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[Tasks, regulations, and functioning of ethics committees].

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  • معلومة اضافية
    • Transliterated Title:
      Aufgaben, Regularien und Arbeitsweise von Ethikkommissionen.
    • المصدر:
      Publisher: Springer Country of Publication: Germany NLM ID: 101181368 Publication Model: Print Cited Medium: Internet ISSN: 1437-1588 (Electronic) Linking ISSN: 14369990 NLM ISO Abbreviation: Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz Subsets: MEDLINE
    • بيانات النشر:
      Original Publication: Berlin : Springer,
    • الموضوع:
      Ethics Committees* ; Research*; Germany
    • نبذة مختصرة :
      Our constitutional order provides comprehensive protection of the freedom of scientific research; any interference with this freedom requires justification. With regard to the obligatory involvement of ethics committees in the research process, this justification is based on a careful balancing of scientific freedom on one hand and the legal interests of study participants, such as the protection of life, health, and self-determination, on the other. How this is achieved, and with what results, is shown below for two areas. The first of these are clinical trials in pharmaceutical and medicinal product law, which are subject to extensive regulations regarding the involvement of ethics committees. Following the amendments at European level, this area has been comprehensively restructured, in particular with regard to the function and importance of ethics committees. Subsequently, the role of ethics committees in university research is discussed as far as this research is not regulated by the German Medicines Act (AMG) and the German Act on Medical Devices (MPG), but instead is mostly subject to university self-government. It is shown, using statistics as an example, that a line must be drawn between legitimate control of scientific research and a sweeping "ethicization" of science. To conclude, this very boundary is examined from a philosophical perspective.
    • Contributed Indexing:
      Keywords: Clinical trials; Freedom of scientific research; Pharmaceutical law; Statistics; University self-government
    • الموضوع:
      Date Created: 20190504 Date Completed: 20190917 Latest Revision: 20190917
    • الموضوع:
      20240628
    • الرقم المعرف:
      10.1007/s00103-019-02945-7
    • الرقم المعرف:
      31049625