Additional Resources

Agencies

U. S. Food and Drug Administration (FDA)

Office for Human Research Protections (OHRP)

Other Information

Department of Health and Human Services (HHS) Protection of Human Subjects Regulations 45 CFR 46

FDA Information Sheets

Belmont Report

Declaration of Helsinki

Nuremberg Code

Electronic Records 21 CFR 11 - These are the FDA regulations on the use of electronic records and electronic signatures in the FDA approval process.