Clinical Research Act of 2005 - Requires the Director of the National Institutes of Health (NIH) to award clinical investigator advancement grants to eligible academic health centers to: (1) establish career development programs for new and mid-level clinician-investigators who are fully committed to academic clinical research careers; (2) support the translation of basic science to patient care by implementing and conducting all aspects of their clinical research mission; and (3) support activities leading to innovative ways to achieve such purposes in an efficient and cost-effective manner. Requires that health centers receive a proportionate share of the total grant money awarded based on the amount invested by the grantee in clinical research compared to the total clinical research investment of all grantees.
Requires the Director to award clinical research infrastructure grants to eligible academic health centers to: (1) foster the use of information technology to facilitate the transformation of basic research findings on disease mechanisms into the development of new methodologies for diagnosis, therapy, and prevention; (2) address the obstacles impeding the expeditious application of new science, including a lack of up-to-date information technology systems and an underrepresentation of some populations in clinical research; and (3) share clinical research infrastructure across academic health centers to enable and facilitate cross-center clinical research collaborations.
Allows the Secretary of Health and Human Services to make up to five grants to eligible academic health centers to form partnerships with health care providers for carrying out clinical human subject research to demonstrate how academic research centers may collaborate with the practicing health care community.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2308 Introduced in House (IH)]
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
demonstration 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 infrastructure grants, and a
demonstration program on partnerships in clinical research, and for
other purposes.
Be it enacted by the Senate and House of Representatives 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 unprecedented supply of
information for improving human health and preventing disease.
(3) Translating the information gained through these basic
discoveries into knowledge that will impact clinical practice
and ultimately human health requires strong clinical research
institutions.
(4) The enhancement of clinical research career programs
and opportunity will sustain the momentum of the discovery,
development, and delivery of important health advances.
(5) Without a sound infrastructure to accomplish 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 increasingly
encumbered by incompatible databases, shortage of qualified
investigators, rising costs, inadequate funding, and mounting
unreimbursed regulatory burdens such as human subject research
protections and additional record-keeping requirements under
the Health Insurance Portability and Accountability Act of
1996.
SEC. 3. DEFINITIONS.
In this Act:
(1) The term ``clinical research'' means--
(A) patient-oriented clinical research conducted
with human subjects;
(B) research on the causes and consequences of
disease in human populations involving 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 inpatient 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 independent research institute, or a
consortium of research 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 investigator 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 eligible academic
health center shall be used only for the following purposes:
(1) To establish career development programs for new and
mid-level clinician-investigators who are fully committed to
academic clinical research careers.
(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 critical to the
conduct of clinical research activities.
(2) Salary cap.--Notwithstanding paragraph (1), no funds
under this section may be used to increase 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 academic health centers
receiving a grant under this section in an amount that bears the same
relation to such appropriated amount as the investment in clinical
research of the grantee involved bears to the total investment in
clinical research of all eligible grantees under this section.
(e) Applications.--To seek a grant under this section, 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 recipient 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 clinical 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 section 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 development 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 technology
systems;
(B) incompatible databases;
(C) a lack of connectivity between academic 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 populations in
clinical research.
(3) Sharing clinical research infrastructure across
academic health centers to enable and facilitate cross-center
clinical research collaborations.
(c) Reports.--The Director shall require each recipient 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 section, 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 partnerships between the
center involved and health care providers for carrying out clinical
human subject research for the purpose of demonstrating how academic
research centers may collaborate with the practicing health care
community 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 section, 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.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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