Office for Human Research Protections (OHRP)

• OHRP Home Page
• OHRP Guidance Documents
• Human Subject Regulation Decision Charts
• Federal Regulations for Research with Human Subjects - Department of Health and Human Services, 45 CFR, Part 46 Including Subpart D, Additional DHHS Protections for Children Involved as Subjects in Research IRB Guidebook for Protecting Human Research Subjects
• The Belmont Report
• The Nuremberg Code
• The World Medical Association Declaration of Helsinki
• Expedited Review Categories

U.S. Food and Drug Administration (FDA)

• FDA Home Page
• Protection of Human Subjects: FDA Regulations, 21 CFR, Part 50
• Institutional Review Boards: FDA Regulations, 21 CFR Part 56
• FDA Information Sheets: Guidance for IRBs and Clinical Investigators
• International Conference on Harmonisation - ICH Guidelines

Policies, Commissions, and Task Forces

• National Bioethics Advisory Commission (NBAC)

Miscellaneous

• The National Library of Medicine Clinical Trials - Provides patients, family members, and members of the public with current information about clinical research studies, in collaboration with all NIH institutes and the FDA.
• Centerwatch Clinical Trials Network - Listing service for clinical trials.