II

105TH CONGRESS

1ST SESSION S. 1421

To amend the Public Health Service Act to provide additional support for

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

IN THE SENATE OF THE UNITED STATES

NOVEMBER 7, 1997

Mr. KENNEDY (for himself, Mr. COCHRAN, Mr. DURBIN, Mr. FAIRCLOTH, and

Ms. MIKULSKI) introduced the following bill; which was read twice and

referred to the Committee on Labor and Human Resources

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 1997’’.

6 SEC. 2. FINDINGS AND PURPOSE.

7 (a) FINDINGS.—Congress makes the following find8 ings:
2

•S 1421 IS

1 (1) Clinical research is critical to the advance2 ment of scientific knowledge and to the development

3 of cures and improved treatment for disease.

4 (2) Tremendous advances in biology are open5 ing doors to new insights into human physiology,

6 pathophysiology and disease, creating extraordinary

7 opportunities for clinical research.

8 (3) Clinical research includes translational re9 search which is an integral part of the research

10 process leading to general human applications. It is

11 the bridge between the laboratory and new methods

12 of diagnosis, treatment, and prevention and is thus

13 essential to progress against cancer and other dis14 eases.

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

16 trillion on health care in 1997, but the Federal

17 budget for health research at the National Institutes

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

19 total.

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

21 National Research Council, and the National Acad22 emy of Sciences have all addressed the current prob23 lems in clinical research.

24 (6) The Director of the National Institutes of

25 Health has recognized the current problems in clini-
3

•S 1421 IS

1 cal research and has through the use of an advisory

2 committee begun to evaluate these problems.

3 (7) The current level of training and support

4 for health professionals in clinical research is frag5 mented, frequently undervalued, and potentially un6 derfunded.

7 (8) Young investigators are not only appren8 tices for future positions but a crucial source of en9 ergy, enthusiasm, and ideas in the day-to-day re10 search that constitutes the scientific enterprise. Seri11 ous questions about the future of life-science re12 search are raised by the following:

13 (A) The number of young investigators ap14 plying for grants dropped by 54 percent be15 tween 1985 and 1993.

16 (B) The number of federally funded re17 search (R01) grants awarded to persons under

18 the age of 36 have decreased by 70 percent

19 from 1985 to 1993.

20 (C) Newly independent life-scientists are

21 expected to raise funds to support their new re22 search programs and a substantial proportion

23 of their own salaries.
4

•S 1421 IS

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

2 the decline in the number of active clinical research3 ers, and those choosing this career path:

4 (A) A medical school graduate incurs an

5 average debt of $80,000, as reported in the

6 Medical School Graduation Questionnaire by

7 the American Association of Medical Colleges

8 (AAMC).

9 (B) The prolonged period of clinical train10 ing required increases the accumulated debt

11 burden.

12 (C) The decreasing number of mentors and

13 role models.

14 (D) The perceived instability of funding

15 from the National Institutes of Health and

16 other Federal agencies.

17 (E) The almost complete absence of clini18 cal research training in the curriculum of train19 ing grant awardees.

20 (F) Academic Medical Centers are experi21 encing difficulties in maintaining a proper envi22 ronment for research in a highly competitive

23 health care marketplace, which are compounded

24 by the decreased willingness of third party pay25 ers to cover health care costs for patients en-
5

•S 1421 IS

1 gaged in research studies and research proce2 dures.

3 (10) In 1960, general clinical research centers

4 were established under the Office of the Director of

5 the National Institutes of Health with an initial ap6 propriation of $3,000,000.

7 (11) Appropriations for general clinical research

8 centers in fiscal year 1997 equaled $153,000,000.

9 (12) In fiscal year 1997, there were 74 general

10 clinical research centers in operation, supplying pa11 tients in the areas in which such centers operate

12 with access to the most modern clinical research and

13 clinical research facilities and technologies.

14 (13) The average annual amount allocated for

15 each general clinical research center is $1,900,000,

16 establishing a current funding level of 75 percent of

17 the amounts approved by the Advisory Council of

18 the National Center for Research Resources.

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

21 programs.
6

•S 1421 IS

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 follow6 ing:

7 ‘‘(l)(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) design test pilot projects and implement

13 the recommendations of the Division of Research

14 Grants Clinical Research Study Group and other

15 recommendations for enhancing clinical research,

16 where applicable; and

17 ‘‘(B) establish an intramural clinical research

18 fellowship program and a continuing education clini19 cal research training program at NIH.

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

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

22 National Institutes of Health, shall support and expand

23 the resources available for the diverse needs of the clinical

24 research community, including inpatient, outpatient, and

25 critical care clinical research.
7

•S 1421 IS

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

2 mechanisms to evaluate applications for—

3 ‘‘(A) clinical research career enhancement

4 awards;

5 ‘‘(B) innovative medical science awards;

6 ‘‘(C) graduate training in clinical investigation

7 awards;

8 ‘‘(D) intramural clinical research fellowships.

9 Such review mechanisms shall include individuals who are

10 exceptionally qualified to appraise the merits of potential

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

12 SEC. 4. GENERAL CLINICAL RESEARCH CENTERS.

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

14 (42 U.S.C. 284 et seq.) is further amended by adding at

15 the end the following:

16 ‘‘SEC. 409B. 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.
8

•S 1421 IS

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

2 Director of NIH shall expand the activities of the general

3 clinical research centers through the increased use of tele4 communications and telemedicine initiatives.

5 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There

6 are authorized to be appropriated to carry out this section,

7 such sums as may be necessary.

8 ‘‘SEC. 409C. ENHANCEMENT AWARDS.

9 ‘‘(a) CLINICAL RESEARCH CAREER ENHANCEMENT

10 AWARD.—

11 ‘‘(1) IN GENERAL.—The Director of the Na12 tional Center for Research Resources shall make

13 grants (to be referred to as ‘clinical research career

14 enhancement awards’) to support individual careers

15 in clinical research at general clinical research cen16 ters or at other institutions that have the infrastruc17 ture and resources deemed appropriate for conduct18 ing patient-oriented clinical research. The Director

19 of the National Center for Research Resources shall,

20 where practicable, collaborate or consult with other

21 Institute Directors in making awards under this

22 subsection.

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

24 grant under this subsection shall be submitted by an
9

•S 1421 IS

1 individual scientist at such time as the Director may

2 require.

3 ‘‘(3) LIMITATIONS.—The amount of a grant

4 under this subsection shall not exceed $125,000 per

5 year per grant. Grants shall be for terms of 5 years.

6 The Director shall award not more than 20 grants

7 in the first fiscal year, and not more than 40 grants

8 in the second fiscal year, in which grants are award9 ed under this subsection.

10 ‘‘(4) AUTHORIZATION OF APPROPRIATIONS.—

11 There is authorized to be appropriated to make

12 grants under paragraph (1), $3,000,000 for fiscal

13 year 1998, and such sums as may be necessary for

14 each subsequent fiscal year.

15 ‘‘(b) INNOVATIVE MEDICAL SCIENCE AWARD.—

16 ‘‘(1) IN GENERAL.—The Director of the Na17 tional Center for Research Resources shall make

18 grants (to be referred to as ‘innovative medical

19 science awards’) to support individual clinical re20 search projects at general clinical research centers or

21 at other institutions that have the infrastructure and

22 resources deemed appropriate for conducting pa23 tient-oriented clinical research. The Director of the

24 National Center for Research Resources shall, where

25 practicable, collaborate or consult with other Insti-
10

•S 1421 IS

1 tute Directors in making awards under this sub2 section.

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

4 grant under this subsection shall be submitted by an

5 individual scientist at such time as the Director re6 quires.

7 ‘‘(3) LIMITATIONS.—The amount of a grant

8 under this subsection shall not exceed $175,000 per

9 year per grant.

10 ‘‘(4) AUTHORIZATION OF APPROPRIATIONS.—

11 There is authorized to be appropriated to make

12 grants under this subsection, $52,500,000 for fiscal

13 year 1998, and such sums as may be necessary for

14 each subsequent fiscal year.

15 ‘‘(c) GRADUATE TRAINING IN CLINICAL INVESTIGA16 TION AWARD.—

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

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

20 clinical investigation awards’) to support individuals

21 pursuing master’s or doctoral degrees in clinical in22 vestigation.

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

24 grant under this subsection shall be submitted by an
11

•S 1421 IS

1 individual scientist at such time as the Director may

2 require.

3 ‘‘(3) LIMITATIONS.—The amount of a grant

4 under this subsection shall not exceed $75,000 per

5 year per grant. Grants shall be for terms of 2 years

6 or more and will provide stipend, tuition, and insti7 tutional support for individual advanced degree pro8 grams in clinical investigation.

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

10 the term ‘advanced degree programs in clinical in11 vestigation’ means programs that award a master’s

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

13 areas such as the following:

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 There is authorized to be appropriated to make

25 grants under this subsection, $3,000,000 for fiscal
12

•S 1421 IS

1 year 1998, and such sums as may be necessary for

2 each subsequent fiscal year.’’.

3 SEC. 5. CLINICAL RESEARCH ASSISTANCE.

4 (a) NATIONAL RESEARCH SERVICE AWARDS.—Sec5 tion 487(a)(1)(C) of the Public Health Service Act (42

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

7 and inserting ‘‘100 such’’.

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

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

10 amended—

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

12 DISADVANTAGED BACKGROUNDS’’;

13 (2) in subsection (a)(1)—

14 (A) by striking ‘‘who are from disadvan15 taged backgrounds’’; and

16 (B) by striking ‘‘as employees of the Na17 tional Institutes of Health’’ and inserting ‘‘as

18 part of a clinical research training position’’;

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

20 and inserting the following:

21 ‘‘(3) APPLICABILITY OF CERTAIN PROVISIONS

22 REGARDING OBLIGATED SERVICE.—With respect to

23 the National Health Service Corps Loan Repayment

24 Program established under subpart III of part D of

25 title III, the provisions of such subpart shall, except
13

•S 1421 IS

1 as inconsistent with this section, apply to the pro2 gram established in this section in the same manner

3 and to the same extent as such provisions apply to

4 such loan repayment program.’’;

5 (4) in subsection (b)—

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

7 the following:

8 ‘‘(1) IN GENERAL.—Amounts’’; and

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

10 ‘‘(2) DISADVANTAGED BACKGROUNDS SET11 ASIDE.—In carrying out this section, the Secretary

12 shall ensure that not less than 50 percent of the

13 contracts involve those appropriately qualified health

14 professionals who are from disadvantaged back15 grounds.’’; and

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

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

18 term ‘clinical research training position’ means an individ19 ual serving in a general clinical research center or in clini20 cal research at the National Institutes of Health, or a phy21 sician receiving a clinical research career enhancement

22 award, an innovative medical science award, or a graduate

23 training in clinical investigation award.
14

•S 1421 IS

1 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There

2 is authorized to be appropriated to carry out this section

3 such sums as may be necessary for each fiscal year.’’.

4 SEC. 6. DEFINITION.

5 Section 409 of the Public Health Service Act (42

6 U.S.C. 284d) is amended—

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

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

9 and

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

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

12 term ‘clinical research’ means patient oriented clinical re13 search conducted with human subjects, or research on the

14 causes and consequences of disease in human populations

15 involving material of human origin (such as tissue speci16 mens and cognitive phenomena) for which an investigator

17 or colleague directly interacts with human subjects in an

18 outpatient or inpatient setting to clarify a problem in

19 human physiology, pathophysiology, or disease; or epi20 demiologic or behavioral studies, outcomes research, or

21 health services research, or developing new technologies or

22 therapeutic interventions.’’.

Æ