Many checklists and worksheets for reviewers are available in the IRB Library to provide reminders, guide decisions, and help document decision criteria.
Important! Checklist information is required by regulations to document the findings that justify your determinations. Fill out the pertinent checklists and attach them when you submit the review form. For committee reviews, attach your individual checklists as described in Preparing Comments for a Meeting.
Worksheets also provide important guidance, but regulations do not require them to be retained.
The following table summarizes some of the key pertinent checklists and worksheets, organized by the types of review decisions you must make. Consult with your IRB policies and procedures for a complete list of Checklists, Worksheets and requirements.
Topic |
Checklists (use and attach) |
Worksheets (for reviewer's use) |
Approval criteria | ||
Level of review | ||
Consent / recruitment | ||
Special populations | ||
Devices / drugs | ||
Federal agencies / laws |