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

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 .

Acceptability, COVID-19, Consultation, Ethics, Human challenge study, Public
2398-502X
49
Barker, Caroline
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Collet, Katharine
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Gbesemete, Diane
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Piggin, Maria
c4f381ee-e3be-400e-b6a4-58fe4d351127
Watson, Daniella
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Pristerà, Philippa
d299cc03-3e88-472c-b494-5b8720518ba4
Lawrence, Wendy
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Smith, Emma
36836138-f86e-4722-8364-adefe15a46ad
Bahrami-Hessari, Michael
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Johnson, Halle
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Baker, Katherine
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Qavi, Ambar
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McGrath, Carmel
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Chiu, Christopher
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Read, Robert C
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Ward, Helen
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Barker, Caroline
67738d0c-3e20-4d23-b5f6-f25e368eaf3e
Collet, Katharine
21d40de1-0798-4536-b102-32ebbf7a288f
Gbesemete, Diane
45c5ae20-20f8-4bc0-b3cd-c9a102e94471
Piggin, Maria
c4f381ee-e3be-400e-b6a4-58fe4d351127
Watson, Daniella
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Pristerà, Philippa
d299cc03-3e88-472c-b494-5b8720518ba4
Lawrence, Wendy
e9babc0a-02c9-41df-a289-7b18f17bf7d8
Smith, Emma
36836138-f86e-4722-8364-adefe15a46ad
Bahrami-Hessari, Michael
d7de1627-160c-4145-b37b-e96cdc829ac5
Johnson, Halle
ca59cc28-26f6-4f66-8bfa-cb422a646438
Baker, Katherine
b7a30fd7-c004-41d0-9886-7f2efa2337be
Qavi, Ambar
4a9e1bbb-140d-4c76-a4e2-8a1acad5e261
McGrath, Carmel
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Chiu, Christopher
1bd7076d-c8f5-4968-bd72-6f35cc0c20e8
Read, Robert C
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Ward, Helen
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Barker, Caroline, Collet, Katharine, Gbesemete, Diane, Piggin, Maria, Watson, Daniella, Pristerà, Philippa, Lawrence, Wendy, Smith, Emma, Bahrami-Hessari, Michael, Johnson, Halle, Baker, Katherine, Qavi, Ambar, McGrath, Carmel, Chiu, Christopher, Read, Robert C and Ward, Helen (2022) Public attitudes to a human challenge study with SARS-CoV-2: a mixed-methods study. Wellcome Open Research, 7, 49, [49]. (doi:10.12688/wellcomeopenres.17516.1).

Record type: Article

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 .

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e-pub ahead of print date: 10 February 2022
Additional Information: Grant information: This work was supported by the Human Infection Challenge Network for Vaccine Development (HIC-Vac) (funded by the GCRF Networks in Vaccines Research and Development which was co-funded by the MRC and BBSRC and is part of the EDCTP2 programme supported by the European Union). National Institute for Health Research (NIHR) Imperial Biomedical Research Centre, Patient Experience Research Centre, NIHR Southampton Biomedical Research Centre, NIHR Southampton Clinical Research Facility and Applied Research Collaboration Wessex receive infrastructure funding from the NIHR. The authors gratefully acknowledge support from the UK Vaccine Taskforce of the Department of Business, Energy and Industrial Strategy of Her Majesty’s Government, the Royal Free London NHS Foundation Trust, and hVIVO Services Ltd. HW is supported by a Wellcome grant [205456]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Keywords: Acceptability, COVID-19, Consultation, Ethics, Human challenge study, Public

Identifiers

Local EPrints ID: 456482
URI: http://eprints.soton.ac.uk/id/eprint/456482
ISSN: 2398-502X
PURE UUID: 31fdce6e-ee80-4ead-ad36-6b10467b33df
ORCID for Caroline Barker: ORCID iD orcid.org/0000-0001-8263-4151
ORCID for Wendy Lawrence: ORCID iD orcid.org/0000-0003-1264-0438
ORCID for Carmel McGrath: ORCID iD orcid.org/0000-0001-7777-2904
ORCID for Robert C Read: ORCID iD orcid.org/0000-0002-4297-6728

Catalogue record

Date deposited: 03 May 2022 16:53
Last modified: 21 Oct 2022 01:54

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Contributors

Author: Caroline Barker ORCID iD
Author: Katharine Collet
Author: Diane Gbesemete
Author: Maria Piggin
Author: Daniella Watson
Author: Philippa Pristerà
Author: Wendy Lawrence ORCID iD
Author: Emma Smith
Author: Michael Bahrami-Hessari
Author: Halle Johnson
Author: Katherine Baker
Author: Ambar Qavi
Author: Carmel McGrath ORCID iD
Author: Christopher Chiu
Author: Robert C Read ORCID iD
Author: Helen Ward

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