The role of public involvement in the design of the first SARS-CoV-2 human challenge study during an evolving pandemic
Maria Piggin,
Emma Smith,
Peter Mankone,
Leah Ndegwa,
Diane Gbesemete,
Philippa Pristerà,
Michael Bahrami-Hessari,
Halle Johnson,
Andrew P. Catchpole,
Peter J.M. Openshaw,
Christopher Chiu,
Robert C. Read,
Helen Ward,
Caroline Barker
Affiliations
Maria Piggin
NIHR Imperial Biomedical Research Centre, Patient Experience Research Centre, Imperial College London, St Mary's Campus, Norfolk Place, Paddington, London W2 1NY, UK; Corresponding author.
Emma Smith
National Heart and Lung Institute, Imperial College London, London W2 1NY, UK
Peter Mankone
Public Contributor
Leah Ndegwa
Public Contributor
Diane Gbesemete
NIHR Southampton Clinical Research Facility and NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, SO16 6YD, UK; School of Clinical and Experimental Sciences, Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton General Hospital, Mailpoint 806, Level D, Southampton SO16 6YD, UK
Philippa Pristerà
NIHR Imperial Biomedical Research Centre, Patient Experience Research Centre, Imperial College London, St Mary's Campus, Norfolk Place, Paddington, London W2 1NY, UK
Michael Bahrami-Hessari
NIHR Southampton Clinical Research Facility and NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, SO16 6YD, UK
Halle Johnson
NIHR Imperial Biomedical Research Centre, Patient Experience Research Centre, Imperial College London, St Mary's Campus, Norfolk Place, Paddington, London W2 1NY, UK
Andrew P. Catchpole
hVIVO Services Limited (Part of Open Orphan), UK
Peter J.M. Openshaw
National Heart and Lung Institute, Imperial College London, London W2 1NY, UK
Christopher Chiu
Department of Infectious Diseases, Imperial College London, London W2 1NY, UK
Robert C. Read
NIHR Southampton Clinical Research Facility and NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, SO16 6YD, UK; School of Clinical and Experimental Sciences, Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton General Hospital, Mailpoint 806, Level D, Southampton SO16 6YD, UK
Helen Ward
NIHR Imperial Biomedical Research Centre, Patient Experience Research Centre, Imperial College London, St Mary's Campus, Norfolk Place, Paddington, London W2 1NY, UK
Caroline Barker
NIHR Southampton Clinical Research Facility and NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, SO16 6YD, UK; NIHR Applied Research Collaboration Wessex, University Hospital Southampton NHS Foundation Trust, Southampton General Hospital, Tremona Road, Southampton SO16 6YD, UK
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.
