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A randomized study of a method for optimizing adolescent assent to biomedical research
Robert D Annett1, Janet L Brody2, David G Scherer3
1a Department of Pediatrics , University of Mississippi Medical Center.
AJOB Empirical Bioethics
|September 27, 2017
Summary
Separating adolescents from parents during research consent improved older teens' understanding of study risks and benefits. This autonomy-enhanced method aids informed assent without affecting participation decisions.
Area of Science:
- Pediatric Research Ethics
- Clinical Trial Methodology
- Adolescent Health
Background:
- Informed consent and assent in pediatric research present unique ethical challenges.
- Autonomy during research participation is crucial for adolescents but often complex to navigate.
- Previous research has not explored manipulating autonomy within consent/assent processes.
Purpose of the Study:
- To evaluate an autonomy-enhanced, individualized assent/consent procedure in a pediatric asthma clinical trial.
- To determine the impact of separating adolescents from parents during consent on assent quality.
- To assess effects on adolescent knowledge, appreciation, and willingness to participate.
Main Methods:
- Randomized trial comparing families remaining together versus separated during consent/assent.
- Sixty-four adolescent-parent dyads participated.
- Assessed knowledge, appreciation, and willingness to participate post-procedure.
Main Results:
- Separating families did not influence participation willingness.
- The autonomy-enhanced procedure improved knowledge of study risks/benefits for older adolescents and their parents.
- Younger adolescents showed lower comprehension of medication and risk/benefit information, irrespective of the procedure.
Conclusions:
- An autonomy-enhanced assent/consent procedure can improve informed consent/assent for adolescents and parents without altering participation decisions.
- Traditional procedures may lead to a diffusion of responsibility, particularly for older adolescents regarding study risks and benefits.
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