Elsevier

Epidemics

Volume 41, December 2022, 100626
Epidemics

The role of public involvement in the design of the first SARS-CoV-2 human challenge study during an evolving pandemic

https://doi.org/10.1016/j.epidem.2022.100626Get rights and content
Under a Creative Commons license
open access

Highlights

  • 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.

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.

Abbreviations

WHO
World Health Organisation
COVID-19
Coronavirus disease 2019
SARS-CoV-2
Severe acute respiratory syndrome coronavirus 2
PIS
Participant Information Sheet
BAME
Black, Asian and minority ethnic

Keywords

Ethics
Human challenge study
Public involvement
SARS-CoV-2

Data availability

No data was used for the research described in the article.

Cited by (0)

1

Joint first author.