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  1. 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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  • Reshaping consent so we might improve participant choice (II) – helping people decide.Hugh Davies, Rosie Munday, Maeve O’Reilly, Catriona Gilmour Hamilton, Arzhang Ardahan, Simon E. Kolstoe & Katie Gillies - 2023 - Research Ethics 19 (4):466-473.
    Research consent processes must provide potential participants with the necessary information to help them decide if they wish to join a study. On the Oxford ‘A’ Research Ethics Committee we’ve found that current research proposals mostly provide adequate detail (even if not in an easily comprehensible format), but often fail to support decision making, a view supported by published evidence. In a previous paper, we described how consent might be structured, and here we develop the concept of an Information and (...)
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  • UK Research Ethics Committee’s review of the global first SARS-CoV-2 human infection challenge studies.Hugh Davies - 2023 - Journal of Medical Ethics 49 (5):322-324.
    This paper describes the UK Research Ethics Committee’s (REC) preparations and review of the global first SARS-CoV-2 human infection challenge studies. To frame our review, we used the WHO guidance and our UK Health Research Authority ethical review framework. The WHO criteria covered most issues we were concerned about, but we would recommend one further criterion directing RECs to consider alternative research designs. Could research questions be equally well answered by less intrusive studies? The committee met virtually, ensuring broad representation (...)
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