Center for Bioethics and Social Sciences in Medicine, University of Michigan, 300 North Ingalls 7C27, Ann Arbor, Michigan 48109, USA.
Nat Rev Neurol. 2011 May 24;7(7):410-4. doi: 10.1038/nrneurol.2011.76.
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.
阿尔茨海默病（AD）的临床研究非常必要，但需要有认知障碍的患者参与，而这些患者难以提供知情同意。尽管已经进行了几十年的辩论，但规范此类研究的政策仍未明确界定。尽管许多研究强调了从受 AD 影响的患者那里获得临床研究知情同意的困难，但越来越多的证据表明，这些患者及其代理人可以做出符合患者价值观的研究参与决策。政策讨论和未来的研究应该考虑如何通过开发促进代理人决策与患者价值观一致性的方法来减轻在研究中招募无行为能力患者的道德保留意见。
