Improving the quality of consent to randomised controlled trials by using continuous consent and clinician training in the consent process
نویسندگان
چکیده
منابع مشابه
Improving the quality of consent to randomised controlled trials by using continuous consent and clinician training in the consent process.
OBJECTIVE To assess whether continuous consent, a process in which information is given to research participants at different stages in a trial, and clinician training in that process were effective when used by clinicians while gaining consent to the Total Body Hypothermia (TOBY) trial. The TOBY trial is a randomised controlled trial (RCT) investigating the use of whole-body cooling for neonat...
متن کاملCLINICAL ETHICS Improving the quality of consent to randomised controlled trials by using continuous consent and clinician training in the consent process
Objective: To assess whether continuous consent, a process in which information is given to research participants at different stages in a trial, and clinician training in that process were effective when used by clinicians while gaining consent to the Total Body Hypothermia (TOBY) trial. The TOBY trial is a randomised controlled trial (RCT) investigating the use of whole-body cooling for neona...
متن کاملInformed consent for pragmatic trials--the integrated consent model.
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...
متن کاملInforming the consent process.
Because the legal and ethical aspects of informed consent are often foremost in clinicians’ minds, it is easy to forget that the purpose of informed consent is to aid in decision making. Informed consent forms, for example, are often written with legal and institutional priorities in mind,1 and patients in turn assume that the primary purpose of such forms is to protect physicians and their ins...
متن کاملInformed consent in randomised controlled trials: development and preliminary evaluation of a measure of Participatory and Informed Consent (PIC)
BACKGROUND Informed consent (IC) is an ethical and legal prerequisite for trial participation, yet current approaches evaluating participant understanding for IC during recruitment lack consistency. No validated measure has been identified that evaluates participant understanding for IC based on their contributions during consent interactions. This paper outlines the development and formative e...
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ژورنال
عنوان ژورنال: Journal of Medical Ethics
سال: 2006
ISSN: 0306-6800
DOI: 10.1136/jme.2005.013722