To amend the Public Health Service Act with respect to appropriate age groupings to be included in research studies involving human subjects.

Bill: 114-hr-2436
Sponsor: full_name: Rep. Blackburn, Marsha [R-TN-7]
Introduced: 2015-05-19
Policy area: Health
Subjects: Aging

Child health

Department of Health and Human Services

Government information and archives

Medical research

National Institutes of Health (NIH)

Research administration and funding
Latest action: action_date: 2015-05-22
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2015-05-19
action_desc: Introduced in House
text: <p>This bill requires the National Institutes of Health (NIH) to convene a workshop within 180 days of enactment of this Act on appropriate age groupings and age exclusions in human research. Not later than 180 days after the conclusion of the workshop, the NIH must publish guidelines addressing consideration of age in human research.</p> The NIH must publish the number of children included in NIH research disaggregated by age group, race, and gender.

tv_txt: I 114th CONGRESS 1st Session H. R. 2436 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mrs. Blackburn (for herself and Mrs. Capps ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Public Health Service Act with respect to appropriate age groupings to be included in research studies involving human subjects.

1. Appropriate age groupings in clinical research (a) Input from experts 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— (1) appropriate age groupings to be included in research studies involving human subjects; and (2) acceptable scientific justifications for excluding participants from a range of age groups from human subjects research studies. (b) Guidelines 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— (1) addressing the consideration of age as an inclusion variable in research involving human subjects; and (2) identifying criteria for justifications for any age-related exclusions in such research. (c) Public availability of findings and conclusions The Director of the National Institutes of Health shall— (1) make the findings and conclusion resulting from the workshop under subsection (a) available to the public on the website of the National Institutes of Health; and (2) 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.