[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 1813 Introduced in Senate (IS)]







106th CONGRESS
  1st Session
                                S. 1813

 To amend the Public Health Service Act to provide additional support 
 for and to expand clinical research programs, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            October 27, 1999

 Mr. Kennedy (for himself, Mr. Frist, Mr. Jeffords, Ms. Mikulski, Mrs. 
  Murray, Mr. Durbin, Mr. Cochran, and Mr. Wellstone) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Clinical Research Enhancement Act of 
1999''.

 SEC. 2. FINDINGS AND PURPOSE.

    (a) Findings.--Congress makes the following findings:
            (1) Clinical research is critical to the advancement of 
        scientific knowledge and to the development of cures and 
        improved treatment for disease.
            (2) Tremendous advances in biology are opening doors to new 
        insights into human physiology, pathophysiology and disease, 
        creating extraordinary opportunities for clinical research.
            (3) Clinical research includes translational research which 
        is an integral part of the research process leading to general 
        human applications. It is the bridge between the laboratory and 
        new methods of diagnosis, treatment, and prevention and is thus 
        essential to progress against cancer and other diseases.
            (4) The United States will spend more than 
        $1,200,000,000,000 on health care in 1999, but the Federal 
        budget for health research at the National Institutes of Health 
        was $15,600,000,000 only 1 percent of that total.
            (5) Studies at the Institute of Medicine, the National 
        Research Council, and the National Academy of Sciences have all 
        addressed the current problems in clinical research.
            (6) The Director of the National Institutes of Health has 
        recognized the current problems in clinical research and 
        appointed a special panel, which recommended expanded support 
        for existing National Institutes of Health clinical research 
        programs and the creation of new initiatives to recruit and 
        retain clinical investigators.
            (7) The current level of training and support for health 
        professionals in clinical research is fragmented, undervalued, 
        and underfunded.
            (8) Young investigators are not only apprentices for future 
        positions but a crucial source of energy, enthusiasm, and ideas 
        in the day-to-day research that constitutes the scientific 
        enterprise. Serious questions about the future of life-science 
        research are raised by the following:
                    (A) The number of young investigators applying for 
                grants dropped by 54 percent between 1985 and 1993.
                    (B) The number of physicians applying for first-
                time National Institutes of Health research project 
                grants fell from 1226 in 1994 to 963 in 1998, a 21 
                percent reduction.
                    (C) Newly independent life-scientists are expected 
                to raise funds to support their new research programs 
                and a substantial proportion of their own salaries.
            (9) The following have been cited as reasons for the 
        decline in the number of active clinical researchers, and those 
        choosing this career path:
                    (A) A medical school graduate incurs an average 
                debt of $85,619, as reported in the Medical School 
                Graduation Questionnaire by the Association of American 
                Medical Colleges (AAMC).
                    (B) The prolonged period of clinical training 
                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 clinical 
                research training in the curriculum of training grant 
                awardees.
                    (F) Academic Medical Centers are experiencing 
                difficulties in maintaining a proper environment for 
                research in a highly competitive health care 
                marketplace, which are compounded by the decreased 
                willingness of third party payers to cover health care 
                costs for patients engaged in research studies and 
                research procedures.
            (10) In 1960, general clinical research centers were 
        established under the Office of the Director of the National 
        Institutes of Health with an initial appropriation of 
        $3,000,000.
            (11) Appropriations for general clinical research centers 
        in fiscal year 1999 equaled $200,500,000.
    Since the late 1960s, spending for general clinical research 
centers has declined from approximately 3 percent to 1 percent of the 
National Institutes of Health budget.
            (12) In fiscal year 1999, there were 77 general clinical 
        research centers in operation, supplying patients in the areas 
        in which such centers operate with access to the most modern 
        clinical research and clinical research facilities and 
        technologies.
    (b) Purpose.--It is the purpose of this Act to provide additional 
support for and to expand clinical research programs.

SEC. 3. INCREASING THE INVOLVEMENT OF THE NATIONAL INSTITUTES OF HEALTH 
              IN CLINICAL RESEARCH.

    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 the following:

``SEC. 409C. CLINICAL RESEARCH.

    ``(a) In General.--The Director of National Institutes of Health 
shall undertake activities to support and expand the involvement of the 
National Institutes of Health in clinical research.
    ``(b) Requirements.--In carrying out subsection (a), the Director 
of National Institutes of Health shall--
            ``(1) consider the recommendations of the Division of 
        Research Grants Clinical Research Study Group and other 
        recommendations for enhancing clinical research; and
            ``(2) establish intramural and extramural clinical research 
        fellowship programs directed specifically at medical and dental 
        students and a continuing education clinical research training 
        program at the National Institutes of Health.
    ``(c) Support for the Diverse Needs of Clinical Research.--The 
Director of National Institutes of Health, in cooperation with the 
Directors of the Institutes, Centers, and Divisions of the National 
Institutes of Health, shall support and expand the resources available 
for the diverse needs of the clinical research community, including 
inpatient, outpatient, and critical care clinical research.
    ``(d) Peer Review.--The Director of National Institutes of Health 
shall establish peer review mechanisms to evaluate applications for the 
awards and fellowships provided for in subsection (b)(2) and section 
409D. Such review mechanisms shall include individuals who are 
exceptionally qualified to appraise the merits of potential clinical 
research training and research grant proposals.''.

SEC. 4. GENERAL CLINICAL RESEARCH CENTERS.

    (a) Grants.--Subpart 1 of part B of title IV of the Public Health 
Service Act (42 U.S.C. 287 et seq.) is amended by adding at the end the 
following:

``SEC. 481C. GENERAL CLINICAL RESEARCH CENTERS.

    ``(a) Grants.--The Director of the National Center for Research 
Resources shall award grants for the establishment of general clinical 
research centers to provide the infrastructure for clinical research 
including clinical research training and career enhancement. Such 
centers shall support clinical studies and career development in all 
settings of the hospital or academic medical center involved.
    ``(b) Activities.--In carrying out subsection (a), the Director of 
National Institutes of Health shall expand the activities of the 
general clinical research centers through the increased use of 
telecommunications and telemedicine initiatives.
    ``(c) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated such sums as 
may be necessary for each fiscal year.''.
    (b) Enhancement Awards.--Part B of title IV of the Public Health 
Service Act (42 U.S.C. 284 et seq.), as amended by section 3, is 
further amended by adding at the end the following:

``SEC. 409D. ENHANCEMENT AWARDS.

    ``(a) Mentored Patient-Oriented Research Career Development 
Awards.--
            ``(1) Grants.--
                    ``(A) In general.--The Director of the National 
                Institutes of Health shall make grants (to be referred 
                to as `Mentored Patient-Oriented Research Career 
                Development Awards') to support individual careers in 
                clinical research at general clinical research centers 
                or at other institutions that have the infrastructure 
                and resources deemed appropriate for conducting 
                patient-oriented clinical research.
                    ``(B) Use.--Grants under subparagraph (A) shall be 
                used to support clinical investigators in the early 
                phases of their independent careers by providing salary 
                and such other support for a period of supervised 
                study.
            ``(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) Authorization of appropriations.--For the purpose of 
        carrying out this subsection, there are authorized to be 
        appropriated such sums as may be necessary for each fiscal 
        year.
    ``(b) Mid-Career Investigator Awards in Patient-Oriented 
Research.--
            ``(1) Grants.--
                    ``(A) In general.--The Director of the National 
                Institutes of Health shall make grants (to be referred 
                to as `Mid-Career Investigator Awards in Patient-
                Oriented Research') to support individual clinical 
                research projects at general clinical research centers 
                or at other institutions that have the infrastructure 
                and resources deemed appropriate for conducting 
                patient-oriented clinical research.
                    ``(B) Use.--Grants under subparagraph (A) shall be 
                used to provide support for mid-career level clinicians 
                to allow such clinicians to devote time to clinical 
                research and to act as mentors for beginning clinical 
                investigators.
            ``(2) Applications.--An application for a grant under this 
        subsection shall be submitted by an individual scientist at 
        such time as the Director requires.
            ``(3) Authorization of appropriations.--For the purpose of 
        carrying out this subsection, there are authorized to be 
        appropriated such sums as may be necessary for each fiscal 
        year.
    ``(c) Graduate Training in Clinical Investigation Award.--
            ``(1) In general.--The Director of the National Institutes 
        of Health shall make grants (to be referred to as `Graduate 
        Training in Clinical Investigation Awards') to support 
        individuals pursuing master's or doctoral degrees in clinical 
        investigation.
            ``(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.--Grants under this subsection shall be 
        for terms of 2 years or more and shall provide stipend, 
        tuition, and institutional support for individual advanced 
        degree programs in clinical investigation.
            ``(4) Definition.--As used in this subsection, the term 
        `advanced degree programs in clinical investigation' means 
        programs that award a master's or Ph.D. degree in clinical 
        investigation after 2 or more years of training in areas such 
        as the following:
                    ``(A) Analytical methods, biostatistics, and study 
                design.
                    ``(B) Principles of clinical pharmacology and 
                pharmacokinetics.
                    ``(C) Clinical epidemiology.
                    ``(D) Computer data management and medical 
                informatics.
                    ``(E) Ethical and regulatory issues.
                    ``(F) Biomedical writing.
            ``(5) Authorization of appropriations.--For the purpose of 
        carrying out this subsection, there are authorized to be 
        appropriated such sums as may be necessary for each fiscal 
        year.
    ``(d) Clinical Research Curriculum Awards.--
            ``(1) In general.--The Director of the National Institutes 
        of Health shall make grants (to be referred to as `Clinical 
        Research Curriculum Awards') to institutions for the 
        development and support of programs of core curricula for 
        training clinical investigators, including medical students. 
        Such core curricula may include training in areas such as the 
        following:
                    ``(A) Analytical methods, biostatistics, and study 
                design.
                    ``(B) Principles of clinical pharmacology and 
                pharmacokinetics.
                    ``(C) Clinical epidemiology.
                    ``(D) Computer data management and medical 
                informatics.
                    ``(E) Ethical and regulatory issues.
                    ``(F) Biomedical writing.
            ``(2) Applications.--An application for a grant under this 
        subsection shall be submitted by an individual institution or a 
        consortium of institutions at such time as the Director may 
        require. An institution may submit only 1 such application.
            ``(3) Limitations.--Grants under this subsection shall be 
        for terms of up to 5 years and may be renewable.
            ``(4) Authorization of appropriations.--For the purpose of 
        carrying out this subsection, there are authorized to be 
        appropriated such sums as may be necessary for each fiscal 
        year.''.

SEC. 5. LOAN REPAYMENT PROGRAM REGARDING CLINICAL RESEARCHERS.

    Part G of title IV of the Public Health Service Act is amended by 
inserting after section 487E (42 U.S.C. 288-5) the following:

``SEC. 487F. LOAN REPAYMENT PROGRAM REGARDING CLINICAL RESEARCHERS.

    ``(a) In General.--The Secretary, acting through the Director of 
the National Institutes of Health, shall establish a program to enter 
into contracts with qualified health professionals under which such 
health professionals agree to conduct clinical research, in 
consideration of the Federal Government agreeing to repay, for each 
year of service conducting such research, not more than $35,000 of the 
principal and interest of the educational loans of such health 
professionals.
    ``(b) Application of Provisions.--The provisions of sections 338B, 
338C, and 338E shall, except as inconsistent with subsection (a) of 
this section, apply to the program established under subsection (a) to 
the same extent and in the same manner as such provisions apply to the 
National Health Service Corps Loan Repayment Program established in 
subpart III of part D of title III.
    ``(c) Funding.--
            ``(1) Authorization of appropriations.--For the purpose of 
        carrying out this section, there are authorized to be 
        appropriated such sums as may be necessary for each fiscal 
        year.
            ``(2) Availability.--Amounts appropriated for carrying out 
        this section shall remain available until the expiration of the 
        second fiscal year beginning after the fiscal year for which 
        the amounts were made available.''.

SEC. 6. 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 the following:
    ``(b) Clinical Research.--As used in this title, the term `clinical 
research' means patient oriented clinical research conducted with human 
subjects, or 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, or epidemiologic or behavioral studies, 
outcomes research or health services research, or developing new 
technologies, therapeutic interventions, or clinical trials.''.

SEC. 7. OVERSIGHT BY GENERAL ACCOUNTING OFFICE.

    Not later than 18 months after the date of enactment of this Act, 
the Comptroller General of the United States shall submit to the 
Congress a reporting describing the extent to which the National 
Institutes of Health has complied with the amendments made by this Act.
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