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The normative status of the requirement to gain an informed consent in clinical trials : Comprehension, obligations, and empirical evidence

In Oonagh Corrigan (ed.), The limits of consent: a socio-ethical approach to human subject research in medicine. New York: Oxford University Press (2009)

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  1. Research Exceptionalism.James Wilson & David Hunter - 2010 - American Journal of Bioethics 10 (8):45-54.
    Research involving human subjects is much more stringently regulated than many other nonresearch activities that appear to be at least as risky. A number of prominent figures now argue that research is overregulated. We argue that the reasons typically offered to justify the present system of research regulation fail to show that research should be subject to more stringent regulation than other equally risky activities. However, there are three often overlooked reasons for thinking that research should be treated as a (...)
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  • Public health research ethics: A research agenda.Marcel Verweij & Angus Dawson - 2009 - Public Health Ethics 2 (1):1-6.
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  • Trust in farm data sharing: reflections on the EU code of conduct for agricultural data sharing.Simone van der Burg, Leanne Wiseman & Jovana Krkeljas - 2020 - Ethics and Information Technology 23 (3):185-198.
    Digital farming technologies promise to help farmers make well-informed decisions that improve the quality and quantity of their production, with less labour and less impact on the environment. This future, however, can only become a reality if farmers are willing to share their data with agribusinesses that develop digital technologies. To foster trust in data sharing, in Europe the EU Code of Conduct for agricultural data sharing by contractual agreement was launched in 2018 which encourages transparency about data use. This (...)
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  • Cancer clinical trial participants' assessment of risk and benefit.Connie M. Ulrich, Sarah J. Ratcliffe, Gwenyth R. Wallen, Qiuping Zhou, Kathleen Knafl & Christine Grady - 2016 - AJOB Empirical Bioethics 7 (1):8-16.
  • Outcome-adaptive randomization in clinical trials: issues of participant welfare and autonomy.Julius Sim - 2019 - Theoretical Medicine and Bioethics 40 (2):83-101.
    Outcome-adaptive randomization has been proposed as a corrective to certain ethical difficulties inherent in the traditional randomized clinical trial using fixed-ratio randomization. In particular, it has been suggested that OAR redresses the balance between individual and collective ethics in favour of the former. In this paper, I examine issues of welfare and autonomy arising in relation to OAR. A central issue in discussions of welfare in OAR is equipoise, and the moral status of OAR is crucially influenced by the way (...)
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  • Can significant difference in regulating medical and non-medical research be justified?David Hunter - 2014 - Monash Bioethics Review 32 (3-4):254-267.
    It is now typical for human subjects research to be regulated by review by an independent research ethics committee in most jurisdictions. However it is common for countries to opt to only compulsorily regulate medical research while leaving some or all non-medical research either unregulated or only regulated on a voluntary basis. In this paper I will argue, using regulation in the UK as an example, that it is difficult to justify this sharp distinction in practices. While I won’t come (...)
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  • The nature and ethics of natural experiments.Angus Dawson & Julius Sim - 2015 - Journal of Medical Ethics 41 (10):848-853.
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  • Pandemic vaccine trials: expedite, but don’t rush.Angus Dawson - 2020 - Research Ethics 16 (3-4):1-12.
    It has been proposed that the urgency of having a vaccine as a response to SARS-CoV-2 is so great, given the potential health, economic and social benefits that we should override the established s...
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  • Information, choice and the ends of health promotion.Angus Dawson - 2014 - Monash Bioethics Review 32 (1-2):106-120.
    In this paper I provide a critique of a set of assumptions relating to agency, choice and the legitimacy of actions impacting health that can be seen in some approaches to health promotion. After a brief discussion about the definition of health promotion, I outline two contrasting approaches to this area of health care practice. The first is focused on the provision of information and the second is concerned with seeking to change people’s preferences in a particular way. It has (...)
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