3 IRB Review Process June 2020
3.1. Policy
3.2. Procedures
3.2.1. Electronic Submission System
3.2.1.1. Mandatory Electronic Submissions
3.2.2. Human Subjects Research Determination
3.2.3. Exempt Studies
3.2.3.1. Limitations on exemptions
3.2.3.1.1. Children/Prisoners
3.2.3.1.2.International research
3.2.3.2. Categories of Exempt Research
3.2.3.3. FDA Exemptions
3.3. Additional Protections
3.3.1. Procedures for Exempt Review
3.3.1.1. Exempt Research Activities
3.3.1.2. Determination Process
3.3.1.2.1. Amendments
3.3.1.2.2. Expiration
3.4. Expedited Review
3.4.1. Categories of Research Eligible for Expedited Review
3.4.2. Expedited Review Procedures
3.4.2.1. Informing the IRB
3.5. Convened IRB Review
3.5.1. IRB Meeting Schedule
3.5.2. Screening
3.5.3. Reviewers
3.5.4. IRB Agenda
3.5.5. Pre-meeting Distribution of Documents to IRB Members
3.5.6. Pre-meeting Distribution of Documents to Reviewers
3.5.7. Quorum
3.5.8. IRB Meeting Procedures
3.5.8.1. Call to Order and Quorum
3.5.8.2. Conflict of Interest of IRB Members
3.5.8.3. Review & Acceptance of Prior Meeting Minutes
3.5.8.4. Initial & Continuing Review & Requests for Modification
3.5.8.5. Recording of Proceedings
3.5.8.6. Consultant Advice – Children
3.5.8.7. Consultant Advice – Vulnerable Populations
3.5.8.8. Prisoner Representatives
3.5.9. Guests & ex officio Guests
3.6. Criteria for IRB Approval of Research
3.6.1. Risk-Benefit Assessment
3.6.1.1.1. Scientific Merit
3.6.2. Equitable Selection of Subjects
3.6.2.1. Recruitment of Subjects
3.6.3. Consent
3.6.4. Safety Monitoring
3.6.5. Privacy and Confidentiality
3.6.5.1. Definitions
3.6.5.2. Privacy
3.6.5.3. Confidentiality
3.6.6. Vulnerable or Potentially Vulnerable Populations
3.7. Additional Considerations during IRB Review and Approval of Research
3.7.1. Determination of Risk
3.7.2. Frequency of Review
3.7.3. Review more often than annually
3.7.4. Independent Verification that no Material Changes have occurred
3.7.5. Consent Monitoring
3.7.6. Investigator Conflicts of Interest
3.7.7. Significant New findings
3.7.8. Advertisements
3.7.9. Payment to Research Subjects
3.7.10. Recruitment Incentives
3.8. Compliance with all Applicable Laws and Regulations
3.9. Possible IRB Actions
3.9.1. Approval
3.9.2. Deferred with minor modifications
3.9.2.1. Definitions
3.9.2.2. Policy
3.9.3. Tabled for Major Modifications
3.9.3.1. Definitions
3.9.3.2. Policy
3.9.3.3. Time Limit for Submitting Requested Changes for New Research Protocol Application Deferral or Tabling
3.9.4. Tabled (for reasons other than major modification)
3.9.5. Disapproved
3.9.6. Approved in Principle
3.10. Study Suspension, Termination and Investigator Hold
3.10.1. Suspension or Termination
3.10.1.1. Procedures
3.10.2. Protection of Currently Enrolled Participants
3.11. Continuing Review
3.11.1. Approval Period
3.11.2. Continuing Review Process
3.11.3. Expedited Review of Continuing Review
3.11.4. Lapse in Continuing Review Approval
3.11.5. Calculating the “date of IRB approval”
3.11.5.1. Approval at a convened meeting.
3.11.5.2. Approval pending changes at a convened IRB committee meeting.
3.11.5.3. Expedited review.
3.11.5.4. Continuing review.
3.11.5.5. Amendments.
3.12. Amendment of an Approved Protocol
3.12.1. Expedited Review of Protocol Amendments/Modifications
3.12.2. Convened IRB Review of Protocol Modifications
3.12.3. Changes in the Consent Document
3.13. Closure of Protocols
3.14. Notice to PI of IRB Actions
3.15. Appeal of IRB Decision to Disapprove