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Hottenstein, Kristi N. – Journal of Research Administration, 2018
The United States is a world leader in biomedical clinical research. America's existing human subject research regulations structure affords sizable protections for the ethical treatment of research volunteers. Early initiatives such as the Belmont Report were specific to federally funded research. Over the past several decades guidelines such as…
Descriptors: Guidelines, Governing Boards, Research Administration, Volunteers
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Mounce, Doug; Curci, Frank X.; Fortenbery, Joshua B. – Journal of Research Administration, 2016
What liability is associated with assuming the role of the "sponsor" in a clinical trial? This article discusses the Food and Drug Administration (FDA) regulations governing sponsorship, and how courts have interpreted those regulations in cases with a claim of injury. There is a natural concern with the responsibility implied by…
Descriptors: Public Agencies, Pretesting, Federal Regulation, Donors