Supported Decision-Making and the Inclusion of People who Lack Decisional Capacity in Greater than Minimal Risk...

In recent years, some have argued that supported decision-making can be ethically superior to surrogate decision-making with respect to decisions involving adults with cognitive and intellectual impairments or disabilities. In this paper, we argue that supported decision-making could also be ethically superior to surrogate decision-making in the context of clinical research that involves greater than minimal net risks. In current practice, adults who lack decisional capacity are often excluded from research that involves greater than minimal net risks (call this the minimal risk requirement). While this approach is intended to protect them, it can be ethically problematic, in part because excluding adults who cannot consent blocks scientifically valuable research that needs to enroll them and undermines the generalizability of the research that excludes them. With this concern in mind, we argue that supported decision-making can provide an ethical means to enroll adults who cannot independently consent in greater than minimal net risk research. Supported decision-making thus offers a valuable modification to the surrogate enrollment requirement, and provides good reason to reject the minimal risk requirement as well.