Reglementation and Ethics

Reglementation

I-Stem participates, directly or indirectly, only in programs authorized by the Biomedicine Agency and carried out under its control.

Research on the embryo has been authorized in France since 2013, after a period of 9 years during which the law of bioethics revised in 2004 and then in 2011 allowed us to carry out research under conditions, by way of derogation from a prohibition that persisted. These conditions were essentially maintained, though now attached to a formal authorization, in 2013 and are placed under the control of the Biomedicine Agency, which is responsible for evaluating import, storage and utilization files for cell research. The law stipulates that: – the research must be justified by a major medical interest, – it must aim at questions whose scientific relevance is proven; – it should not be possible to conduct comparable studies using non-embryonic cells; – the rules of ethics must be scrupulously respected, especially as regards the signing of informed consents by the donor couple. This research is strictly supervised by the Biomedicine Agency, which ensures at each stage that it complies with the legal framework and ethical rules.

Thus, all the research carried out on human embryonic stem cell lines, as on the cells of various phenotypes derived from these lines, must be aimed at the exploration of mechanisms or at the development and validation of therapeutics applicable to human embryonic stem cell lines. serious diseases. The laboratory, within the framework of the I-Stem project, benefitted from the first authorization issued by the Biomedicine Agency for the importation into France of hES lines coming from abroad in 2005. Inspected by the Agency on a regular basis, I-Stem benefited from an entirely favorable report after each visit, without any request for modification, both for its facilities, its procedures and for the respect of its project commitments. he embryo research is currently banned in France. By way of derogation, the revised bioethics law in 2011, however, allows the realization of research justified by a major medical interest, provided that the relevant scientific studies is justified, it is not possible to conduct similar studies in the using cells from an embryo and not the rules of ethics are respected, particularly with regard to the signing of informed consent by the couple whose embryo came they sought their destruction before one is proposed possible use for research. This research is strictly supervised by the Biomedicine Agency ensures that at each stage of their compliance with legal and ethical rules.

 

Ethics

I-Stem researchers regularly participate in debates on ethical reflection on the scientific work and medical perspectives of human embryonic stem cell research. The Scientific Director of I-Stem and the Scientific Director of UMR 861 are regularly auditioned by the various committees and councils whose opinion is requested by the Parliament on these subjects, as well as the hearings carried out by the elected representatives of the National Assembly and Senate. This was again the case in 2018 as part of the work leading to further revisions of the Bioethics Laws. Cécile Martinat also represented the French Society of Research on Stem Cells (FSSCR) of which she is president-founder.