“…To be eligible for such “fast-track” review, protocols must entail only “minimal risks” to participants. In an editorial to these two papers, Chassany [99] reminds us that the EU directive and all provisions it sets up cover only the area of drug research, and that the rest of clinical research, on medical devices, surgery, pathophysiology, etc., is totally left out. This is a major cause for the heterogeneity of ethical review within the EU.…”