II

104TH CONGRESS

2D SESSION S. 1534

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

JANUARY 26, 1996

Mr. HATFIELD (for himself and Mr. KENNEDY) 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 1996’’.

6 SEC. 2. FINDINGS AND PURPOSE.

7 (a) FINDINGS.—Congress finds the following:
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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) The United States spent more than $1 tril9 lion on health care in 1994, but the Federal budget

10 for health research at the National Institutes of

11 Health was $10 billion, only 1 percent of that total.

12 (4) Studies at the Institute of Medicine, the

13 National Research Council, and the National Acad14 emy of Sciences have all addressed the current prob15 lems in clinical research.

16 (5) The Director of the National Institutes of

17 Health has recognized the current problems in clini18 cal research and has through the use of an advisory

19 committee begun to evaluate these problems.

20 (6) The current level of training and support

21 for health professionals in clinical research is frag22 mented, frequently undervalued, and potentially un23 derfunded.

24 (7) Young investigators are not only appren25 tices for future positions but a crucial source of en-
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1 ergy, enthusiasm, and ideas in the day-to-day re2 search that constitutes the scientific enterprise. Seri3 ous questions about the future of life-science re4 search are raised by the following:

5 (A) The number of young investigators ap6 plying for grants dropped by 54 percent be7 tween 1985 and 1993.

8 (B) The number of federally funded re9 search (R01) grants awarded to persons under

10 the age of 36 have decreased by 70 percent

11 from 1985 to 1993.

12 (C) Newly independent life-scientists are

13 expected to raise funds to support their new re14 search programs and a substantial proportion

15 of their own salaries.

16 (8) The following have been cited as reasons for

17 the decline in the number of active clinical research18 ers, and those choosing this career path:

19 (A) A medical school graduate incurs an

20 average debt of $63,000, as reported in the

21 Medical School Graduation Questionnaire by

22 the American Association of Medical Colleges

23 (AAMC).
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1 (B) The prolonged period of clinical train2 ing required increases the accumulated debt

3 burden.

4 (C) The decreasing number of mentors and

5 role models.

6 (D) The perceived instability of funding

7 from the National Institutes of Health and

8 other Federal agencies.

9 (E) The almost complete absence of clini10 cal research training in the curriculum of train11 ing grant awardees.

12 (F) Academic Medical Centers are experi13 encing difficulties in maintaining a proper envi14 ronment for research in a highly competitive

15 health care marketplace, which are compounded

16 by the decreased willingness of third party pay17 ers to cover health care costs for patients en18 gaged in research studies and research proce19 dures.

20 (9) In 1960, general clinical research centers

21 were established under the Office of the Director of

22 the National Institutes of Health with an initial ap23 propriation of $3,000,000.

24 (10) Appropriations for general clinical research

25 centers in fiscal year 1995 equal $136,640,000.
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1 (11) In fiscal year 1995, there are 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 (12) The average annual amount allocated for

7 each general clinical research center is $1,000,000,

8 establishing a current funding level of 75 percent of

9 the amounts approved by the Advisory Council of

10 the National Center for Research Resources.

11 (b) PURPOSE.—It is the purpose of this Act to pro12 vide additional support for and to expand clinical research

13 programs.

14 SEC. 3. PRESIDENT’S CLINICAL RESEARCH PANEL.

15 Part H of title IV of the Public Health Service Act

16 (42 U.S.C. 289 et seq.) is amended by adding at the end

17 thereof the following new section:

18 ‘‘SEC. 498C. PRESIDENT’S CLINICAL RESEARCH PANEL.

19 ‘‘(a) ESTABLISHMENT.—The President shall estab20 lish a panel to be known as the ‘President’s Clinical Re21 search Panel’ (hereafter referred to in this section as the

22 ‘Panel’) as a part of the Office of Science and Technology

23 Policy, to carry out the duties described in this section.

24 ‘‘(b) MEMBERSHIP.—
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1 ‘‘(1) IN GENERAL.—The Panel shall be com2 posed of 12 individuals appointed by the President

3 and selected from recommendations submitted by

4 the President of the Institute of Medicine of the Na5 tional Academy of Sciences.

6 ‘‘(2) QUALIFICATIONS.—Individuals appointed

7 to the panel under paragraph (1) shall, by virtue of

8 their training, experience and background, be excep9 tionally qualified to appraise the status of clinical re10 search both within and outside of the Federal Gov11 ernment, and should represent distinguished re12 search scientists and physicians, insurance compa13 nies, pharmaceutical companies, health maintenance

14 organizations, accreditation and certification organi15 zations and academic research administrators, and

16 patients.

17 ‘‘(3) EXCLUSION AND ADVISORS.—Officers or

18 employees of the Federal Government shall not be

19 eligible to be appointed to the Panel. The Secretary

20 of Health and Human Services, the Secretary of De21 fense, the Secretary of Veterans Affairs, the Assist22 ant to the President for Science and Technology,

23 and other Cabinet officers as the President deter24 mines to be appropriate may serve as advisors to the

25 Panel.
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1 ‘‘(c) TERMS AND VACANCIES.—

2 ‘‘(1) TERMS.—Members of the Panel shall be

3 appointed for 3-year terms, except that—

4 ‘‘(A) any member appointed to fill a va5 cancy occurring on the Panel prior to the expi6 ration of the term for which the member’s pred7 ecessor was appointed, shall be appointed for

8 the remainder of such term; and

9 ‘‘(B) a member may serve until the mem10 ber’s successor has taken office.

11 ‘‘(2) VACANCIES.—If a vacancy on the Panel

12 occurs, the President shall make an appointment to

13 fill the vacancy not later than 90 days after the date

14 on which the vacancy occurred.

15 ‘‘(3) REAPPOINTMENTS.—A member of the

16 Panel may be reappointed but may not serve more

17 than 2 consecutive terms.

18 ‘‘(d) DATE OF APPOINTMENT.—The initial members

19 of the Panel shall be appointed not later than 120 days

20 after the date of enactment of this section.

21 ‘‘(e) CHAIRPERSON AND VICE CHAIRPERSON.—The

22 President shall designate one of the members of the Panel

23 to serve as the chairperson of the Panel and one member

24 to serve as the vice chairperson of the Panel, each to serve

25 for a term of 1 year.
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1 ‘‘(f) MEETINGS.—The Panel shall meet at the call of

2 the chairperson, but in no event less than 4 times each

3 year. A transcript shall be kept of the proceedings of each

4 such meeting of the Panel, and the chairperson shall make

5 such transcripts available to the public. Not later than 30

6 days after the date on which all members of the Panel

7 have been appointed, the Panel shall hold its first meeting.

8 ‘‘(g) DUTIES.—The Panel shall evaluate the status

9 of the clinical research environment throughout the United

10 States, and prepare and submit periodic progress reports

11 to the President. The Panel shall submit to the President,

12 the Secretary of Health and Human Services, the Sec13 retary of Defense, the Secretary of Veterans Affairs, and

14 the Congress an annual evaluation of the clinical research

15 environment in the United States and recommendations

16 for improvements and shall submit such other reports as

17 the President shall direct.

18 ‘‘(h) PERSONNEL MATTERS.—

19 ‘‘(1) COMPENSATION.—Each member of the

20 Panel shall be compensated at a rate equal to the

21 daily equivalent of the annual rate of basic pay pre22 scribed for level IV of the Executive Schedule under

23 section 5315 of title 5, United States Code, for each

24 day (including travel time) during which such mem-
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1 ber is engaged in the performance of the duties of

2 the Panel.

3 ‘‘(2) TRAVEL EXPENSES.—The members of the

4 Panel shall be allowed travel expenses, including per

5 diem in lieu of subsistence, at rates authorized for

6 employees of agencies under subchapter I of chapter

7 57 of title 5, United States Code, while away from

8 their homes or regular places of business in the per9 formance of services for the Panel.

10 ‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—There

11 are authorized to be appropriated such sums as may be

12 necessary to enable the Panel to carry out this section.’’.

13 SEC. 4. ADVISORY COMMITTEE TO THE DIRECTOR ON CLIN14 ICAL RESEARCH.

15 Part H of title IV of the Public Health Service Act

16 (42 U.S.C. 289 et seq.), as amended by section 3, is fur17 ther amended by adding at the end thereof the following

18 new section:

19 ‘‘SEC. 498D. ADVISORY COMMITTEE TO THE DIRECTOR ON

20 CLINICAL RESEARCH.

21 ‘‘(a) IN GENERAL.—The advisory committee estab22 lished by the Director of the National Institutes of Health

23 and known as the Advisory Committee to the Director on

24 Clinical Research (hereafter referred to in this section as

25 the ‘Advisory Committee’) shall report to such Director
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1 and to the President’s Clinical Research Panel established

2 under section 498C and shall implement recommendations

3 as determined necessary by the Advisory Committee to

4 remedy deficiencies in clinical research within the National

5 Institutes of Health.

6 ‘‘(b) TERMINATION.—The Advisory Committee shall

7 terminate on the date that occurs 5 years after the date

8 of enactment of this Act.’’.

9 SEC. 5. STUDY SECTION REVIEW.

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

11 (42 U.S.C. 284 et seq.) is amended by adding at the end

12 thereof the following new section:

13 ‘‘SEC. 409B. STUDY SECTION REVIEW.

14 ‘‘(a) IN GENERAL.—The President’s Clinical Re15 search Panel shall direct the Office of Science and Tech16 nology Policy to conduct a review of the compositions,

17 functions, and outcomes of study section activities at all

18 Federal agencies which conduct or fund such activities as

19 such activities relate to clinical research proposals for in20 vestigator-initiated support.

21 ‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—There

22 are authorized to be appropriated such sums as may be

23 necessary to carry out this section.’’.
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1 SEC. 6. INCREASE 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 thereof the

6 following new subsection:

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) increase the number of FIRST grants

13 (R29) for young clinical investigators;

14 ‘‘(B) design test pilot projects and implement

15 the recommendations of the Division of Research

16 Grants Clinical Research Study Group; and

17 ‘‘(C) establish an intramural clinical research

18 fellowship program (similar to the program estab19 lished under section 738(b)) and a continuing edu20 cation clinical research training program at NIH.

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

22 Director of the National Institutes of Health and the Di23 rectors of the Institutes, Centers, and Divisions of the Na24 tional Institutes of Health, shall support and expand the

25 resources available for the diverse needs of the clinical re-
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1 search community, including inpatient, outpatient, and

2 critical care clinical research.

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

4 Director of the National Center for Research Resources,

5 shall establish peer review mechanisms to evaluate applica6 tions for intramural clinical research fellowships, clinical

7 research career enhancement awards, and innovative med8 ical science award programs. Such review mechanisms

9 shall include individuals who are exceptionally qualified to

10 appraise the merits of potential clinical research train11 ees.’’.

12 SEC. 7. GENERAL CLINICAL RESEARCH CENTERS.

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

14 (42 U.S.C. 284 et seq.) as amended by section 5, is fur15 ther amended by adding at the end thereof the following

16 new sections:

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

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

19 for Research Resources shall award grants for the estab20 lishment of general clinical research centers to provide the

21 infrastructure for clinical research including clinical re22 search training and career enhancement. Such centers

23 shall support clinical studies and career development in

24 all settings of the hospital or academic medical center in25 volved.
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1 ‘‘(b) ACTIVITIES.—In carrying out subsection (b), 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 make grants under

7 subsection (a), $200,000,000 for fiscal year 1997, and

8 such sums as may be necessary for each subsequent fiscal

9 year.

10 ‘‘SEC. 409D. ENHANCEMENT AWARDS.

11 ‘‘(a) CLINICAL RESEARCH CAREER ENHANCEMENT

12 AWARD.—

13 ‘‘(1) IN GENERAL.—The Director of the Na14 tional Center for Research Resources shall make

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

16 enhancement awards’) to support individual careers

17 in clinical research.

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

19 grant under this subsection shall be submitted by an

20 individual scientist at such time as the Director may

21 require.

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

23 under this subsection shall not exceed $130,000 per

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

25 The Director shall award not more than 20 grants
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1 in the first fiscal year, and not more than 40 grants

2 in the second fiscal year, in which grants are award3 ed under this subsection.

4 ‘‘(4) AUTHORIZATION OF APPROPRIATIONS.—

5 There are authorized to be appropriated to make

6 grants under paragraph (1), $300,000,000 for fiscal

7 year 1997, and such sums as may be necessary for

8 each subsequent fiscal year.

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

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

12 grants (to be referred to as ‘innovative medical

13 science awards’) to support individual clinical re14 search projects.

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

16 grant under this subsection shall be submitted by an

17 individual scientist at such time as the Director re18 quires.

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

20 under this subsection shall not exceed $100,000 per

21 year per grant.

22 ‘‘(4) AUTHORIZATION OF APPROPRIATIONS.—

23 There are authorized to be appropriated to make

24 grants under paragraph (1), $30,000,000 for fiscal
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1 year 1997, and such sums as may be necessary for

2 each subsequent fiscal year.’’.

3 SEC. 8. 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), by striking ‘‘who are

14 from disadvantaged backgrounds’’;

15 (3) 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 thereof the fol20 lowing new paragraph:

21 ‘‘(2) DISADVANTAGED BACKGROUNDS SET22 ASIDE.—In carrying out this section, the Secretary

23 shall ensure that not less than 50 percent of the

24 amounts appropriated for a fiscal year are used for

25 contracts involving those appropriately qualified
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1 health professionals who are from disadvantaged

2 backgrounds.’’; and

3 (4) by adding at the end thereof the following

4 new subsections:

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

6 term ‘clinical research training position’ means an individ7 ual serving in a general clinical research center, or a physi8 cian receiving a clinical research career enhancement

9 award or NIH intramural research fellowship.

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

11 are authorized to be appropriated to carry out this section

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

13 SEC. 9. INSURANCE COVERAGE OF INVESTIGATIONAL

14 TREATMENTS.

15 (a) PARTICIPATION.—A health plan shall allow indi16 viduals, when medically appropriate, to participate in an

17 investigational therapy, and shall cover the patient care

18 provided pursuant to investigational treatments as de19 scribed in subsection (b). The plan shall permit an individ20 ual to participate in an investigational treatment, subject

21 to the limitations and cost sharing requirements applicable

22 to the item or service, when the item or service is provided

23 to an individual in the course of an investigational treat24 ment, if—
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1 (1) the treatment is a qualifying investigational

2 treatment; and

3 (2) the item or service is required to provide

4 patient care pursuant to the design of an approved

5 clinical research trial, except those services normally

6 paid for by other funding sources such as the cost

7 of the investigational agent or device itself, and the

8 costs of managing the research.

9 A plan may not discriminate against or refuse plan partici10 pation by an individual participating in an investigational

11 treatment.

12 (b) DEFINITIONS.—For purposes of subsection (a):

13 (1) QUALIFYING INVESTIGATIONAL TREAT14 MENT.—The term ‘‘qualifying investigational treat15 ment’’ means a treatment—

16 (A) the effectiveness of which has not been

17 determined; and

18 (B) that is under clinical investigation as

19 part of an approved research trial.

20 (2) APPROVED RESEARCH TRIAL.—The term

21 ‘‘approved research trial’’ means—

22 (A) a research trial approved by the Sec23 retary of Health and Human Services, the Di24 rector of the National Institutes of Health, the

25 Commissioner of the Food and Drug Adminis-
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1 tration, the Secretary of Veterans Affairs, the

2 Secretary of Defense, or a qualified nongovern3 mental research entity as defined in guidelines

4 of the National Institutes of Health; or

5 (B) a peer-reviewed and approved research

6 program, as defined by the Secretary of Health

7 and Human Services, conducted for the primary

8 purpose of determining whether or not a treat9 ment is safe, efficacious, or having any other

10 characteristic of a treatment which must be

11 demonstrated in order for the treatment to be

12 medically necessary or appropriate.

13 SEC. 10. 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 thereof the following

20 new subsection:

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

22 term ‘clinical research’ means patient oriented clinical re23 search conducted with human subjects, or research on the

24 causes and consequences of disease in human populations,

25 or on material of human origin (such as tissue specimens
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1 and cognitive phenomena) for which an investigator or col2 league directly interacts with human subjects in an out3 patient or inpatient setting to clarify a problem in human

4 physiology, pathophysiology, or disease.’’.

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