Regulation in research ethics: a scarecrow for physicians?

Abstract

Background Regulations on research ethics in France have evolved considerably over the past four years: the implementation of the Jardé law and of the General Data Protection Regulations have changed the landscape of research ethics for research involving or not involving human persons. In a context of creation of an Institutional Review Board at the University of Bordeaux, France, we sought to explore research ethics practices and perceptions in the medical community of our University Hospital. Methods A short questionnaire was sent to all physicians of the University Hospital of Bordeaux. The questionnaire included closed questions and main topics were: physicians’ education in research ethics, ethics practices concerning researches non implying human persons, and physicians’ perceptions about current regulations. Results 86 questionnaires were sent back (response rate: 24.2%). If a majority of physicians have validated Good Clinical Practices (GCPs) trainings (76%), there was a low rate of specific training on fundamental references in research ethics and a high proportion of responders do not consider themselves as educated in research ethics after completion of GCPs (56%). Regulations on research ethics have many implications on medical research, especially by inducing changes in protocols in order to alleviate ethical requirements (57%). Malpractices were acknowledged like false mention of positive opinion from an ethics committee (21%). If If a majority of responders considers regulations as a positive answer to research ethics, a large majority considers it as a constraint and a complexification of research process. For 58%, regulations in research ethics are perceived as a hindrance for research initiatives. Conclusion Because of their impact on research process, regulations seem to constitute a scarecrow for physicians. Lack of training, bad representations and questionable practices (or even malpractices) highlight the need to improve education and to propose concrete guidance for medical researchers.