The core value of both international codes is that medical research cannot be
performed without the freely given (uncoerced) consent of the potential
subjects. In a refinement of the Nuremberg Code, the Declaration of Helsinki
distinguishes between therapeutic and nontherapeutic research, requiring the
physician to exercise special care in performing research that cannot personally
benefit the patient. Legally, informed consent shifts the risk of nonnegligent
injury to the patient in therapeutic research. In nontherapeutic research,
however, it is arguable that the physician–experimenter is strictly liable
(regardless of negligence) for injuries to the patient. This distinction is
reflected in the federal regulations with the requirement that the risk of the
experiment be compared with both the benefits to the patient and to society.