The exempt research checklist provides detailed information on what qualifies as exempt research. The checklist is available on the Forms & Submissions page. Research activities are exempt from regulations for the protection of human research subjects when they are considered minimal risk (the probability or magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performancy of routine physical or psychological examinations or tests [as defined by 45 CFR 46.102(i)]) and the ONLY involvement of human subjects falls within one or more of the categories listed on the checklist.
The IRB will not consider any research exempt that involves prisoners, that involves a test article regulated by the FDA, unless the research meets the criteria for exemption described in 45 CFR 46.101(b)(6) and 21 CFR 56.104(d). Additionally, the research must fulfill the institution’s ethical standards to be considered exempt.
The expedited research checklist provides detailed information on what qualifies as exempt research. The checklist is available on the Forms & Submissions page. Research activities that: 1) present no more than minimal privacy, psychological and/or physical risk to human subjects, and 2) involve only procedures listed in one or more of the expedited categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on the expedited checklist. Inclusion on the list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
The categories in the expedited checklist apply regardless of the age of the subjects, except as noted. The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. The expedited review procedure may not be used for classified research involving human subjects. The standard requirements for informed consent and authorization (or their waiver, alteration, or exception) apply regardless of the type of review.
Full Board Studies:
If the study does not qualify as a non-research study project, a research project no subject to FDA or Common Rule definition of human subjects research, or exempt or expedited review, full review by the IRB is required.
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