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Randomized Controlled Trial
. 2017 Jul-Sep;8(3):189-197.
doi: 10.1080/23294515.2016.1251507. Epub 2016 Oct 24.

A randomized study of a method for optimizing adolescent assent to biomedical research

Robert D Annett  1 , Janet L Brody  2 , David G Scherer  3 , Charles W Turner  2 , Jeanne Dalen  4 , Hengameh Raissy  5
Affiliations
Randomized Controlled Trial

A randomized study of a method for optimizing adolescent assent to biomedical research

Robert D Annett et al. AJOB Empir Bioeth. 2017 Jul-Sep.

Abstract

Purpose: Voluntary consent/assent with adolescents invited to participate in research raises challenging problems. No studies to date have attempted to manipulate autonomy in relation to assent/consent processes. This study evaluated the effects of an autonomy-enhanced individualized assent/consent procedure embedded within a randomized pediatric asthma clinical trial.

Methods: Families were randomly assigned to remain together or separated during a consent/assent process; the latter we characterize as an autonomy-enhanced assent/consent procedure. We hypothesized that separating adolescents from their parents would improve adolescent assent by increasing knowledge and appreciation of the clinical trial and willingness to participate.

Results: Sixty-four adolescent-parent dyads completed procedures. The together versus separate randomization made no difference in adolescent or parent willingness to participate. However, significant differences were found in both parent and adolescent knowledge of the asthma clinical trial based on the assent/consent procedure and adolescent age. The separate assent/consent procedure improved knowledge of study risks and benefits for older adolescents and their parents but not for the younger youth or their parents. Regardless of the assent/consent process, younger adolescents had lower comprehension of information associated with the study medication and research risks and benefits, but not study procedures or their research rights and privileges.

Conclusions: The use of an autonomy-enhanced assent/consent procedure for adolescents may improve their and their parent's informed assent/consent without impacting research participation decisions. Traditional assent/consent procedures may result in a "diffusion of responsibility" effect between parents and older adolescents, specifically in attending to key information associated with study risks and benefits.

Keywords: adolescent; asthma; autonomy; biomedical research; consent/assent.

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Conflict of interest statement

CONFLICTS OF INTEREST: <Pending completion of COI>

Conflicts: The authors have no conflicts of interest to declare

Figures

Figure 1
Figure 1
Relationship of consent intervention on KAS knowledge of risk and benefit, The group X A age interaction F=3.097; p=.05; eta2=.096
See this image and copyright information in PMC

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