Hostname: page-component-cd9895bd7-fscjk Total loading time: 0 Render date: 2024-12-18T12:46:10.845Z Has data issue: false hasContentIssue false
  • English
  • Français

Fear of Dementia and the Obligation to Provide Aggregate Research Results to Study Participants

Published online by Cambridge University Press:  18 November 2022

Mackenzie Graham ,
Francesca Farina ,
Craig W. Ritchie ,
Brian Lawlor  and
Lorina Naci
Mackenzie Graham
Affiliation:
1Wellcome Centre for Ethics and Humanities, University of Oxford, Oxford, UK
Francesca Farina
Affiliation:
2Feinberg School of Medicine, Northwestern University, Chicago, USA
Craig W. Ritchie
Affiliation:
3Edinburgh Dementia Prevention, University of Edinburgh, Edinburgh, UK
Brian Lawlor
Affiliation:
4Trinity College Institute of Neuroscience, School of Psychology, Trinity College Dublin, Dublin, Ireland and Global Brain Health Institute, Trinity College Dublin, Dublin, Ireland
Lorina Naci*
Affiliation:
4Trinity College Institute of Neuroscience, School of Psychology, Trinity College Dublin, Dublin, Ireland and Global Brain Health Institute, Trinity College Dublin, Dublin, Ireland
*
*Corresponding author. Email: [email protected]
Get access Rights & Permissions [Opens in a new window]

Abstract

A general obligation to make aggregate research results available to participants has been widely supported in the bioethics literature. However, dementia research presents several challenges to this perspective, particularly because of the fear associated with developing dementia. The authors argue that considerations of respect for persons, beneficence, and justice fail to justify an obligation to make aggregate research results available to participants in dementia research. Nevertheless, there are positive reasons in favor of making aggregate research results available; when the decision is made to do so, it is critical that a clear strategy for communicating results is developed, including what support will be provided to participants receiving aggregate research results.

Keywords

DementiaAlzheimer’s diseasebiomarkersimagingethicsresearch results
Type
Research Article
Information
Cambridge Quarterly of Healthcare Ethics , Volume 31 , Issue 4 , October 2022 , pp. 498 - 505
Copyright
© The Author(s), 2022. Published by Cambridge University Press

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Notes

1. World Health Organization (WHO). Global Status Report on the Public Health Response to Dementia. Geneva: World Health Organization; 2021; available at https://www.who.int/publications/i/item/9789240033245 Accessed March 1, 2022.

2. See note 1, WHO 2021.

3. van der Flier, RM, Scheltens, P. Epidemiology and risk factors of dementia. Journal of Neurology, Neurosurgery, and Psychiatry 2005;76:v2–7 CrossRefGoogle ScholarPubMed.

4. See note 1, WHO 2021.

5. Dubois, B, Hampel, H, Feldman, HH, Scheltens, P, Aisen, P, Andrieu, S, et al. Preclinical Alzheimer’s disease: Definition, natural history, and diagnostic criteria. Alzheimer’s and Dementia 2016;12(3):292–323 CrossRefGoogle ScholarPubMed.

6. Molinuevo, JL, Cami, J, Carne, X, Carrillo, MC, Georges, J, Isaac, MB, et al. Ethical challenges in preclinical Alzheimer’s disease observational studies and trials: Results of the Barcelona summit. Alzheimer’s and Dementia 2016;12(5):614–22CrossRefGoogle ScholarPubMed.

7. See note 5, Dubois 2016.

8. See note 5, Dubois 2016.

9. Milne, R, Bunnik, E, Diaz, A, Richard, E, Badger, S, Gove, D, et al. Perspectives on communicating biomarker-based assessments of Alzheimer’s disease to cognitively healthy individuals. Journal of Alzheimer’s Disease 2018;62(2):487–98CrossRefGoogle ScholarPubMed.

10. Fox, C, Lafortune, L, Boustani, M, Brayne, C. The pros and cons of early diagnosis in dementia. British Journal of General Practice 2013;65(612):e510–2 CrossRefGoogle Scholar.

11. Neumann, PJ, Hammitt, JK, Mueller, C, Fillit, HM, Hill, J, Tetteh, NA, et al. Public attitudes about genetic testing for Alzheimer’s disease. Health Affairs 2001;20(5):252–64CrossRefGoogle ScholarPubMed.

12. Caselli, R, Langbaum, J, Marchant, GE, Lindor, RA, Hunt, KS, Henslin, BR, et al. Public perceptions of presymptomatic testing for Alzheimer’s disease. Mayo Clinic Proceedings 2014;89(10):1389–96CrossRefGoogle Scholar.

13. Goobler, J, Roe, CM, Selsor, NJ, Gabel, MJ, Morris, JC. Attitudes of research participants and the general public regarding disclosure of Alzheimer’s disease research results. JAMA Neurology 2015;72(12):1484–90CrossRefGoogle Scholar.

14. Robinson, L, Dickinson, C, Magklara, E, Newton, L, Prato, L, Bamford, C. Proactive approaches to identifying dementia and dementia risk: A qualitative study of public attitudes and preferences. BMJ Open 2018;8(2):e018677CrossRefGoogle Scholar.

15. See note 13, Gooblar 2015.

16. Partridge, AH, Winer, EP. Informing trial participants about study results. JAMA 2002;288(3):363–5CrossRefGoogle ScholarPubMed.

17. Fernandez, CV, Kodish, E, Weijer, C. Informing study participants of research results: An ethical imperative. IRB 2003;25(3):12–9CrossRefGoogle Scholar.

18. Shalowitz, DI, Miller, FG. Disclosing individual results of clinical research: Implications of respect for persons. JAMA 2005;294(6):737–40CrossRefGoogle Scholar.

19. Beskow, LM, Burke, W, Fullerton, SM, Sharp, R. Offering aggregate results to participants in genomic research: Opportunities and challenges. Genetics in Medicine 2012;14:490–6CrossRefGoogle ScholarPubMed.

20. Miller, FA, Christensen, R, Giacomini, M, Robert, JS. Duty to disclose what? Querying the putative obligation to return research results to participants. Journal of Medical Ethics 2008;34(3):210–3Google ScholarPubMed.

21. Knoppers, BM, Joly, Y, Simard, J, Durocher, F. The emergence of an ethical duty to disclose genetic research results: International perspectives. European Journal of Human Genetics 2006;14(11):1170–8CrossRefGoogle ScholarPubMed.

22. Kessler, EM, Bowen, CE, Baer, M, Froelich, L, Wahl, HW. Dementia worry: A psychological examination of an unexplored phenomenon. European Journal of Aging 2012;9(4):275–84CrossRefGoogle ScholarPubMed.

23. See note 22, Kessler 2012.

24. Kinzer, A, Suhr, JA. Dementia worry and its relationship to dementia exposure, psychological factors, and subjective memory concerns. Applied Neuropsychology Adult 2016;23(3):196–204 CrossRefGoogle ScholarPubMed.

25. Caughie, C, Bean, P, Tiede, P, Cobb, J, McFarland, C, Hall, S. Dementia worry and neuropsychological performance in health older adults. Archives of Clinical Neuropsychology 2020;36(1):29–36 CrossRefGoogle Scholar.

26. Roberts, JR, Maxfield, M. A 2-study psychometric evaluation of the modified dementia worry scale. American Journal of Alzheimer’s Disease and Other Dementias 2021;36 Google ScholarPubMed:1533317521995322.

27. See note 22, Kessler 2012.

28. See note 24, Kinzer 2016.

29. Cutler, SJ, Bragaru, C. Do worries about cognitive functioning and concerns about developing Alzheimer’s disease affect psychological well-being? Journal of Aging and Health 2017;29(8):1271–87CrossRefGoogle ScholarPubMed.

30. Lineweaver, TT, Bondi, MW, Galasko, D, Salmon, DP. Effect of knowledge of APOE genot ype on subjective and objective memor y performance in health y older adults. American Journal of Ps ychiatr y 2014;171(2):201–8CrossRefGoogle Scholar.

31. See note 24, Kinzer 2016.

32. Freeson, M, Dardenne, B, Geurten, M, Meulemans, T. The effect of stereotype threat on older people’s clinical cognitive outcomes: Investigating the moderating role of dementia worry. The Clinical Neuropsychologist 2017;31(8):1306–28CrossRefGoogle Scholar.

33. See note 26, Roberts 2021

34. Fratiglioni, L, Paillard-Borg, S, Winblad, B. An active and socially integrated lifestyle in late life might protect against dementia. Lancet Neurology 2004;3(6):343–53CrossRefGoogle ScholarPubMed.

35. Farina, FR, Bennett, M, Griffith, JW, Lenaert, B. Fear of memory loss predicts increased memory failures and lower quality of life in older adults: Preliminary findings from a fear-avoidance of memory loss (FAM) scale. Aging and Mental Health 2022;26(3):486–92CrossRefGoogle ScholarPubMed.

36. See note 24, Kinzer 2016.

37. See note 24, Kinzer 2016.

38. McWhirter, L, Ritchie, C, Stone, J, Carson, A. Functional cognitive disorders: A systematic review. Lancet Psychiatry 2020;7(2):191–207 CrossRefGoogle ScholarPubMed.

39. PREVENT Dementia Study; 2022 available at https://preventdementia.co.uk/ (last accessed 7 March 2022).

40. See note 17, Fernandez 2003.

41. Parfit D. On What Matters, Vol. I. Oxford: Oxford University Press; 2011.

42. Beauchamp, TL, Childress, JF. Principles of Biomedical Ethics. 8th ed. Oxford: Oxford University Press; 2019 Google ScholarPubMed.

43. See note 18, Shalowitz 2005.

44. Meltzer, LA. Undesirable implications of disclosing individual genetic results to research participants. American Journal of Bioethics 2006;6(6):28–30 CrossRefGoogle ScholarPubMed.

45. Tiffin, N. Potential risks and solutions for sharing genome summary data from African populations. BMC Medical Genomics 2019;12:152 CrossRefGoogle ScholarPubMed.

46. See note 19, Beskow 2012.

47. Seiffert, DJ, Veach, PM, LeRoy, B, Guan, W, Zierhut, H. Beyond medical actionability: Public perceptions of important actions in response to hypothetical genetic testing results. Journal of Genetic Counselling 2019;28(2):355–66CrossRefGoogle ScholarPubMed.

48. Long, C, Stewart, MK, McElfish, P. Health research participants are not receiving research results: Acollaborative solution is needed. Trials 2017;18:449 CrossRefGoogle ScholarPubMed.

49. See note 17, Fernandez 2003.