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• 1. Committee Mission 
  • 1.1 Introduction to the Boards, the Principles, and their Authority 
  • 1.2 Committee Membership (Sec. __.107) 
  • 1.3 Operations of the IRB (Sec. __.108) 
    • 1.3.1 Medical Safety Subcommittee Review 
    • 1.3.2 Guidelines for Continuing Review of Research
    • 1.3.3 Guidelines for Review of Modifications 
    • 1.3.4 Conducting IRB Business in the Event of a Pandemic or Other Significant Emergency 
    • 1.3.5 IRB Minutes 
  • 1.4 Public Records and Open Meetings (Vermont Law) 
  • 1.5 IRB Jurisdiction

• 2. Institutional Ancillary Reviews
• 3. IRB Review Categories (Sec._46.109(a))
  • 3.1 Full Committee Review
  • 3.2 Expedited Review (Sec._46.110)
  • 3.3 Limited Review (Sec._46.104)
  • 3.4 Exemption Determination
  • 3.5 Not Human Subjects Research Determination
  • 3.6 Projects Not Requiring IRB Review
  • 3.6.1 Case Studies
  • 3.7 Determination of Institutional Engagement in Research
  • 3.8 De Novo Review of Protocols
• 4. IRB Review Determinations 46.109 and 46.113
  • 4.1 Administrative Hold, Suspension, or Termination of IRB-Approved Approvals
• 5. Eligibility to Perform Research At UVM/UVMMC
  • 5.1 Responsibilities of Principal Investigators
  • 5.2 Key Personnel Responsibilities
  • 5.3 Access To and Retention of Research Records
  • 5.4 CITI Training Requirements
  • 5.5 Guidance on Data Management in Human Subjects Research
  • 5.6 Managing Research Prior to Departure, Sabbatical, Medical Leave, or Other Absence
  • 5.7 Data and Biospecimen Sharing
  • 5.8 Enrollment Incentives
• 6. Conflict of Interest
• 7. Non-Faculty Researcher Requirement
  • 7.1 Student Class Project Guidelines
• 8. Types of Research
  • 8.1 Standard Clinical Trial Protocol
    • 8.1.1 Elements Found in a Standard Protocol
    • 8.1.2 Requirement to include a full Protocol Title in the Electronic Medical Record (EPIC)
    • 8.1.3 Plans for Recruitment/Screening/Retention 
    • 8.1.4 Participant Compensation
  • 8.2 Chart Review Protocol
  • 8.3 Qualitative Research Protocol
  • 8.4 Biological Specimens/Data Repository Protocols
    • 8.4.1 Research Tissue Acquisition Policy
  • 8.5 Blood Collection Protocols 46.110
    • 8.5.1 Blood Drawing Limits
  • 8.6 Research Involving Coded Private Information or Biological Specimens
  • 8.7 Sustainable Agriculture Research and Education (SARE) Grant Projects
  • 8.8 Department of Defense (DoD) Supported Research Projects
  • 8.9 Exception from Informed Consent Emergency Research
    • 8.9.1 Review Flow for Planned Emergency Research
    • 8.9.2 Designing a Plan for Community Consultation and Public Disclosure in Planned Emergency Research
    • 8.9.3 Data Collection Expectations for Exception from Informed Consent for Emergency Research
    • 8.9.4 Operations of Exception from Informed Consent for Emergency Research Advisory Panel
  • 8.10 Research Conducted in Public Schools
  • 8.11 International Research: Information on Conducting Research Outside of the United States
• 9. Consent (§____.116)
  • 9.1 Children
    • 9.1.1 Children Reaching Legal Age of Consent While Enrolled in a Study Policy
  • 9.2 Surrogate Consent for Research (Legally Authorized Representatives)
  • 9.3 Cases of Physical Compromise
  • 9.4 Informed Consent and HIPAA Authorization Process for Non-English Speaking Individuals
  • 9.5 Waiver of Informed Consent, Alteration of Informed Consent, or Waiver of Documentation §____.116(c)
  • 9.6 Consent Process for Legally Blind or Impaired Vision Research Participants
  • 9.7 Guidance for Researchers Using Deception or Incomplete Disclosure in Research
    • 9.7.1 Debriefing
    • 9.7.2 Additional IRB Considerations when using Deception or Incomplete Disclosure in Research
  • 9.8 Media Consent
  • 9.9 Obtaining Electronic Written Consent
  • 9.10 Telemedicine and Research Visits
  • 9.11 Technical Guidance for Remote Visit
• 10. Data Protection Regulations
  • 10.1 Health Insurance and Portability Act (HIPAA)
  • 10.2 Waiver, Partial Waiver or Alteration of HIPAA Authorization 45 CFR 164.512
  • 10.3 European Union (EU) Participants and EU General Data Protections (GDPR)
  • 10.4 Decedent Data
  • 10.5 National Institutes of Health Genomic Data Sharing Policy
• 11. Certificates of Confidentiality
• 12. Exceptions to Confidentiality Guidance
• 13. Cooperative Research (Single IRB) Policy (Sec. __.114)
  • 13.1 Cooperative Research (Single IRB) Roles and Responsibilities
  • 13.2 Collaborative Agreements
  • 13.3  Procedures for Reliance on External IRB (Sec __.114(b)(1))
  • 13.4 Non-Collaborative Review and UVM IRB
  • 13.5 Procedures for Reviewing or Relying for NNE-CTR Grants (Sec __.114(b)(1))
  • 13.6 Collaborative Research Between UVM and the VT Agency of Human Services (AHS)
  • 13.7 Collaborations with Community Partners
  • 13.8 Procedures for Reviewing or Relying for NNE-CTR Grants
• 14. Funding/Contracts/Fees
  • 14.1 When the Project is a New Competing or a Competing Renewal Application and the New Protocol is Identical or Substantially Similar to an Approved Protocol
  • 14.2 IRB Review of Just-in-Time (JIT) Protocols
  • 14.3 Grant Proposals Lacking Definite Plans for Involvement of Human Subjects
  • 14.4 Contracts/Agreements
  • 14.5 Changes to the Scope of a NIH Awarded Project
  • 14.6 Fees for Committee on Human Research Review of Sponsored Trials
• 15. Modification to Previously Approved Protocol
• 16. Continuing Review Requirements
• 17. Closing a Protocol by the PI
  • 17.1 Closure of Protocol by Committee
• 18. Reportable New Information (includes unanticipated problems and adverse events)
  • 18.1 Reportable New Information on External IRB Studies
• 19. Incidental Findings in Neuroimaging Protocols – Detection and Management
  • 19.1 Standards and Language for Studies Involving MRI
• 20. Investigational Drugs (including Biologics)
  • 20.1 Use of Approved Drugs for Off-Label Indications
  • 20.2 Expanded Access of Investigational Drugs (Compassionate Use)
  • 20.3 Food and Food-Derived Products, Spices/Herbs, or Dietary Supplements
  • 20.4 Controlled Substances Used in Research
• 21. Investigational Devices
  • 21.1 Expanded Access of Investigational Devices
• 22. Humanitarian Use Device (HUD) Designation and Humanitarian Device Exemptions (HDE)
• 23. Emergency Use of an Investigational Drug or Biologic or Investigation Device
• 24. Subjects Vulnerable to Coercion or Undue Influence
  • 24.1 Pregnant Women, Fetuses, Neonates of Uncertain Viability and Non-Viable Neonates 45 CFR 46 Subpart B
  • 24.2 Research Involving Prisoners - Subpart C
  • 24.3 Children
  • 24.4 Non-English Speaking Individuals Participating in Research
• 25. Pregnancy Testing in Minor Research Subjects
• 26. Human Subject Quality Assurance Reviews 
  • 26.1 Human Subject Quality Assurance Reviews on External IRB Studies
• 27. Noncompliance Policy and Procedures
  • 27.1 Non-Compliance Review Procedures
  • 27.2 Definitions, Guidance, and Examples Referenced as Part of Non-Compliance Reviews
  • 27.3 Non-compliance Policy on External IRB Studies
• 28. Electronic Signatures Policy
• 29. Regulatory Definitions
• 30. Statement of Compliance for the Committees on Human Research
• 31. 2018 Common Rule Transition