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

Abstract

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.

Cutting-edge issues in sympathetic ophthalmia approach and six case reports: a T cell-mediated autoimmune response

“…However, severe involvement can lead to posterior synechiae formation. The blockade of inflammatory cells in the trabecular meshwork and inflammation of the ciliary body may increase the intraocular pressure, which may further reduce the secondary involvement of the ciliary body (5,9,10) .…”

“…Moderate-to-severe vitreitis with yellowish-white choroidal lesions in the posterior pole, equator, and middle periphery of the retina, known as Dalen-Fuchs nodules, may be present. Other granulomatous inflammatory ophthalmic pathologies may also present with Dalen-Fuchs nodules, including VKH syndrome and sarcoidosis (6,7,9) . The inflammation can also lead to serous retinal detachment (SRD); optic nerve edema; cataracts; glaucoma; choroidal neovascularization; subretinal fibrosis; optic nerve, retinal, or choroidal atrophy; and phthisis bulbi (5)(6)(7)11) .…”

“…In addition, no laboratory studies have established a diagnosis. However, targeted clinical tests can be used to rule out other entities with a similar clinical presentation (4,8,9) . In addition to laboratory tests, imaging examinations such as B-mode ocular ultrasonography, OCT, FA, and indocyanine green angiography can elucidate the condition and rule out infectious causes of uveitis (6,10,11,13) .…”

“…Occasionally, late staining of the optic nerve head is observed even in the absence of clinical papillitis or edema (5,9,10,13) . As the process predominantly involves the choroid, indocyanine green angiography can complement FA both for diagnosis and assessment of treatment response.…”

Cluster randomised trials of prescribing policy: an ethical approach to generating drug safety evidence? A discussion of the ethical application of a new research method

“…Indeed, some believe a lack of individual informed consent means that a study cannot ethically proceed [24]. Currently accepted methods of informing patients about research studies are not always effective at achieving these aims [25,26]. Also, obtaining individual consent can significantly add to the cost and duration of a study [27][28][29][30] and may damage the generalisability of findings by restricting recruitment to more motivated and literate participants [31,32].…”