The Ethics Of Research With Subjects Who Have Dementia

Author(s): Stephen G. Post, Ph.D.

Background and Module Content

In the major epidemiological study in the U.S., an estimated 47% of persons 85 years and older (the "old-old") had probable AD (Evans, Funkenstein, Albert, et al., 2556). Numbers are roughly equivalent throughout the industrialized western world. According to a Swiss study, 10% of nondemented persons between the ages of 85 and 88 will become demented each year (Aevarsson and Skoog, 1460). Without delaying or preventive interventions, AD will increase proportionately in the U.S. alone from 2.9 million in 1980, to 4.8 million by 2000, to 14.3 million by 2050 as the number of old-old in the United States grows (Evans, Scherr, Cook, et. al., 267-269 and Gladwell, 125-127). Medicine, families, and society have a new problematic of epidemic proportions and financial consequences (Rice, Fox, Max, et. al., 164-176).

Human subjects research in the effort to prevent, delay onset, slow progression, or mitigate the symptoms of Alzheimer Disease (AD) is among the most pressing medical-scientific imperatives of the 21st century and its aging societies. Yet there is considerable disagreement in both principle and practice with respect to the ethics of AD research. The case scenarios presented in this module present largely unresolved and highly debatable issues for discussion, if not for resolution. This course covers the key issues that arise when research is conducted with dementia patients.

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Method and Scenarios

Distribution of scenarios to the students and faculty.

Panel discussion based on those scenarios and questions and any others that students or faculty wish to add.

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Readings (recommended for discussion of scenarios)

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Objectives

  • Understanding of key ethical principles that arise in research with dementia patients/subjects and how these principles are appropriately exercised in such matters.
  • Increased ability to discuss these ethical issues and to prevent misunderstandings.

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Bibliography (for further reading)

Cahill, M, Wichman A., "Research Involving Persons with Cognitive Impairments: Results of a Survey of Alzheimer Disease Research Centers in the United States." Alzheimer Disease and Associated Disorders. 14(1): 20-27; 2000. What is the current practice of federally-funded Alzheimer disease research centers? How is the capacity to consent determined in these settings? These authors asked directors of 29 U.S. Alzheimer Disease research centers funded by the National Institute on Aging to provide policies or guidelines used in their research with cognitively impaired subjects. Additional topics covered: 1) surrogate decision maker; 2) a subject's dissent; 3) risk.

High, D. M., Whitehouse, P. J., Post, S. G., Berg, L., "Guidelines for Addressing Ethical and Legal Issues in Alzheimer Disease Research: A Position Paper." Alzheimer Disease and Associated Disorders (1994) 8 (Suppl. 4): 66-74. This article summarizes a survey of Alzheimer's Disease research centers. It discusses six basic recommendations: 1) recruitment, selection, and enrollment; 2) informed consent; 3) surrogate consent; 4) communicative difficulties; 5) conflict of interest in patient care; 6) risks and potential harms. Because no consensus currently exists regarding acceptable degrees of risk for persons who are cognitively impaired, further national studies should be undertaken.

Kawas, CH, Clark, MC, Farlow, MR, et. al., "Clinical Trials in Alzheimer's Disease: Debate on the Use of Placebo Controls." Alzheimer's Disease and Associated Disorders. 13(3): 124-129; 1999. What is the status of current debate with regard to the ethics of placebo drug trials? How are views on the issue likely to change in the future?

Post, S G., "Why the Tolerance of Potential Harms? Research Ethics in Alzheimer Disease." Accountability in Research 7: 241-253; 1999. What is the current view of the Alzheimer's Association on acceptable risks in research? How has the national debate on acceptable risk unfolded?

For further reading please see the additional Annotated Bibliography

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>Relevant Web Resources

The Alzheimer's Association has several readings on research ethics as well as other ethical issues that arise with respect to patients with dementia.
Ethical And Policy Issues In Research Involving Human Participants by the National Bioethics Advisory Commission
Expert Panel to the National Institutes of Health on Research Involving Individuals with Questionable Capacity to Consent
Cite this page: "The Ethics Of Research With Subjects Who Have Dementia" Online Ethics Center for Engineering 8/17/2006 National Academy of Engineering Accessed: Monday, July 28, 2014 <www.onlineethics.org/Resources/TeachingTools/Modules/19237/ADreseth.aspx>