In response to an April National Institutes of Health (NIH) Request for Information on “the appropriate inclusion of pediatric and older populations in research studies involving human subjects,” FASEB submitted comments in June. This was an opportunity for the scientific community and the public to express their views, and additional feedback was gathered from subject matter experts at an accompanying workshop held on the NIH campus.
FASEB recommended three general steps NIH should take to promote age group inclusion:
- Enrollment in clinical research should operate under the assumption that all ages be included barring scientific justification for excluding one or more age groups.
- Participants’ precise ages at the time of enrollment should be reported, as opposed to categorizing them into age groups.
- NIH should explicitly state in funding opportunity announcements (FOAs) for clinical trials that age inclusion be a criterion considered by reviewers when arriving at an application’s score.