This article reviews four areas of pediatric research in which we have identified questionable levels of allowable risk, exceeding those foreseen by the Commission. They are the following: the categorization of increasingly risky interventions as minimal risk in a variety of protocols; the increasing number of applications for federal panel review of research not otherwise approvable because of higher projected risk levels; research on asymptomatic at risk children; and the inclusion of children and adolescents in placebo-controlled trials for participants of (...) all ages without performing subgroup analysis. While embracing the imperative to include children in research is an encouraging step towards providing the pediatric population with effective medical care and finally eradicating the therapeutic orphan, we must ensure that this research does not become overly permissive. (shrink)

Persons of diminished capacity, especially those who are still legally competent but are de facto incompetent should still be able to participate in moderately risky research projects that benefit the class of persons with similar diseases. It is argued that this view can be supported with a modified communitarianism, a philosophy ofmedicine that holds that health care is a joint responsibility that meets foundational human needs. The mechanism for obtaining a substituted consent I call ``community consent,'' and distinguish this from (...) the usual family or surrogate consent for treatment. Care givers are included in the community that might consent for an individual who has no identifiable family members. (shrink)