Public attitudes to a human challenge study with SARS-CoV-2: a mixed-methods study.

Caroline Barker,Carmel Mcgrath,Christopher Chiu,Wendy Lawerence,Robert C Read,Diane Gbesemete,Daniella Watson,Katharine Collet,Ambar Qavi,Katherine Baker,Maria Piggin,Emma Smith,Michael Bahrami-Hessari,Halle Johnson,Helen Ward,Philippa Pristerà

doi:10.12688/wellcomeopenres.17516.1

Abstract

Background: Human challenge studies involve the deliberate exposure of healthy volunteers to an infectious micro-organism in a highly controlled and monitored way. They are used to understand infectious diseases and have contributed to the development of vaccines. In early 2020, the UK started exploring the feasibility of establishing a human challenge study with SARS-CoV-2. Given the significant public interest and the complexity of the potential risks and benefits, it is vital that public views are considered in the design and approval of any such study and that investigators and ethics boards remain accountable to the public. Methods: Mixed methods study comprising online surveys conducted with 2,441 UK adults and in-depth virtual focus groups with 57 UK adults during October 2020 to explore the public's attitudes to a human challenge study with SARS-CoV-2 taking place in the UK. Results: There was overall agreement across the surveys and focus groups that a human challenge study with SARS-CoV-2 should take place in the UK. Transparency of information, trust and the necessity to provide clear information on potential risks to study human challenge study participants were important. The perceived risks of taking part included the risk of developing long-term effects from COVID, impact on personal commitments and mental health implications of isolation. There were a number of practical realities to taking part that would influence a volunteer's ability to participate (e.g. Wi-Fi, access to exercise, outside space and work, family and pet commitments). Conclusions: The results identified practical considerations for teams designing human challenge studies. Recommendations were grouped: 1) messaging to potential study participants, 2) review of the protocol and organisation of the study, and 3) more broadly, making the study more inclusive and relevant. This study highlights the value of public consultation in research, particularly in fields attracting public interest and scrutiny .

Highlights

The COVID-19 pandemic has had a devastating impact on health, society, and the economy at a global level
Focus group discussions were split into those who are typically eligible, by age, for a human challenge study (18–30 years) and those who were not, to ensure only relevant topics were explored with discussants
Acceptability of a human challenge study The findings indicate that, at the time of the consultation (October 2020) there was a high degree of agreement that a human challenge study with coronavirus should take place

Summary

Introduction

The COVID-19 pandemic has had a devastating impact on health, society, and the economy at a global level. Controlled human infection, is a clinical research methodology involving the deliberate exposure of human volunteers to specified infectious micro-organisms in a highly controlled and monitored way. This allows detailed study of the specific infection from the point of exposure, providing valuable insight into the interactions between microorganism and host. Human challenge studies involve the deliberate exposure of healthy volunteers to an infectious micro-organism in a highly controlled and monitored way They are used to understand infectious diseases and have contributed to the development of vaccines. Methods: Mixed methods study comprising online surveys conducted with 2,441 UK adults and in-depth virtual focus groups with 57 UK adults during October 2020 to explore the public’s attitudes to a human challenge study with SARS-CoV-2 taking place in the UK.

Methods

Results

Discussion

Conclusion