A Randomized Study of a Method for Optimizing Adolescent Assent to Biomedical Research

Overview

Journal AJOB Empir Bioeth

Specialties General Medicine
Medical Ethics

Date 2017 Sep 27

PMID 28949898

Citations 5

Authors

Robert D Annett

Janet L Brody

David G Scherer

Charles W Turner

Jeanne Dalen

Hengameh Raissy

Affiliations

Soon will be listed here.

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.

Citing Articles

Describing the content of trial recruitment interventions using the TIDieR reporting checklist: a systematic methodology review.

Hudek N, Carroll K, Semchishen S, Vanderhout S, Presseau J, Grimshaw J BMC Med Res Methodol. 2024; 24(1):85.

PMID: 38589803 PMC: 11000410. DOI: 10.1186/s12874-024-02195-5.

Assessment of Consent Comprehension Among Kenyan Adolescents, Young Adults, and Parents: Comparison of Enhanced and Standard Consenting Procedures.

Luseno W, Iritani B, Hartman S, Odongo F, Otieno F, Ongili B J Adolesc Health. 2023; 74(3):605-612.

PMID: 38069940 PMC: 10873115. DOI: 10.1016/j.jadohealth.2023.10.009.

What information and the extent of information to be provided in an informed assent/consent form of pediatric drug trials.

Koonrungsesomboon N, Charoenkwan P, Natesirinilkul R, Fanhchaksai K, Sakuludomkan W, Morakote N BMC Med Ethics. 2022; 23(1):113.

PMID: 36384589 PMC: 9670601. DOI: 10.1186/s12910-022-00856-y.

Improving assent in health research: a rapid systematic review.

Soll D, Magdalena Guraiib M, Rollins N, Reis A BMC Med Res Methodol. 2020; 20(1):114.

PMID: 32404063 PMC: 7222594. DOI: 10.1186/s12874-020-01000-3.

Helping Them Decide: A Scoping Review of Interventions Used to Help Minors Understand the Concept and Process of Assent.

Weisleder P Front Pediatr. 2020; 8:25.

PMID: 32117832 PMC: 7020747. DOI: 10.3389/fped.2020.00025.

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