Human Research Protection Program

Committee Member Resources  

Checklists 

• Additional Federal Agencies Requirements Checklist (doc)

• Advertisement and Recruitment Checklist (doc)

• Amendment Reviewer Checklist (doc)

• CPR Reviewer Checklist (doc)

• Emergency Use Checklist (doc)

• Exemption Form for IRB Reviewers Checklist (doc)

• Expedited Approval Form for IRB Reviewer Checklist (doc)

• IRB Committee ICH-GCP E.6 Review Checklist (doc)

• New Protocol Reviewer Checklist (doc)
   
• Planned Emergency Research Reviewer Checklist (doc)
   
• Prisoner Protocol Checklist (doc)
   
• Reportable Event Reviewer Checklist (doc)
   
• Treatment Use Reviewer Checklist (doc)

IRB Member Forms

• IRB Service Description (doc)

• IRB Member & Chair Evaluation Form (doc)

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)