Regulations and Guidance
Belmont Report
Office of Human Research Protection (OHRP)
Title 45 CFR 46: Protection of Human Subjects
OHRP Policy and Guidance
OHRP Decision Charts
OHRP Compliance Oversight
OHRP International Activities Program
Food and Drug Administration (FDA)
21 CFR Part 50 - Protection of Human Subjects
21 CFR Part 56 - Institutional Review Boards
21 CFR Part 312 - Investigational New Drug Applications (INDs)
21 CFR Part 812 - Investigational Device Exemptions (IDEs)
Running Clinical Trials
Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors
Guide to Informed Consent - Information Sheet
IRB FAQs Information Sheet
MedWatch: The FDA Safety Information and Adverse Event Reporting Program
National Institutes of Health (NIH) (FDA)
National Library of Medicine
National Human Genome Research Institute (NHGRI)
Resources for the Public
Resources for Research Subjects
Resources at Adventist Healthcare, Inc.
