A new research programme has been launched to address the exclusion of people who are unable to give informed consent for clinical research amid evidence that current systems can limit participation among some of the most vulnerable groups.
The Accord programme, led by Dr Victoria Shepherd at the Cardiff University Centre for Trials Research, has received funding of £2.14m through a Wellcome Career Development Award and will run for eight years.
It will examine the legal, ethical and practical barriers that prevent adults who lack capacity to consent from taking part in research and develop approaches to support more inclusive studies.
Groups affected include people living with dementia, severe mental illness, learning disabilities, critical illness or acute medical emergencies.
The programme will explore how current consent frameworks operate in practice and develop interventions to support researchers, clinicians and ethics committees in making decisions about participation.
It will combine legal analysis, ethics research and empirical data to produce system-level recommendations intended to inform policy and practice in the UK and internationally.
The work builds on the Consult programme, previously funded through Health and Care Research Wales and also led by Dr Shepherd, which identified significant ethical and practical challenges in including adults who lack capacity in studies.
Risk of an unrepresentative evidence base
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.
‘Researchers, ethics committees and clinicians are often uncertain how the legal and ethical frameworks apply when people are unable to provide informed consent themselves.’
A version of this article was originally published by our sister publication The Pharmacist.
