Replacing Surrogate Decision-Making with Supported Decision-Making for Minimal Risk Research.

We advocate for a change in the way individuals with cognitive impairment are enrolled in minimal risk clinical research. We do so in the hope that such a change will lead to more cognitively impaired individuals being enrolled in research. Our proposal applies only to cases where would-be participa...

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Publicado en:Journal of Law, Medicine & Ethics Vol. 54; no. 2; pp. 94 - 103
Autores principales: Hawkins, Jennifer, Segal, Aaron Eli, Wendler, David, Howard, Dana
Formato: questions and answers Journal Article
Publicado: Cambridge University Press Summer2026
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Summer2026
      vid: 54
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      pub: Cambridge University Press
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        10.1017/jme.2025.10192
        194133290
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        atl: Replacing Surrogate Decision-Making with Supported Decision-Making for Minimal Risk Research.
      aug:
        au:
          Hawkins, Jennifer
          Segal, Aaron Eli
          Wendler, David
          Howard, Dana
        affil: Department of Philosophy, Duke University, United States
      sug:
        subj:
          Cognition Disorders
          Research, Medical
          Research Subjects
          Decision Making
          Research Subject Recruitment
          Consent (Research)
          Research Ethics
          Patient Autonomy
      ab: We advocate for a change in the way individuals with cognitive impairment are enrolled in minimal risk clinical research. We do so in the hope that such a change will lead to more cognitively impaired individuals being enrolled in research. Our proposal applies only to cases where would-be participants retain some interest in decision-making as well as the ability to express a decision. In these cases, we argue that the common practice whereby researchers either obtain consent from the individual or consent from a surrogate and assent from the individual, is ethically unnecessary. Instead, a process of facilitated decision-making based on SDM (supported decision-making) should be employed. Although it is possible that this process of facilitation will enable some individuals to make a capacitated choice who would not otherwise have done so, this should not be a requirement of getting to choose. In those cases where a would-be participant, despite support, fails to make a capacitated choice, the individual should still have the final say about participation. In this respect, our proposal deviates from standard practice. However, we argue that our proposal offers participants as much ethical protection as the more common procedures involving surrogates.
      pubtype: Academic Journal
      doctype:
        questions and answers
        Journal Article
      ougenre: Article
    language: English
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