Federal 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 federal regulations on the protection of human subjects in research (note that such research activities remain subject to Brandeis University policies and procedures).
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 termination and final report.
Investigators may not make the determination that their own research is exempt: Only the IRB can make the determination that research is exempt from from the federal regulations.
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. For further assistance, see Exempt Categories Considerations and Examples.
Note that research which falls into any of the following categories does not qualify for exempt status:
1) Research that exposes subjects to discomfort or distress beyond that normally encountered in daily life
2) Research in which a breach of confidentiality could reasonably place subjects at risk of criminal or civil liability, or be damaging to their financial standing, employability, or reputation
3) Research that involves deception or incomplete disclosure of information to subjects
4) Research that involves prisoners or their data
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 fast-tracked or conducted with less rigor, rather fewer reviewers are required.
Expedited review may 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 prisoners, 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.