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  1. How local IRBs view central IRBs in the US.Robert Klitzman - 2011 - BMC Medical Ethics 12 (1):13.
    Background: Centralization of IRB reviews have been increasing in the US and elsewhere, but many questions about it remain. In the US, a few centralized IRBs (CIRBs) have been established, but how they do and could operate remain unclear. Methods: I contacted 60 IRBs (every fourth one in the list of the top 240 institutions by NIH funding), and interviewed leaders from 34 (response rate = 55%) and an additional 12 members and administrators. Results: These interviewees had often interacted with (...)
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  • The IRB's Monitoring Function: Four Concepts of Monitoring.Erica J. Heath - 1979 - IRB: Ethics & Human Research 1 (5):1.
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  • Us irbs confronting research in the developing world.Robert L. Klitzman - 2012 - Developing World Bioethics 12 (2):63-73.
    Increasingly, US-sponsored research is carried out in developing countries, but how US Institutional Review Boards (IRBs) approach the challenges they then face is unclear.METHODS: I conducted in-depth interviews of about 2 hours each, with 46 IRB chairs, directors, administrators and members. I contacted the leadership of 60 IRBs in the United States (US) (every fourth one in the list of the top 240 institutions by National Institutes of Health (NIH) funding), and interviewed IRB leaders from 34 (55%).RESULTS: US IRBs face (...)
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  • Monitoring Clinical Research: An Obligation Unfulfilled.Charles Weijer, Stanley Shapiro, Abraham Fuks, Kathleen Cranley Glass & Myriam Skrutkowska - unknown
    The revelation that data obtained for the US-based National Surgical Adjuvant Breast and Bowel Project (NSABP) from subjects enrolled at Hôpital Saint-Luc in Montreal was falsified has eroded public trust in research. Institutions can educate researchers and help prevent unethical research practices by establishing procedures to monitor research involving human subjects. Research monitoring encompasses four categories of activity: annual reviews of continuing research, monitoring of informed consent, monitoring of adherence to approved protocols and monitoring of the integrity of data. The (...)
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  • The IRB paradox: Could the protectors also encourage deceit?Patricia Keith-Spiegel & Gerald P. Koocher - 2005 - Ethics and Behavior 15 (4):339 – 349.
    The efforts of some institutional review boards (IRBs) to exercise what is viewed as appropriate oversight may contribute to deceit on the part of investigators who feel unjustly treated. An organizational justice paradigm provides a useful context for exploring why certain IRB behaviors may lead investigators to believe that they have not received fair treatment. These feelings may, in turn, lead to intentional deception by investigators that IRBs will rarely detect. Paradoxically, excessive protective zeal by IRBs may actually encourage misconduct (...)
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