For Bernadette McCauley, a historian, one of the most-trying experiences of her academic career began with an attempt to talk to four elderly nuns.
In late 2004, Ms. McCauley, who teaches American history at the City University of New York’s Hunter College, sought to connect several of her students doing research on the city’s Washington Heights neighborhood with a group of nuns who had grown up in the area, with plans for an informal conversation. But before she could set up a meeting, she says, Hunter’s Committee for the Protection of Human Research Participants warned her to immediately halt her research.
The planned conversation with the nuns, they told her, constituted research on human subjects. That meant it had to be approved by the committee, which screened all such research at Hunter to make sure it fit within federal safety and ethics guidelines. In bypassing the committee, they said, Ms. McCauley had committed a serious professional offense.
“The whole thing was extremely surreal,” she says. “I received this registered letter at my home telling me I could not do any research at all, on any subject, until the committee had time to investigate me.” The matter was eventually resolved.
Since the federal government began to establish stringent ethical oversight of medical research in the 1970s, institutional review boards like Hunter’s have become a regular feature in the bureaucratic landscape of American colleges and universities, with the responsibility of safeguarding the rights of individuals who become subjects of research. While it is clear that vaccine trials and experimental drug tests demand a watchful eye from the outside, cases like Ms. McCauley’s are less cut and dried.
Institutional review boards have purview over any research on “human subjects” that creates “generalizable knowledge,” but whether that murky definition encompasses or excludes conducting interviews, obtaining oral histories, or doing other types of humanities research involving living people has largely been left up to individual institutions, creating decades of inconsistent policy toward the disciplines.
Those inconsistencies, however, could soon be eliminated. The federal government announced last month that, for the first time, it is contemplating substantially revising its 1991 statute on human-research procedures, known as the Common Rule.
Among the changes the government is considering is one that would exclude certain “minimal risk” studies from requiring approval by an institutional review board. That category includes all “educational tests, surveys, focus groups, interviews, and similar procedures” conducted with consenting adults.
Many historians, in particular, see the contemplated change as an opportunity to free themselves from a form of regulation they say is ill-suited to their profession. The current rules, they argue, not only waste their time and stymie promising research but can actually go against their professional ethics—by, for example, demanding that scholars make interviews anonymous or destroy their tapes after a project ends.
And historians welcome a potential end to the contradictory policies that leave many scholars fearful of breaking the rules without ever really understanding what those rules are.
“It’s like if you pulled into a parking space and it said, ‘Two-hour parking on weekdays. No parking Monday through Friday,’” says Zachary M. Schrag, an associate professor of history at George Mason University and the author of Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009. “It is nonsense, and the regulators explicitly refused to clarify what the requirements really are.”
Clarifying an Exemption
As it stands, the Common Rule puts interviews in a category of research that is exempt from institutional-review-board approval so long as they meet criteria for being low risk to participants. Scholars working on oral histories often seek that exemption, but, unlike the proposed change, the current exemption does not free them from significant review-board scrutiny. They must still apply to the board simply to receive the exemption—a process that often involves a lengthy questionnaire and can take weeks to complete.
Some observers argue that oral histories should not be subject to institutional-review-board approval at all. In 2003, the Office for Human Research Protections in the U.S. Department of Health and Human Services wrote that it concurred with a policy recommendation put forward by a group of historians that oral histories generally did not need to be reviewed by an institutional review board. Without further directives from the federal government, however, most colleges continued to require that oral-history projects pass through review boards in some manner, a 2006 American Historical Association survey showed.
Laws related to human-subjects research are problematic for historians in large part because they were developed around an explicitly biomedical code of ethics, says Robert B. Townsend, deputy director of the American Historical Association. At the center of the Common Rule, for instance, is the idea that people who are the subjects of research deserve protection from harm.
“It’s not clear to me what kind of harm you can do to somebody by interviewing them for an oral history,” Mr. Townsend says.
In the past, members of his organization have complained that institutional review boards insisted that historians keep their interview subjects anonymous to protect their privacy or avoid topics that might upset or embarrass them.
While perhaps reasonable in scientific or behavioral research, Mr. Townsend says, those demands go against the fiber of historical inquiry, where the credibility of an interview often depends on the researcher and reader knowing who the narrator is. And why, historians ask, shouldn’t consenting adults be allowed to decide for themselves what subjects they feel comfortable discussing?
“A lot of the people on these review boards are amateurs when it comes to the humanities and social sciences,” Mr. Townsend says. “So they filter those proposals narrowly through the written rules to make sure they are compliant.”
That can lead to boards imposing onerous conditions on scholars conducting interviews, like requiring them to provide an advance list of the exact questions they will ask—something that can be nearly impossible to do for a personal interview that is intended to be open-ended. And review boards have been known to tell researchers that they must destroy their tapes after the research project is complete to safeguard their subjects.
“In some cases, the only way to get approval is to lie,” says Mr. Schrag of George Mason. “It’s really agonizing for people who care about doing ethical research to have to begin their project with lies.”
Concern for Ethical Standards
But not all historians see exemption from review-board approval as a satisfactory fix.
Current review-board procedures are “tedious and nonsensical” for historians, says Horacio N. Roque Ramírez, president-elect of the Oral History Association, but scholars doing oral-history research still need to think carefully about the ethical implications of their work. The association provides detailed guidelines for oral-history projects, he says, but some scholars, especially graduate students, may never come in contact with the group. Having some approval procedure at the institutional level, whether through a review board or some other body, is a valuable way to make sure historians are held to high ethical standards, he says.
The Common Rule review begins with a 60-day public comment period, during which individuals and professional organizations have the opportunity to weigh in on the changes the federal government is considering. The government will then take into account the feedback and submit its proposed changes in the Common Rule to another round of public comment before making the changes final. The bulk of the proposed policy changes being reviewed during that time are related to the hard sciences, the area in which most institutional-review-board work is concentrated. But Mr. Schrag says he is glad to see issues related to the social sciences considered as well.
“One of the exciting things happening here is that after years of historians complaining that the guidelines are not clear, the regulators have finally recognized that, yes, the guidelines are not clear,” he says. “That’s a good start.”
