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factors (illness during the previous H1N1 pandemic, experience of life-threatening illness) and social factors (historical references, media, public health information).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
387-395
Gobat, Nina H.
1399ab1f-21b3-4c19-9baf-8f06fdb5afc2
Gal, Micaela
2d266726-f171-4a55-a381-29c5a2e42ec1
Butler, Christopher C.
1bf09f7b-0ff9-4e05-bce0-f4d60920313c
Webb, Steve A.R.
81913fc9-8a5b-49ea-b915-7066caa62f25
Francis, Nicholas A.
9b610883-605c-4fee-871d-defaa86ccf8e
Stanton, Helen
05e8526c-706a-4615-add9-c942abf8d12a
Anthierens, Sibyl
0022fa80-cacc-4326-bf4f-4b626445626f
Bastiaens, Hilde
6114313a-29fb-408b-8a35-ebc02b303b18
Godycki-ćwirko, Maciek
e571eac4-da0a-4137-8de5-bf962fd105cc
Kowalczyk, Anna
271a5de2-3622-4174-9fff-4bb9a23c4b7c
Pons-Vigués, Mariona
790e487b-b49c-4d7c-8041-be92e2ecc56e
Pujol-Ribera, Enriqueta
18e5810a-a75e-4581-9008-97203b0da517
Berenguera, Anna
956440cf-06b0-4895-aa2f-0feed46bd5f6
Watkins, Angela
d8a5365d-56db-4f3c-8b18-1fbe908778d4
Sukumar, Prasanth
0c066c94-d1e0-4609-9e2f-026e16d393cf
Moore, Ronald G.
0e98ee5a-186e-4ec9-9601-2876047fe5d0
Hood, Kerenza
14a61c0b-dc19-4218-a5f1-f62421eea9c8
Nichol, Alistair
e2d19735-a029-431b-ac3a-921630440c80
1 February 2018
Gobat, Nina H.
1399ab1f-21b3-4c19-9baf-8f06fdb5afc2
Gal, Micaela
2d266726-f171-4a55-a381-29c5a2e42ec1
Butler, Christopher C.
1bf09f7b-0ff9-4e05-bce0-f4d60920313c
Webb, Steve A.R.
81913fc9-8a5b-49ea-b915-7066caa62f25
Francis, Nicholas A.
9b610883-605c-4fee-871d-defaa86ccf8e
Stanton, Helen
05e8526c-706a-4615-add9-c942abf8d12a
Anthierens, Sibyl
0022fa80-cacc-4326-bf4f-4b626445626f
Bastiaens, Hilde
6114313a-29fb-408b-8a35-ebc02b303b18
Godycki-ćwirko, Maciek
e571eac4-da0a-4137-8de5-bf962fd105cc
Kowalczyk, Anna
271a5de2-3622-4174-9fff-4bb9a23c4b7c
Pons-Vigués, Mariona
790e487b-b49c-4d7c-8041-be92e2ecc56e
Pujol-Ribera, Enriqueta
18e5810a-a75e-4581-9008-97203b0da517
Berenguera, Anna
956440cf-06b0-4895-aa2f-0feed46bd5f6
Watkins, Angela
d8a5365d-56db-4f3c-8b18-1fbe908778d4
Sukumar, Prasanth
0c066c94-d1e0-4609-9e2f-026e16d393cf
Moore, Ronald G.
0e98ee5a-186e-4ec9-9601-2876047fe5d0
Hood, Kerenza
14a61c0b-dc19-4218-a5f1-f62421eea9c8
Nichol, Alistair
e2d19735-a029-431b-ac3a-921630440c80
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), .
(doi:10.1111/hex.12634).
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.
Text
hex.12634
- Version of Record
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
Catalogue record
Date deposited: 14 Oct 2020 16:33
Last modified: 18 Mar 2024 03:54
Export record
Altmetrics
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
Download statistics
Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.
View more statistics
