The trial protocol should be considered by an ethics review board. The board will generally be established at an institutional level but boards existing at a regional or national level can also be used. The board will be an independent body constituted of both medical and non-medical members who are not involved in the experimental activity of the trial under review. The board will verify that the rights of the patients participating in the trial are protected and that the trial is justified in medical and social terms. The board will also consider the suitability of the trial protocol, patient selection and patient protection, and issues of informed consent of patients. The work of the board should be guided by the World Medical Association’s Declaration of Helsinki (Annex 2).
The board will work under standard operating procedures which will be developed by each institution taking into consideration all necessary requirements of local regulatory authorities and related governmental agencies including such rules as those for Good Clinical Practice (GCP).