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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.