The Mental Capacity Act 2005 has stipulated that in England and Wales the ethical implications of carrying out research with people who are unable to consent must be considered alongside the ethical implications of excluding them from research altogether. This paper describes the methods that were used to enable people with severe and profound intellectual disabilities, who lacked capacity, to participate in a study that examined their experience of receiving intimate care. The safeguards that were put in place to protect the rights and well-being of participants are described, and it is argued that the approaches used in this study met the requirements set out in the Mental Capacity Act 2005. Although this paper is based on research involving people with intellectual disabilities, it has implications for research involving other groups who may also lack capacity to consent, including people with mental health problems, head injuries and dementia.
MacInnesD. Ethical issues in clinical research: Nursing Times clinical monographs, No. 14. London: NT Books, 1999.
2.
HersheyNMillerRD. Human experimentation and the law. GermantownMd: Aspen Systems Corporation, 1976.
3.
OliverM. Changing relations of research production?Disability, Handicap and Society1992; 7: 101–114.
4.
ZarbG. On the road to Damascus: First steps towards changing the relations of disability research production. Disability, Handicap and Society1992; 7: 125–138.
5.
Royal College of Nursing. Research ethics: RCN guidance for nurses. London: RCN, 2009.
6.
Department of Health. Seeking consent: Working with people with learning disabilities. London: The Stationery Office, 2001.
7.
GellingL. Researching patients in a vegetative state: Difficulties of studying this patient group. Nursing Times Research2004; 9: 7–17.
8.
ClarkJ. Intimate care in the lives of people with severe intellectual disabilities. Paper presented at the 2007 Dignity Conference, 4 July, Thames Valley University, London.
9.
ClarkJ. Providing intimate continence care for people with learning disabilities. Nurs Times2009; 105: 26–28.
10.
ClarkJ. Defining the concept of dignity and developing a model to promote its use in practice. Nurs Times2010; 106: 16–19.
11.
Department of Health. Research governance for health and social care, 2nd edn. London: The Stationery Office, 2005.
12.
ClarkJ. The implications of the Mental Capacity Act 2005 for research with adults who lack capacity to consent. Paper presented at the Royal College of Nursing 2007 International Research Conference, 1–4 May, Dundee.
13.
PMLDNetwork. Valuing people with profound and multiple intellectual disabilities (PMLD). London: Mencap, 2002.
14.
SamuelJPritchardM. The ignored minority: meeting the needs of people with profound learning disability. Tizard Learning Disability Review2001; 6: 34–44.
15.
CambridgePCarnabyS. Getting personal: An exploratory study of intimate and personal care provision for people with profound and multiple intellectual disabilities. J Intellect Disabil Res2002; 46: 120–132.
16.
Mirfin-VeitchB,ConderJ,BrayA. Intimate and personal care for adults with high support needs: Understanding the experiences of receivers and providers in New Zealand. Paper presented at the 12th IASSID World Congress, 2004, 14–19 June, Montpellier, France.
17.
ToombsSK. The lived experience of disability. Human Studies1995; 18: 9–23.
18.
KiernanC. Participation in research by people with learning disability: origins and issues. Br J Learn Disabil1999; 27: 43–47.
19.
KellettMNindM. Ethics in quasi-experimental research in people with severe learning disabilities: dilemmas and compromises. Br J Learn Disabil2001; 29: 51–55.
20.
CumminsRA. Proxy responding for subjective well-being: a review. Int Rev Res Ment Retard2002; 25: 183–207.
21.
KlotzJ. Sociocultural study of intellectual disability: Moving beyond labelling and social constructionist perspectives. Br J Learn Disabil2004; 32: 93–104.
22.
LaiRElliottDOullette-KuntzH. Attitudes of research ethics committee members toward individuals with intellectual disabilities: the need for more research. J Pol Pract Intellect Disabil2006; 3: 114–118.
23.
BeauchampTLChildressJF. Principles of biomedical ethics. Oxford: Oxford University Press, 1989.
24.
Royal College of Nursing. Research ethics: Guidance for nurses involved in research or any investigative project involving human subjects. London: RCN, 1998.
25.
National Bioethics Advisory Committee. Research involving persons with mental disorders that may affect decision-making capacity, vol. 1: Report and recommendations of the National Bioethics Advisory Commission. http://bioethics.georgetown.edu/nbac/capacity/TOC.htm(1998, accessed 30 April 2008).
LoflandJLoflandLH. Analyzing social settings: A guide to qualitative observation and analysis. Belmont, CA: Wadsworth, 1984.
28.
DaltonAJMcVillyKR. Ethics guidelines for international, multicentre research involving people with intellectual disabilities. J Pol Pract Intellect Disabil2006; 1: 55–70.
29.
IaconoTMurrayV. Issues of informed consent in conducting medical research involving people with intellectual disability. J Appl Res Intellect Disabil2003; 16: 41–51.
30.
LlewellynPJ. An investigation into the advocacy role of the learning disability nurse. PhD thesis, University of Glamorgan, UK, 2005.
31.
SilvermanD. Interpreting qualitative data: Methods for analysing talk, text and interaction. London: Sage, 2001.
32.
DyeLHendySHareDJBurtonM. Capacity to consent to participate in research: a recontextualization. Br J Learn Disabil2004; 32: 144–150.
33.
KnoxMMokMMagdalenaMParmenterTR. Working with the experts: Collaborative research with people with an intellectual disability. Disabil Soc2000; 15: 49–61.
34.
SachsGAStockingCBSternREthical aspects of dementia research: informed consent and proxy consent. Clin Res1994; 42: 403–412.
35.
SlaughterSColeEJReimerMA. Consent and assent to participate in research from people with dementia. Nurs Ethics2000; 14: 27–40
36.
PorterJOuvryCMorganMDownsC. Interpreting the communication of people with profound and multiple learning difficulties. Br J Learn Disabil2001; 29: 12–16.
37.
HoggJ. Competence and quality in the lives of people with profound and multiple intellectual disabilities: some recent research. Tizard Intellectual Disability Review1998; 3: 6–17.
38.
RegnardCReynoldsJWatsonBMatthewsDGibsonLClarkeC. Understanding distress in people with severe communication difficulties: piloting and assessing DisDAT. J Intellect Disabil Res2007; 51: 277–292.
39.
GroveNBunningKPorterKOlssonC. See what I mean: Interpreting the meaning of communication by people with severe and profound intellectual disabilities. J Appl Res Intellect Disabil1999; 12: 190–203.
40.
HoggJReevesDRobertsJMudfordOC. Consistency, context and confidence in judgment of affective communication on adults with profound intellectual and multiple disabilities. J Intellect Disabil Res2001; 45: 18–29.
41.
MillarS. Personal communication passports. Paper presented at the SENSE Conference, 1997, Westpark Centre, University of Dundee.
42.
LiuKPYLeeTYanAUse of the Interact Short Form as a tool to evaluate emotion of people with profound intellectual disabilities. J Intellect Disabil Res2007; 51: 884–891.
