PhD Candidate Saint Louis University Madison, Georgia
Abstract: Any research study exposes its participants to more than just the proposed intervention; there are numerous other study components whose sole purpose is collecting data designed to facilitate research hypotheses and agendas. The performance of these additional procedures is of particular concern when the research is with children. Within ethically permitted categories of pediatric research (46.404-407), it is difficult to discern what criteria should govern the inclusion of non-therapeutic components. Most frequently, risk minimization in accordance with the General Rule (45 CFR 46) is used as the criterion, however in the case of potentially beneficial research (46.405) this strategy falls short in two ways: it fails to place a bound on the amount of research data collection burden to be placed on ill children, and it fails to find an appropriate reference point against which to gauge the acceptable level of risk posed to ill children. The purpose of this paper is to critically evaluate the inclusion of non-therapeutic components in pediatric research with ill or otherwise afflicted children (46. 405). An historic argument from Paul Ramsey is updated in light of current practice to provide the desired analysis of non-therapeutic research components. Ramsey’s position succeeds in providing the necessary limitation on non- therapeutic research components in studies with ill or afflicted children, but it does so in ways that may prove problematic for the ethical permissibility for the category of non-therapeutic pediatric research in general (46. 403 & 406).
Keywords: Pediatric research, Research ethics, Philosophy of childhood
Learning Objectives:
After participating in this conference, attendees should be able to:
Articulate the distinction between therapeutic and non-therapeutic components of a research study design.
Critique the current federal guidelines for the inclusion of non-therapeutic elements in pediatric clinical trials in light of Paul Ramsey's argument about adult obligations to children.
Describe the ways in which those who are sick form a morally significant category who should be protected from an expectation to use their bodies on behalf of societal goods.
.png)
