On the Alleged Right to Participate in High-Risk Research.

Reigning regulatory frameworks for biomedical research impose on researchers and research ethics committees an obligation to protect research participants from risks that are unnecessary, disproportionate to potential research benefits, and non-minimized. Where the research has no potential to produ...

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Publicado en:Bioethics Vol. 29; no. 7; pp. 451 - 462
Autor principal: Różyńska, Joanna
Formato: Journal Article
Publicado: Wiley-Blackwell Sep2015
Acceso en línea:Ver este registro en EBSCOhost
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        atl: On the Alleged Right to Participate in High-Risk Research.
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        au: Różyńska, Joanna
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        subj:
          Consent (Research) Ethical Issues
          Research Subjects
          Volunteer Workers
          Autonomy
          Research Ethics
          Risk Assessment
          Institutional Review
          Truth Disclosure
      ab: Reigning regulatory frameworks for biomedical research impose on researchers and research ethics committees an obligation to protect research participants from risks that are unnecessary, disproportionate to potential research benefits, and non-minimized. Where the research has no potential to produce results of direct benefit to the subjects and the subjects are unable to give consent, these requirements are strengthened by an additional condition, that risks should not exceed a certain minimal threshold. In this article, I address the question of whether there should be limits of permissible risks in non-therapeutic research involving competent and healthy subjects. Some commentators argue that competent and informed individuals should have a right to participate even in extremely risky research and that research ethics committees should never reject studies because they are too dangerous. To use David Shaw's expression, competent volunteers should have 'a right to participate in high-risk research'. I argue that this idea is ill-founded, as it does not take into account the social mission and complex collaborative nature of research practice as well as the inequity of power between researchers and subjects. Imposition of limits on permissible risks for healthy volunteers is justified by the need to protect research enterprise and the need to protect the weaker party, namely the subjects. Also, I suggest that the best way to set boundaries on research risks is to leave the judgment of risk acceptability to research ethics committees.
      pubtype: Academic Journal
      doctype: Journal Article
      ougenre: Article
    language: English
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