IB

Union Calendar No. 585

106TH CONGRESS

2D SESSION H. R. 1798

[Report No. 106–1002]

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

MAY 13, 1999

Mr. GREENWOOD (for himself, Mrs. LOWEY, Mrs. JOHNSON of Connecticut,

Mr. BROWN of Ohio, Mr. BURR of North Carolina, Mr. WAXMAN, Mr.

PICKERING, Mr. DEAL of Georgia, Mrs. MORELLA, Mr. FRANK of Massachusetts, Ms. DELAURO, Mr. NETHERCUTT, Mr. LEACH, Mr. ENGLISH,

Mr. TOWNS, Mr. COYNE, Mr. LEWIS of Georgia, Mr. NADLER, Mr. WICKER, Mr. FILNER, and Ms. PELOSI) introduced the following bill; which

was referred to the Committee on Commerce

OCTOBER 25, 2000

Additional sponsors: Ms. SLAUGHTER, Mr. CAPUANO, Mr. MCGOVERN, Mr.

FROST, Mr. UPTON, Mr. WYNN, Mr. HOYER, Mr. MCNULTY, Mr. GONZALEZ, Mr. SANDLIN, Mr. NORWOOD, Mr. DEUTSCH, Ms. ESHOO, Mrs.

THURMAN, Mr. BARRETT of Wisconsin, Mr. EHRLICH, Mr. PRICE of

North Carolina, Mr. MARTINEZ, Mrs. MALONEY of New York, Mr.

DIXON, Ms. STABENOW, Mr. BILBRAY, Mr. MARKEY, Ms. DEGETTE, Mr.

SANDERS, Mr. STARK, Mr. GORDON, Mr. RODRIGUEZ, Mr. TAUZIN, Mr.

HILLIARD, Mr. ROGAN, and Mr. BOEHLERT

OCTOBER 25, 2000

Committed to the Committee of the Whole House on the State of the Union

and ordered to be printed
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A BILL

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’’.

6 SEC. 2. FINDINGS AND PURPOSE.

7 (a) FINDINGS.—Congress makes the following find8 ings:

9 (1) Clinical research is critical to the advance10 ment of scientific knowledge and to the development

11 of cures and improved treatment for disease.

12 (2) Tremendous advances in biology are open13 ing doors to new insights into human physiology,

14 pathophysiology and disease, creating extraordinary

15 opportunities for clinical research.

16 (3) Clinical research includes translational re17 search which is an integral part of the research

18 process leading to general human applications. It is

19 the bridge between the laboratory and new methods

20 of diagnosis, treatment, and prevention and is thus
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1 essential to progress against cancer and other dis2 eases.

3 (4) The United States will spend more than $1

4 trillion on health care in 1997, but the Federal

5 budget for health research at the National Institutes

6 of Health was $12.7 billion, only 1 percent of that

7 total.

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

9 National Research Council, and the National Acad10 emy of Sciences have all addressed the current prob11 lems in clinical research.

12 (6) The Director of the National Institutes of

13 Health has recognized the current problems in clin14 ical research and appointed a special advisory com15 mittee, which recommended expanded support for

16 existing NIH clinical research programs and the cre17 ation of new initiatives to recruit and retain clinical

18 investigators.

19 (7) The current level of training and support

20 for health professionals in clinical research is frag21 mented, frequently undervalued, and potentially un22 derfunded.

23 (8) Young investigators are not only appren24 tices for future positions but a crucial source of en25 ergy, enthusiasm, and ideas in the day-to-day re-
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1 search that constitutes the scientific enterprise. Seri2 ous questions about the future of life-science re3 search are raised by the following:

4 (A) The number of young investigators ap5 plying for grants dropped by 54 percent be6 tween 1985 and 1993.

7 (B) The number of physicians applying for

8 first-time NIH research project grants fell from

9 838 in 1994 to 575 in 1997, a 31 percent re10 duction.

11 (C) Newly independent life-scientists are

12 expected to raise funds to support their new re13 search programs and a substantial proportion

14 of their own salaries.

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

16 the decline in the number of active clinical research17 ers, and those choosing this career path:

18 (A) A medical school graduate incurs an

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

20 Medical School Graduation Questionnaire by

21 the American Association of Medical Colleges

22 (AAMC).

23 (B) The prolonged period of clinical train24 ing required increases the accumulated debt

25 burden.
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1 (C) The decreasing number of mentors and

2 role models.

3 (D) The perceived instability of funding

4 from the National Institutes of Health and

5 other Federal agencies.

6 (E) The almost complete absence of clin7 ical research training in the curriculum of

8 training grant awardees.

9 (F) Academic Medical Centers are experi10 encing difficulties in maintaining a proper envi11 ronment for research in a highly competitive

12 health care marketplace, which are compounded

13 by the decreased willingness of third party pay14 ers to cover health care costs for patients en15 gaged in research studies and research proce16 dures.

17 (10) In 1960, general clinical research centers

18 were established under the Office of the Director of

19 the National Institutes of Health with an initial ap20 propriation of $3,000,000.

21 (11) Appropriations for general clinical research

22 centers in fiscal year 1998 equaled $167,000,000.

23 Since the late 1960s, spending for general clinical

24 research centers has declined from approximately 3

25 percent to 1 percent of the NIH budget.
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1 (12) In fiscal year 1998, there were 75 general

2 clinical research centers in operation, supplying pa3 tients in the areas in which such centers operate

4 with access to the most modern clinical research and

5 clinical research facilities and technologies.

6 (b) PURPOSE.—It is the purpose of this Act to pro7 vide additional support for and to expand clinical research

8 programs.

9 SEC. 3. INCREASING THE INVOLVEMENT OF THE NATIONAL

10 INSTITUTES OF HEALTH IN CLINICAL RE11 SEARCH.

12 Section 402 of the Public Health Service Act (42

13 U.S.C. 282) is amended by adding at the end the fol14 lowing:

15 ‘‘(m)(1) The Director of NIH shall undertake activi16 ties to support and expand the involvement of the National

17 Institutes of Health in clinical research.

18 ‘‘(2) In carrying out paragraph (1), the Director of

19 NIH shall—

20 ‘‘(A) implement the recommendations of the Di21 vision of Research Grants Clinical Research Study

22 Group and other recommendations for enhancing

23 clinical research, where applicable; and
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1 ‘‘(B) establish an intramural clinical research

2 fellowship program and a continuing education clin3 ical research training program at NIH.

4 ‘‘(3) The Director of NIH, in cooperation with the

5 Directors of the Institutes, Centers, and Divisions of the

6 National Institutes of Health, shall support and expand

7 the resources available for the diverse needs of the clinical

8 research community, including inpatient, outpatient, and

9 critical care clinical research.

10 ‘‘(4) The Director of NIH shall establish peer review

11 mechanisms to evaluate applications for—

12 ‘‘(A) Mentored Patient-Oriented Research Ca13 reer Development Awards;

14 ‘‘(B) Mid-Career Investigator Awards in Pa15 tient-Oriented Research;

16 ‘‘(C) graduate training in clinical investigation

17 awards;

18 ‘‘(D) intramural clinical research fellowships.

19 Such review mechanisms shall include individuals who are

20 exceptionally qualified to appraise the merits of potential

21 clinical research training and research grant proposals.’’.

22 SEC. 4. GENERAL CLINICAL RESEARCH CENTERS.

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

24 (42 U.S.C. 284 et seq.) is further amended by adding at

25 the end the following:
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1 ‘‘SEC. 409C. GENERAL CLINICAL RESEARCH CENTERS.

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

3 for Research Resources shall award grants for the estab4 lishment of general clinical research centers to provide the

5 infrastructure for clinical research including clinical re6 search training and career enhancement. Such centers

7 shall support clinical studies and career development in

8 all settings of the hospital or academic medical center in9 volved.

10 ‘‘(b) ACTIVITIES.—In carrying out subsection (a), the

11 Director of NIH shall expand the activities of the general

12 clinical research centers through the increased use of tele13 communications and telemedicine initiatives.

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

15 purpose of carrying out this section, there are authorized

16 to be appropriated such sums as may be necessary for

17 each fiscal year.

18 ‘‘SEC. 409D. ENHANCEMENT AWARDS.

19 ‘‘(a) MENTORED PATIENT-ORIENTED RESEARCH CA20 REER DEVELOPMENT AWARDS.—

21 ‘‘(1) IN GENERAL.—The Director of the Na22 tional Center for Research Resources shall make

23 grants (to be referred to as ‘Mentored Patient-Ori24 ented Research Career Development Awards’) to

25 support individual careers in clinical research at gen26 eral clinical research centers or at other institutions
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1 that have the infrastructure and resources deemed

2 appropriate for conducting patient-oriented clinical

3 research. The Director of the National Center for

4 Research Resources shall, where practicable, collabo5 rate or consult with other Institute Directors in

6 making awards under this subsection.

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

8 grant under this subsection shall be submitted by an

9 individual scientist at such time as the Director may

10 require.

11 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—

12 For the purpose of carrying out this subsection,

13 there are authorized to be appropriated such sums

14 as may be necessary for each fiscal year.

15 ‘‘(b) MID-CAREER INVESTIGATOR AWARDS IN PA16 TIENT-ORIENTED RESEARCH.—

17 ‘‘(1) IN GENERAL.—The Director of the Na18 tional Center for Research Resources shall make

19 grants (to be referred to as ‘Mid-Career Investigator

20 Awards in Patient-Oriented Research’) to support

21 individual clinical research projects at general clin22 ical research centers or at other institutions that

23 have the infrastructure and resources deemed appro24 priate for conducting patient-oriented clinical re25 search. The Director of the National Center for Re-
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1 search Resources shall, where practicable, collabo2 rate or consult with other Institute Directors in

3 making awards under this subsection.

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

5 grant under this subsection shall be submitted by an

6 individual scientist at such time as the Director re7 quires.

8 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—

9 For the purpose of carrying out this subsection,

10 there are authorized to be appropriated such sums

11 as may be necessary for each fiscal year.

12 ‘‘(c) GRADUATE TRAINING IN CLINICAL INVESTIGA13 TION AWARD.—

14 ‘‘(1) IN GENERAL.—The Director of the Na15 tional Center for Research Resources shall make

16 grants (to be referred to as ‘graduate training in

17 clinical investigation awards’) to support individuals

18 pursuing master’s or doctoral degrees in clinical in19 vestigation.

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

21 grant under this subsection shall be submitted by an

22 individual scientist at such time as the Director may

23 require.

24 ‘‘(3) LIMITATIONS.—Grants shall be for terms

25 of 2 years or more and will provide stipend, tuition,
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1 and institutional support for individual advanced de2 gree programs in clinical investigation.

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

4 the term ‘advanced degree programs in clinical in5 vestigation’ means programs that award a master’s

6 or Ph.D. degree after 2 or more years of training

7 in areas such as the following:

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

9 study design.

10 ‘‘(B) Principles of clinical pharmacology

11 and pharmacokinetics.

12 ‘‘(C) Clinical epidemiology.

13 ‘‘(D) Computer data management and

14 medical informatics.

15 ‘‘(E) Ethical and regulatory issues.

16 ‘‘(F) Biomedical writing.

17 ‘‘(5) AUTHORIZATION OF APPROPRIATIONS.—

18 For the purpose of carrying out this subsection,

19 there are authorized to be appropriated such sums

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

21 SEC. 5. CLINICAL RESEARCH ASSISTANCE.

22 (a) NATIONAL RESEARCH SERVICE AWARDS.—Sec23 tion 487(a)(1)(C) of the Public Health Service Act (42

24 U.S.C. 288(a)(1)(C)) is amended by striking ‘‘50 such’’

25 and inserting ‘‘100 such’’.
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1 (b) LOAN REPAYMENT PROGRAM.—Section 487E of

2 the Public Health Service Act (42 U.S.C. 288–5) is

3 amended—

4 (1) in the section heading, by striking ‘‘FROM

5 DISADVANTAGED BACKGROUNDS’’;

6 (2) in subsection (a)(1)—

7 (A) by striking ‘‘who are from disadvan8 taged backgrounds’’; and

9 (B) by striking ‘‘as employees of the Na10 tional Institutes of Health’’ and inserting ‘‘as

11 part of a clinical research training position’’;

12 (3) in subsection (a), by striking paragraph (3)

13 and inserting the following:

14 ‘‘(3) APPLICABILITY OF CERTAIN PROVISIONS

15 REGARDING OBLIGATED SERVICE.—With respect to

16 the National Health Service Corps Loan Repayment

17 Program established under subpart III of part D of

18 title III, the provisions of such subpart shall, except

19 as inconsistent with this section, apply to the pro20 gram established in this section in the same manner

21 and to the same extent as such provisions apply to

22 such loan repayment program.’’;

23 (4) in subsection (b)—

24 (A) by striking ‘‘Amounts’’ and inserting

25 the following:
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1 ‘‘(1) IN GENERAL.—Amounts’’; and

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

3 ‘‘(2) DISADVANTAGED BACKGROUNDS SET4 ASIDE.—In carrying out this section, the Secretary

5 shall ensure that not less than 50 percent of the

6 contracts involve those appropriately qualified health

7 professionals who are from disadvantaged back8 grounds.’’; and

9 (5) by adding at the end the following:

10 ‘‘(c) DEFINITION.—As used in subsection (a)(1), the

11 term ‘clinical research training position’ means an indi12 vidual serving in a general clinical research center or in

13 clinical research at the National Institutes of Health, or

14 a physician receiving a clinical research career enhance15 ment award, or a graduate training in clinical investiga16 tion award.

17 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For the

18 purpose of carrying out this section, there are authorized

19 to be appropriated such sums as may be necessary for

20 each fiscal year.’’.

21 SEC. 6. DEFINITION.

22 Section 409 of the Public Health Service Act (42

23 U.S.C. 284d) is amended—
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1 (1) by striking ‘‘For purposes’’ and inserting

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

3 and

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

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

6 term ‘clinical research’ means patient oriented clinical re7 search conducted with human subjects, or research on the

8 causes and consequences of disease in human populations

9 involving material of human origin (such as tissue speci10 mens and cognitive phenomena) for which an investigator

11 or colleague directly interacts with human subjects in an

12 outpatient or inpatient setting to clarify a problem in

13 human physiology, pathophysiology, or disease; or epi14 demiologic or behavioral studies, outcomes research, or

15 health services research, or developing new technologies or

16 therapeutic interventions.’’.

17 SEC. 7. OVERSIGHT BY GENERAL ACCOUNTING OFFICE.

18 Not later than 18 months after the date of the enact19 ment of this Act, the Comptroller General of the United

20 States shall submit to the Congress a reporting describing

21 the extent to which the National Institutes of Health has

22 complied with the amendments made by this Act.

Union Calendar No. 585

106TH CONGRESS

2D SESSION H. R. 1798

[Report No. 106–1002]

A BILL

To amend the Public Health Service Act to provide

additional support for and to expand clinical research programs, and for other purposes.

OCTOBER 25, 2000

Committed to the Committee of the Whole House on the

State of the Union and ordered to be printed