Patient and Practitioner workshops for an Intellectual Disabilities and Epilepsy Neuropsychiatric Genetic Research Database Register: Ethical dilemmas for study design

Background
There is a need for more research studies focussed on People with ID (PwID) and Epilepsy and for the design of these studies to be shaped by this complex and vulnerable population and those who care for and support them.
Aims
To develop understanding as to how a future NHS genetic research database register for PwID and Epilepsy should be conducted in a way which is inclusive, suitable and appropriate for them, their carers and the NHS settings where the research would be undertaken.
Methods
Three workshops were completed with 17 formal participants: (1) PwID and Epilepsy (n2); (2) carers of PwID and Epilepsy (n6); (3) NHS practitioners working with PwID and Epilepsy (n9). Patient and public involvement and engagement and co-production methods were applied. Workshop transcription and researcher notes were analysed for themes using ethnographic techniques.
Results
Four key themes identified were: (1) Comprehension and how to achieve it; (2.) The value of participating and how to explain it; (3) Perception of risks and reservations and how to help reduce them; (4.) A flexible, person-centred approach. A specific “hard to reach” population of PwID and Epilepsy were also discussed (theme 5.)
Conclusion
Themes build on previous work addressing the need for flexible and nuanced approaches to ensure research with PwID is communicated appropriately and delivered in inclusive, ethical ways. These approaches raise challenges and ethical dilemma for researchers defining study delivery protocols and processes that fit NHS Research Ethics Committee (REC) application and approval processes.