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  1. COVID-19 human challenge trials and randomized controlled trials: lessons for the next pandemic.Charles Weijer - 2024 - Research Ethics 20 (4):636-649.
    The COVID-19 pandemic touched off an unprecedented search for vaccines and treatments. Without question, the development of vaccines to prevent COVID-19 was an enormous scientific accomplishment. Further, the RECOVERY and Solidarity trials identified effective treatments for COVID-19. But all was not success. The urgent need for COVID-19 prevention and treatment fueled an embrace of risks—to research participants and to the reliability of the science itself—as allegedly necessary costs to speed scientific progress. Scientists and (even) ethicists supported overturning longstanding norms protecting (...)
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  • Risk, benefit, and social value in Covid-19 human challenge studies: pandemic decision making in historical context.Mabel Rosenheck - 2022 - Monash Bioethics Review 40 (2):188-213.
    AbstractDuring the Covid-19 pandemic, ethicists and researchers proposed human challenge studies as a way to speed development of a vaccine that could prevent disease and end the global public health crisis. The risks to healthy volunteers of being deliberately infected with a deadly and novel pathogen were not low, but the benefits could have been immense. This essay is a history of the three major efforts to set up a challenge model and run challenge studies in 2020 and 2021. The (...)
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  • Reshaping consent so we might improve participant choice (III) – How is the research participant’s understanding currently checked and how might we improve this process?Hugh Davies, Simon E. Kolstoe & Anthony Lockett - 2024 - Research Ethics 20 (3):604-612.
    Valid consent requires the potential research participant understands the information provided. We examined current practice in 50 proposed Clinical Trials of Investigational Medicinal Products to determine how this understanding is checked. The majority of the proposals ( n = 44) indicated confirmation of understanding would take place during an interactive conversation between the researcher and potential participant, containing questions to assess and establish understanding. Yet up until now, research design and review have not focussed upon this, concentrating more on written (...)
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