Published online October 2, 2006
PEDIATRICS
Vol. 118
No. 4
October 2006, pp.
1800-1801
(doi:10.1542/peds.2006-1577)
Assent in Pediatric Research
Catherine Stevens-Simon, MD
Department of Pediatrics
Colorado Adolescent Maternity Program and Adolescent Medicine Fellowship Program
University of Colorado Health Sciences Center
Children's Hospital
Denver, CO 80218
To the Editor.—
I read with interest the commentary "Assent in Pediatric Research."1 I would like to comment on 2 points. The first is Kon's assertion that having the right to participate in decision-making about research participation does not oblige minors to do so. This is true. However, the concept that minors should be allowed to relinquish this right conflicts with the basic percepts of preventative pediatrics and anticipatory guidance. Here the goal is not just to prevent pathology but also to promote healthy development. In response to chronic disease, minors often regress developmentally. As a result, many abdicate responsibility for treatment planning and medications to their parents. The enmeshment that inevitably ensues manifests as problems such as school avoidance and somatization disorders. A well-designed consent process can help families resolve such developmental conflicts and promote healthy development. A bad process, one that ignores well-established developmental milestones, is apt to exacerbate the situation. Parents are strongly encouraged (and even "obliged") to toilet train preschoolers. Why should the consent process be different?2 Second, only development-conscious, judicious investigators can protect minors from the inappropriate use of compensation. For a narcissistic middle adolescent, non–study-related "benefits," which are invisible to the adult eye (eg, the opportunity to increase peer-standing by wearing a pager or reporting in by cell phone), may be far more enticing than the type of "undo influence" from which the American Academy of Pediatrics guidelines3 are designed to shield them. Here, beneficence does not obligate investigators to withhold information about compensation until the decision about participation has been made but rather to be certain that everyone is aware of and can separate study-related and non–study-related risks and benefits.
REFERENCES
- Kon AA. Assent in pediatric research.
Pediatrics. 2006;117
:1806
–1810[Free Full Text]
- Forrow L, Arnold RM, Parker LS. Preventive ethics: expanding the horizons of clinical ethics.
J Clin Ethics. 1993;4
:287
–294[ISI][Medline]
- American Academy of Pediatrics, Committee on Drugs. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations.
Pediatrics. 1995;95
:286
–294[Abstract/Free Full Text]
PEDIATRICS (ISSN 1098-4275). ©2006 by the American Academy of Pediatrics
