Decision Tree for Children Inclusion Plan
Table of Contents
- If yes:
- Continue to Step 3.
- If no:
- Absent (negative impact on the score, bar to award or application not reviewed)
- What is the actual representation of children and adults?
- Both children and adults are included in scientifically appropriate numbers and with appropriate age ranges for children? (Code C1: both adults and children)
- Only children are included? (Code C2: children only)
- All or some age ranges of children are excluded because one of the following exceptions applies?
- The research topic is irrelevant to children
- Laws or regulations bar inclusion of children in the research
- The data already exists or is being obtained for children (must document); duplicative studies are unnecessary
- A separate, age-specific study in children is preferable (e.g., conditions are rare in children vs. adults; most eligible subjects already enrolled in nationwide study; study design issues preclude applying hypotheses/interventions to both groups in parallel fashion)
- Existing data in adults is insufficient to judge risks in children
- Proposal is to obtain follow-up data on a prior adult study which enrolled no children
- Other special cases acceptable to the review group and Institute Director. (Code C3: adults only; or may be Code C1: both adults and children, though participation of children is limited)
- Representation of children in specimens or datasets cannot be accurately determined and this does not compromise the scientific objectives? (Code C4: children representation unknown)
- Is representation of children acceptable?
|Gender Representation||Representation is scientifically...|
|Acceptable||Unacceptable (bar to award)|
|Both children and adults||C1A||C1U|
|Unknown (cannot be known)||C4A||C4U|