1. Involving people with learning disability in research – should the net be widened? Lesley Goldsmith School of Nursing and Midwifery Faculty of Health University of Plymouth

2. My study The context Methods Ethical issues and challenges

3. Informed consent to pharmacogenomic testing in people with learning disability Aims: To explore the information needs of people with learning disabilities with respect to consent for new types of genetic test To identify ways of facilitating informed consent

4. The context (1) Advances in genetic health applications Antenatal screening and diagnostic tests More advanced diagnosis Asymptomatic testing Susceptibility to common diseases Personalised medicine?

5. The context (2) People with learning disabilities as a ‘vulnerable’ group Health inequalities in people with LD Advances should be available to all The challenge of valid consent

6. The context (3) The law on consent to participate in research (Mental Capacity Act, 2005) Researchers should assume capacity unless proven otherwise Potential participants should receive support in their decision re participation Guidelines on research involving people who lack capacity

7. Capacity – the 2 step test “Does the person have an impairment of the mind or brain, or is there some sort of disturbance affecting the way their mind or brain works?” “Does that impairment or disturbance mean that the person is unable to make the decision in question at the time it needs to be made?” (Department of Health, 2005; Ministry of Justice, 2007).

8. Capacity A person should be able to: understand (relevant) information about the decision to be made retain that information in their mind use or weigh that information as part of the decision-making process, and communicate their decision (by talking, using sign language or any other means).

9. Method (Recruitment) Use of gatekeepers – given inclusion and exclusion criteria and summary of study –asked to nominate suitable participants Consent interview – Accessible information sheet –Supporter present –Capacity confirmed (or not) by researcher and supporter

10. The recruitment process Gatekeeper Nominates suitable participants Potential participants ‘Consented’ participants Data collection Judgement of capacity Overprotective? Bias? Right to decline Capacity?

11. The challenges (1) Frustration of not recruiting directly Ensuring that gatekeepers understand their role and the purpose of the study The risk that gatekeepers are biased in their selection of participant

12. The challenges (2) Satisfying the criteria for valid consent Informed consent Disclosure of information Voluntariness (freedom from coercion) Capacity

13. A voluntary decision? Varying experience of decision making Tendency to acquiesce to wishes of others Influence of others – parents, carers etc

14. Disclosure of information How much information? What is ‘relevant’ information? What is an appropriate format?

16. Judging capacity Decision-specific Time-specific Support must be offered

17. Reflections on the study Decision about who to include in the study Aimed for maximum variation sample, but.. How different would the findings have been: o if participants who lacked capacity had been included? o If a different recruitment method had been used?

18. Ethical issues “Non-inclusive and discriminatory decisions” (Iacono, 2006, p173) Incomplete evidence base (Lennox et al, 2005)

19. Conclusions Careful consideration should be given to inclusion and exclusion criteria when planning research involving people with a learning disability Extra time should be allocated for production of appropriate study materials and the recruitment and consent processes Be prepared for challenges!

20. References Department of Health (2005) 'Mental Capacity Act 2005 - Summary'. 8 February 2007. [Online]. Available at: http://www.dh.gov.uk/en/Publicationsandstatistics/Bulletins/theweek/Chiefexecutivebulletin/D H_4108436 (Accessed: 8 September 2008). Department of Health (2003) 'Our Inheritance, Our Future. Realising the potential of genetics in the NHS'. Her Majesty's Stationery Office. Iacono, T. (2006) 'Ethical challenges and complexities of including people with intellectual disability as participants in research'. Journal of Intellectual and Developmental Disability, 31 (3). pp 173-179. Lennox, N., Taylor, M., Rey-Conde, T., Bain, C., Purdie, D. & Boyle, F. (2005) 'Beating the barriers: recruitment of people with intellectual disability to participate in research'. Journal of Intellectual Disability Research, 49 (4). pp 296-305. Michael, J. (2008) 'Healthcare for all: Report of the independent inquiry into access to healthcare for people with learning disabilities'. [Online]. Available at: http://www.oldt.nhs.uk/documents/Healthcareforall.pdf (Accessed: 22 September 2008). Ministry of Justice (2007) 'Mental Capacity Act 2005. Code of Practice'. The Stationery Office. [Online]. Available at: http://webarchive.nationalarchives.gov.uk/+/http://www.justice.gov.uk/docs/mca-cp.pdf (Accessed: 2 September 2010).