I 
109TH CONGRESS 
1ST SESSION H. R. 2308
To amend the Public Health Service Act to provide for clinical research 
support grants, clinical research infrastructure grants, and a demonstra-
tion program on partnerships in clinical research, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 11, 2005
Mr. WELDON of Florida (for himself and Mr. DOYLE) introduced the following 
bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Public Health Service Act to provide for 
clinical research support grants, clinical research infra-
structure grants, and a demonstration program on part-
nerships in clinical research, 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 Act 
of 2005’’. 
SEC. 2. FINDINGS. 
The Congress finds the following:
(1) Strong academic health centers are essential 
to a vigorous clinical research enterprise. 
(2) Breakthroughs in basic biomedical sciences 
over the past 5 decades have provided an unprece-
dented supply of information for improving human 
health and preventing disease. 
(3) Translating the information gained through 
these basic discoveries into knowledge that will im-
pact clinical practice and ultimately human health 
requires strong clinical research institutions. 
(4) The enhancement of clinical research career 
programs and opportunity will sustain the momen-
tum of the discovery, development, and delivery of 
important health advances. 
(5) Without a sound infrastructure to accom-
plish this translation in a systematic and coherent 
way, the sum of data and information produced by 
the basic science enterprise will not result in tangible 
public benefit. 
(6) The clinical research environment is in-
creasingly encumbered by incompatible databases, 
shortage of qualified investigators, rising costs, inad-
equate funding, and mounting unreimbursed regu-
latory burdens such as human subject research pro-
tections and additional record-keeping requirements
under the Health Insurance Portability and Ac-
countability Act of 1996. 
SEC. 3. DEFINITIONS. 
In this Act: 
(1) The term ‘‘clinical research’’ means—
(A) patient-oriented clinical research con-
ducted with human subjects; 
(B) research on the causes and con-
sequences of disease in human populations in-
volving material of human origin (such as tissue 
specimens and cognitive phenomena) for which 
an investigator or colleague directly interacts 
with human subjects in an outpatient or inpa-
tient setting to clarify a problem in human 
physiology, pathophysiology or disease; 
(C) epidemiologic or behavioral studies; 
(D) outcomes research; 
(E) health services research; or 
(F) development of new technologies, 
therapeutic interventions, or clinical trials. 
(2) The term ‘‘Director’’ means the Director of 
the National Institutes of Health. 
(3) The term ‘‘eligible academic health center’’ 
means an academic institution and an affiliated 
teaching hospital, a teaching hospital, an inde-
pendent research institute, or a consortium of re-
search institutions which conduct clinical research 
and receive funds from the Department of Health 
and Human Services for basic, applied, or clinical 
biomedical or behavioral research in the fields of 
dentistry, medicine, and nursing. 
(4) The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services. 
SEC. 4. CLINICAL INVESTIGATOR ADVANCEMENT GRANTS. 
(a) AUTHORIZATION.—For the purposes described in 
subsection (b), the Director shall make a clinical investi-
gator advancement grant in the amount determined under 
subsection (d) to each eligible academic health center that 
submits an application in accordance with this section. 
(b) PURPOSES.—A grant under this section to an eli-
gible academic health center shall be used only for the fol-
lowing purposes: 
(1) To establish career development programs 
for new and mid-level clinician-investigators who are 
fully committed to academic clinical research ca-
reers. 
(2) To support the translation of basic science 
to patient care by implementing and conducting all 
aspects of their clinical research mission.
(3) To support activities leading to innovative 
ways to meet the purposes described in paragraphs 
(1) and (2) in an efficient and cost effective manner. 
(c) CAREER DEVELOPMENT PROGRAMS.—
(1) USE OF FUNDS.—In implementing a career 
development program under subsection (b)(1), the 
Director may conduct or support activities to provide 
financial assistance and other support to—
(A) young clinical researchers receiving 
peer-reviewed grants who wish to make the 
transition to research independence; 
(B) experienced scientists who wish to 
broaden their scientific capabilities; and 
(C) other medical personnel who are crit-
ical to the conduct of clinical research activities. 
(2) SALARY CAP.—Notwithstanding paragraph 
(1), no funds under this section may be used to in-
crease the rate of pay of an individual to a rate 
greater than the rate of basic pay for level I of the 
Executive Schedule. 
(d) ALLOCATION.—Of the amount appropriated to 
carry out this section for a fiscal year, the Director shall 
allocate such appropriated amount among the eligible aca-
demic health centers receiving a grant under this section 
in an amount that bears the same relation to such appro-
priated amount as the investment in clinical research of 
the grantee involved bears to the total investment in clin-
ical research of all eligible grantees under this section. 
(e) APPLICATIONS.—To seek a grant under this sec-
tion, an eligible academic health center shall submit an 
application to the Director in such manner, at such time, 
and containing such information and assurances as the 
Director may require. 
(f) REPORTS.—The Director shall require each re-
cipient of a grant under this section to submit an annual 
report to the Director detailing how the recipient has used 
the grant to meet the purposes described in subsection (b). 
(g) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there is authorized to be appropriated 
$40,000,000 for each of the fiscal years 2006 through 
2010. 
SEC. 5. CLINICAL RESEARCH INFRASTRUCTURE GRANTS. 
(a) AUTHORIZATION.—The Director shall make clin-
ical research infrastructure grants on a competitive basis 
to eligible academic health centers. 
(b) USE OF FUNDS.—The Director may not make a 
grant to an eligible academic health center under this sec-
tion unless the center agrees to use the grant only for the 
following:
(1) Fostering the use of information technology 
to facilitate the transformation of basic research 
findings on disease mechanisms into the develop-
ment of new methodologies for diagnosis, therapy, 
and prevention. 
(2) Addressing the many obstacles impeding the 
expeditious application of new science, such as—
(A) a lack of up-to-date information tech-
nology systems; 
(B) incompatible databases; 
(C) a lack of connectivity between aca-
demic health centers, teaching hospitals, and 
independent research institutes; 
(D) the absence of a coordinated strategy 
to enhance public understanding of, support 
for, and participation in clinical research; and 
(E) the underrepresentation of some popu-
lations in clinical research. 
(3) Sharing clinical research infrastructure 
across academic health centers to enable and facili-
tate cross-center clinical research collaborations. 
(c) REPORTS.—The Director shall require each re-
cipient of a grant under this section to submit an annual 
report to the Director detailing how the recipient has used
the grant to meet the objectives described in subsection 
(b). 
(d) APPLICATIONS.—To seek a grant under this sec-
tion, an eligible academic health center shall submit an 
application to the Director in such manner, at such time, 
and containing such information and assurances as the 
Director may require. 
(e) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there is authorized to be appropriated 
$125,000,000 for each of fiscal years 2006 through 2010. 
SEC. 6. DEMONSTRATION PROGRAM ON PARTNERSHIPS IN 
CLINICAL RESEARCH. 
(a) GRANTS.—The Secretary may make grants to not 
more than 5 eligible academic health centers to form part-
nerships between the center involved and health care pro-
viders for carrying out clinical human subject research for 
the purpose of demonstrating how academic research cen-
ters may collaborate with the practicing health care com-
munity in such research. 
(b) MAXIMUM AMOUNT.—The Secretary may not 
make a grant to any eligible academic health center under 
this section in an amount that is greater than $5,000,000. 
(c) APPLICATIONS.—To seek a grant under this sec-
tion, an eligible academic health center shall submit an 
application to the Director in such manner, at such time,
and containing such information and assurances as the 
Director may require. 
(d) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there is authorized to be appropriated 
$25,000,000 for the period of fiscal years 2006 through 
2010.
Æ