IRB Policies and Procedures
Policies & Procedures
- An Overview
- Application Process and Deadlines
- Approval of Research
- Closure or Withdrawal
- Continuing Review
- Deception or Incomplete Disclosure
- Departmental Review Boards
- Dietary Supplements
- European Union’s General Data Protection
- Exempt Review
- Expedited Review
- Full Review
- Incentives in Research
- Informed Consent, Parental Permission and Child Assent
- International Research
- IRB Administration
- IRB Review Process
- Mandatory Reporting
- Mandatory Training
- Non-English Speaking Participants
- Oral History
- Prisoner Research
- Records Retention
- Recruitment of Participants
- Reproductive Risk in Clinical Research
- Research Advisors
- Responsibilities of Investigators and Sponsors
- Revisions to Approved Research
- Separation of Principal Investigators
- Student Research
- Suspension or Termination
- Whistleblower Policy
Research is defined by the federal government as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (Public Welfare Protection of Human Subjects, 2010).
Oral history is defined as “a field of study and a method of gathering, preserving and interpreting the voices and memories of people, communities, and participants in past events” (Oral History Association, n.d.).
Many oral history projects are formulated by researchers to provide an enhanced understanding of specific historical events and actions. Such projects may not require formal review by an Institutional Review Board (IRB) because they do not seek to develop or contribute to generalizable knowledge, and therefore do not meet the federal definition of “research.”
In contrast, some oral history projects might be designed to draw conclusions, create general explanations about what has occurred in the past, or inform policy. They might test economic, sociological, or anthropological models or theories. Such projects would meet the federal definition of “research” and therefore would require formal IRB review.
In its posted document entitled, “Human Subjects Research FAQs,” the Smithsonian Institution explained, “The hallmark of an oral history is that it stands alone as a unique perspective rather than an item of data that can be qualitatively analyzed to reach a general conclusion or explanation” (Schrag, 2010).
A project including oral history interviews with survivors of the Rwandan genocide for viewing at the Kigali Memorial Center, with a purpose to document specific personal events and share stories
A project employing oral history interviews in order to develop an understanding of the impact of Post-Traumatic Stress Disorder (PTSD) on Gulf War veterans, with intent to examine what kinds of war exposures may have led to the development of PTSD
Determinations about whether or not a project is considered “research” may only be made by an administrator in tResearch and Sponsored Programs. A researcher must submit a Request for Determination about Human Research form through IRBNet to either the Exempt Review Committee (ERC) or Institutional Review Board (IRB). Administrators of both boards will review submissions on an alternating basis. If clarification is needed before a decision can be made, an administrator will contact the Principle Investigator (PI). Otherwise, an administrator will publish a determination letter in IRBNet stating:
- that the study is “not research” according to the federal definition, meaning that further, formal review is not required and that the project may begin immediately; or
- that formal IRB or ERC review and approval is required before the project may commence.
Oral History Association. (n.d.). Oral History: Defined. Retrieved April 25, 2013, from Oral History Association: http://www.oralhistory.org/about/do-oral-history/
Public Welfare Protection of Human Subjects, 45 C.F.R. § 46.102 (2010).
Schrag, Zachary M. (2010, July 30). Smithsonian Frees Oral History, Journalism, and Folklore [Web Log Post]. Retrieved April 29, 2013, from http://www.institutionalreviewblog.com/2010/07/smithsonian-frees-oral-history.html.