ABSTRACT
According to the Declaration of Helsinki medical research involving human beings should comply with four morally relevant principles and/or distinctions: first, the principle of free and informed consent; second, the distinction between therapeutic research and non-therapeutic research; third, the assessment of potential risks versus presupposed benefits; and last, but not the least, the principle that concern for the interests of the research subject should always prevail over the interests of science and society. The problem with the strategy of extrapolating from studies performed in adults, according to Brody, is that it implies exposing children to 'greater risks to get quicker benefits'. The participation of children is indispensable for research into diseases of childhood and conditions to which children are particularly susceptible. Children should not be excluded from participating in research that is potentially directly beneficial to them as individual participants and, with appropriate safeguards, indirectly beneficial to them as a group.
