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Continuing Review - uu 2025

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The document outlines the application process for continuing review of research involving human subjects at the University. It details the requirements for obtaining approval from the Institutional Review Board (IRB), including necessary information about the project, participant demographics, and any adverse events. The document emphasizes the responsibilities of both the principal investigator and faculty advisor in ensuring ethical conduct and compliance with regulations.

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What are the three types of IRB review?

There are three major types of review: Exempt, Expedited, and Full.

What does continuing review mean?

Continuing review provides the IRB with an opportunity to determine whether there is any new information that should be considered to represent such a significant new finding and therefore be communicated to subjects who have already enrolled in the research (e.g., important new toxicity information or new adverse

How often should an IRB continuing review be conducted?

Expedited Review: For new studies determined to qualify for expedited review under revised Common Rule, the regulations now stipulate that Continuing Review is not required unless justified by the IRB. Therefore, most expedited studies will not require continuing review.

What is the Common Rule of 45 CFR 46?

This set of regulations aims to protect human subjects in federally funded research through three basic requirements. These include informed consent of research subjects; review of the proposed research by an Institutional Review Board (IRB); and assurances of compliance with regulations by the institutions involved.

What is the Common Rule in simple terms?

An IRB must conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year (45 CFR 46.109(e)).

What is the common rule no continuing review?

A. Under the Revised Common Rule, the regulations no longer require annual continuing review for minimal risk (expedited) research studies. The IRB may; 1) still require a continuing review, 2) require submission of a progress report at periodic intervals, or 3) not require additional reporting on the studys progress.

How to submit a continuing review in the IRB?

Submitting in iRIS Open the study via the IRB Study Assistant. Go to My Studies under the IRB Study Assistant. Start and complete the new form. Click on the Continuing Review Submission Form link. Attach consent forms. PI must submit.

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