An informed consent process for people with learning disabilities and their carers Dr Anita Young Health Services Research Group The Robert Gordon University

Policy framework 1991NHS R&D Strategy – users views to be reflected in research 1995Publication of DOH Report – consumers and Research in the NHS (Blaxter) 2000MRC Guidelines recommend: consultation with patients.... Especially in clinical and applied research 2002Scot. Exec. (R/GF/work) – refers to patients/clients: patient/client groups and The Public as key people in.... a research study

Legal framework 1998Human Rights Act promotes self determination 2000Adults with Incapacity (Scotland) Act gives guidance on assessment of capacity that is decision or action - specific

Ethical framework Involvement of participants in research requires ethical approval from the appropriate Research Ethics Committee (including seeking consent process) Key questions on ethics form guide approach to obtaining valid consent

Translating policy into practice Developing a consent process to be used in a research project involving adults with learning disabilities, their carers and care workers Consent process - same for everyone (although safeguards required for adults with learning disabilities)

Informed consent Literature reports 3 necessary elements: 1Provision of accurate and balanced information 2The person must be capable of making a decision (re participation) 3The decision must be made voluntarily

Additional key points re consent Legal perspective (In Practice: Shepherd & Wedderburn) UK Model (professionally driven) USA Model (person centred) Adults always assumed competent unless demonstrated otherwise Giving and obtaining consent is usually a process, not a one-off event

The project consent procedure Potential participants nominated by staff/carers (guidance on selection provided) Researcher approaches individual to seek consent

Individuals given information (oral, written, pictorial) What is the project about? What will I be asked to do? What kind of help will I get to take part? Do I have to take part? What will the study achieve? Individuals have knowledge to decide if info understood, believed, retained

Consent Form

Individuals helped to complete the consent form Information discussed - questions encouraged Capacity to decide: individs prompted to weigh up info and choose bet alts Decision recorded on consent form

Judgement of voluntary response Awareness of undue influence of others Power balance in relationships Tendency towards acquiescence Time allowed for reflection on decision. Then, Do you still want to say yes?

Additional safeguards for adults with learning disabilities Face to face consent interview completed separately Supporter/witness present during consent interview

Additional safeguards Clear, simple language used in info sheet Symbolised consent form Greater emphasis on oral information giving and reinforcement Pace of info giving and discussion Every possible assistance given to enable understanding

How has it worked so far? All nominated participants have been engaged in and able to complete the consent process (3 adults, 4 carers, 2 care workers) All able to reach a decision All decisions judged to be informed

Conclusion A process for seeking informed consent from adults with learning disabilities and carers regarding research participation has been developed to the level of: a) being approved by LREC; and b) being implemented in practice Thinking about a process for people with communication difficulties is beneficial for ALL participants