The federal government is inviting comments (at www.hhs.gov/ohrp/documents/20071026.htm) on a draft policy on institutional review boards (IRBs). This is a rare opportunity for historians to comment about federal policies that could potentially have an intrusive impact on their work. Every historian who conducts oral history, or who advises students who use oral history methods, should respond to this request especially since previous formulations of this policy have been applied to history research in many colleges and universities inappropriately and in arbitrary ways. The deadline for offering comments is December 26, 2007.

IRBs were set up at universities and research centers primarily to protect "human subjects" (understood as living people) from dangerous medical and psychological experiments. Unfortunately, the federal government's rather vague policies together with university administrators' instincts to avoid potential liability brought practices in a number of other social science and humanities fields—including oral history research—into the orbit of bureaucratic regulation. As a result, the American Historical Association has been receiving regular complaints that the degrees of history doctoral students have been withheld, that the research projects of some faculty have been put on hold, and that 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 reverse (or at least secure clarifications about) this policy of using IRBs to regulate oral history. The Association sought to do this first by working with the federal Office of Human Research Protections (OHRP) to clarify their policy, and then by encouraging history 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 complex patchwork of institutional policies developed from an imperfectly understood/vague federal policies (a report about the survey can be read at www.historians.org/perspectives/issues/2006/0602/0602new1.cfm).

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 pronouncements of the 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 also to oversight of archival research) and category 7 (which specifies oral history).

The proposed change to category 5 could potentially bring collections of oral histories as well as Web projects like George Mason University's September 11 Digital Archive under IRB purview. According to the policies now in place, category 5 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 proposed new language broadens the coverage and drops some of the clarifying language in the previous version that appeared to exclude oral history and the gathering of other testimony from IRB oversight.

In the new draft under discussion, the category is redefined as follows:

(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 interpret 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 the draft federal policy under discussion seems very troubling. The proposed language for 5(c) 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 those who have 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 other scientific practices. 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 IRB oversight extending further into basic collection practices of oral historians is a cause for deep concern.

The other problem in the proposed regulations is not only the continued inclusion of oral history in the revised language for Category 7 but also its further expansion 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 the federal government's request for comments, and offer some assessment of the problems evident in the two categories. But in general terms, historians may wish to express their concerns about the ambiguous and often arbitrary way these policies are being 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."

Comments can be sent by e-mail to expeditedreviewohrp@hhs.gov, or faxed to 301-402-2071. They can also be mailed to Expedited Review, Office for Human Research Protections, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Inquiries for details may be addressed to Glen Drew, Office for Human Research Protections at the same mailing address, or by telephone (866-447-4777). He can also be reached by e-mail at glen.drew@hhs.gov.

—Robert Townsend is the AHA's assistant director for research and publications. This essay is adapted from a version that appeared originally on the AHA's blog, AHA Today, at https://www.historians.org/research-and-publications/perspectives-on-history/november-2007/the-feds-and-irbs-your-opportunity-to-weigh-in.