New Federal Rule Exempts Oral History From IRB Review

 

On January 19 the federal government issued its final rule governing Institutional Review Boards (IRB), which “explicitly removes” oral history and journalism from the Federal Policy for the Protection of Human Subjects. It was originally promulgated as the “Common Rule” in 1991. The historical community, collaborating through the National Coalition for History, has long argued that scholarly history projects should not be subject to standard IRB procedures since they are designed for the research practices of the sciences. The new rule goes into effect January 19, 2018.

The rule acknowledges that oral history and historical studies more generally depend on the identification of individual actors in history, and concludes that, “For purposes of this part, the following activities are deemed not to be research: (1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information that focus directly on the specific individuals about whom the information is collected.” https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-the-protection-of-human-subjects

In issuing this change, the federal agencies also recognized that discipline-specific codes of ethical conduct already exist, such as the Best Practices of Oral History Association (http://www.oralhistory.org/principles-and-practices/).

On October 30, 2015, the National Coalition for History (NCH) submitted a letter to the HHS during the public comment period on the draft rule. NCH’s comments focused on the treatment of oral history under the rule and strongly endorsed the recommendation to exclude oral history from the “Common Rule.” Fifteen NCH member organizations also endorsed the comments and were listed as individual signatories. http://historycoalition.org/wp-content/uploads/2015/10/NCH-HHS-Human-Subjects-Proposed-Rule-10-30-15.pdf

Background:

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 formed at every research institution, and 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 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 which 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 in which 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.” Yet such language did not serve to clarify, or to 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.