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Application for Expedited IRB Review

Application for Expedited IRB Review 2025

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The document outlines the application process for expedited Institutional Review Board (IRB) review of research activities involving human subjects that pose no more than minimal risk. It specifies categories of research eligible for expedited review, including noninvasive data collection, blood sample collection, moderate exercise studies, analysis of existing data, behavioral research, and collection of biological materials. Researchers must attach this application to their proposal and submit it to the IRB Chair.

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Which of the following applies to an expedited IRB review?

The following types of research are commonly processed under expedited review: Studies involving collection of hair or saliva samples. Studies of blood samples from healthy volunteers. Studies involving noninvasive and minimal risk FDA-approved medical devices (e.g., MRI, electrocardiography, ultrasound, etc.)

Which type of research can expedite IRB approval?

Federal regulations (45 CFR 46.110) authorize the use of an expedited review process for: Minimal risk human subjects research that meets one or more of the OHRP Expedited Review Categories. Minor changes to research previously approved by the full board.

What do expedited reviews refer to?

The expedited review category is used for certain types of research involving no more than minimal risk and minor changes to research previously approved by the full committee, during the period for which approval has been authorized.

What qualifies for expedited review?

In order to qualify for review via expedited procedures, the research must not be greater than minimal risk and fall into at least one of the expedited categories defined by the federal regulations.

Which study might qualify for an expedited IRB review?

Category 7 indicates that protocols may be categorized as Expedited if the research is on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research

What is the expedited review process?

Unlike Full Committee Review, expedited review is done by a single experienced reviewer. The reviewer will evaluate the research for the criteria for approval. Reviewers conducting an expedited review may exercise all of the authority of the IRB except that they may not disapprove a study.

Application for Expedited IRB Review 2025

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