IRB Policies, Procedures and Guidance

Part A: IRB Overview

UIW Human Research Protection Program

• IRB Authority, Purpose, and Principles
• What Needs Review – Determination of Human Subjects Research
• Institutional Review Board Policies and Procedures Development

IRB Membership, Organization, and Responsibilities

• IRB Member Appointment, Terms of Service, and Composition
• IRB Member Responsibilities
• IRB Member Conflicts of Interest
• IRB Confidentiality

Part B: IRB Operations

General Operations

• Conduct of Full Board Meetings
• Reporting to Regulatory and Oversight Agencies

Review Types

• Exempt Status Review
• Expedited Review
• Full Board Review
• Continuing Review
• Review of Amendments
• Suspension or Termination of Previously Approved Research
• Investigations of General, Serious, or Continuing Noncompliance

Principal Investigator Requirements and Responsibilities

Responsibilities of the Principal Investigator for Research in Progress

Monitoring and Reporting Activities

Required Reporting of Unanticipated Problems and Protocol Deviations

Informed Consent

• Recruitment and Selection of Participants
• Informed Consent

Part C: Special Requirements

Additional Approval Considerations

• Additional Approvals
• International Research

Special Guidance

Additional Reference Materials

• Student Class Projects
• Quality Improvement/Quality Assurance Projects
• Secondary Data Analysis
• Restrospective Chart Review
• Ethnographic Research
• IRB Reliance Agreements
• Application for IRB Review