ABSTRACT
The practice of obtaining informed consent from patients involved in medical research was first clearly expressed in The Nuremberg Code, which defined informed consent as an absolute condition for medical research. The process of informed consent includes several separate elements that must be present if a consent, once obtained, is to be considered valid. Informed consent is seen as a vital defence of the welfare of the research subject against poor or unscrupulous research. Important ethical and practical questions therefore arise with regard to emergency research on neonates, where a standard informed consent by proxy often is difficult to obtain. Therapeutic research is thus partly a misleading and unscientific word, it suggests that the desired aim of the study is already a reality. It could thus be argued that the term therapeutic research offers an alibi for researchers to expose patients to treatment and interventions that could possibly be less effective than standard care, or even have serious side effects.
