I 

109TH CONGRESS 

1ST SESSION H. R. 2124 

To amend the Public Health Service Act 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 HOUSE OF REPRESENTATIVES 

MAY 5, 2005 

Mr. WELDON of Florida introduced the following bill; which was referred to 

the Committee on Energy and Commerce 

A BILL 

To amend the Public Health Service Act 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: 
2 

•HR 2124 IH 

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 
3 

•HR 2124 IH 

1 under the Health Insurance Portability and Ac2 countability Act of 1996. 

3 SEC. 3. DEFINITIONS. 

4 In this Act: 

5 (1) The term ‘‘clinical research’’ means— 

6 (A) patient-oriented clinical research con7 ducted with human subjects; 

8 (B) research on the causes and con9 sequences of disease in human populations in10 volving material of human origin (such as tissue 

11 specimens and cognitive phenomena) for which 

12 an investigator or colleague directly interacts 

13 with human subjects in an outpatient or inpa14 tient setting to clarify a problem in human 

15 physiology, pathophysiology or disease; 

16 (C) epidemiologic or behavioral studies; 

17 (D) outcomes research; 

18 (E) health services research; or 

19 (F) development of new technologies, 

20 therapeutic interventions, or clinical trials. 

21 (2) The term ‘‘Director’’ means the Director of 

22 the National Institutes of Health. 

23 (3) The term ‘‘eligible academic health center’’ 

24 means an academic institution and an affiliated 

25 teaching hospital, a teaching hospital, an inde-
4 

•HR 2124 IH 

1 pendent research institute, or a consortium of re2 search institutions which conduct clinical research 

3 and receive funds from the Department of Health 

4 and Human Services for basic, applied, or clinical 

5 biomedical or behavioral research in the fields of 

6 dentistry, medicine, and nursing. 

7 (4) The term ‘‘Secretary’’ means the Secretary 

8 of Health and Human Services. 

9 SEC. 4. CLINICAL INVESTIGATOR ADVANCEMENT GRANTS. 

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

11 subsection (b), the Director shall make a clinical investi12 gator advancement grant in the amount determined under 

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

14 submits an application in accordance with this section. 

15 (b) PURPOSES.—A grant under this section to an eli16 gible academic health center shall be used only for the fol17 lowing purposes: 

18 (1) To establish career development programs 

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

20 fully committed to academic clinical research ca21 reers. 

22 (2) To support the translation of basic science 

23 to patient care by implementing and conducting all 

24 aspects of their clinical research mission. 
5 

•HR 2124 IH 

1 (3) To support activities leading to innovative 

2 ways to meet the purposes described in paragraphs 

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

4 (c) CAREER DEVELOPMENT PROGRAMS.— 

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

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

7 Director may conduct or support activities to provide 

8 financial assistance and other support to— 

9 (A) young clinical researchers receiving 

10 peer-reviewed grants who wish to make the 

11 transition to research independence; 

12 (B) experienced scientists who wish to 

13 broaden their scientific capabilities; and 

14 (C) other medical personnel who are crit15 ical to the conduct of clinical research activities. 

16 (2) SALARY CAP.—Notwithstanding paragraph 

17 (1), no funds under this section may be used to in18 crease the rate of pay of an individual to a rate 

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

20 Executive Schedule. 

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

22 carry out this section for a fiscal year, the Director shall 

23 allocate such appropriated amount among the eligible aca24 demic health centers receiving a grant under this section 

25 in an amount that bears the same relation to such appro-
6 

•HR 2124 IH 

1 priated amount as the investment in clinical research of 

2 the grantee involved bears to the total investment in clin3 ical research of all eligible grantees under this section. 

4 (e) APPLICATIONS.—To seek a grant under this sec5 tion, an eligible academic health center shall submit an 

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

7 and containing such information and assurances as the 

8 Director may require. 

9 (f) 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 purposes described in subsection (b). 

13 (g) AUTHORIZATION OF APPROPRIATIONS.—To carry 

14 out this section, there is authorized to be appropriated 

15 $40,000,000 for each of the fiscal years 2006 through 

16 2010. 

17 SEC. 5. CLINICAL RESEARCH INFRASTRUCTURE GRANTS. 

18 (a) AUTHORIZATION.—The Director shall make clin19 ical research infrastructure grants on a competitive basis 

20 to eligible academic health centers. 

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

22 grant to an eligible academic health center under this sec23 tion unless the center agrees to use the grant only for the 

24 following: 
7 

•HR 2124 IH 

1 (1) Fostering the use of information technology 

2 to facilitate the transformation of basic research 

3 findings on disease mechanisms into the develop4 ment of new methodologies for diagnosis, therapy, 

5 and prevention. 

6 (2) Addressing the many obstacles impeding the 

7 expeditious application of new science, such as— 

8 (A) a lack of up-to-date information tech9 nology systems; 

10 (B) incompatible databases; 

11 (C) a lack of connectivity between aca12 demic health centers, teaching hospitals, and 

13 independent research institutes; 

14 (D) the absence of a coordinated strategy 

15 to enhance public understanding of, support 

16 for, and participation in clinical research; and 

17 (E) the underrepresentation of some popu18 lations in clinical research. 

19 (3) Sharing clinical research infrastructure 

20 across academic health centers to enable and facili21 tate cross-center clinical research collaborations. 

22 (c) REPORTS.—The Director shall require each re23 cipient of a grant under this section to submit an annual 

24 report to the Director detailing how the recipient has used 
8 

•HR 2124 IH 

1 the grant to meet the objectives described in subsection 

2 (b). 

3 (d) APPLICATIONS.—To seek a grant under this sec4 tion, an eligible academic health center shall submit an 

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

6 and containing such information and assurances as the 

7 Director may require. 

8 (e) AUTHORIZATION OF APPROPRIATIONS.—To carry 

9 out this section, there is authorized to be appropriated 

10 $125,000,000 for each of fiscal years 2006 through 2010. 

11 SEC. 6. DEMONSTRATION PROGRAM ON PARTNERSHIPS IN 

12 CLINICAL RESEARCH. 

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

14 more than 5 eligible academic health centers to form part15 nerships between the center involved and health care pro16 viders for carrying out clinical human subject research for 

17 the purpose of demonstrating how academic research cen18 ters may collaborate with the practicing health care com19 munity in such research. 

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

21 make a grant to any eligible academic health center under 

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

23 (c) APPLICATIONS.—To seek a grant under this sec24 tion, an eligible academic health center shall submit an 

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

•HR 2124 IH 

1 and containing such information and assurances as the 

2 Director may require. 

3 (d) AUTHORIZATION OF APPROPRIATIONS.—To carry 

4 out this section, there is authorized to be appropriated 

5 $25,000,000 for the period of fiscal years 2006 through 

6 2010. 

Æ