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Sökning: hsv:(SAMHÄLLSVETENSKAP) hsv:(Juridik) > Medicin och hälsovetenskap > Johansson Mats

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  • Broström, Linus, et al. (författare)
  • Strict Ethics Regulation Without Appropriate Institutional Implementation Won’t Protect Decisionally Incapacitated Research Subjects: Lessons fom Sweden
  • 2015
  • Konferensbidrag (refereegranskat)abstract
    • The standard requirement of informed consent cannot be met when potential research subjects are decisionally incapacitated due to e.g. dementia, intellectual disabilities, or other mental health problems. Such research subjects are generally recognized as being in need of special protection, particularly when the relevant research cannot be expected to benefit the participating individuals themselves. Consequently international regulation and guidelines, such as the European Council’s Convention on Human Rights and Biomedicine or the Declaration of Helsinki, as well as national legislation in many countries, allow for research enrollment of the decisionally incapacitated only under certain (seemingly) strict conditions. However, the protection of vulnerable research subjects is not stronger than the weakest link in the legal and institutional chain. In this presentation we shall illustrate this worry with findings from an ongoing study on how Ethical Review Boards in Sweden have handled issues about decisional capacity, risk-benefit analyses, surrogate decision-making and more. We end with a few suggestions on how efforts to strengthen the protection of incapacitated research subjects should target the implementation of protective provisions.
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