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Chapter 1 - Ethical and Regulatory Mandates to Protect Human Research Participants
Chapter 2 - Purpose of the Human Research Protection Office and Institutional Review Board
Chapter 3 - Human Subject Research and the Authority and Jurisdiction of the University of Pittsburgh Human Research Protection Office and IRB
Chapter 4 - Roles and Responsibilities of Investigators and Research Staff
Chapter 5 - Management of the HRP and IRB
Chapter 6 - IRB Committees
Chapter 7 - IRB Committee Membership
Chapter 8 - General Procedures for All IRB Submissions
Chapter 9 - Determination that Project is Not Research, or Does Not Involve Human Subjects
Chapter 10 - Exempt Determinations
Chapter 11 - Expedited Reviews
Chapter 12 - Procedures Specific to Protocols Reviewed by the Convened IRB
Chapter 13 - Informed Consent and Documentation
Chapter 14 - Considerations for Special Subject Populations
Chapter 15 - Subject Recruitment and Review of Advertisements
Chapter 16 - Considerations for FDA Regulated Research
Chapter 17 - Reportable New Information
Chapter 18 - Reporting of IRB Determinations
Chapter 19 - Suspensions and Terminations
Chapter 20 - Conflict of Interest
Chapter 21 - IRB Recordkeeping and Retention
Chapter 22 - Education and Training
Chapter 23 - Reporting Concerns and Undue Influence
Chapter 24 - IRB Reliance Mechanisms
Chapter 25 - Multi-Cultural Considerations
Chapter 26 - Additional Requirements for Research Supported by Other Federal Agencies
Chapter 27 - Maintenance of Standard Operating Procedures
Chapter 1 - Ethical and Regulatory Mandates to Protect Human Research Participants
