Decision Tree for Participation of Children in Research
HUMAN SUBJECTS INVOLVED (EVEN IF EXEMPTED UNDER 45 CFR 46)? | | NO YES (Policy does not apply) | | | STUDY INVOLVES ONLY THOSE UNDER AGE 21? | | YES NO | | | STUDY RELEVANT TO CHILDREN? | | | | NO YES | (Excepted: Provide | | Justification *) | | | | LEGAL/REGULATORY BARS TO CHILD SUBJECTS? | | | | YES NO | (Excepted: Provide | | Justification*) | | | | STUDY REDUNDANT? | | | | YES NO | (Excepted: Provide | | Justification*) | | | | SEPARATE AGE-SPECIFIC STUDY WARRANTED? | | | | YES NO | (Excepted: Provide | | Justification*) | | PROCEED | | | |
The application should describe plans to include children, justifying the age range of children chosen for inclusion as well as the expertise of the investigative team for dealing with children at ages included, 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.
* Exceptions will be granted with a clear and compelling rationale and justification establishing that inclusion would be inappropriate according to the above-delineated decision tree.