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What is the role of NIH and NHLBI in clinical research?

The National Institutes of Health ( NIH ) of the Department of Health and Human Services ( DHHS ) has played a vital role in clinical research. In 1930, the Ransdell Act transformed the Public Health Service’s ( PHS ) Hygienic Laboratory into the National Institute of Health. The Act authorized the establishment of research fellowships in both basic science and medical research and represented a turning point in the public funding of medical research. Interesting historical information can be found in A Short History of the National Institutes of Health. Today, the NIH is composed of numerous Institutes and Centers and supports the largest number of clinical trials of any governmental agency.

The National Heart, Lung and Blood Institute( NHLBI ) was established as the National Heart Institute, its primary purpose was to lead the nation’s research program in heart disease. In 1972, the National Heart, Blood Vessel, Lung, and Blood Act mandated an expanded program to address all aspects of heart disease, including high blood pressure, elevated cholesterol levels, stroke, and particular blood diseases such as sickle-cell anemia. NHLBI has carried out many of the largest and most complex observational cohort studies involving thousands of patients with decades of follow-up.

Clinical research is a complex undertaking in which policies and procedures emerge and change frequently. Clinical research may involve many organizations outside of NHLBI, such as the FDA , OHRP , DHHS, and CMS . DHHS regulations (45 CFR 46) apply to research funded in whole or part by DHHS. FDA regulations (21 CFR 50 and 21 CFR 56) apply to research involving products regulated by FDA. Some clinical research funded by NHLBI may be subject to both sets of regulations.

Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov

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