Abstract

In France, any request to carry out research involving human beings is evaluated by two distinct and independent structures: the ANSM (National Agency for the Safety of Health Products) and the CPP (Committees for the Protection of Persons). Those two bodies are decision-making bodies, since both must issue a favorable opinion before clinical research can be initiated. Within the next year, trials wishing to include French patients will be able to submit their clinical research application in any European country. However, even with this change in regulations, the ANSM and CPP will still have to approve the trial within France. The French CPPs are commonly referred to as ethics committees, since they analyze the research through the perspective of medical ethics. They have equivalents in most European countries. Amongst other things, they evaluate the following criteria: the honesty of the previous work on which the trial was proposed, the beneficence and foreseeable non-abuse towards the patient included (absence of unjustified analyses), the appropriateness of the trial (adequacy of the objectives and evaluation criteria), the adequacy of the human and material resources, and the fairness to the patient (clarity of information). These criteria may slightly differ from one country to another—a difference which has been particularly highlighted during the pandemic—leading to disparate degrees of allowance between European countries. There is competition between European countries for the organization of clinical trials, with each wanting to be the most attractive to sponsors of these trials. Thus, in order to ensure that the comparative strength or weakness of the criteria for approval of clinical research does not become a key determinant of the country in which clinical trials are conducted, it would be of particular interest for European ethical structures to harmonize their requirements.