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

Wellcome Open Research

article

Caroline Barker¹  Katharine Collet³  Diane Gbesemete¹  Maria Piggin³  Daniella Watson⁵  Philippa Pristerà³  Wendy Lawerence¹  Emma Smith⁷  Michael Bahrami-Hessari¹  Halle Johnson³  Katherine Baker²  Ambar Qavi³  Carmel McGrath¹  Christopher Chiu⁸  Robert C. Read¹  Helen Ward³ 

[1] NIHR Southampton Clinical Research Facility and NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust;NIHR Applied Research Collaboration Wessex, University Hospital Southampton NHS Foundation Trust;NIHR Imperial Biomedical Research Centre, Patient Experience Research Centre, Imperial College London;School of Clinical and Experimental Sciences, Faculty of Medicine and Institute for Life Sciences, University of Southampton;MRC Lifecourse Epidemiology Unit, University of Southampton;Global Health Research Institute, School of Human Development and Health, Faculty of Medicine, University of Southampton;National Heart and Lung Institute, Imperial College London;Department of Infectious Diseases, Imperial College London

关键词: Ethics;    human challenge study;    consultation;    public;    acceptability;    COVID-19;   

DOI  :  10.12688/wellcomeopenres.17516.1

学科分类：内科医学

来源: Wellcome

【 摘 要 】

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.

【 授权许可】

CC BY