In welcome news for oral historians, the US Department of Health and Human Services (HHS) and 15 other federal departments and agencies have announced proposed revisions to the regulations for protection of human subjects in research. A Notice of Proposed Rulemaking (NPRM) was published in the Federal Register on September 8, 2015, with the provision of a 90-day comment period. A summary of the issue and the proposed rule itself is available on the HHS web page at www.hhs.gov/ohrp/humansubjects/regulations/nprmhome.html.

The new recommendations for human subject research protection specifically state that “oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information is collected” be explicitly excluded from “the scope of the Common Rule” (explained below). Moreover, the recommendations acknowledge the importance and value within oral history, and historical studies more generally, of identifying individual actors in history. The recommendations also recognize that discipline-specific codes of ethical conduct already exist. This presents a marked shift in both tone and content from previous ­iterations.

Since the Oral History Association (OHA) has a great deal of expertise in the issue, it took the lead in preparing comments on the proposed rule. The National Coalition for History (NCH) has issued a statement on the matter, originally submitted to HHS in October.1 Fifteen NCH member organizations signed a joint statement endorsing the proposed changes.

It is important to note that a final rule is far from imminent, given the number of federal agencies involved in the process and the complexity of the issue. In fact, it will be not a matter of months but likely a year or more before HHS issues the revised regulations.

The Common Rule and Oral History

Beginning in the mid-1990s, college and university students, faculty, and staff who conducted oral history interviews increasingly found their interviewing protocols subject to review by their local Institutional Review Board (IRB), a body charged by the federal government with the protection of human subjects in research. Human subject risk regulation had its roots in the explosion of government-funded medical research after World War II as well as with the revelation of glaring medical abuses, including Nazi doctors’ experiments on Holocaust victims and the Tuskegee syphilis study. History and other humanities disciplines were never originally intended to fall within the purview of the regulation, generally known as the Common Rule, which addressed biomedical and behavioral research.

The growing inclusion of oral history under IRB review began an often contentious, confusing, and chaotic process. Was oral history—or were historical studies more generally—the type of “generalizable” research covered by the Common Rule? What about research that clearly manifested no or minimal human risk? How could oral history be properly evaluated within a framework originally designed to regulate medical and biological science? The ensuing years witnessed numerous examples of IRBs overreaching with regard to oral history, with often damaging results and chilling effects. The list includes class projects that had to be jettisoned, IRBs limiting or rejecting projects citing largely nonexistent risks, and researchers who were asked to submit their questions in advance, guarantee ­anonymity of the people they interviewed, or even destroy their tapes and transcripts.

Recognizing the disconnect between actual oral history practice and the way IRBs frequently treated oral history, federal authorities have periodically attempted to introduce clarifying language. At times the federal Office of Human Research Protections (OHRP) has recommended that most oral history be placed in the “expedited” category before IRBs, at other times that oral history as a rule be “exempt.” In 2003, Michael Carome, the associate director for regulatory affairs at OHRP, concurred that oral history interviewing activities “in general” fell outside the federal definition of research requiring IRB review. Yet such language did not serve to clarify or stop undue regulation. Instead, we continued to have what AHA executive director James Grossman has termed “the hodgepodge of rules and regulations governing oral history research at the various colleges and universities in the United States,” and complaints about oral history oversight by IRBs ­persisted.

In 2011, HHS called for public comment in response to proposed regulatory changes aimed at “enhancing protection for research subjects and reducing burden, delay, and ambiguity for investigators.”2 The OHA, the AHA, the Organization of American Historians, and many other individuals and entities commented about oral history in particular. Their remarks centered around a number of points: that oral history interview practice is inherently open-ended and not bound by a set of preexisting interview questions; that in its focus on particular individuals, oral history fell outside the “generalizable” research targeted by the Common Rule; that requiring the anonymity of subjects was antithetical to oral history, and to the discipline of history more generally; that oral historians already operated under a code of ethics, including the principle of informed consent; and that efforts to force oral history and historical inquiry into a regulatory framework designed for scientific research caused harm, confusion, and undue burden. Therefore, we feel strongly that oral history should be excluded altogether from IRB review.

Again, the proposed HHS rule changes are a very positive development, but until the rule is changed, oral historians must continue to seek IRB approval for their projects. The NCH and OHA encourage interested parties to take advantage of the short time remaining to comment on the NPRM.

Clifford Kuhn passed away November 8. He was executive director of the Oral History Association and associate professor of history at Georgia State University. Lee White is executive director of the National Coalition for History. Passages from this article originally appeared at www.oralhistory.org/wp-content/uploads/2015/10/Background-on-the-Current-HHS-Recommendations-Concerning-IRBs.pdf.

Notes

1. Lee White, National Coalition for History, letter to US Department of Health and Human Services, October 30, 2015, http://historycoalition.org/wp-content/uploads/2015/10/NCH-HHS-Human-Subjects-Proposed-Rule-10-30-15.pdf.

2. “ANPRM for Revision to Common Rule,” US Department of Health and Human Services, http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html.

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