Resources and Regulations

The following links provide more information on the regulatory foundations and the ethical codes that guide human research and links to federal guidance on special topics.

• 45 CFR 46 Human Subject Regulations (DHHS) Code of Federal Regulations- Public Welfare: Protection of Human Subjects 
• Subpart A: Federal Policy for the Protection of Human Subjects 
• Subpart B: Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research 
• Subpart C: Additional DHHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects 
• Subpart D: Additional DHHS Protections for Children Involved as Subjects in Research 
• 21 CFR Part 50 - Protection of Human Subjects 
• 21 CFR Part 56 - Institutional Review Boards

• Belmont Report 
• The World Medical Association (WMA) – Declaration of Helsinki  
• Nuremberg Code

• Office of Human Protections (OHRP) Guidance Library 
• FDA Guidance: E6(R2) Good Clinical Practice 
• International Conference on Harmonization (ICH), Good Clinical Practice Guidelines

• DHHS Office for Human Research Protections (OHRP) 
• DHHS Office of Research Integrity 
• FDA Center for Drug Evaluation and Research (CDER) 
• FDA Center for Biologics Evaluation and Research (CBER) 
• FDA Center for Devices and Radiological Health (CDRH) 
• FDA: Laws, Regulations, Policies and Procedures for Drug Applications 
• National Cancer Institute (NCI)