Sec. 1083. Appropriate age groupings in clinical research
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Not later than 180 days after the date of enactment of this Act, the Director of the National Institutes of Health shall convene a workshop of experts on pediatrics and experts on geriatrics to provide input on— appropriate age groupings to be included in research studies involving human subjects; and acceptable scientific justifications for excluding participants from a range of age groups from human subjects research studies. Not later than 180 days after the conclusion of the workshop under subsection (a), the Director of the National Institutes of Health shall publish guidelines— addressing the consideration of age as an inclusion variable in research involving human subjects; and identifying criteria for justifications for any age-related exclusions in such research.
The Director of the National Institutes of Health shall— make the findings and conclusions resulting from the workshop under subsection
(a)available to the public on the website of the National Institutes of Health; and not less than biennially, disclose to the public on such website the number of children included in research that is conducted or supported by the National Institutes of Health, disaggregated by developmentally appropriate age group, race, and gender.