Public attitudes to a human challenge study with SARS-CoV-2: a mixed-methods study.
Public attitudes to a human challenge study with SARS-CoV-2: a mixed-methods study.
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公众对SARS-COV-2：混合方法研究的人类挑战研究的态度。
DOI：
10.12688/wellcomeopenres.17516.1
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发表时间：
2022
影响因子：
--
通讯作者：
Ward H
中科院分区：
文献类型：
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作者：
Barker C;Collet K;Gbesemete D;Piggin M;Watson D;Pristerà P;Lawerence W;Smith E;Bahrami-Hessari M;Johnson H;Baker K;Qavi A;McGrath C;Chiu C;Read RC;Ward H
背景资料：人体挑战研究涉及以高度受控和监测的方式故意将健康志愿者暴露于传染性微生物。它们被用来了解传染病，并有助于疫苗的开发。2020年初，英国开始探索建立SARS-CoV-2人体挑战研究的可行性。考虑到重大的公共利益以及潜在风险和利益的复杂性，在设计和批准任何此类研究时考虑公众意见至关重要，研究人员和道德委员会必须对公众负责。 研究方法：混合方法研究包括2020年10月期间对2，441名英国成年人进行的在线调查和对57名英国成年人进行的深入虚拟焦点小组，以探索公众对英国发生的SARS-CoV-2人类挑战研究的态度。 结果：调查和焦点小组的总体一致意见是，应在英国进行SARS-CoV-2的人体挑战研究。信息的透明度、信任以及向人类挑战研究参与者提供关于潜在风险的明确信息的必要性都很重要。参与的感知风险包括COVID产生长期影响的风险、对个人承诺的影响以及隔离对心理健康的影响。参加活动有一些实际情况会影响志愿人员的参与能力（例如无线网络、获得锻炼、外部空间和工作、家庭和宠物承诺）。 结论：结果确定了设计人体挑战研究的团队的实际考虑因素。建议分为以下几类：1）向潜在的研究参与者传递信息，2）审查研究方案和组织，3）更广泛地使研究更具包容性和相关性。这项研究强调了公众咨询在研究中的价值，特别是在吸引公众兴趣和监督的领域。
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 .