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A University’s Clinical Trial Oversight Practices are Skewered

Discussion in 'Other Health News and Research' started by Kati, Apr 21, 2015.

  1. Kati

    Kati Patient in training

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    This may be of interest to those who are looking at the 'science' (or lack of) behind psychiatry, and how medical ethics may not be protecting patients especially in regards to

    http://blogs.wsj.com/pharmalot/2015...nical-trial-oversight-practices-are-skewered/

    Exerpt:

    [​IMG]
    Corbis
    A widely anticipated report about clinical trial oversight at the University of Minnesota found that its institutional ethics committee lacks expertise to review study protocols and its policies must be upgraded to protect study participants. Moreover, the report also cited a “culture of fear” in the university psychiatry department, which first triggered concerns about clinical trial practices.

    “The university’s efforts with regard to human subjects protections do not consistently reflect ‘best practices’ and are not, at this point, ‘beyond reproach,’ “ according to the Association for the Accreditation of Human Research Protection Programs, a non-profit that accredits research programs at various organizations and was retained by the university to review procedures for running clinical trials.

    “There are significant problems with core functions of the human research protections program, including Institutional Review Board review, investigator education, practices related to consent to research, and the effective coordination of administrative oversight, clinical care, and research,” the non-profit concludes.

    “Given the history of concern and scrutiny of its programs, the university leadership should have taken more informed and affirmative steps to identify and address deficiencies, particularly within the Department of Psychiatry.” The non-profit noted department faculty and staff discussed “intimidation by researchers and fear of retaliation” if they complained of practices.
     
    Esther12, Roy S, Sean and 5 others like this.
  2. Esther12

    Esther12 Senior Member

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    The faith some people have in systems like this is worrying.
     
    *GG* and Valentijn like this.

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