IRB Resource Guide
The IRB Resource Guide includes sources from which the ethical principles for conducting human research originated, and significant federal regulations.
Examples of Auxiliary Regulations/Policy
Department of Health and Human Services (DHHS)
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]
- FDA Guidance for Clinical Investigators, Sponsors, and IRBs: Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND
- Summary of FDA Regulations on Exemption from IND Requirements [PDF]
- Summary of FDA Regulations on Investigational Device Exemptions and Exemption from IDE 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 [PDF]
- U.S. Dept. of Education/Protection of Pupil Rights Amendment (PPRA) [PDF]
- Summary of Department of Education (DoED) Requirements [PDF]
- Summary of Department of Energy (DoE) Requirements [PDF]
- Summary of Department of Justice (DoJ), National Institute of Justice (NIJ), and Bureau of Prisons (BoP) Requirements [PDF]
- U.S. Department of Veteran Affairs
- Summary of Environmental Protection Agency (EPA) Requirements [PDF]
- University of Kentucky (UK) Family Educational Rights and Privacy Act (FERPA) Guidance [PDF]