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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.
Learn more about the Inclusion Across the Lifespan policy on our webpage and this “All About Grants” podcast (MP3 / Transcript).
At my university, there is a lot of confusion as to the headers to use for this new inclusion. For example, the current headers are “Inclusion of women and minorities” and “Inclusion of children.” Should there be a heading for “inclusion across the lifespan” and if so, is that instead of inclusion of children – or in addition to that? Thank you!
Applicants are expected to address the Inclusion Across the Lifespan policy in the Inclusion of Children upload (see the application instructions for this section).
PLEASE consider making all of these things POST AWARD. Why load this Pablum onto the front end. Can you actually imagine a grant falling below the pay line for an inadequate boilerplate statement?
More work for writers and reviewers. NIH stop it with some of these nit pickey changes. For example, premise is now called rigor of prior research. Please allow us to focus on the science.