Institutional Review Board (IRB)

MSSM IRB Forms

Checklists for Applications

Document	Format
1. Protocol Summary for New and Continuing Protocols
2A. ENGLISH Combined Consent / HIPAA Authorization Form Template       Do not use to enroll children or wards - Use Form 2F
2A. SPANISH Combined Consent / HIPAA Authorization Form Template
2B. ENGLISH Standalone Consent Form Template
2B. SPANISH Standalone Consent Form Template
2C. Consent Documentation pages for subjects unable to read the document
2D. Consent Documentation pages for subjects unable to sign the document
2E. NO SIGN English Combined Consent / HIPAA Authorization Form Template
2F. CHILD English Combined Permission/ HIPAA Authorization Form Template
2G. WARD English Combined Permission/ HIPAA Authorization Form Template
3. Drug/Biologic Information Sheet
4. Assurances
5. Annual Adverse Event Form
6. Annual Enrollment Form
7. Request for Waiver of Informed Consent
8. Request for Waiver of Signed Consent
9. Certification of Assent of Minor
10A Internal Adverse Event/Unanticipated Problem Report Form
10B Report of Death on a Protocol
11. Acknowledgement of Receipt Form
12. HIV Testing Consent Form
13. HIV Spanish Consent Form
14. To Be Announced
15. Retrospective Clinical Data Study (if this is sole research activity, use INFOED instead)
16 Retrospective Research Data Study (if this is sole research activity, use INFOED instead)
17. HIV Data Review Form
18. Retrospective Clinical Specimen Study (if this is sole research activity, use INFOED instead)
19. Retrospective Research Specimen Study (if this is sole research activity, use INFOED instead)
20. Device Form
21. Humanitarian Use Device Only Form
22. Data and Safety Monitoring Plan Form
23. Emergency Use Form (Unapproved Drugs/Biologics)
24. Emergency Use Form (Unapproved Devices)
25. Emergency Use Consent Form Template
26. Engagement in Research Form (Component Research)
27. Clinical Investigator's Brochure Update Form

HIPAA Forms