This section should provide a description of the plan to include children or an explanation of the reasons for excluding children as participants. The research topic is irrelevant to children. There are laws barring their inclusion. The knowledge being sought is already available for children. A separate age-specific study in children is warranted.
Insufficient data are available to judge the risk of participation to children.
The study involves follow-up on a previous adult study. Other justifications are found acceptable by review groups and the Institute Director. Also scientific review groups will be required to evaluate the proposed research plan for inclusion or exclusion of children as acceptable or unacceptable. For the complete policy, see the NIH web site .