Three steps to protecting pediatric research participants from excessive risks.

Abstract

There is growing recognition that pediatric research is needed to improve pediatric medicine [1,2]. Research guidelines try to accommodate this need by allowing children to be enrolled in research when it offers an appropriate risk–benefit profile. These guidelines allow children to undergo research interventions that offer a compensating potential for clinical benefit. Most guidelines also allow children to undergo research interventions that do not offer a compensating potential for clinical benefit, provided the risks are acceptably low. To implement this threshold on acceptable risks, review committees, known variously as ethics review committees, institutional review boards, or research ethics committees (RECs), must make three related assessments. They must identify the research interventions included in the study under review, determine which, if any, of the research interventions fail to offer participants a compensating potential for clinical benefit, and ensure that these interventions do not pose excessive risks. These steps, while vital to protecting pediatric participants from excessive risks, have not been systematically described. This essay attempts to address this gap by describing the assessment appropriate for each of these three steps.