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IRB Checklists and Worksheets
Checklists and worksheets are used by the IRB staff and reviewers to document required IRB determinations and to guide the IRB review. Investigators may consult these documents when drafting the research protocols. These documents should not be included in the submission as they are not required to be completed by the investigators.
Checklists are used by the IRB staff and reviewers to document required IRB determinations. Investigators may consult the checklists to understand the regulatory requirements related to research, however, Investigators are not required to complete the checklists:
- HRP-410 - Waiver or Alteration of the Consent Process
- HRP-411 - Waiver of Written Documentation of the Consent Process
- HRP-412 - Research Involving Pregnant Women
- HRP-413 - Research Involving Non-Viable Neonates
- HRP-414 - Research Involving Neonates of Uncertain Viability
- HRP-415 - Research Involving Prisoners
- HRP-416 - Research Involving Children
- HRP-417 - Research Involving Cognitively Impaired Adults
- HRP-418 - Non-Significant Risk Device
- HRP-419 - Waiver of the Consent Process for Emergency Research
- HRP-441 - HIPAA Waiver of Authorization
Worksheets provide the IRB staff and reviewers with additional information about regulatory requirements and guidance related to the IRB review and approval of research. Investigators may consult the worksheets to understand the regulatory landscape related to human subjects research, however, Investigators are not required to complete the worksheets:
- HRP-302 - Approval Intervals
- HRP-304 - IRB Composition
- HRP-306 - Drugs and Biologics
- HRP-307 - Devices
- HRP-308 - Pre-Review
- HRP-310 - Human Research Determination
- HRP-311 - Engagement Determination
- HRP-312 - Exemption Determination
- HRP-313 - Eligibility for Review Using the Expedited Procedure
- HRP-314 - Criteria for Approval
- HRP-315 - Advertisements
- HRP-316 - Payments
- HRP-317 - Short Form of Consent Documentation
- HRP-318 - Additional Federal Agency Criteria
- HRP-319 - Limited IRB Review and Broad Consent
- HRP-320 - Scientific or Scholarly Review
- HRP-321 - Review of Information Items
- HRP-322 - Emergency Use
- HRP-323 - Criteria for Approval HUD
- HRP-330 - HIPAA Authorization
- HRP-331 - FERPA Compliance
- HRP-332 - NIH GDS Institutional Certification