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  • Title: Law No. 88-1138 on the protection of persons participating in biomedical research, 20 December 1988.
    Author: France.
    Journal: Annu Rev Popul Law; 1988; 15():207. PubMed ID: 12289409.
    Abstract:
    Provisions of this French Law relating to biomedical research performed on pregnant women and children are as follows: "Article L. 209-4. Research without direct therapeutic objectives on pregnant or breast-feeding women shall not be permitted unless there is no foreseeable risk to the health of the woman or of the child and it is relevant to knowledge of phenomena associated with pregnancy or breast-feeding. Article L. 209-6. Minors, majors subject to guardianship, persons staying in a health or welfare establishment, and patients constituting emergency cases may not be requested to participate in biomedical research unless direct benefit for their health may be anticipated. Nevertheless, research without direct therapeutic objectives may be permitted if the following three conditions are met: such research does not entail any serious foreseeable risk to the health of such persons; it is of benefit to persons displaying the same characteristics of age, disease, or disability; and it cannot be carried out otherwise. Article L. 209-10. If biomedical research is carried out on minors, or on majors subject to guardianship: consent shall be given in accordance with the rules laid down in Article L. 209-9 of this Code by the persons entitled to exercise parental authority on behalf of unemancipated minors. In the case of minors or majors subject to guardianship, consent may be given by the guardian to research with direct therapeutic objectives not involving any serious foreseeable risk and in other cases by the guardian authorized by the Family Council or the judge supervising guardianship; and the consent of the minor or of the major subject to guardianship shall also be sought if he is capable of exercising judgment. His refusal or revocation of consent may not be disregarded."
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