Barker Caroline, Collet Katharine, Gbesemete Diane, Piggin Maria, Watson Daniella, Pristerà Philippa, Lawerence Wendy, Smith Emma, Bahrami-Hessari Michael, Johnson Halle, Baker Katherine, Qavi Ambar, McGrath Carmel, Chiu Christopher, Read Robert C, Ward Helen
NIHR Southampton Clinical Research Facility and NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, SO16 6YD, UK.
NIHR Applied Research Collaboration Wessex, University Hospital Southampton NHS Foundation Trust, Southampton, SO16 6YD, UK, UK.
Wellcome Open Res. 2022 Feb 10;7:49. doi: 10.12688/wellcomeopenres.17516.1. eCollection 2022.
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. 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. 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). 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
人体挑战研究涉及以高度可控和可监测的方式故意让健康志愿者接触传染性微生物。这些研究用于了解传染病，并为疫苗的研发做出了贡献。2020年初，英国开始探索开展针对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的人体挑战研究的可行性。鉴于公众的高度关注以及潜在风险和益处的复杂性，在设计和批准任何此类研究时考虑公众意见至关重要，而且研究人员和伦理委员会应对公众负责。这是一项混合方法研究，在2020年10月对2441名英国成年人进行了在线调查，并与57名英国成年人进行了深入的虚拟焦点小组讨论，以探讨公众对在英国开展SARS-CoV-2人体挑战研究的态度。调查和焦点小组总体上一致认为，英国应该开展针对SARS-CoV-2的人体挑战研究。信息透明度、信任以及向人体挑战研究参与者提供有关潜在风险的清晰信息的必要性都很重要。参与研究被认为存在的风险包括感染新冠病毒后出现长期影响的风险、对个人事务的影响以及隔离对心理健康的影响。参与研究存在一些实际情况会影响志愿者的参与能力（例如无线网络、锻炼机会、户外空间以及工作、家庭和宠物方面的事务）。研究结果确定了设计人体挑战研究的团队需要考虑的实际因素。建议分为三类：1）向潜在研究参与者传达信息，2）审查研究方案和研究组织，3）更广泛地说，使研究更具包容性和相关性。这项研究凸显了公众咨询在研究中的价值，尤其是在吸引公众关注和审视的领域。
