Abstract

Scientific discoveries and precision medicine research, especially efforts to identify individually tailored approaches to healthcare considering individual variability in genetics, environmental, and lifestyle factors, have the potential to transform health. This goal is especially critical for those who experience social injustices and substantial health disparities. Yet the inclusion of adults with intellectual disability in precision medicine research, a growing field in clinical and translational genomic research, raises ethical, social, and legal concerns about their ability to make informed decisions to participate, and subsequently whether this population should be excluded altogether or enrolled only via proxy consent. Both practices demand scrutiny and are sometimes without legal or ethical justification. Supported decision-making, a reasonable accommodation and relatively recent legal and ethical construct, can facilitate first-person consent and maintain the prospective participant’s position as the decision-maker. As such, supported decision-making is a promising development with critical implications for consent to precision medicine research. Using findings from our national survey with adults with intellectual disability and a legal analysis, our academic-community research partnership developed recommendations and a tool for using supported decision-making for enrollment in precision medicine research. We conclude with persistent challenges that need resolving to ensure the responsible inclusion of adults with intellectual disability in precision medicine research, and clinical research more generally.