The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) have passed regulations regarding human subjects research (45 CFR Part 46 and 21 CFR Parts 50 and 56). DHHS, through its Office for Human Research Protections (OHRP), and the FDA also issue periodic guidance documents for institutions and investigators. Sections of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule at 45 CFR Part 160 and Part 164 are also relevant to IRB review of research. Questions regarding the regulations or guidance documents may be directed to ORIP at (715) 389-3022.
Department of Health and Human Services Office for Human Research Protections (OHRP)
Regulation - 45 CFR 46 Protection of Human Subjects
OHRP Policy and Guidance Library
Guidance - Categories of Research That May Be Reviewed By The IRB Through Expedited Review
Food and Drug Adminstration (FDA)
Guidance - 21 CFR 50 Protection of Human Subjects
Guidance - 21 CFR 56 Institutional Review Boards