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  1. Equipoise, standard of care, and consent: Responding to the authorisation of new COVID-19 treatments in randomised controlled trials.Soren Holm, Jonathan Lewis & Rafael Dal-Ré - 2022 - Journal of Medical Ethics:1-6.
    In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well-known research ethics issues. In this paper, we identify three such issues by focusing on the authorisation of Molnupiravir, a novel antiviral medicine aimed (...)
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  • The Politicization of Research Ethics and Integrity and its Implications for Research Governance.Ian Slesinger & Kadri Simm - forthcoming - Journal of Academic Ethics:1-7.
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  • Equipoise, standard of care and consent: responding to the authorisation of new COVID-19 treatments in randomised controlled trials.Soren Holm, Jonathan Lewis & Rafael Dal-Ré - 2023 - Journal of Medical Ethics 49 (7):465-470.
    In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well-known research ethics issues. In this paper, we identify three such issues by focusing on the authorisation of molnupiravir, a novel antiviral medicine aimed (...)
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  • Challenges and proposed solutions in making clinical research on COVID-19 ethical: a status quo analysis across German research ethics committees.Alice Faust, Anna Sierawska, Joerg Hasford, Anne Wisgalla, Katharina Krüger & Daniel Strech - 2021 - BMC Medical Ethics 22 (1):1-11.
    Background In the course of the COVID-19 pandemic, the biomedical research community’s attempt to focus the attention on fighting COVID-19, led to several challenges within the field of research ethics. However, we know little about the practical relevance of these challenges for Research Ethics Committees. Methods We conducted a qualitative survey across all 52 German RECs on the challenges and potential solutions with reviewing proposals for COVID-19 studies. We de-identified the answers and applied thematic text analysis for the extraction and (...)
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  • COVID-19 and the ethics of human challenge trials.Bert Gordijn & Henk ten Have - 2021 - Medicine, Health Care and Philosophy 24 (1):1-2.
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