Children in clinical research: a conflict of moral values

Am J Bioeth. Winter 2003;3(1):W-IF 2. doi: 10.1162/152651603322781639.

Abstract

This paper examines the culture, the dynamics and the financial underpinnings that determine how medical research is being conducted on children in the United States. Children have increasingly become the subject of experiments that offer them no potential direct benefit but expose them to risks of harm and pain. A wide range of such experiments will be examined, including a lethal heartburn drug test, the experimental insertion of a pacemaker, an invasive insulin infusion experiment, and a fenfluramine "violence prediction" experiment. Emphasis, however, is given to psychoactive drug tests because of the inherent ethical and diagnostic problems involved in the absence of any objective, verifiable diagnostic tool. Effort is made to provide readers comprehensive reference sources to evidence-based reports about the serious risks these drugs pose for adults and children so that the reader may judge whether the benefits (if any) outweigh the risks for children.

MeSH terms

  • Adolescent*
  • Attention Deficit Disorder with Hyperactivity / drug therapy
  • Behavior Control
  • Biomedical Research
  • Child*
  • Clinical Trials as Topic / ethics*
  • Conflict of Interest
  • Depression / drug therapy
  • Drug Industry
  • Ethics Committees, Research
  • Ethics, Research
  • Government Regulation*
  • Human Experimentation / ethics*
  • Humans
  • Methylphenidate / adverse effects
  • Methylphenidate / therapeutic use
  • National Institutes of Health (U.S.)
  • Psychotropic Drugs / adverse effects
  • Psychotropic Drugs / therapeutic use
  • United States
  • United States Food and Drug Administration*

Substances

  • Psychotropic Drugs
  • Methylphenidate