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• W2143443178 abstract "Informed consent in human research involves a process of communicating informationabout a research study so as to promote informed decision-making. Current researchsuggests, however, that a high proportion of participants do not fully understand what itis they are consenting to when enrolling onto a research study. In other words, for manyparticipants consent to participate in research is not truly informed. Evaluatinginformed consent information through the use ofcomprehension tests is one possible method for increasing the likelihood that consent totake part in research is truly informed. This thesis, therefore, comprises a series of bothqualitative and quantitative studies that build upon one another culminating in thedevelopmentcomprehension of informed consent information.Assessments of readability provide a preliminary indication of document complexity interms of writing style (word choice, sentence length). Therefore, a small-scaledescriptive study, as described in Chapter 2, was conducted: i) to measure thereadability of Australian-based clinical trial informed consent documents; and ii) todetermine whether national or local ethics committees within Australia have formallyestablished informed consent readability standards. The results of the study revealedthat the majority of informed consent documents were written at a reading levelappropriate for individuals with some university education thus beyond the readingability of a majority of Australian adults. Official readability recommendations and/orstandards could not be located at the national or local level.One method of gathering evidence of informed consent comprehension is through theuse of comprehension tests. Chapter 3 consists of a systematic review, which identifiesand critically evaluates instruments that have been developed to measure clinical trialinformed consent comprehension in non-cognitively impaired adults. A total of threeinstruments were identified. Strengths and limitations of each instrument wereevaluated against the following criteria: i) method of item generation; ii) type and format of test items; iii) administration and interpretation of test results; and iv)psychometric properties.None of the instruments identified in Chapter 3 were developed based on a constructdefinition. This may be due to the absence of an accepted construct definition ofinformed consent comprehension. A construct definition provides a framework fordetermining how an instrument should be constructed, implemented, interpreted andapplied. Furthermore, the validity of what is being measured will rest largely on thatdefinition. Chapter 4 describes and reports on the results of a qualitative study,involving an international expert panel, which was conducted to develop consensus fora construct definition of informed consent comprehension.The construct definition proposed in Chapter 4 was utilized as the conceptualframework for the development a new of informed consent comprehension instrument,called the Modular Informed Consent…" @default.
• W2143443178 created "2016-06-24" @default.
• W2143443178 creator A5031844521 @default.
• W2143443178 date "2009-01-01" @default.
• W2143443178 modified "2023-09-27" @default.
• W2143443178 title "Developing an instrument to measure informed consent comprehension in non-cognitively impaired adults" @default.
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