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Regulations & guidance governing human subject research

• The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
• Code of Federal Regulations (FDA) Title 21, Part 50 [21 CFR 50] – Protection of Human Subjects
• Code of Federal Regulations (FDA) Title 21, Part 56 [21 CFR 56] – Institutional Review Boards
• Code of Federal Regulations (FDA) Title 21, Part 312 [21 CFR 312] – Investigational New Drug Application
• Code of Federal Regulations (FDA) Title 21, Part 812 [21 CFR 812] – Investigational Device Exemptions
• Code of Federal Regulations (DHHS) Title 45, Part 46 [“Common Rule” “Subpart A”] including Subparts B, C and D
• Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance (“ICH GCPs”)