Informed Consent in the Twenty-First Century: What It Is, What It Isn't, and Future Challenges in Informed Consent and Shared Decision Making

Consent evolved from judge-made law in Great Britain in 1767. The term informed consent entered the judicial lexicon in 1957. The first court case to articulate a reasonable person standard adopted by the high courts in Canada and Australia was heard in the U.S. in 1972. Today, informed consent continues to develop in four areas: (i) the court-based doctrines of consent and informed consent in clinical care in judge-made law; (ii) federal regulations related to research on human study participants; (iii) shared decision making adopted by care organizations and medical societies in the US, Canada, and Europe; and (iv) areas including decision analysis, discourse analysis, ethics, linguistic analysis, patient–physician communication, risk and evidence communication, and social theory. In this paper, we will focus on consent and informed consent in the first part of the twenty-first century. We will examine a range of information and decision making frameworks from the oldest court-established frameworks of consent and informed consent to recent conceptions of information and decision making in evidence-based decision making and shared decision making in the patient–physician relationship. This paper is divided into three parts: I. What informed consent is, II. What informed consent isn't, and III. Future challenges in informed consent and shared decision making.