FRI Grants Administration

IRB Policies and Guidance

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 CONSIDERATIONS
Initial Review Considerations - IRB Policy 107.1
Advertisements - IRB Policy 107.2

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 AND NOTIFICATION
IRB Communication and Notification - IRB Policy 113.1

RESPONSIBILITIES OF INVESTIGATORS
Responsibilities of Investigators - IRB Policy 114.1

QUALITY ASSURANCE
Quality Assurance - IRB Policy 115.1