۳٫۱ The informed consent of the patient is a prerequisite for any medical intervention.
۳٫۲ A patient has the right to refuse or to halt a medical intervention. The implications of refusing or halting such an intervention must be carefully explained to the
patient
۳٫۳ When a patient is unable to express his or her will and a medical intervention is urgently needed, the consent of the patient may be presumed, unless it is obvious from a previous declared expression of will that consent would be refused in the situation.
۳٫۴ When the consent of a legal representative is required and the proposed intervention is urgently needed, that intervention may be made if it is not possible to obtain, in time, the representative’s consent.
۳٫۵ When the consent of a legal representative is required, patients (whether minor or adult) must nevertheless be involved in the decision-making process to the fullest extent which their capacity allows.
۳٫۶ If a legal representative refuses to give consent and the physician or other provider is of the opinion that the intervention is in the interest of the patient, then the decision must be referred to a court or some form of arbitration.
۳٫۷ In all other situations where the patient is unable to give informed consent and where there is no legal representative or representative designated by the patient for this purpose, appropriate measures should be taken to provide for a substitute decision making process, taking into account what is known and,, to the greatest extent possible, what may be presumed about the wishes of the patient
۳٫۸ The consent of the patient is required for the preservation and use of all substances of the human body. Consent may be presumed when the substances are to be used in the current course of diagnosis, treatment and care of that patient.
۳٫۹ The informed consent of the patient is needed for participation in clinical teaching.
۳٫۱۰ The informed consent of the patient is a prerequisite for participation in scientific research. All protocols must be submitted to proper ethical review procedures. Such research should not be carried out on those who are unable to express their will, unless the consent of a legal representative has been obtained and the research would likely be in the interest of the patient.
As an exception to the requirement of involvement being in the interest of the patient, an incapacitated person may be involved in observational research which is not of direct benefit to his or her health provided that that person offers no objection, that the risk andfor burden is minimal, that the research is of significant value and that no alternative methods and other research subjects are available.