All of those presidential candidates who promise to change the world on “my first day in office” have a lot to learn about the federal government’s glacial pace. The government does tend to do the right thing, so long as you have the patience to wait a few years (or decades). On 8 September 2015, a 20-year struggle culminated in a ruling from the US Department of Health and Human Services that specifically excludes the following from human subject regulation: “Oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information is collected.”
The federal government began issuing rules that required universities to review human subject research back in 1980. At first, the regulations applied only to medical and behavioral research, but in 1991, the government broadened its requirements to include any “interaction with living individuals.” In 1995, a university hierarchy declined to accept a doctoral dissertation because the history graduate student had failed to consult the university’s institutional review board (IRB)—an entity none of her professors knew existed. She eventually received a retroactive exemption, but the incident sent shivers through the oral history community.
IRBs at universities, staffed almost entirely by those in the medical and behavioral sciences, began trying to fit oral history interviewing into protocols more designed for blood samples. IRBs instructed oral historians to keep their interviews anonymous, erase their recordings, and avoid asking possibly intrusive questions, which defeated the purpose of their projects. One student was met with resistance for naming the scholars in her field whom she had interviewed. Others were cautioned not to ask about illegal activities—even when interviewing civil rights activists who remained proud of the civil disobedience that led to their arrests. At their most illogical, there were boards that wanted researchers to obtain permission from third parties who had been mentioned during an interview, and even urged archivists to require researchers to apply for IRB clearance just to read an oral history transcript or listen to a recording in their collections.
Some scholars simply abandoned interviewing as a research or teaching tool to avoid the hassle. For years, a professor had partnered her college students with local high school students to conduct community-based oral histories, but she had to abandon the project when her campus IRB asked for certification that all participants in research activities were over the age of eighteen. Boards also expected faculty advisors who supervised theses and dissertations using oral history to take a standardized test on research ethics, despite its painfully clear orientation towards pharmacology.
In 2003, the Office of Human Research Protection (OHRP) approved a statement drafted by representatives of the Oral History Association and American Historical Association that defined oral history practices as fundamentally different from the quantitative research that the federal regulations had intended to cover. It argued that oral historians “do not reach for generalizable principles of historical or social development; nor do they seek underlying principles of laws of nature that have predicative value and can be applied to other circumstances for the purpose of controlling outcomes.” The OHRP agreed that people should be free to give their informed consent to be interviewed and to have those interviews opened for research, without any federally-mandated review. It has taken another dozen years for the government to issue that statement on its own. This decision is a victory for common sense and lifts a great burden from all oral historians. Let us hope that the IRBs get the message.
Image Credit: “A woman interviews her father for StoryCorps” by romanlily. CC BY NC ND 2.0 via Flickr.
Even this breakthrough amounts to a mere “work-around.” Oral history should have to meet this standard: does agreement to participate put the subject in a situation that exceeds the risk of everyday life?
That should also be the standards for such related fields as interviewing in sociology. Someone’s research in sociology should not be subject to review because sociologists sometimes reach numerical conclusions. What does THAT have to do with risk to the subject?? My own research on sundown towns could be characterized as sociology or as history. Hardly ever do I try to reach numerical conclusions. But if I identify a person who spoke with me, especially if she does not NEED to be identified by name, if I thereby get her in trouble with her neighbors, then I have committed ethically shoddy research, regardless of whether I did so as a historian or a sociologist. On the other hand, if I ask her, “May I use your name and quote you?” and she says “Sure,” then she has given me permission to do so. If something bad then happens to her, well, it could have happened had I been a journalist or myself one of her neighbors. In short, it is a risk of everyday life.
We should still minimize such risks, but we should not have to meet inappropriate standards at IRBs.
There is no ruling. There is a set of proposed changes, a “notice of proposed rulemaking” or NPRM.
This article needs more sources to verify its claim that the rule has passed. According to the HHS website, the Notice Of Proposed Rulemaking was posted on September 8, incorporating the recommendations to add oral history and other historical activities to the list of exemptions (https://www.federalregister.gov/articles/2015/09/08/2015-21756/federal-policy-for-the-protection-of-human-subjects). However, there has not been an update since September 8, and the current Code of Federal Regulations still shows the old exemptions (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101)
It appears the rule is not yet official and that comments are still being received. There will be a hearing on October 20 in Washington DC and the Department of Health and Human Services (https://www.federalregister.gov/articles/2015/10/07/2015-25564/public-town-hall-meeting-on-the-federal-policy-for-the-protection-of-human-subjects-notice-of)
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I remember an AHA panel in Washington about a decade ago, at which a HHS functionary first laid out a maximal definition of the protections required by ill-drafted statutes, but then graciously added, “these apply only to research, but what historians do is not research.”
The government is now codifying this workaround, it appears, which makes me wonder what consequences down the line (in terms of funding eligibility…”the NEH can only fund research as defined by the Federal Government”, anybody?) this might have.
Still, official recognition of what I gather is the current status quo — oral history and related fields often are required to inform IRB boards, but these boards no longer simplistically apply the rules suitable to pharmacology — is a step forward in the practical life of public and contemporary historians.
Anyone know why this proposed rule (TL;DR yet) didn’t include Interior dept and agencies such as IMLS, NEH, NEA?
[…] Don Ritchie reports, […]
The Department of Health and Human Services has recommended that oral history be explicitly excluded from review by institutional review boards, and alluded to the fact that oral history already has its own code of ethics, including the principle of informed consent. It is not a ruling but a recommendation. Now there is a 90 day period, ending in early December, during which individuals and organizations may add their own commentary. Then a final determination will be made.
This is potentially a big breakthrough in what has been a twenty-year struggle over oral history and IRB review. Full exclusion would remove an large, often contentious burden from both practitioners and IRBs.
If anything, however, full exclusion demands more than ever that oral history practitioners adhere to the principle of informed consent and other high ethical standards in all phases of the oral history process. Since the 1960s, the Oral History Association, the national professional organization, has developed guidelines for oral history, now embodied in the OHA’s Principles and Best Practices (http://www.oralhistory.org/about/principles-and-practices/). Look for updates on the oral history/IRB situation on the OHA website at http://www.oralhistory.org/.
Cliff Kuhn
Executive Director
Oral History Association
As Eira Tansey observes, this is still a proposed rule. It is not yet finalized in the Code of Federal Regulations.
Part of my job involves monitoring and reviewing regulations from one particular government agency, so I’ve picked up a few things about the process. The issuance of a proposed rule with comment period is a pretty common first step. During the comment period, anyone may submit a public comment (although I suspect that being able to identify yourself as “stakeholder” probably helps get your comment taken seriously; in this case being an academic under the auspices of a U.S. institution who made use of oral history would qualify you as a stakeholder). My impression (and keep in mind this is based upon one agency) is that contents of the proposed rule are likely to make it into the final rule unless there is significant disagreement in the public comments.
If you are concerned about this issue, I would suggest the following steps:
1.) Go to the Federal Register page for the proposed rule: https://www.federalregister.gov/articles/2015/09/08/2015-21756/federal-policy-for-the-protection-of-human-subjects
2.) Read the actual relevant regulation text (Warning: bureaucratese lies ahead). The bit you want is section II. A. 2. a. ii. Oral History, Journalism, Biography, and Historical Scholarship Activities.
3.) Submit a comment. Even if it is just to register approval of the rule as written, this can be valuable. If you don’t think it goes far enough, tell them that. They probably won’t expand the scope of the exemption this year, but if they get enough feedback in the comments it increases the likelihood of it happening sooner rather than later. Comments are due by December 7. There is a big green button on the web page labeled “Submit a Formal Comment,” or there are instructions near the top of the document on other ways to submit a comment.
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