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

Cancer Radiother

Service de pharmacologie médicale, comité de protection des personnes Sud-Ouest et outre-mer III, hôpital Pellegrin, centre hospitalier universitaire de Bordeaux, 33076 Bordeaux, France; Faculté de pharmacie, université de Bordeaux, 146, rue Léo-Saignat, 33076 Bordeaux, France.

Published: July 2020

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.

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.canrad.2020.02.012DOI Listing

Publication Analysis

Top Keywords

french regulations
12
involving human
12
human beings
12
researches involving
8
beings require
8
[research ethics
4
ethics french
4
regulations
4
regulations applications
4
applications radiation
4

Similar Publications

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!