Seven vulnerabilities in the pediatric research subject.

Abstract

Most recent thinking about the vulnerability of research subjects uses a "subpopulation" focus. So conceived, the problem is to work out special standards for prisoners, pregnant women, the mentally ill, children, and similar groups. In contrast, an "analytical" approach would identify characteristics that are criteria for vulnerability. Using these criteria, one could support a judgment that certain individuals are vulnerable and identify needed accommodations if they are to serve as research subjects. Seven such characteristics can be evident in children: they commonly lack the capacity to make mature decisions; they are subject to the authority of others; they (and their parents) may be deferential in ways that can mask underlying dissent; their rights and interests may be socially undervalued; they may have acute medical conditions requiring immediate decisions not consistent with informed consent; they may have serious medical conditions that cannot be effectively treated; and they (and their parents) may lack important socially distributed goods. Each of these vulnerabilities can call for special care in the design and implementation of research protocols.