The National Institutes of Health (NIH) is strengthening its policies to ensure children are included in research.
The Academy has been advocating for such changes for two decades.
The new NIH policy replaces one from 1998 and updates the acceptable criteria for excluding children from research. Children can be excluded only if:
- diseases do not occur in their age group,
- research already is available,
- a separate study for their age group is preferable,
- the study includes pre-enrolled participants,
- regulations prohibit their inclusion, or
- they would be subjected to unacceptable risk.
In addition, the policy changes will improve accountability by requiring investigator progress reports to include data on participant ages. They will apply to research grant applications beginning Jan. 25, 2019.
Watch future issues of AAP News for additional coverage of these changes.
