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Clinical Trial Decisions in Difficult Circumstances: Parental Consent Under Time Pressure

Marijke C Jansen-van der Weide1, Patrina H Y Caldwell2, Bridget Young3

  • 1Pediatric Clinical Research Office, Emma Children's Hospital, Academic Medical Center, Amsterdam, Netherlands; Jansen.mc@amc.uva.nl.

Pediatrics
|September 30, 2015
PubMed

Insights

Obtaining parental informed consent for pediatric emergency research is challenging when time is limited. This article explores ethical options for managing consent in urgent situations.

Area of Science:

  • Pediatric Emergency Medicine
  • Clinical Trial Ethics
  • Informed Consent Procedures

Background:

  • Evidence-based treatments are crucial for children in emergencies.
  • Parental informed consent is ethically mandatory for pediatric research.
  • Urgent situations pose challenges to the informed consent process.

Purpose of the Study:

  • To address ethical challenges in obtaining informed consent for pediatric research during emergencies.
  • To explore practical and ethical options for consent when time is limited.

Main Methods:

  • Review of ethical guidelines and existing literature on informed consent in emergency research.
  • Discussion of potential alternatives to prospective informed consent in time-sensitive situations.

Main Results:

  • Limited evidence currently guides consent processes in emergency pediatric research.
  • The acute nature of emergencies and parental distress can impair informed consent.
  • Several practical and ethical options for managing consent in limited-time scenarios are proposed.

Conclusions:

  • Developing clear guidelines for informed consent in pediatric emergency research is essential.
  • Alternative consent strategies may be necessary and ethically justifiable in specific urgent circumstances.
  • Further research is needed to establish best practices for consent in time-constrained pediatric clinical trials.

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