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.
Be it enacted by the Senate and House of Representa-
tives 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 find-
ings:
(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 prod-
ucts.
(3) Currently only 1 out of 5 drugs on the mar-
ket 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 pedi-
atric 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 involve-
ment in research relative to adults. Yet, current
Federal guidelines for the protection of children in-
volved in research have not been updated since
1981. Only research funded by the Department of
Health and Human Services and the Department of
Education have additional regulations for the protec-
tion of children in research. These regulations have
not been adopted by other Federal agencies, are not
required for research regulated by the Food and
Drug Administration, and do not apply to other non-
federally funded research.
(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 spe-
cialty 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 protec-
tion of children involved in research by—
(A) reviewing and updating as needed the
Federal regulations that provide additional pro-
tections 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 re-
search 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 Govern-
ment; and
(2) ensure that an adequate number of pedi-
atric clinical researchers, including pediatric phar-
macologists, 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 ac-
cess 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 ex-
pertise 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 regu-
lations under subpart D of part 45 of title 46, Code of
Federal Regulations, considered any modifications nec-
essary to ensure the adequate and appropriate protection
of children participating in research, and implement any
modifications necessary to ensure human subject protec-
tions of children in research.
(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, includ-
ing legal status;
(2) the definition of ‘‘minimal risk’’ and ‘‘a
minor increase over minimum 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 ‘‘permis-
sion’’ for child clinical research participants and
their parents or guardians and of ‘‘adequate provi-
sions’’ for soliciting assent or permission in research
as such definitions relate to the process of obtaining
the informed consent of children participating in re-
search and the parents or guardians of such chil-
dren;
(4) the definitions of ‘‘direct benefit to the indi-
vidual subjects’’ and ‘‘generalizable knowledge about
the subject’s disorder or condition’’;
(5) whether or not payment (financial or other-
wise) may be provided to a child or his or her parent
or guardian for the participation of the child in re-
search, and if so, the amount and type given;
(6) the expectations of child research partici-
pants 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 viola-
tions 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 Serv-
ices shall consult broadly with experts in the field, includ-
ing pediatric pharmacologists, pediatricians, bioethics ex-
perts, clinical investigators, institutional review boards, in-
dustry experts, and children who have participated in re-
search studies and the parents or guardians of such chil-
dren.
(d) CONSIDERATION OF ADDITIONAL PROVISIONS.—
In conducting the review under subsection (a), the Sec-
retary 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 na-
tional data and safety monitoring boards to review
adverse events associated with research involving
children; and
(2) whether the institutional review board over-
sight 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 provi-
sion of law, not later than 6 months after the date of en-
actment 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 Depart-
ment of Health and Human Services be in compliance with
subpart D of part 45 of title 46, Code of Federal Regula-
tions.
(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 ad-
ditional protections for children involved in research.
(c) REQUIREMENTS
FOR INSTITUTIONAL REVIEW
BOARDS.—When reviewing a proposal that will include a
child as a subject of research, the Institutional Review
Board involved shall include members who are experts in
the issues involving pediatric research. Such members
shall be allowed to fully participate in the Board review
process and have the same voting rights as other Board
members.
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 ap-
propriate expertise to provide training in pediatric clinical
pharmacology, such as the Pediatric Pharmacology Re-
search Units of the National Institute of Child Health and
Human Development, and the Research Units of the Na-
tional 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 pedi-
atric clinical pharmacologists.
(b) AMOUNT OF GRANT.—In awarding grants under
subsection (a), the Secretary of Health and Human Serv-
ices 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. PEDIATRIC RESEARCH LOAN REPAYMENT PRO-
GRAM.
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. PEDIATRIC RESEARCH LOAN REPAYMENT PRO-
GRAM.
‘‘(a) IN GENERAL.—The Secretary, in consultation
with the Director of the National Institute of Child Health
and Human Development, shall establish a pediatric re-
search loan repayment program. Through such program—
‘‘(1) the Secretary shall enter into contracts
with qualified pediatricians under which such pedia-
tricians will agree to conduct pediatric research, in-
cluding pediatric pharmacology, in consideration of
the Federal Government agreeing to repay, for each
year of such service, not more than $35,000 of the
principal and interest of the educational loans of
such pediatricians; and
‘‘(2) the Secretary shall, for the purpose of pro-
viding reimbursements for tax liability resulting
from payments made under paragraph (1) on behalf
of an individual, make payments, in addition to pay-
ments under such paragraph, to the individual in an
amount equal to 39 percent of the total amount of
loan repayments made for the taxable year involved.
‘‘(b) APPLICATION
OF OTHER PROVISIONS.—The
provisions of sections 338B, 338C, and 338E shall, except
as inconsistent with subsection (a), apply to the program
established under such subsection to the same extent and
in the same manner as such provisions apply to the Na-
tional Health Service Corps Loan Repayment Program es-
tablished under subpart III of part D of title III.
‘‘(c) AVAILABILITY
OF
FUNDS.—Amounts made
available to carry out this section shall remain available
until the expiration of the second fiscal year beginning
after the fiscal year for which such amounts were made
available.
‘‘(d) 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. 7. LOAN FORGIVENESS PROGRAM FOR HEALTH CARE
PROFESSIONALS 
CONDUCTING 
RESEARCH
INTO CHILDHOOD DISEASES.
Part G of title IV of the Public Health Service Act,
as amended by section 6 of this Act, is amended by insert-
ing after section 487F the following:
‘‘SEC. 487G. LOAN FORGIVENESS PROGRAM FOR HEALTH
CARE 
PROFESSIONALS 
CONDUCTING 
RE-
SEARCH INTO CHILDHOOD DISEASES.
‘‘(a) IN GENERAL.—The Secretary, in consultation
with the Director of the National Institutes of Health,
shall establish a loan forgiveness program for health care
professionals conducting research into childhood diseases.
Through such program—
‘‘(1) the Secretary shall enter into contracts
with qualified health care professionals under which
such health care professionals will agree to conduct
research into diseases that are prevalent in children
in consideration of the Federal government agreeing
to repay, for each year of such service, not more
than $35,000 of the principal and interest of the
educational loans of such health care professionals;
and
‘‘(2) the Secretary shall, for the purpose of pro-
viding reimbursements for tax liability resulting
from payments made under paragraph (1) on behalf