[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 1543 Introduced in Senate (IS)]


109th CONGRESS
  1st Session
                                S. 1543

  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 SENATE OF THE UNITED STATES

                             July 28, 2005

 Mr. Santorum introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
  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) Clinical research.--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) Director.--The term ``Director'' means the Director of 
        the National Institutes of Health.
            (3) Eligible academic health center.--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, or nursing.
            (4) Secretary.--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) To devise, deploy, and support new technologies that 
        facilitate the clinical investigators' ability to--
                    (A) improve the safety of human subjects in 
                clinical research;
                    (B) ensure the confidentiality of research data; 
                and
                    (C) streamline the regulatory processes to ensure 
                better compliance for clinical research.
            (3) 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.
            (4) 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.
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