[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 2809 Introduced in Senate (IS)]







106th CONGRESS
  2d Session
                                S. 2809

  To protect the health and welfare of children involved in research.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 28, 2000

 Mr. Dodd (for himself and Mr. DeWine) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
  To protect the health and welfare of children involved in research.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Children's Research Protection 
Act''.

SEC. 2. FINDINGS, PURPOSES, AND DEFINITION.

    (a) Findings.--Congress makes the following findings:
            (1) Children are the future of the Nation and the 
        preservation and improvement of child health is in the national 
        interest.
            (2) The preservation and improvement of child health may 
        require the use of pharmaceutical products.
            (3) Currently only 1 out of 5 drugs on the market in the 
        United States have been approved for use by children. The 
        enactment of the provisions of the Food and Drug Administration 
        Modernization Act (Public Law 105-115) relating to pediatric 
        studies of drugs, however, is expected to increase the 
        pediatric testing of pharmaceuticals and thus to increase the 
        numbers of children involved in research.
            (4) Children are a vulnerable population and thus need 
        additional protections for their involvement in research 
        relative to adults. Yet, current Federal guidelines for the 
        protection of children involved in research have not been 
        updated since 1981, do not currently apply to Food and Drug 
        Administration-regulated research that is not Federally funded, 
        and have not been adopted by all Federal agencies that conduct 
        research involving children.
            (5) Currently, in the United States, there is a shortage of 
        pharmacologists trained to address the unique aspects of 
        developing therapies for children. There are fewer than 200 
        academic-based clinical pharmacologists in the United States, 
        of which 20 percent or fewer are pediatricians. Currently, only 
        20 physicians complete clinical pharmacology specialty training 
        programs each year, and of these, only 2 or fewer specialize in 
        pediatric pharmacology.
    (b) Purposes.--It is the purpose of this Act to--
            (1) ensure the adequate and appropriate protection of 
        children involved in research by--
                    (A) reviewing and updating as needed the Federal 
                regulations that provide additional protections for 
                children participating in research as contained in 
                subpart D of part 45 of title 46, Code of Federal 
                Regulations;
                    (B) extending such subpart D to all research 
                regulated by the Secretary of Health and Human 
                Services; and
                    (C) requiring that all Federal agencies adopt 
                regulations for additional protections for children 
                involved in research that is conducted, supported, or 
                regulated by the Federal Government; and
            (2) ensure that an adequate number of pediatric clinical 
        pharmacologists are trained and retained, in order to meet the 
        increased demand for expertise in this area created by the 
        pediatric studies provisions of the Food and Drug 
        Administration Modernization Act (Public Law 105-115), so that 
        all children have access to medications that have been 
        adequately and properly tested on children.
    (c) Definition.--In this Act, the term ``pediatric clinical 
pharmacologist'' means an individual--
            (1) who is board certified in pediatrics; and
            (2) who has additional formal training and expertise in 
        human pharmacology.

SEC. 3. REVIEW OF REGULATIONS.

    (a) Review.--By not later than 6 months after the date of enactment 
of this Act, the Secretary of Health and Human Services shall have 
conducted a review of the regulations under subpart D of part 45 of 
title 46, Code of Federal Regulations, considered any modifications 
necessary to ensure the adequate and appropriate protection of children 
participating in research, and report the findings of the Secretary 
back to Congress.
    (b) Areas of Review.--In conducting the review under subsection 
(a), the Secretary of Health and Human Services shall consider--
            (1) the appropriateness of the regulations for children of 
        differing ages and maturity levels, including legal status;
            (2) the definition of ``minimal risk'' and the manner in 
        which such definition varies for a healthy child as compared to 
        a child with an illness;
            (3) the definitions of ``assent'' and ``permission'' for 
        child clinical research participants and their parents or 
        guardians and of ``adequate provisions'' for soliciting assent 
        or permission in research as such definitions relate to the 
        process of obtaining the informed consent of children 
        participating in research and the parents or guardians of such 
        children;
            (4) the definitions of ``direct benefit to the individual 
        subjects'' and ``generalizable knowledge about the subject's 
        disorder or condition'';
            (5) whether or not payment (financial or otherwise) may be 
        provided to a child or his or her parent or guardian for the 
        participation of the child in research, and if so, the amount 
        and type given;
            (6) the expectations of child research participants and 
        their parent or guardian for the direct benefits of the child's 
        research involvement;
            (7) safeguards for research involving children conducted in 
        emergency situations with a waiver of informed assent;
            (8) parent and child notification in instances in which the 
        regulations have not been complied with;
            (9) compliance with the regulations in effect on the date 
        of enactment of this Act, the monitoring of such compliance, 
        and enforcement actions for violations of such regulations; and
            (10) the appropriateness of current practices for 
        recruiting children for participation in research.
    (c) Consultation.--In conducting the review under subsection (a), 
the Secretary of Health and Human Services shall consult broadly with 
experts in the field, including pediatric pharmacologists, 
pediatricians, bioethics experts, clinical investigators, institutional 
review boards, industry experts, and children who have participated in 
research studies and the parents or guardians of such children.
    (d) Consideration of Additional Provisions.--In conducting the 
review under subsection (a), the Secretary of Health and Human Services 
shall consider and, not later than 6 months after the date of enactment 
of this Act, report back to Congress concerning--
            (1) whether the Secretary should establish national data 
        and safety monitoring boards to review adverse events 
        associated with research involving children; and
            (2) whether the institutional review board oversight of 
        clinical trials involving children is adequate to protect the 
        children.

SEC. 4. REQUIREMENT FOR ADDITIONAL PROTECTIONS FOR CHILDREN INVOLVED IN 
              RESEARCH.

    (a) In General.--Notwithstanding any other provision of law, not 
later than 6 months after the date of enactment of this Act, the 
Secretary of Health and Human Services shall require that all research 
involving children that is conducted, supported, or regulated by the 
Department of Health and Human Services be in compliance with subpart D 
of part 45 of title 46, Code of Federal Regulations.
    (b) Other Federal Agencies.--Not later than 12 months after the 
date of enactment of this Act, all Federal agencies shall have 
promulgated regulations to provide additional protections for children 
involved in research.

SEC. 5. GRANTS FOR PEDIATRIC PHARMACOLOGY.

    (a) In General.--The Secretary of Health and Human Services shall 
award grants to qualified academic research institutions and research 
networks with the appropriate expertise to provide training in 
pediatric clinical pharmacology, such as the Pediatric Pharmacology 
Research Units of the National Institute of Child Health and Human 
Development, and the Research Units of the National Institute of Mental 
Health, to enable such entities to provide fellowship training to 
individuals who hold an M.D. in order to ensure the specialized 
training of pediatric clinical pharmacologists.
    (b) Amount of Grant.--In awarding grants under subsection (a), the 
Secretary of Health and Human Services shall ensure that each grantee 
receive adequate amounts under the grant to enable the grantee to fund 
at least 1 fellow each year for a 3-year period, at a total of $100,000 
per fellowship per year.
    (c) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated such sums as 
may be necessary for each fiscal year.

SEC. 6. LOAN REPAYMENT PROGRAM REGARDING CLINICAL RESEARCHERS.

    Part G of title IV of the Public Health Service Act is amended by 
inserting after section 487E (42 U.S.C. 288-5) the following:

``SEC. 487F. LOAN REPAYMENT PROGRAM REGARDING PEDIATRIC PHARMACOLOGY.

    ``(a) In General.--The Secretary, acting through the Director of 
the National Institutes of Health, shall establish a program to enter 
into contracts with qualified individuals who hold an M.D. under which 
such individuals agree to undergo training in, and practice, pediatric 
pharmacology, in consideration of the Federal Government agreeing to 
repay, for each year of service as a pediatric pharmacologist, not more 
than $35,000 of the principal and interest of the educational loans of 
such individuals.
    ``(b) Application of Provisions.--The provisions of sections 338B, 
338C, and 338E shall, except as inconsistent with subsection (a) of 
this section, apply to the program established under subsection (a) to 
the same extent and in the same manner as such provisions apply to the 
National Health Service Corps Loan Repayment Program established in 
subpart III of part D of title III.
    ``(c) Funding.--
            ``(1) Authorization of appropriations.--For the purpose of 
        carrying out this section, there are authorized to be 
        appropriated such sums as may be necessary for each fiscal 
        year.
            ``(2) Availability.--Amounts appropriated for carrying out 
        this section shall remain available until the expiration of the 
        second fiscal year beginning after the fiscal year for which 
        the amounts were made available.''.

SEC. 7. EFFECTIVE DATE.

    The provisions of sections 5 and 6 shall take effect on the date 
that is 6 months after the date of enactment of this Act.
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