Subjects with Dementia in Scientific Research
- The Ethics of Research with Human Subjects who have Dementia
- A teaching module using scenarios and other methods to stimulate discussion of the ethics of doing research with people in various stages of Alzheimer's Disease.
- The Ethics of Research with Vulnerable Populations
- A teaching module using scenarios and other methods to stimulate discussion of the ethics research with vulnerable populations such as children, mentally ill subjects, and subjects with dementia.
- Gene Therapy for Alzheimer's Disease
- A scenario about research with patients who have dementia meant to stimulate discussion about the ethical issues that arise in this type of research.
- A Cognitive Enhancing Drug Requiring Blood Draws
- A scenario about research in which blood is drawn from patients with dementia who cannot understand why it is being drawn.
- An Anti-Oxident Compound to Slow Progression
- A scenario meant to stimulate discussion about the ethical issues that arise when study designs must include placebo controls and lengthy participation by Alzheimer's patients.
- Post-Menopausal Women at Risk
- A scenario meant to stimulate discussion about the ethical issues that arise in randomized research trials studying the effects of hormones on thwarting Alzheimer's Disease in women who are particularly susceptible to the disease.
- Part I and Part II, Explanation of Federal Regulations (45CFR46) on research with human subjects.
- Reading Questions
- Federal Regulations on research with human subjects.
- Research Involving Persons With Mental Disorders That May Affect Decisionmaking Capacity,
- The National Bioethics Advisory Commission's report.
- Reading Questions for The National Bioethics Advisory Commission's report on Research Involving Persons With Mental Disorders That May Affect Decisionmaking Capacity
Relevant Web Resources
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- The Alzheimer's Association has an Ethical Issues in Dementia reading list
- Contains readings on research ethics as well as other ethical issues that arise with respect to patients with dementia.
- National Bioethics Advisory Commission Ethical and Policy Issues in Research Involving Human Participants
- Includes a summary, appendices, commissoned papers and staff analysis.
- Expert Panel to the National Institutes of Health on Research Involving Individuals with Questionable Capacity to Consent
- DOE's Radiation Research Using Human Subjects
- Helsinki Declaration of the World Medical Association
- on Biomedical Research Using Human Subjects
- Guidelines for the Conduct of Research Involving Human Subjects at the National Institutes of Health
- Canadian Code of Conduct for Research Involving Humans
Relevant Literature on this Topic
- 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?
In-depth Annotated Bibliography of the above items.
- Whitbeck, Caroline. 1998. Ethics in Engineering Practice and Research.
- New York: Cambridge University Press. Other keywords for this article: ethics and prudence; preferences vs. values; negligence; trust, distrust; ambiguity; moral ambiguity; responsibilities, general; professional responsibility; public safety; worker safety;laboratory safety; design process; engineering competence;environmental issues, global; environmental issues, chemical;conflict of interest; ethical codes and guidelines from professional societies; harassment, sexual harassment and aggression; workplace relationships; research misconduct;falsification and fabrication; plagiarism; authorship; animals in scientific research.