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Pediatric Participation in Non-Therapeutic Research

Published online by Cambridge University Press:  01 January 2021

Marilyn C. Morris
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Extract

Pediatric participation in non-therapeutic research that poses greater than minimal risk has been the subject of considerable thought-provoking debate in the research ethics literature. While the need for more pediatric research has been called morally imperative, and concerted efforts have been made to increase pediatric medical research, the importance of protecting children from undue research risks remains paramount.

United States research regulations are derived largely from the deliberations and report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The authors of this report specifically designated children as a vulnerable population and suggested additional protections, most of which became U.S. law. One of the more contested sets of regulations surrounds non-therapeutic research, e.g., research that does not offer the potential for direct benefit to participants. Federal regulations allow local Institutional Review Boards (IRBs) to approve non-therapeutic research posing a minor increase above minimal risk when it involves children who have the disease or medical condition that the research addresses (Table 1).

Type
Independent
Information
Journal of Law, Medicine & Ethics , Volume 40 , Issue 3 , Fall 2012 , pp. 665 - 672
Copyright
Copyright © American Society of Law, Medicine and Ethics 2012

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