If we refer to the law of 5 March 2012, the context we can mention is the "research involving human person."
It brings together under a generic term three categories depending on the risk to research participants:
- interventional studies where it is possible to intervene in treatment decisions and that do not constitute the subject's usual care (Interventional Studies)
- interventional studies that present minimal risks and constraints and that do not involve pharmaceutical products, a list of which will be set out in a ministerial decision (Interventional Studies Presenting Minimal Risks)
- studies where it is not possible to intervene in treatment decisions and where the researcher observes treatment and results in a systematic manner without changing, influencing or interfering with diagnosis, treatment or monitoring (Observational Studies).
Last edited: 08/03/2013