I
105TH CONGRESS
1ST SESSION
H. R. 3001
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
NOVEMBER 9, 1997
Mrs. LOWEY (for herself, Mrs. JOHNSON of Connecticut, Mr. HOYER, Mrs.
MORELLA, Mr. NADLER, Mr. STEARNS, Ms. DELAURO, Mr. LEACH, Mr.
LEWIS of Georgia, Mr. WICKER, and Mr. CARDIN) introduced the follow-
ing bill; which was referred to the Committee on Commerce
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 1997’’.
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 clini-
cal research and has through the use of an advisory
committee begun to evaluate these problems.
(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 federally funded re-
search (R01) grants awarded to persons under
the age of 36 have decreased by 70 percent
from 1985 to 1993.
(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 $80,000, 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 clini-
cal research training in the curriculum of train-
ing 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 1997 equaled $153,000,000.
(12) In fiscal year 1997, there were 74 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.
(13) The average annual amount allocated for
each general clinical research center is $1,900,000,
establishing a current funding level of 75 percent of
the amounts approved by the Advisory Council of
the National Center for Research Resources.
(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
RESEARCH.
Section 402 of the Public Health Service Act (42
U.S.C. 282) is amended by adding at the end the follow-
ing:
‘‘(l)(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) design test pilot projects and implement
the recommendations of the Division 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 clini-
cal 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) clinical research career enhancement
awards;
‘‘(B) innovative medical science awards;
‘‘(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. 409B. 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.—There
are authorized to be appropriated to carry out this section,
such sums as may be necessary.
‘‘SEC. 409C. ENHANCEMENT AWARDS.
‘‘(a) CLINICAL RESEARCH CAREER ENHANCEMENT
AWARD.—
‘‘(1) IN GENERAL.—The Director of the Na-
tional Center for Research Resources shall make
grants (to be referred to as ‘clinical research career
enhancement awards’) to support individual careers
in clinical research at general clinical research cen-
ters or at other institutions that have the infrastruc-
ture and resources deemed appropriate for conduct-
ing patient-oriented clinical research. The Director
of the National Center for Research Resources shall,
where practicable, collaborate 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) LIMITATIONS.—The amount of a grant
under this subsection shall not exceed $125,000 per
year per grant. Grants shall be for terms of 5 years.
The Director shall award not more than 20 grants
in the first fiscal year, and not more than 40 grants
in the second fiscal year, in which grants are award-
ed under this subsection.
‘‘(4) AUTHORIZATION
OF
APPROPRIATIONS.—
There is authorized to be appropriated to make
grants under paragraph (1), $3,000,000 for fiscal
year 1998, and such sums as may be necessary for
each subsequent fiscal year.
‘‘(b) INNOVATIVE MEDICAL SCIENCE AWARD.—
‘‘(1) IN GENERAL.—The Director of the Na-
tional Center for Research Resources shall make
grants (to be referred to as ‘innovative medical
science awards’) to support individual clinical re-
search projects at general clinical research centers or
at other institutions that have the infrastructure and
resources deemed appropriate for conducting pa-
tient-oriented clinical research. The Director of the
National Center for Research Resources shall, where
practicable, collaborate or consult with other Insti-
tute Directors in making awards under this sub-
section.
‘‘(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) LIMITATIONS.—The amount of a grant
under this subsection shall not exceed $175,000 per
year per grant.
‘‘(4) AUTHORIZATION
OF
APPROPRIATIONS.—
There is authorized to be appropriated to make
grants under this subsection, $52,500,000 for fiscal
year 1998, and such sums as may be necessary for
each subsequent 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.—The amount of a grant
under this subsection shall not exceed $75,000 per
year per grant. Grants shall be for terms of 2 years
or more and will provide stipend, tuition, and insti-
tutional support for individual advanced degree pro-
grams 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.—
There is authorized to be appropriated to make
grants under this subsection, $3,000,000 for fiscal
year 1998, and such sums as may be necessary for
each subsequent 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 individ-
ual serving in a general clinical research center or in clini-
cal research at the National Institutes of Health, or a phy-
sician receiving a clinical research career enhancement
award, or a graduate training in clinical investigation
award.
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There
is authorized to be appropriated to carry out this section
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.’’.
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