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Institutional Review Board
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TOC
Institutional Review Board
Rationale
Course Outline
Introduction
Yale's Commitment
Federalwide Assurance (FWA)
History of Ethical Guidelines
The Belmont Report
Current Federal Regulations
Federal Regulations and Yale Policy
Institutional Review Boards
IRBs and the Public Interest
Summary
IRB Review
Evaluating the Need for IRB Review
What is Human Subjects Research
Is Your Activity Research?
Does Your Research Involve Human Subjects?
Is Your Research Exempt from IRB Review?
Is Your Research Exempt? (continued)
Research Protocol
Additional Documents
IRB Review Criteria
IRB Action
Summary
Working with Human Subjects
Informed Consent
Requirements of Informed Consent
Requirements of Informed Consent (continued)
Additional Aspects of Informed Consent
Special Circumstances
Risks and Benefits
Levels of Risk
Risk/Benefit Analysis
Confidentiality and Privacy
Special Populations
Special Populations (continued)
Equitable Selection of Subjects
Summary
Reviewing Your Responsibilities
Developing the Project
Performing the Research
Complying with Federal Regulations and Yale Policies
Yale's IRBs
Summary
IRB: IRB Quiz