Guidance & FAQs

The links on this page are meant to assist researchers in preparing their application for review of research involving human subjects.

• Office for Human Research Protections (OHRP)
  • 45 CFR 46
• Food and Drug Administration (FDA)
  • 21 CFR 50 - Protection of Human Subjects
  • 21 CFR 54 - Financial Disclosure by Clinical Investigators
  • 21 CFR 56 - Institutional Review Boards
  • 21 CFR 312 - Investigational New Drug Application
  • 21 CFR 812 - Investigational Device Exemptions
• Bill of Rights (doc)