As you plan your human subjects research, use the Inclusion Across the Lifespan Case Studies to help you determine if your proposed study population is appropriate. Following the Inclusion Across the Lifespan policy, NIH-supported research must include individuals of all ages unless there is a scientific or ethical reason not to include a specific age group.
The Case Studies summarize the scientific and ethical aspects of age-related inclusion in four fictional study scenarios. Consider Case #1:
- Study summary: An investigator is planning a study analyzing stress and anxiety levels in children involved in caregiving responsibilities for parents or younger siblings with cancer. The investigator will include standardized measures of stress and anxiety, observations of behavior, and review of the medical records for both the children and the family member with cancer.
- Inclusion planning: The investigator plans to exclude individuals 60 years of age and over because the goal is to focus on parent/sibling relationships rather than grandparents. The investigator anticipates that most individuals under the age of 18 will have parents below the excluded age range.
- Consider: Is there a scientific reason for excluding specific age groups? Is there an ethical reason to exclude specific age groups? In this case, the answer for both questions is no.
- Take away: Age should only be used as an exclusion criterion when necessary. Instead of using age as exclusion criteria, the investigator can specify the types of relationships that allow individuals to be eligible for the study.
For more, check the other three Inclusion Across the Lifespan Case Studies.
Learn about Inclusion Policies for Research Involving Human Subjects and how you must address inclusion in your applications, proposals, and progress reports.
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