II 

109TH CONGRESS 

1ST SESSION S. 1543 

To provide for clinical research support grants, clinical research infrastructure 

grants, and a demonstration program on partnerships in clinical research, 

and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JULY 28, 2005 

Mr. SANTORUM introduced the following bill; which was read twice and 

referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To provide for clinical research support grants, clinical research infrastructure grants, and a demonstration program on partnerships in clinical research, 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 Act 

5 of 2005’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds the following: 
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1 (1) Strong academic health centers are essential 

2 to a vigorous clinical research enterprise. 

3 (2) Breakthroughs in basic biomedical sciences 

4 over the past 5 decades have provided an unprece5 dented supply of information for improving human 

6 health and preventing disease. 

7 (3) Translating the information gained through 

8 these basic discoveries into knowledge that will im9 pact clinical practice and ultimately human health 

10 requires strong clinical research institutions. 

11 (4) The enhancement of clinical research career 

12 programs and opportunity will sustain the momen13 tum of the discovery, development, and delivery of 

14 important health advances. 

15 (5) Without a sound infrastructure to accom16 plish this translation in a systematic and coherent 

17 way, the sum of data and information produced by 

18 the basic science enterprise will not result in tangible 

19 public benefit. 

20 (6) The clinical research environment is in21 creasingly encumbered by incompatible databases, 

22 shortage of qualified investigators, rising costs, inad23 equate funding, and mounting unreimbursed regu24 latory burdens such as human subject research pro25 tections and additional record-keeping requirements 
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1 under the Health Insurance Portability and Ac2 countability Act of 1996. 

3 SEC. 3. DEFINITIONS. 

4 In this Act: 

5 (1) CLINICAL RESEARCH.—The term ‘‘clinical 

6 research’’ means— 

7 (A) patient-oriented clinical research con8 ducted with human subjects; 

9 (B) research on the causes and con10 sequences of disease in human populations in11 volving material of human origin (such as tissue 

12 specimens and cognitive phenomena) for which 

13 an investigator or colleague directly interacts 

14 with human subjects in an outpatient or inpa15 tient setting to clarify a problem in human 

16 physiology, pathophysiology or disease; 

17 (C) epidemiologic or behavioral studies; 

18 (D) outcomes research; 

19 (E) health services research; or 

20 (F) development of new technologies, 

21 therapeutic interventions, or clinical trials. 

22 (2) DIRECTOR.—The term ‘‘Director’’ means 

23 the Director of the National Institutes of Health. 

24 (3) ELIGIBLE ACADEMIC HEALTH CENTER.— 

25 The term ‘‘eligible academic health center’’ means 
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1 an academic institution and an affiliated teaching 

2 hospital, a teaching hospital, an independent re3 search institute, or a consortium of research institu4 tions which conduct clinical research and receive 

5 funds from the Department of Health and Human 

6 Services for basic, applied, or clinical biomedical or 

7 behavioral research in the fields of dentistry, medi8 cine, or nursing. 

9 (4) SECRETARY.—The term ‘‘Secretary’’ means 

10 the Secretary of Health and Human Services. 

11 SEC. 4. CLINICAL INVESTIGATOR ADVANCEMENT GRANTS. 

12 (a) AUTHORIZATION.—For the purposes described in 

13 subsection (b), the Director shall make a clinical investi14 gator advancement grant in the amount determined under 

15 subsection (d) to each eligible academic health center that 

16 submits an application in accordance with this section. 

17 (b) PURPOSES.—A grant under this section to an eli18 gible academic health center shall be used only for the fol19 lowing purposes: 

20 (1) To establish career development programs 

21 for new and mid-level clinician-investigators who are 

22 fully committed to academic clinical research ca23 reers. 
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1 (2) To support the translation of basic science 

2 to patient care by implementing and conducting all 

3 aspects of their clinical research mission. 

4 (3) To support activities leading to innovative 

5 ways to meet the purposes described in paragraphs 

6 (1) and (2) in an efficient and cost effective manner. 

7 (c) CAREER DEVELOPMENT PROGRAMS.— 

8 (1) USE OF FUNDS.—In implementing a career 

9 development program under subsection (b)(1), the 

10 Director may conduct or support activities to provide 

11 financial assistance and other support to— 

12 (A) young clinical researchers receiving 

13 peer-reviewed grants who wish to make the 

14 transition to research independence; 

15 (B) experienced scientists who wish to 

16 broaden their scientific capabilities; and 

17 (C) other medical personnel who are crit18 ical to the conduct of clinical research activities. 

19 (2) SALARY CAP.—Notwithstanding paragraph 

20 (1), no funds under this section may be used to in21 crease the rate of pay of an individual to a rate 

22 greater than the rate of basic pay for level I of the 

23 Executive Schedule. 

24 (d) ALLOCATION.—Of the amount appropriated to 

25 carry out this section for a fiscal year, the Director shall 
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1 allocate such appropriated amount among the eligible aca2 demic health centers receiving a grant under this section 

3 in an amount that bears the same relation to such appro4 priated amount as the investment in clinical research of 

5 the grantee involved bears to the total investment in clin6 ical research of all eligible grantees under this section. 

7 (e) APPLICATIONS.—To seek a grant under this sec8 tion, an eligible academic health center shall submit an 

9 application to the Director in such manner, at such time, 

10 and containing such information and assurances as the 

11 Director may require. 

12 (f) REPORTS.—The Director shall require each re13 cipient of a grant under this section to submit an annual 

14 report to the Director detailing how the recipient has used 

15 the grant to meet the purposes described in subsection (b). 

16 (g) AUTHORIZATION OF APPROPRIATIONS.—To carry 

17 out this section, there is authorized to be appropriated 

18 $40,000,000 for each of the fiscal years 2006 through 

19 2010. 

20 SEC. 5. CLINICAL RESEARCH INFRASTRUCTURE GRANTS. 

21 (a) AUTHORIZATION.—The Director shall make clin22 ical research infrastructure grants on a competitive basis 

23 to eligible academic health centers. 

24 (b) USE OF FUNDS.—The Director may not make a 

25 grant to an eligible academic health center under this sec-
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1 tion unless the center agrees to use the grant only for the 

2 following: 

3 (1) Fostering the use of information technology 

4 to facilitate the transformation of basic research 

5 findings on disease mechanisms into the develop6 ment of new methodologies for diagnosis, therapy, 

7 and prevention. 

8 (2) To devise, deploy, and support new tech9 nologies that facilitate the clinical investigators’ abil10 ity to— 

11 (A) improve the safety of human subjects 

12 in clinical research; 

13 (B) ensure the confidentiality of research 

14 data; and 

15 (C) streamline the regulatory processes to 

16 ensure better compliance for clinical research. 

17 (3) Addressing the many obstacles impeding the 

18 expeditious application of new science, such as— 

19 (A) a lack of up-to-date information tech20 nology systems; 

21 (B) incompatible databases; 

22 (C) a lack of connectivity between aca23 demic health centers, teaching hospitals, and 

24 independent research institutes; 
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1 (D) the absence of a coordinated strategy 

2 to enhance public understanding of, support 

3 for, and participation in clinical research; and 

4 (E) the underrepresentation of some popu5 lations in clinical research. 

6 (4) Sharing clinical research infrastructure 

7 across academic health centers to enable and facili8 tate cross-center clinical research collaborations. 

9 (c) REPORTS.—The Director shall require each re10 cipient of a grant under this section to submit an annual 

11 report to the Director detailing how the recipient has used 

12 the grant to meet the objectives described in subsection 

13 (b). 

14 (d) APPLICATIONS.—To seek a grant under this sec15 tion, an eligible academic health center shall submit an 

16 application to the Director in such manner, at such time, 

17 and containing such information and assurances as the 

18 Director may require. 

19 (e) AUTHORIZATION OF APPROPRIATIONS.—To carry 

20 out this section, there is authorized to be appropriated 

21 $125,000,000 for each of fiscal years 2006 through 2010. 

22 SEC. 6. DEMONSTRATION PROGRAM ON PARTNERSHIPS IN 

23 CLINICAL RESEARCH. 

24 (a) GRANTS.—The Secretary may make grants to not 

25 more than 5 eligible academic health centers to form part-
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1 nerships between the center involved and health care pro2 viders for carrying out clinical human subject research for 

3 the purpose of demonstrating how academic research cen4 ters may collaborate with the practicing health care com5 munity in such research. 

6 (b) MAXIMUM AMOUNT.—The Secretary may not 

7 make a grant to any eligible academic health center under 

8 this section in an amount that is greater than $5,000,000. 

9 (c) APPLICATIONS.—To seek a grant under this sec10 tion, an eligible academic health center shall submit an 

11 application to the Director in such manner, at such time, 

12 and containing such information and assurances as the 

13 Director may require. 

14 (d) AUTHORIZATION OF APPROPRIATIONS.—To carry 

15 out this section, there is authorized to be appropriated 

16 $25,000,000 for the period of fiscal years 2006 through 

17 2010. 

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