A neuroimaging proof of principle study of Down's syndrome and dementia: Ethical and methodological challenges in intrusive research

Journal of Intellectual Disability Research

Volumn 57, Issue 2, 2013, Pages 105-118

  d'Abrera, J C ^a   Holland, A J ^a   Landt, J ^a   Stocks Gee, G ^a   Zaman, S H ^a  

^a UNIVERSITY OF CAMBRIDGE   (United Kingdom)

Author keywords

Alzheimer's disease; Amyloid; Down's syndrome; Ethics; Intellectual disabilities; Intrusive research

Indexed keywords

ARTICLE; BRAIN SCINTISCANNING; DEMENTIA; DOWN SYNDROME; HEALTH CARE POLICY; HUMAN; INTELLECTUAL IMPAIRMENT; MEDICAL ETHICS; MEDICAL RESEARCH; MEDICOLEGAL ASPECT; METHODOLOGY; NEUROIMAGING; NUCLEAR MAGNETIC RESONANCE IMAGING; POSITRON EMISSION TOMOGRAPHY; PRACTICE GUIDELINE;

BIOMEDICAL RESEARCH; BRAIN; COHORT STUDIES; DEMENTIA; DOWN SYNDROME; FEASIBILITY STUDIES; HUMANS; INFORMED CONSENT; MAGNETIC RESONANCE IMAGING; NEUROIMAGING; PATIENT SATISFACTION; PATIENT SELECTION; POSITRON-EMISSION TOMOGRAPHY; RESEARCH DESIGN;

EID: 84872125581     PISSN: 09642633     EISSN: 13652788     Source Type: Journal    
DOI: 10.1111/j.1365-2788.2011.01495.x     Document Type: Article

References (64)

1. Abma T. A. (2005) Responsive evaluation: its meaning and special contribution to health promotion. Evaluation and Program Planning 28, 279-89.
2. Aman M. G. & Handen B. (2006) Reactions to 'Ethical challenges and complexities of including people with intellectual disability as participants in research' by Dr Teresa Iacono. Journal of Intellectual & Developmental Disability 31, 180-2.
3. Arscott K., Dagnan D. & Kroese B. S. (1999) Assessing the ability of people with a learning disability to give informed consent to treatment. Psychological Medicine 29, 1367-75.
4. Bach M. & Rock M. (1996) Seeking Consent to Participate in Research From People Whose Ability to Make an Informed Decision Could Be Questioned: The Supported Decision-Making Model. The Roeher Institute, Ontario.
5. Beecher H. K. (1966) Ethics and clinical research. New England Journal of Medicine 274, 1354-60.
6. Bielby P. (2008) Competence and vulnerability in biomedical research. In: International Library of Ethics, Law, and the New Medicine (ed. D. N. Weisstub), 40, pp. 139-66. Springer, Dordrecht.
7. Boxall K. & Ralph S. (2009) Research ethics and the use of visual images in research with people with intellectual disability. Journal of Intellectual & Developmental Disability 34, 45-54.
8. Boxall K. & Ralph S. (2010) Research ethics committees and the benefits of involving people with profound and multiple learning disabilities in research. British Journal of Learning Disabilities 39, 173-80. doi: 10.1111/j.1468-3156.2010.00645.x.
9. Boyden P., Esscopri N., Ogi L., Brennan A. & Kalsy-Lillico S. (2009) Service users leading the way: focus group methodology in developing accessible information DVD's with people with learning disabilities. Journal of Intellectual Disabilities 13, 183-94.
10. Cleaver S., Ouellette-Kuntz H. & Sakar A. (2010) Participation in intellectual disability research: a review of 20 years of studies. Journal of Intellectual Disability Research 54, 187-93.
11. Clements J., Rapley M. & Cummins R. A. (1999) On, to, for, with - vulnerable people and the practices of the research community. Behavioural and Cognitive Psychotherapy 27, 103-15.
12. Craig M. C., Zaman S. H., Daly E. M., Cutter W. J., Roberston D. M., Hallahan B. etal. (2007) Women with autistic-spectrum disorder: magnetic resonance imaging study of brain anatomy. British Journal of Psychiatry 191, 224-8.
13. Dalton A. J. & McVilly K. R. (2004) Ethics guidelines for international multicenter research involving people with intellectual disabilities. Journal of Policy and Practice in Intellectual Disabilities 1, 57-70.
14. Department of Health (2005) The Mental Capacity Act.
15. Dresser R. (1996) Mentally disabled research subjects: the enduring policy issues. Journal of the American Medical Association 276, 67-72.
16. Ecker C., Marquand A., Mourão-Miranda J., Johnston P., Daly E. M., Brammer M. J. etal. (2010) Describing the brain in autism in five dimensions - magnetic resonance imaging-assisted diagnosis of autism spectrum disorder using a multiparameter classification approach. Journal of Neuroscience 32, 10612-23.
17. Elliott J., Hatton C. & Emerson E. (2003) The health of people with learning disabilities in the UK: evidence and implications for the NHS. Journal of Integrated Care 11, 9-17.
18. Erikson E. H. (1958) The nature of clinical evidence. In: Evidence and Inference (ed. D. Lerner), pp. 75-95. The Free Press of Glencoe, Glencoe, IL.
19. Flory J. & Emanuel E. (2004) Interventions to improve research participants' understanding in informed consent for research: a systematic review. Journal of the American Medical Association 292, 1593-601.
20. Freedman R. I. (2001) Ethical challenges in the conduct of research involving persons with mental retardation. Mental Retardation 39, 130-41.
21. Goldgaber D., Lerman M. I., McBride W. O., Saffiotti U. & Gajdusek D. C. (1987) Isolation, characterisation, and chromosomal localisation of human brain cDNA clones coding for the precursor of the amyloid of brain in Alzheimer's disease, Down's syndrome and ageing. Journal of Neural Transmission. Supplementum 24, 23-8.
22. Griffin T. & Balandin S. (2004) Ethical research involving people with intellectual disabilities. In: The International Handbook of Applied Research in Intellectual Disabilities (eds E. Emerson, C. Hatton, T. Thompson & T. R. Parmenter), pp. 61-82. John Wiley & Sons, Chichester, UK.
23. Hagerman R. J., Berry-Kravis E., Kaufmann W. E., Ono M. Y., Tartaglia N., Lachiewicz A. etal. (2009) Advances in the treatment of fragile X syndrome. Pediatrics 123, 378-90.
24. Hallahan B., Daly E. M., McAlohan G., Loth E., Toal F., O'Brien F. etal. (2009) Brain morphometry volume in autistic spectrum disorder: a magnetic resonance imaging study of adults. Psychological Medicine 39, 337-46.
25. Hardy J. & Selkoe D. J. (2002) The amyloid hypothesis of Alzheimer's disease: progress and problems on the road to therapeutics. Science 297, 353-6.
26. Hassiotis A. (2009) Research in mental health learning disabilities: present challenges and future drivers. Psychiatry 8, 457-60.
27. High D. M. (1992) Research with Alzheimer's disease subjects: informed consent in proxy decision making. Journal of the American Geriatrics Society 40, 950-7.
28. Holland A., Whittington J., Cohen O., Curfs L., Delahaye F., Dudley O. etal. (2009) The European Prader-Willi Syndrome Clinical Research Database: an aid in the investigation of a rare genetically determined neurodevelopmental disorder. Journal of Intellectual Disability Research 53, 538-47.
29. Holland A. J., Hon J., Huppert F. A., Stevens F. & Watson P. (1998) Population-based study of the prevalence and presentation of dementia in adults with Down's syndrome. British Journal of Psychiatry 172, 493-8.
30. Holland A. J., Hon J., Huppert F. A. & Stevens F. (2000) Incidence and course of dementia in people with Down's syndrome: findings from a population-based study. Journal of Intellectual Disability Research 44, 138-46.
31. Iacono T. (2006) Ethical challenges and complexities of including people with intellectual disability as participants in research. Journal of Intellectual & Developmental Disability 31, 173-9.
32. Iacono T. & Murray V. (2003) Issues of informed consent in conducting medical research involving people with intellectual disability. Journal of Applied Research in Intellectual Disabilities 16, 41-51.
33. Kampmeier R. H. (1974) Final report on the 'Tuskegee syphilis study'. Southern Medical Journal 67, 1349-53.
34. Kiernan C. (1999) Participation in research by people with learning disability: origins and issues. British Journal of Learning Disabilities 27, 43-7.
35. Klunk W. E., Engler H., Nordberg A., Wang Y., Blomqvist G., Holt D. P. etal. (2004) Imaging brain amyloid in Alzheimer's disease with Pittsburgh Compound-B. Annals of Neurology 55, 306-19.
36. Lai F. & Williams R. S. (1989) A prospective study of Alzheimer disease in Down syndrome. Archives of Neurology 46, 849-53.
37. Lai R., Elliott D. & Ouellette-Kuntz H. (2006) Attitudes of research ethics committee members toward individuals with intellectual disabilities: the need for more research. Journal of Policy and Practice in Intellectual Disabilities 3, 114-18.
38. Landt J., D'Abrera C., Holland A. J., Aigbirhio F. I., Fryer T. D., Canales R. etal. (2011) Using positron emission tomography and Carbon 11-labeled Pittsburgh Compound B to image brain fibrillar {beta}-amyloid in adults with Down syndrome: safety, acceptability, and feasibility. Archives of Neurology 68, 890-6. doi: 10.1001/archneurol.2011.36.
39. Lennox N., Taylor M., Rey-Conde T., Bain C., Purdie D. M. & Boyle F. (2005) Beating the barriers: recruitment of people with intellectual disability to participate in research. Journal of Intellectual Disability Research 49, 296-305.
40. Lewis D. A. (2002) The human brain revisited: opportunities and challenges in postmortem studies of psychiatric disorders. Neuropsychopharmacology 26, 143-54.
41. Mann D. M. (1998) The pathological association between Down syndrome and Alzheimer disease. Mechanisms of Ageing and Development 43, 99-136.
42. McAllister C. J., Whittington J. E. & Holland A. J. (2010) Development of the eating behaviour in Prader-Willi Syndrome: advances in our understanding. International Journal of Obesity 35, 188-97.
43. McDonald K. E. & Keys C. B. (2008) How the powerful decide: access to research participation by those at the margins. American Journal of Community Psychology 42, 79-93.
44. McVilly K. R. & Dalton A. J. (2006) Commentary on Iacono (2006): 'Ethical challenges and complexities of including people with intellectual disabilities as participants in research'. Journal of Intellectual & Developmental Disability 31, 186-8.
45. Melton G. B. & Stanley B. H. (1996) Research involving special populations. In: Research Ethics: A Psychological Approach (eds B. H. Stanley & J. E. Seiber), pp. 177-202. University of Nebraska Press, Lincoln, NE.
46. Murphy D. G. M., Crtichley H. D., Schmitz N., McAlonan G., van Amelsvoort T., Robertson D. etal. (2002) Asperger syndrome: a proton magnetic resonance spectroscopy study of brain. Archives of General Psychiatry 59, 885-91.
47. National Commission for the Protection of Human Subjects in Biomedical and Behavioural Research (1979) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Public Health Service, Washington, D.C.
48. Nickel P. J. (2006) Vulnerable populations in research: the case of the seriously ill. Theoretical Medicine and Bioethics 27, 245-64.
49. Nierse C. J. & Abma T. A. (2011) Developing voice and empowerment: the first step towards a broad consultation in research agenda setting. Journal of Intellectual Disability Research 55, 411-21.
50. Oliver P. C., Piachaud J., Done J., Regan A., Cooray S. & Tyrer P. (2002) Difficulties in conducting a randomised controlled trial of health service interventions in intellectual disability: implications for evidence-based practice. Journal of Intellectual Disability Research 46, 340-5.
51. Oliver-Africano P., Dickens S., Ahmed Z., Bouras N., Cooray S., Deb S. etal. (2010) Overcoming the barriers experienced in conducting a medication trial in adults with aggressive challenging behaviour and intellectual disabilities. Journal of Intellectual Disability Research 54, 17-25.
52. Schön D. (1983) The Reflective Practitioner: How Professionals Think in Action. Basic Books, New York.
53. Schuklenk U. (2000) Protecting the vulnerable: testing times for clinical research ethics. Social Science & Medicine 51, 969-77.
54. Sherratt C., Soteriou T. & Evans S. (2007) Ethical issues in social research involving people with dementia. Dementia 6, 463-79.
55. Siegel P. E. & Ellis N. R. (1985) Note on the recruitment of subjects for mental retardation research. American Journal of Mental Deficiency 89, 431-3.
56. Smith L. J. (2008) How ethical is ethical research? Recruiting marginalized, vulnerable groups into health services research. Journal of Advanced Nursing 62, 248-57.
57. Törnqvist E., Månsson A., Larsson E. M. & Hallström I. (2006) Impact of extended written information on patient anxiety and image motion artifacts during magnetic resonance imaging. Acta Radiologica 47, 474-80.
58. Ulrich C., Wallen G. R. & Grady C. (2002) Research vulnerability and patient advocacy: balance-seeking perspectives for the clinical nurse scientist? Nursing Research 51, 71-2.
59. Veenstra M. Y., Walsh P. N., van Schrojenstein Lantman-de Valk H. M., Haveman M. J., Linehan C., Kerr M. P. etal. (2010) Sampling and ethical issues in a multicenter study on health of people with intellectual disabilities. Journal of Clinical Epidemiology 63, 1091-100.
60. de Vries P. J. (2010) Treatments for cognitive and neurodevelopmental disorders in tuberous sclerosis complex. Neurotherapeutics 7, 275-82.
61. Walmsley J. (2004) Involving users with learning difficulties in health improvement: lessons from inclusive learning disability research. Nursing Inquiry 11, 54-64.
62. Weiss L. W. & Roberts B. (1999) Psychiatric Research ethics: an overview of evolving guidelines and current ethical dilemmas in the study of mental illness. Biological Psychiatry 46, 1025-38.
63. Wong P. C., Borchelt D. R. & Price D. L. (2002) Genetically engineered mouse models of neurodegenerative diseases. Nature Neuroscience 5, 633-9.
64. World Medical Association (2008) World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Available at: http://www.wma.net/en/30publications/10policies/b3/ (retrieved 10 June 2011).