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Talking to the people that really matter about their participation in pandemic clinical research: a qualitative study in four European countries

Talking to the people that really matter about their participation in pandemic clinical research: a qualitative study in four European countries
Talking to the people that really matter about their participation in pandemic clinical research: a qualitative study in four European countries

Background: Pandemics of new and emerging infectious diseases are unpredictable, recurrent events that rapidly threaten global health and security. We aimed to identify public views regarding provision of information and consent to participate in primary and critical care clinical research during a future influenza-like illness pandemic.

Methods: Descriptive-interpretive qualitative study, using focus groups (n = 10) and semi-structured interviews (n = 16), with 80 members of the public (>18 years) in Belgium, Spain, Poland and the UK. Local qualitative researchers followed a scenario-based topic guide to collect data. Data were transcribed verbatim, translated into English and subject to framework analysis.

Results: Public understandings of pandemics were shaped by personal factors (illness during the previous H1N1 pandemic, experience of life-threatening illness) and social factors (historical references, media, public health information). Informants appreciated safeguards provided by ethically robust research procedures, but current enrolment procedures were seen as a barrier. They proposed simplified enrolment processes for higher risk research and consent waiver for certain types of low-risk research. Decision making about research participation was influenced by contextual, research and personal factors. Informants generally either carefully weighed up various approaches to research participation or responded instinctively. They supported the principle of using routinely collected, anonymized clinical biological samples for research without explicit consent, but regarded this as less acceptable if researchers were motivated primarily by commercial gain.

Conclusions: This bottom-up approach to ascertaining public views on pandemic clinical research has identified support for more proportionate research protection procedures for publically funded, low-risk studies.

epidemic, infectious disease outbreak, influenza, informed consent, pandemic, patient and public involvement
1369-6513
387-395
Gobat, Nina H.
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Gal, Micaela
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Butler, Christopher C.
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Webb, Steve A.R.
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Francis, Nicholas A.
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Stanton, Helen
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Anthierens, Sibyl
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Bastiaens, Hilde
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Godycki-ćwirko, Maciek
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Kowalczyk, Anna
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Pons-Vigués, Mariona
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Pujol-Ribera, Enriqueta
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Berenguera, Anna
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Watkins, Angela
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Sukumar, Prasanth
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Moore, Ronald G.
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Hood, Kerenza
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Nichol, Alistair
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Gobat, Nina H.
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Gal, Micaela
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Butler, Christopher C.
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Webb, Steve A.R.
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Francis, Nicholas A.
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Stanton, Helen
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Anthierens, Sibyl
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Bastiaens, Hilde
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Godycki-ćwirko, Maciek
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Kowalczyk, Anna
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Pons-Vigués, Mariona
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Pujol-Ribera, Enriqueta
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Berenguera, Anna
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Watkins, Angela
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Sukumar, Prasanth
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Moore, Ronald G.
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Hood, Kerenza
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Nichol, Alistair
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Gobat, Nina H., Gal, Micaela, Butler, Christopher C., Webb, Steve A.R., Francis, Nicholas A., Stanton, Helen, Anthierens, Sibyl, Bastiaens, Hilde, Godycki-ćwirko, Maciek, Kowalczyk, Anna, Pons-Vigués, Mariona, Pujol-Ribera, Enriqueta, Berenguera, Anna, Watkins, Angela, Sukumar, Prasanth, Moore, Ronald G., Hood, Kerenza and Nichol, Alistair (2018) Talking to the people that really matter about their participation in pandemic clinical research: a qualitative study in four European countries. Health Expectations, 21 (1), 387-395. (doi:10.1111/hex.12634).

Record type: Article

Abstract

Background: Pandemics of new and emerging infectious diseases are unpredictable, recurrent events that rapidly threaten global health and security. We aimed to identify public views regarding provision of information and consent to participate in primary and critical care clinical research during a future influenza-like illness pandemic.

Methods: Descriptive-interpretive qualitative study, using focus groups (n = 10) and semi-structured interviews (n = 16), with 80 members of the public (>18 years) in Belgium, Spain, Poland and the UK. Local qualitative researchers followed a scenario-based topic guide to collect data. Data were transcribed verbatim, translated into English and subject to framework analysis.

Results: Public understandings of pandemics were shaped by personal factors (illness during the previous H1N1 pandemic, experience of life-threatening illness) and social factors (historical references, media, public health information). Informants appreciated safeguards provided by ethically robust research procedures, but current enrolment procedures were seen as a barrier. They proposed simplified enrolment processes for higher risk research and consent waiver for certain types of low-risk research. Decision making about research participation was influenced by contextual, research and personal factors. Informants generally either carefully weighed up various approaches to research participation or responded instinctively. They supported the principle of using routinely collected, anonymized clinical biological samples for research without explicit consent, but regarded this as less acceptable if researchers were motivated primarily by commercial gain.

Conclusions: This bottom-up approach to ascertaining public views on pandemic clinical research has identified support for more proportionate research protection procedures for publically funded, low-risk studies.

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More information

Accepted/In Press date: 11 September 2017
e-pub ahead of print date: 11 September 2017
Published date: 1 February 2018
Keywords: epidemic, infectious disease outbreak, influenza, informed consent, pandemic, patient and public involvement

Identifiers

Local EPrints ID: 444373
URI: http://eprints.soton.ac.uk/id/eprint/444373
ISSN: 1369-6513
PURE UUID: 501bfd57-593b-4e20-8375-744224ed15de
ORCID for Nicholas A. Francis: ORCID iD orcid.org/0000-0001-8939-7312

Catalogue record

Date deposited: 14 Oct 2020 16:33
Last modified: 26 Nov 2021 03:20

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Contributors

Author: Nina H. Gobat
Author: Micaela Gal
Author: Christopher C. Butler
Author: Steve A.R. Webb
Author: Helen Stanton
Author: Sibyl Anthierens
Author: Hilde Bastiaens
Author: Maciek Godycki-ćwirko
Author: Anna Kowalczyk
Author: Mariona Pons-Vigués
Author: Enriqueta Pujol-Ribera
Author: Anna Berenguera
Author: Angela Watkins
Author: Prasanth Sukumar
Author: Ronald G. Moore
Author: Kerenza Hood
Author: Alistair Nichol

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