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Ethical and cross cultural questions concerning pediatric clinical trials

D Pilpel1, F J Leavitt, E Elizur-Leiberman

  • 1Unit of Epidemiology and Evaluation of Health Services, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.

Controlled Clinical Trials
|June 1, 1996
PubMed

Insights

This study explores ethical issues in using recombinant growth hormone for children with short stature. It questions informed consent, decision-making autonomy, and potential psychological dependence during long-term treatment.

Area of Science:

  • Pediatric Endocrinology
  • Bioethics
  • Clinical Trials

Background:

  • Recombinant growth hormone (rGH) therapy is used for children with short stature.
  • Ethical considerations arise regarding the use of rGH in otherwise healthy children.

Purpose of the Study:

  • To identify and discuss the ethical dilemmas encountered during a clinical trial of rGH in short, healthy children.
  • To examine issues of informed consent, patient autonomy, and long-term psychological effects.

Main Methods:

  • The study involved a clinical trial of rGH in a cohort of children with short stature.
  • Ethical problems were identified and discussed in a cross-cultural context.

Main Results:

  • Key ethical challenges include balancing benefits and risks, ensuring true informed consent from parents and children, and determining decision-making capacity.
  • Concerns were raised about psychological dependence on medical professionals and the child's freedom to withdraw from long-term treatment.

Conclusions:

  • The use of rGH in children necessitates careful consideration of complex ethical issues, including patient autonomy and the definition of medical necessity versus cosmetic concerns.
  • A cross-cultural perspective is crucial for navigating these ethical dilemmas in pediatric treatment decisions.

Keywords:
Biomedical and Behavioral Research

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