Lidz offers a new critique of what he calls the ''strong version'' of informed consent.
The critique is part of the larger question ''How should we define ethical research?''. He describes a formal model
where I is adequate information about the nature, risks, and benefits of a clinical experiment, C represents competence, U represents understanding, V represents voluntary consent, and D represents an ethically valid decision. His focus is on the therapeutic misconception (TM), which biases patients in clinical trials to misinterpret the nature of the research or the intent of the researchers. Because of TM, subjects may not achieve adequate understanding despite formally appropriate methods of conveying information. The absence of understanding implies that subjects are incompetent to make ethically valid decisions about their participation in experiments. Lidz argues that this implication is actually incorrect, and he asks us to ''rethink the overly rationalistic ideas about decision making that are often imbedded in discussions of informed consent.'' This commentary will build on Lidz's argument from the perspective of clinicians and clinical investigators. We believe that the neurobiology of social cognition supports Lidz's request to ''rethink'' how subjects make decisions in the research setting. We first focus on why patients agree to participate in research, and then offer ideas on how to address TM, and conclude that ethical research requires a stronger safeguard than a reflex dependence on voluntary informed consent.
A body of research in social cognition indicates that when people evaluate information, this evaluation is affected by the source of the information. We evaluate facts reported in the National Enquirer differently from how we evaluate information in the Wall Street Journal, even though the information may be formally the same. When we invite patients to give their voluntary, informed consent, they evaluate not just the research proposal, but the researchers, the research institution, and in fact the very idea of research. Before a potential subject even thinks about the research proposal, he is considering whether he believes the source of the information, namely the researchers. Lidz argues that patients have conceptions about research