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When Is Social Value Proportionate to Research Risks?

Robert Steel1

  • 1Clinical Center Department of Bioethics, US National Institutes of Health, Bethesda, Maryland, USA.

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Summary

Ethical research requires risks to be proportionate to social value. This study defines internal proportionality based on expected health effects, offering a framework for Institutional Review Boards/Research Ethics Committees (IRBs/RECs) to assess research ethics.

Keywords:
proportionalityresearch ethicsrisk‐benefit assessmentrisk‐benefit ratiosocial value

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Area of Science:

  • Bioethics
  • Research Ethics
  • Human Subjects Research

Background:

  • Ethical human subjects research necessitates an acceptable risk-benefit ratio, where participant risks are proportionate to the research's social value.
  • Current scholarship lacks a clear explanation of how to determine proportionality between risks and social value in research.
  • Institutional Review Boards/Research Ethics Committees (IRBs/RECs) are tasked with evaluating this proportionality.

Purpose of the Study:

  • To distinguish between internal and external senses of proportionality in research ethics.
  • To propose a framework for assessing internal proportionality, defining it as a literal ratio of expected health effects.
  • To argue against intuitive comparisons as a method for assessing proportionality.

Main Methods:

  • Conceptual analysis distinguishing internal and external proportionality.
  • Development of a literal ratio model for internal proportionality based on expected health effects.
  • Application of the proposed framework to the case of controlled human infection studies with SARS-CoV-2.

Main Results:

  • Internal proportionality, not external, is the appropriate focus for IRB/REC review.
  • A literal ratio of expected health effects provides a more objective measure of proportionality than intuitive comparisons.
  • Trials with substantial potential beneficiaries can be deemed internally proportional even with low success probabilities.

Conclusions:

  • The proposed framework offers a clearer, more objective method for IRBs/RECs to assess the ethical acceptability of human subjects research.
  • This approach is crucial for evaluating novel research methodologies, such as controlled human infection studies.
  • Prioritizing internal proportionality ensures that research risks are rigorously evaluated against tangible social benefits.