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

The National Institutes of Health ( NIH 

National Institutes of Health (NIH)
the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage.
) of the Department of Health and Human Services ( DHHS 
Department of Health and Human Services (DHHS)
the United States government's principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. (also known as HHS) Department of Health and Human Services Homepage
) has played a vital role in clinical research.  In 1930, the Ransdell Act transformed the Public Health Service’s ( PHS 
Public Health Service (PHS)
governmental division comprised of agencies related to health and human services such Agency for Healthcare Research and Quality (AHRQ), Centers for Medicare & Medicaid Services ( CMS ), Food and Drug Administration (FDA), and National Institutes of Health (NIH) to name a few. DHHS Homepage
) 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 

National Heart, Lung, Blood Institute (NHLBI)
a NIH Institute that provides leadership for a national program in diseases of the heart, lung, and blood as well as blood resources, sleep disorders and the Woman's Health Initiative. NHLBI Homepage.
) 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 

Food and Drug Administration (FDA)
is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. Food and Drug Administration Homepage
, OHRP 
Office for Human Research Protections (OHRP)
HHS office overseeing human subject protection for HHS-supported research. OHRP protects the rights, welfare, and well-being of subjects involved in research conducted or supported by HHS and helps ensure that such research is carried out in accordance with the regulations described in 45 CFR 46. OHRP Homepage.
, DHHS, and CMS 
Centers for Medicare and Medicaid Services (CMS)
a federal agency under DHHS 
Health and Human Services(HHS)
a federal government department to which NIH belongs whose mission is to protect the health of Americans and provide essential human services. Also referred to as Department of Health and Human Services (DHHS). HHS Homepage.
that administers the Medicare program, partners with states to administer Medicaid, surveys and certifies health care facilities and regulates all laboratory testing. CMS Homepage
.  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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