[Polarization in activities of ethics committees].

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  • Author(s): Zemcíková A;Zemcíková A; Strnadová V
  • Source:
    Casopis lekaru ceskych [Cas Lek Cesk] 2012; Vol. 151 (2), pp. 83-7.
  • Publication Type:
    English Abstract; Journal Article
  • Language:
    Czech
  • Additional Information
    • Transliterated Title:
      Problematika cinnosti etických komisí v Ceské republice.
    • Source:
      Publisher: Ceskoslovenska Lekarska Spolecnost Country of Publication: Czech Republic NLM ID: 0004743 Publication Model: Print Cited Medium: Print ISSN: 0008-7335 (Print) Linking ISSN: 00087335 NLM ISO Abbreviation: Cas Lek Cesk Subsets: MEDLINE
    • Publication Information:
      Original Publication: Praha : Ceskoslovenska Lekarska Spolecnost
    • Subject Terms:
      Ethics Committees, Clinical/*organization & administration; Czech Republic ; Data Collection ; Humans
    • Abstract:
      Background: The goal of this work was to acquire data concerning characteristics, ways of assessing presented documentation, publishing attitudes and other related activities of ethics committees established according to the Act No. 378/2007 Coll., on Pharmaceuticals, and to use evaluated data subsequently for mapping actual state of assessing clinical trial projects with emphasis to observance of legislation, as well as description of differences between individual ethics committees.
      Methods and Results: An on-line questionnaire, comprised of 36 questions, was filled in by 66 ethics committees. That is 64% out of 104 approached active ethics committees. All participating ethics committees continue working in 2011. 74% of the ethics committees work in accordance with the legislation. 62% ethics committees also apply ethical recommendations above the scope of law and only 26% ethics committees break some part of the legislation.
      Conclusions: Being able to focus only on a formal part of ethics committees' activity, it is possible to say that individual ethics committees differ from each other particularly in the general characteristics, conditions made for their work and in some trial aspect, but it doesn't automatically mean serious law breach and the immediate need of rectification. It seems that not all members of ethics committees realize adequately the seriousness of their actions from the ethical point of view at current research done with human subjects.
    • Publication Date:
      Date Created: 20120421 Date Completed: 20120515 Latest Revision: 20120420
    • Publication Date:
      20231215
    • Accession Number:
      22515014