109th Congress

Clinical Research Act

H.R. 2124, H.R. 2308, S. 1543

Background

Representative Dave Weldon (R-FL) and Senator Rick Santorum (R-PA) introduced this legislation in order to speed the translation of research advances at academic health centers (AHCs) to patient care. AHCs, which consist of medical schools and their affiliated educational and clinical institutions, have a long and distinguished history of providing leadership to the Nation in enhancing the health of both their communities and the larger society. AHCs have specialized capabilities, and the services they provide distinguish them from other health care entities. They assume a major role in the conduct of biomedical research, education of health care professionals, training of biomedical investigators, delivery of cutting-edge and high-technology medical services, assessment and treatment of patients with rare disorders and highly complex conditions, provision of continuous innovation in patient care, and delivery of most of the care provided to poor and uninsured patients in their communities.

Provisions of the Legislation/Impact on NIH

Section 4 of the legislation would require the Director of the National Institutes of Health (NIH) to award Clinical Investigator Advance Grants to eligible AHCs. The purpose of the grants would be to establish career development programs for new and mid-level clinician-investigators and support the translation of basic science to patient care. The Director would also be authorized to implement career development programs to provide financial assistance to young clinical research grantees to become independent researchers, experienced scientists who want to broaden their scientific capabilities, and other medical personnel essential to the conduct of clinical research activities. To carry out these programs, $40 million would be authorized for fiscal years (FYs) 2006 through 2010.

Section 5 of the legislation would authorize the Director of NIH to award clinical research infrastructure grants to eligible AHCs. The purpose of the grants would be to foster the use of information technology to facilitate the translation of research findings to methodologies for diagnosis, therapy, and prevention; address obstacles to the expeditious application of new science; and share the clinical research infrastructure across AHCs in the support of cross-center clinical research collaborations. The Senate version has an additional provision that the grants would be used to devise, deploy, and support new technologies that facilitate clinical investigators' ability to improve the safety of human subjects in clinical research, ensure the confidentiality of research data, and streamline the regulatory processes to ensure better compliance for clinical research. A total of $125 million would be authorized for each of the FYs 2006 through 2010.

Section 6 of the legislation would authorize the Secretary of Health and Human Services to award grants to no more than five eligible AHCs to establish partnerships between each center and health care providers for the conduct of clinical trials. The purpose of the grants would be to demonstrate how AHCs can collaborate with the practicing health care community. The legislation stipulates that the Secretary may not make an award of more than $5 million. In order to carry out this provision, $25 million would be authorized for FYs 2006 through 2010.

Status and Outlook

H.R. 2124 was introduced by Representative Weldon on May 5, 2005, and was referred to the House Committee on Energy and Commerce. No further action has occurred on this legislation.

H.R. 2308 was introduced by Representative Weldon on May 11, 2005, and was referred to the House Committee on Energy and Commerce. H.R. 2308 and H.R. 2124 are identical. Representative Weldon reintroduced the bill so that he could add Representative Mike Doyle (D-PA) as an original cosponsor. No further action has occurred on this legislation.

S. 1543 was introduced by Senator Santorum on July 28, 2005, and was referred to the Senate Committee on Health, Education, Labor and Pensions. No further action has occurred on this legislation.