Office for Human Research Protections (OHRP)
Access OHRP federal regulations for Protection of Human Research Subjects or obtain a list of guidance topics from OHRP:
45 CFR 46 DHHS Regulations: This part applies to institutions and investigators that are engaged in human subjects research that is supported or conducted by the Department of Health and Human Services.
- OHRP Decision Charts provides graphic aids as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46 . The charts address decisions on whether an activity is research that must be reviewed by an IRB, among other topics (referenced in other sections of this guide).
45 CFR 164 HIPAA Regulations: This part applies to investigators using protected health information during the course of a clinical investigation.
OHRP Federal Guidance by Topic
OHRP 2015 Edition of the International Compilation of Human Research Standards
U.S. Food and Drug Administration (FDA)
Access FDA federal regulations for Protection of Human Research Subjects, Information Sheets, information on early/expanded access to unapproved devices, applications and information on IND, NDA, biologic license and premarket approval: