IB
Union Calendar No. 585
106TH CONGRESS
2D SESSION
H. R. 1798
[Report No. 106–1002]
To amend the Public Health Service Act to provide additional support for
and to expand clinical research programs, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
MAY 13, 1999
Mr. GREENWOOD (for himself, Mrs. LOWEY, Mrs. JOHNSON of Connecticut,
Mr. BROWN of Ohio, Mr. BURR of North Carolina, Mr. WAXMAN, Mr.
PICKERING, Mr. DEAL of Georgia, Mrs. MORELLA, Mr. FRANK of Massa-
chusetts, Ms. DELAURO, Mr. NETHERCUTT, Mr. LEACH, Mr. ENGLISH,
Mr. TOWNS, Mr. COYNE, Mr. LEWIS of Georgia, Mr. NADLER, Mr. WICK-
ER, Mr. FILNER, and Ms. PELOSI) introduced the following bill; which
was referred to the Committee on Commerce
OCTOBER 25, 2000
Additional sponsors: Ms. SLAUGHTER, Mr. CAPUANO, Mr. MCGOVERN, Mr.
FROST, Mr. UPTON, Mr. WYNN, Mr. HOYER, Mr. MCNULTY, Mr. GON-
ZALEZ, Mr. SANDLIN, Mr. NORWOOD, Mr. DEUTSCH, Ms. ESHOO, Mrs.
THURMAN, Mr. BARRETT of Wisconsin, Mr. EHRLICH, Mr. PRICE of
North Carolina, Mr. MARTINEZ, Mrs. MALONEY of New York, Mr.
DIXON, Ms. STABENOW, Mr. BILBRAY, Mr. MARKEY, Ms. DEGETTE, Mr.
SANDERS, Mr. STARK, Mr. GORDON, Mr. RODRIGUEZ, Mr. TAUZIN, Mr.
HILLIARD, Mr. ROGAN, and Mr. BOEHLERT
OCTOBER 25, 2000
Committed to the Committee of the Whole House on the State of the Union
and ordered to be printed
A BILL
To amend the Public Health Service Act to provide additional
support for and to expand clinical research programs,
and for other purposes.
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 ‘‘Clinical Research En-
hancement Act of 1999’’.
SEC. 2. FINDINGS AND PURPOSE.
(a) FINDINGS.—Congress makes the following find-
ings:
(1) Clinical research is critical to the advance-
ment of scientific knowledge and to the development
of cures and improved treatment for disease.
(2) Tremendous advances in biology are open-
ing doors to new insights into human physiology,
pathophysiology and disease, creating extraordinary
opportunities for clinical research.
(3) Clinical research includes translational re-
search which is an integral part of the research
process leading to general human applications. It is
the bridge between the laboratory and new methods
of diagnosis, treatment, and prevention and is thus
essential to progress against cancer and other dis-
eases.
(4) The United States will spend more than $1
trillion on health care in 1997, but the Federal
budget for health research at the National Institutes
of Health was $12.7 billion, only 1 percent of that
total.
(5) Studies at the Institute of Medicine, the
National Research Council, and the National Acad-
emy of Sciences have all addressed the current prob-
lems in clinical research.
(6) The Director of the National Institutes of
Health has recognized the current problems in clin-
ical research and appointed a special advisory com-
mittee, which recommended expanded support for
existing NIH clinical research programs and the cre-
ation of new initiatives to recruit and retain clinical
investigators.
(7) The current level of training and support
for health professionals in clinical research is frag-
mented, frequently undervalued, and potentially un-
derfunded.
(8) Young investigators are not only appren-
tices for future positions but a crucial source of en-
ergy, enthusiasm, and ideas in the day-to-day re-
search that constitutes the scientific enterprise. Seri-
ous questions about the future of life-science re-
search are raised by the following:
(A) The number of young investigators ap-
plying for grants dropped by 54 percent be-
tween 1985 and 1993.
(B) The number of physicians applying for
first-time NIH research project grants fell from
838 in 1994 to 575 in 1997, a 31 percent re-
duction.
(C) Newly independent life-scientists are
expected to raise funds to support their new re-
search programs and a substantial proportion
of their own salaries.
(9) The following have been cited as reasons for
the decline in the number of active clinical research-
ers, and those choosing this career path:
(A) A medical school graduate incurs an
average debt of $85,619, as reported in the
Medical School Graduation Questionnaire by
the American Association of Medical Colleges
(AAMC).
(B) The prolonged period of clinical train-
ing required increases the accumulated debt
burden.
(C) The decreasing number of mentors and
role models.
(D) The perceived instability of funding
from the National Institutes of Health and
other Federal agencies.
(E) The almost complete absence of clin-
ical research training in the curriculum of
training grant awardees.
(F) Academic Medical Centers are experi-
encing difficulties in maintaining a proper envi-
ronment for research in a highly competitive
health care marketplace, which are compounded
by the decreased willingness of third party pay-
ers to cover health care costs for patients en-
gaged in research studies and research proce-
dures.
(10) In 1960, general clinical research centers
were established under the Office of the Director of
the National Institutes of Health with an initial ap-
propriation of $3,000,000.
(11) Appropriations for general clinical research
centers in fiscal year 1998 equaled $167,000,000.
Since the late 1960s, spending for general clinical
research centers has declined from approximately 3
percent to 1 percent of the NIH budget.
(12) In fiscal year 1998, there were 75 general
clinical research centers in operation, supplying pa-
tients in the areas in which such centers operate
with access to the most modern clinical research and
clinical research facilities and technologies.
(b) PURPOSE.—It is the purpose of this Act to pro-
vide additional support for and to expand clinical research
programs.
SEC. 3. INCREASING THE INVOLVEMENT OF THE NATIONAL
INSTITUTES OF HEALTH IN CLINICAL RE-
SEARCH.
Section 402 of the Public Health Service Act (42
U.S.C. 282) is amended by adding at the end the fol-
lowing:
‘‘(m)(1) The Director of NIH shall undertake activi-
ties to support and expand the involvement of the National
Institutes of Health in clinical research.
‘‘(2) In carrying out paragraph (1), the Director of
NIH shall—
‘‘(A) implement the recommendations of the Di-
vision of Research Grants Clinical Research Study
Group and other recommendations for enhancing
clinical research, where applicable; and
‘‘(B) establish an intramural clinical research
fellowship program and a continuing education clin-
ical research training program at NIH.
‘‘(3) The Director of NIH, in cooperation with the
Directors of the Institutes, Centers, and Divisions of the
National Institutes of Health, shall support and expand
the resources available for the diverse needs of the clinical
research community, including inpatient, outpatient, and
critical care clinical research.
‘‘(4) The Director of NIH shall establish peer review
mechanisms to evaluate applications for—
‘‘(A) Mentored Patient-Oriented Research Ca-
reer Development Awards;
‘‘(B) Mid-Career Investigator Awards in Pa-
tient-Oriented Research;
‘‘(C) graduate training in clinical investigation
awards;
‘‘(D) intramural clinical research fellowships.
Such review mechanisms shall include individuals who are
exceptionally qualified to appraise the merits of potential
clinical research training and research grant proposals.’’.
SEC. 4. GENERAL CLINICAL RESEARCH CENTERS.
Part B of title IV of the Public Health Service Act
(42 U.S.C. 284 et seq.) is further amended by adding at
the end the following:
‘‘SEC. 409C. GENERAL CLINICAL RESEARCH CENTERS.
‘‘(a) GRANTS.—The Director of the National Center
for Research Resources shall award grants for the estab-
lishment of general clinical research centers to provide the
infrastructure for clinical research including clinical re-
search training and career enhancement. Such centers
shall support clinical studies and career development in
all settings of the hospital or academic medical center in-
volved.
‘‘(b) ACTIVITIES.—In carrying out subsection (a), the
Director of NIH shall expand the activities of the general
clinical research centers through the increased use of tele-
communications and telemedicine initiatives.
‘‘(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. 409D. ENHANCEMENT AWARDS.
‘‘(a) MENTORED PATIENT-ORIENTED RESEARCH CA-
REER DEVELOPMENT AWARDS.—
‘‘(1) IN GENERAL.—The Director of the Na-
tional Center for Research Resources shall make
grants (to be referred to as ‘Mentored Patient-Ori-
ented Research Career Development Awards’) to
support individual careers in clinical research at gen-
eral clinical research centers or at other institutions
that have the infrastructure and resources deemed
appropriate for conducting patient-oriented clinical
research. The Director of the National Center for
Research Resources shall, where practicable, collabo-
rate or consult with other Institute Directors in
making awards under this subsection.
‘‘(2) APPLICATIONS.—An application for a
grant under this subsection shall be submitted by an
individual scientist at such time as the Director may
require.
‘‘(3) AUTHORIZATION
OF
APPROPRIATIONS.—
For the purpose of carrying out this subsection,
there are authorized to be appropriated such sums
as may be necessary for each fiscal year.
‘‘(b) MID-CAREER INVESTIGATOR AWARDS IN PA-
TIENT-ORIENTED RESEARCH.—
‘‘(1) IN GENERAL.—The Director of the Na-
tional Center for Research Resources shall make
grants (to be referred to as ‘Mid-Career Investigator
Awards in Patient-Oriented Research’) to support
individual clinical research projects at general clin-
ical research centers or at other institutions that
have the infrastructure and resources deemed appro-
priate for conducting patient-oriented clinical re-
search. The Director of the National Center for Re-
search Resources shall, where practicable, collabo-
rate or consult with other Institute Directors in
making awards under this subsection.
‘‘(2) APPLICATIONS.—An application for a
grant under this subsection shall be submitted by an
individual scientist at such time as the Director re-
quires.
‘‘(3) AUTHORIZATION
OF
APPROPRIATIONS.—
For the purpose of carrying out this subsection,
there are authorized to be appropriated such sums
as may be necessary for each fiscal year.
‘‘(c) GRADUATE TRAINING IN CLINICAL INVESTIGA-
TION AWARD.—
‘‘(1) IN GENERAL.—The Director of the Na-
tional Center for Research Resources shall make
grants (to be referred to as ‘graduate training in
clinical investigation awards’) to support individuals
pursuing master’s or doctoral degrees in clinical in-
vestigation.
‘‘(2) APPLICATIONS.—An application for a
grant under this subsection shall be submitted by an
individual scientist at such time as the Director may
require.
‘‘(3) LIMITATIONS.—Grants shall be for terms
of 2 years or more and will provide stipend, tuition,
and institutional support for individual advanced de-
gree programs in clinical investigation.
‘‘(4) DEFINITION.—As used in this subsection,
the term ‘advanced degree programs in clinical in-
vestigation’ means programs that award a master’s
or Ph.D. degree after 2 or more years of training
in areas such as the following:
‘‘(A) Analytical methods, biostatistics, and
study design.
‘‘(B) Principles of clinical pharmacology
and pharmacokinetics.
‘‘(C) Clinical epidemiology.
‘‘(D) Computer data management and
medical informatics.
‘‘(E) Ethical and regulatory issues.
‘‘(F) Biomedical writing.
‘‘(5) AUTHORIZATION
OF
APPROPRIATIONS.—
For the purpose of carrying out this subsection,
there are authorized to be appropriated such sums
as may be necessary for each fiscal year.’’.
SEC. 5. CLINICAL RESEARCH ASSISTANCE.
(a) NATIONAL RESEARCH SERVICE AWARDS.—Sec-
tion 487(a)(1)(C) of the Public Health Service Act (42
U.S.C. 288(a)(1)(C)) is amended by striking ‘‘50 such’’
and inserting ‘‘100 such’’.
(b) LOAN REPAYMENT PROGRAM.—Section 487E of
the Public Health Service Act (42 U.S.C. 288–5) is
amended—
(1) in the section heading, by striking ‘‘FROM
DISADVANTAGED BACKGROUNDS’’;
(2) in subsection (a)(1)—
(A) by striking ‘‘who are from disadvan-
taged backgrounds’’; and
(B) by striking ‘‘as employees of the Na-
tional Institutes of Health’’ and inserting ‘‘as
part of a clinical research training position’’;
(3) in subsection (a), by striking paragraph (3)
and inserting the following:
‘‘(3) APPLICABILITY OF CERTAIN PROVISIONS
REGARDING OBLIGATED SERVICE.—With respect to
the National Health Service Corps Loan Repayment
Program established under subpart III of part D of
title III, the provisions of such subpart shall, except
as inconsistent with this section, apply to the pro-
gram established in this section in the same manner
and to the same extent as such provisions apply to
such loan repayment program.’’;
(4) in subsection (b)—
(A) by striking ‘‘Amounts’’ and inserting
the following:
‘‘(1) IN GENERAL.—Amounts’’; and
(B) by adding at the end the following:
‘‘(2) 
DISADVANTAGED
BACKGROUNDS
SET-
ASIDE.—In carrying out this section, the Secretary
shall ensure that not less than 50 percent of the
contracts involve those appropriately qualified health
professionals who are from disadvantaged back-
grounds.’’; and
(5) by adding at the end the following:
‘‘(c) DEFINITION.—As used in subsection (a)(1), the
term ‘clinical research training position’ means an indi-
vidual serving in a general clinical research center or in
clinical research at the National Institutes of Health, or
a physician receiving a clinical research career enhance-
ment award, or a graduate training in clinical investiga-
tion award.
‘‘(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. 6. DEFINITION.
Section 409 of the Public Health Service Act (42
U.S.C. 284d) is amended—
(1) by striking ‘‘For purposes’’ and inserting
‘‘(a) HEALTH SERVICE RESEARCH.—For purposes’’;
and
(2) by adding at the end the following:
‘‘(b) CLINICAL RESEARCH.—As used in this title, the
term ‘clinical research’ means patient oriented clinical re-
search conducted with human subjects, or research on the
causes and consequences of disease in human populations
involving material of human origin (such as tissue speci-
mens and cognitive phenomena) for which an investigator
or colleague directly interacts with human subjects in an
outpatient or inpatient setting to clarify a problem in
human physiology, pathophysiology, or disease; or epi-
demiologic or behavioral studies, outcomes research, or
health services research, or developing new technologies or
therapeutic interventions.’’.
SEC. 7. OVERSIGHT BY GENERAL ACCOUNTING OFFICE.
Not later than 18 months after the date of the enact-
ment of this Act, the Comptroller General of the United
States shall submit to the Congress a reporting describing
the extent to which the National Institutes of Health has
complied with the amendments made by this Act.
Union Calendar No. 585
106TH CONGRESS
2D SESSION
H. R. 1798
[Report No. 106–1002]
A BILL
To amend the Public Health Service Act to provide
additional support for and to expand clinical re-
search programs, and for other purposes.
OCTOBER 25, 2000
Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed