Federal human research oversight of clinical trials in the United States.

Abstract

Federal HumanResearchOversight of Clinical Trials in the United States The primary federal human subjects protections (HSP) policies in the United States, including requirements for institutional review board review and informed consent, are the US FoodandDrugAdministration (FDA)HSP regulations1 and the CommonRule.2 The first covers FDA-regulated clinical investigations of drugs, biologics, and devices, regardless of funding source, whereas the second applies to human studies funded or conducted by 17 federal entities, regardless of the typeof interventionstudied.These regulationsare largely consistent but contain differences. Concerns have been raised about burdens and inefficiencies for studies covered by both regulations (overlap trials),3 and about some studies that are covered by neither (gap trials).4 To inform such discussions, weestimatedthenumbersofactiveUS-basedclinical trials subject to these regulations.

DOI: 10.1001/jama.2013.284306

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Cite this paper

@article{Zarin2014FederalHR, title={Federal human research oversight of clinical trials in the United States.}, author={Deborah A. Zarin and Tony Tse and Jerry Menikoff}, journal={JAMA}, year={2014}, volume={311 9}, pages={960-1} }