An independent body (a review board or a committee, institutional, regional national or supranational), constituted of medical/scientific professionals and non-medical / non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial to provide public assurance of that protection by, among other things, reviewing and approving / providing favorable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.