Improving practices regarding information, consent and non-opposition in health genetics in France – INFOGENETIC-FR

The current sequencing technologies used in genetics and the massive data generated in healthcare and research are challenging patients' rights to prior information, consent and non-opposition. Respect for autonomy is an ethical and legal requirement in France, which means that individuals must participate in decisions concerning their health. In the case of genetics, these requirements are heightened because the information provided may be predictive, shared with part of family members, requires specific informed consent prior to the test, implies rigorous (multi)professional support for the interpretation and communication of results, and has its own timeframe. In this context: do the practices of information, consent and non-opposition in genetics meet the customs and expectations of the parties involved, and do they comply with French law? Is consent given as part of a genuine co-decision process? Are practices consistent across all medical specialities and reseearch in France? The aim of our transdisciplinary research is to encourage the emergence of an informed choice from people undergoing genetic analysis. We are using participatory, human and social science and public health approaches to 1/define the concepts of information, consent and non-opposition in genetics, 2/assess practices (geneticists and other prescribers, Personal Protection Committees, experiences of patients/research participants) and 3/improve existing information and decision-making tools and produce new ones if necessary in a co-construction approach, with stakeholders, in order to clarify the information processes required prior to any consent or non-opposition. More generally, our results will help to improve public health policies for the benefit of patients, their families and professionals.