Regulations, Policies, and Reports

Office for Human Research Protections

• Protection of Human Subjects 45 CFR 46 - OPRR
• Protecting Human Research Subjects: Institutional Review Board Guidebook (NIH/OPRR)
• Certificates of Confidentiality

Food and Drug Administration

• FDA Information and Regulations
• Good Clinical Practice in FDA-Regulated Clinical Trials
• Protection of Human Subjects 21 CFR 50
• Institutional Review Boards 21 CFR 56
• Investigational New Drug Application 21 CFR 312
• Investigational Device Exemptions 21 CFR 812
• Code of Federal Regulations
• Center for Drug Evaluation and Research - Information for Clinical Investigators

National Institutes of Health

• Frequently Asked Questions
• Office of Biotechnology Activities
• NIH Registry of Clinical Trials

Ethical Principles and Codes

• National Bioethics Advisory Commission
• Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
• Nuremberg Code
• World Medical Association Declaration of Helsinki

Health

• HIPAA
• UNLV Human Subjects Policy PDF