Embryo research

Research on the human embryo aims to gain a better understanding of embryonic development, to study certain genetic diseases or to find solutions to infertility. It can only be carried out on embryos conceived in vitro as part of medically assisted procreation, which are no longer the subject of a parental project, and for which the couple or woman concerned has consented to the research. Such research is only possible for medical or scientific purposes, when no other alternative method can be envisaged with equivalent results. The law sets clear limits, including the prohibition on creating embryos for research purposes and the maximum duration of in vitro embryo culture.

Human embryonic stem cells are used for their ability to differentiate into various cell types, opening up new perspectives in the understanding of diseases and regenerative medicine. Their use and conservation for research purposes are subject to declaration, and their import or export is subject to specific authorizations issued by the Agence de la biomédecine, in compliance with the ethical principles defined by law.

The Agence de la biomédecine's main missions in this area include :

• Issuing research authorizations: the Agency examines applications for embryo research protocols and issues authorizations after assessing scientific relevance, scientific and medical purposes, and compliance with ethical principles;
• Authorization for embryo storage: when embryos are stored for research purposes outside medical biology laboratories authorized by regional health agencies, the Agency issues the necessary authorizations, ensuring compliance with safety standards and ethical principles;
• Authorization to move human embryonic stem cells: any project involving the import or export of human embryonic stem cells for research purposes must obtain prior authorization from the Agency;
• Examination of declarations of research projects using human embryonic stem cells: the Agency can oppose the start of research within two months if it does not meet the conditions defined by law; ;
• Control and vigilance: the Agency can suspend or withdraw authorizations in the event of non-compliance with legal provisions. It carries out inspections, with the support of independent experts, to monitor the conditions under which authorized research is carried out.

The Agency provides project sponsors with model dossiers, guides and practical documents detailing the steps to follow when applying for authorization or declaring a research project. These tools facilitate the preparation of research protocols, while ensuring compliance with the regulatory framework.