These Guidelines are intended to facilitate and support ethical review in all countries around the world. They are based on a close examination of the requirements for ethical review as established in international guidelines, as well as on an evaluation of existing practices of ethical review in countries around the world.
They do not, however, purport to replace the need for national and local guidelines for the ethical review of biomedical research, nor do they intend to supersede national laws and regulations.
The objective of these Guidelines is to contribute to the development of quality and consistency in the ethical review of biomedical research.
The Guidelines should be used by national and local bodies in developing, evaluating, and progressively refining standard operating procedures for the ethical review of biomedical research.