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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-401 - CHECKLIST Pre-Review

HRP-402 - CHECKLIST Non-Committee Review

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-415 - CHECKLIST Prisoners

HRP-416 - CHECKLIST Children

HRP-417 - CHECKLIST Cognitively Impaired Adults

HRP-418 - CHECKLIST Non-Significant Risk Device

HRP-419 - CHECKLIST Waiver Consent Process - Emergency Research

HRP-441 - CHECKLIST HIPAA - Waiver Authorization

HRP-442 - CHECKLIST Genetic Biobanking Studies

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-429 - CHECKLIST Post Approval Monitoring: Biomedical Research

HRP-430 - CHECKLIST Post Approval Monitoring: Social Behavioral Research

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