IRB reviewer forms and tools
Revised Common Rule (RCR) IRB Reviewer documents
- Transition to Revised Common Rule Appendix
- RCR-Continuation Reviewer Form (updated 3/2021)
- RCR-Additional Informed Consent Checklist
eProtocol Reviewer Documents
Initial Submission Checklists
- Initial Full Board Reviewer Checklist (updated May 2023)
- Initial Expedited Reviewer Checklist (updated May 2023)
- Humanitarian Use Device Reviewer Checklist (12/2021)
- Exempt Reviewer Checklist (updated November 2023)
- Administrative Application Reviewer Checklist (12/2021)
Initial Submission Guidance Tools
- Initial Submission Primary/Secondary Reviewer Guidance Tool (Full Board)
- Initial Submission Non-Primary Reviewer (NPR) Guidance Tool(Full Board)
- Initial Submission Expedited and Exempt Reviewer Guidance Tool
Amendment Submission Checklists
- Full Board Amendment Reviewer Checklist (3/2021 updated)
- Expedited Amendment Checklist (updated November 2023 eProtocol & paper based)
Continuation Submission Checklists
- Continuation Reviewer Checklist (updated 7/2021)
User Manuals/Tools
Additional Tools
- Full Board Amendment Reviewer Form - 7/2013 (.docx) (paper based submissions)
- Follow-up, Tabled, or SMR Reviewer Form - 10/2013 (.doc)
- Waiver of written documentation of consent reviewer checklist
- Alteration of informed consent reviewer checklist
- Coordinating Center Reviewer Checklist (10/2021)
HIPAA
Appendices & eProtocol Addendum Reviewer Checklists
- IRB Reviewer Form - Children as Research Participants - 9/2012 (.docx)
- IRB Reviewer Form - Pregnancy, Fetuses, Neonates - 5/2011 (.doc)
- IRB Reviewer Form - Studies Conducted At or By The VA (updated 8.2022)
- IRB Reviewer Form - Department of Defense - 5/2011 (.doc)
- IRB Reviewer Form - Prisoners as Research Participants - 10/2013 (.doc)
- IRB Reviewer Form-NIH Genomic Data Sharing -(12/2019)
- IRB Reviewer Form-Resumption In-Person Research (no longer required as of December 1, 2022)
Informed consent
Unanticipated Problem Reports
- Unanticipated Problem Report Reviewer Checklist (updated 11.2021)