임상시험에서 연구자의 주의의무

Abstract

Clinical Trials can be grouped specifically into practices that pertain to both research and treatment or to research alone. Accordingly, Physician's’ duty of care in research-related medical practices differs from their duty of care in medical practices. Furthermore, research-related medical practices in clinical trials may not harm the body, it should be managed similarly to criminal negligence and to legal judgments upon the physician’s duty of care. The Korean Good Clinical Practice (KGCP) is the most detailed regulation concerning pharmaceutical clinical trials, as well as most appropriate bases for determining a physician’s duty of care in research-related medical practice. More importantly, it is practicable imposing lawful compulsion in itself. Nevertheless, the matter of the duty of care and judgments of negligence in medical practices based on individual case, differ in legal character from standard medical practices. The purpose of the strengthening of duty of care, it is clear that the negligence will become the damage to the body inevitable, as well as high potential risk of damage to property.