A new research programme led by the Centre for Trials Research at Cardiff University is set to address one of the most persistent ethical and practical challenges in health research -ensuring people who cannot give informed consent are not excluded from studies that could improve care.
The ACCORD programme, led by Dr Victoria Shepherd at the Centre for Trials Research, is supported by a £2.14m Wellcome Career Development Award and will run for eight years. The research will examine the legal, ethical and practical barriers that prevent adults who lack capacity to consent from taking part in clinical research and will develop practical solutions to support more inclusive studies.
Across the UK and internationally, large groups of people are routinely excluded from research because they are unable to provide informed consent themselves. This includes people living with dementia, severe mental illness, learning disabilities, critical illness or acute medical emergencies. Yet these are often the very populations most affected by serious health conditions..
ACCORD will examine how current systems work in practice and develop evidence based interventions that support researchers, ethics committees and clinicians to navigate decisions about research participation. The programme aims to improve the way policies, guidance and decision making processes operate across the research system.
The work builds on Dr Shepherd's earlier CONSULT programme, funded by Welsh Government through Health and Care Research Wales, which explored the experiences of researchers, clinicians and family members involved in studies with adults who lack capacity to consent. That work highlighted complex ethical dilemmas and practical barriers that can make inclusion difficult.
One influential study described these challenges as a "black box" of uncertainty in research decision making, where legal requirements, ethical responsibilities and real world clinical pressures intersect in ways that are not always well understood.
Dr Shepherd said: "Many people who lack capacity to consent are excluded from research not because researchers do not want to include them, but because the systems around consent are complex and often difficult to navigate in practice.
"This means we risk building an evidence base that does not represent some of the people most affected by illness or with the most complex care needs. ACCORD aims to understand these challenges in depth and develop practical approaches that help researchers include people in ways that are ethical, lawful and supportive for them and their families.
"Researchers, ethics committees and clinicians are often uncertain how the legal and ethical frameworks apply when people are unable to provide informed consent themselves. This can mean they decide to exclude this group from research, or make decisions that don't accurately reflect the frameworks."
Through ACCORD we want to develop clearer processes, better guidance and supportive tools that help everyone involved make decisions with confidence.
By bringing together legal analysis, ethics, empirical research and practical intervention development, ACCORD aims to produce system level recommendations that could influence research policy and practice across the UK and internationally.
Dr Shepherd's work has previously been supported through Health and Care Research Wales and the National Institute for Health and Care Research, and the Wellcome Career Development Award will now enable the next phase of this research to expand significantly.
The findings are expected to help shape future research guidance and ensure that people who are currently under represented in studies have a fair opportunity to contribute to research that may ultimately improve care for them and others.
