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Clinical research on Alzheimer disease (AD) is much needed but requires the participation of patients with substantial cognitive impairment who have difficulty providing informed consent.
Despite decades of debate, policies regulating such research are not well-defined. Although numerous studies have underscored the difficulties of obtaining informed consent for clinical
research from patients compromised by AD, there is also increasing evidence that such individuals and their surrogates can make decisions about research participation that are consistent
with the patients' values. Policy discussions and future research should consider how the ethical reservations about enrolling incapacitated patients in research could be mitigated by
developing ways to promote the congruence between surrogates' decisions and patients' values.
The author's work is supported in part by grants R01-AG029550 and R01-MH075023 from the NIH, and by the Greenwall Foundation Faculty Scholars in Bioethics Award. The author also thanks
Raymond De Vries for critical feedback on earlier drafts of this article, Kerry Ryan for editorial assistance, and the reviewers for excellent suggestions to improve the paper.
Center for Bioethics and Social Sciences in Medicine, University of Michigan, 300 North Ingalls 7C27, Ann Arbor, 48109, Michigan, USA
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