Decision Tree for Children Inclusion Plan

Table of Contents

• Graphical Flowchart
• Text Version of Flowchart
• Summary of Codes

See the main index of Decision Trees or Research Using Human Subjects

Graphical Flowchart

Credit: NIAID

Text Version of Flowchart

Step 1. Are human subjects involved? (even if exempted under 45 CFR Part 46)?

• If yes, continue to Step 2.
• If no:
  • The policy does not apply.
  • Human Subjects Code: 10.
  • End.

Step 2. Is the information on representation of children provided?

• If yes:
  • Continue to Step 3.
• If no:
  • Absent (negative impact on the score, bar to award or application not reviewed)
  • End.

Step 3.

• What is the actual representation of children and adults?
  1. Both children and adults are included in scientifically appropriate numbers and with appropriate age ranges for children? (Code C1: both adults and children)
  2. Only children are included? (Code C2: children only)
  3. 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)
  4. 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?
  • If yes:
    • Acceptable.
    • Code C1A, C2A, C3A, or C4A.
    • End.
  • If no:
    • Unacceptable
    • Code C1U, C2U, C3U or C4U.
    • Negative impact on score.
    • End.

Summary of Codes