Checklists & Worksheets
- Checklists contain important elements from pertinent regulations. IRB members, Designated Reviewers, and Compliance Analysts are required to complete these checklists as they review the research study.
- Study teams may use checklists to anticipate criteria for approval but they are not required.
- Study teams are also encouraged to use post-approval monitoring checklists to regularly monitor their research compliance. Study teams may be required to complete post-approval monitoring checklists upon request, but they are not submitted in eIRB+.
- Worksheets are guidance materials used by IRB Reviewers and Designated Reviewers during initial reviews, continuing reviews, and modification reviews to enhance compliance with federal, state, and local requirements.
- Study teams are encouraged to review worksheets as they write their protocols to address the criteria for approval but they are not required.
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General Checklists
HRP-410 - CHECKLIST Waiver or Alteration of Consent Process
HRP-411 - CHECKLIST Waiver of Written Documentation of Consent
HRP-412 - CHECKLIST Pregnant Women
HRP-413 - CHECKLIST Non-Viable Neonates
HRP-414 - CHECKLIST Neonates of Uncertain Viability
HRP-417 - CHECKLIST Adults with Impaired Decision-making Capacity
HRP-418 - CHECKLIST Non-Significant Risk Device
HRP-419 - CHECKLIST Waiver Consent Process - Emergency Research
HRP-441 - CHECKLIST HIPAA - Waiver Authorization
HRP-1403 - CHECKLIST IRB Member Appointment
HRP-1404 - CHECKLIST IRB Member Re-Appointment
HRP-1408 - CHECKLIST Principal Investigator (PI) Transfer of Responsibilities
Post-Approval Monitoring Checklists
HRP-443 - CHECKLIST Observation of the Consent Process
HRP-427 - CHECKLIST Post Approval Monitoring: Drug or Device Clinical Trial
HRP-428 - CHECKLIST Post Approval Monitoring: Participant File
HRP-430 - CHECKLIST Post Approval Monitoring: Human Research
HRP-433 - CHECKLIST Post Approval Monitoring: Studies Without an Expiration Date
HRP-1401 - CHECKLIST Post Approval Monitoring: Recruitment Activities
HRP-1405 - CHECKLIST Post Approval Monitoring: Registry, Data Review, and/or Specimen Collection
HRP-1406 - CHECKLIST Post Approval Monitoring: Studies Under External IRB Review
HRP-1407 - CHECKLIST Post Approval Monitoring: Site File
HRP-1409 - CHECKLIST Post Approval Monitoring: Humanitarian Use Device
HRP-301 WORKSHEET Review Materials
HRP-302 WORKSHEET Approval Intervals
HRP-303 WORKSHEET Communication of Review Results
HRP-304 WORKSHEET IRB Composition
HRP-305 WORKSHEET Quorum and Expertise
HRP-306 WORKSHEET Drugs and Biologics
HRP-310 WORKSHEET Human Research Determination
HRP-311 WORKSHEET Engagement Determination
HRP-312 WORKSHEET Exemption Determination
HRP-313 WORKSHEET Expedited Review
HRP-314 WORKSHEET Criteria for Approval
HRP-315 WORKSHEET Advertisements (Recruitment Materials)
HRP-317 WORKSHEET Short Form Consent Documentation
HRP-318 WORKSHEET Additional Federal Agency Criteria
HRP-320 WORKSHEET Scientific or Scholarly Review
HRP-321 WORKSHEET Reportable New Information Items
HRP-322 WORKSHEET Emergency Use
HRP-323 WORKSHEET Criteria for Approval for HUD
HRP-325 WORKSHEET Compassionate Use of an Unapproved Medical Device
HRP-330 WORKSHEET HIPAA Authorization
HRP-331 WORKSHEET FERPA Compliance
HRP-332 WORKSHEET NIH GDS Certification
HRP-333 WORKSHEET Certificate of Confidentiality
HRP-334 WORKSHEET Media Relations
HRP-335 WORKSHEET GDPR Data Protection
HRP-336 WORKSHEET Mobile Apps and Mobile Medical Apps
HRP-830 WORKSHEET Communication and Responsibilities
HRP-1301 WORKSHEET Industry Sponsored Agreement Guidelines
HRP-1302 WORKSHEET Permission to Serve as PI
HRP-1303 WORKSHEET Genetic Biobanking Studies