For More Information
Download the list identifying and defining the research review categories to help determine whether your research qualifies for exempt or expedited status.
Research involving human subjects is subject to the Federal regulations at 45 CFR 46.
These regulations provide for three categories under which human subjects research is to be reviewed: Exempt, Expedited and Full Committee Review.
The Federal 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.
If your human subjects research qualifies for exempt status you must still complete a full application, prepare an informed consent statement, submit a modification request if you plan to make changes to the research, 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 applications that qualify for exempt status are reviewed by the IRB on a rolling basis and may be submitted at any time.
For help determining whether your research qualifies for exempt status, download the list identifying and defining the research review categories.
Research projects that qualify for expedited review may be reviewed and approved without convening a meeting of the full 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.
Investigators are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) also apply to expedited review.
Research applications that qualify for expedited review are reviewed by the IRB on a rolling basis and may be submitted at any time.
For help determining whether your research qualifies for expedited status, download the list identifying and defining the research review categories.
Full Committee Review
Research involving greater than minimal risk requires approval by the fully convened IRB.
Such projects will be reviewed at the monthly IRB meeting. It is advisable to submit your application for full committee review at least six weeks prior to the time you wish to commence your research, so that your research is not delayed due to the IRB review process.
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.