ABSTRACT
The US Food and Drug Administration (FDA) statutes that are published in Title 21 of the Code of Federal Regulations (21 CFR) identify and define the activities involved in the clinical research process. These codified regulations are designed to protect the rights, safety, and welfare of subjects of clinical investigations. An amendment to Title 21, dated July 27, 1981, specifically required that the conduct of clinical investigations would include (1) obtaining the informed consent of all subjects and (2) approval of all research proposals by Institutional Review Boards (IRBs).
