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    Safety Monitoring and Withdrawal of Psychiatric Research Participants

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    Authors
    Pivovarova, Ekaterina
    Candilis, Philip J.
    UMass Chan Affiliations
    Systems and Psychosocial Advances Research Center
    Department of Psychiatry
    Document Type
    Book Chapter
    Publication Date
    2014-12-01
    Keywords
    Bioethics and Medical Ethics
    Clinical Psychology
    Psychiatry
    Psychiatry and Psychology
    
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    Link to Full Text
    http://dx.doi.org/10.1093/oxfordhb/9780198732372.013.14
    Abstract
    This chapter examines how clinical investigators ensure the safety of psychiatric research participants while maintaining the integrity of research protocols. It discusses the ethical issues arising from data monitoring, disclosure of interim data, and termination of clinical trials. It outlines unique features of psychiatric research and related cultural issues that may warrant consideration before and during clinical trials. It focuses on the Data Safety Monitoring Boards (DSMBs) overseeing clinical trials their development of detailed plans for monitoring safety and protocol adherence. It looks at the use of statistical programs by DSMBs to document the progression of research studies and make early termination decisions; whether DSMBs actually improve the safety of participants or the integrity of research; how independent DSMBs are; and the factors that DSMBs consider when terminating a trial. Cultural issues involved in clinical trials and challenges that may compromise the neutrality and function of DSMBs are analyzed.
    Source

    Pivovarova, E. & Candilis, P. J. (2014). Safety monitoring and withdrawal of psychiatric research participants. In: Oxford Handbook of Psychiatric Ethics. New York: Oxford Press. doi:10.1093/oxfordhb/9780198732372.013.14

    DOI
    10.1093/oxfordhb/9780198732372.013.14
    Permanent Link to this Item
    http://hdl.handle.net/20.500.14038/45514
    ae974a485f413a2113503eed53cd6c53
    10.1093/oxfordhb/9780198732372.013.14
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