To qualify for expedited review procedures under 45 CFR 46.110 and 21 CFR 56.110, all research activities must:
- present no more than minimal privacy, psychological and/or physical risk to human subjects and
only involve procedures listed in one or more of the seven categories listed below.
The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this 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 following guidelines also apply to expedited research:
- The categories in this list 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, or 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 categories outlined below do not apply to 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.
- Studies involving randomized use of drugs, biologics, or devices do not meet the definition of minimal risk and thus do not qualify for expedited review.