The reliance of subjects and researchers on the current regulatory scheme for human subject protection is misplaced. Investigators often assume that compliance with the requirements of the Common Rule, including Institutional Review Board approval of their research project, adequately fulfills the spirit of the federal regulation and protects them from liability for lack of adequate informed co...

Learning health care systems hold great promise for improving medical care by systematically integrating the delivery of medical services with clinical research. In such systems, the generation of knowledge would be “embedded into the core of the practice of medicine,” leading to “continual improvement in care.”1 But is the goal of systematically integrating knowledge generation with health car...

liability protection The Supreme Court of Canada has described obtaining consent as a process, not merely paperwork. Vol. 3, No. 2, December 1994 Consent may be implicit or explicit. Holding out an arm to have a blood pressure taken is implicit consent, whereas an ECG or blood gases may require explicit consent. The main types of consent in the health care setting are general consent as require...

BACKGROUND In studies publishing identifying personal information, obtaining consent is regarded as necessary, as it is impossible to ensure complete anonymity. However, current journal practices around specific points to consider when obtaining consent, the contents of consent forms and how consent forms are managed have not yet been fully examined. This study was conducted to identify potenti...

One policy tool that could be deployed to increase organ donation rates is legislative defaults. Currently, there are two legislative regimes: “informed consent”, in which an explicit declaration makes the person a potential organ donor; and “presumed consent”, in which an explicit declaration is required for not being a potential donor. In this study, we examine how an institutional setting, n...

Two types of legislation underlie cadaveric organ donations: presumed consent (PC) and informed consent (IC). In informed consent countries, people are only donors when deceased if they registered to do so while alive. Conversely, in presumed consent countries, anybody is a potential donor when deceased. People have thus to register if they do not want to donate their body. PC has always been p...

objective: this study was conducted to identify the characteristics of patients with psychosis who had escaped from hospital or were discharged prematurely and against medical advice. method: we carried out this retrospective study on 72 patients with psychosis who were discharged prematurely over a 38-month period and compared them to 76 patients with psychosis who were discharged according to...