Application of a Readability Score in Informed Consent forms for Clinical Studies

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readability 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...

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Readability 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...

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Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China

PURPOSE To explore the readability and content integrity of informed consent forms (ICFs) used in China and to compare the quality of Chinese local ICFs with that of international ICFs. METHODS The length, readability and content of 155 consent documents from phase II-IV drug clinical trials from the Third Xiangya Hospital Ethics Committee from November 2009 to January 2015 were evaluated. Re...

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Readability standards for informed-consent forms as compared with actual readability.

BACKGROUND Institutional review boards (IRBs) are charged with safeguarding potential research subjects with limited literacy but may have an inadvertent role in promulgating unreadable consent forms. We hypothesized that text provided by IRBs in informed-consent forms falls short of the IRBs' own readability standards and that readability is influenced by the level of research activity, local ...

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[Readability of surgical informed consent in Spain].

INTRODUCTION To assess the readability of informed consent documents (IC) of the different national surgical societies. METHODS During January 2012 we collected 504 IC protocols of different specialties. To calculate readability parameters the following criteria were assessed: number of words, syllables and phrases, syllables/word and word/phrase averages, Word correlation index, Flesch-Szigr...

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ژورنال

عنوان ژورنال: Journal of Clinical Research & Bioethics

سال: 2013

ISSN: 2155-9627

DOI: 10.4172/2155-9627.1000156