Children in Research: Human Subjects Considerations for the Inclusion of Children as Research Participants

Abstract

Health researchers are becoming increasingly aware of the need to include children as participants (subjects) in studies, both to improve the generalizability of findings of research and to benefit children in terms of medical care. However, because institutional review boards examine proposed research involving children very carefully, researchers often are hesitant to involve children in studies. This article discusses regulatory issues with regard to children in research, outlines specific issues of concern to institutional review boards, and provides guidelines for researchers examining children's health issues.