IRB Policy Manual

The Institutional Review Board's policy manual details its institutional commitment, membership requirements, review of research, informed consent, recruitment, vulnerable population protection, biologics, confidentiality policy and more.

Authority and institutional commitment

• Institutional Commitment and Authority
• Mayo Clinic Serving 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 Conflict 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
• Data and Safety Monitoring Plan (DSMP) Guidelines
• Department of Defense (DoD)-Sponsored Research
• Exempt Human Subjects Research
• Expedited Review of Human Subject Research
• Expired IRB Approval
• Human Biospecimen and Information Research Repositories
• International Research
• IRB Initial Approval of Research
• IRB Determinations — Arizona, Florida, Rochester
• IRB Records and Retention
• Knowledge of the Local Research Context
• Management of Information Among Multi-Site Research
• Modifications to Previously Approved or Exempt Research
• Exception from Informed Consent in Emergency Research
• Submitting a Reportable Event to the IRB
• Submitting a Reportable Event when Mayo Clinic is not the IRB of Record
• Scientific Review of Research Involving Human Subjects
• Suspension or Termination of IRB Approval of Research
• Use of Consultants by the IRB
• Verification of No Material Changes Since Previous IRB Review

Informed consent and recruitment

• Informed Consent and the Research Subject
• Re-Consent or Notification of Subjects About Significant New Findings Developed During the Course of Research — Arizona, Florida, Rochester
• Recruitment Methods Involving Identification of Potential Research Participants from Medical Records Indicating a Specific Medical Diagnosis
• Selecting a Legally Authorized Representative
• Guidance for Investigators and the IRB Informed Consent and Assessment of Capacity to Consent to Research
• Assessment of Capacity to Consent and Informed Consent to Research

Protected and vulnerable populations

• Special Categories of Research: Children
• Special Categories of Research: Vulnerable Human Subjects
• Special Categories of Research: Pregnant Women, Human Fetuses, and Neonates
• Special Categories of Research: Prisoners

Investigational devices, drugs and biologics

• Control of Investigational Devices
• Humanitarian Use Devices for Clinical Treatment or Diagnosis
• Emergency Single-Case 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

• Health Insurance Portability and Accountability Act (HIPAA) Policy
• Protection of Privacy Interest and Maintenance of Confidentiality of Data of Research Subjects
• Release of Human Subject Identifiers
• Return of Research Laboratory Test Results