ABSTRACT

The need of a widely accepted regulation in the field of medical and biomedical research has become more and more evident after the Second World War. In the treatment of a patient, where proven prophylactic, diagnostic, and therapeutic methods do not exist or have been ineffective, the physician, with informed consent of the patient, must be free to use unproven or new prophylactic, diagnostic, and therapeutic measures, if in the physician’s judgement it offers hope of saving life, reestablishing health or alleviating suffering. For all medical exposure of individuals for radio-therapeutic purposes, exposures of target volumes shall be individually planned, taking into account that doses to non-target volumes and tissues shall be as low as reasonably achievable and consistent with the intended radiotherapeutic purpose of the exposure. The exposure to ionizing radiation of volunteers participating to medical and biomedical research programs is allowed only after a freely expressed consent.