Profili legali della sperimentazione clinica

Abstract

The iter of a clinical trial includes some steps: except for the earliest one, the preclinical phase, each step involves human beings that could be exposed to adverse events or unknown reactions caused by the new treatment. Starting from Nuremberg Code in 1949, an in-depth legislation has been developed to define the relationship between the two protagonists of the clinical trial: the experimenter and the volunteer or patient who takes the new drug. Responsibilities and possible faults are established, taking into account patient’s rights to be preserved and informed of the risks and experimenter’s responsibility in case of not-predictable side effects.