[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3587 Introduced in House (IH)]







104th CONGRESS
  2d Session
                                H. R. 3587

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              June 5, 1996

  Mr. Nadler introduced the following bill; which was referred to the 
                         Committee on Commerce

_______________________________________________________________________

                                 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 
1996''.

SEC. 2. FINDINGS AND PURPOSE.

    (a) Findings.--Congress finds the following:
            (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) The United States spent more than $1 trillion on health 
        care in 1994, but the Federal budget for health research at the 
        National Institutes of Health was $10 billion, only 1 percent 
        of that total.
            (4) 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.
            (5) 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.
            (6) The current level of training and support for health 
        professionals in clinical research is fragmented, frequently 
        undervalued, and potentially underfunded.
            (7) 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.
            (8) 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 $63,000, 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.
            (9) 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.
            (10) Appropriations for general clinical research centers 
        in fiscal year 1995 equal $136,640,000.
            (11) In fiscal year 1995, there are 75 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.
            (12) The average annual amount allocated for each general 
        clinical research center is $1,000,000, 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. PRESIDENT'S CLINICAL RESEARCH PANEL.

    Part H of title IV of the Public Health Service Act (42 U.S.C. 289 
et seq.) is amended by adding at the end thereof the following new 
section:

``SEC. 498C. PRESIDENT'S CLINICAL RESEARCH PANEL.

    ``(a) Establishment.--The President shall establish a panel to be 
known as the `President's Clinical Research Panel' (hereafter referred 
to in this section as the `Panel') as a part of the Office of Science 
and Technology Policy, to carry out the duties described in this 
section.
    ``(b) Membership.--
            ``(1) In general.--The Panel shall be composed of 12 
        individuals appointed by the President and selected from 
        recommendations submitted by the President of the Institute of 
        Medicine of the National Academy of Sciences.
            ``(2) Qualifications.--Individuals appointed to the panel 
        under paragraph (1) shall, by virtue of their training, 
        experience and background, be exceptionally qualified to 
        appraise the status of clinical research both within and 
        outside of the Federal Government, and should represent 
        distinguished research scientists and physicians, insurance 
        companies, pharmaceutical companies, health maintenance 
        organizations, accreditation and certification organizations 
        and academic research administrators, and patients.
            ``(3) Exclusion and advisors.--Officers or employees of the 
        Federal Government shall not be eligible to be appointed to the 
        Panel. The Secretary of Health and Human Services, the 
        Secretary of Defense, the Secretary of Veterans Affairs, the 
        Assistant to the President for Science and Technology, and 
        other Cabinet officers as the President determines to be 
        appropriate may serve as advisors to the Panel.
    ``(c) Terms and Vacancies.--
            ``(1) Terms.--Members of the Panel shall be appointed for 
        3-year terms, except that--
                    ``(A) any member appointed to fill a vacancy 
                occurring on the Panel prior to the expiration of the 
                term for which the member's predecessor was appointed, 
                shall be appointed for the remainder of such term; and
                    ``(B) a member may serve until the member's 
                successor has taken office.
            ``(2) Vacancies.--If a vacancy on the Panel occurs, the 
        President shall make an appointment to fill the vacancy not 
        later than 90 days after the date on which the vacancy 
        occurred.
            ``(3) Reappointments.--A member of the Panel may be 
        reappointed but may not serve more than 2 consecutive terms.
    ``(d) Date of Appointment.--The initial members of the Panel shall 
be appointed not later than 120 days after the date of enactment of 
this section.
    ``(e) Chairperson and Vice Chairperson.--The President shall 
designate one of the members of the Panel to serve as the chairperson 
of the Panel and one member to serve as the vice chairperson of the 
Panel, each to serve for a term of 1 year.
    ``(f) Meetings.--The Panel shall meet at the call of the 
chairperson, but in no event less than 4 times each year. A transcript 
shall be kept of the proceedings of each such meeting of the Panel, and 
the chairperson shall make such transcripts available to the public. 
Not later than 30 days after the date on which all members of the Panel 
have been appointed, the Panel shall hold its first meeting.
    ``(g) Duties.--The Panel shall evaluate the status of the clinical 
research environment throughout the United States, and prepare and 
submit periodic progress reports to the President. The Panel shall 
submit to the President, the Secretary of Health and Human Services, 
the Secretary of Defense, the Secretary of Veterans Affairs, and the 
Congress an annual evaluation of the clinical research environment in 
the United States and recommendations for improvements and shall submit 
such other reports as the President shall direct.
    ``(h) Personnel Matters.--
            ``(1) Compensation.--Each member of the Panel shall be 
        compensated at a rate equal to the daily equivalent of the 
        annual rate of basic pay prescribed for level IV of the 
        Executive Schedule under section 5315 of title 5, United States 
        Code, for each day (including travel time) during which such 
        member is engaged in the performance of the duties of the 
        Panel.
            ``(2) Travel Expenses.--The members of the Panel shall be 
        allowed travel expenses, including per diem in lieu of 
        subsistence, at rates authorized for employees of agencies 
        under subchapter I of chapter 57 of title 5, United States 
        Code, while away from their homes or regular places of business 
        in the performance of services for the Panel.
    ``(i) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary to enable the Panel to carry 
out this section.''.

SEC. 4. ADVISORY COMMITTEE TO THE DIRECTOR ON CLINICAL RESEARCH.

    Part H of title IV of the Public Health Service Act (42 U.S.C. 289 
et seq.), as amended by section 3, is further amended by adding at the 
end thereof the following new section:

``SEC. 498D. ADVISORY COMMITTEE TO THE DIRECTOR ON CLINICAL RESEARCH.

    ``(a) In General.--The advisory committee established by the 
Director of the National Institutes of Health and known as the Advisory 
Committee to the Director on Clinical Research (hereafter referred to 
in this section as the `Advisory Committee') shall report to such 
Director and to the President's Clinical Research Panel established 
under section 498C and shall implement recommendations as determined 
necessary by the Advisory Committee to remedy deficiencies in clinical 
research within the National Institutes of Health.
    ``(b) Termination.--The Advisory Committee shall terminate on the 
date that occurs 5 years after the date of enactment of this Act.''.

SEC. 5. STUDY SECTION REVIEW.

    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 thereof the following new 
section:

``SEC. 409B. STUDY SECTION REVIEW.

    ``(a) In General.--The President's Clinical Research Panel shall 
direct the Office of Science and Technology Policy to conduct a review 
of the compositions, functions, and outcomes of study section 
activities at all Federal agencies which conduct or fund such 
activities as such activities relate to clinical research proposals for 
investigator-initiated support.
    ``(b) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary to carry out this 
section.''.

SEC. 6. INCREASE 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 thereof the following new subsection:
    ``(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) increase the number of FIRST grants (R29) for young 
        clinical investigators;
            ``(B) design test pilot projects and implement the 
        recommendations of the Division of Research Grants Clinical 
        Research Study Group; and
            ``(C) establish an intramural clinical research fellowship 
        program (similar to the program established under section 
        738(b)) and a continuing education clinical research training 
        program at NIH.
    ``(3) The Director of NIH, in cooperation with the Director of the 
National Institutes of Health and 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, in cooperation with the Director of the 
National Center for Research Resources, shall establish peer review 
mechanisms to evaluate applications for intramural clinical research 
fellowships, clinical research career enhancement awards, and 
innovative medical science award programs. Such review mechanisms shall 
include individuals who are exceptionally qualified to appraise the 
merits of potential clinical research trainees.''.

SEC. 7. GENERAL CLINICAL RESEARCH CENTERS.

    Part B of title IV of the Public Health Service Act (42 U.S.C. 284 
et seq.) as amended by section 5, is further amended by adding at the 
end thereof the following new sections:

``SEC. 409C. 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 (b), 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 make grants under subsection (a), $200,000,000 for 
fiscal year 1997, and such sums as may be necessary for each subsequent 
fiscal year.

``SEC. 409D. 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.
            ``(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 $130,000 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 are 
        authorized to be appropriated to make grants under paragraph 
        (1), $300,000,000 for fiscal year 1997, 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.
            ``(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 $100,000 per year per grant.
            ``(4) Authorization of appropriations.--There are 
        authorized to be appropriated to make grants under paragraph 
        (1), $30,000,000 for fiscal year 1997, and such sums as may be 
necessary for each subsequent fiscal year.''.

SEC. 8. 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), by striking ``who are from 
        disadvantaged backgrounds'';
            (3) in subsection (b)--
                    (A) by striking ``Amounts'' and inserting the 
                following:
            ``(1) In general.--Amounts''; and
                    (B) by adding at the end thereof the following new 
                paragraph:
            ``(2) Disadvantaged backgrounds set-aside.--In carrying out 
        this section, the Secretary shall ensure that not less than 50 
        percent of the amounts appropriated for a fiscal year are used 
        for contracts involving those appropriately qualified health 
        professionals who are from disadvantaged backgrounds.''; and
            (4) by adding at the end thereof the following new 
        subsections:
    ``(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 a physician receiving a clinical research 
career enhancement award or NIH intramural research fellowship.
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section such sums as may be necessary 
for each fiscal year.''.

SEC. 9. INSURANCE COVERAGE OF INVESTIGATIONAL TREATMENTS.

    (a) Participation.--A health plan shall allow individuals, when 
medically appropriate, to participate in an investigational therapy, 
and shall cover the patient care provided pursuant to investigational 
treatments as described in subsection (b). The plan shall permit an 
individual to participate in an investigational treatment, subject to 
the limitations and cost sharing requirements applicable to the item or 
service, when the item or service is provided to an individual in the 
course of an investigational treatment, if--
            (1) the treatment is a qualifying investigational 
        treatment; and
            (2) the item or service is required to provide patient care 
        pursuant to the design of an approved clinical research trial, 
        except those services normally paid for by other funding 
        sources such as the cost of the investigational agent or device 
        itself, and the costs of managing the research.
A plan may not discriminate against or refuse plan participation by an 
individual participating in an investigational treatment.
    (b) Definitions.--For purposes of subsection (a):
            (1) Qualifying investigational treatment.--The term 
        ``qualifying investigational treatment'' means a treatment--
                    (A) the effectiveness of which has not been 
                determined; and
                    (B) that is under clinical investigation as part of 
                an approved research trial.
            (2) Approved research trial.--The term ``approved research 
        trial'' means--
                    (A) a research trial approved by the Secretary of 
                Health and Human Services, the Director of the National 
                Institutes of Health, the Commissioner of the Food and 
                Drug Administration, the Secretary of Veterans Affairs, 
                the Secretary of Defense, or a qualified 
                nongovernmental research entity as defined in 
                guidelines of the National Institutes of Health; or
                    (B) a peer-reviewed and approved research program, 
                as defined by the Secretary of Health and Human 
                Services, conducted for the primary purpose of 
                determining whether or not a treatment is safe, 
                efficacious, or having any other characteristic of a 
                treatment which must be demonstrated in order for the 
                treatment to be medically necessary or appropriate.

SEC. 10. 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 thereof the following new 
        subsection:
    ``(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, or on 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.''.
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