Table of Contents
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.
- 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?
Summary of Codes
Gender Representation | Representation is scientifically... | |
---|---|---|
Acceptable | Unacceptable (bar to award) | |
Both children and adults | C1A | C1U |
Children only | C2A | C2U |
Adults only | C3A | C3U |
Unknown (cannot be known) | C4A | C4U |
Content last reviewed on April 19, 2016