Decision Tree for Age Inclusion Plan

Table of Contents

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Graphical Flowchart

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Credit: NIAID

Text Version of Flowchart

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

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

  • If yes:
  • 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, adults, and older adults?
    1. Children, adults, and older adults are included in scientifically appropriate numbers and with appropriate age ranges? (Code C1: children, adults, and older adults)
    2. 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)
    3. Age representation in specimens or datasets cannot be accurately determined and this does not compromise the scientific objectives? (Code C4: age representation unknown)
    4. Original review occured prior to age coding policy. (Code C5: historical inactive value)

Step 4

  • Is representation of indivduals of all ages acceptable?
    • If yes:
      • Acceptable.
      • Code C1A, C2A, C3A, C4A, C5A, C6A, C7A, C8A, or C9A.
      • End.
    • If no:
      • Unacceptable
      • Code C1U, C2U, C3U, C4U, C5U, C6U, C7U, C8U, or C9U.
      • Negative impact on score.
      • End.

Learn more and see the full list of Human Subjects Inclusion Codes.

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

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