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Oral History Projects and Research Involving Human Subjects



Authoring Institution Association for Practical and Professional Ethics (APPE)
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Contributor(s) Brian Schrag
Volume 7
Year 2006
Publisher Association for Practical and Professional Ethics
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  • Peter R. Finn

    Posted 3 years and 5 months ago


    The Institutional Review Board as adversary

    This case illustrates some of the tensions that exist between Institutional Review Boards (IRBs), the Office for Human Research Protections (OHRP), and disciplines that previously had not been included in the IRB review process. It was not until the late 1980s to early 1990s that the Department of Health and Human Services (DHHS) came to realize that the regulations governing the protection of human subjects in research (45 CFR 46) covered a broader range of research activities than what was traditionally included. Up until then, IRBs typically reviewed studies from the medical, behavioral, and social sciences, including education. However, research in history, oral history, ethnography, anthropology, and folklore was not generally reviewed (although this varied across different universities). After considering a number of issues and cases, the DHHS noted that 45 CFR 46 covered all research that included humans as participants, including those disciplines that did not consider themselves subject to the regulations. The change in how the law was understood and the subsequent requirement that these disciplines submit their projects for IRB review and approval contributed to a strong adversarial relationship between researchers in these disciplines and IRBs.

    These disciplines expressed many legitimate concerns about having their research reviewed by IRBs. These concerns included a lack of understanding of qualitative research on the part of IRBs, a lack of representation on the IRB of people from their discipline, and an incompatibility of the model of research for their discipline with scientific—quantitative—experimental models of research that appeared to be the basis for the development of 45 CFR 46 and the different policies and procedures of IRBs. For instance, a very legitimate point made by ethnographers was that they could not outline in their applications to the IRB exactly what would be asked in an interview, because the topic and focus of the interview developed as a result of the comments, experiences, and interests of the interviewee. This presented problems with the IRB requirement of being informed of exactly what would be asked in an interview prior to approving the interview. Many also pointed out that the traditional method of documented informed consent via written forms actually could impede research as it introduced an awkward formality into the relationship between the researcher and subject, which seemed to counter the attempts to form long-lasting trusting collaborations between researcher and subject. Ethnographers also pointed out that using written forms of documented informed consent in non-western cultures could create tension and a lack of trust in the subject for the researcher. These very legitimate concerns required flexibility and some change in the IRB review process for these kinds of studies. It is extremely important that IRBs reach out to researchers in these disciplines, learn more about and better represent these disciplines, and work with researchers in these disciplines to solve the problem of how to do a reasonable and fair review of this kind of research while still protecting subjects and remaining within the limits of the regulations. Clearly, there is flexibility in the regulations to handle different approaches to obtaining consent and to deal with other specific concerns raised by researchers in oral history and other disciplines previously excluded from review.

    A more contentious issue raised by researchers in these disciplines was that IRB review represented an infringement on their right to academic freedom and general freedom of speech. It is true that some IRBs can be inflexible and pose unreasonable constraints on research in these domains. Such IRBs need to work with these disciplines. However, the basis for the complaint that IRBs infringe on academic freedom is based to a great degree on the misunderstandings that IRBs would change the substance of the researcher’s study, and misunderstandings about what constitutes academic freedom. It is a very rare event that an IRB will tell a researcher in the humanities that they cannot conduct a particular study. Usually the IRB will require minor changes in the manner of subject recruitment and the process of obtaining informed consent. If an IRB does not allow a particular study it is because the risks associated with that study are not managed properly. There are limits to academic freedom. Academic freedom does not mean that academics can do what they want no matter what. Academic freedom means that academics can express their ideas, take specific stances on issues, and research those issues, but the research must be done within the confines of commonly held ethical principles.


    Oral History, the OHRP, and 45 CFR 46

    The case provides a scenario that exemplifies the disagreement between some oral historians and IRBs or the OHRP, and the misunderstanding about what constitutes research according to the regulations. The case seems to suggest that the primary goal of the AHA and OHA is to find a way to side-step the requirement of IRB review, rather than carefully considering the primary issue of how to make sure that research is done in an ethical manner whether or not the regulations really do cover their research.

    All parties agree that research should be done ethically and within the law, but there is disagreement on how to accomplish this goal. The OHRP - IRB perspective is that a third party review has great value because researchers are likely to be biased when left on their own to monitor themselves, there have been many cases of studies where unethical behavior and simple failure to think through all of the ethical issues have led to significant harm, and a common system is likely to work best as it should be able to structure and organize the process. The AHA/OHA perspective is that they can do it on their own having historians be informed by their own professional ethics; all the problems noted in the past have been the responsibility of biomedical or psychological researchers, not people in their discipline; and the IRB review system, even the definition of research, was not designed for historians. The case suggests that the decision of the research advisor not to support the project if it was submitted to the IRB is based on the strong opposition to the IRB review requirement and the animosity felt toward IRBs and the OHRP, rather than on a careful consideration of what an IRB review might accomplish in regards to the shared value of protecting research subjects. The position expressed by the graduate student researcher, Putnam, is that IRB review could be helpful given some of the concerns about the risks involved in the study.

    The case outlines the AHA’s primary argument against having oral history projects reviewed by an IRB which is based in the idea that oral histories really do not add to generalizable knowledge, and therefore do not fit the definition of research. It is true that some oral histories are taken simply to understand an individual or group of individuals or to archive such histories in an institution, and not to derive any broader conclusions about individuals, cultures, or historical contexts. However, many oral history projects are planned with the idea that information about certain individual’s experiences in certain contexts can lead to a greater understanding of specific periods in history or cultural processes. It is especially difficult to imagine that oral historians who also are university faculty do not do their work to add to generalizable knowledge. The case suggests that some oral historians are motivated more by the goal of side-stepping the regulations, than by fully appreciating what the regulations mean by the term “research.”


    Formation of Students: When political agendas interfere with faculty responsibility

    Finally, this case demonstrates how specific political agendas may interfere with the responsibility of a faculty member to be as objective as possible in providing guidance and support to graduate students. Unfortunately, Putnam’s advisor has allowed his political agenda concerning IRB review to interfere with his commitment to advise his graduate student. Rather than responding to Putnam’s basic concern about risk and the regulations, he puts his political agenda and self/departmental concerns ahead of the student’s concern and takes the extreme position of threatening to withdraw support for the student’s project if the student involves the IRB. Such an action clearly puts Putnam and his graduate/academic career in jeopardy.  Not only is the advisor not thinking about the ethical concerns in the particular study, but he acts selfishly by putting his own self-interest first, and he acts unethically by threatening the graduate student with withdrawal of support and by encouraging the graduate student to do something that may make him liable for not consulting with the IRB. In fact, in this case, it is the specific behavior of the research advisor in relation to his graduate student that is the most unethical.

  • Anonymous  Participant

    Posted 3 years and 5 months ago


    “Oral History Projects and Research Involving Human Subjects” focuses on a number of prominent issues in the ongoing debate about whether or not oral history is “research” defined by HHS and subject to HHS regulations, namely, IRB review.  Through this case, questions about the role of IRBs and professional organizations develop and illustrate the problems that emerge when IRB guidelines are applied to disciplines previously excluded from such review (e.g., oral history, anthropology, ethnography, and folklore).  While this case primarily focuses on whether or not oral history is subject to IRB review, other issues develop, such as the role of professional organizations in the research process and their relationship to IRB governance, how academic and professional goals inhibit ethical judgments, and how the role of a student’s advisor differs from his or her mentor.  In this commentary, I will focus on the debate on whether or not oral history interviewing should be subject to IRB review.



    On September 22, 2003, Michael A. Carome, Associate Director for Regulatory Affairs for the Office of Human Research Protections (OHRP), concurred with a policy statement drafted by the American Historical Association (AHA) and the Oral History Association (OHA) stating that most oral history interviews do not need Institutional Review Board approval.  After this concurrence, the position that the AHA and OHA strongly supported was oral history “does not meet the regulatory definition of ‘research’ and therefore is excluded entirely [emphasis mine] from IRB review, without seeking formal exemption.”1 Since the OHRP never released its own policy on oral history interviewing, IRBs around the country did not adopt the AHA and OHA’s policy statement.  In October of 2003, at the request of the Office for Protection of Research Subjects at UCLA, Dr. Carome stated his position on the AHA and OHA’s policy statement:

    In summary, the August 26, 2003 Policy Statement attached to OHRP’s September 22, 2003 letter was not drafted by OHRP, does not constitute OHRP guidance, and the characterizations of oral history activities in the third paragraph of the Policy Statement alone do not provide sufficient basis for OHRP’s determination that oral history activities in general do not involve research as defined by HHS regulations at 45 CFR part 46.2

    This statement seemingly contradicted his prior concurrence; however, Carome’s statement did make it clear that the OHRP did not exclude oral history from IRB review.  But even after Carome’s statement to UCLA was widely distributed, the AHA issued a press release on June 8, 2004 that reaffirmed that most forms of oral history can be excluded from IRB oversight and ignored Carome’s communication entirely.


    Ethical Issues and Analysis

    The position of the AHA and OHA is based on the belief that IRBs have overstepped their purpose and jeopardized academic freedom by including oral history in the IRB review process. To them, the division between the scientific and nonscientific disciplines is vast and using the same federal guidelines to regulate all research is problematic.  Linda Shopes, a representative of the AHA, stated, “Applied to oral history interviews and other forms of nonscientific research, they [IRBs] present numerous, serious difficulties, especially because many IRBs are constituted of medical and behavioral scientists, who have little understanding of the principles and protocols of humanistic inquiry.”3  Furthermore, Linda Shopes stated, “Institutional Review Boards were established to prevent the very real physical and mental harm that some biomedical and behavioral research had inflicted on human subjects.”4 Instead of IRB review, the AHA and OHA defend the position that with firm ethical guidelines in place oral history can be effectively monitored through professional organizations and processes such as peer review.5

    The essential questions presented by the AHA and OHA are what is research defined by HHS and what, if any, harm can come of oral history interviewing. The AHA and OHA do not believe that oral history interviewing leads to “generalizable knowledge” and, therefore, does not meet the definition of research as defined by HHS.  When Michael Carome clarified his position on oral history interviewing, he stated,

    Oral history activities, such as open-ended interviews, that ONLY [emphasis in original] document a specific historical event or the experiences of individuals without an intent to draw conclusions or generalize findings would NOT [emphasis in original] constitute “research” as defined by HHS regulations.6

    This position made it evidently clear that most oral history interviewing does require IRB review since oral history interviewing, especially by academics, leads to the formation of conclusions and general findings (i.e., generalizable knowledge).  In addition, oral history interviewing that is archived has the potential to be used by other researchers and become the source of generalizable knowledge as defined by the HHS.7

    In addition, the potential for psychological harm for oral history subjects, while perhaps minimal in most cases, presents risks to human subjects.  The AHA and OHA have totally ignored these risks in their policy statement.  E. Taylor Atkins, associate professor at Northern Illinois University, expressed concern on the AHA and OHA’s policy statement and stated, “The principal concern of the AHA and OHA is the academic freedom of their members, but the recent decision [policy statement] does nothing to reduce the possible risks to interview subjects who participate in oral history projects.”8  Atkins also reminded researchers of Alistair Thomson’s Oral History Reader that warns of the risks associated with interviewing groups such as Holocaust survivors and veterans with post-traumatic stress disorder.9



    This case sheds light on the ongoing debate between those who believe oral history interviewing should be excluded from IRB review and those who believe that IRB oversight is necessary.  The AHA and OHA’s policy statement advocating the exclusion of oral history interviews fails to show that oral history interviewing is not generalizable knowledge and ignores the inherent risks for oral history subjects. The AHA and OHA policy statement is, above all else, an attempt to avoid a perceived inconvenience, IRB review.  When what is ethically right is weighed against this, it is obvious that oral historians should value IRB oversight.  Other professional organizations such as the American Anthropological Association advocate that researchers involve the IRB and hold their research to the highest standards.  It is time that the AHA and OHA commit to a similar position.10



    1American Historical Association, “Questions Regarding the Policy Statement,” American Historical Association

    2Office for Protection of Research Subjects UCLA, memorandum

    3Linda Shopes, “Institutional Review Boards Have a Chilling Effect on Oral History,” Perspectives 38, no. 6 (September 2000)

    4Linda Shopes and Donald A. Ritchie, letter to the editor, Perspectives 41, no. 9 (December 2003)

    5Two examples include John N. Neuenschwander Oral History and the Law (Denton, Texas, Oral History Association, 1985) and Oral History Association, “Evaluation Guidelines,” Oral History Association


    6Office for Protection of Research Subjects UCLA, memorandum,


    8E. Taylor Atkins, letter to the editor, Perspectives 41, no. 9 (December 2003)


    10American Anthropological Association, “American Anthropological Association Statement on Ethnography and Institutional Review Boards,” American Anthropological Association

Cite this page: "Oral History Projects and Research Involving Human Subjects" Online Ethics Center for Engineering 3/8/2016 OEC Accessed: Thursday, August 22, 2019 <>