Statement of Authority and Purpose
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Statement of Authority and Purpose
IRB Policy 100.1
General Administration
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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
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Conflict of Interest
IRB Policy 102.1
IRB Organization
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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
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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
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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
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Collaborative Research
IRB Policy 106.1
Initial Review Consideration
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Advertisements
IRB Policy 107.1 -
Initial Review Considerations
IRB Policy 107.1
Informed Consent
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Informed Consent
IRB 108.1
Vulnerable Populations
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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
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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
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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
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Study Close-Out
IRB Policy 112.1
IRB Communication
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IRB Communication and Notification
IRB Policy 113.1
Responsibilities
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Responsibilities of Investigators
IRB Policy 114.1
Quality Assurance
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Quality Assurance
IRB Policy 115.1