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  1. (1 other version)Moving Forward on Consent Practices in Australia.Lisa Eckstein & Rebekah E. McWhirter - 2018 - Journal of Bioethical Inquiry 15 (2):243-257.
    Allowing persons to make an informed choice about their participation in research is a pre-eminent ethical and legal requirement. Almost universally, this requirement has been addressed through the provision of written patient information sheets and consent forms. Researchers and others have raised concerns about the extent to which such forms—particularly given their frequent lengthiness and complexity—provide participants with the tools and knowledge necessary for autonomous decision-making. Concerns are especially pronounced for certain participant groups, such as persons with low literacy and (...)
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  • Ethics Creep or Governance Creep?: Challenges for Australian Human Research Ethics Committees.Susanna M. Gorman - 2011 - Monash Bioethics Review 29 (4):23-38.
    Australian Human Research Ethics Committees have to contend with ever-increasing workloads and responsibilities which go well beyond questions of mere ethics. In this article, I shall examine how the roles of HRECs have changed, and show how this is reflected in the iterations of the National Statement on Ethical Conduct in Human Research 2007. In particular I suggest that the focus of the National Statement has shifted to concentrate on matters of research governance at the expense of research ethics, compounded (...)
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  • Views of clinical trial participants on the readability and their understanding of informed consent documents.Rita Sommers, Cornelius Van Staden & Francois Steffens - 2017 - AJOB Empirical Bioethics 8 (4):277-284.
    Background: One of the ethical imperatives for a valid consent process in clinical medication trials is that the process be guided by and recorded in an informed consent document (ICD). Concerns have been expressed, however, about readability and participant understanding of ICDs, which are often 10–20 pages long. Objective measures of readability and understanding have been used to support these concerns in several articles, but surprisingly the voice of trial participants on ICDs has not been heard in previous studies. Hence, (...)
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  • (1 other version)Moving Forward on Consent Practices in Australia.Rebekah E. McWhirter & Lisa Eckstein - 2018 - Journal of Bioethical Inquiry 15 (2):243-257.
    Allowing persons to make an informed choice about their participation in research is a pre-eminent ethical and legal requirement. Almost universally, this requirement has been addressed through the provision of written patient information sheets and consent forms. Researchers and others have raised concerns about the extent to which such forms—particularly given their frequent lengthiness and complexity—provide participants with the tools and knowledge necessary for autonomous decision-making. Concerns are especially pronounced for certain participant groups, such as persons with low literacy and (...)
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