Consent and Assent in Pediatric Research

D Micah Hester; Skye A Miner

doi:10.1016/j.pcl.2023.08.003

Consent and Assent in Pediatric Research

Pediatr Clin North Am. 2024 Feb;71(1):83-92. doi: 10.1016/j.pcl.2023.08.003. Epub 2023 Sep 11.

Authors

D Micah Hester¹, Skye A Miner²

Affiliations

¹ Department of Medical Humanities and Bioethics, College of Medicine, University of Arkansas for Medical Science, 4301 West Markham Street, #646, Little Rock, AR 72205, USA. Electronic address: dmhester@uams.edu.
² Department of Medical Humanities and Bioethics, College of Medicine, University of Arkansas for Medical Science, 4301 West Markham Street, #646, Little Rock, AR 72205, USA.

PMID: 37973309
DOI: 10.1016/j.pcl.2023.08.003

Abstract

Research involving pediatric populations has important ethical and regulatory considerations. As children generally cannot consent to research, there are special protections put in place to ensure that the decisional vulnerability is protected, including parental permission and often the child's assent. Assent is an ethically important part of the research because it allows the child to participate in the process of agreeing to research, develop their autonomy, and express their values. This article explores a case where the child and parent disagree about the child's participation. In doing so, the regulatory requirements of pediatric research are outlined and the process and product of obtaining assent from a minor is described.

Keywords: Assent; Common rule; Pediatric research; Therapeutic misconception.

Publication types

Review

MeSH terms

Biomedical Research*
Child
Decision Making
Humans
Informed Consent
Parent-Child Relations
Parents