THE RISK ASSESSMENT REQUIREMENTS CAN BE MET IN THE ETHICAL EVALUATION OF A RESEARCH PROTOCOL INVOLVING HUMAN BEINGS

Risk assessment is an inescapable stage for the approval of a non-therapeutic research protocol involving human subjects. However, this evaluation is very difficult and many specialists believe that human subjects are insufficiently protected against ethically unacceptable experiments. It is possible that difficulties encountered during this evaluation are the result of a bad definition of the concept of "risk", a definition that ignores some fundamental characteristics of risk and which brings into question its quantifiable and predictable nature: 1) the quantification of risk, 2) anticipation of risk and 3) the establishment of a level of risk beyond which an experiment becomes ethically unacceptable.