Table of Contents

1. IRB Authority and Institutional Commitment

   1. Institutional Oversight of Mayo Clinic's Federalwide Assurance

      (Procedure) Institutional Oversight of Mayo Clinic's Federalwide Assurance

   2. Activities Subject to IRB Jurisdiction

      (Procedure) Activities Subject to IRB Jurisdiction

   3. Knowledge of Local Research Context

      (Procedure) Knowledge of Local Research Context

   4. IRB of Record

      New (Procedure) Mayo Clinic IRBs Serving as the IRB of Record for a Relying Organization

      (Procedure) External IRB as IRB of Record Procedure

2. IRB Compliance

   1. IRB Compliance Responsibilities

      (Procedure) Directed On-Site Review

      (Procedure) Internal Compliance Review Internal Compliance Review of Allegations of Suspected or Actual Noncompliance

      (Procedure) Routine On Site Quality Review

      (Procedure) Review of Allegations of Noncompliance by an IRB Committee

   2. Administrative Hold, Suspension, or Termination of IRB Approval

      (Procedure) Administrative Hold Activation by the Principal Investigator

      (Procedure) Suspension for Cause and Termination for Cause on a Study

   3. Reporting to the Appropriate Institutional Officials and Department or Agency Head(s)

      (Procedure) Reporting to the Appropriate Institutional Officials and Department or Agency Head(s)

   4. (Procedure) Review of Allegations of Noncompliance by a Full Committee

3. IRB Review Procedures

   1. Institutional Review Board Committee Review Responsibilities

      (Procedure) Institutional Review Board Member Review Responsibilities

      (Procedure) IRB Member Expectations, Roles, Recruitment and Evaluation Program

   2. IRB Committee Determinations/Motions

      (Procedure) IRB Committee Determinations/Motions – Full Committee Procedure

   3. IRB Review of Human Subjects Research – Exempt

      (Procedure) IRB Review of Human Subjects Research – Exempt

   4. IRB Review of Human Subjects Research – Expedited

      (Procedure) IRB Review of Human Subjects Research – Expedited

   5. IRB Review of Human Subjects Research – Full Committee

      (Procedure) Management of IRB Member and Consultant Conflicts of Interest

      (Procedure) Conduct of IRB Meetings

   6. IRB Approval of Research

      (Procedure) IRB Approval of Research

   7. Documentation of IRB Determinations
   8. Modifications to Previously Approved Research
   9. IRB Continuing Review

      (Procedure) Continuing Review

      (Procedure) Expired IRB Approval

      (Procedure) Final Report

   10. Reporting Unanticipated Problems Involving Risk to Subjects or Others

       (Procedure) Reporting Unanticipated Problems Involving Risks to Subjects or Others

   11. (Procedure) Scientific Review of Research Involving Human Subjects

       • (Form) Scientific Review

4. Informed Consent Process

   Informed Consent Policies

   1. Legally Effective and Prospectively Obtained Informed Consent

      (Guidance) Selecting a Legally Authorized Representative

   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

   Informed Consent Procedures

   • Planning and the Informed Consent Process
   • Recruitment and the Informed Consent Process
   • Enrollment and the Informed Consent Process
   • Documentation and the Informed Consent Process
   • Study Participation and the Informed Consent Process

   Vulnerable Populations

   • Research with Children and the Assent Process
   • Obtaining and Documenting Informed Consent of Subjects who do not Speak English

   Special Considerations

   • Requesting a Waiver of Written Informed Consent
   • Waiving the Documentation of Informed Consent
   • Re-consenting Study Subjects

   Responsibilities

   • Summary of Investigator Responsibilities
   • Summary of IRB Members Responsibilities

   Tools

   • Quick Reference Guide – Informed Consent Process: Planning Through Study Closure
   • Consent, Assent, and HIPAA Authorization Forms – Guidance for Revisions
   • IRB Consent Form Template
   • Oral Consent Script
   • Telephone Script
   • Contact Letter Template
   • Assent Form Template
   • IRB Handbook

5. IRB Records and Documents
   1. IRB Records
6. Committee Roles and Responsibilities
   1. IRB Committee Membership

      (Procedure) IRB Committee Membership

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

      (Procedure) Special Categories of Research: Pregnant Women, Human Fetuses, and Neonates

   2. Special Categories of Research: Prisoners
   3. Special Categories of Research: Children

      (Procedure) Special Categories of Research: Children

   4. Special Categories of Research: Other Participants Who May Be Vulnerable to Coercion or Undue Influence

      (Procedure) 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
   4. Release of Human Subject Identifiers for Research Purposes

10. Investigational Drugs, Biologics, and Devices

    (Process) Emergency Use of an Investigational Drug, Agent, Biologic or Device

    1. Investigational, Drugs, Agents, and Biologics

       (Procedure) Emergency Use of an Investigational Drug, Agent or Biologic

       (Procedure) Investigational New Drug (IND) Use in a Clinical Investigation

       (Procedure) Investigational New Drug (IND) or Investigational Device Exemption (IDE) Applications; Reporting Requirements for Sponsor-Investigators

    2. Investigational Devices

       (Procedure) Emergency Use of an Investigational Device

       (Procedure) Investigational Device Exemptions (IDE)

       (Procedure) Control of Investigational Devices in Clinical Research

       (Procedure) Investigational New Drug (IND) or Investigational Device Exemption (IDE) Applications; Reporting Requirements for Sponsor-Investigators

    3. Humanitarian Use Devices

       (Procedure) Humanitarian Use Devices (HUD)