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, adults, and older adults?
- Children, adults, and older adults are included in scientifically appropriate numbers and with appropriate age ranges? (Code C1: children, adults, and older adults)
- All or some age ranges are excluded because one of the following exceptions applies?
- The disease or condition does not occur in the excluded age group, or the research topic is not relevant to the excluded age group
- The knowledge being sought in the research is already available for the excluded age group or will be obtained from another ongoing study, and an additional study will be redundant.
- A separate age-specific study in the excluded age group is warranted and preferable. While this situation may represent a justification for excluding individuals based on age, consideration should be given to taking age differences into account in the study design, whenever feasible.
- The study will collect or analyze data on pre-enrolled study participants and data inclusive of individuals across the lifespan are not available to address the scientific question.
- There are laws or regulations barring the inclusion of individuals in a specific age group in research.
- The study proposes an unacceptable risk to the excluded group, such that their participation would not be considered ethical by the local IRB, peer review, and/or NIH staff.
- Other special cases acceptable to the review group and Institute Director.
- (Code C2: children only; Code C3: adults and older adults only; Code C6: children and adults only; Code C7: adults only, Code C8: older adults only; Code C9: children and older adults only)
- Age representation in specimens or datasets cannot be accurately determined and this does not compromise the scientific objectives? (Code C4: age representation unknown)
- Original review occured prior to age coding policy. (Code C5: historical inactive value)
- Is representation of indivduals of all ages acceptable?
Learn more and see the full list of Human Subjects Inclusion Codes.