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Deadline extended for comments on human subjects research rule excluding oral history from IRB review

Oral historians have until Jan. 6, 2016, to submit comments on a proposed landmark rule change that would exempt oral history and other related scholarship from federal rules aimed at protecting research subjects.

Initially intended to protect subjects of biomedical and behavioral research, the rules promulgated by the U.S. Department of Health and Human Services’ Office for Human Research Protections, have been interpreted variously by campus Institutional Review Boards, whose membership often is dominated by biomedical researchers with little understanding of oral history or research in the humanities.

Leaders of the OHA and other history-related organizations have advocated for changes in the rules for nearly 20 years, arguing that application of rules meant for medical research are inappropriate for oral history interviews. OHA leaders urged that the OHA’s Evaluation Guidelines be used as the standard by which to judge ethical performance in oral history work.

In October, the OHA joined 14 other members of the National Coalition for History in submitting comments to HHS strongly endorsing the proposed rule change. In commenting on the new policy proposal, the coalition’s letter said: “In its content, tone and recommendations, the document reflects a sensitivity toward and appreciation of the work that historians do.”

The proposed change to the rule, known as the Common Rule, would exclude from IRB review “oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information is collected.”

The federal proposal also notes that in such research, “the ethical requirement is to provide an accurate and evidence-based portrayal of the individuals involved, and not to protect them from public scrutiny. Therefore, the protections afforded to individuals by the Common Rule seem unhelpful in furthering the aforementioned ethical goal in this context. Additionally, these fields of research have their own codes of ethics, according to which, for example, consent is obtained for oral histories. It is believed that because of these reasons, explicit exclusion of these activities from the scope of the Common Rule is appropriate.”

The history coalition said in its letter commenting on the proposal:

“We concur with this recommendation of full exclusion of such activities from IRB oversight. It reflects an appreciation that these activities should not be evaluated under frameworks originally designed with the sciences in mind. It recognizes the value and attributes of these forms of scholarship. It eliminates any ambiguity about review, regulation and enforcement, and thus removes an enormous and contentious burden for both scholars and IRBs.”

The coalition letter also notes that the historical fields specified by HHS “have long maintained their own explicit ethical standards concerning the wishes and rights of the narrators in oral history interviews.”

It added that the historical organizations signing the letter “firmly believe in the principle and practice of informed consent and will continue to work to ensure that scholarship in these areas is of a high ethical quality.”

People interested in more detailed information might want to follow by Zachary M. Schrag, a history professor at George Mason University, who has followed the evolution of IRBs for many years.