I
106TH CONGRESS
1ST SESSION
H. R. 1798
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
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% reduction.
(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% to 1% 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
RESEARCH.
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.