Annex 5 Informed Consent Capacity/Competency A patient must be competent to consent to an examination or procedure. Competency refers to a patient’s mental ability to understand the nature of information discussed related to the examination and appreciate the consequences of any decision taken. In many jurisdictions, minors26 are presumed to be incompetent to consent and the informed consent of a parent or guardian will be required prior to any procedure or examination. In this regard, also the provisions of the Convention of the Rights of the Child should be respected, in particular Article 3 related to the best interest of the child and Article 12 related to the right to participate in decision-making processes that may be relevant in their lives and to influence decisions taken in their regard. Information The duty to provide adequate information to the patient regarding the examination rests with the examiner. The language used should clarify rather than confuse. Avoid using professional jargon. When informed consent is sought from a child the language should be appropriate for the child’s age and development. 36 from undue coercion and that, to the extent feasible, the examination be conducted in a context that allows voluntary choice. Information should clearly indicate that the patient can choose to participate or not • T he type and duration of examination; how it will be carried out • The process: describe or explain the exact process that will be followed on a step-by-step basis, including approximate duration • Potential risks: Explain and describe any possible risk, describe possible actions that can be undertaken and limitations in case something goes wrong • The possibilities and limitations of the mission • • The use of evidence • Contact persons Confidentiality procedures: the patient should be informed of confidentiality procedures for sensitive information and which, if any, third parties will have access to records produced during the examination Information includes: Consent • • Only if the above issues have been addressed and the patient has fully understood the information can she or he be asked to give consent. Consent should be obtained for the examination or procedure and separately for any The purpose of the examination oluntary participation: a patient V must voluntarily agree to participate in an examination or procedure. This requires that the patient be free