Droit des personnes dans les études de recherche clinique et particularités de l’oncologie (en France)

Abstract

Purpose. – Clinical research in oncology is part of the care, instead of being theoretical, because it can offer new drugs to patients who are suffering from severe illnesses, but also because it offers better practices. The vulnerability of patients suffering from cancers, at each stage of the disease, requires special protection. Because of its multiple aspects, clinical research in oncology asks ethical questions. Medical deontology and laws, national and supranational, allow research with respect to the subject. The present article reviews these texts. Current knowledge and key points. – The rights of the person involved in clinical trials essentially consist of information and consent, but also the right to refuse, and the confidentiality of data collected. More subtle rights are now emerging because of new technologies, such as genetics. One of them is the right to be protected as a member of the human race, which is in continuity with human rights. Future and projects. – Finally, medical responsibility during research is increasing. It responds to the right of each person to see that his dignity is respected, although this dignity may be difficult to define. One of the more pertinent questions in building ‘evidence-based ethics’ concerns research into the evaluation by the persons themselves involved in the research.