[Congressional Record Volume 145, Number 165 (Friday, November 19, 1999)]
[Senate]
[Pages S15214-S15216]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




               CLINICAL RESEARCH ENHANCEMENT ACT OF 1999

  Ms. COLLINS. Mr. President, I ask unanimous consent that HELP 
Committee be discharged from further consideration of S. 1813 and the 
Senate proceed to its immediate consideration.
  The PRESIDING OFFICER. Without objection, it is so ordered. The clerk 
will report the bill by title.
  The legislative clerk read as follows:

       A bill (S. 1813) to amend the Public Health Service Act to 
     provide additional support for and to expand clinical 
     research programs, and for other purposes.

  There being no objection, the Senate proceeded to consider the bill.
  Ms. COLLINS. Mr. President, I ask unanimous consent that the bill be 
read a third time and passed, the motion to reconsider be laid upon the 
table, and that any statements relating to the bill be printed in the 
Record.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The bill (S. 1813) was read the third time and passed, as follows:

                                S. 1813

       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.

[[Page S15215]]

       (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.

[[Page S15216]]

       ``(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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