Autonomy, Desperation, and Consent In Experimental Medicine

The most salient bioethics principle in American medical care is respect for autonomous decision-making. This principle of autonomy is established in law through ‘informed consent’ rules, which have been refined in American law for more than a century. Desperately ill individuals who enroll in research trials often believe they are accessing new therapies that will benefit them personally, even when the consent forms they sign explicitly state that no benefit is promised. This ‘therapeutic misconception’ and related autonomy-based concerns cast doubt on the genuineness of informed consent obtained from desperately ill patients enrolling in research trials. Related concerns about comprehension and consent have shaped debates about whether terminally ill patients should have access to experimental medical products outside of research trials. Suggestions are offered for enhancing informed consent by desperately ill patients and for alternatives to steering them towards research trials.