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.

Summary: Clinical Research Act of 2004 - Requires the Director of the National Institutes of Health to award clinical research support grants to eligible academic health centers to: (1) defray the costs of unfunded Federal requirements for the protection of human research costs; and (2) support activities leading to innovative ways to meets such requirements 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.

Allows the Director to award clinical research infrastructure grants to eligible academic health centers for: (1) necessary infrastructure to facilitate the transfer of new understandings of disease mechanisms gained in the laboratory into the development of new methodologies for diagnosis, therapy, and prevention; (2) the initial testing of human subjects; and (3) addressing obstacles impeding the expeditious application of new science, including a lack of up-to-date information technology systems and a shortage of willing participants.

Allows the Secretary of Health and Human Services to make up to five grants to eligible academic health centers to form partnerships between the centers involved and health care providers for carrying out clinical human subject research to demonstrate how academic research centers may collaborate with the practicing health care community in such research.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Clinical Research Act of 2004''.

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) 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.
            (5) The clinical research environment is increasingly 
        encumbered by facility decay, 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) Director.--The term ``Director'' means the Director of 
        the National Institutes of Health.
            (2) Eligible academic health center.--The term ``eligible 
        academic health center'' means--
                    (A) an academic institution that receives an annual 
                average of not less than $20,000,000 in grant funds 
                from the Department of Defense, the Department of 
                Veterans Affairs, and the Department of Health and 
                Human Services for basic, applied, or clinical 
                biomedical or behavioral research in the fields of 
                dentistry, medicine, and nursing; or
                    (B) a consortium of such academic institutions.
            (3) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.

SEC. 4. CLINICAL RESEARCH SUPPORT GRANTS.

    (a) Authorization.--For the purposes described in subsection (b), 
the Director shall award a clinical research support grant in the 
amount determined under subsection (c) to each eligible academic health 
center that submits an application in accordance with this section.
    (b) Purpose.--A funding agreement for a grant under this section is 
that the eligible academic health center involved will use the grant 
only for the following purposes:
            (1) To defray the costs of unfunded Federal requirements 
        for the protection of human research subjects, including the 
        costs of complying with the Health Insurance Portability and 
        Accountability Act of 1996 (Pub. Law 104-191) and maintaining 
        institutional review boards.
            (2) To support activities leading to innovative ways to 
        meet the requirements described in paragraph (1) in an 
        efficient and cost effective manner.
    (c) 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 grantees under this section.
    (d) Applications.--To be eligible for 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 $40,000,000 for each of the 
fiscal years 2005 through 2009.

SEC. 5. CLINICAL RESEARCH INFRASTRUCTURE GRANTS.

    (a) Authorization.--The Director may award clinical research 
infrastructure grants on a competitive basis to eligible academic 
health centers.
    (b) Use of Funds.--The Director may not award a grant to an 
eligible academic health center under this section unless the center 
agrees to use the grant only for the following:
            (1) Infrastructure that is necessary to facilitate the 
        transfer of new understandings of disease mechanisms gained in 
        the laboratory into the development of new methodologies for 
        diagnosis, therapy, and prevention.
            (2) The initial testing of human subjects.
            (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) the need for training and mentoring required 
                for increasing the supply of qualified clinical 
                investigators; and
                    (D) a shortage of willing participants.
    (c) Applications.--To be eligible for 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 $125,000,000 for each of fiscal 
years 2005 through 2009.

SEC. 6. DEMONSTRATION PROGRAM ON PARTNERSHIPS IN CLINICAL RESEARCH.

    (a) Grants.--The Secretary may award 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 award a grant to any 
eligible academic health center under this section in an amount that is 
greater than $5,000,000.
    (c) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $25,000,000 for the period of 
fiscal years 2005 through 2009.