Table of Contents

1. IRB Authority and Institutional Commitment
   1. Institutional Oversight of Mayo Clinic’s Federalwide Assurance
   2. Activities Subject to IRB Jurisdiction
   3. Knowledge of Local Research Context
   4. IRB of Record
2. IRB Compliance
   1. IRB Compliance Responsibilities
   2. Administrative Hold, Suspension, or Termination of IRB Approval
   3. Reporting to the Appropriate Institutional Officials and Department or Agency Head(s)
3. IRB Review Procedures
   1. Institutional Review Board Committee Review Responsibilities
   2. IRB Committee Determinations/Motions
   3. IRB Review of Human Subjects Research – Exempt
   4. IRB Review of Human Subjects Research – Expedited
   5. IRB Review of Human Subjects Research – Full Committee
   6. IRB Approval of Research
   7. Documentation of IRB Determinations
   8. Modifications to Previously Approved Research
   9. IRB Continuing Review
   10. Reporting Unanticipated Problems Involving Risk to Subjects or Others
4. Informed Consent Process
   1. Legally Effective and Prospectively Obtained Informed Consent
   2. Documentation of Informed Consent for Human Subjects Research
   3. Waiver of Informed Consent for Human Subjects Research or Exception of Informed Consent for Emergency Research
   4. Requirements for Permission by Parents or Guardians and for Assent by Children
5. IRB Records and Documents
   1. IRB Records
   2. Development, Approval, and Maintenance of IRB Policies and Procedures
6. Committee Roles and Responsibilities
   1. IRB Committee Members
7. IRB Education and Training
   1. Investigator, Study Personnel, IRB Committee Member and Staff Training
8. Vulnerable Populations
   1. Special Categories of Research: Pregnant Women, Human Fetuses and Neonates
   2. Special Categories of Research: Prisoners
   3. Special Categories of Research: Children
   4. Special Categories of Research: Other Participants Who May Be Vulnerable to Coercion or Undue Influence
9. Privacy and Confidentiality
   1. Health Insurance Portability and Accountability Act (HIPAA) Policy
   2. Minnesota Research Authorization
   3. Certificate of Confidentiality
10. Investigational Drugs, Biologics, and Devices
    1. Investigational, Drugs, Agents, and Biologics
    2. Investigational Devices
    3. Humanitarian Use Devices