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A study of consent for participation in a non-therapeutic study in the pediatric intensive care population

Kusum Menon1, Roxanne Ward,

  • 1Department of PICU, CHEO, , Ottawa, Ontario, Canada.

Journal of Medical Ethics
|January 25, 2013
PubMed

Insights

Legal guardians faced barriers like unavailability and feeling overwhelmed when consenting to paediatric critical care research. Addressing these issues is crucial for future study validity and generalizability.

Area of Science:

  • Critical care medicine
  • Pediatric research ethics
  • Informed consent processes

Background:

  • Obtaining informed consent for pediatric critical care research presents unique challenges.
  • Understanding guardian-related barriers is essential for improving participation rates.

Purpose of the Study:

  • To identify legal guardian-related barriers to consent procurement in a pediatric critical care research study.
  • To document the reasons provided by guardians for non-participation.

Main Methods:

  • A multicenter, prospective cohort study involving 1707 eligible patients.
  • Data collected on consent encounters, guardian availability, language barriers, and reasons for refusal.

Main Results:

  • Key barriers included guardian unavailability (321/1707) and language issues (84/1707).
  • The overall consent rate was 42% among 917 approached guardians.
  • Common reasons for refusal included feeling overwhelmed (117/429) and not wanting additional interventions (63/429).

Conclusions:

  • Consent procurement in pediatric critical care research is hindered by multiple factors, notably guardian availability and feeling overwhelmed.
  • Further research is needed to assess the impact on study validity and develop effective consent models.
Abstract

Keywords:
ChildrenInformed ConsentMinors/Parental ConsentResearch EthicsResearch on Special Populations

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