The Legal Landscape for Supported Decision-Making in the United States and its Application to Clinical Research

Supported decision-making is rapidly gaining attention as an alternative to guardianship and other forms of surrogate decision-making for people with cognitive disabilities. This article provides an overview of the legal status of supported decision-making in the United States, with particular attention to how states are recognizing supported decision-making in different legal contexts. It then explores how the law of supported decision-making applies to clinical research. It explains that although federal research regulations and guidance do not explicitly address formal supported decision-making, individuals may use supported decision-making to make decisions about participating in clinical research and researchers may be required to allow such use under federal laws that protect against disability discrimination. It then concludes by considering legal barriers to greater use of supported decision-making and how these barriers might be overcome.