After IRB training is completed, you must choose which category of review your research requires.
There are four main categories of IRB review:
There is one other category of IRB review:
An exempt review doesn't require monitoring by the IRB. Exempt categories are outlined by the Department of Health and Human Services in 45 CFR 46.101(b).
It is important to note that while a project may be exempt from IRB regulations, the ethical principles of conducting human subject research still apply. More importantly, it is not up to the researcher to determine whether a project is exempt. Researchers that believe their project is exempt should submit their research application to the IRB, selecting exempt for their category of review.
Exempt reviews are carried out by the IRB Chair or their designee.
Find the forms and documents for an exempt review.
An expedited review is typically carried out by the IRB Chair or their designee.
It involves research that doesn't involve more than minimal risk to participants. Minimal risk is defined as: the probability and magnitude of harm or discomfort anticipated in the research are not greater than those encountered in daily life or through the performance of routine physical or psychological exams/tests.
While the IRB Chair can review and approve expedited review research, the Chair cannot disapprove research proposals without moving the research project to full review.
A full review is necessary when the IRB Chair deems participant risk is more than minimal or when the Chair disapproves an expedited review and moves the research project to full committee review.
Find the forms and documents for a full review.
A continuing review is necessary when the research project is not complete after one year.
A continuing review reevaluates a project's:
- Informed consent
- Participant safeguards
If it is deemed that there is less than minimal risk for participants, the continuing review will be reviewed by the IRB Chair. If there is more than minimal risk, the project will be reviewed by the full IRB.
Full reviews require the researcher to provide a summary protocol and a status report on:
- The number of subjects accrued or withdrawn
- Adverse events
- Any research complaints received
- New risks that may be present
- New informed consent
- Any new literature regarding the research topic
As part of continuing review, researchers must submit a closure form to the IRB when they have completed their research.
The revised Common Rule requires studies that are minimal risk, qualify for exempt review, and maintain subjects' identifiable information or identifiable biospecimens, to include a "limited IRB review" whereby the security, privacy, and confidentiality of identifiable private information are adequately protected.
Limited IRB is increased oversight by the IRB for low-risk research (e.g. certain exempt categories) to ensure that either:
- The identifiable private information or biospecimens collected have the appropriate
data security and privacy protections in place to reduce the chance of inappropriate
- Broad consent was obtained for the use of stored identifiable data or biospecimens.
Updated May 09, 2019