IRB Standard Operating Procedures

 

I. Overview of the Institutional Review Board
  • A. The Mission of the Institutional Review Board
  • B. Role of the IRB in Ethical Review
  • C. Federalwide Assurance System

    • II. What Is Subject to Review
  • A. Scope of Review
  • B. Whose Research Is Reviewed?
  • C. Funded Research
  • D. Class Research Projects
  • E. Institutional Quality Assurance, Quality Control, and Program Evaluation

    • III. Procedures for Conducting Initial Review of Research
  • A. The Process of Informed Consent
  • B. Determining the Type of Evaluation
  • C. Special Considerations for Vulnerable Populations
  • D. Submission Timeline - New Proposals

    • IV. Continuing Review
  • A. Reasons for Continuing Review
  • B. Documentation Required for Continuing Review
  • C. Submission Timeline - Continuing Review (Progress Reports)
  • D. Consequences of Late Progress Reports for Continuing Review
  • E. Evaluation of Continuing Review Packets (Progress Reports)

    • V. Additional Administrative Actions Requiring IRB Review/Approval
  • A. Review of Amendments/Revisions
  • B. Reporting Unexpected Adverse Events

    • VI. Closing Out a Study
    VII. Protocol Deviation
    VIII. Monitoring of Studies and/or Reporting Noncompliance
    IX. IRB Administration
  • A. Resources
  • B. IRB Relationship to UNF
  • C. Membership
  • D. IRB Meetings
  • E. IRB Recording Requirements
  • F. Appeal of IRB Decisions and Processes
  • G. Internal Monitoring of Compliance and Annual Reports

    • X. Responsibilities of Key Individuals
  • A. Principal Investigators
  • B. IRB Office Administrators
  • C. Assistant Vice President for Research
  • D. Vice President for Academic Affairs of the University

    • XI. Cooperative Research
  • A. Individual Investigator Agreement
  • B. IRB Authorization Agreements

    • XII. Approval of the UNF IRB Standard Operating Procedures