The role of public involvement in the design of the first SARS-CoV-2 human challenge study during an evolving pandemic
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Published version
Author(s)
Type
Journal Article
Abstract
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.
Date Issued
2022-12
Date Acceptance
2022-08-31
Citation
Epidemics: the journal of infectious disease dynamics, 2022, 41, pp.1-6
ISSN
1755-4365
Publisher
Elsevier
Start Page
1
End Page
6
Journal / Book Title
Epidemics: the journal of infectious disease dynamics
Volume
41
Copyright Statement
© 2022 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Identifier
https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000862280500002&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=a2bf6146997ec60c407a63945d4e92bb
Subjects
Science & Technology
Life Sciences & Biomedicine
Infectious Diseases
Ethics
Human challenge study
Public involvement
SARS-CoV-2
Publication Status
Published
Article Number
ARTN 100626
Date Publish Online
2022-09-01