When Is Social Value Proportionate to Research Risks?

Ethical human subjects research must have an acceptable risk‐benefit ratio, which requires that the net risks participants face be proportionate to the research's social value. Yet existing scholarship does not explain what makes risks proportionate to social value. Here, I distinguish internal and...

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Publicado en:Bioethics Vol. 40; no. 7; pp. 707 - 717
Autor principal: Steel, Robert
Formato: Artículo
Publicado: Wiley-Blackwell Sep2026
Materias:
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Sep2026
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      pub: Wiley-Blackwell
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        atl: When Is Social Value Proportionate to Research Risks?
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        au: Steel, Robert
        affil: Clinical Center Department of Bioethics, US National Institutes of Health, Bethesda Maryland, , USA
      su:
        Human research subjects
        Bioethics
        Decision making
        Medical research
        Social values
        Research ethics
        Safety
        Risk assessment
        Institutional review boards
        Ethics committees
        COVID-19
      sug:
        subj:
          Human research subjects
          Bioethics
          Decision making
          Medical research
          Social values
          Research ethics
          Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
          Safety
          Risk assessment
          Institutional review boards
          Ethics committees
          COVID-19
      keyword:
        proportionality
        research ethics
        risk‐benefit assessment
        risk‐benefit ratio
        social value
        proportionality
        research ethics
        risk‐benefit assessment
        risk‐benefit ratio
        social value
      ab: Ethical human subjects research must have an acceptable risk‐benefit ratio, which requires that the net risks participants face be proportionate to the research's social value. Yet existing scholarship does not explain what makes risks proportionate to social value. Here, I distinguish internal and external senses of proportionality and argue that it is internal proportionality that is the proper object of IRB/REC review. I propose understanding internal proportionality in terms of a literal ratio of expected health effects; I also argue against the alternative of attempting to assess proportionality through intuitive comparisons. I illustrate the potential implications of this account through a discussion of the proposal to engage in controlled human infection studies with the novel coronavirus. This case highlights that trials with enormous numbers of potential beneficiaries can be internally proportional even when they are very unlikely to succeed.
      pubtype: Academic Journal
      doctype: Article
      src: R
    language: English
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