title: Ethical and cross cultural questions concerning pediatric clinical trials.
abstract: 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 with the foreseeable risks associated with this therapy? Can the doctor really inform the parent and/or the child about the outcomes of the treatment? Who must make the decision about participation in the trial? From which age can the child himself decide about continuing or dropping 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 to withdraw from the treatment? Is there a conflict between the doctor's autonomy to propose the treatment and the patient's autonomy to decide about participation? Is there a clear threshold between life-threatening problems and minor, cosmetic problems? These dilemmas are discussed in a cross-cultural context.
authors.affiliation: Unit of Epidemiology and Evaluation of Health Services, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
authors.forename: D
authors.initials: D
authors.lastname: Pilpel
authors.forename: F J
authors.initials: FJ
authors.lastname: Leavitt
authors.forename: E
authors.initials: E
authors.lastname: Elizur-Leiberman
mesh_terms: D000293:Adolescent; D000328:Adult; D001827:Body Height / Q000187:drug effects; D002648:Child; D002986:Clinical Trials as Topic; D003469:Culture; D004992:Ethics, Medical; D005260:Female; D006130:Growth Disorders / Q000188:drug therapy*; D019382:Human Growth Hormone / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007258:Informed Consent; D008297:Male; D012307:Risk Factors; D014342:Truth Disclosure
chemical_list: D019382:Human Growth Hormone