ETHICAL AND CROSS-CULTURAL QUESTIONS CONCERNING PEDIATRIC CLINICAL-TRIALS

During a clinical trial of recombinant growth hormone in a population of short stature but otherwise healthy children the following ethical problems were confronted: What are the prospective benefits compared w ith the foreseeable risks associated with this therapy? Can the doctor really inform the parent and/or the child about the outcomes of the t reatment? Who must make the decision about participation in the trial? From which age can the child himself decide about continuing or dropp ing out? Since the treatment requires frequent check-ups for years, to what extent does the child become psychologically dependent upon the medical profession? Given this possibility, is the child really free t o withdraw from the treatment? Is there a conflict between the doctor' s autonomy to propose the treatment and the patient's autonomy to deci de about participation? Is there a clear threshold between life-threat ening problems and minor, cosmetic problems? These dilemmas are discus sed in a cross-cultural context.