Issued in 1974, 45 CFR 46 Raised to Regulatory Status

In 1974, the National Research Act established the first national regulations on the protection of human research participants. The Act included regulations that later became known as the Common Rule, 45 CFR 46. 45 CFR 46 is a set of federal regulations outlining requirements for federally-funded research that involves human participants. These regulations are binding on all institutions that receive funding from a Common Rule agency. Since 1974, the Common Rule has become a critical element in U.S. efforts to protect human research participants.

The Common Rule outlines general requirements for protecting human research participants and sets out specific requirements for informed consent, institutional review board review, and more recently, the monitoring of clinical trials. It applies to research that is supported by any federal department or agency, with certain exemptions. 45 CFR 46 is now commonly referred to as the “Common Rule” because the same basic requirements are used by all federal departments and agencies that fund research with human participants.

45 CFR 46 provides a crucial layer of protection for human research participants. It defines the duties of researchers and institutions to protect participants and outlines procedures for obtaining informed consent and ethical review by institutional review boards. In addition, the Common Rule requires that research be monitored to ensure that participants are not exposed to any unnecessary risks. These requirements have become essential to protecting the safety and rights of human research participants.

The Common Rule is widely recognized as a national standard for protecting human research participants. It has been adopted by the majority of states, and it is referenced by professional societies, universities, and other organizations. 45 CFR 46 has become a central part of U.S. efforts to safeguard the rights and safety of research participants, and its importance cannot be overstated.