Regulations and Guidance
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:
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:
|Click HERE to search the FDA's CFR Title 21 database|
Belmont Report: The fundamental ethical principles for all human subject research – respect for persons, beneficence, and justice.
Declaration of Helsinki: The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.
Good Clinical Practice (GRP) and Good Laboratory Practice (GLP)
HIPAA for Research