I

106TH CONGRESS

2D SESSION S. 1813

IN THE HOUSE OF REPRESENTATIVES

JANUARY 27, 2000

Referred to the Committee on Commerce

AN ACT

To amend the Public Health Service Act to provide additional

support for and to expand clinical research programs,

and for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Clinical Research En5 hancement Act of 1999’’.
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1 SEC. 2. FINDINGS AND PURPOSE.

2 (a) FINDINGS.—Congress makes the following find3 ings:

4 (1) Clinical research is critical to the advance5 ment of scientific knowledge and to the development

6 of cures and improved treatment for disease.

7 (2) Tremendous advances in biology are open8 ing doors to new insights into human physiology,

9 pathophysiology and disease, creating extraordinary

10 opportunities for clinical research.

11 (3) Clinical research includes translational re12 search which is an integral part of the research

13 process leading to general human applications. It is

14 the bridge between the laboratory and new methods

15 of diagnosis, treatment, and prevention and is thus

16 essential to progress against cancer and other dis17 eases.

18 (4) The United States will spend more than

19 $1,200,000,000,000 on health care in 1999, but the

20 Federal budget for health research at the National

21 Institutes of Health was $15,600,000,000 only 1

22 percent of that total.

23 (5) Studies at the Institute of Medicine, the

24 National Research Council, and the National Acad25 emy of Sciences have all addressed the current prob26 lems in clinical research.
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1 (6) The Director of the National Institutes of

2 Health has recognized the current problems in clin3 ical research and appointed a special panel, which

4 recommended expanded support for existing Na5 tional Institutes of Health clinical research programs

6 and the creation of new initiatives to recruit and re7 tain clinical investigators.

8 (7) The current level of training and support

9 for health professionals in clinical research is frag10 mented, undervalued, and underfunded.

11 (8) Young investigators are not only appren12 tices for future positions but a crucial source of en13 ergy, enthusiasm, and ideas in the day-to-day re14 search that constitutes the scientific enterprise. Seri15 ous questions about the future of life-science re16 search are raised by the following:

17 (A) The number of young investigators ap18 plying for grants dropped by 54 percent be19 tween 1985 and 1993.

20 (B) The number of physicians applying for

21 first-time National Institutes of Health research

22 project grants fell from 1226 in 1994 to 963 in

23 1998, a 21 percent reduction.

24 (C) Newly independent life-scientists are

25 expected to raise funds to support their new re-
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1 search programs and a substantial proportion

2 of their own salaries.

3 (9) The following have been cited as reasons for

4 the decline in the number of active clinical research5 ers, and those choosing this career path:

6 (A) A medical school graduate incurs an

7 average debt of $85,619, as reported in the

8 Medical School Graduation Questionnaire by

9 the Association of American Medical Colleges

10 (AAMC).

11 (B) The prolonged period of clinical train12 ing required increases the accumulated debt

13 burden.

14 (C) The decreasing number of mentors and

15 role models.

16 (D) The perceived instability of funding

17 from the National Institutes of Health and

18 other Federal agencies.

19 (E) The almost complete absence of clin20 ical research training in the curriculum of

21 training grant awardees.

22 (F) Academic Medical Centers are experi23 encing difficulties in maintaining a proper envi24 ronment for research in a highly competitive

25 health care marketplace, which are compounded
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1 by the decreased willingness of third party pay2 ers to cover health care costs for patients en3 gaged in research studies and research proce4 dures.

5 (10) In 1960, general clinical research centers

6 were established under the Office of the Director of

7 the National Institutes of Health with an initial ap8 propriation of $3,000,000.

9 (11) Appropriations for general clinical research

10 centers in fiscal year 1999 equaled $200,500,000.

11 (12) Since the late 1960s, spending for general

12 clinical research centers has declined from approxi13 mately 3 percent to 1 percent of the National Insti14 tutes of Health budget.

15 (13) In fiscal year 1999, there were 77 general

16 clinical research centers in operation, supplying pa17 tients in the areas in which such centers operate

18 with access to the most modern clinical research and

19 clinical research facilities and technologies.

20 (b) PURPOSE.—It is the purpose of this Act to pro21 vide additional support for and to expand clinical research

22 programs.
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1 SEC. 3. INCREASING THE INVOLVEMENT OF THE NATIONAL

2 INSTITUTES OF HEALTH IN CLINICAL RE3 SEARCH.

4 Part B of title IV of the Public Health Service Act

5 (42 U.S.C. 284 et seq.) is amended by adding at the end

6 the following:

7 ‘‘SEC. 409C. CLINICAL RESEARCH.

8 ‘‘(a) IN GENERAL.—The Director of National Insti9 tutes of Health shall undertake activities to support and

10 expand the involvement of the National Institutes of

11 Health in clinical research.

12 ‘‘(b) REQUIREMENTS.—In carrying out subsection

13 (a), the Director of National Institutes of Health shall—

14 ‘‘(1) consider the recommendations of the Divi15 sion of Research Grants Clinical Research Study

16 Group and other recommendations for enhancing

17 clinical research; and

18 ‘‘(2) establish intramural and extramural clin19 ical research fellowship programs directed specifi20 cally at medical and dental students and a con21 tinuing education clinical research training program

22 at the National Institutes of Health.

23 ‘‘(c) SUPPORT FOR THE DIVERSE NEEDS OF CLIN24 ICAL RESEARCH.—The Director of National Institutes of

25 Health, in cooperation with the Directors of the Institutes,

26 Centers, and Divisions of the National Institutes of
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1 Health, shall support and expand the resources available

2 for the diverse needs of the clinical research community,

3 including inpatient, outpatient, and critical care clinical

4 research.

5 ‘‘(d) PEER REVIEW.—The Director of National Insti6 tutes of Health shall establish peer review mechanisms to

7 evaluate applications for the awards and fellowships pro8 vided for in subsection (b)(2) and section 409D. Such re9 view mechanisms shall include individuals who are excep10 tionally qualified to appraise the merits of potential clin11 ical research training and research grant proposals.’’.

12 SEC. 4. GENERAL CLINICAL RESEARCH CENTERS.

13 (a) GRANTS.—Subpart 1 of part B of title IV of the

14 Public Health Service Act (42 U.S.C. 287 et seq.) is

15 amended by adding at the end the following:

16 ‘‘SEC. 481C. GENERAL CLINICAL RESEARCH CENTERS.

17 ‘‘(a) GRANTS.—The Director of the National Center

18 for Research Resources shall award grants for the estab19 lishment of general clinical research centers to provide the

20 infrastructure for clinical research including clinical re21 search training and career enhancement. Such centers

22 shall support clinical studies and career development in

23 all settings of the hospital or academic medical center in24 volved.
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1 ‘‘(b) ACTIVITIES.—In carrying out subsection (a), the

2 Director of National Institutes of Health shall expand the

3 activities of the general clinical research centers through

4 the increased use of telecommunications and telemedicine

5 initiatives.

6 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the

7 purpose of carrying out this section, there are authorized

8 to be appropriated such sums as may be necessary for

9 each fiscal year.’’.

10 (b) ENHANCEMENT AWARDS.—Part B of title IV of

11 the Public Health Service Act (42 U.S.C. 284 et seq.),

12 as amended by section 3, is further amended by adding

13 at the end the following:

14 ‘‘SEC. 409D. ENHANCEMENT AWARDS.

15 ‘‘(a) MENTORED PATIENT-ORIENTED RESEARCH CA16 REER DEVELOPMENT AWARDS.—

17 ‘‘(1) GRANTS.—

18 ‘‘(A) IN GENERAL.—The Director of the

19 National Institutes of Health shall make grants

20 (to be referred to as ‘Mentored Patient-Ori21 ented Research Career Development Awards’)

22 to support individual careers in clinical research

23 at general clinical research centers or at other

24 institutions that have the infrastructure and re-
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1 sources deemed appropriate for conducting pa2 tient-oriented clinical research.

3 ‘‘(B) USE.—Grants under subparagraph

4 (A) shall be used to support clinical investiga5 tors in the early phases of their independent ca6 reers by providing salary and such other sup7 port for a period of supervised study.

8 ‘‘(2) APPLICATIONS.—An application for a

9 grant under this subsection shall be submitted by an

10 individual scientist at such time as the Director may

11 require.

12 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—

13 For the purpose of carrying out this subsection,

14 there are authorized to be appropriated such sums

15 as may be necessary for each fiscal year.

16 ‘‘(b) MID-CAREER INVESTIGATOR AWARDS IN PA17 TIENT-ORIENTED RESEARCH.—

18 ‘‘(1) GRANTS.—

19 ‘‘(A) IN GENERAL.—The Director of the

20 National Institutes of Health shall make grants

21 (to be referred to as ‘Mid-Career Investigator

22 Awards in Patient-Oriented Research’) to sup23 port individual clinical research projects at gen24 eral clinical research centers or at other institu25 tions that have the infrastructure and resources
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1 deemed appropriate for conducting patient-ori2 ented clinical research.

3 ‘‘(B) USE.—Grants under subparagraph

4 (A) shall be used to provide support for mid-ca5 reer level clinicians to allow such clinicians to

6 devote time to clinical research and to act as

7 mentors for beginning clinical investigators.

8 ‘‘(2) APPLICATIONS.—An application for a

9 grant under this subsection shall be submitted by an

10 individual scientist at such time as the Director re11 quires.

12 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—

13 For the purpose of carrying out this subsection,

14 there are authorized to be appropriated such sums

15 as may be necessary for each fiscal year.

16 ‘‘(c) GRADUATE TRAINING IN CLINICAL INVESTIGA17 TION AWARD.—

18 ‘‘(1) IN GENERAL.—The Director of the Na19 tional Institutes of Health shall make grants (to be

20 referred to as ‘Graduate Training in Clinical Inves21 tigation Awards’) to support individuals pursuing

22 master’s or doctoral degrees in clinical investigation.

23 ‘‘(2) APPLICATIONS.—An application for a

24 grant under this subsection shall be submitted by an
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1 individual scientist at such time as the Director may

2 require.

3 ‘‘(3) LIMITATIONS.—Grants under this sub4 section shall be for terms of 2 years or more and

5 shall provide stipend, tuition, and institutional sup6 port for individual advanced degree programs in

7 clinical investigation.

8 ‘‘(4) DEFINITION.—As used in this subsection,

9 the term ‘advanced degree programs in clinical in10 vestigation’ means programs that award a master’s

11 or Ph.D. degree in clinical investigation after 2 or

12 more years of training in areas such as the fol13 lowing:

14 ‘‘(A) Analytical methods, biostatistics, and

15 study design.

16 ‘‘(B) Principles of clinical pharmacology

17 and pharmacokinetics.

18 ‘‘(C) Clinical epidemiology.

19 ‘‘(D) Computer data management and

20 medical informatics.

21 ‘‘(E) Ethical and regulatory issues.

22 ‘‘(F) Biomedical writing.

23 ‘‘(5) AUTHORIZATION OF APPROPRIATIONS.—

24 For the purpose of carrying out this subsection,
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1 there are authorized to be appropriated such sums

2 as may be necessary for each fiscal year.

3 ‘‘(d) CLINICAL RESEARCH CURRICULUM AWARDS.—

4 ‘‘(1) IN GENERAL.—The Director of the Na5 tional Institutes of Health shall make grants (to be

6 referred to as ‘Clinical Research Curriculum

7 Awards’) to institutions for the development and

8 support of programs of core curricula for training

9 clinical investigators, including medical students.

10 Such core curricula may include training in areas

11 such as the following:

12 ‘‘(A) Analytical methods, biostatistics, and

13 study design.

14 ‘‘(B) Principles of clinical pharmacology

15 and pharmacokinetics.

16 ‘‘(C) Clinical epidemiology.

17 ‘‘(D) Computer data management and

18 medical informatics.

19 ‘‘(E) Ethical and regulatory issues.

20 ‘‘(F) Biomedical writing.

21 ‘‘(2) APPLICATIONS.—An application for a

22 grant under this subsection shall be submitted by an

23 individual institution or a consortium of institutions

24 at such time as the Director may require. An insti25 tution may submit only 1 such application.
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1 ‘‘(3) LIMITATIONS.—Grants under this sub2 section shall be for terms of up to 5 years and may

3 be renewable.

4 ‘‘(4) AUTHORIZATION OF APPROPRIATIONS.—

5 For the purpose of carrying out this subsection,

6 there are authorized to be appropriated such sums

7 as may be necessary for each fiscal year.’’.

8 SEC. 5. LOAN REPAYMENT PROGRAM REGARDING CLIN9 ICAL RESEARCHERS.

10 Part G of title IV of the Public Health Service Act

11 is amended by inserting after section 487E (42 U.S.C.

12 288–5) the following:

13 ‘‘SEC. 487F. LOAN REPAYMENT PROGRAM REGARDING

14 CLINICAL RESEARCHERS.

15 ‘‘(a) IN GENERAL.—The Secretary, acting through

16 the Director of the National Institutes of Health, shall es17 tablish a program to enter into contracts with qualified

18 health professionals under which such health professionals

19 agree to conduct clinical research, in consideration of the

20 Federal Government agreeing to repay, for each year of

21 service conducting such research, not more than $35,000

22 of the principal and interest of the educational loans of

23 such health professionals.

24 ‘‘(b) APPLICATION OF PROVISIONS.—The provisions

25 of sections 338B, 338C, and 338E shall, except as incon-
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1 sistent with subsection (a) of this section, apply to the pro2 gram established under subsection (a) to the same extent

3 and in the same manner as such provisions apply to the

4 National Health Service Corps Loan Repayment Program

5 established in subpart III of part D of title III.

6 ‘‘(c) FUNDING.—

7 ‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—

8 For the purpose of carrying out this section, there

9 are authorized to be appropriated such sums as may

10 be necessary for each fiscal year.

11 ‘‘(2) AVAILABILITY.—Amounts appropriated for

12 carrying out this section shall remain available until

13 the expiration of the second fiscal year beginning

14 after the fiscal year for which the amounts were

15 made available.’’.

16 SEC. 6. DEFINITION.

17 Section 409 of the Public Health Service Act (42

18 U.S.C. 284d) is amended—

19 (1) by striking ‘‘For purposes’’ and inserting

20 ‘‘(a) HEALTH SERVICE RESEARCH.—For purposes’’;

21 and

22 (2) by adding at the end the following:

23 ‘‘(b) CLINICAL RESEARCH.—As used in this title, the

24 term ‘clinical research’ means patient oriented clinical re25 search conducted with human subjects, or research on the
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1 causes and consequences of disease in human populations

2 involving material of human origin (such as tissue speci3 mens and cognitive phenomena) for which an investigator

4 or colleague directly interacts with human subjects in an

5 outpatient or inpatient setting to clarify a problem in

6 human physiology, pathophysiology or disease, or epi7 demiologic or behavioral studies, outcomes research or

8 health services research, or developing new technologies,

9 therapeutic interventions, or clinical trials.’’.

10 SEC. 7. OVERSIGHT BY GENERAL ACCOUNTING OFFICE.

11 Not later than 18 months after the date of enactment

12 of this Act, the Comptroller General of the United States

13 shall submit to the Congress a reporting describing the

14 extent to which the National Institutes of Health has com15 plied with the amendments made by this Act.

Passed the Senate November 19, 1999.

Attest: GARY SISCO,

Secretary.