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  • The role of public involvem...
    Piggin, Maria; Smith, Emma; Mankone, Peter; Ndegwa, Leah; Gbesemete, Diane; Pristerà, Philippa; Bahrami-Hessari, Michael; Johnson, Halle; Catchpole, Andrew P.; Openshaw, Peter J.M.; Chiu, Christopher; Read, Robert C.; Ward, Helen; Barker, Caroline

    Epidemics, 12/2022, Letnik: 41
    Journal Article

    High quality health care research must involve patients and the public. This ensures research is important, relevant and acceptable to those it is designed to benefit. The world’s first human challenge study with SARS-CoV-2 undertook detailed public involvement to inform study design despite the urgency to review and establish the study. The work was integral to the UK Research Ethics Committee review and approval of the study. Discussion with individuals from ethnic minorities within the UK population supported decision-making around the study exclusion criteria. Public review of study materials for consent processes led to the addition of new information, comparisons and visual aids to help volunteers consider the practicalities and risks involved in participating. A discussion exploring the acceptability of a human challenge study with SARS-CoV-2 taking place in the UK, given the current context of the pandemic, identified overall support for the study. Public concern for the wellbeing of trial participants, as a consequence of isolation, was identified. We outline our approach to public involvement and its impact on study design. Display omitted •Public involvement informed the design of a SARS-CoV-2 human challenge study.•Discussions supported decision making around study exclusion criteria.•Study materials and consent processes were changed following public review.•The public were concerned for the wellbeing of participants.•Human challenge studies were seen as efficient and fast.•Public insights supported ethical review of the study.