Contact Information

Organization

THE COMMITTEE ON HUMAN RESEARCH

FEDERAL REGULATIONS AND GUIDANCE - Regulations, Policies, and Reports (links to sites outside UCSF)

Office for Human Research Protections
	•	Protection of Human Subjects 45 CFR 46 - OPRR
	•	Protecting Human Research Subjects: Institutional Review Board Guidebook (NIH/OPRR)
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
	•	Office of Biotechnology Activities
	•	NIH Protection of Human Research Subjects On-Line Training Module
		•	Frequently Asked Questions
	•	NIH Registry of Clinical Trials
	•	Certificate of Confidentiality Kiosk
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
	•		International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)