Exempt Review
The federal government has identified certain categories of research involving human subjects that qualify for exemption from federal regulations. Virginia Commonwealth University (VCU) is authorized by the federal government to determine whether studies thought by the principal investigator (PI) to be exempt from federal regulations -- actually qualify for exemption. Such determination is made on behalf of VCU by the IRB. Only the IRB has authority to make a determination that a study is exempt from federal regulations and from IRB review and approval. When the IRB notifies a PI that a research project is EXEMPT, it also notifies the PI that the research is approved for initiation or continuation.

In order to qualify for exemption, a research study must fall entirely within one or more of the six categories for exemption and it cannot place subjects at greater than minimal risk. If the research involves prisoners, then it does not qualify for exemption from federal regulations and IRB review.

What Exemption Means: "Exemption" as used in this document means exemption from the requirements set forth in Regulations for the Protection of Human Subjects (Title 45 Part 46 of the Code of Federal Regulations), such as the requirement for a written informed consent document. At VCU, determinations of exemption are made by the IRB.

What Exemption Does Not Mean: "Exemption" does not mean that the research activity is exempt from the laws of the Commonwealth of Virginia, and it does not mean that the research need not conform to the canons of sound research ethics.

For additional information regarding Exempt Review categories, see OHRP Decision Charts #2-7 for Exempt Categories.

Expedited Review
Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. A list of categories of research has been established in the Federal Register that may be reviewed by the IRB through an expedited review procedure. An IRB may use the expedited review procedure to review either or both of the following:

Some or all of the research appearing on the list of categories of research (established in the Federal Register) and found by the reviewer(s) to involve no more than minimal risk,

Minor changes in previously approved research during the period (of one year or less) for which approval is authorized.

Criteria: The following criteria must be met in order for research to be considered for expedited review:

The research activities must present no more than minimal risk to human subjects. 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.

All of the research activities involve only procedures listed in one or more of the research categories established in the Federal Register. The categories in this list apply regardless of the age of subjects, except as noted. Categories one (1) through (7) pertain to both initial and continuing IRB review.

For additional information regarding expedited review categories, see OHRP Guidance and OHRP Decision Chart #8.

Full Review
If the study does not meet the criteria for exempt or expedited review, then it must be submitted for full review.