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Institutional Review Board

 

About Institutional Review Board (IRB)

Watch a webinar about IRBAn Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects. The purpose of the IRB is to ensure that all human subject research be conducted in accordance with all federal, institutional, and ethical guidelines.

Our goal is to provide all APUS community members with information, guidance, forms, and related materials needed to secure IRB approval for human subject research. The American Public University System consists of both the American Public University (APU) and the American Military University (AMU).  The Institutional Review Board was established to review, approve, require modifications to, or deny human subject research conducted under the Aegis of APUS.

If the research involves APUS faculty, staff, and/or students, this research may also need approval of the Internal Research Review Board (IRRB).

Read more about the IRB & IRRB Committee Members.

IRB Resources

 

What is Meant by “Under the Aegis of APUS?

All human subject research, regardless of funding source, must be reviewed and approved by the IRB before initiation.

How is a Human Subject Defined?

A human subject is defined by Federal Regulations as “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information” (45 CFR 46.102(f)).

Human participants include those who:

The IRB reviews research that:

  1. involves living individuals about whom "an investigator conducting research obtains data through intervention or interaction with the individual"
  2. contains "identifiable private information" (Title 45 CFR, Part 46.102.f)
  3. includes secondary analysis of existing datasets where participants are individually identifiable

How is Research Defined?

Although biographers, historians, and other scholars may do a great deal of research in the course of their work, the knowledge they are developing is particular to the individual or individuals they are studying. Thus biography, most journalism, artistic endeavors, and other similar activities are outside the purview of the IRB and do not require review. Many projects fall in gray areas. 

Oral History Project

Oral histories are NOT automatically excluded from oversight by IRBs. Also, please consider the following information when preparing your oral history project:

Remember: If you are not sure about your own project, please contact the IRB.

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Full Board

The IRB consists of eight members. All eight members review applications requiring a full board review.  A five member quorum is required for all full board IRB votes.

Expedited and Exempt Applications

A subcommittee of five members of the full board reviews applications that are expedited. The Director of Graduate Studies and the Assistant Provost for Graduate Studies review exempt requests.

Expedited Review

Data CollectionStudies are reviewed by a qualified member of the IRB committee. This member reviews the appropriate materials and consults with the Principal Investigator (PI) if necessary to come to a decision about the approval of the study. This type of review is carried out for studies that involve minimal risk to subjects and fit into an expedited review category of research.

Minimal Risk: "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" (from 45 CFR 46.102(i)).

When making a decision about minimal risk of research, consider both magnitude and likelihood of risk.

Minimal Risk to Subjects

Only research involving no more than minimal risk to subjects may be considered for expedited review. This includes:

Federal guidelines also provide categories for expedited review. Examples of categories include:

Exempt from Continuing IRB Review

Research with very minimal risk to human subjects as determined by regulatory guidelines may be exempted from continuing review at the discretion of the IRB. An exemption is granted by the IRB upon review of the application.Since this constitutes a review, protocols that are deemed exempt at APUS are effectively “exempt from continuing review.” 

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