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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.
Summary
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.
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.
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