OBJECTIVE One of the basic issues in clinical studies is to receive the informed consent; that is to say, all the activities applied in patient's involvement in the information, decision-making, ability and volunteering in diagnosis, cure and care. In as much as most cancer patients require information about their individual needs, the present study is conducted to determine the perceived infor...

This study examined perceptions of the informed consent process in healthy men participating in a cancer prevention clinical trial. Specifically, we examined influence of the consent form on participation and understanding, adequacy of the consent process in preparing participants for trial experiences, and perceived needs for additional follow-up strategies. Participants (n = 69) enrolled in t...

OBJECTIVE Patients are commonly presented with complex documents that they have difficulty understanding. The objective of this study was to design and evaluate an animated computer agent to explain research consent forms to potential research participants. METHODS Subjects were invited to participate in a simulated consent process for a study involving a genetic repository. Explanation of th...

This study examined perceptions of the informed consent process in healthy men participating in a cancer prevention clinical trial. Specifically, we examined influence of the consent form on participation and understanding, adequacy of the consent process in preparing participants for trial experiences, and perceived needs for additional follow-up strategies. Participants (n 69) enrolled in the...

BACKGROUND There is an urgent need to assess and improve the consent process in clinical trials of innovative therapies for neurodegenerative disorders. METHODS We performed a longitudinal study of the consent of Huntington's disease patients during the Multicenter Fetal Cell Intracerebral Grafting Trial in Huntington's Disease (MIG-HD) in France and Belgium. Patients and their proxies comple...

OBJECTIVE To analyse the completeness of written consent for laparoscopic tubal occlusion and to consider the medico-legal implications of incomplete written consent. METHODS A retrospective review was undertaken of the medical records of all women who had laparoscopic tubal occlusion in 2006 in a district general hospital to elicit details of risks of the procedure as recorded on the consent...

Over the past third of a century, there has been a revolution in the way that health-care providers and patients make most medical decisions. Paternalism has slowly gone the way of the long-play record, and in its place has emerged a consent process in which the patient is a more fully informed and active participant. This process takes time however, and for the busy health-care provider there ...

Standards expected by doctors' regulatory bodies in respect of the process of consent to treatment have arguably sought to restructure the nature of the doctor-patient relationship from one of the paternalism to that of shared decision-making. Yet, few studies have explored empirically, from patients' perspectives, the extent to which the process of consent to treatment enables or disables pati...