Informed consent in clinical trials

Informed Consent and Subject Motivation to Participate in a Large, Population-Based Genomics Study: The Marshfield Clinic Personalized Medicine Research Project

“…There is a vast body of literature on the quality of informed consent procedures, especially in relation to clinical trials of therapeutic agents. Patient recall and comprehension of informed consent has been shown to be relatively low for both therapeutic and non-therapeutic studies [2, 3] and a number of methods have been proposed, but not uniformly adopted, to improve patient comprehension and recall.…”

Enhancing Informed Consent for Research and Treatment

“…An extensive literature consistently reports a variety of problems related to the understanding component of decision making (Taub and Baker 1984;Taub 1986;Verheggen and van Wijmen 1996;Edwards et al 1998;Silva and Sorrell 1988;Sugarman et al 1998;Gotay 1991). These deficits are, however, not restricted to patients with psychiatric diagnoses or cognitive impairments.…”

“…Deficiencies in patients' understanding include lack of awareness of being a subject in a research study; poor recall of supplied information; lack of understanding of randomization procedures and placebo treatments; inadequate recall of important risks of procedures or treatments; lack of awareness of the ability to withdraw from a research study at any time; the "therapeutic misconception" (i.e., the belief that treatment decisions are being made solely with the individual subject's benefit in mind); and confusion about the dual roles of physician/researchers (Levine 1992;Silva and Sorrell 1988;Verheggen and van Wijmen 1996;Edwards et al 1998;Sugarman et al 1998;Robinson and Merav 1976;Muss et al 1979;Cassileth et al 1980).…”

“…Review of these articles' texts and references led to identification of other relevant sources. We also carefully searched a recent annotated bibliography on empirical research on informed consent , as well as several reviews of this topic (Taub and Baker 1984;Taub 1986;Verheggen and van Wijmen 1996;Edwards et al 1998;Silva and Sorrell 1988;Sugarman et al 1998;Gotay 1991).…”

Informed Consent in the Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) Trial: A Survey of Collaborating Physicians

“…However, it is a cumbersome task from the viewpoint of the investigator (1). Both obtaining and giving IC are very complex processes, and especially so in randomized controlled trials (RCTs).…”