Which statement best describes an expedited IRB review?

Study for the BCPS Regulatory Test. Prepare with flashcards and multiple choice questions, each question includes hints and explanations to get you ready for the exam!

Multiple Choice

Which statement best describes an expedited IRB review?

Explanation:
Expedited IRB review is a faster review path used for studies that carry no more than minimal risk and fit specific categories allowed by the rules. It is conducted by the IRB chair or a designated reviewer rather than the full board. Importantly, it can cover minor modifications to an already approved protocol, which can be approved without convening the full IRB. Larger changes or anything above minimal risk still require full board review. So the description that expedited review applies to minimal risk and allows minor changes to approved protocols best captures how this process works.

Expedited IRB review is a faster review path used for studies that carry no more than minimal risk and fit specific categories allowed by the rules. It is conducted by the IRB chair or a designated reviewer rather than the full board. Importantly, it can cover minor modifications to an already approved protocol, which can be approved without convening the full IRB. Larger changes or anything above minimal risk still require full board review. So the description that expedited review applies to minimal risk and allows minor changes to approved protocols best captures how this process works.

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