Institutional Review Board

About IRB

What is an IRB?

An 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. 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.

What is Meant by “Under the Aegis of APUS?”

• The research is sponsored by APUS
• The research is conducted or directed by any employee or trainee of the university in connection with his or her APUS responsibilities
• The research involves access to any property or facility of APUS

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

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.

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:

• Are actively involved in the research process (being interviewed, filling out surveys, etc.)
• Provided medical samples, left records of their activities through applying for marriage licenses, etc.

The IRB review 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?

• Research contributes to generalizable knowledge
• Research is designed in advance
• Research utilizes a systematic approach

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

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

• Are the purposes clearly set forth? How realistic are they?
• What factors demonstrate a significant need for the project?
• What is the research design? How clear and realistic is it?
• Are the terms, conditions, and objectives of funding clearly made known to judge the potential effect of such funding on the scholarly integrity of the project? Is the allocation of funds adequate to allow the project goals to be accomplished?
• How do institutional relationships affect the purpose and objectives?

A Full-Committee Review

Studies are reviewed by a fully-convened IRB committee. The committee discusses the study and makes an approval decision. This type of review is carried out for studies greater than minimal risk to subjects.

Expedited Review

Studies 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.

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

• Collection of data through noninvasive procedures
• Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes
• Collection of data from voice, video, digital, or image recordings made for research purposes
• Research on individual or group characteristics or behavior
• Continuing review of research previously approved by the convened IRB
• Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no

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

• blood sampling in minimal amounts
• review of records collected for non-research purposes (such as chart reviews)
• survey research

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.”