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Related Experiment Videos

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
Summary

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

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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.
Keywords:
Biomedical and Behavioral Research

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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.