Expedited Review
If investigators believe that their new project qualifies for expedited reivew, they should submit the IRB Protocol Summary Form along with any required documentation (informed consent form, questionnaires, advertisements, etc.) to the Office of Research Compliance.
Please note on the protocol form which expedited review category you believe your research falls under (see below for explanation of all 9 expedited review categories). The ORC and the IRB Chair will determine if your project qualifies for exemption. If you have questions, please contact the ORC.
Applicability
Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories may be reviewed by the IRB through the expedited process 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 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 categories in this list apply regardless of the age of 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.
IRBs are reminded that the standard requirements for informed
consent (or its waiver, alteration, or exception) apply regardless
of the type of review—expedited or convened full review—used
by the IRB.
Expedited Review Categories
Research activities that involve
human subjects in one or more of the following 9 research
categories qualify for expedited review. This list applies
regardless of
the age of subjects, except as noted:
An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110.
Deadline: There is no deadline. Expeditable protocols will be reviewed as they are received.
Submission: One original and one copy of the IRB Protocol Summary Form and research tools; One copy of the grant application, if applicable.
Investigator Notification: Please allow four weeks for review. Notification will be promptly mailed to the investigator at their respective department. For student PIs, approval is sent to the student's advisor on campus. Expedited approval must be received before initiating the research study.
