In this section
Regulations and guidance
The U.S. Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP), and the Food and Drug Administration (FDA) oversee the operations of the Institutional Review Board (IRB).
Guiding ethical principles in human subject research
The Food and Drug Administration (FDA)
Food and Drug Administration (FDA) website
21 CFR 50: Protection of human subjects
21 CFR 56: Institutional review boards
21 CFR 312: Investigational new drug application
21 CFR 314: Applications for FDA approval to market a new drug
21 CFR 601: Applications for FDA approval of a biologic license
21 CFR 812: Investigational device exemptions
21 CFR 814: Premarket approval for medical devices
FDA guidance for industry: Investigator responsibilities – Protecting the rights, safety, and welfare of study subjects
The Office for Human Research Protections (OHRP)
Good clinical practices (GCP)
Good clinical practice (GCP) guidelines - FDA
Good clinical practice – International conference of harmonization (ICH GCP)
HIPAA regulations with human subject research
45 CFR 164: HIPAA regulations