Reviewer Checklists and Other Guidance

• Reviewer Presentation Tool for New Study (DOCX)
• Continuing Review Checklist (PDF)
• Criteria for Approval (PDF)
• Criteria for Approval-VA (PDF)
• Informed Consent Checklist (DOC)
• DSMP checklist (DOCX) (New)
• Guidance: Pending or Deferred (PDF)
• Guidance: Reviewing Research Involving Adult Participants with Diminished Decision Capacity (PDF)
• Procedural Risk Guidance

• Emory Subpart B Checklist (DOC)
• Emory Subpart C Checklist (DOC)
• Emory Subpart D Checklist (DOC)
• Emory Checklist- Cognitively Impaired Subjects (DOCX)
• Checklist for HIPAA determination and Waivers of Consent and Authorization (DOCX)

Please see the Reportable New Information section of the IRB website for guidance documents regarding protocol deviations, potential noncompliance or unanticipated events, and related matters.

• Dietary Supplements FAQ (DOCX)
• Dietary Supplements and/or Medical Foods Worksheet (DOCX)
• Guidance for Emory Sponsor-Investigators (PDF)
• HUD Patient Information Sheet (DOCX)
• Investigational Drugs and Devices (DOC)
• Investigator Justification for IDE Exemption
• Investigator Justification for IND Exemption (DOCX)
• In Vitro Diagnostic Device Studies Guidance (PDF)
• Emory IRB Medical Device Guidance (PDF)
• Emory IRB Decision chart for Devices used in Human Subject Research Studies (PDF)
• Emory IRB Decision Chart for Drugs Used in Human Subject Research Studies (PDF)
• S-I study review guidance (PDF) - NEW

• Certificates of Confidentiality for Members- Guidance from NIH
• Code of Federal Regulations 45 CFR 46 Basic HHS policy for protection of research subjects
  • Subpart B - Additional protections for pregnant women, human fetuses, and neonates involved in research
  • Subpart C - Additional protections pertaining to biomedical and behavioral research involving prisoners as subjects
  • Subpart D - Additional protections for children involved as subjects in research

• ICH-GCP information (PDF)
  
  • AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonization – Good Clinical Practice
• FDA IRB Regulations: 21 CFR 56
• Protection of Human Subjects: 21 CFR 50 (Informed Consent)
• FDA-CDER Chronicles: Drug, Not a drug, or More (PDF)

IRB Webinars and OHRP Instructional Videos

Retreat 2023

Emory IRB Single IRB (sIRB) Plan and Process Slide Deck