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Information about IRBs


The relationship of oral history to human subject research regulations has been widely debated since the 1990s, in particular whether oral history should be reviewed by Institutional Review Boards, or IRBs.  OHA has played and continues to play a central role in these discussions.

Update: July 2020
Update: July 2018
IRB News- December 2015
Additional Resources on Oral History and IRB


Update: July 2020

Oral History, The Protection of Human Subjects in Research and Institutional Review Board Oversight

Federal Institutional Review Board (IRB) oversight policies for the protection of human subjects in research have been an issue of great concern to oral historians for many years. (See Linda Shopes “Oral History, Human Subjects, and Institutional Review Boards” for more context and history). Many universities and research organizations that accept federal research funds required oral historians to present their research protocols to their IRB for approval. Often, this led IRBs to require burdensome conditions that directly violated accepted principles and best practices of oral history in the name of addressing nonexistent risks. Overall, oral historians have found the IRB process poorly suited to the consensual, shared authority interview methods that are the foundation of sound oral history practice. Furthermore, IRB policies that mandated confidentiality, and even the destruction of interviews after a period of time, directly contradict the principle of narrator ownership of copyright and best practices on archival preservation.

Revisions to the U.S. Department Health and Human Services “Policy for Protection of Human Research Subjects” (known as the Common Rule) in 2019 now exclude oral history from IRB review through a strict definition of research. The exclusion is related in the final regulations under section “§46.102:

  1. Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. 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.

The Office for Human Research Protections, which oversees federal policy on human subjects research, has offered additional guidance. Oral history is excluded as long as it falls under the category of “scholarly and journalistic activities that collect and use information about specific individuals themselves.” On the other hand “studies using methods such as participant observation and ethnographic studies, in which investigators gather information from individuals in order to understand the beliefs, customs, and practices, not only of those individuals, but also of the community or group to which they belong” would represent “generalizable knowledge” and therefore not excluded from IRB review under these new rules.

Despite these federal policy changes excluding oral history from IRB oversight, oral historians must continue to hold themselves to the highest professional and ethical standards as spelled out by the Oral History Association’s Principles and Best Practices.

 

Louis M. Kyriakoudes
Co-Executive Director, OHA
Professor of History, Middle Tennessee State University

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Update: July 2018

Institutional Review Boards and Oral History

The best way to characterize current federal policy on the protection of human subjects in research, Institutional Review Boards (IRB), and oral history methods is that regulatory changes are pointed in the right direction, but are still in flux.

As part of the proposed changes to the common rule, interview methods like oral history which preserve the unique perspective of an individual and do not lead to systematic, “generalizable knowledge” are exempted from the definition of research for purposes of IRB review. Here is the specific language with our highlights:

“(l) Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.

 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.gpo.gov/fdsys/pkg/CFR-2017-title24-vol1/xml/CFR-2017-title24-vol1-part60.xml ]

The implementation of these regulations has been delayed twice, first in January 2018 and again in June 2018. They are now supposed to take effect January 21, 2019.

However, as an interim measure, three “burden reducing” components of the proposed rules can go forward. One of these is the implementing the revised definition of research that exempts oral history and other scholarly activities as noted above. Here is the relevant section of the Federal Register indicating that these burden reducing provisions may go forward: https://www.federalregister.gov/documents/2018/04/20/2018-08231/federal-policy-for-the-protection-of-human-subjects-proposed-six-month-delay-of-the-general

IRBs can implement the burden-reducing provision that exempt oral history projects immediately. For researchers at institutions where oral history does not already have an exemption from review, we recommend bringing these changes to the attention of your IRB and request implementation of the exception for oral history as indicated in the regulations.

We continue to monitor these developments and keep the oral history community informed of new developments.

Louis M Kyriakoudes and Kristine McCusker,
Co-Executive Directors
Oral History Association

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IRB News- December 2015

On September 8, 2015, the U.S. Department of Health and Human Services issued a set of recommended revisions to the regulations concerning human subject research. Specifically, it recommended that oral history be explicitly excluded from review by institutional review boards (IRBs), noting that oral history already has its own code of ethics, including the principle of informed consent.

The fact that all of the relevant federal agencies have agreed on this statement represents a big breakthrough in a twenty-year struggle over IRB review of oral history. Since there is a 90-day period during which individuals and organizations may add their own commentary, the Oral History Association has worked with other professional associations to develop a collective response to the recommendations. That commentary can be found on the website of the National Coalition for History.

OHA encourages members to support this development by sending comments. The comment period has been extended to January 6, 2016.  Comments can be submitted at the www. regulations.gov website.  To reach the correct page, click comment. Once on the regulations page, you will see a “comment now” button on the right side of the page.

OHA executive director Cliff Kuhn has written an overview of the IRB situation leading up to the current recommendations. See Background on the Current HHS Recommendations Concerning IRBs.

Read the History News Network article about IRB review.

To read the entire document, go to Federal Register.

For more information go to the Institutional Review Blog maintained by George Mason University professor Zachary Schrag: Institutional Review Blog.

For specific responses to the recent recommendations, see http://www.institutionalreviewblog.com/2015/09/nprm-proposes-freedom-for-historians.html and http://www.institutionalreviewblog.com/2015/09/nprm-freedom-for-historians-if-they-can.html.

The OHA will continue to monitor and publicize new developments as they take place.

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Additional reading on oral history and IRBs

“Oral History, Human Subjects, and Institutional Review Boards” – an essay by Linda Shopes

Bibliography: Oral Historians and Institutional Review Boards

Regulation of Research on Human Subjects: Academic Freedom and the Institutional Review Board – March 2013 report by the American Association of University Professors

NCH Comments on HHS Rule on Protection of Human Subjects in Research

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