When to Submit Oral History Projects to the Mary Baldwin IRB

Oral history is defined by the Oral History Association (OHA) as “a method of gathering and preserving historical information through recorded interviews with participants in past events and ways of life.” Some oral history projects do not need to automatically be submitted for IRB review.

Please refer all oral history projects to program director for exemption determination.

Please submit your oral history project for IRB review if it:

• Seeks to contribute to generalizable knowledge (Information where the intended use of the research findings can be applied to populations or situations beyond that studied, HSR, n.d.)., OR
• Involves vulnerable populations (children, prisoners, pregnant women, individuals with physical disabilities, or individuals with mental disabilities or cognitive impairments), OR
• Poses more than minimal risk to participants, OR is one that you wish to have reviewed by IRB for grant review or any other reason. 

---

Before submitting an Oral History to the IRB, ask 3 questions:

1. The first question is whether the project constitutes human subjects research as defined in federal regulations.

• Human subjects – A human subject is a living individual about whom an investigator (whether professional or student) conducting research obtains
  • Data through intervention or interaction with the individual, or
  • Identifiable private information, which is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
• Research – Code of Federal Regulation, Title 45, (2/16/2024). Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge
  • Generalizable knowledge may be defined by as “Information where the intended use of the research findings can be applied to populations or situations beyond that studied” (HSR, n.d.).
  • The following activities are deemed not to be research and should not be submitted to the IRB. Instead, the responsibility for monitoring lies with the faculty supervisor (who should complete human subjects ethics research training):  

(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.

(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).

(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.

(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

• Some oral history projects do seek to contribute to generalizable knowledge and therefore would be considered research and should be submitted to the IRB.
  • Example: A study of the long-term social impact of the Vietnam War on American culture that includes oral history interviews with veterans (not generalizable knowledge) vs. Research using oral histories to gain an understanding of the impact of PTSD on Vietnam veterans as part of a project to allow the researcher to predict what kinds of exposure in war situations lead to the development of PTSD (generalizable knowledge). 

2. The second question: Does your research involve vulnerable populations (children, prisoners, pregnant women, individuals with physical disabilities, or individuals with mental disabilities or cognitive impairments)?

• If so, it should be submitted to the IRB, regardless of whether it meets the federal definition of human subject’s research.

3. And thirdly, consider whether your research poses minimal risk to participants. 

• Definition of Minimal Risk [45 CFR 46.102(j) and 21 CFR 56.110]. Minimal risk means the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life. Risks can include but are not limited to:

1. Physical risks such as bodily contact or administration of a substance, etc.
2. Psychological / Emotional risks such as feeling uncomfortable or upset
3. Social risks such as economic impacts, loss of status, employability, or reputation
4. Legal risks such as arrest, subpoena, or recording without consent In order for IRB to review and classify a study as ‘minimal risk’ and use the expedited procedure, all of the study procedures must fall into one or more of the federally defined expedited review categories.

• If your MBU project is minimal risk and does not involve a vulnerable population and does not meet the federal definition of human subjects research, then it does not have to be submitted to the IRB and can instead be supervised solely by your faculty advisor.
• If the research is more than minimal risk, it should be submitted to the IRB no matter what.

---

Summary

Please submit your oral history project for IRB review if it:

• Seeks to contribute to generalizable knowledge, OR
• Involves vulnerable populations (children, prisoners, pregnant women, individuals with physical disabilities, or individuals with mental disabilities or cognitive impairments), OR
• Poses more than minimal risk to participants, OR
• Is one that you wish to have reviewed by IRB for grant review or any other reason. 

---

References

• CITI Training. Populations in Research Requiring Additional Considerations and/or Protections
• https://www.citiprogram.org/members/index.cfm?pageID=665&ce=1#view
• Code of Federal Regulations, Title 45, (2/16/2024)
• https://www.hhs.gov/ohrp/sites/default/files/OHRP-HHS-Learning-Module-Lesson2.pdf
• Definition of Oral History and guidelines. https://oralhistory.org/about/principles-and-practices-revised-2009/oral-history-evaluation-guidelines-revised-in-2000/
• Definition of Generalizable Knowledge. https://hso.research.uiowa.edu/defining-research#:~:text=%22Generalizable%20knowledge%22%20is%20information%20where,or%20situations%20beyond%20that%20studied
• Middle Tennessee State University position on human subject systematic research and generalizability. https://w1.mtsu.edu/irb/FAQ/IsIRBRequired.php
• White (2017) ORAL HISTORY RESEARCH EXCLUDED FROM IRB OVERSIGHT
• https://www.historians.org/research-and-publications/perspectives-on-history/january-2017/oral-history-research-excluded-from-irb-oversight
• Ritchie (2015) Good news for scholars doing oral history! The federal government is preparing to grant them a right to be excluded from IRBs. https://blog.oup.com/2015/10/oral-history-federal-regulation/; https://historynewsnetwork.org/article/160885
• American University IRB submission guidelines. https://www.american.edu/irb/irb-no-review.cfm
• Institutional Review Boards and Oral History 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.