Including Adults with Intellectual Disability in Precision Medicine Research - Project ENGAGE - Adults with intellectual disability (ID) experience significant negative health outcomes and may benefit from advances in precision medicine research (PMR) but are often excluded from research. Key reasons for this outcome are common presumptions about incompetency to consent and questions about the appropriateness of proxy consent. In the Parent R01, Project ENGAGE, we address these challenges by creating The ENGAGE Toolkit, an empirically-based, ID-tailored, PMR study-adaptable consent toolkit comprised of legal, educational, and practical tools to support the inclusion of adults with ID in PMR. Yet, we identified through this work an additional key barrier: how to practically, fairly, and accurately screen for consent capacity among adults with ID. Despite evidence that most adults with ID have consent capacity and NIH’s guidance that those with questionable capacity should be individually assessed, adults with ID are often presumed to lack consent capacity for research decisions. Additionally, existing consent capacity tools are not appropriate for adults with ID—a resource gap that may also partially explain why standardized consent capacity evaluations are rare. Evidence shows that tools may not transfer across populations and that tools without tailoring to the study population are likely to result in inaccurate evaluations. Adults with ID are thus at risk that they will be determined to lack capacity, regardless of ability, or to have capacity when they do not. Both options undermine autonomy, consent and protection of research participants—contrary to foundational principles in bioethics and research, including PMR. Tailored consent capacity tools that are practical and cognitively accessible for adults with ID can enhance the culture of responsible inclusion in PMR and remove a barrier to research that might offer direct benefit to adults with ID. They can minimize inaccurate conclusions, preserve first person consent, reduce unneeded proxy consent, and in the long run, enhance representativeness in cohorts, increase generalizability of PMR findings, and promote more applicability of emerging knowledge from PMR to adults with ID. Yet, no validated ID-tailored consent capacity screening tool currently exists. The proposed bioethics research study leverages our academic-community partnership to close this gap by: (1) Adapting an ID-tailored cognitively accessible brief and easy-to-administer consent capacity screening tool for adults with ID; and 2) Validating the ID-tailored tool by establishing its a) content validity via cognitive interviews with adults with ID and subject matter expert review, and b) psychometric properties via its administration with 100 adults with ID and studying its reliability and validity. The ID-tailored consent capacity screening tool will be added to the web-based Parent R01’s ENGAGE Toolkit for PMR, and available for use in an array of clinical studies. We will disseminate findings through workshops, webinars, peer-reviewed publications, and professional presentations. This work will, over time, generate real-world knowledge for biomedical research while promoting health.
