Informing for consent: Concepts and methods

Consent doctrine seeks to protect individual autonomy and self-determination of potential subjects or patients. It was created and mandated in reaction to perceived abuses in patient/subject and healthcare professional relationships. In part because of the speed in which these occurred, the doctrine was created as an imperative in the absence of solid theoretical and empirical bases on how people acquire and use information. The Informing for Consent framework is presented so that the mandates of consent can be more fully examined. The implications of this framework and the need for empirical study are discussed with reference to the following areas: when children become competent to self-consent and for which areas in decision making; when competence to self-consent changes during poor physical or mental health; when people become unable to consent; and when protections such as surrogate decision makers should be instituted or removed. The implications to individual professionals and to regulatory bodies are also discussed.