Is it Possible to Protect Pediatric Research Subjects without Blocking Appropriate Research?

摘要

Because most children are unable to provide informed consent, some guidelines exclude them from participation in clinical research. The German guidelines of 1931, perhaps the first systematic guidelines for clinical research, prohibit nontherapeutic research with children and research that "in any way endangers" children." The Nuremberg Code's stipulation that consent is "essential" to ethical research seems to prohibit all research with children.Excluding children from research would definitively address the potential to exploit them. Yet, this approach also has the potential to cripple society's ability to ensure medical interventions are safe and effective for children. Indeed, estimates that approximately 70% of medications have not been tested in children, even for basic safety and efficacy, underscore the costs of declining to conduct research with children.More recent guidelines attempt to protect children without blocking appropriate research by allowing pediatric research that offers a "prospect" of direct benefit, and pediatric research that poses minimal risk or, at most, a minor increase over minimal risk. A good deal has been written on the minimal risk standard and how it might be improved. Few articles have evaluated whether the prospect of direct benefit standard protects children without blocking appropriate research.