[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[S. 1421 Introduced in Senate (IS)]







105th CONGRESS
  1st Session
                                S. 1421

 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

                            November 7, 1997

 Mr. Kennedy (for himself, Mr. Cochran, Mr. Durbin, Mr. Faircloth, and 
 Ms. Mikulski) introduced the following bill; which was read twice and 
         referred to the Committee on Labor and Human Resources

_______________________________________________________________________

                                 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 
1997''.

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 trillion on 
        health care in 1997, but the Federal budget for health research 
        at the National Institutes of Health was $12.7 billion, 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 has 
        through the use of an advisory committee begun to evaluate 
        these problems.
            (7) The current level of training and support for health 
        professionals in clinical research is fragmented, frequently 
        undervalued, and potentially 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 federally funded research (R01) 
                grants awarded to persons under the age of 36 have 
                decreased by 70 percent from 1985 to 1993.
                    (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 $80,000, as reported in the Medical School 
                Graduation Questionnaire by the American Association of 
                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 1997 equaled $153,000,000.
            (12) In fiscal year 1997, there were 74 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.
            (13) The average annual amount allocated for each general 
        clinical research center is $1,900,000, establishing a current 
        funding level of 75 percent of the amounts approved by the 
        Advisory Council of the National Center for Research Resources.
    (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.

    Section 402 of the Public Health Service Act (42 U.S.C. 282) is 
amended by adding at the end the following:
    ``(l)(1) The Director of NIH shall undertake activities to support 
and expand the involvement of the National Institutes of Health in 
clinical research.
    ``(2) In carrying out paragraph (1), the Director of NIH shall--
            ``(A) design test pilot projects and implement the 
        recommendations of the Division of Research Grants Clinical 
        Research Study Group and other recommendations for enhancing 
        clinical research, where applicable; and
            ``(B) establish an intramural clinical research fellowship 
        program and a continuing education clinical research training 
        program at NIH.
    ``(3) The Director of NIH, 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.
    ``(4) The Director of NIH shall establish peer review mechanisms to 
evaluate applications for--
            ``(A) clinical research career enhancement awards;
            ``(B) innovative medical science awards;
            ``(C) graduate training in clinical investigation awards;
            ``(D) intramural clinical research fellowships.
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.

    Part B of title IV of the Public Health Service Act (42 U.S.C. 284 
et seq.) is further amended by adding at the end the following:

``SEC. 409B. 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 
NIH shall expand the activities of the general clinical research 
centers through the increased use of telecommunications and 
telemedicine initiatives.
    ``(c) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section, such sums as may be necessary.

``SEC. 409C. ENHANCEMENT AWARDS.

    ``(a) Clinical Research Career Enhancement Award.--
            ``(1) In general.--The Director of the National Center for 
        Research Resources shall make grants (to be referred to as 
        `clinical research career enhancement 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. The Director of the 
        National Center for Research Resources shall, where 
        practicable, collaborate or consult with other Institute 
        Directors in making awards under this subsection.
            ``(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.--The amount of a grant under this 
        subsection shall not exceed $125,000 per year per grant. Grants 
        shall be for terms of 5 years. The Director shall award not 
        more than 20 grants in the first fiscal year, and not more than 
        40 grants in the second fiscal year, in which grants are 
        awarded under this subsection.
            ``(4) Authorization of appropriations.--There is authorized 
        to be appropriated to make grants under paragraph (1), 
        $3,000,000 for fiscal year 1998, and such sums as may be 
        necessary for each subsequent fiscal year.
    ``(b) Innovative Medical Science Award.--
            ``(1) In general.--The Director of the National Center for 
        Research Resources shall make grants (to be referred to as 
        `innovative medical science awards') 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. The Director of the National Center for 
        Research Resources shall, where practicable, collaborate or 
        consult with other Institute Directors in making awards under 
        this subsection.
            ``(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) Limitations.--The amount of a grant under this 
        subsection shall not exceed $175,000 per year per grant.
            ``(4) Authorization of appropriations.--There is authorized 
        to be appropriated to make grants under this subsection, 
        $52,500,000 for fiscal year 1998, and such sums as may be 
        necessary for each subsequent fiscal year.
    ``(c) Graduate Training in Clinical Investigation Award.--
            ``(1) In general.--The Director of the National Center for 
        Research Resources 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.--The amount of a grant under this 
        subsection shall not exceed $75,000 per year per grant. Grants 
        shall be for terms of 2 years or more and will 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 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.--There is authorized 
        to be appropriated to make grants under this subsection, 
        $3,000,000 for fiscal year 1998, and such sums as may be 
        necessary for each subsequent fiscal year.''.

SEC. 5. CLINICAL RESEARCH ASSISTANCE.

    (a) National Research Service Awards.--Section 487(a)(1)(C) of the 
Public Health Service Act (42 U.S.C. 288(a)(1)(C)) is amended by 
striking ``50 such'' and inserting ``100 such''.
    (b) Loan Repayment Program.--Section 487E of the Public Health 
Service Act (42 U.S.C. 288-5) is amended--
            (1) in the section heading, by striking ``from 
        disadvantaged backgrounds'';
            (2) in subsection (a)(1)--
                    (A) by striking ``who are from disadvantaged 
                backgrounds''; and
                    (B) by striking ``as employees of the National 
                Institutes of Health'' and inserting ``as part of a 
                clinical research training position'';
            (3) in subsection (a), by striking paragraph (3) and 
        inserting the following:
            ``(3) Applicability of certain provisions regarding 
        obligated service.--With respect to the National Health Service 
        Corps Loan Repayment Program established under subpart III of 
        part D of title III, the provisions of such subpart shall, 
        except as inconsistent with this section, apply to the program 
        established in this section in the same manner and to the same 
        extent as such provisions apply to such loan repayment 
        program.'';
            (4) in subsection (b)--
                    (A) by striking ``Amounts'' and inserting the 
                following:
            ``(1) In general.--Amounts''; and
                    (B) by adding at the end the following:
            ``(2) Disadvantaged backgrounds set-aside.--In carrying out 
        this section, the Secretary shall ensure that not less than 50 
        percent of the contracts involve those appropriately qualified 
        health professionals who are from disadvantaged backgrounds.''; 
        and
            (5) by adding at the end the following:
    ``(c) Definition.--As used in subsection (a)(1), the term `clinical 
research training position' means an individual serving in a general 
clinical research center or in clinical research at the National 
Institutes of Health, or a physician receiving a clinical research 
career enhancement award, an innovative medical science award, or a 
graduate training in clinical investigation award.
    ``(d) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section such sums as may be necessary 
for each fiscal year.''.

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 or therapeutic interventions.''.
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