French Public Health Code
In forceI.-Pursuant to III of Article 16-10 of the Civil Code, the examination of a person's genetic characteristics for scientific research purposes may be carried out using elements of that person's body taken for other purposes when that person, having been duly informed of the research programme within the meaning of Article L. 1243-3 of this Code, has not expressed his or her opposition.
Opposition to the examination provided for in the first paragraph of this I may be expressed without form as long as there has been no intervention on the element concerned as part of the research.
II.-In the event of the discovery of genetic characteristics which may be responsible for a condition justifying preventive or therapeutic measures for the person or members of his or her family who may be concerned, the person shall be informed, unless he or she has previously objected.
If, in the course of research, such genetic characteristics are discovered and, where applicable, confirmed by a medical biology laboratory authorised in application of article L. 1131-2-1, the doctor holding the person's identity, contacted by the person responsible for the research programme, will then inform the person, if he or she has not objected, of the existence of medical information concerning him or her and invite him or her to attend a consultation with a doctor qualified in genetics for treatment under the conditions laid down in Chapter I of this Title, without informing him or her of the genetic characteristics in question or the associated risks. The person may, without formality and at any time, object to being informed of such discoveries.
The doctor consulted by the person shall be informed by the person responsible for the research programme of the genetic characteristics in question.
III.-Where the person is a minor, the objection is expressed by the parents exercising parental authority or, where applicable, by the guardian.
Where the person is the subject of a legal protection measure with representation relating to the person, he or she expresses his or her objection alone insofar as his or her condition allows, where applicable assisted by the person in charge of the protection measure.
If the person cannot be found or is deceased or is unable to express his or her wishes and it is therefore impossible to provide the information provided for in the first paragraph of I, the research must be submitted for the opinion of a committee for the protection of individuals to which the person responsible for the research programme has recourse under the conditions laid down in Chapter III of Title II of this Book. This committee will assess the reasons why it is impossible to inform the person and will decide whether it is appropriate to examine his or her genetic characteristics in the light of this situation and the ethical and scientific relevance of the research.
IV.-This article does not apply to research where publication of the results is likely to allow the anonymity of the persons concerned to be lifted.
V.-A decree shall set out the procedures for informing the persons concerned and allowing them to express their opposition.
