Statement of Authority and Purpose

• Statement of Authority and Purpose
  IRB Policy 100.1

General Administration

• Policies and Procedures Maintenance
  IRB Policy 101.1
• Training and Education
  IRB Policy 101.2
• Management of IRB Personnel
  IRB Policy 101.3
• Signatory Authority
  IRB Policy 101.4

Conflict of Interest

• Conflict of Interest
  IRB Policy 102.1

IRB Organization

• Composition of the IRB
  IRB Policy 103.1
• Management of the IRB
  IRB Policy 103.2
• Duties of IRB Members
  IRB Policy 103.3

Functions and Operations

• Research Submission Requirements
  IRB Policy 104.1
• IRB Meeting Administration
  IRB Policy 104.2
• Administrative Review and Distribution of Materials
  IRB Policy 104.3
• Documentation and Document Management
  IRB Policy 104.4

Types of IRB Review

• Human Subjects Research
  IRB Policy 105.1
• Exemptions from IRB Review
  IRB Policy 105.2
• Emergency Use of an Investigational Article
  IRB Policy 105.3
• Expedited Review
  IRB Policy 105.4
• Full Board Review
  IRB Policy 105.5

Collaborative Research

• Collaborative Research
  IRB Policy 106.1

Initial Review Consideration

• Advertisements
  IRB Policy 107.1
• Initial Review Considerations
  IRB Policy 107.1

Informed Consent

• Informed Consent
  IRB 108.1

Vulnerable Populations

• Vulnerable Research Subjects
  IRB Policy 109.1
• Prisoners
  IRB Policy 109.2
• Children
  IRB Policy 109.3
• Pregnant Women, Human Fetuses, and Neonates
  IRB Policy 109.4

Reviews Requiring Special Consideration

• AIDS Related Research
  IRB Policy 110.1
• International Research
  IRB Policy 110.2
• Medical Devices
  IRB Policy 110.3
• Investigational Use of Drugs and Biologics
  IRB Policy 110.4
• Research Requiring the Use of Birth Control
  IRB Policy 110.5
• Genetic Research
  IRB Policy 110.6
• Research in Emergency Setting
  IRB Policy 110.7

Post-IRB Approval Reviews

• Amendments or Addenda
  IRB Policy 111.1
• Serious Adverse Events and Unanticipated Problems
  IRB Policy 111.2
• Significant New Findings
  IRB Policy 111.3
• Protocol Deviations
  IRB Policy 111.4
• Continuing Reviews
  IRB Policy 111.5

Study Close-out

• Study Close-Out
  IRB Policy 112.1

IRB Communication

• IRB Communication and Notification
  IRB Policy 113.1

Responsibilities

• Responsibilities of Investigators
  IRB Policy 114.1

Quality Assurance

• Quality Assurance
  IRB Policy 115.1