Developing a dementia friendly approach to consent in dementia research

References

• Alzheimer’s Association (2016). End-of-life decisions honoring the wishes of a person with Alzheimer’s Disease. https://www.alz.org/national/documents/brochure_endoflifedecisions.pdf
   Google Scholar
• Alzheimer’s Europe. (2019). Overcoming ethical challenges affecting the involvement of people with dementia in research: Recognising diversity and promoting inclusive research. (ISBN 978-2-9199578-0-4).
   Google Scholar
• Australian Institute of Health and Welfare. (2012). Australia’s health 2012. (Australia’s Health Series no.13. Cat. no. AUS 156). AIHW.
   Google Scholar
• Black, B. S., Rabins, P. V., Sugarman, J., & Karlawish, J. H. (2010). Seeking assent and respecting dissent in dementia research. The American Journal of Geriatric Psychiatry: Official Journal of the American Association for Geriatric Psychiatry, 18(1), 77–85. https://doi.org/10.1097/JGP.0b013e3181bd1de2
   PubMed Web of Science ®Google Scholar
• Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3(2), 77–101. https://doi.org/10.1191/1478088706qp063oa
   Google Scholar
• Chandra, M., Harbishettar, V., Sawhney, H., & Amanullah, S. (2021). Ethical issues in dementia research. Indian Journal of Psychological Medicine, 43(5 Suppl), S25–S30. https://doi.org/10.1177/02537176211022224
   PubMedGoogle Scholar
• Dementia Action Alliance. (2010). The Dementia Statements. [online]. https://www.dementiaaction.org.uk/nationaldementiadeclaration
   Google Scholar
• Dementia Alliance International. (2021). Our Core Beliefs. [online]. https://dementiaallianceinternational.org/about/our-core-beliefs
   Google Scholar
• Dewing, J. (2007). Participatory research: A method for process consent with persons who have dementia. Dementia, 6(1), 11–25. https://doi.org/10.1177/1471301207075625
   Google Scholar
• Evans, C. J., Yorganci, E., Lewis, P., Koffman, J., Stone, K., Tunnard, I., Wee, B., Bernal, W., Hotopf, M., & Higginson, I. L, MORECare_Capacity. (2020). Processes of consent in research for adults with impaired mental capacity nearing the end of life: Systematic review and transparent expert consultation (MORECare_Capacity statement). BMC Medicine, 18(1), 221. https://doi.org/10.1186/s12916-020-01654-2
   PubMed Web of Science ®Google Scholar
• Forchuk, C., Meier, A., Montgomery, P., & Rudnick, P. (2015). Peer support as a direct benefit of focus group research: Findings from a secondary analysis. International Journal of Psychosocial Rehabilitation, 19(1), 88–100. https://doi.org/10.37200/V19I1/8140
   Google Scholar
• Guarino, P. D., Vertrees, J. E., Asthana, S., Sano, M., Llorente, M. D., Pallaki, M., Love, S., Schellenberg, G. D., & Dysken, M. W. (2016). Measuring informed consent capacity in an Alzheimer’s disease clinical trial. Alzheimer’s & Dementia (New York, N. Y.), 2(4), 258–266. https://doi.org/10.1016/j.trci.2016.09.001
   PubMedGoogle Scholar
• Haberstroh, J., Müller, T., Knebel, M., Kaspar, R., Oswald, F., & Pantel, J. (2014). Can the mini-mental state examination predict capacity to consent to treatment? GeroPsych, 27(4), 151–159. https://doi.org/10.1024/1662-9647/a000113
   Google Scholar
• Hake, A. M., Dacks, P. A., & Arnerić, S. P, CAMD ICF working group. (2017). Concise informed consent to increase data and biospecimen access may accelerate innovative Alzheimer’s disease treatments. Alzheimer’s & Dementia, 3(4), 536–541. https://doi.org/10.1016/j.trci.2017.08.003
   Google Scholar
• Health Research Authority. (2019). Informing participants and seeking consent. https://www.hra.nhs.uk/planning-and-improving-research/best-practice/informing-participants-and-seeking-consent/
   Google Scholar
• Hegde, S., & Ellajosyula, R. (2016). Capacity issues and decision-making in dementia. Annals of Indian Academy of Neurology, 19(Suppl 1), S34–S39. https://doi.org/10.4103/0972-2327.192890
   PubMedGoogle Scholar
• Holden, T. R., Keller, S., Kim, A., Gehring, M., Schmitz, E., Hermann, C., Gilmore-Bykovskyi, A., & Kind, A. J. H. (2018). Procedural framework to facilitate hospital-based informed consent for dementia research. Journal of the American Geriatrics Society, 66(12), 2243–2248. https://doi.org/10.1111/jgs.15525
   PubMed Web of Science ®Google Scholar
• Jayes, M., & Palmer, R. (2014). Initial evaluation of the consent support tool: A structured procedure to facilitate the inclusion and engagement of people with aphasia in the informed consent process. International Journal of Speech-Language Pathology, 16(2), 159–168. https://doi.org/10.3109/17549507.2013.795999
   PubMed Web of Science ®Google Scholar
• Jongsma, K. R., & van de Vathorst, S. (2015). Dementia research and advance consent: It is not about critical interests. Journal of Medical Ethics, 41(8), 708–709. https://doi.org/10.1136/medethics-2014-102445
   PubMed Web of Science ®Google Scholar
• Mittal, D., Palmer, B. W., Dunn, L. B., Landes, R., Ghormley, C., Beck, C., Golshan, S., Blevins, D., & Jeste, D. V. (2007). Comparison of two enhanced consent procedures for patients with mild Alzheimer Disease or mild cognitive impairment. The American Journal of Geriatric Psychiatry : official Journal of the American Association for Geriatric Psychiatry, 15(2), 163–167. https://doi.org/10.1097/JGP.0b013e31802dd379
   PubMed Web of Science ®Google Scholar
• Mental Capacity Act. (2005). Mental Capacity Act 2005. HMSO. https://www.legislation.gov.uk/ukpga/2005/9/contents
   Google Scholar
• Mueller, T., Haberstroh, J., Knebel, M., Oswald, F., Kaspar, R., Kemper, C., Halder-Sinn, P., Schroeder, J., & Pantel, J. (2017). Assessing capacity to consent to treatment with cholinesterase inhibitors in dementia using a specific and standardized version of the MacArthur Competence Assessment Tool (MacCAT-T). International Psychogeriatrics, 29(2), 333–343. https://doi.org/10.1017/S104161021600154X
   PubMed Web of Science ®Google Scholar
• Overton, E., Appelbaum, P. S., Fisher, S. R., Dohan, D., Roberts, L. W., & Dunn, L. B. (2013). Alternative decision-makers’ perspectives on assent and dissent for dementia research. The American Journal of Geriatric Psychiatry: Official Journal of the American Association for Geriatric Psychiatry, 21(4), 346–354. https://doi.org/10.1016/j.jagp.2013.01.027
   PubMed Web of Science ®Google Scholar
• Parmar, D. (2021). Ethical aspects of informed consent in dementia. Global Bioethics Enquiry Journal, 9(1), 42–45. https://doi.org/10.38020/GBE.9.1.2021.42-45
   Google Scholar
• Prosser, J., Clark, A., & Wiles, R. (2008). Realities working papers: Visual research ethics at the crossroads. Economic and Social Research Centre National Centre for Research Methods.
   Google Scholar
• Poth, A., Penger, S., Knebel, M., Müller, T., Pantel, J., Oswald, F., & Haberstroh, J. (2023). Empowering patients with dementia to make legally effective decisions: A randomized controlled trial on enhancing capacity to consent to treatment. Aging & Mental Health, 27(2), 292–300. https://doi.org/10.1080/13607863.2021.2024797
   PubMed Web of Science ®Google Scholar
• Russell, A. M., Shepherd, V., Woolfall, K., Young, B., Gillies, K., Volkmer, A., Jayes, M., Huxtable, R., Perkins, A., Noor, N. M., Nickolls, B., & Wade, J. (2023). Complex and alternate consent pathways in clinical trials: Methodological and ethical challenges encountered by underserved groups and a call to action. Trials, 24(1), 151. https://doi.org/10.1186/s13063-023-07159-6
   PubMed Web of Science ®Google Scholar
• Schütz, H., Heinrichs, B., Fuchs, M., & Bauer, A. (2016). Informierte einwilligung in der demenzforschung. eine qualitative studie zum informationsverständnis von probanden. Ethik in Der Medizin, 28(2), 91–106. https://doi.org/10.1007/s00481-015-0359-3
   Google Scholar
• Slaughter, S., Cole, D., Jennings, E., & Reimer, M. (2007). Consent and assent to participate in research from people with dementia. Nursing Ethics, 14(1), 27–40. https://doi.org/10.1177/0969733007071355
   PubMed Web of Science ®Google Scholar
• Smithson, J. (2000). Using and analysing focus groups: Limitations and possibilities. International Journal of Social Research Methodology, 3(2), 103–119. https://doi.org/10.1080/136455700405172
   Google Scholar
• Synnot, A., Ryan, R., Prictor, M., Fetherstonhaugh, D., & Parker, B. (2014). Audio-visual presentation of information for informed consent for participation in clinical trials. The Cochrane Database of Systematic Reviews, 2014(5), CD003717. https://doi.org/10.1002/14651858.CD003717
   PubMedGoogle Scholar
• Thoft, D. S., Ward, A., & Youell, J. (2021). Journey of ethics – Conducting collaborative research with people with dementia. Dementia (London, England), 20(3), 1005–1024. https://doi.org/10.1177/1471301220919887
   PubMedGoogle Scholar
• Tucker, R., Vickers, R., Adams, E., Burgon, C., Lock, J., Goldberg, S., Gladman, J., Masud, T., Orton, E., Timmons, S., & Harwood, R. H. (2023). Factors influencing the commissioning and implementation of health and social care interventions for people with dementia: Commissioner and stakeholder perspectives. MedRxiv the Preprint Service for Health Sciences. https://doi.org/10.1101/2023.03.26.23287750
   Google Scholar
• United Nations. (1991). Resolution 46/119 Principles for the Protection of Persons with Mental Illness and the Improvement of Mental Health Care. United Nations General Assembly.
   Google Scholar
• United Nations. (2006). Convention on the Rights of Persons with Disabilities (CRPD). [online]. https://social.desa.un.org/issues/disability/crpd/convention-on-the-rights-of-persons-with-disabilities-crpd
   Google Scholar
• The UK Network of Dementia Voices (DEEP). (2019). Dementia Enquirers research pack. Carrying out your research project Simple guidance and ideas for DEEP groups. https://www.dementiavoices.org.uk/wp-content/uploads/2019/06/Dementia-Enquirers-Research-Pack.pdf
   Google Scholar
• Wolverson, E., Harrison Dening, K., Gower, Z., Brown, P., Cox, J., McGrath, V., Pepper, A., & Prichard, J. (2023). What are the information needs of people with dementia and their family caregivers when they are admitted to a mental health ward and do current ward patient information leaflets meet their needs? Health Expectations: An International Journal of Public Participation in Health Care and Health Policy, 26(3), 1227–1235. https://doi.org/10.1111/hex.13738
   PubMed Web of Science ®Google Scholar
• World Health Organisation. (2004). WHO Mental Health Policy and Service Guidance Package: Mental Health Legislation and Human Rights (updated version). World Health Organization.
   Google Scholar