I
104TH CONGRESS
2D SESSION
H. R. 3587
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
JUNE 5, 1996
Mr. NADLER 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 1996’’.
SEC. 2. FINDINGS AND PURPOSE.
(a) FINDINGS.—Congress finds the following:
(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) The United States spent more than $1 tril-
lion on health care in 1994, but the Federal budget
for health research at the National Institutes of
Health was $10 billion, only 1 percent of that total.
(4) 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.
(5) 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.
(6) The current level of training and support
for health professionals in clinical research is frag-
mented, frequently undervalued, and potentially un-
derfunded.
(7) 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.
(8) 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 $63,000, 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.
(9) 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.
(10) Appropriations for general clinical research
centers in fiscal year 1995 equal $136,640,000.
(11) In fiscal year 1995, there are 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.
(12) The average annual amount allocated for
each general clinical research center is $1,000,000,
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. PRESIDENT’S CLINICAL RESEARCH PANEL.
Part H of title IV of the Public Health Service Act
(42 U.S.C. 289 et seq.) is amended by adding at the end
thereof the following new section:
‘‘SEC. 498C. PRESIDENT’S CLINICAL RESEARCH PANEL.
‘‘(a) ESTABLISHMENT.—The President shall estab-
lish a panel to be known as the ‘President’s Clinical Re-
search Panel’ (hereafter referred to in this section as the
‘Panel’) as a part of the Office of Science and Technology
Policy, to carry out the duties described in this section.
‘‘(b) MEMBERSHIP.—
‘‘(1) IN GENERAL.—The Panel shall be com-
posed of 12 individuals appointed by the President
and selected from recommendations submitted by
the President of the Institute of Medicine of the Na-
tional Academy of Sciences.
‘‘(2) QUALIFICATIONS.—Individuals appointed
to the panel under paragraph (1) shall, by virtue of
their training, experience and background, be excep-
tionally qualified to appraise the status of clinical re-
search both within and outside of the Federal Gov-
ernment, and should represent distinguished re-
search scientists and physicians, insurance compa-
nies, pharmaceutical companies, health maintenance
organizations, accreditation and certification organi-
zations and academic research administrators, and
patients.
‘‘(3) EXCLUSION AND ADVISORS.—Officers or
employees of the Federal Government shall not be
eligible to be appointed to the Panel. The Secretary
of Health and Human Services, the Secretary of De-
fense, the Secretary of Veterans Affairs, the Assist-
ant to the President for Science and Technology,
and other Cabinet officers as the President deter-
mines to be appropriate may serve as advisors to the
Panel.
‘‘(c) TERMS AND VACANCIES.—
‘‘(1) TERMS.—Members of the Panel shall be
appointed for 3-year terms, except that—
‘‘(A) any member appointed to fill a va-
cancy occurring on the Panel prior to the expi-
ration of the term for which the member’s pred-
ecessor was appointed, shall be appointed for
the remainder of such term; and
‘‘(B) a member may serve until the mem-
ber’s successor has taken office.
‘‘(2) VACANCIES.—If a vacancy on the Panel
occurs, the President shall make an appointment to
fill the vacancy not later than 90 days after the date
on which the vacancy occurred.
‘‘(3) REAPPOINTMENTS.—A member of the
Panel may be reappointed but may not serve more
than 2 consecutive terms.
‘‘(d) DATE OF APPOINTMENT.—The initial members
of the Panel shall be appointed not later than 120 days
after the date of enactment of this section.
‘‘(e) CHAIRPERSON AND VICE CHAIRPERSON.—The
President shall designate one of the members of the Panel
to serve as the chairperson of the Panel and one member
to serve as the vice chairperson of the Panel, each to serve
for a term of 1 year.
‘‘(f) MEETINGS.—The Panel shall meet at the call of
the chairperson, but in no event less than 4 times each
year. A transcript shall be kept of the proceedings of each
such meeting of the Panel, and the chairperson shall make
such transcripts available to the public. Not later than 30
days after the date on which all members of the Panel
have been appointed, the Panel shall hold its first meeting.
‘‘(g) DUTIES.—The Panel shall evaluate the status
of the clinical research environment throughout the United
States, and prepare and submit periodic progress reports
to the President. The Panel shall submit to the President,
the Secretary of Health and Human Services, the Sec-
retary of Defense, the Secretary of Veterans Affairs, and
the Congress an annual evaluation of the clinical research
environment in the United States and recommendations
for improvements and shall submit such other reports as
the President shall direct.
‘‘(h) PERSONNEL MATTERS.—
‘‘(1) COMPENSATION.—Each member of the
Panel shall be compensated at a rate equal to the
daily equivalent of the annual rate of basic pay pre-
scribed for level IV of the Executive Schedule under
section 5315 of title 5, United States Code, for each
day (including travel time) during which such mem-
ber is engaged in the performance of the duties of
the Panel.
‘‘(2) TRAVEL EXPENSES.—The members of the
Panel shall be allowed travel expenses, including per
diem in lieu of subsistence, at rates authorized for
employees of agencies under subchapter I of chapter
57 of title 5, United States Code, while away from
their homes or regular places of business in the per-
formance of services for the Panel.
‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—There
are authorized to be appropriated such sums as may be
necessary to enable the Panel to carry out this section.’’.
SEC. 4. ADVISORY COMMITTEE TO THE DIRECTOR ON CLIN-
ICAL RESEARCH.
Part H of title IV of the Public Health Service Act
(42 U.S.C. 289 et seq.), as amended by section 3, is fur-
ther amended by adding at the end thereof the following
new section:
‘‘SEC. 498D. ADVISORY COMMITTEE TO THE DIRECTOR ON
CLINICAL RESEARCH.
‘‘(a) IN GENERAL.—The advisory committee estab-
lished by the Director of the National Institutes of Health
and known as the Advisory Committee to the Director on
Clinical Research (hereafter referred to in this section as
the ‘Advisory Committee’) shall report to such Director
and to the President’s Clinical Research Panel established
under section 498C and shall implement recommendations
as determined necessary by the Advisory Committee to
remedy deficiencies in clinical research within the National
Institutes of Health.
‘‘(b) TERMINATION.—The Advisory Committee shall
terminate on the date that occurs 5 years after the date
of enactment of this Act.’’.
SEC. 5. STUDY SECTION REVIEW.
Part B of title IV of the Public Health Service Act
(42 U.S.C. 284 et seq.) is amended by adding at the end
thereof the following new section:
‘‘SEC. 409B. STUDY SECTION REVIEW.
‘‘(a) IN GENERAL.—The President’s Clinical Re-
search Panel shall direct the Office of Science and Tech-
nology Policy to conduct a review of the compositions,
functions, and outcomes of study section activities at all
Federal agencies which conduct or fund such activities as
such activities relate to clinical research proposals for in-
vestigator-initiated support.
‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—There
are authorized to be appropriated such sums as may be
necessary to carry out this section.’’.
SEC. 6. INCREASE 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 thereof the
following new subsection:
‘‘(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) increase the number of FIRST grants
(R29) for young clinical investigators;
‘‘(B) design test pilot projects and implement
the recommendations of the Division of Research
Grants Clinical Research Study Group; and
‘‘(C) establish an intramural clinical research
fellowship program (similar to the program estab-
lished under section 738(b)) and a continuing edu-
cation clinical research training program at NIH.
‘‘(3) The Director of NIH, in cooperation with the
Director of the National Institutes of Health and the Di-
rectors of the Institutes, Centers, and Divisions of the Na-
tional Institutes of Health, shall support and expand the
resources available for the diverse needs of the clinical re-
search community, including inpatient, outpatient, and
critical care clinical research.
‘‘(4) The Director of NIH, in cooperation with the
Director of the National Center for Research Resources,
shall establish peer review mechanisms to evaluate applica-
tions for intramural clinical research fellowships, clinical
research career enhancement awards, and innovative med-
ical science award programs. Such review mechanisms
shall include individuals who are exceptionally qualified to
appraise the merits of potential clinical research train-
ees.’’.
SEC. 7. GENERAL CLINICAL RESEARCH CENTERS.
Part B of title IV of the Public Health Service Act
(42 U.S.C. 284 et seq.) as amended by section 5, is fur-
ther amended by adding at the end thereof the following
new sections:
‘‘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 (b), 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 make grants under
subsection (a), $200,000,000 for fiscal year 1997, and
such sums as may be necessary for each subsequent fiscal
year.
‘‘SEC. 409D. 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.
‘‘(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 $130,000 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 are authorized to be appropriated to make
grants under paragraph (1), $300,000,000 for fiscal
year 1997, 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.
‘‘(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 $100,000 per
year per grant.
‘‘(4) AUTHORIZATION
OF
APPROPRIATIONS.—
There are authorized to be appropriated to make
grants under paragraph (1), $30,000,000 for fiscal
year 1997, and such sums as may be necessary for
each subsequent fiscal year.’’.
SEC. 8. 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), by striking ‘‘who are
from disadvantaged backgrounds’’;
(3) in subsection (b)—
(A) by striking ‘‘Amounts’’ and inserting
the following:
‘‘(1) IN GENERAL.—Amounts’’; and
(B) by adding at the end thereof the fol-
lowing new paragraph:
‘‘(2) 
DISADVANTAGED
BACKGROUNDS
SET-
ASIDE.—In carrying out this section, the Secretary
shall ensure that not less than 50 percent of the
amounts appropriated for a fiscal year are used for
contracts involving those appropriately qualified
health professionals who are from disadvantaged
backgrounds.’’; and
(4) by adding at the end thereof the following
new subsections:
‘‘(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 a physi-
cian receiving a clinical research career enhancement
award or NIH intramural research fellowship.
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There
are authorized to be appropriated to carry out this section
such sums as may be necessary for each fiscal year.’’.
SEC. 9. INSURANCE COVERAGE OF INVESTIGATIONAL
TREATMENTS.
(a) PARTICIPATION.—A health plan shall allow indi-
viduals, when medically appropriate, to participate in an
investigational therapy, and shall cover the patient care
provided pursuant to investigational treatments as de-
scribed in subsection (b). The plan shall permit an individ-
ual to participate in an investigational treatment, subject
to the limitations and cost sharing requirements applicable
to the item or service, when the item or service is provided
to an individual in the course of an investigational treat-
ment, if—
(1) the treatment is a qualifying investigational
treatment; and
(2) the item or service is required to provide
patient care pursuant to the design of an approved
clinical research trial, except those services normally
paid for by other funding sources such as the cost
of the investigational agent or device itself, and the
costs of managing the research.
A plan may not discriminate against or refuse plan partici-
pation by an individual participating in an investigational
treatment.
(b) DEFINITIONS.—For purposes of subsection (a):
(1) 
QUALIFYING
INVESTIGATIONAL
TREAT-
MENT.—The term ‘‘qualifying investigational treat-
ment’’ means a treatment—
(A) the effectiveness of which has not been
determined; and
(B) that is under clinical investigation as
part of an approved research trial.
(2) APPROVED
RESEARCH
TRIAL.—The term
‘‘approved research trial’’ means—
(A) a research trial approved by the Sec-
retary of Health and Human Services, the Di-
rector of the National Institutes of Health, the
Commissioner of the Food and Drug Adminis-
tration, the Secretary of Veterans Affairs, the
Secretary of Defense, or a qualified nongovern-
mental research entity as defined in guidelines
of the National Institutes of Health; or
(B) a peer-reviewed and approved research
program, as defined by the Secretary of Health
and Human Services, conducted for the primary
purpose of determining whether or not a treat-
ment is safe, efficacious, or having any other
characteristic of a treatment which must be
demonstrated in order for the treatment to be
medically necessary or appropriate.
SEC. 10. 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 thereof the following
new subsection:
‘‘(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,
or on material of human origin (such as tissue specimens
and cognitive phenomena) for which an investigator or col-
league directly interacts with human subjects in an out-
patient or inpatient setting to clarify a problem in human
physiology, pathophysiology, or disease.’’.
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