[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2436 Introduced in House (IH)]

114th CONGRESS
  1st Session
                                H. R. 2436

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


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                    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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 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.
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