French Public Health Code
In forceI.- Unemancipated minors, protected adults or adults who are unable to express their consent and who are not the subject of a legal protection measure shall, when their participation in research involving the human person is envisaged, receive the information provided for in Article L. 1122-1 adapted to their capacity for understanding, both from the investigator and from the persons, bodies or authorities responsible for assisting them, representing them or authorising the research, who are themselves informed by the investigator.
They are consulted as far as their condition allows. Their personal agreement to participate in research involving the human person is sought. In any event, their refusal or revocation of their consent cannot be ignored.
II -Where research involving the human person is carried out on an unemancipated minor, consent, where required, is given by the holders of parental authority. However, consent may be given by the only person exercising parental authority present, subject to compliance with the following conditions:
-the research involves only minimal risks and constraints ;
-the minor does not lend himself or herself to the research as a healthy volunteer;
-the other person exercising parental authority is unable to give authorisation within a timeframe compatible with the methodological requirements of the research in relation to its aims.
When a minor participating in research becomes of age during the course of his or her participation, confirmation of his or her consent is required after appropriate information has been provided.
When research involving the human person is carried out on a minor, who may be under guardianship, authorisation is given by the minor's legal representative and, if the committee referred to in Article L. 1123-1 considers that the research entails a serious risk of infringing privacy or the integrity of the human body due to the extent of the constraints or the specific nature of the interventions to which it leads, by the family council if it has been set up, or by the guardianship judge.
When, at the end of the research, the minor who has undergone the research has acquired legal capacity, he or she becomes the personal recipient of any information communicated by the investigator or the sponsor.
III - A person under legal protection may not be asked to participate in research involving the human person.
When research involving the human person is carried out on an adult under guardianship, consent is given by the person concerned assisted by their guardian. However, if a person of full age under guardianship is asked to take part in research which the committee mentioned in article L. 1123-1 considers involves a serious risk of infringing privacy or the integrity of the human body, due to the extent of the constraints or the specific nature of the interventions to which it leads, the guardianship judge is asked to ensure that the person of full age is capable of giving consent. In the event of incapacity, the judge decides whether or not to authorise research involving the human person.
When research involving the human person is carried out on a person of full age who is the subject of a future protection mandate, a family power of attorney or a guardianship measure, with representation relating to the person, authorisation is given by the person responsible for representing him or her. However, if the committee referred to in article L. 1123-1 considers that the research entails a serious risk of infringing the privacy or integrity of the human body, due to the extent of the constraints or the specific nature of the interventions to which it leads, authorisation is given by the family council if it has been formed or by the guardianship judge.
When research involving the human person which satisfies the conditions laid down by article L. 1121-8 is planned on a person of full age who is unable to give consent and is not the subject of a legal protection measure, authorisation is given by the trusted support person provided for in article L. 1111-6 or, failing this, by the family or, failing this, by a person with whom the person concerned has a close and stable relationship. The person concerned is informed as soon as possible and asked to consent to any continuation of this research if he/she regains the capacity to consent. However, if the committee referred to in article L. 1123-1 considers that the research entails a serious risk of infringing privacy or the integrity of the human body, due to the extent of the constraints or the specific nature of the interventions to which it leads, authorisation is given by the guardianship judge.
IV - The consent provided for in the second paragraph of III is given in the form provided for in Article L. 1122-1-1. The authorisations provided for in the first and sixth paragraphs of II and the third and fourth paragraphs of III are given in writing.
