This tool, which was developed by Caroline Miner, appears in the Health Care Compliance Association’s Healthcare Compliance Forms and Tools.[1]
Instructions
1. Use this worksheet/checklist to conduct the institutional review of an external single institutional review board (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