Assure appropriate assent and consent in pediatric clinical research
Assure appropriate assent and consent in pediatric clinical research: Excerpt from Avoiding Common Pediatric Errors
Author:
Sarika Joshi, MD
What to Do - Gather Appropriate Data,
Take Action
The values of autonomy, beneficence, nonmaleficence, and justice guide
bioethics and clinical research in the United States and around the world today. The Nuremberg code established the requirement of informed consent
and limited research involving children, in order to protect this vulnerable
population from exploitation; however, this ruling resulted in a lack of research targeting this special population. Federal guidelines in the United
States now encourage the inclusion of children in clinical research so that
this population can benefit from new studies and technology. The issue of
consent in pediatric research aims to reconcile the competing ideas of informed consent and research application to all, requiring both informed
consent from parents and assent from children.
Informed consent necessitates disclosure by the researcher, discussion
betweentheresearcherandpotentialsubject,andasubject'sfullunderstanding of the proposed research. Once these requirements are fulfilled, a subject
may then voluntarily wish to participate in the research protocol. By law, informed consent must be given by an autonomous individual who is younger
than 18 years of age and makes independent decisions and is responsible for
them. In pediatric research, parental consent permits the researcher to ask
the child if he or she wants to participate in the protocol. The researcher
must then ask for assent from the child. Assent should be obtained using
developmentally appropriate tools.
There are both internal and external factors that affect a child's ability to give assent. Internal factors include age and developmental maturity.
Younger children have more difficulty understanding research protocols. Individual Institutional Review Boards (IRBs) are responsible for determining
age requirements for children's assent to participate in research. A specific
child's developmental maturity must also be taken into account, because
children advance through developmental stages at varying rates. External
factors that affect a child's ability to give assent include the effects of role
constraints, of family, and of the consent seeker on the child. Role constraints are created by social and institutional customs. In addition, both
family and the consent seeker may directly affect a child's ability to give
assent.
There are three levels of protection for children who participate in
research. The first is the IRB. The second is the family, who must give
informed consent. The third is the requirement for voluntary assent from
thechild.Someapproachestoensuringvoluntaryassentfromachildinclude
using a variety of developmentally appropriate media and obtaining consent
in an environment that minimizes family influences. Pediatric research must
strike a balance between protecting children from the burdens of research
and allowing them to participate so that they may benefit from it.
Suggested Readings
Barfield RC, Church C. Informed consent in pediatric clinical trials. Curr Opin Pediatr. 2005;
17(1):20–24.
Meaux JB, Bell PL. Balancing recruitment and protection: children as research subjects. Issues
Compr Pediatr Nurs. 2001;24(4):241–251.
Book Source Details
- Book Title: Avoiding Common Pediatric Errors
- Author(s): Anthony D Slonim MD, DrPH; Lisa Marcucci MD
- Year of Publication: 2008
- Copyright Details: Avoiding Common Pediatric Errors, Copyright © 2008 Lippincott Williams & Wilkins.
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Copyright notice for book excerpts: Copyright © 2008 Lippincott Williams & Wilkins. All rights reserved.
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More About This Book:
Title: Avoiding Common Pediatric Errors
Authors: Anthony D Slonim MD, DrPH; Lisa Marcucci MD
Publisher: Lippincott Williams & Wilkins
Copyright: 2008
ISBN: 0-7817-7489-6
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