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  1. Informed consent as an ethical requirement in clinical trials: an old, but still unresolved issue. An observational study to evaluate patient's informed consent comprehension.Virginia Sanchini, Michele Reni, Giliola Calori, Elisabetta Riva & Massimo Reichlin - 2014 - Journal of Medical Ethics 40 (4):269-275.
    We explored the comprehension of the informed consent in 77 cancer patients previously enrolled in randomised phase II or phase III clinical trials, between March and July 2011, at the San Raffaele Scientific Institute in Milano. We asked participants to complete an ad hoc questionnaire and analysed their answers. Sixty-two per cent of the patients understood the purpose and nature of the trial they were participating in; 44% understood the study procedures and 40% correctly listed at least one of the (...)
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  • Informed consent in paediatric critical care research – a South African perspective.Brenda M. Morrow, Andrew C. Argent & Sharon Kling - 2015 - BMC Medical Ethics 16 (1):62.
    Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe, efficacious treatment. In South Africa and other low and middle-income countries, research is needed to optimise care and ensure rational, equitable allocation of scare paediatric critical care resources.
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  • An exploratory study of therapeutic misconception among incarcerated clinical trial participants.Paul P. Christopher, Michael D. Stein, Sandra A. Springer, Josiah D. Rich, Jennifer E. Johnson & Charles W. Lidz - 2016 - AJOB Empirical Bioethics 7 (1):24-30.
    Background: Therapeutic misconception, the misunderstanding of differences between research and clinical care, is widely prevalent among non-incarcerated trial participants. However, little attention has been paid to its presence among individuals who participate in research while incarcerated. Methods: This study examined the extent to which 72 incarcerated individuals may experience therapeutic misconception about their participation in one of six clinical trials, and its correlation with participant characteristics and potential influences on research participation. Results: On average, participants endorsed 70% of items suggestive (...)
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