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

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.

Safety, tolerability and viral kinetics during SARS-CoV-2 human challenge in young adults

“…Public consultation and involvement. Building on earlier work in the UK 48 , broad consultation was undertaken to explore public understanding of the concept of a human challenge study in general and the acceptability of a human challenge study with SARS-CoV-2 taking place in the UK 49 . This involved a cross-sectional survey (2,441 participants) and a series of focus groups (57 participants in nine groups).…”

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

“…Concern for the mental wellbeing of participants was identified in our broad public consultation work ( Barker et al, 2022 ) and was also raised by discussants at this public involvement session. The group wanted to know what support and counselling would be provided to participants.…”

“…The section in the PIS explaining the risk of participation was seen by discussants as a fundamental part of making an informed decision. The wider public consultation work also identified the importance of a clear explanation of risk ( Barker et al, 2022 ). Discussants reviewing the PIS felt that more of the document should be dedicated to explaining risk, with the data presented in different ways.…”

“…Session 3 was attended by 27 people who had participated in the broad public consultation ( Barker et al, 2022 ) or public involvement session 1.…”

“…We have previously reported outcomes from a broad public consultation (comprising of surveys and focus groups) regarding the perceived relevance, value and acceptability of a SARS-CoV-2 challenge study ( Barker et al, 2022 , Gbesemete et al, 2020 ), which identified a high level of public acceptance before the study protocol was developed. In this paper we describe the insights public involvement sessions provided in shaping the study design, consent process, participant information provided, and which also supported the UK Research Ethics Committee’s review of the study ( Davies, 2021 ).…”