[Requests for genetic characteristics analysis by sequencing in clinical research: Legal and ethical considerations]

More and more practitioners are being led to propose to their patients an analysis of their genetic characteristics (structural or functional genomics) either to confirm a diagnosis or to adapt a treatment (personalized medicine). Patients treated in hospitals are also offered analyses of their genetic characteristics either because they have not objected to their biological samples taken during care being used for research, or because they are included in a clinical study. The revised bioethics laws for application on 1/1/2021 provide a complete and clear framework for practices concerning genetics. However, most patients or healthy volunteers who have agreed (or not objected) to genetic testing are not aware of the potential consequences for them and their families. This is mostly due to a lack of information (inclusion of a sample without seeking express consent) or partial information due to either a lack of training of the prescriber himself or, in the context of clinical trials, an inadequate information leaflet. In order to help prescribers and evaluators of clinical trial applications to propose fair and clear information and consent letters to patients and thus ensure patient protection, we have produced an exegesis of the legal and ethical elements on which to base a proposal for genetic characteristics analysis. We include examples of requests for analysis of genetic characteristics, specifying the cases in which the research is authorized or not and mentioning the corresponding legal texts. We have generated here a useful pedagogical tool for all prescribers, researchers or simply French citizens.