Glossary of Terms

George Mason University is considered engaged in research when its employees or agents, for the purposes of non-exempt research project obtain (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; (3) the informed consent of human subjects for the research; or (4) when the institution receives a direct federal award to conduct human subject research, even when all activities involving human subjects are carried out by a subcontractor.

An individual who receives all IRB information, attends meetings, and participates in discussions due to their position with the university. These individuals are non-voting and do not count toward quorum.

GMU has identified several categories of research available for exempt review. This determination must not be made by the PI, but by the IRB or someone appointed by the IRB.

45 CFR 46.110 and 21 CFR 56.110 identifies several categories of minimal risk research that may be reviewed through an expedited review process. For more information, please see OHRP’s “Categories of Research that may be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure.”

An IRB member is considered experienced if the IRB chair considers the IRB member to have sufficient experience in and knowledge of conducting IRB reviews.

The first date that the protocol is no longer approved. Under federal regulations, IRB approval of non-exempt projects is valid for a maximum period of one year. The approval period will be listed on approval letters posted to investigators in IRBNet, including both the approval date and the expiration date. Researchers wishing to continue study activities, including data collection and analysis, beyond the expiration of IRB approval must submit and receive approval for renewal prior to the expiration.