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Participation in biomedical research: the consent process as viewed by children, adolescents, young adults, and

E J Susman1, L D Dorn, J C Fletcher

  • 1Laboratory of Developmental Psychology, National Institute of Mental Health, Bethesda, Maryland.

The Journal of Pediatrics
|October 1, 1992
PubMed

Insights

Children and young adults understand concrete research details but struggle with abstract concepts like study purpose. Age did not impact comprehension of informed consent elements in biomedical research.

Area of Science:

  • Pediatric Health
  • Bioethics
  • Clinical Research

Background:

  • Informed consent is crucial for ethical biomedical research.
  • Understanding assent and consent capacity in minors is vital.
  • Gaps in knowledge may affect participation decisions.

Purpose of the Study:

  • To assess comprehension of informed consent elements in pediatric and young adult research participants.
  • To identify what physician-investigators deem essential for these age groups to know.
  • To explore the relationship between age and knowledge of research participation.

Main Methods:

  • Structured interviews were conducted with 44 participants aged 7-20.
  • Participants were hospitalized for pediatric cancer or obesity treatment.
  • Knowledge was assessed using federal informed consent guidelines.

Main Results:

  • Participants excelled in understanding concrete elements (e.g., benefits, freedom to ask questions).
  • Comprehension of abstract elements (e.g., scientific purpose, alternatives) was lower.
  • Chronological age did not correlate with knowledge of consent elements.

Conclusions:

  • Younger populations grasp tangible aspects of research participation more readily.
  • Abstract concepts require tailored educational strategies for improved understanding.
  • Reasoning about research parallels general understanding of physical phenomena.

Keywords:
Biomedical and Behavioral ResearchEmpirical Approach

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