[Research ethics: French regulations and applications in radiation oncology]

Cancer Radiother. 2020 Jul;24(4):306-315. doi: 10.1016/j.canrad.2020.02.012. Epub 2020 Jun 1.
[Article in French]

Abstract

French regulations about research ethics are based on the so-called Jardé law, which defines researches involving human beings. Researches involving human beings require the submission of research protocols to a committee for protection of persons with a precise list of documents to submit for a favourable opinion. This law describes different categories of researches and determines the ethical procedures to apply before setting up a research protocol. This issue of categorisation is central and must be taken into account by researchers from the beginning of the research process. Researches considered as not involving human beings also require a set of ethical precautions focused on patients' information and the collection of their non-opposition (due to the application of the General Data Protection Regulation adopted by the European Parliament). Thus, many regulations exist and they require a real work for researchers to meet these requirements in research ethics. This article aims to summarise French regulations. Selected examples are specifically taken into the field of radiation oncology research.

Keywords: Comité de protection des personnes; Committee for Protection of Persons; Ethics; Human beings; Oncologie radiothérapie; Personne humaine; Radiation oncology; Recherche; Research; Éthique.

MeSH terms

  • Biomedical Research / ethics
  • Biomedical Research / legislation & jurisprudence
  • Ethics, Research*
  • France
  • Government Regulation*
  • Humans
  • Patient Safety / legislation & jurisprudence
  • Radiation Oncology / ethics*
  • Radiation Oncology / legislation & jurisprudence
  • Research Subjects / legislation & jurisprudence