Policies and Procedures
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Section I: Committee Information
Section II: Research Guidance
Body
- 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
- 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
- 8. Types of Research
- 8.1 Standard Clinical Trial Protocol
- 8.2 Chart Review Protocol
- 8.3 Qualitative Research Protocol
- 8.4 Biological Specimens/Data Repository Protocols
- 8.5 Blood Collection Protocols 46.110
- 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
- 9.2 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
- 9.8 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
- 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
- 18. Reportable New Information (includes unanticipated problems and adverse events)
- 19. Incidental Findings in Neuroimaging Protocols – Detection and Management
- 20. Investigational Drugs (including Biologics)
- 21. 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
- 25. Pregnancy Testing in Minor Research Subjects
- 26. Human Subject Quality Assurance Reviews
- 27. Noncompliance Policy and Procedures
- 28. Electronic Signatures Policy
- 29. Regulatory Definitions
- 30. Statement of Compliance for the Committees on Human Research
- 31. 2018 Common Rule Transition