Supported Decision-Making for Clinical Research Participants with Mental Illness

Federal disability anti-discrimination laws expect clinical trials to render study processes and sites accessible to potential participants, including through the provision of reasonable accommodations. Nonetheless, people with disabilities, and particularly people with mental illness, are often excluded from clinical trials. Supported decision-making, a strategy that allows people to select trusted others to help them understand and communicate decisions, is an important accommodation to further inclusion. However, because mental illness can be dynamic and vary widely in nature (e.g., diagnosis, symptom severity, functional impairment) and duration (e.g., short-term, intermittent, progressive, permanent), supported decision-making is neither a one-size-fits-all strategy nor one that can serve as a reasonable accommodation in every situation. While prior work on supported decision-making has focused predominantly on adults with intellectual and developmental disabilities or dementias, people with mental illness may also benefit from supported decision-making, although the variability in decision-making capacity in mental illness presents nuanced challenges. Here, we explore supported decision-making in the case of people with intermittent or episodic mental illness that may impact decision-making capacity to varying degrees at different times.