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Human Research Protection Policy Manual

Below is the complete Human Research Protection Policy Manual.

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Oversight of Human Research Protection

Overview: Ethical Standards and Federal Regulations for Human Research Subjects

Agency-Specific Requirements for Human Subject Research

Research Populations

Recruitment and Consent

Risks, Benefits, and Safety Monitoring

Privacy and Confidentiality

Submission Requirements, and Processes

Review Types and Processes

IRB Records


Quality Improvement Program

Policy I4 Reporting Venues and Outreach, and Community Involvement in Research

Policy I6 Disclosures and Management of Personal and Institutional Interests in Human Subjects Research



Policy II1 Recruitment, Appointment, Terms and Evaluation of IRB Members and Chairs



Policy II3B Data and Safety Monitoring


Policy II5 IRB Requirements for Record-keeping, and Biological Specimen Retention and Transfer

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