Improving informed consent: insights from behavioral decision research.

Abstract

With publication of The Belmont Report concerning ethical principles, informed consent gained explicit guidelines for the protection of human subjects of research. However, there is still little evidence about how well informed consent works to assist patients to reach informed decisions about research participation. To review behavioral decision theory and research to identify implications for informed consent. Traditional literature review and hand search of literature were used. Psychological research on biases and heuristics identifies cognitive biases in information processing (selection and interpretation of risks and benefits) that have implications for improving the informing process. A growing literature on patient decision aids provides evidence for the feasibility of more fully informing patients, and includes examples of "debiasing" procedures (to improve information comprehension and consent). Informing and consenting involve conceptually different challenges concerning effectiveness versus values. Debiasing techniques need to be developed and empirically tested to determine their effectiveness in informing patients. Consenting involves both social and individual values. Appealing to altruism when summarizing the goals of research may increase research participation and does not necessarily violate voluntariness of informed consent. Additional research is needed to determine when information-processing biases occur problematically in health-related informed consent, and whether appealing to altruism increases research participation.