Council for international organizations of medical sciences perspectives: protecting persons through international ethics guidelines

The purpose of guidelines in the field of medical ethics is to help physicians to make the best decisions or follow the right course of action in difficult medical situations. For other guidelines, the purpose is to help investigators, sponsors and Institutional Review Boards (IRB) or the equivalent to design, support or approve only studies involving human beings that fulfil a set of conditions, principally the scientific validity of the project, the protection of the participants and the respect of their rights, including that of giving their free informed consent. They are not algorithms or decision trees to deal with a disease, or recipes to conceive a hypothesis, and then write a protocol to confirm or reject it. All these guidelines are derived from more basic general declarations and codes of conduct. The terminology used in these various documents to define the subjects of their consideration reflects the degree of generality or specificity.