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. This principle was later modified by The Declaration of Helsinki, first adopted by the World Medical Assembly in 1964 and last amended in 1996. Informed consent is seen as a vital defence of the welfare of the research subject against poor or unscrupulous research. The Food and Drug Administration Rules on Emergency Research from 1995 have tried to define the basic criteria needed for including patients in research without informed consent. Much of the confusion in distinguishing between the need for improved medical care and the patient’s individual rights, between the safeguard of the individual infant versus the collective interest of all newborn infants, stems from the term therapeutic research, introduced by The Declaration of Helsinki. Neonatal research is mostly performed in large hospitals such as university hospitals.
