Sachs Greg A
Department of Medicine, University of Chicago, Illinois.
Alzheimer Dis Assoc Disord. 1994;8(Suppl. 4):19-27.
Informed consent is a fundamental ethical concern for dementia research that involves the participation of human subjects. The central dilemma is how to obtain valid informed consent from a population of potential subjects who are losing their decision-making capacity while still providing adequate protection for this vulnerable group of people. One model for informed consent for dementia research would be to obtain consent in advance of the loss of decision-making capacity, perhaps using written advance directives similar to those used for clinical decisions on life-sustaining treatments. This article examines the advance consent model, contrasts the life-sustaining treatment arena with dementia research issues, and suggests that written advance consent should not be required to conduct dementia research. Instead, an argument is presented in favor of a more informal advance consent process that builds upon the existing practice of using subject assent plus proxy consent.
知情同意是涉及人类受试者参与的痴呆症研究的一个基本伦理问题。核心困境在于如何从一群正在丧失决策能力的潜在受试者中获得有效的知情同意，同时仍为这一弱势群体提供充分保护。痴呆症研究的一种知情同意模式是在丧失决策能力之前获得同意，或许可以使用类似于用于维持生命治疗的临床决策的书面预先指示。本文探讨了预先同意模式，将维持生命治疗领域与痴呆症研究问题进行了对比，并表明进行痴呆症研究不应要求书面预先同意。相反，本文提出了一种支持更非正式的预先同意程序的观点，该程序建立在使用受试者同意加代理人同意的现有做法之上。
