I

106TH CONGRESS

1ST SESSION H. R. 1798

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

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’’.
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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 $1

19 trillion on health care in 1997, but the Federal

20 budget for health research at the National Institutes

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

22 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 advisory com4 mittee, which recommended expanded support for

5 existing NIH clinical research programs and the cre6 ation of new initiatives to recruit and retain clinical

7 investigators.

8 (7) The current level of training and support

9 for health professionals in clinical research is frag10 mented, frequently undervalued, and potentially un11 derfunded.

12 (8) Young investigators are not only appren13 tices for future positions but a crucial source of en14 ergy, enthusiasm, and ideas in the day-to-day re15 search that constitutes the scientific enterprise. Seri16 ous questions about the future of life-science re17 search are raised by the following:

18 (A) The number of young investigators ap19 plying for grants dropped by 54 percent be20 tween 1985 and 1993.

21 (B) The number of physicians applying for

22 first-time NIH research project grants fell from

23 838 in 1994 to 575 in 1997, a 31% 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 American Association of 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 1998 equaled $167,000,000.

11 Since the late 1960s, spending for general clinical

12 research centers has declined from approximately

13 3% to 1% of the NIH budget.

14 (12) In fiscal year 1998, there were 75 general

15 clinical research centers in operation, supplying pa16 tients in the areas in which such centers operate

17 with access to the most modern clinical research and

18 clinical research facilities and technologies.

19 (b) PURPOSE.—It is the purpose of this Act to pro20 vide additional support for and to expand clinical research

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

2 INSTITUTES OF HEALTH IN CLINICAL

3 RESEARCH.

4 Section 402 of the Public Health Service Act (42

5 U.S.C. 282) is amended by adding at the end the fol6 lowing:

7 ‘‘(m)(1) The Director of NIH shall undertake activi8 ties to support and expand the involvement of the National

9 Institutes of Health in clinical research.

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

11 NIH shall—

12 ‘‘(A) implement the recommendations of the Di13 vision of Research Grants Clinical Research Study

14 Group and other recommendations for enhancing

15 clinical research, where applicable; and

16 ‘‘(B) establish an intramural clinical research

17 fellowship program and a continuing education clin18 ical research training program at NIH.

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

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

21 National Institutes of Health, shall support and expand

22 the resources available for the diverse needs of the clinical

23 research community, including inpatient, outpatient, and

24 critical care clinical research.

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

26 mechanisms to evaluate applications for—
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1 ‘‘(A) Mentored Patient-Oriented Research Ca2 reer Development Awards;

3 ‘‘(B) Mid-Career Investigator Awards in Pa4 tient-Oriented Research;

5 ‘‘(C) graduate training in clinical investigation

6 awards;

7 ‘‘(D) intramural clinical research fellowships.

8 Such review mechanisms shall include individuals who are

9 exceptionally qualified to appraise the merits of potential

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

11 SEC. 4. GENERAL CLINICAL RESEARCH CENTERS.

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

13 (42 U.S.C. 284 et seq.) is further amended by adding at

14 the end the following:

15 ‘‘SEC. 409C. GENERAL CLINICAL RESEARCH CENTERS.

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

17 for Research Resources shall award grants for the estab18 lishment of general clinical research centers to provide the

19 infrastructure for clinical research including clinical re20 search training and career enhancement. Such centers

21 shall support clinical studies and career development in

22 all settings of the hospital or academic medical center in23 volved.

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

25 Director of NIH shall expand the activities of the general
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1 clinical research centers through the increased use of tele2 communications and telemedicine initiatives.

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

4 purpose of carrying out this section, there are authorized

5 to be appropriated such sums as may be necessary for

6 each fiscal year.

7 ‘‘SEC. 409D. ENHANCEMENT AWARDS.

8 ‘‘(a) MENTORED PATIENT-ORIENTED RESEARCH CA9 REER DEVELOPMENT AWARDS.—

10 ‘‘(1) IN GENERAL.—The Director of the Na11 tional Center for Research Resources shall make

12 grants (to be referred to as ‘Mentored Patient-Ori13 ented Research Career Development Awards’) to

14 support individual careers in clinical research at gen15 eral clinical research centers or at other institutions

16 that have the infrastructure and resources deemed

17 appropriate for conducting patient-oriented clinical

18 research. The Director of the National Center for

19 Research Resources shall, where practicable, collabo20 rate or consult with other Institute Directors in

21 making awards under this subsection.

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

23 grant under this subsection shall be submitted by an

24 individual scientist at such time as the Director may

25 require.
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1 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—

2 For the purpose of carrying out this subsection,

3 there are authorized to be appropriated such sums

4 as may be necessary for each fiscal year.

5 ‘‘(b) MID-CAREER INVESTIGATOR AWARDS IN PA6 TIENT-ORIENTED RESEARCH.—

7 ‘‘(1) IN GENERAL.—The Director of the Na8 tional Center for Research Resources shall make

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

10 Awards in Patient-Oriented Research’) to support

11 individual clinical research projects at general clin12 ical research centers or at other institutions that

13 have the infrastructure and resources deemed appro14 priate for conducting patient-oriented clinical re15 search. The Director of the National Center for Re16 search Resources shall, where practicable, collabo17 rate or consult with other Institute Directors in

18 making awards under this subsection.

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

20 grant under this subsection shall be submitted by an

21 individual scientist at such time as the Director re22 quires.

23 ‘‘(3) 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 ‘‘(c) GRADUATE TRAINING IN CLINICAL INVESTIGA4 TION AWARD.—

5 ‘‘(1) IN GENERAL.—The Director of the Na6 tional Center for Research Resources shall make

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

8 clinical investigation awards’) to support individuals

9 pursuing master’s or doctoral degrees in clinical in10 vestigation.

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

12 grant under this subsection shall be submitted by an

13 individual scientist at such time as the Director may

14 require.

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

16 of 2 years or more and will provide stipend, tuition,

17 and institutional support for individual advanced de18 gree programs in clinical investigation.

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

20 the term ‘advanced degree programs in clinical in21 vestigation’ means programs that award a master’s

22 or Ph.D. degree after 2 or more years of training in

23 areas such as the following:

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

25 study design.
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1 ‘‘(B) Principles of clinical pharmacology

2 and pharmacokinetics.

3 ‘‘(C) Clinical epidemiology.

4 ‘‘(D) Computer data management and

5 medical informatics.

6 ‘‘(E) Ethical and regulatory issues.

7 ‘‘(F) Biomedical writing.

8 ‘‘(5) 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 SEC. 5. CLINICAL RESEARCH ASSISTANCE.

13 (a) NATIONAL RESEARCH SERVICE AWARDS.—Sec14 tion 487(a)(1)(C) of the Public Health Service Act (42

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

16 and inserting ‘‘100 such’’.

17 (b) LOAN REPAYMENT PROGRAM.—Section 487E of

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

19 amended—

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

21 DISADVANTAGED BACKGROUNDS’’;

22 (2) in subsection (a)(1)—

23 (A) by striking ‘‘who are from disadvan24 taged backgrounds’’; and
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1 (B) by striking ‘‘as employees of the Na2 tional Institutes of Health’’ and inserting ‘‘as

3 part of a clinical research training position’’;

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

5 and inserting the following:

6 ‘‘(3) APPLICABILITY OF CERTAIN PROVISIONS

7 REGARDING OBLIGATED SERVICE.—With respect to

8 the National Health Service Corps Loan Repayment

9 Program established under subpart III of part D of

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

11 as inconsistent with this section, apply to the pro12 gram established in this section in the same manner

13 and to the same extent as such provisions apply to

14 such loan repayment program.’’;

15 (4) in subsection (b)—

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

17 the following:

18 ‘‘(1) IN GENERAL.—Amounts’’; and

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

20 ‘‘(2) DISADVANTAGED BACKGROUNDS SET21 ASIDE.—In carrying out this section, the Secretary

22 shall ensure that not less than 50 percent of the

23 contracts involve those appropriately qualified health

24 professionals who are from disadvantaged back25 grounds.’’; and
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1 (5) by adding at the end the following:

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

3 term ‘clinical research training position’ means an indi4 vidual serving in a general clinical research center or in

5 clinical research at the National Institutes of Health, or

6 a physician receiving a clinical research career enhance7 ment award, or a graduate training in clinical investiga8 tion award.

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

10 purpose of carrying out this section, there are authorized

11 to be appropriated such sums as may be necessary for

12 each fiscal year.’’.

13 SEC. 6. DEFINITION.

14 Section 409 of the Public Health Service Act (42

15 U.S.C. 284d) is amended—

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

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

18 and

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

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

21 term ‘clinical research’ means patient oriented clinical re22 search conducted with human subjects, or research on the

23 causes and consequences of disease in human populations

24 involving material of human origin (such as tissue speci25 mens and cognitive phenomena) for which an investigator
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1 or colleague directly interacts with human subjects in an

2 outpatient or inpatient setting to clarify a problem in

3 human physiology, pathophysiology, or disease; or epi4 demiologic or behavioral studies, outcomes research, or

5 health services research, or developing new technologies or

6 therapeutic interventions.’’.

7 SEC. 7. OVERSIGHT BY GENERAL ACCOUNTING OFFICE.

8 Not later than 18 months after the date of the enact9 ment of this Act, the Comptroller General of the United

10 States shall submit to the Congress a reporting describing

11 the extent to which the National Institutes of Health has

12 complied with the amendments made by this Act.

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