The IRB Resource Guide includes sources from which the ethical principles for conducting human research originated, and significant federal regulations.
IRB Resource Guide
Ethics of Human Subjects Research
Basic IRB Regulations
Examples of Auxiliary Regulations/Policy
Department of Health and Human Services (DHHS)
OHRP Compliance Activities: Determinations of Noncompliance
Food and Drug Administration (FDA)
21 CFR 312 Investigational New Drug Application
21 CFR 812 Investigational Device Exemptions
Acute Care Waiver of Informed Consent Reference (PDF)
Summary of FDA Regulations on Exemption from IND Requirements (PDF)
Summary of FDA Requirements For Investigators Who Are Also Considered Sponsors of New Devices (PDF)
Summary of FDA Requirements For Investigators Who Are Also Considered Sponsors of New Drugs (PDF)
FDA Bioresearch Monitoring Program
Other Selected Agency Information
Summary of Requirements for Department of Defense Supported Human Research
U.S. Dept. of Education/Protection of Pupil Rights Amendment (PPRA)
Summary of Department of Education (DoED) Requirements
Summary of Department of Energy (DoE) Requirements
U.S. Department of Veteran Affairs
Summary of Environmental Protection Agency (EPA) Requirements
University of Kentucky (UK) Family Educational Rights and Privacy Act (FERPA) Guidance