Enjeux éthiques et temporalité de l'information des patients sur les résultats des recherches cliniques

In 2004, French law established a right for patients participating in a clinical trial to be informed of the results of the research. However, no standardized process has been established to provide such results to the patient. The terms relating to the communication of the results to the patient are defined by each promoter in the informed consent or in the information leaflet provided to the patient when the patient agrees to participate in the clinical trial and will vary from one informed consent, or leaflet, to another. Furthermore, the timing of the research is different to the patient's timing, with the results generally only being available a long time after the patient participated in the trial. Our focus is based on the communication of results to patients suffering from hematologic disease. A review of the relevant literature shows that few papers have been published on this topic. We will undertake a qualitative study by semi-structured interviews with healthcare professionals working in haematology and doing clinical research with and haematological patients participating in a trial. The originality of our work is to have associated patients to our questioning. The objective is to describe how communication of trial results is perceived by patients and to identify ethical issues on communicating this information to the patient. This focus opens to new perspectives on the meaning of participating to a clinical trial, the link between the individual and the general interests and the relation to the others from an individual perspective.