The 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). To be eligible for exempt, research must be deemed no more than minimal risk.
While a project may be exempt from the regulations, the ethical principles of conducting research with humans — minimizing risk, maximizing benefit and ensuring privacy — still apply, and all of the rights and protection afforded to human subjects in research are required in exempt status cases.
If you believe your human subjects research qualifies for exempt status, submit an Initial Protocol. Once accepted as exempt, you must submit a Modification Request form if you plan to make changes to the research, and complete a Termination and Final Report form at the conclusion of the project.
If your research changes midproject and no longer qualifies as exempt, you must complete a new Initial Research Protocol in conjunction with a Modification Request form. The modification request and initial or secondary data protocol will be reviewed as expedited or by the full committee, as appropriate.
Keep in Mind
- Investigators may not make the determination that their own research is exempt; only HRPP staff and the Institutional Review Board can make the determination that research is exempt from the federal regulations.
- Research protocols that qualify for exempt status are reviewed on a rolling basis and may be submitted at any time.
- For help determining whether your research qualifies for exempt status, see the list Exempt Research Categories or contact the HRPP office for help.
Note that research that falls into any of the following categories does not qualify for exempt status:
Research that exposes subjects to discomfort or distress beyond that normally encountered in daily life.
Research that involves deception or incomplete disclosure of information to subjects unless subjects prospectively agree to the incomplete disclosure.
- Research that involves prisoners (explicitly) or their data (note that research involving prisoners only incidentally may be exempt).
Research projects that qualify for expedited review may be reviewed and approved without convening a meeting of the full Institutional Review Board.
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 protocols 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 Expedited Review Categories.
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 protocol 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; surveys involving sensitive questions, information about sexual practice or illegal behavior; or questions likely to be stressful to the subject.
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