I

106TH CONGRESS

2D SESSION H. R. 5198

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

IN THE HOUSE OF REPRESENTATIVES

SEPTEMBER 18, 2000

Ms. DEGETTE (for herself and Mr. LATOURETTE) introduced the following

bill; which was referred to the Committee on Commerce

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:

9 (1) Children are the future of the Nation and

10 the preservation and improvement of child health is

11 in the national interest.
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1 (2) The preservation and improvement of child

2 health may require the use of pharmaceutical prod3 ucts.

4 (3) Currently only 1 out of 5 drugs on the mar5 ket in the United States have been approved for use

6 by children. The enactment of the provisions of the

7 Food and Drug Administration Modernization Act

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

9 of drugs, however, is expected to increase the pedi10 atric testing of pharmaceuticals and thus to increase

11 the numbers of children involved in research.

12 (4) Children are a vulnerable population and

13 thus need additional protections for their involve14 ment in research relative to adults. Yet, current

15 Federal guidelines for the protection of children in16 volved in research have not been updated since

17 1981. Only research funded by the Department of

18 Health and Human Services and the Department of

19 Education have additional regulations for the protec20 tion of children in research. These regulations have

21 not been adopted by other Federal agencies, are not

22 required for research regulated by the Food and

23 Drug Administration, and do not apply to other non24 federally funded research.
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1 (5) Currently, in the United States, there is a

2 shortage of pharmacologists trained to address the

3 unique aspects of developing therapies for children.

4 There are fewer than 200 academic-based clinical

5 pharmacologists in the United States, of which 20

6 percent or fewer are pediatricians. Currently, only

7 20 physicians complete clinical pharmacology spe8 cialty training programs each year, and of these,

9 only 2 or fewer specialize in pediatric pharmacology.

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

11 (1) ensure the adequate and appropriate protec12 tion of children involved in research by—

13 (A) reviewing and updating as needed the

14 Federal regulations that provide additional pro15 tections for children participating in research as

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

17 Code of Federal Regulations;

18 (B) extending such subpart D to all re19 search regulated by the Secretary of Health and

20 Human Services; and

21 (C) requiring that all Federal agencies

22 adopt regulations for additional protections for

23 children involved in research that is conducted,

24 supported, or regulated by the Federal Govern25 ment; and
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1 (2) ensure that an adequate number of pedi2 atric clinical researchers, including pediatric phar3 macologists, are trained and retained, in order to

4 meet the increased demand for expertise in this area

5 created by the pediatric studies provisions of the

6 Food and Drug Administration Modernization Act

7 (Public Law 105–115), so that all children have ac8 cess to medications that have been adequately and

9 properly tested on children.

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

11 clinical pharmacologist’’ means an individual—

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

13 (2) who has additional formal training and ex14 pertise in human pharmacology.

15 SEC. 3. REVIEW OF REGULATIONS.

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

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

18 Human Services shall have conducted a review of the regu19 lations under subpart D of part 45 of title 46, Code of

20 Federal Regulations, considered any modifications nec21 essary to ensure the adequate and appropriate protection

22 of children participating in research, and implement any

23 modifications necessary to ensure human subject protec24 tions of children in research.
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1 (b) AREAS OF REVIEW.—In conducting the review

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

3 Services shall consider—

4 (1) the appropriateness of the regulations for

5 children of differing ages and maturity levels, includ6 ing legal status;

7 (2) the definition of ‘‘minimal risk’’ and ‘‘a

8 minor increase over minimum risk’’ and the manner

9 in which such definition varies for a healthy child as

10 compared to a child with an illness;

11 (3) the definitions of ‘‘assent’’ and ‘‘permis12 sion’’ for child clinical research participants and

13 their parents or guardians and of ‘‘adequate provi14 sions’’ for soliciting assent or permission in research

15 as such definitions relate to the process of obtaining

16 the informed consent of children participating in re17 search and the parents or guardians of such chil18 dren;

19 (4) the definitions of ‘‘direct benefit to the indi20 vidual subjects’’ and ‘‘generalizable knowledge about

21 the subject’s disorder or condition’’;

22 (5) whether or not payment (financial or other23 wise) may be provided to a child or his or her parent

24 or guardian for the participation of the child in re25 search, and if so, the amount and type given;
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1 (6) the expectations of child research partici2 pants and their parent or guardian for the direct

3 benefits of the child’s research involvement;

4 (7) safeguards for research involving children

5 conducted in emergency situations with a waiver of

6 informed assent;

7 (8) parent and child notification in instances in

8 which the regulations have not been complied with;

9 (9) compliance with the regulations in effect on

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

11 such compliance, and enforcement actions for viola12 tions of such regulations; and

13 (10) the appropriateness of current practices

14 for recruiting children for participation in research.

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

16 subsection (a), the Secretary of Health and Human Serv17 ices shall consult broadly with experts in the field, includ18 ing pediatric pharmacologists, pediatricians, bioethics ex19 perts, clinical investigators, institutional review boards, in20 dustry experts, and children who have participated in re21 search studies and the parents or guardians of such chil22 dren.

23 (d) CONSIDERATION OF ADDITIONAL PROVISIONS.—

24 In conducting the review under subsection (a), the Sec25 retary of Health and Human Services shall consider and,
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1 not later than 6 months after the date of enactment of

2 this Act, report back to Congress concerning—

3 (1) whether the Secretary should establish na4 tional data and safety monitoring boards to review

5 adverse events associated with research involving

6 children; and

7 (2) whether the institutional review board over8 sight of clinical trials involving children is adequate

9 to protect the children.

10 SEC. 4. REQUIREMENT FOR ADDITIONAL PROTECTIONS

11 FOR CHILDREN INVOLVED IN RESEARCH.

12 (a) IN GENERAL.—Notwithstanding any other provi13 sion of law, not later than 6 months after the date of en14 actment of this Act, the Secretary of Health and Human

15 Services shall require that all research involving children

16 that is conducted, supported, or regulated by the Depart17 ment of Health and Human Services be in compliance with

18 subpart D of part 45 of title 46, Code of Federal Regula19 tions.

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

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

22 agencies shall have promulgated regulations to provide ad23 ditional protections for children involved in research.

24 (c) REQUIREMENTS FOR INSTITUTIONAL REVIEW

25 BOARDS.—When reviewing a proposal that will include a
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1 child as a subject of research, the Institutional Review

2 Board involved shall include members who are experts in

3 the issues involving pediatric research. Such members

4 shall be allowed to fully participate in the Board review

5 process and have the same voting rights as other Board

6 members.

7 SEC. 5. GRANTS FOR PEDIATRIC PHARMACOLOGY.

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

9 Human Services shall award grants to qualified academic

10 research institutions and research networks with the ap11 propriate expertise to provide training in pediatric clinical

12 pharmacology, such as the Pediatric Pharmacology Re13 search Units of the National Institute of Child Health and

14 Human Development, and the Research Units of the Na15 tional Institute of Mental Health, to enable such entities

16 to provide fellowship training to individuals who hold an

17 M.D. in order to ensure the specialized training of pedi18 atric clinical pharmacologists.

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

20 subsection (a), the Secretary of Health and Human Serv21 ices shall ensure that each grantee receive adequate

22 amounts under the grant to enable the grantee to fund

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

24 of $100,000 per fellowship per year.
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1 (c) AUTHORIZATION OF APPROPRIATIONS.—For the

2 purpose of carrying out this section, there are authorized

3 to be appropriated such sums as may be necessary for

4 each fiscal year.

5 SEC. 6. PEDIATRIC RESEARCH LOAN REPAYMENT PRO6 GRAM.

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

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

9 288–5) the following:

10 ‘‘SEC. 487F. PEDIATRIC RESEARCH LOAN REPAYMENT PRO11 GRAM.

12 ‘‘(a) IN GENERAL.—The Secretary, in consultation

13 with the Director of the National Institute of Child Health

14 and Human Development, shall establish a pediatric re15 search loan repayment program. Through such program—

16 ‘‘(1) the Secretary shall enter into contracts

17 with qualified pediatricians under which such pedia18 tricians will agree to conduct pediatric research, in19 cluding pediatric pharmacology, in consideration of

20 the Federal Government agreeing to repay, for each

21 year of such service, not more than $35,000 of the

22 principal and interest of the educational loans of

23 such pediatricians; and

24 ‘‘(2) the Secretary shall, for the purpose of pro25 viding reimbursements for tax liability resulting
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1 from payments made under paragraph (1) on behalf

2 of an individual, make payments, in addition to pay3 ments under such paragraph, to the individual in an

4 amount equal to 39 percent of the total amount of

5 loan repayments made for the taxable year involved.

6 ‘‘(b) APPLICATION OF OTHER PROVISIONS.—The

7 provisions of sections 338B, 338C, and 338E shall, except

8 as inconsistent with subsection (a), apply to the program

9 established under such subsection to the same extent and

10 in the same manner as such provisions apply to the Na11 tional Health Service Corps Loan Repayment Program es12 tablished under subpart III of part D of title III.

13 ‘‘(c) AVAILABILITY OF FUNDS.—Amounts made

14 available to carry out this section shall remain available

15 until the expiration of the second fiscal year beginning

16 after the fiscal year for which such amounts were made

17 available.

18 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For the

19 purpose of carrying out this section, there are authorized

20 to be appropriated such sums as may be necessary for

21 each fiscal year.’’.
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1 SEC. 7. LOAN FORGIVENESS PROGRAM FOR HEALTH CARE

2 PROFESSIONALS CONDUCTING RESEARCH

3 INTO CHILDHOOD DISEASES.

4 Part G of title IV of the Public Health Service Act,

5 as amended by section 6 of this Act, is amended by insert6 ing after section 487F the following:

7 ‘‘SEC. 487G. LOAN FORGIVENESS PROGRAM FOR HEALTH

8 CARE PROFESSIONALS CONDUCTING RE9 SEARCH INTO CHILDHOOD DISEASES.

10 ‘‘(a) IN GENERAL.—The Secretary, in consultation

11 with the Director of the National Institutes of Health,

12 shall establish a loan forgiveness program for health care

13 professionals conducting research into childhood diseases.

14 Through such program—

15 ‘‘(1) the Secretary shall enter into contracts

16 with qualified health care professionals under which

17 such health care professionals will agree to conduct

18 research into diseases that are prevalent in children

19 in consideration of the Federal government agreeing

20 to repay, for each year of such service, not more

21 than $35,000 of the principal and interest of the

22 educational loans of such health care professionals;

23 and

24 ‘‘(2) the Secretary shall, for the purpose of pro25 viding reimbursements for tax liability resulting

26 from payments made under paragraph (1) on behalf
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1 of an individual, make payments, in addition to pay2 ments under such paragraph, to the individual in an

3 amount equal to 39 percent of the total amount of

4 loan repayments made for the taxable year involved.

5 ‘‘(b) APPLICATION OF OTHER PROVISIONS.—With

6 respect to the National Health Service Corps Loan Repay7 ment Program established in subpart III of part D of title

8 III, the provisions of such subpart shall, except as incon9 sistent with subsection (a) of this section, apply to the pro10 gram established in such subsection (a) in the same man11 ner and to the same extent as such provisions apply to

12 the National Health Service Corps Loan Repayment Pro13 gram established in such subpart.

14 ‘‘(c) AVAILABILITY OF FUNDS.—Amounts made

15 available to carry out this section shall remain available

16 until the expiration of the second fiscal year beginning

17 after the fiscal year for which such amounts were made

18 available.

19 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For the

20 purpose of carrying out this section, there are authorized

21 to be appropriated such sums as may be necessary for

22 each of the fiscal years 2001 through 2005.’’.
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1 SEC. 8. EFFECTIVE DATE.

2 The provisions of sections 5, 6, and 7 shall take effect

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

4 of this Act.

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