Human Research Protection Program

Committee Member Resources  

Checklists  

• New Protocol Reviewer Checklist (doc)

• Amendment Reviewer Checklist (doc)

• CPR Reviewer Checklist (doc)
  

• Reconcile Federal Grants & Contracts policy (pdf)

• Review and Evaluation of National Cancer Institute Cooperative Group Consent Forms (pdf)

  • Modifications to the NCI Cooperative Group Informed Consent (doc)

Expedited and Exempt Review Resources  

• Guidelines for Determining "Exempt" and "Expedited" Eligibility (pdf)

• Exemption Form for IRB Reviewers (doc)

• Expedited Approval Form for IRB Reviewers (doc)

Regulations for IRB Review of Human Subject Research 

• Informed consent-basic elements and additional elements (45 CFR 46.116)

• Waiver of informed consent procedure (45 CFR 46.116)

• Waiver of informed consent documentation (45 CFR 46.117)

• 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)