Ethical and cross cultural questions concerning pediatric clinical trials

Dina Pilpel, Frank J. Leavitt, Esther Elizur-Leiberman

    Research output: Contribution to journalArticlepeer-review

    8 Scopus citations

    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 abut 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.

    Original languageEnglish
    Pages (from-to)201-208
    Number of pages8
    JournalControlled Clinical Trials
    Volume17
    Issue number3
    DOIs
    StatePublished - 1 Jan 1996

    Keywords

    • Clinical trials
    • Cross cultural bioethics
    • Doctor's and patient's autonomy
    • Ethics
    • Informed consent
    • Pediatrics
    • Recombinant growth hormone

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