IRB Member Review Guide: Primary Reviewer

This page provides information to ED/SBS IRB members about the role of a Primary Reviewer

When listed as the Primary Reviewer on a protocol, use this guide when presenting your review to the committee.

Summary
Provide 2-3 sentence summary of the study to remind the committee of the study. There is no need to provide an in-depth description or study specifics as all members should have a basic understanding of the study from their own review.

Recommendation
Before identifying specific issues, identify your recommendation as logged in the application workspace (using the Reviewer Checklist activity):
  • Approve as submitted: No issues identified, ready for approval;
  • Conditionally approve, pending minor modifications: Determined to be minimal risk, but there are issues to address; identified issues can be sent as directives; responses can either be reviewed by Staff Reviewer or sent to another IRB member for approval;
  • Defer: Requires questions be answered by the study team to better understand the study, the purpose, level of risk, etc.; responses will be sent back to the reviewing committee for additional review;
  • Refer to Expedited: Move that the protocol clearly could have been reviewed at the expedited level; While there are issues that need to be addressed, the study is clearly minimal risk and meets the criteria for expedited review (45 CFR 46.110)
  • Disapprove: Cannot be reviewed and approved, as presently outlined.
Continuing Review
Indicate if continuing review is needed per campus policy. If the study does not require continue review per campus policy but you feel continuing review may be beneficial (i.e. participant's will reveal very personal or sensitive information such as illegal or stigmatizing behavior), note that and bring it up for discussion.  

Issues Noted
Note any issues that need to be modified, clarified, or added, as well as any issues that necessitate discussion.

Motion
Make a motion, reflecting the recommendation and any discussion, following Secondary Reviewer comments.




Keywords:IRB member, review, primary reviewer, full   Doc ID:43134
Owner:Casey P.Group:Education and Social/Behavioral Science IRB
Created:2014-08-22 14:22 CSTUpdated:2018-10-16 13:56 CST
Sites:Education and Social/Behavioral Science IRB, VCRGE and Graduate School
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