Informed consent
Domain : Involvement in research
Category : My daily life
Simplified definition
An agreement freely given, by words or actions, by someone to participate in a clinical trial. The person must be clearly informed of the purpose of the study, the time it will take, the method that will be used, and the potential risks.
Source: Houria Aiouaz, for Alzheimer Foundation
Referenced definition
“Since the Nuremberg Code (1947), consent has been an essential principle, both legal and ethical, in the practice of biomedical research on humans. Anyone who takes part in biomedical research must have been clearly informed – orally and in writing – and must have given their consent in the form of a signed document.”
Source: Philippe Amouyel, General Manager of the Alzheimer Foundation
Context
“The [informed] consent of the person examined or treated must be sought in all cases. When the patient, in a state to express his wishes, refuses the investigations or treatment proposed, the doctor must respect this refusal after having informed the patient of its consequences. If the patient is unable to express his wishes, the doctor cannot intervene without the person of trust, failing which, the family or one of his relatives has been notified and informed, except in an emergency or if this is impossible.”
Source: A translation of the article R.4127-36 of the French public health code.