1. Nicole Palmer & Professor Rachel Forrester-Jones
Are people with Intellectual and Developmental Disabilities who lack capacity to consent at risk of being excluded from research? Ethical implications of the Mental Capacity Act 2005
Nicole Palmer & Professor Rachel Forrester-Jones

2. Background Mental Capacity Act (2005) enacted in 2007
Covers ‘intrusive’ research involving participants who lack capacity to consent
Requires favourable opinion from NHS REC before initiation
Risks to social science research from overly prescriptive medical model of ethical scrutiny
(Boddy et al. 2006; Dingwall 2006)
‘Ethics creep’
(Haggerty et al. 2004, p.394; Guta et al. 2013)

3. Implications
Social care research brought within formalised regulatory process designed to deal with interventional clinical research
(Dingwall 2006; Haggerty 2004; Parker et al. 2011)
Concern that NHS RECs are predisposed towards quantitative clinical research and lack knowledge and expertise for fair assessment of qualitative social care research
(Haggerty 2004; Angell et al. 2007)
Establishment of National Social Care REC (SCREC) in 2009
Membership reflects social care context
However, review process is onerous with rigorous burden of proof

4. Consequence? Purpose of study: Aims: Objective:
Is the MCA leading to the exclusion of people with Intellectual and Developmental Disabilities (IDD) who lack capacity to consent from research from which they could benefit?
Aims:
To analyse REC decision letters
To interview researchers who have gone through the review process
Objective:
To explore whether this additional regulatory burden is affecting researchers’ decisions on whether to involve people with IDD who lack capacity to consent in their projects?

5. Research project Methods: Ongoing study – two parts
Retrospective review and content analysis of NHS REC decision letters for social science applications involving people with IDD who lack capacity to consent over a 3-year period
In-depth interviews with social science researchers who have experienced NHS REC reviews of projects seeking to involve people with IDD who lack capacity to consent
Favourable ethical opinion granted by Tizard Centre REC before data collection. Informed consent was obtained from each participant

6. Part 1 – REC decision letters
NHS REC decision letters for 12 studies that were reviewed for compliance with the MCA were identified for the 3-year period between 2011 and 2014
7 studies reviewed by SCREC
5 by an NHS REC
All 12 studies needed amendments or additional information before a final favourable opinion was granted

7. Analysis of REC decision letters
Latent content analysis identified the most common themes raised by RECs. The top 3 were:
Methodological questions; issues with documentation; consent

8. Part 2 – Interviews Methodology: Semi-structured interviews
Convenience, purposive sampling framework used to recruit participants
Identified due to their research area
Semi-structured interviews
All interviews were audio-recorded and transcribed verbatim

9. Interviews – findings so far
Inductive thematic analysis of transcribed interviews (Braun & Clarke 2008)
Coding categories derived directly from the text
Categories grouped to provide themes
Main themes identified:
Lack of proportionality
Conflicting interpretations of MCA
Bad meeting experiences
Bad outcomes

10. Theme 1 Lack of proportionality
Over-cautious attitude of Committee
Over-bureaucratic process
Disproportionate burden of proof
“I kind of felt that the Committee didn’t have a very good handle of the risks versus benefits, so they overreacted a lot to things that were very, very low risk” participant 002

11. Theme 2 Conflicting interpretations of MCA
Misunderstandings
Inflexibility of Committee
Assumptions
“I think the Committee didn’t understand our research at all. They said we couldn’t interview staff about people with IDD and could only ask staff their own opinions” participant 001

12. Theme 3 Bad meeting experiences
Adversarial / confrontational
Rudeness / negativity
Researcher preference to attend one Committee (type) over another
“It was actually a very negative experience and I felt really quite upset by it all” “…she just wouldn’t accept it and she was shouting at me in the Committee…” participant 004

13. Decisions to exclude people who lack capacity to consent
Theme 4
Bad outcomes
Delays to research
High financial cost
Decisions to exclude people who lack capacity to consent
“I know for a fact that it stops people doing research with this group…we decided that because of the way this project’s funded there’s absolutely no way it can go through the MCA. So we have excluded people without capacity to consent” participant 002

14. Theoretical framework
Mechanism by which MCA can lead to researcher decisions to exclude people with IDD who lack capacity to consent from their research

15. Conclusions
‘Methodological questions’ & ‘consent issues’ (REC decision letters)
Conflicting interpretation of MCA (interviews)
‘Issues with documentation’ (REC decision letters)
Perceived lack of proportionality (interviews)
Differences in MCA interpretation must be explored

16. Further research plans
More interviews with researchers planned
Wider recruitment
Interviews with REC members planned
Alternative viewpoint
Work to identify strategies for improving outcomes

17. References
Angell, E.L., Jackson, C.J., Ashcroft, R.E., Bryman, A., Windridge, K., Dixon-Woods, M. (2007), ‘Is ‘inconsistency’ in research ethics committee decision-making really a problem? An empirical investigation and reflection’, Clinical Ethics, vol.2, no.2, pp92-99
Boddy, J., Boaz, A., Lupton, C., Pahl, J. (2006), ‘What counts as research? The implications for research governance in social care’, International Journal of Social Research Methodology, vol.9, no.4, pp
Braun, V., Clarke, V. (2006), ‘Using thematic analysis in psychology’, Qualitative Research in Psychology, vol.3, no.2, pp77-101
Dingwall, R. (2006), ‘An exercise in fatuity: research governance and the emasculation of HSR’, Journal of Health Services Research & Policy, vol.11, no.4, pp
Guta, A., Nixon, S.A., Wilson, M.G. (2013), ‘Resisting the seduction of “ethics creep”: Using Foucault to surface complexity and contradiction in research ethics review’, Social Science & Medicine, vol.98, pp
Haggerty, K.D. (2004), ‘Ethics creep: Governing social science research in the name of ethics’, Qualitative Sociology, vol.27, no.4, pp
Parker, J., Penhale, B., Stanley, D. (2011), ‘Research ethics review: Social care and social science research and the Mental Capacity Act 2005’, Ethics & Social Welfare, vol.5, no.4, pp