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Institutional review board : management and function
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ISBN: 0763730491 9780763730499 Year: 2006 Publisher: Sudbury, Mass.: Jones and Bartlett,

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Information sheet : guidance for institutional review boards and clinical investigators (sponsor - investigator - IRB interrelationship).
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Year: 1998 Publisher: [Rockville, MD] : [U.S. Dept. of Health and Human Services, Food and Drug Administration],

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Information sheet guidance for sponsors, clinical investigators, and IRBs : frequently asked questions, statement of investigator (form FDA 1572).
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Year: 2008 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration,

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Institutional review boards in the U.S.-México border : current protocols and practices.
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Year: 2010 Publisher: [Washington, D.C.?] : United States-México Border Health Commission,

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Information sheet : guidance for institutional review boards and clinical investigators (cooperative research)
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Year: 1998 Publisher: [Rockville, MD] : [U.S. Dept. of Health and Human Services, Food and Drug Administration],

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Final report on low-volume institutional review boards.
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Year: 1998 Publisher: [Washington, D.C.] : Department of Health and Human Services, Office of Inspector General,

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Final report on low-volume institutional review boards.
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Year: 1998 Publisher: [Washington, D.C.] : Department of Health and Human Services, Office of Inspector General,

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Book
Information sheet guidance for sponsors, clinical investigators, and IRBs : frequently asked questions, statement of investigator (form FDA 1572).
Author:
Year: 2008 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration,

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Regulating human research : IRBs from peer review to compliance bureaucracy
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ISBN: 150361123X 9781503611238 9781503610149 1503611221 9781503611221 Year: 2020 Publisher: Stanford, California : Stanford University Press,

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Institutional review boards (IRBs) are panels charged with protecting the rights of humans who participate in research studies ranging from biomedicine to social science. Regulating Human Research provides a fresh look at these influential and sometimes controversial boards, tracing their historic transformation from academic committees to compliance bureaucracies: non-governmental offices where specialized staff define and apply federal regulations. In opening the black box of contemporary IRB decision-making, author Sarah Babb argues that compliance bureaucracy is an adaptive response to the dynamics and dysfunctions of American governance. Yet this solution has had unforeseen consequences, including the rise of a profitable ethics review industry.


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Information sheet : guidance for institutional review boards and clinical investigators (use of investigational products when subjects enter a second institution).
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Year: 1998 Publisher: [Rockville, MD] : [U.S. Dept. of Health and Human Services, Food and Drug Administration],

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