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handsReviewer Checklists (information for reviewers)

Reviewer checklists support reviewer’s judgments and documentation of those judgments. These checklists are completed by reviewers and are used in conjunction with a specific form that would have already been completed and submitted by the researcher to the reviewer.

Exempt Determination Review:  All reviewers, including RRC Decentral Reviewers, use the Exempt Study Reviewer Checklist to support their review of a researcher’s completed submission of the General Request for Exempt Determination form. 

Waiver Review: There is a reviewer guide/checklist form for the purpose of documenting a judgment on a researcher's request to waive/alter informed consent or its documentation. Only an IRB member or an IRB Direct-Certified Decentral Reviewers is authorized to use the following form. In the context of an exempt determination, reviewers submit the completed checklist to the IRB Administrator. In the context of an expedited review, an IRB member submits it to the IRB chair.

Expedited Review: Only IRB members are authorized to complete an expedited review. IRB Members submit the following form to the IRB Chair in support of an expedited review.

EXPEDITED REVIEW: Review of proposed research by the IRB chair or a designated voting member or group of voting members rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research. [Federal Policy 45 CFR 46.110]

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