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Human Research Participant Protection Program
Guidance on IRB Review of Projects Collecting Oral (or Life) Histories,
Journalism or Case Studies
Issued: 5/14/14
I. Subject
Some research involving the collection and use of oral histories or life histories may not meet
the federal definition of ‘human subjects research’ and therefore may not require involvement
of the IRB office; other research using the same methods may meet this definition of human
subjects research and can be exempted from IRB review; and some may require IRB review.
Likewise, determining whether journalism projects or the development of case studies is
subject to oversight by the IRB office is not always clear. This document is intended to provide
guidance on the policies that govern whether projects in the areas of oral history, journalism or
case study development constitute human subject research as defined under the Federal
Regulations. Investigators should contact the IRB office ([email protected]u) if they have further
questions about this guidance or how it applies to their particular research project.
II. Scope
This document provides guidance on applying IRB policy ‘Determining whether a research
activity needs IRB review and approval: SOP#1’ to the use of oral history or life history
techniques, journalism and case studies.
If funders of sponsored research (e.g. the National Institutes of Health) require IRB approval or
certification of exemption from IRB review as a condition of the award, that requirement takes
precedence over this guidance.
III. Terms and Definitions (please see the Cornell IRB glossary for more definitions)
Research is a ‘systematic investigation, including research development, testing and
evaluation, designed to develop or contribute to generalizable knowledge.’
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Generalizable knowledge has not been explicitly defined in federal regulations, but can be:
a) applied to individuals outside the research sample; b) predictive of future events; or c)
widely applied as theories or principles that enhance scientific or academic understanding
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;
or d) create general explanations about all that has happened in the past.
Human Subjects or Human Participants are ‘living individuals about whom an investigator
(whether professional or student) conducting research obtains:
DISCLAIMER: This document has not
been updated to reflect regulatory
changes effective January 21, 2019.
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1. data through intervention or interaction with the individual or
2. identifiable private information.’
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Interaction: ‘includes communication or interpersonal contact between investigator and
subject.’
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Human Subjects Research is ‘research’ involving ‘human subjects’ (as defined above).
Oral History: The National Oral History Association (OHA) defines oral history as ‘a method
of gathering and preserving historical information through recorded interviews with
participants in past events and ways of life’. Oral history is a recorded conversation about
the past with named individuals in which knowledge about specific events and individual
lives is narrated in story form and made available to the public through deposit in archives.
Biographical in nature and historical in scope, the scholarly oral history interview is rooted
in particular recollections about history based on the individual perspective of the narrator.
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Life histories (or life stories): include ‘any retrospective account by the individual of his [or
her] life in whole or part, in written or oral form, that has been elicited or prompted by
another person.’
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Life stories intend ‘to show something about the kind of person a speaker
is.’
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Case studies are in-depth explorations of a particular project, policy, institution, program or
system in a ‘real life’ context.
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Case studies are sometimes developed for classroom
instruction using the ‘case method’.
Journalism includes activities focused on the collection, verification, and reporting of
information or facts on current events, trends, newsworthy issues or stories about people
or events, with no intent to develop or test a hypothesis.
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IV. Guidance
Determining whether research in oral history, journalism or case study development
constitutes federally-regulated ‘human subjects research’ rests on whether the activities are
part of a systematic investigation designed to contribute to generalizable knowledge.
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1. Projects that only document or report
Projects that only document or report on events, situations, policies, institutions or systems
without the intent to form hypotheses, draw conclusions, or generalize findings outside the
sample are generally not considered research with human participants as defined in the federal
regulations. These include:
Case studies developed for pedagogical use, such as those commonly used in business
and law schools
Reporting of current events, trends, newsworthy issues or stories about people or
events, such as those presented in the news, magazines and non-scholarly periodicals
Oral history interviews that document specific historical events or the experiences of
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individuals or communities over periods of time
Example: Veterans Oral History Project
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A student is planning a dissertation on the long-term social impact of the Vietnam War
on American culture. The student wants to conduct life histories of a group of veterans
for the sake of documenting what the war meant in the rest of their lives. The
interviews will be contributed to the Veterans Oral History Project at the Smithsonian
Institution.
Rationale:
The project, as described above, is not considered research with human subjects
because the information collected from the interviews is not intended to develop or
contribute to generalizable knowledge.
Investigators undertaking such projects do not need to take any action with the IRB office.
Investigators should continue to exercise professional ethics appropriate to the field.
2. Projects that intend to develop generalized knowledge
Systematic investigations involving interviews that are designed to develop or contribute to
generalizable knowledge are ‘research’ under federal definitions, and need to be assessed for
potential risk to participants. Much research using oral history or life history methods involves
minimal risk to participants. A risk is minimal when the probability and magnitude of harm or
discomfort anticipated in the proposed research are not greater, in and of themselves, than
those ordinarily encountered in daily life or during the performance of any proposed activities if
they occurred outside the research context.
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Talking with participants about past events and
life experiences, even unpleasant ones, is generally not considered more than minimal risk.
Such studies include:
Ethnographic studies designed to describe human beliefs or behaviors in a specific
cultural setting
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Studies that use multiple case studies to draw conclusions that are applicable in a
generalizable context, or to address a hypothesis
Reporting intended to draw conclusions in an effort to influence public policy or opinion
Example: Returning Veterans Employment Study
A post-doc is planning a study on the transition from active military service to civilian
life, and the long term economic impact of war on the lives of American veterans. The
post-doc wants to conduct life histories of a group of veterans, including their
experiences job hunting immediately following active service, and their employment
history before and after active service. The interviews will be contributed to the
Veterans Oral History Project at the Smithsonian Institution. Findings would be used to
better target future employment-related services provided by the Veterans
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Administration.
Rationale:
Based on the information provided, this project would collect information that is
designed to contribute to generalizable knowledge. Information gained through the
interviews would be used to predict the behavior and circumstance of future veterans,
and to tailor service for those future veterans. However, it is unlikely that the disclosure
of the interview data would reasonably place the participants at risk. The above project
does require submission of an application to the IRB office, but is likely to be considered
exempt from further IRB review.
Researchers conducting projects that involve oral and life history interviews that meet the
regulatory definition of human subject research but pose minimal risk to participants should
submit a Request for Exemption from IRB review to the IRB office. Research can begin once a
certification of exemption is issued by the IRB office.
It is possible that participating in research that uses oral history or life history methods could
place participants at greater risk, or face a different type of risk, than they would in their daily
lives. The most likely risk from research in studies that use oral or life history techniques, case
studies or journalism is that the “disclosure of the human subjects’ responses outside the
research could reasonably place the subjects at risk of criminal or civil liability or be damaging
to the subjects’ financial standing, employability, or reputation.”
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Such risks might include:
Being seen speaking to the investigator of a study of historical changes in HIV-related
drug availability might inadvertently disclose an individual’s health condition.
Investigators may ask about sensitive topics such as participants’ criminal activity or
unethical behavior, or may obtain other information that is perilous or stigmatizing in
the cultural context in which the research takes place.
For projects with such risk, the IRB will want details about the data security provisions of the
planned archive, in addition to other information and materials described in the application
for IRB review.
Example: Post-Traumatic Stress Disorder in Veterans
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A faculty member is planning to conduct oral histories to gain an understanding of the
impacts of war on post-traumatic stress disorder. The faculty member wants to work
with a veterans Post Traumatic Stress Disorder [PTSD] support group to take life
histories to see how war has influenced the rest of the veterans' lives. The group agrees
in writing to allow the faculty member to meet with the members as a part of the group,
and individually. One goal of the research is to make assessments that will allow the
faculty member to predict what kinds of exposure in war situations leads to the
development of PTSD. While the veterans want to contribute their memories to the
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national Veterans oral history project run by the Smithsonian, they want to keep specific
information which would link PTSD material to their life histories private. The faculty
member plans to use the data collected through these life histories to prepare a
scientific presentation.
Rationale:
The above project does require IRB approval because, based on the information
provided, the information that will be collected from the interviewees is designed to
contribute to generalizable knowledge. Further, the accidental disclosure of individually
identifiable private health information, such as about PTSD, could damage the
participant’s financial standing, employability, or reputation. This study requires IRB
oversight of research procedures including the data security measures put in place by
the investigator to minimize any risk of disclosure.
Researchers should make a preliminary assessment of risk to participants, and submit an Initial
Approval Request to the IRB office for review. Research can begin once an approval is issued by
the IRB office.
V. References
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45 CFR 46.102 http://www.hhs.gov/ohrp/policy/ohrpregulations.pdf
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Adapted from: University of California-San Diego, Human Research Protections Program, Oral
History/Journalism Fact Sheet (2013). Available at: http://irb.ucsd.edu/History_Journalism.pdf.
Accessed 3/5/2014.
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Shopes, Linda. Oral History, Human Subjects, and Institutional Review Boards (date unknown).
Available at: http://www.oralhistory.org/about/do-oral-history/oral-history-and-irb-review/
Accessed 1/13/2014.
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Watson, LC and Watson-Franke, MB (1985). Interpreting Life Histories: An Anthropological
Enquiry. New Jersey: Rutgers University Press.
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Linde, Charlotte (1993). Life Stories: The Creation of Coherence. New York, NY: Oxford
University Press. p. 22.
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Simons, H. (2009). Case study research in practice. London: SAGE.
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Adapted from University of California Los Angeles, Office of Human Research Protection
Program (2013). Guidance: Determining Which Activities Require UCLA OHRPP/IRB Review.
Available at:
http://ora.research.ucla.edu/OHRPP/Documents/Policy/3/Activities_Requiring_Review.pdf
Accessed: 3/17/14.
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Adapted from: Columbia University Institutional Review Board Policy: IRB Review of Oral
History Projects. Available at:
