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Download the list identifying and defining the research review categories.
Researchers conducting human subject research are subject to the regulations at 45 CFR 46.
These regulations provide for three categories under which human subject research is to be reviewed: Exempt, Expedited and Full Committee Review.
The regulations identify specific categories of research activities that are exempt from the regulations on the protection of human subjects in research.
While a project may be exempt from the regulations, the ethical principles of conducting research with humans still apply (minimizing risk, maximizing benefit, and ensuring privacy) and all of the rights and protection afforded to human subjects in research are required in Exempt status cases.
At Brandeis, researchers engaged in human subject research that qualifies for Exempt status must still complete a full application form, prepare an informed consent statement, and at the conclusion of the project, complete a Final Report and Termination Form.
Investigators may not make the determination that their own research is exempt: Only the IRB can make the determination that research is exempt from IRB review.
Research projects that qualify for Expedited review may be reviewed and approved without convening a meeting of the entire IRB.
The term "expedited" can be misleading: reviews of this type are not "quicker" or conducted with less rigor, rather fewer reviewers are required.
Expedited review can be considered when research activities present no more than minimal risk to human subjects and involve only procedures listed in one or more of the nine categories identified in the regulations or for minor changes to previously approved research.
Researchers are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) also apply to expedited review.
Full Committee Review
Projects involving greater than minimal risk require approval by the fully convened IRB.
Such projects will be reviewed at the monthly IRB meeting.
Some examples of Full Committee Review research includes research with children and other vulnerable populations; invasive procedures; any research involving deception; surveys involving sensitive questions, information about sexual practice or illegal behavior, or questions likely to be stressful to the subject.