definiens: or means an independent body ( a review board or a committee, institutional, regional, national, or su pranational ), constituted of medical professionals and non - medical members, whose responsibility it is to ensu re the protection of the rights, safety and well - be ing of human subjects involved in a trial and to provide public assurance of that protection, by, among other thing s, reviewing and approving / providing favorable opinion on, the trial protocol, the suitability of the investigato r(s ), facilities, and the methods and material to be used in obtainin g and documenting informed consent of the trial sub jects, all to the extent required by the Applicable Laws and R egulations or by the applicable Regulatory Authorit y. The legal status, composition, function, operations and regulatory requirements pertaining to IEC may diff er among countries, but should allow the Independent Ethics Committee to act in agreement with GCP as described in this guideline . 1.68 means a separate and distinct disease, disorder o r medical condition in humans or non - human animals classified as a three - character c ategory in International Statistical Classification of Diseases and Related Health Problems ( or ) 10 - CM published by the World Health Organization, for which a Product can be used to diagnose, treat or prevent, which us e is the subject of a separate Regulatory Filing to support a Regulatory Approval for such use