Historians, OHRP and IRBs looking for common ground on oral history projects

Is IRB review necessary? Historians say no,’ OHRP says maybe’

Add one more discipline to the list of those that have issues with IRB review: Oral historians, who maintain that they should not be required to seek review for their interviews with participants.

Oral history involves gathering interviews, in written or recorded form, from participants in past events in an effort to help understand the events or past ways of life. Historians argue that these types of interviews, which participants usually agree to store in archives in an identifiable way, don’t conform to a definition of research that would require the review of an IRB. OHRP, asked to weigh in on the matter three years ago, agreed that "oral history activities in general [italics added] do not involve research as defined by the HHS regulations."

But some oral historians say that other OHRP guidelines on the issue have been vague and potentially contradictory, and that IRBs have been using them as a pretext to unnecessarily require IRB review of their work. Linda Shopes, MA, who works as a public historian at the Pennsylvania Historical and Museum Commission in Harrisburg and has represented the American Historical Association (AHA) in discussions with OHRP on the issue, says IRB involvement in oral history proposals has had a chilling effect on some projects.

One professor, Shopes says, was told by an IRB that he couldn’t conduct interviews about race relations in a Texas community because the results could embarrass the community. She says other historians have been warned not to ask about potentially criminal behavior — even civil disobedience within the civil rights movement that may have resulted in criminal charges.

"In many cases, it’s just an annoyance and on some level, it’s an insulting annoyance," she says. "But beyond that kind of annoyance, there is a real threat to free inquiry implicit in a lot of IRB actions."

One IRB that has grappled with the issue say it’s possible to craft a policy that is sensitive to the needs of oral historians and which also sensitizes historians to the requirements to protect the people they interview.

"We’re an interdisciplinary committee and there are no historians on our committee, so you have to understand a different field of study and what their scholarship is all about," says Nancy Fishwick, PhD, FNP, associate professor of nursing and chair of the human subjects review committee at the University of Maine in Orono. "The human subjects committee has to be educated about history as a field of study and oral history as their scholarly method. But you also have to educate the history department about what the spirit or the intent is for human subjects protection. So it’s a two-way street."

Confidentiality, psychological harm

Shopes says the controversy over IRBs and oral history first came to her attention in 1997, when she was president-elect of the Oral History Association, an international professional organization of oral historians. She says the organization began to receive reports from members about incidents such as dissertations being refused because the author had failed to seek an IRB review for an oral history project, or IRBs issuing requirements that were at odds with the general practice of oral history.

Shopes says there are two areas in which IRBs and oral historians tend to clash: confidentiality and psychological harm. In biomedical or social-behavioral research, participants are assured that their privacy will be protected and that personally identifiable information about them won’t be revealed to others. But in oral history, Shopes says, participants’ statements are usually included in archives with identifying information.

"A fundamental practice in oral history is to secure a signed release form from a narrator [participant] which dictates the terms in which the interview can be used," she says. "Oral history interviews are understood as copyrightable documents owned by the narrator and until the narrator signs over a release, we can’t use them.

"That would seem would obviate any concern about confidentiality," Shopes says. "The narrator determines whether he or she wishes to remain confidential. They can close part of an interview. They can say, I’m sorry, you can’t use any of this interview.’ They can request anonymity. We don’t like them to do that, but that’s their right."

In regards to psychological harm, Shopes says some IRBs are concerned that speaking with a participant about a traumatic event may cause some type of psychological harm.

"That is a slippery slope and it is an undocumented slippery slope," she says. "There’s good evidence, both anecdotal and scientific, that discussion of sensitive topics does not harm people, but in fact is often salutary. But there is excessive concern about psychological harm."

She says the deeper point of contention between IRBs and oral historians is a difference in focus. "There is a presumption in the regulations that the individual is to be protected at all costs — that is the primary concern. That is not the primary concern of historians," Shopes says. "Our job is to follow the evidence, not to protect people from their past actions or from where the evidence leads."

Shopes says oral historians, through their professional organization, do promote good judgment and practices, including giving narrators their full rights. "But our fundamental job is to follow the evidence, not necessarily to protect individuals."

OHRP enters the debate

In a September 2003 letter to Shopes, Michael Carome, MD, OHRP’s associate director for regulatory affairs, stated that because oral history activities in general are not designed to contribute to generalizable knowledge, they do not involve research as defined by regulations (45 CFR 46.102) and don’t require 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," he wrote. "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."

Carome noted that oral history participants are not anonymous or chosen randomly. Questions tend to be open-ended rather than a standardized questionnaire. He did note that if an investigator conducting true research used oral history methods in obtaining data, that would require IRB review.

Later that year, in response to questions from IRBs asking for further clarification of its position, Carome included some OHRP recommendations for evaluating whether a project required review:

— Oral history activities that only document a specific historical event or the experiences of individuals, without the intention of drawing conclusions or generalizing findings, would not constitute research, or require IRB review.

An example cited was an oral history recording of interviews with Holocaust survivors created for viewing in the Holocaust Museum. The sole purpose of the recording is to create a historical record and provide an outlet for survivors’ stories, not to draw conclusions, so it would not be considered research for HHS purposes.

— On the other hand, systematic investigations using open-ended interviews "designed to contribute to generalizable knowledge," for example, to draw conclusions or to inform policy, would be considered research under the HHS guidelines, and would require review.

An example OHRP cited would be interviews with Gulf War veterans to document their experiences and draw conclusions about those experiences, inform policy or generalize findings. That project which would be considered research for HHS purposes.

— If oral historians seek to create an archive of interviews for the purpose of providing a resource for others to do research later, the project itself would be considered research and be subject to IRB review.

The example cited would be someone seeking to interview surviving Negro League baseball players to create an archive for future research. That would itself be considered research under OHRP’s interpretation and would require IRB review.

Shopes says that OHRP’s various comments on the topic have given IRBs a means by which they claim authority over much of the oral history work being undertaken at their institutions.

She points to an AHA survey conducted last year of IRB policies regarding oral history. AHA staffers surveyed policies posted on the web sites of 152 research universities with history PhD programs, as well as sites from a random sample of 100 other four-year colleges and universities.

They found that on almost 95% of the sites, there was little guidance to faculty or students about oral histories, except for a passing reference to oral history as one research method subject to expedited review by IRBs. Few explicitly stated that oral histories were generally excluded from review.

In November, Ron Rosenzweig, vice president for research for the American Historical Associa-tion, wrote to OHRP Director Bernard Schwetz to reiterate their concerns about OHRP’s various statements on the subject of oral histories, and asking for further clarification.

Shopes says that to date, OHRP has not responded. Her organization now is working to advise its members on how best to answer concerns by IRBs, and is preparing a pamphlet and supporting documents that can be used in discussion with boards.

Fostering a collegial relationship

At the University of Maine, Gayle Anderson, special assistant for research administration in the Office of Research and Sponsored Programs, says her office met with the head of with the university’s Folklife Center several times over the past few years to discuss the issue of how to handle oral histories.

"It was an issue we grappled with, so we decided to try to come to a conclusion about whether they required review or didn’t require review," she says.

Fishwick notes that traditionally, historians haven’t believed that their work required IRB review. "They haven’t considered their work to be research by the strict definition of research, systematic data collection and analysis, and so forth," she says.

"They seemed to believe that anything they did didn’t need to come through the human subjects review committee, but upon rare occasion there is something that probably should. It may be judged exempt, but nevertheless, someone else should be making that decision besides the researcher."

The university’s guidelines hew closely to the OHRP recommendations, and oral historians are usually directed to read those recommendations carefully when deciding whether to submit proposals for review.

Anderson and Fishwick agree that the guidelines themselves aren’t definitive.

"It kind of gives the spirit of the intent of the process, but they can’t be terribly specific, because it really is a case-by-case basis in that particular field of study," Fishwick says.

"Is this going to be systematic data collection that’s going to be used for any kind of generalizable conclusion? Sometimes maybe it doesn’t quite meet that definition, but they’re planning on publication in peer-reviewed journals or presentations at large conferences," she adds. "And more and more journals are expecting people to have gone through a human subjects process."

Fishwick says that to the best of her recollection, her board has never asked for changes in a proposed oral history project that has been submitted for review. She notes that most are very low-risk activities that don’t involve sensitive subjects.

Anderson and Fishwick say they don’t know of any continuing controversy over the issue with historians at the University of Maine.

But Fishwick says that this issue, like others involving the limits of IRB review, is bound to come up again. She says the key is to maintain collegial relationships with departments to ease the process.

"Gayle Anderson fields questions every day from people in all the different departments on campus," Fishwick says. "If you have a central place and a knowledgeable and cordial person who will answer people’s questions, then you don’t end up with tension. We’d rather have them ask the questions and to submit extra applications for consideration than to not be doing that."

To view the University of Maine’s guidance on when oral history activities require IRB review (including OHRP statements on the issue), visit http://orspdocs.umesp.maine.edu/Ethical/oralhistory.htm.