Review of Research Policies & Forms

RR 401 Expedited Review

• RR 401-A Determination of Qualifications for Expedited Review
• RR 401-B Guidance - Expedited Review
• RR 401-C Expedited Review Determination

RR 402 Initial Review - Criteria for IRB Approval

• RR 402-A Protocol Review Worksheet - Primary Reviewer(s)
• RR 402-B Risk Assessment Checklist for Research Studies
• RR 402-C Significant and Non-Significant Risk Checklist (Medical Devices)

RR 403 Continuing Review - Ongoing (Site Visits and Third Party Verification; Serious and/or Unexpected Adverse Events: Amendments)

• RR 403-A IRB Reporting of Unanticipated Internal Problems and/or Adverse Events
• FO 301-C Application for Revision and/or Amendment
• RR 403-C Site Visit Confirmation
• RR 403-D Site Visit Worksheet
• RR 403-E Site Visit Report

RR 404 Continuing Review - Criteria for Renewal

• FO 301-B Application for Renewed Approval

Policies & Forms: General Administration IRB Organization Functions and Operations Review of Research Review Requiring Special Consideration IRB Communication and Notification Informed Consent Responsibilities of Investigators Quality Assurance

Appendix: A Belmont Report with Acknowledgement Form B Statement Authorizing the IRB (FWA) C Studies Requiring IRB Review D List of Committees E Expedited Review Procedures F Significant Risk and Nonsignificant Risk Medical Device Studies

RR 405 Humanitarian Use Device (HUD/HDE)

• RR 405-A HDE Product Use Report
• RR 405-B HDE Follow-Up Report

RR 406 Study Completion

• RR 406-A Application for Closure

RR 407 Categories of Action

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