Ethical complications of clinical therapeutic research on children.

Usual discussion by ethicists and physicians of the ethical implications of research on children with catastrophic disease, and the guidelines established by the Federal Government for this research, rest on applying general moral principles to problems. Whatever the merits of this approach for establishing policy, it does not adequately reflect the life situation of patients and the complexity of a single regimen which is simultaneously both therapeutic and research oriented. Also, the issues become more complex when there is disagreement among the parents about a course of treatment. It is our contention that such cases are properly resolved by considering the degree of paternalism to be exercised by the clinician-researcher.