Common Rule

Also known as the Federal Policy for the Protection of Human Subjects, the Common Rule was published in 1991 and codified in separate regulations by 15 Federal departments and agencies. For all participating departments and agencies the Common Rule outlines the basic provisions for IRBs, informed consent, and Assurances of Compliance. Human subject research conducted or supported by each federal department/agency is governed by the regulations of that department/agency. The head of that department/agency retains final judgment as to whether a particular activity it conducts or supports is covered by the Common Rule. – HHS