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HELPFUL WEB LINKS

Code of Federal Regulations Title 21 Part 50 (Food and Drug Administration) Protection of Human Subjects

Code of Federal Regulations Title 21 Part 56 (Food and Drug Administration) Institutional Review Boards

Code of Federal Regulations Title 45 Part 46 (Department of Health and Human Services) Protection of Human Subjects

Code of Federal Regulations Title 21 Part 312 (Food and Drug Administration) Investigational New Drug Application

Code of Federal Regulations Title 21 Part 812 (Food and Drug Administration) Device Exemptions

Office of Human Research Protections (OHRP) IRB Guidebook

Department of Health and Human Services Summary of the HIPAA Privacy Rule

The Belmont Report: Ethical Principles and Guidelines for the Protection of Human subjects of Research