The description must also include the appropriateness of the available facilities to accommodate the children and the inclusion of a sufficient number of children to contribute to a meaningful analysis relative to the purpose of the study. There are laws or regulation barring the inclusion of children in the research. The knowledge being sought in the research is already available for children or will be obtained form another ongoing study, and an additional study will be redundant. A separate, age-specific study in children is warranted and preferable. The number of children is limited because the majority are already accessed by a nationwide pediatric disease research network, so that requiring inclusion of children in the proposed adult study would be both difficult and unnecessary, as well as counterproductive.
Insufficient data are available in adults to judge potential risk to children.
Study designs aimed at collecting additional data on pre-enrolled adult study participants. A Decision Tree for the Participation of Childen is available. Rich Text Format Go to Top of Page Back to the Institutional Review Board home page.