Publication Date

October 17, 2011

As regular readers of AHA Today know, the federal government is offering a significant opportunity to weigh in on rules that cover institutional review boards (IRBs) and often interfere with legitimate history work. The current proposal seems to be a very mixed bag for history—offering both a tantalizing opportunity to address past concerns about the effect IRBs have on oral history and potentially new problems for history under the label of “information risk.”

Over the past month, we have been consulting extensively with members of the discipline, trying to identify a set of core principles for a response to the proposal. After careful deliberation, we offer the following “talking points” that will guide our response. We do this to invite comments and concerns from members as we craft our response, and as a guide to historians and related specialists looking to craft their own response to the federal proposal.

1) In response to the proposal’s broad question about whether there are “certain fields of study whose usual methods of inquiry were not intended to or should not be covered,” we will argue forcefully for the full exclusion of oral history from IRB oversight.

2) The argument on behalf of oral history will stress:

a. That oral history research focuses on eliciting information about the particular experiences of the past, and suffers irreparable harm when forced into rubrics developed to treat human beings in a general (or “generalizable”) way by engaging them in tests, trials, or medical procedures;

b. That the methodology of oral history research is built on a free and open dialogue with the interviewee, and cannot be reviewed or assessed in the structured or systematic framework of an IRB;

c. That the proposed “excused” category does not address our concerns, because it keeps oral history tied into inappropriate frameworks of the sciences and would add the further burden of rules designed to prevent “information risk”;

d. That this is not a simple plea to be free of all professional standards. The AHA endorsed the Oral History Association’s Statement of Principles and Best Practices and maintains its own Statement on Professional Standardsbecause we believe history work should be conducted in a rigorous and professional way, but our standards are organized and applied in ways that are fundamentally different from the scientific procedures and criteria administered by IRBs.

3) In addition to making a case for freeing oral history from the heavy hand of IRBs, we will also make an argument about the potential implications for future historians in the proposed rules to limit “information risk.” This argument will consist of three main points:

a. A regime that sets an impossibly high bar for the future use of archival or public use data sources will seriously inhibit our understanding of the past, including future projects that would hold scientists accountable for their misuse of research subjects (such as the recent study exposing U.S. research practices in Guatemala in the 1940s); and

b. In the case of oral history, our protocols already mandate fully informed consent by the interviewee prior to the interview; and a signed “release” at the end of the interview, by means of which the interviewee explicitly states the terms by which the interview can be used in the future.

c. The federal proposal reflects precisely the sort of “one size fits all” approach that makes these rules such a danger to oral history research.

4) History was never envisioned as falling under these rules; it is not in the enabling legislation and has not been a subject of substantial rulemaking review. This review of the rules offers HHS an opportunity to correct the misapplication of those rules and authorities.

As always, we welcome members’ suggestions and comments on this approach. We have until October 26th to submit a formal response.

We encourage you to write HHS with your own thoughts and observations on the issues raised by the proposal. The comment period has been extended to October 26, 2011, and can be submitted online (click on “Submit a Comment” follow the instructions, and just ignore the item at the top that comments are closed) or by mail to Jerry Menikoff at jerry.menikoff@hhs.gov or Office of Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.

This post first appeared on AHA Today.

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