Abstract Clinical research for Alzheimer’s disease is essential, yet ethically complex, as cognitive impairment often hinders the informed consent process for the required human subjects. Research advance directives (RADs), which allow individuals to document future research wishes while capacitated, are often proposed to protect precedent autonomy. Some scholars have championed RADs, but we contend that upholding patient autonomy relies on a "tripod" of interrelated components. First, capacity assessment is essential to determine when a research advance directive takes effect or if a patient retains the ability to rescind it. Second, surrogate decision-making remains indispensable. Surrogates must navigate the difficult substituted judgment standard for complex trials and are crucial for interpreting a patient’s best interests or resolving conflicts when an incapacitated patient’s current preferences diverge from their past directive. Third, the research advance directive itself serves as vital evidence of the patient’s values. We conclude that research advance directives must function alongside robust capacity assessment and active surrogate involvement to balance patient legacy interests with their current well-being, facilitating ethical research.
Omelianchuk et al. (Wed,) studied this question.