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  • Readability and complexity of written information presented to hospitalised patients for trial consent during the COVID-19 pandemic in the UK: a retrospective document analysis

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Readability and complexity of written information presented to hospitalised patients for trial consent during the COVID-19 pandemic in the UK: a retrospective document analysis
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  • Published on: 28 April 2025
    Fair Informed Consent: is the tide turning?

    This article continues the evidence that the current Participant Information Sheet isn’t fit for its purpose. It no longer supports fair consent, rather, it has become a legal document focused on the needs of the research team, not the potential participant. Having spent much time as Research Ethics Advisor to the National Research Ethics Advisor and subsequently the Health Research Authority trying (unsuccessfully) to address this, I would support the authors' concluding sentence.
    But I believe the tide is turning (https://blogs.bmj.com/medical-ethics/posts-page/). The USA Food and Drug Administration draft guidance / requirements support and expect all patient-facing material to start with a comprehensible summary of information of importance to potential participants. Their requirements, if accepted, will carry great weight (https://www.fda.gov/media/176663/download) . On the Oxford A UK Research Ethics Committee, we were similarly concerned about this issue and together drew up and published proposals, which, perhaps unsurprisingly, overlap with the USA material (https://journals.sagepub.com/doi/10.1177/17470161231176932l ).
    These were shown to patient groups who responded very positively, but they now need to be tested in real practice, involving all with...

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    Conflict of Interest:
    None declared.