Institutional sIRB Review Worksheet/Checklist
INSTRUCTIONS:
1. Use this worksheet/checklist to conduct the institutional review of an external, single IRB (sIRB).
Study Title: ___________________________________________
Study ID Number: ______________________________________
sIRB Name: ___________________________________________
sIRB Registration Number: _______________________________
sIRB Study ID Number: __________________________________
Reviewer: _____________________________________________
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1. The sIRB is qualified to serve (Quality Standard): ☐ Accredited ☐ Current Self-Assessment ☐ Other (provide rationale) |
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2. sIRB is qualified to serve (Expertise Standard): ☐ IRB membership is appropriate for the research being conducted ☐ Other (provide rationale) |
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3. IRB Reliance Agreement Status: ☐ Fully Executed ☐ In progress ☐ Institutional Point of Contact: ☐ Institutional signatory: |
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4. There is documentation that the sIRB review includes this site. ☐ Yes ☐ No ☐ Other (describe) |
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5. Does the sIRB review for HIPAA considerations? ☐ Yes ☐ N/A ☐ No ☐ Protocol needs waiver(s) ☐ Authorization document contains all required elements and statements ☐ Authorization is acceptable |
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6. Is the protocol information specific to this site (e.g., Local Context Supplement) complete, sufficient and appropriate? ☐ Yes ☐ No ☐ Other (describe) |
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7. All listed investigators have completed training? ☐ Yes ☐ No ☐ Other (describe) |
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8. All listed investigators have appropriate privileges and credentials? ☐ Yes ☐ No ☐ Other (describe) |
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9. Any investigator financial interests that need to be managed? ☐ Yes ☐ No ☐ Other (describe) |
☐ I recommend institutional approval
☐ I recommend institutional approval pending