Research that does not require IRB review

Questions?

  • Institutional Review Board
    202-885-3447
    irb@american.edu
    4200 Wisconsin Ave, NW, Room 201

    Zembrzuski, Matt
    IRB Coordinator

Mailing Address

Classroom research

Most research conducted for classroom assignments does not meet the definition of human subjects research. It is the instructor's responsibility to ensure the ethical conduct of research. Classroom research involving collection or utilization of data on human subjects will not require review from the IRB if it meets the following conditions.

  1. The research results are not conducted with the purpose of creating generalizable knowledge, e.g., are not published or presented at a conference
  2. The course instructor has completed human subjects research ethics training
  3. The research does not involve vulnerable populations (children, prisoners, pregnant women, or handicapped or mentally disabled persons),
  4. The research poses minimal risk to the participants, meaning that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

SIS Significant Research Projects (SRP)

Projects undertaken for the purpose of completing an SRP do not automatically have to be submitted to the IRB. There are 3 questions to ask yourself about your project first. Please review this guide, SRP and the IRB, before submitting an IRB application.

Data sets

The IRB recognizes that the analysis of de-identified, publicly available data does not constitute human subjects research as defined in federal regulations, and that it does not require IRB review. Some examples of data available from large data consolidation bureaus and consortiums are:

  • Inter-University Consortium for Political and Social Research (ICPSR)
  • U.S. Bureau of the Census
  • National Center for Health Statistics
  • National Center for Education Statistics
  • National Election Studies
Research that is limited to the analysis of data held by these organizations are not considered human subjects research and do not require IRB review.

For other secondary data set usage, please see the IRB data set policy

Please note, IRB approval cannot be granted retroactively, so research conducted for a classroom assignment without IRB approval can never be used as the basis for a publication. If there is a possibility that it might be used for a future publication, it is advisable to seek IRB approval.

Oral History

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.” Many oral history projects do not need to be submitted for IRB review, because they do not seek to contribute to generalizable knowledge and therefore are not “research” per the federal regulations governing the IRB process. Instead, such projects aim to provide a deep understanding of specific historical events and actions. 

On the other hand, some oral history projects do seek to contribute to generalizable knowledge and therefore would be considered research and should be submitted to the IRB. Columbia University’s policy statement on oral history and IRB gives this 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).  

Also, IRB review is required for any oral history studies, whether or not they seek to develop generalizable knowledge, posing greater than minimal risk to participants. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. If the research is more than minimal risk, it should be submitted to the IRB no matter what. Finally, researchers conducting oral history projects for which IRB review is not required may, at their discretion, voluntarily request IRB review if required by granting agencies or for any other reason.

In summary, please submit your oral history project for IRB review if it:

  1. Seeks to contribute to generalizable knowledge; OR
  2. Poses more than minimal risk to participants; OR
  3. Is one that you wish to have reviewed by IRB for grant review or other purposes.  
Otherwise, if none of the above conditions holds, then do not submit it for IRB review.

Questions?

Please contact Matt Zembrzuski, the IRB coordinator (x3447) with questions about research which does not require IRB review.