IRB Policy Manual

Authority and Institutional Commitment

• Institutional Commitment and Authority
• Knowledge of the Local (domestic and international) Research Context
• Mayo Clinic Service as the IRB of Record for a Non-Mayo Clinic Relying Organization
• Relying on an External IRB
• Reporting to the Institutional Official and Regulatory Agencies

Membership

• Composition of Institutional Review Boards
• IRB Member Responsibilities
• Management of IRB Member and Consultant Conflicts of Interest
• Roles, Qualifications and Evaluation of IRB Members

Review of Research

• Administrative Hold Activation by the Principal Investigator
• Closure of IRB Applications
• Continuing Review of Research Projects
• Department of Defense (DoD)-Sponsored Research
• Exempt Human Subjects Research
• Expedited Review of Human Subject Research
• Expired IRB Approval
• International Research
• IRB Initial Approval of Research
• IRB Determinations
• IRB Records and Retention
• Modifications to Previously Approved or Exempt Research
• Planned Research in an Emergency Setting
• Reporting an Unanticipated Problem Involving Risks to Subjects or Others (UPIRTSO) to the IRB
• Scientific Review of Research Involving Human Subjects
• Suspension or Termination of IRB Approval of Research
• Verification of No Material Changes Since Previous IRB Review

Informed Consent ⁄ Assent

• Health Insurance Portability and Accountability Act (HIPAA) Policy
• Informed Consent and the Research Subject
• Re-Consent or Notification of Significant New Findings Developed During the Course of Research
• Selecting a Legally Authorized Representative

Protected ⁄ Vulnerable Populations

• Special Categories of Research: Children
• Special Categories of Research: Participants Who May Be Vulnerable to Coercion or Undue Influence
• Special Categories of Research: Pregnant Women, Human Fetuses and Neonates
• Special Categories of Research: Prisoners

Investigational Devices⁄Drugs⁄Biologics

• Control of Investigational Devices
• Humanitarian Use Devices
• One Time Emergency Use of an Investigational Device, Drug or Biologic Product
• Reporting Requirements for Sponsor-Investigators Conducting Investigational New Drug (IND) or Investigational Device Exemption (IDE) Research
• Use of an Investigational Device in Human Subjects Research
• Use of Investigational, Drugs or Biologic Products in Human Subject Research

Privacy and Confidentiality

• Protection of Privacy Interest and Maintenance of Confidentiality of Data of Research Subjects
• Release of Human Subject Identifiers

Researcher Tools

• Data and Safety Monitoring Plan Guidelines
• Human Specimen Research Repositories