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  1.  27
    Why Is Therapeutic Misconception So Prevalent?Charles W. Lidz, Karen Albert, Paul Appelbaum, Laura B. Dunn, Eve Overton & Ekaterina Pivovarova - 2015 - Cambridge Quarterly of Healthcare Ethics 24 (2):231-241.
    Abstract:Therapeutic misconception (TM)—when clinical research participants fail to adequately grasp the difference between participating in a clinical trial and receiving ordinary clinical care—has long been recognized as a significant problem in consent to clinical trials. We suggest that TM does not primarily reflect inadequate disclosure or participants’ incompetence. Instead, TM arises from divergent primary cognitive frames. The researchers’ frame places the clinical trial in the context of scientific designs for assessing intervention efficacy. In contrast, most participants have a cognitive frame (...)
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  2.  33
    Reliance agreements and single IRB review of multisite research: Concerns of IRB members and staff.Charles W. Lidz, Ekaterina Pivovarova, Paul Appelbaum, Deborah F. Stiles, Alexandra Murray & Robert L. Klitzman - 2018 - AJOB Empirical Bioethics 9 (3):164-172.
    The new National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research was adopted primarily to simplify and speed the review of complex multisite clinical trials. However, speeding review requires overcoming a number of obstacles. Perhaps the most substantial obstacle is the time and effort needed to develop reliance agreements among the participating sites. We conducted 102 semistructured interviews with sIRB personnel, including directors, chairs, reviewers, and staff, from 20 IRBs that (...)
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    Reducing the Single IRB Burden: Streamlining Electronic IRB Systems.Alexandra Murray, Ekaterina Pivovarova, Robert Klitzman, Deborah F. Stiles, Paul Appelbaum & Charles W. Lidz - 2021 - AJOB Empirical Bioethics 12 (1):33-40.
    Electronic institutional review board systems (eIRBs) have become an integral component in ensuring compliance with Human Research Protection Program (HRPP) and IRB requirements. Despite this, few of these systems are configured to administer the single IRB (sIRB) process mandated by the National Institutes of Health (NIH) for multisite research. We interviewed 103 sIRB administrators, chairs, members, and staff members about their experiences with sIRB multisite research review. We observed three main obstacles to adapting existing eIRB systems to accommodate the sIRB (...)
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