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Permission and assent for clinical research in pediatric anesthesia

Thomas O Erb1, Scott R Schulman, Jeremy Sugarman

  • 1Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina 27710, USA.

Anesthesia and Analgesia
|April 26, 2002
PubMed

Insights

Obtaining meaningful informed consent in pediatric anesthesia requires both proxy permission and child assent tailored to their developmental abilities. This ensures ethical clinical research participation for children.

Area of Science:

  • Pediatric Anesthesiology
  • Clinical Research Ethics
  • Child Psychology

Background:

  • Informed consent is crucial for ethical clinical research.
  • Pediatric populations present unique challenges in the informed consent process.
  • Ensuring comprehension and voluntariness in children is paramount.

Purpose of the Study:

  • To delineate the process of informed consent in pediatric anesthesia research.
  • To define the specific requirements for valid informed consent in this population.
  • To emphasize the dual requirements of proxy permission and child assent.

Main Methods:

  • Review of ethical guidelines and legal standards for informed consent.
  • Analysis of developmental psychology principles relevant to assent.
  • Discussion of practical considerations in pediatric anesthesia research settings.

Main Results:

  • Meaningful informed consent necessitates obtaining permission from the child's proxy.
  • Child assent must be carefully tailored to be sensitive to their cognitive and emotional abilities.
  • The process must respect the child's evolving capacity to understand and agree.

Conclusions:

  • Effective informed consent in pediatric anesthesia research hinges on a dual approach.
  • Proxy permission and developmentally appropriate child assent are essential components.
  • Adherence to these principles ensures ethical conduct and protects pediatric research participants.
Abstract

Keywords:
Biomedical and Behavioral Research

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