IRB Policies and Procedures
Policies & Procedures
- An Overview
- Application Process and Deadlines
- Board Authority and Composition
- Board Determinations
- Closure or Withdrawal
- Continuing Review
- Deception or Incomplete Disclosure
- Dietary Supplements
- Exempt Review
- Expedited Review
- Full Review
- General Data Protection Regulation
- Incentives in Research
- Informed Consent and Assent
- International Research
- Mandatory Reporting
- Mandatory Training
- Non-English Speaking Participants
- Oral History and Journalism
- 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
Oral History and Journalism
The purpose is to outline the policy and procedures for oral history, journalism and other similar activities that may or not qualify as research according to the Federal definition.
Journalism is the activity and product of gathering, assessing, creating, and reporting news and information. Its results are usually published in newspapers, magazines or various broadcast media.
Oral History is a method of gathering and preserving historical information through recorded interviews with participants in past events and ways of life, and which is biographical in nature. It includes 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.
Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. It is designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to knowledge which may be expressed in theories, principles, and statements of relationships that enhance scientific or academic understanding.
Investigators sometimes formulate projects in order to provide an understanding of specific historical events and actions. 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, usually do not meet the Federal definition of research and therefore do not require formal Institutional Review Board (IRB) or Exempt Review Committee (ERC) review.
In contrast, investigators may design projects with the intent 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 or ERC review.
According to the Smithsonian Institution's “Human Subjects Research FAQs" (as cited in Schrag, 2010), “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."
Determinations about whether or not a project meets the Federal definition of research are to be made by the IRB/ERC office. The investigator may be asked to submit a Request for Determination about Human Research form through IRBNet. If clarification is needed before a decision may be made, the investigator will be contacted. Otherwise, a letter will be published in IRBNet with the determination of either:
- Not Research: Formal IRB or ERC review is not required and the project may proceed
- Research: Formal IRB or ERC review and approval is required before the project may proceed
- The investigator contacts email@example.com to describe the project, including an explanation of its intent and goals.
- If requested, the investigator completes and submits a Determination about Human Research form through IRBNet at www.irbnet.org, choosing Exempt Review Committee (ERC) as the recipient.
- Unless there are further questions, IRB/ERC staff publish a determination letter in IRBNet. Based on the determination, the investigator either proceeds with the project without need for formal review or submits a formal application package for review and approval.
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.
Smithsonian Institution. (n.d.). Human Subjects Research FAQs [PDF file]. Retrieved July 16, 2019 from https://www.si.edu/osp/policies/Compliance/Human%20Subjects%20in%20Research/HUMAN%20SUBJECTS%20RESEARCH%20FAQs.doc
04/29/2013 - Created
07/16/2019 - Updated as a result of the Revised Common Rule