Committee Member Resources  

Checklists 

• Amendment Reviewer Checklist
• CPR Reviewer Checklist
• Conversion CPR Reviewer Checklist
• Emergency Use Checklist
• New Protocol Reviewer Checklist
• Planned Emergency Research Reviewer Checklist
• Reportable Event Reviewer Checklist
• Treatment Use Reviewer Checklist

Committee #5 Checklists

• Exemption Form for IRB Reviewers Checklist
• Expedited Approval Form for IRB Reviewer Checklist

Additional Checklists

These checklists may be required to support the review of a project if it involves a vulnerable population, ICH Guidelines, advertisements or involves a federal agency with additional requirements such as DoD, DoE, DoEd, DoJ or BoP

• Additional Federal Agencies Requirements Checklist
• Advertisement and Recruitment Checklist
• IRB Committee ICH-GCP E.6 Review Checklist
• Prisoner Protocol Checklist
• Subpart D (Minors) Checklist

IRB Member Forms

• IRB Service Description
• IRB Member & Chair Evaluation Form

Regulations for IRB Review of Human Subject Research 

• Criteria for Approval

• Criteria for Waiver of Informed Consent Documentation

• Criteria for Waiver of Informed Consent Procedure

• Informed consent-basic elements and additional elements (45 CFR 46.116)
   
• Waiver of HIPAA authorization (HIPAA/OCR guidance)

• Exempt Approval Criteria

• Expedited Approval Criteria

• 45 CFR 46 Subpart B (additional protections for pregnant women, fetuses and neonates)

• 45 CFR 46 Subpart C (additional protections for prisoners)

• 45 CFR 46 Subpart D (additional protections for children)