Recall of informed consent information by healthy volunteers in clinical trials
نویسندگان
چکیده
منابع مشابه
Recall of informed consent information by healthy volunteers in clinical trials.
BACKGROUND Information sheets for clinical research are becoming increasingly complex but the extent to which they are understood is uncertain. AIMS To assess, as our primary outcome, recall by healthy volunteers of key facts in a patient information sheet in a phase 3 clinical trial. As secondary outcomes, we examined whether there was a difference between medical student and non-medically t...
متن کاملInformed consent for clinical trials: a review.
OBJECTIVE To identify and highlight challenges related to informed consent process for clinical trials in sub-Saharan Africa. DATA SOURCES Published original research findings and reviews in the English literature, together with anecdotal information from our current professional experiences with clinical trials. DESIGN Review of peer-reviewed articles. DATA EXTRACTION Online searches wer...
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The primary goal of the thousands of registered trials in cancer research is to extend survival. With evaluation of efficacy, safety, and tolerability, healthcare providers must ensure that the principles described in the Belmont Report are upheld and that patients are truly informed when signing a consent form. In this article, two cases are highlighted, and reasons for participating in clinic...
متن کاملreadability of informed consent forms in clinical trials conducted in a skin research center
obtaining informed consents is one of the most fundamental principles in conducting a clinical trial. in order for the consent to be informed, the patient must receive and comprehend the information appropriately. complexity of the consent form is a common problem that has been shown to be a major barrier to comprehension for many patients. the objective of this study was to assess the readabil...
متن کاملAspects of vulnerable patients and informed consent in clinical trials
SCOPE To discuss the rationale behind informed consent in clinical trials focusing on vulnerable patients from a European and German viewpoint. METHODS Scientific literature search via PubMed, Medline, Google. RESULTS Voluntary informed consent is the cornerstone of policies regulating clinical trials. To enroll a patient into a clinical trial without having obtained written and signed cons...
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ژورنال
عنوان ژورنال: QJM
سال: 2008
ISSN: 1460-2725,1460-2393
DOI: 10.1093/qjmed/hcn067