‘‘(10) TRANSFER OF FUNDS.—The Foundation
may transfer funds to the National Institutes of
Health. Any funds transferred under this paragraph
shall be subject to all Federal limitations relating to
federally-funded research.
‘‘(k) DUTIES OF THE DIRECTOR.—
‘‘(1) APPLICABILITY OF CERTAIN STANDARDS
TO NON-FEDERAL EMPLOYEES.—In the case of any
individual who is not an employee of the Federal
Government and who serves in association with the
National Institutes of Health, with respect to finan-
cial assistance received from the Foundation, the
Foundation may not provide the assistance of, or
otherwise permit the work at the National Institutes
of Health to begin until a memorandum of under-
standing between the individual and the Director of
NIH, or the designee of such Director, has been exe-
cuted specifying that the individual shall be subject
to such ethical and procedural standards of conduct
relating to duties performed at the National Insti-
tutes of Health, as the Director of NIH determines
is appropriate.
‘‘(2) SUPPORT
SERVICES.—The Director of
NIH may provide facilities, utilities and support
services to the Foundation if it is determined by the
Director to be advantageous to the research pro-
grams of the National Institutes of Health.
‘‘(l) FUNDING.—
‘‘(1) AUTHORIZATION
OF
APPROPRIATIONS.—
For the purpose of carrying out this part, there are
authorized to be appropriated such sums as may be
necessary for fiscal year 2002 and each subsequent
fiscal year.
‘‘(2) LIMITATION REGARDING OTHER FUNDS.—
Amounts appropriated under any provision of law
other than paragraph (1) may not be expended to
establish or operate the Foundation.’’.
SEC. 5. OFFICE OF PEDIATRIC THERAPEUTICS.
(a) ESTABLISHMENT.—The Secretary of Health and
Human Services shall establish an Office of Pediatric
Therapeutics within the Office of the Commissioner of
Food and Drugs.
(b) DUTIES.—The Office of Pediatric Therapeutics
shall be responsible for oversight and coordination of all
activities of the Food and Drug Administration that may
have any effect on a pediatric population or the practice
of pediatrics or may in any other way involve pediatric
issues.
(c) STAFF.—The staff of the Office of Pediatric
Therapeutics shall include—
(1) employees of the Department of Health and
Human Services who, as of the date of enactment of
this Act, exercise responsibilities relating to pediatric
therapeutics;
(2) 1 or more additional individuals with exper-
tise concerning ethical issues presented by the con-
duct of clinical research in the pediatric population;
and
(3) 1 or more additional individuals with exper-
tise in pediatrics who shall consult and collaborate
with all components of the Food and Drug Adminis-
tration concerning activities described in subsection
(b).
SEC. 6. STUDY CONCERNING RESEARCH INVOLVING CHIL-
DREN.
(a) CONTRACT WITH INSTITUTE OF MEDICINE.—
The Secretary of Health and Human Services shall enter
into a contract with the Institute of Medicine for—
(1) the conduct, in accordance with subsection
(b), of a review of—
(A) Federal regulations in effect on the
date of the enactment of this Act relating to re-
search involving children;
(B) federally-prepared or supported reports
relating to research involving children; and
(C) federally-supported evidence-based re-
search involving children; and
(2) the submission to the appropriate commit-
tees of Congress, by not later than 2 years after the
date of enactment of this Act, of a report concerning
the review conducted under paragraph (1) that in-
cludes recommendations on best practices relating to
research involving children.
(b) AREAS OF REVIEW.—In conducting the review
under subsection (a)(1), the Institute of Medicine shall
consider the following:
(1) The written and oral process of obtaining
and defining ‘‘assent’’, ‘‘permission’’ and ‘‘informed
consent’’ with respect to child clinical research par-
ticipants and the parents, guardians, and the indi-
viduals who may serve as the legally authorized rep-
resentatives of such children (as defined in subpart
A of part 46 of title 45, Code of Regulations).
(2) The expectations and comprehension of
child research participants and the parents, guard-
ians, or legally authorized representatives of such
children, for the direct benefits and risks of the
child’s research involvement, particularly in terms of
research versus therapeutic treatment.
(3) The definition of ‘‘minimal risk’’ with re-
spect to a healthy child or a child with an illness.
(4) The appropriateness of the regulations ap-
plicable to children of differing ages and maturity
levels, including regulations relating to legal status.
(5) Whether payment (financial or otherwise)
may be provided to a child or his or her parent,
guardian, or legally authorized representative for the
participation of the child in research, and if so, the
amount and type of payment that may be made.
(6) Compliance with the regulations referred to
in subsection (a)(1)(A), the monitoring of such com-
pliance (including the role of institutional review
boards), and the enforcement actions taken for viola-
tions of such regulations.
(7) The unique roles and responsibilities of in-
stitutional review boards in reviewing research in-
volving children, including composition of member-
ship on institutional review boards.
(c) REQUIREMENTS OF EXPERTISE.—The Institute
of Medicine shall conduct the review under subsection
(a)(1) and make recommendations under subsection (a)(2)
in conjunction with experts in pediatric medicine, pediatric