Short title

This Act may be cited as the

Clinical Research Act of 2005

Findings

The Congress finds the following: (1)Strong academic health centers are essential to a vigorous clinical research enterprise. (2)Breakthroughs in basic biomedical sciences over the past 5 decades have provided an unprecedented supply of information for improving human health and preventing disease. (3)Translating the information gained through these basic discoveries into knowledge that will impact clinical practice and ultimately human health requires strong clinical research institutions. (4)The enhancement of clinical research career programs and opportunity will sustain the momentum of the discovery, development, and delivery of important health advances. (5)Without a sound infrastructure to accomplish this translation in a systematic and coherent way, the sum of data and information produced by the basic science enterprise will not result in tangible public benefit. (6)The clinical research environment is increasingly encumbered by incompatible databases, shortage of qualified investigators, rising costs, inadequate funding, and mounting unreimbursed regulatory burdens such as human subject research protections and additional record-keeping requirements under the Health Insurance Portability and Accountability Act of 1996.

Definitions

In this Act: (1)The term clinical research means— (A)patient-oriented clinical research conducted with human subjects; (B)research on the causes and consequences of disease in human populations involving material of human origin (such as tissue specimens and cognitive phenomena) for which an investigator or colleague directly interacts with human subjects in an outpatient or inpatient setting to clarify a problem in human physiology, pathophysiology or disease; (C)epidemiologic or behavioral studies; (D)outcomes research; (E)health services research; or (F)development of new technologies, therapeutic interventions, or clinical trials. (2)The term Director means the Director of the National Institutes of Health. (3)The term eligible academic health center means an academic institution and an affiliated teaching hospital, a teaching hospital, an independent research institute, or a consortium of research institutions which conduct clinical research and receive funds from the Department of Health and Human Services for basic, applied, or clinical biomedical or behavioral research in the fields of dentistry, medicine, and nursing. (4)The term Secretary means the Secretary of Health and Human Services.

Clinical investigator advancement grants

(a)

Authorization

For the purposes described in subsection (b), the Director shall make a clinical investigator advancement grant in the amount determined under subsection (d) to each eligible academic health center that submits an application in accordance with this section. (b)

Purposes

A grant under this section to an eligible academic health center shall be used only for the following purposes: (1)To establish career development programs for new and mid-level clinician-investigators who are fully committed to academic clinical research careers. (2)To support the translation of basic science to patient care by implementing and conducting all aspects of their clinical research mission. (3)To support activities leading to innovative ways to meet the purposes described in paragraphs (1) and (2) in an efficient and cost effective manner. (c)

Career development programs

(1)

Use of funds

In implementing a career development program under subsection (b)(1), the Director may conduct or support activities to provide financial assistance and other support to— (A)young clinical researchers receiving peer-reviewed grants who wish to make the transition to research independence; (B)experienced scientists who wish to broaden their scientific capabilities; and (C)other medical personnel who are critical to the conduct of clinical research activities. (2)

Salary cap

Notwithstanding paragraph (1), no funds under this section may be used to increase the rate of pay of an individual to a rate greater than the rate of basic pay for level I of the Executive Schedule. (d)

Allocation

Of the amount appropriated to carry out this section for a fiscal year, the Director shall allocate such appropriated amount among the eligible academic health centers receiving a grant under this section in an amount that bears the same relation to such appropriated amount as the investment in clinical research of the grantee involved bears to the total investment in clinical research of all eligible grantees under this section. (e)

Applications

To seek a grant under this section, an eligible academic health center shall submit an application to the Director in such manner, at such time, and containing such information and assurances as the Director may require. (f)

Reports

The Director shall require each recipient of a grant under this section to submit an annual report to the Director detailing how the recipient has used the grant to meet the purposes described in subsection (b). (g)

Authorization of Appropriations

To carry out this section, there is authorized to be appropriated $40,000,000 for each of the fiscal years 2006 through 2010.

Clinical research infrastructure grants

(a)

Authorization

The Director shall make clinical research infrastructure grants on a competitive basis to eligible academic health centers. (b)

Use of Funds

The Director may not make a grant to an eligible academic health center under this section unless the center agrees to use the grant only for the following: (1)Fostering the use of information technology to facilitate the transformation of basic research findings on disease mechanisms into the development of new methodologies for diagnosis, therapy, and prevention. (2)Addressing the many obstacles impeding the expeditious application of new science, such as— (A)a lack of up-to-date information technology systems; (B)incompatible databases; (C)a lack of connectivity between academic health centers, teaching hospitals, and independent research institutes; (D)the absence of a coordinated strategy to enhance public understanding of, support for, and participation in clinical research; and (E)the underrepresentation of some populations in clinical research. (3)Sharing clinical research infrastructure across academic health centers to enable and facilitate cross-center clinical research collaborations. (c)

Reports

The Director shall require each recipient of a grant under this section to submit an annual report to the Director detailing how the recipient has used the grant to meet the objectives described in subsection (b). (d)

Applications

Authorization of Appropriations

To carry out this section, there is authorized to be appropriated $125,000,000 for each of fiscal years 2006 through 2010.

Demonstration program on partnerships in clinical research

(a)

Grants

The Secretary may make grants to not more than 5 eligible academic health centers to form partnerships between the center involved and health care providers for carrying out clinical human subject research for the purpose of demonstrating how academic research centers may collaborate with the practicing health care community in such research. (b)

Maximum Amount

The Secretary may not make a grant to any eligible academic health center under this section in an amount that is greater than $5,000,000. (c)

Applications

Authorization of Appropriations

To carry out this section, there is authorized to be appropriated $25,000,000 for the period of fiscal years 2006 through 2010.