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Protection of human participants in health research - a comparison of some US Federal Regulations and South African Research Ethics guidelines

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اقرأ أكثر حفظ في قائمتي
  • المؤلفون: Cleaton-Jones, P; Wassenaar, D
  • المصدر:
    South African Medical Journal; Vol 100, No 11 (2010); 710,712-716 ; 2078-5135 ; 0256-9574
  • الموضوع:
    Bioethics; research ethics
  • نوع التسجيلة:
    article in journal/newspaper
    review
  • اللغة:
    English
  • معلومة اضافية
    • Contributors:
      not applicable
    • بيانات النشر:
      South African Medical Association
    • الموضوع:
      2010
    • Collection:
      South African Medical Journal (SAMJ)
    • الموضوع:
      South Africa; Not applcable
    • الموضوع:
      1966 to 010
    • نبذة مختصرة :
      In response to criticism of ethical review of a South African clinical trial, we contrast aspects of the United States Common Rule with South African research ethics requirements. In the USA the Common Rule does not apply to all health research and allows many exemptions from ethics review and waivers of informed consent. At a structural level research ethics review in South Africa is in many cases equivalent to the US institutional review board (IRB) and Office for Human Research Protections (OHRP) oversight system, is wider reaching, and has no exclusions.
    • File Description:
      application/pdf
    • Relation:
      http://samj.org.za/index.php/samj/article/view/4525/2993; http://samj.org.za/index.php/samj/article/view/4525
    • الرقم المعرف:
      10.7196/SAMJ.4525
    • الدخول الالكتروني :
      http://samj.org.za/index.php/samj/article/view/4525
      https://doi.org/10.7196/SAMJ.4525
    • Rights:
      Copyright of published material remains in the Authors’ name. This allows authors to use their work for their own non-commercial purposes without seeking permission from the Publisher, subject to properly acknowledging the Journal as the original place of publication. Authors are free to copy, print and distribute their articles, in full or in part, for teaching activities, and to deposit or include their work in their own personal or institutional database or on-line website. Authors are requested to inform the Journal/Publishers of their desire/intention to include their work in a thesis or dissertation or to republish their work in any derivative form (but not for commercial use). Material submitted for publication in the SAMJ is accepted provided it has not been published or submitted for publication elsewhere. Please inform the editorial team if the main findings of your paper have been presented at a conference and published in abstract form, to avoid copyright infringement.
    • الرقم المعرف:
      edsbas.3944E3D9