and federal regulators.

The dispute can be traced back to the mid-1990s, when IRBs began to assert jurisdiction over oral history interviews. In response, representatives of the American Historical Association and the Oral History Association lobbied federal regulators to exclude oral history from the oversight of IRBs, on the grounds that oral history did not fit the federal definition of research: “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” In 2003, they drafted a statement that “most oral history interviewing projects . . . can be excluded from oversight because they do not involve research as defined by the . . . regulations.” In September 2003, Dr. Michael Carome, the associate director for regulatory affairs of the federal Office of Human Research Protections (OHRP) concurred with that statement, though he qualified it to state that “oral history interviews, in general, are not designed to contribute to ‘generalizable knowledge.’”

Just five weeks later, however, the UCLA Office of Protection of Research Subjects called Carome to seek more OHRP guidance on “qualitative research utilizing open-ended interviews, especially activities performed by oral historians and other social scientists.” A memorandum of that call, prepared by UCLA but apparently approved by Carome, confirmed that “oral history activities, as described to OHRP by the oral history representatives, in general are designed to create a record of specific historical events and, as such, are not intended to contribute to generalizable knowledge.”

But the memo then went on to discuss three hypothetical projects—apparently drafted by the UCLA IRB office with no input from any historian. The interpretations of these examples made meaningless the September agreement between the historians and OHRP. In particular, the memo suggested that an “an oral history video recording of interviews with holocaust survivors. . . to create a historical record of specific personal events and experiences” would not be considered human subjects research. But it went on to say that another project would be considered research if “the intent of the archive is to create a repository of information for other investigators to conduct research.” In other words, oral history would not be regulated if it was designed to “create a historical record,” but it would be subject to review if it was designed to “create a repository of information.”

Beyond this baffling distinction, the UCLA memo proposed a new definition of “generalizable research.” Ignoring previous uses of the term, the memo declared that research was “generalizable” if “designed to draw conclusions, inform policy, or generalize findings.” Particularly radical was the idea that an intent to “inform policy” should trigger review, since U.S. jurisprudence holds that speech intended to inform policy deserves fewer restrictions, not more. By concurring with the historians’ draft and then endorsing the UCLA memo, Carome adopted two contradictory positions, and then refused to draft formal guidance on the issue.

For the past five years, then, universities have been left to interpret for themselves the contradictory statements of the federal government. Several have adopted the UCLA position, demanding that historians submit projects for IRB review. But others, including Amherst College, Columbia University, the University of Michigan, and the University of Nebraska-Lincoln, explicitly exclude oral history from IRB review, relying on Carome’s earlier assurances to the historians’ organizations.

According to UIC history department chair James Searing (himself an oral historian), in 2005, members of the history faculty and the university’s human subjects administrators agreed that historians would not routinely submit interview projects for IRB review. The historians promised to screen proposals involving interviews—especially graduate dissertation prospectuses—and forward any that met the federal definitions. For example, a researcher who was writing about the history of medicine, using patient records, would need IRB review. But, explains Searing, they expected that 99 percent of oral history projects would proceed without requiring any IRB clearance. For the past several years, few, if any, interview projects have been submitted for IRB review. The new UIC-OPRS policy appears to void that agreement, and instead insists that only the IRB—not the department—can decide that an interview project does not constitute research under the federal definition.

The “policy rationale” accompanying the policy claims OHRP “has provided the following guidance,” but much of the material that follows is in fact drawn from the 2003 UCLA memo, whose status as federal guidance is a matter of some dispute. This includes the provision that a historian is conducting “human subjects research” if she is planning to “draw conclusions, inform policy” or “creat[e] an archive or repository for future research.” The UIC-OPRS has elaborated on this language, claiming that “by applying qualitative methodologies to interviews with Holocaust survivors, researchers might analyze how alienation from official Nazi German culture was expressed and draw generalizable conclusions or develop policies regarding the amelioration of sub-group alienation from any ‘official’ or hegemonic cultural standards.” It is not clear from the memo whether the university consulted with any federal officials, yet this language is presented as OHRP guidance.

Nor has the UIC-OPRS adopted a consistent definition of what constitutes generalizable research. The new policy requires researchers to fill out a form (last updated in October 2008) to help administrators decide if a project “represents human subjects research.” To determine whether a project is designed to contribute to generalizable knowledge, the form asks researchers “if the activity employs a systematic approach involving predetermined methods for studying a specific topic, answering a specific question, testing a specific hypothesis, or developing a theory.” Unlike the policy, the form says nothing about drawing conclusions, informing policy, or creating archives.

In an e-mail to me, James Fischer, the director of UIC-OPRS, states that he also drew on a 2004 OHRP recommendation “that investigators not be given the authority to make an independent determination that research involving coded private information or specimens does not involve human subjects.” That guidance refers to research in which “identifying information (such as name or social security number) . . . has been replaced with a number, letter, symbol, or combination thereof,” which is rare in oral history interviewing. Nor does the OHRP guidance appear to preclude the kind of department-level review earlier in place at UIC.

Fischer argues that historians have nothing to fear from the new policy. “The UIC IRB does not exist to forbid research or make unnecessary demands on researchers, but to protect the rights and welfare of research subjects,” he writes. “The board views their role not to inhibit research, but promote and facilitate the conduct of ethical research.” Moreover, he suggests that in most cases, historians would spend 20-30 minutes completing a form and receive a determination in 1-2 business days.

Still, the new policy came as an unwelcome surprise to oral historians on UIC’s faculty, including Searing, who learned about it only when I asked them for comments. Apparently, the UIC-OPRS did consult with Professor Michael Alexander, a historian of the Roman Republic, and persuaded him that the policy would not interfere with the work of the department. But not everyone got the word, and as of late February, the department’s website was still advising graduate students that “graduate students in the History Department do not normally submit their research projects to the IRB for review and approval.”

Zachary M. Schrag is Assistant Professor of History at George Mason University and founder of the Institutional Review Blog (institutionalreviewblog.com).