In the development of clinical research guidelines and regulations over the past 60 years, those relating to research ethics have deserved special attention. Among these, all those referring to the role that independent committees—i.e., research ethics committees (RECs) in Europe or institutional review boards (IRBs) in the United States —in reviewing and approving clinical trial protocols and other documents, such as participant information sheets and informed consent forms (PIS/ICF)— have been the subject of multiple revisions on both sides of the Atlantic.
