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

Jennifer Hawkins1, Aaron Eli Segal2, David Wendler3

  • 1Department of Philosophy, https://ror.org/00py81415Duke University, United States.

The Journal of Law, Medicine & Ethics : a Journal of the American Society of Law, Medicine & Ethics
|May 28, 2026
PubMed
Summary
This summary is machine-generated.

We propose supported decision-making (SDM) for minimal risk clinical research enrollment for individuals with cognitive impairment who can express a decision. This approach ethically enhances participation while ensuring robust protections.

Keywords:
Clinical Research EthicsCognitive ImpairmentMinimal Risk ResearchSupported Decision Making

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Area of Science:

  • Bioethics
  • Clinical Research Ethics
  • Cognitive Impairment Research

Background:

  • Current enrollment practices for cognitively impaired individuals in minimal risk research often involve surrogate consent, potentially limiting participation.
  • Individuals with cognitive impairment who retain some decision-making interest and expression ability may be underserved by standard consent procedures.

Purpose of the Study:

  • To advocate for a shift from traditional consent models to supported decision-making (SDM) for enrolling individuals with cognitive impairment in minimal risk clinical research.
  • To increase enrollment of cognitively impaired individuals by implementing a more inclusive and ethically sound consent process.

Main Methods:

  • Proposing a facilitated decision-making process based on supported decision-making (SDM) principles.
  • Advocating for the individual's final say in participation, even if a capacitated choice is not fully achieved with support.

Main Results:

  • The proposed SDM process may enable some individuals to make capacitated choices who otherwise would not.
  • The individual's preference should be respected as the final decision, regardless of achieving full capacity with support.

Conclusions:

  • Supported decision-making (SDM) offers an ethically sound alternative to surrogate consent for minimal risk research involving cognitively impaired individuals.
  • This revised approach aims to ethically increase research participation among individuals with cognitive impairment while maintaining participant protection.