II

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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Children’s Research

5 Protection Act’’.

6 SEC. 2. FINDINGS, PURPOSES, AND DEFINITION.

7 (a) FINDINGS.—Congress makes the following find8 ings:
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1 (1) Children are the future of the Nation and

2 the preservation and improvement of child health is

3 in the national interest.

4 (2) The preservation and improvement of child

5 health may require the use of pharmaceutical prod6 ucts.

7 (3) Currently only 1 out of 5 drugs on the mar8 ket in the United States have been approved for use

9 by children. The enactment of the provisions of the

10 Food and Drug Administration Modernization Act

11 (Public Law 105–115) relating to pediatric studies

12 of drugs, however, is expected to increase the pedi13 atric testing of pharmaceuticals and thus to increase

14 the numbers of children involved in research.

15 (4) Children are a vulnerable population and

16 thus need additional protections for their involve17 ment in research relative to adults. Yet, current

18 Federal guidelines for the protection of children in19 volved in research have not been updated since

20 1981, do not currently apply to Food and Drug Ad21 ministration-regulated research that is not Federally

22 funded, and have not been adopted by all Federal

23 agencies that conduct research involving children.

24 (5) Currently, in the United States, there is a

25 shortage of pharmacologists trained to address the
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1 unique aspects of developing therapies for children.

2 There are fewer than 200 academic-based clinical

3 pharmacologists in the United States, of which 20

4 percent or fewer are pediatricians. Currently, only

5 20 physicians complete clinical pharmacology spe6 cialty training programs each year, and of these,

7 only 2 or fewer specialize in pediatric pharmacology.

8 (b) PURPOSES.—It is the purpose of this Act to—

9 (1) ensure the adequate and appropriate protec10 tion of children involved in research by—

11 (A) reviewing and updating as needed the

12 Federal regulations that provide additional pro13 tections for children participating in research as

14 contained in subpart D of part 45 of title 46,

15 Code of Federal Regulations;

16 (B) extending such subpart D to all re17 search regulated by the Secretary of Health and

18 Human Services; and

19 (C) requiring that all Federal agencies

20 adopt regulations for additional protections for

21 children involved in research that is conducted,

22 supported, or regulated by the Federal Govern23 ment; and

24 (2) ensure that an adequate number of pedi25 atric clinical pharmacologists are trained and re-
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1 tained, in order to meet the increased demand for

2 expertise in this area created by the pediatric studies

3 provisions of the Food and Drug Administration

4 Modernization Act (Public Law 105–115), so that

5 all children have access to medications that have

6 been adequately and properly tested on children.

7 (c) DEFINITION.—In this Act, the term ‘‘pediatric

8 clinical pharmacologist’’ means an individual—

9 (1) who is board certified in pediatrics; and

10 (2) who has additional formal training and ex11 pertise in human pharmacology.

12 SEC. 3. REVIEW OF REGULATIONS.

13 (a) REVIEW.—By not later than 6 months after the

14 date of enactment of this Act, the Secretary of Health and

15 Human Services shall have conducted a review of the regu16 lations under subpart D of part 45 of title 46, Code of

17 Federal Regulations, considered any modifications nec18 essary to ensure the adequate and appropriate protection

19 of children participating in research, and report the find20 ings of the Secretary back to Congress.

21 (b) AREAS OF REVIEW.—In conducting the review

22 under subsection (a), the Secretary of Health and Human

23 Services shall consider—
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1 (1) the appropriateness of the regulations for

2 children of differing ages and maturity levels, includ3 ing legal status;

4 (2) the definition of ‘‘minimal risk’’ and the

5 manner in which such definition varies for a healthy

6 child as compared to a child with an illness;

7 (3) the definitions of ‘‘assent’’ and ‘‘permis8 sion’’ for child clinical research participants and

9 their parents or guardians and of ‘‘adequate provi10 sions’’ for soliciting assent or permission in research

11 as such definitions relate to the process of obtaining

12 the informed consent of children participating in re13 search and the parents or guardians of such chil14 dren;

15 (4) the definitions of ‘‘direct benefit to the indi16 vidual subjects’’ and ‘‘generalizable knowledge about

17 the subject’s disorder or condition’’;

18 (5) whether or not payment (financial or other19 wise) may be provided to a child or his or her parent

20 or guardian for the participation of the child in re21 search, and if so, the amount and type given;

22 (6) the expectations of child research partici23 pants and their parent or guardian for the direct

24 benefits of the child’s research involvement;
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1 (7) safeguards for research involving children

2 conducted in emergency situations with a waiver of

3 informed assent;

4 (8) parent and child notification in instances in

5 which the regulations have not been complied with;

6 (9) compliance with the regulations in effect on

7 the date of enactment of this Act, the monitoring of

8 such compliance, and enforcement actions for viola9 tions of such regulations; and

10 (10) the appropriateness of current practices

11 for recruiting children for participation in research.

12 (c) CONSULTATION.—In conducting the review under

13 subsection (a), the Secretary of Health and Human Serv14 ices shall consult broadly with experts in the field, includ15 ing pediatric pharmacologists, pediatricians, bioethics ex16 perts, clinical investigators, institutional review boards, in17 dustry experts, and children who have participated in re18 search studies and the parents or guardians of such chil19 dren.

20 (d) CONSIDERATION OF ADDITIONAL PROVISIONS.—

21 In conducting the review under subsection (a), the Sec22 retary of Health and Human Services shall consider and,

23 not later than 6 months after the date of enactment of

24 this Act, report back to Congress concerning—
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1 (1) whether the Secretary should establish na2 tional data and safety monitoring boards to review

3 adverse events associated with research involving

4 children; and

5 (2) whether the institutional review board over6 sight of clinical trials involving children is adequate

7 to protect the children.

8 SEC. 4. REQUIREMENT FOR ADDITIONAL PROTECTIONS

9 FOR CHILDREN INVOLVED IN RESEARCH.

10 (a) IN GENERAL.—Notwithstanding any other provi11 sion of law, not later than 6 months after the date of en12 actment of this Act, the Secretary of Health and Human

13 Services shall require that all research involving children

14 that is conducted, supported, or regulated by the Depart15 ment of Health and Human Services be in compliance with

16 subpart D of part 45 of title 46, Code of Federal Regula17 tions.

18 (b) OTHER FEDERAL AGENCIES.—Not later than 12

19 months after the date of enactment of this Act, all Federal

20 agencies shall have promulgated regulations to provide ad21 ditional protections for children involved in research.

22 SEC. 5. GRANTS FOR PEDIATRIC PHARMACOLOGY.

23 (a) IN GENERAL.—The Secretary of Health and

24 Human Services shall award grants to qualified academic

25 research institutions and research networks with the ap-
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1 propriate expertise to provide training in pediatric clinical

2 pharmacology, such as the Pediatric Pharmacology Re3 search Units of the National Institute of Child Health and

4 Human Development, and the Research Units of the Na5 tional Institute of Mental Health, to enable such entities

6 to provide fellowship training to individuals who hold an

7 M.D. in order to ensure the specialized training of pedi8 atric clinical pharmacologists.

9 (b) AMOUNT OF GRANT.—In awarding grants under

10 subsection (a), the Secretary of Health and Human Serv11 ices shall ensure that each grantee receive adequate

12 amounts under the grant to enable the grantee to fund

13 at least 1 fellow each year for a 3-year period, at a total

14 of $100,000 per fellowship per year.

15 (c) AUTHORIZATION OF APPROPRIATIONS.—For the

16 purpose of carrying out this section, there are authorized

17 to be appropriated such sums as may be necessary for

18 each fiscal year.

19 SEC. 6. LOAN REPAYMENT PROGRAM REGARDING CLIN20 ICAL RESEARCHERS.

21 Part G of title IV of the Public Health Service Act

22 is amended by inserting after section 487E (42 U.S.C.

23 288–5) the following:
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1 ‘‘SEC. 487F. LOAN REPAYMENT PROGRAM REGARDING PE2 DIATRIC PHARMACOLOGY.

3 ‘‘(a) IN GENERAL.—The Secretary, acting through

4 the Director of the National Institutes of Health, shall es5 tablish a program to enter into contracts with qualified

6 individuals who hold an M.D. under which such individ7 uals agree to undergo training in, and practice, pediatric

8 pharmacology, in consideration of the Federal Government

9 agreeing to repay, for each year of service as a pediatric

10 pharmacologist, not more than $35,000 of the principal

11 and interest of the educational loans of such individuals.

12 ‘‘(b) APPLICATION OF PROVISIONS.—The provisions

13 of sections 338B, 338C, and 338E shall, except as incon14 sistent with subsection (a) of this section, apply to the pro15 gram established under subsection (a) to the same extent

16 and in the same manner as such provisions apply to the

17 National Health Service Corps Loan Repayment Program

18 established in subpart III of part D of title III.

19 ‘‘(c) FUNDING.—

20 ‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—

21 For the purpose of carrying out this section, there

22 are authorized to be appropriated such sums as may

23 be necessary for each fiscal year.

24 ‘‘(2) AVAILABILITY.—Amounts appropriated for

25 carrying out this section shall remain available until

26 the expiration of the second fiscal year beginning
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1 after the fiscal year for which the amounts were

2 made available.’’.

3 SEC. 7. EFFECTIVE DATE.

4 The provisions of sections 5 and 6 shall take effect

5 on the date that is 6 months after the date of enactment

6 of this Act.

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