Also known as 45CFR46, the Common Rule is federal legislation that protects human research subjects. It relies on the process of informed consent, which is designed to make sure research subjects understand what will happen to them in the course of research. Close Window
Volume 45, U. S. Code of Federal Regulations, Chapter 46 (45CFR46) covers medical research protections for patients. The main thrust of these rules is to protect patients from physical injury, in case they participate in research that might injure them. HIPAA is a supplement, added to protect patients from breach of confidentiality of their medical information.
The "Common Rule" refers to Federal statutes governing the protection of human subjects in research, enacted in 1991 and adopted by 17 Federal agencies. The Common Rule is set forth in the Code of Federal Regulations, 45 CFR 46, and covers all federally funded research supported by the Departments of Agriculture, Energy, Commerce, HUD, Justice, Defense, Education, Veterans Affairs, Transportation, and HHS, as well as NSF, NASA, EPA, AID, Social Security Administration, CIA, and the Consumer Product Safety Commission. The provisions are identical to the DHHS Regulations (45 CFR 46, Subpart A).
The common federal policy for protecting human subjects, promulgated in regulation and contained in the CFR, that outlines the provisions regarding the review and approval of research, is generally referred to as the "Common Rule". It was signed by 17 federal agencies which are thus bound by it.