AHA Today

The Feds and IRBs: Your Opportunity to Weigh in

Robert B. Townsend | Nov 6, 2007

The federal government is inviting comments (at http://www.hhs.gov/ohrp/documents/20071026.htm) on policies that lead to the intrusion of institutional review boards (IRBs) into oral history research. This provides a rare opportunity for members of our profession to register their objections. I urge every historian who conducts oral history, or is responsible for students who use oral history methods, to respond to this request and express their concerns about the inappropriate and often arbitrary way this policy has been applied to history research in many colleges and universities. You have until December 26, 2007 (send comments to the mailing and email addresses listed at the end of this post).

For those who do not follow this issue, IRBs were set up at universities and research centers to protect “human subjects” (living people) from dangerous medical and psychological experiments. Unfortunately, the federal government’s rather vague policies joined with university administrators’ instinct to avoid potential liability, caught up practices in a number of other social science and humanities fields—including oral history research in our discipline. As a result, we receive regular complaints that the degrees of history doctoral students have been withheld, the research of some faculty have been put on hold, and history teachers and students have been threatened with substantial fines, just for talking to people about past experiences.

Over the past seven years, the AHA made a number of efforts to clarify or reverse this policy of using IRBs to regulate oral history, first by working with the federal Office of Human Research Protections (OHRP) to clarify their policy, and then by encouraging departments to engage the IRBs at their home institutions to clarify these policies. Despite all these efforts, an AHA staff survey last year found a patchwork of institutional policies that belie the notion that this is a federally-mandated policy.

The proposed changes to the regulations that are now open for comment provide a good example of the problems in the way federal policies are translated into practice at the college or university level. The often oracular policies of OHRP make it hard to really estimate the potential impact of the regulatory changes that are now being proposed (which deal with the categories subject to “expedited review”). But they are specifically requesting comment on two items that have been most troubling to oral historians—category 5 (which seems to open the door to oversight of archival research) and category 7 (which specifies oral history).

As I read it (and I certainly welcome opinions to the contrary) the proposed change to category 5 could potentially bring the collection of oral histories as well as web projects like George Mason University’s September 11 Digital Archive under IRB purview. The current category applies to “research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis)” with a side note that “some research in this category may be exempt from the HHS regulations.” But the new language broadens the coverage and drops some of the clarifying language that seems to absolve oral history and the gathering of other testimonials from IRB oversight. The new proposed language would cover:

(5) Research involving materials (data, documents, records, or specimens) that (a) have previously been collected for nonresearch purposes; (b) have previously been collected for research purposes, provided the materials were not collected for the currently proposed research; or (c ) will be collected solely for nonresearch purposes. Note: Some research under section (a) or (b) of this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.

IRBs seem inclined to define these categories and their mandate quite broadly, as “anything done by faculty and students here at the university that could get us sued.” So the clarification in this language seems very troubling. The proposed language for 5c seems to bring projects that merely gather oral histories or personal testimonies for future scholarly research explicitly under IRB review, and goes a step further by excluding it from exemption (since “c” is not among those listed in the disclaimer). At the same time, this also seems to invite review of the use of materials gathered by other scholars and placed on deposit in an oral history archives.

To anyone who has not gone through the review process, this may not seem like a big deal. But as many oral historians have discovered, IRBs are generally comprised of faculty with no expertise in oral history methods, who nevertheless try to fit the square peg of history into the round hole of their scientific protocols. As a result, oral historians report that IRBs are applying rigid criteria on things like “research protocols”—insisting on specific sets of questions (as if dialogue was not a vital part of the interview process) and occasionally insisting on the confidentiality of sources (as if the interviewees particular knowledge or expertise was not the purpose of the interview). This is made all the more complex by the often vague notions of the potential harm that can be done by an oral history interview (is it the trauma of reliving a bad experience, or the potential personal or legal jeopardy their comments might expose them to?) So the possibility of further extending IRB oversight into basic collection practices should be actively resisted by anyone who cares about future research in the discipline.

The other problem in the proposed regulations is the continued inclusion of oral history in the revised language for category 7. But now the category is further expanded to include a wider array of subjects of research, including “affective states” and “interpersonal relationships.” That just seems to tie the noose even tighter around the kind of oral history topics the IRBs can review.

It will probably pay to be responsive to the particulars of their request, and offer some assessment of the problems evident in the two categories. But in general terms, historians should express their objections to the ambiguous and often arbitrary way these policies are implemented in a field where the risk of harm is minimal. The best solution seems to be the one recommended by the American Association of University Professors, that “research on autonomous adults whose methodology consists entirely in collecting data by surveys, conducting interviews, or observing behavior in public places, be exempt from the requirement of IRB review—straightforwardly exempt, with no provisos, and no requirement of IRB approval of the exemption.”

Please make your opinion known on this subject.

Comments can be sent to:

Office for Human Research Protections
The Tower Building
1101 Wootton Parkway, Suite 200
Rockville, MD 20852

Comments may also be sent by e-mail to expeditedreviewohrp@hhs.gov, or faxed to 301-402-2071.

For further information, contact Mr. Glen Drew, Office for Human Research Protections, The Tower Building, 1101 Wootton Parkway, Suite
200, Rockville, MD 20852, 1-866-447-4777 or by e-mail to: glen.drew@hhs.gov.

This post first appeared on AHA Today.

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