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: September 2025
Update: July 2020
Update: July 2018
IRB News- December 2015
Additional Resources on Oral History and IRB
Update: September 2025
The Current State of the Relationship between Oral History and Institutional Review Boards
by Mary Larson
When the OHA last updated its guidance on this issue five years ago, Institutional Review Boards (IRBs) were just beginning to grapple with the most recent revisions to the Common Rule, which went into effect in January 2019. The history behind the change in IRB oversight of oral history is detailed in previous essays below. Rather than revisit that ground again, this update addresses what has happened over the last five years and what related conversations are part of our scholarly discourse at present. A much more thorough survey and study of oral history and IRBs in the United States is currently underway by others and will provide a more in-depth view of the topic. This is meant as an interim update on the situation.
Who Is Exempt?
The 2019 revisions exempted certain oral history projects (45 CFR 46.102[l]), but now there is considerable misunderstanding about what it actually means for a study to be exempt. Contrary to what is often assumed, “exemption” does not mean that the IRB can be bypassed entirely. It simply means that the IRB will not conduct ongoing oversight of a project, but based on the Health and Human Services (HHS) guidelines, most institutions still require an initial determination by their board that a project is, indeed, exempt. Exemption cannot be decided by the person undertaking the work, so an initial form must be submitted to an IRB for this designation to be assigned. In most institutions, this process will be significantly less onerous than a full review, but, in order for something to truly be considered exempt, that determination must be assigned by a board.
If a study is labeled exempt after an initial review by an IRB, no further contact is usually required with the board unless the intent of the work changes significantly or if unforeseen challenges affect the nature of the perceived risks to participants. Even taking into consideration the exemption clause, some IRBs may assign a project to a different category either because of anticipated risks or the involvement of vulnerable populations. They are permitted to do that. Institutional IRBs are required to follow the Common Rule as the baseline of their regulations, but they are allowed to go beyond that baseline if they choose to do so. They just cannot drop below it.
While, to this point, oral historians have been used to dealing with university IRBs, and occasionally corporate ones, tribal IRBs are also increasingly common and need to factor into any discussion of IRB regulation. Since, as noted earlier, IRBs are allowed to set their own guidelines, as long as they are at least as stringent as the baseline established in 45 CFR 46, scholars working within Indigenous communities should be aware of and in contact with tribal IRBs. Oral historians should always ensure that their work is in compliance with tribal boards as well as with any others under whose auspices they fall.
Oral History as Research
One aspect of the exemption, a source of much discussion, is the fact that, according to this particular HHS definition, oral history does not constitute “research”. Many scholars of oral history have taken that personally, but the regulations make it clear that this is a very narrow definition solely for the purpose of this specific context. It is not a value judgment or an assessment that oral history is not considered research in the broader world. All it means is that, in this limited compliance code, oral history does not meet the governmental definition of what needs to be regulated. The language in the code reflects this in no uncertain terms, stating, “For purposes of this part, the following activities are deemed not to be research….” (emphasis mine), implying that this definition is meant to extend no further than this specific part of the regulatory environment.
This HHS definition of “research” hinges on the concept of “generalizable knowledge”, which is discussed at greater length in the July 2018 and July 2020 updates and in Office of Research Integrity guidance. With that established, it will not be covered here in any depth except to note how some IRBs are now interpreting that phrase when it comes to graduate work, particularly. A number of university IRBs have been especially attentive to proposals for graduate student research using oral history, with the understanding that theses and dissertations usually contain something that might look very much like generalizable knowledge and will thus fall outside of the oral history exemption. Graduate students utilizing interviews as part of their methodology should be prepared for extra scrutiny.
Issues of Consent
An important element in IRB considerations, whether for exempt or non-exempt studies, is the idea of consent. Since the earliest days of the Belmont Report, consent has been a keystone concept in regulation which also has a prominent place in the Oral History Association’s Principles and Best Practices. Our understandings of what consent entails have evolved over the years along with theoretical, methodological, and technical developments. The same is true in our current context.
Beginning with the OHA symposium AI in OH in the summer of 2024 and following with annual conference sessions and a special issue of the Oral History Review, oral historians have begun to seriously consider how this latest technological shift will impact the increasingly complicated issue of consent. There are so many unknowns regarding how (and from where) various AI corporations harvest online materials to train their software models. Even institutions or platforms with bot-management software cannot be sure if their archival data is being crawled, and that poses ethical issues about consent.
This is a recurring discussion, of course – one that last appeared when programs first started to consider putting collections online – but it will still be an important consideration as oral historians work through what “informed consent” means in our current context. This will require oral historians and archivists to know their collections, be aware of recent trends, and understand the shifting risk landscape. The conversation is just beginning, but it is one that merits attention as we think about our responsibilities to interviewees and communities within the larger scope of IRB regulation.
Ethical Considerations
The overall intent of IRBs is to hold researchers to ethical standards, and that does not change with exempted oral history projects. In order to be considered exempt by most boards, oral historians must continue to provide evidence of appropriate protocols for key IRB issues like consent, and some IRBs will also ask project managers to adhere to the OHA’s own guidelines if they are not covered by ongoing board oversight. In either case – whether governed by continuing IRB review or not –oral historians have guidance to follow regarding what we should do and what we must do to operate ethically in our field. Responsibilities to chroniclers and their communities do not stop at the IRB door. The IRB process is the start of ethical considerations, not the completion of them (as per item 10 of the OHA’s Core Principles).
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:
- 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:
- 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
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
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 https://www.institutionalreviewblog.com/2015/09/nprm-proposes-freedom-for-historians.html and https://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.
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
NCH Comments on HHS Rule on Protection of Human Subjects in Research