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Institutional Review Board
Regulations and Guidance
Regulations for the Conduct of Human Subjects Research
Office for Human Research Protections (OHRP): 45 CFR 46
FDA Regulations Search
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FDA Regulations: Protection of Human Subjects (21 CFR 50)
FDA Regulations: Institutional Review Board (21 CFR 56)
FDA Regulations: Investigational New Drug Application (21 CFR 312)
FDA Regulations: Investigational Device Exemptions (21 CFR 812)
FDA Regulations: Premarket Approval of Medical Devices (21 CFR 814)
FDA Regulations: Financial Disclosure by Clinical Investigators (21 CFR 54)
The Privacy Rule (HIPAA): 45 CFR 164, Subpart E
14 CRR-NY 27.10
(mental health patients in NY)
International Compilation of Human Research Standards
Additional Regulations that Impact the Conduct of Human Subjects Research
NYS Civil Rights Law: Section 79-1
(genetic research)
Protection of Pupil Rights Amendment (PPRA)
(34 CFR 98) (student surveys)
Family Educational Rights and Privacy Act (FERPA)
(34 CFR 99) (student records)
NJSA 18A:36-34
(student surveys in NJ)
Federal Guidance for the Conduct of Human Subjects Research
OHRP Policy & Guidance Index
Selected FDA GCP/Clinical Trial Guidance Documents
Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors
ICH Guidance Documents
GCP/Clnical Trial Notices