Effective for due dates January 25, 2019 or later, keep in mind the following changes to your applications and progress reports.
Applications must address the age-appropriate inclusion or exclusion of individuals in the proposed research project by including:
- A description of plans for including individuals across the lifespan, including a rationale for selecting the specific age range
- An acceptable justification for the exclusion, if individuals will be excluded from the research based on age
For progress reports for awards from applications due Jan. 25th and later, to improve access to age-related information and better understand study outcomes across age groups:
- Submit de-identified participant-level data on sex/gender, race, ethnicity, and age at enrollment in progress reports.
As we announced through this guide notice and recent Open Mike blog, the Inclusion of Children Policy has been expanded to individuals of all ages. The revised policy, now known as the Inclusion Across the Lifespan policy, requires individuals of all ages (including children and older adults) be included in clinical research studies unless there are scientific or ethical reasons to exclude them. The policy applies to competing applications submitted for due dates January 25, 2019 or later, contract solicitations issued or after this date, and intramural studies initiated after this date.