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Legal and regulatory standards of informed consent in research

In Ezekiel J. Emanuel (ed.), The Oxford textbook of clinical research ethics. New York: Oxford University Press. pp. 613--32 (2008)

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  1. Informed Consent, Error and Suspending Ignorance: Providing Knowledge or Preventing Error?Arnon Keren & Ori Lev - 2022 - Ethical Theory and Moral Practice 25 (2):351-368.
    The standard account of informed consent has recently met serious criticism, focused on the mismatch between its implications and widespread intuitions about the permissibility of conducting research and providing treatment under conditions of partial knowledge. Unlike other critics of the standard account, we suggest an account of the relations between autonomy, ignorance, and valid consent that avoids these implausible implications while maintaining the standard core idea, namely, that the primary purpose of the disclosure requirement of informed consent is to prevent (...)
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  • Informed Consent: What Must Be Disclosed and What Must Be Understood?Joseph Millum & Danielle Bromwich - 2021 - American Journal of Bioethics 21 (5):46-58.
    Over the last few decades, multiple studies have examined the understanding of participants in clinical research. They show variable and often poor understanding of key elements of disclosure, such as expected risks and the experimental nature of treatments. Did the participants in these studies give valid consent? According to the standard view of informed consent they did not. The standard view holds that the recipient of consent has a duty to disclose certain information to the profferer of consent because valid (...)
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  • Patients without borders: medical tourism.Ann Boyd, Brianna Higgins & Katelyn Millison - 2020 - Eubios Journal of Asian and International Bioethics 30 (1):2-8.
    Medical tourism is a form of medical travel wherein patients move across borders from their home country to another for the purpose of seeking medical trea tmen t tha t is unavailable or unaffordable at home, for the privacy of a transnational location, or for the tourist destination attractions. Medical tourist may seek procedures not approved at home, such as stem cell treatments, or physician assisted suicide. International travel for procedures legal at home and in the destination c oun t (...)
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  • Implications of the concept of minimal risk in research on informed choice in clinical practice.Kyoko Wada & Jeff Nisker - 2015 - Journal of Medical Ethics 41 (10):804-808.
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  • (2 other versions)Disclosure and Consent to Medical Research Participation.Danielle Bromwich & Joseph Millum - 2015 - Journal of Moral Philosophy 12 (2):195-219.
    Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard view (...)
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