Addressing consent-based challenges to improve inclusivity in research (ACCORD) (360G-Wellcome-316585_Z_24_Z)

A global ageing population brings rising prevalence of conditions affecting decisional capacity. Yet adults lacking capacity to consent are frequently excluded from research due to the complex ethico-legal issues involved. Consent-based exclusion affects the generalisability of results and leads to inequalities in care. Unless the issues driving exclusionary practices are better understood, research will fail to meet tomorrow’s health and care needs. We must unlock two fundamental questions: 1) which ethico-legal issues limit inclusion and what contextual and intersectional factors affect this, and 2) how are these navigated by those involved in designing, approving, and conducting research? In this project I will address these questions, generating significant shifts in understanding of these issues and developing implementable interventions to improve inclusion. I will (1) explore how ethical and legal frameworks governing research involving adults lacking capacity are currently interpreted, (2) use the findings to develop new conceptual understandings of the ethico-legal issues, and (3) co-design behaviourally informed interventions in collaboration with public and professional stakeholders to target individual-level and system-wide barriers. This paradigm shift in understanding the barriers to inclusion will enable research to meet future populations’ needs. Engagement with policymakers and focusing on implementation will ensure national and international impact.