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. [ABSTRACT FROM AUTHOR]