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Informed consent in pediatric clinical trials

Raymond C Barfield1, Christopher Church

  • 1Division of Stem Cell Transplantation, Department of Hematology/Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee 38105-2794, USA. raymond.barfield@stjude.org

Current Opinion in Pediatrics
|January 22, 2005
PubMed

Insights

Informed consent in pediatric clinical trials is complex. Newer methods like staged consent and technology improve understanding for parents and children, addressing research gaps.

Area of Science:

  • Pediatric Clinical Research
  • Informed Consent Process
  • Bioethics

Background:

  • Increasing clinical research involving children raises concerns about inclusion/exclusion and informed consent.
  • Ensuring adequate understanding of trial concepts like randomization is crucial for ethical pediatric research.

Purpose of the Study:

  • To review and characterize the latest literature on informed consent in pediatric clinical trials.
  • To address pressing issues surrounding informed consent for pediatric participants.

Main Methods:

  • Literature review of recent studies on the informed consent process in pediatric trials.
  • Analysis of emerging approaches and variables impacting consent and assent.
  • Examination of regulatory and oversight gaps.

Main Results:

  • Parents and older children often misunderstand core research concepts (e.g., randomization, trial phases).
  • Novel strategies like staged informed consent, interactive computer technologies, and multifactorial competence assessments are being developed.
  • Individual experiences, cultural background, and regulatory gaps significantly influence the consent process.

Conclusions:

  • Improved oversight, understanding of assent, cultural sensitivity, and enhanced communication are vital for future pediatric consent studies.
  • Lessons learned will refine and improve the informed consent process in pediatric clinical trials.
Abstract

Keywords:
Biomedical and Behavioral Research

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