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Key stakeholder perceptions about consent to participate in acute illness research: a rapid, systematic review to inform epi/pandemic research preparedness

Key stakeholder perceptions about consent to participate in acute illness research: a rapid, systematic review to inform epi/pandemic research preparedness
Key stakeholder perceptions about consent to participate in acute illness research: a rapid, systematic review to inform epi/pandemic research preparedness
Background A rigorous research response is required to inform clinical and public health decision-making during an epi/pandemic. However, the ethical conduct of such research, which often involves critically ill patients, may be complicated by the diminished capacity to consent and an imperative to initiate trial therapies within short time frames. Alternative approaches to taking prospective informed consent may therefore be used. We aimed to rapidly review evidence on key stakeholder (patients, their proxy decision-makers, clinicians and regulators) views concerning the acceptability of various approaches for obtaining consent relevant to pandemic-related acute illness research. Methods We conducted a rapid evidence review, using the Internet, database and hand-searching for English language empirical publications from 1996 to 2014 on stakeholder opinions of consent models (prospective informed, third-party, deferred, or waived) used in acute illness research. We excluded research on consent to treatment, screening, or other such procedures, non-emergency research and secondary studies. Papers were categorised, and data summarised using narrative synthesis. Results We screened 689 citations, reviewed 104 full-text articles and included 52. Just one paper related specifically to pandemic research. In other emergency research contexts potential research participants, clinicians and research staff found third-party, deferred, and waived consent to be acceptable as a means to feasibly conduct such research. Acceptability to potential participants was motivated by altruism, trust in the medical community, and perceived value in medical research and decreased as the perceived risks associated with participation increased. Discrepancies were observed in the acceptability of the concept and application or experience of alternative consent models. Patients accepted clinicians acting as proxy-decision makers, with preference for two decision makers as invasiveness of interventions increased. Research regulators were more cautious when approving studies conducted with alternative consent models; however, their views were generally under-represented. Conclusions Third-party, deferred, and waived consent models are broadly acceptable to potential participants, clinicians and/or researchers for emergency research. Further consultation with key stakeholders, particularly with regulators, and studies focused specifically on epi/pandemic research, are required. We highlight gaps and recommendations to inform set-up and protocol development for pandemic research and institutional review board processes.
1745-6215
1-21
Gobat, Nina Helene
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Gal, Micaela
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Francis, Nicholas Andrew
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Hood, Kerenza
af7cf839-ca85-4ea9-83c3-3dd31be88b32
Watkins, Angela
d8a5365d-56db-4f3c-8b18-1fbe908778d4
Turner, Jill
7ef74b17-56b8-4d51-bf65-3378de799d05
Moore, Ronald
bed5b1c7-f51f-465a-87d7-9593815e90f8
Webb, Steve A. R.
81913fc9-8a5b-49ea-b915-7066caa62f25
Butler, Christopher Collett
d2f9102c-54c2-4570-be4e-32324c8c8f1d
Nichol, Alistair
e2d19735-a029-431b-ac3a-921630440c80
Gobat, Nina Helene
1399ab1f-21b3-4c19-9baf-8f06fdb5afc2
Gal, Micaela
2d266726-f171-4a55-a381-29c5a2e42ec1
Francis, Nicholas Andrew
9b610883-605c-4fee-871d-defaa86ccf8e
Hood, Kerenza
af7cf839-ca85-4ea9-83c3-3dd31be88b32
Watkins, Angela
d8a5365d-56db-4f3c-8b18-1fbe908778d4
Turner, Jill
7ef74b17-56b8-4d51-bf65-3378de799d05
Moore, Ronald
bed5b1c7-f51f-465a-87d7-9593815e90f8
Webb, Steve A. R.
81913fc9-8a5b-49ea-b915-7066caa62f25
Butler, Christopher Collett
d2f9102c-54c2-4570-be4e-32324c8c8f1d
Nichol, Alistair
e2d19735-a029-431b-ac3a-921630440c80

Gobat, Nina Helene, Gal, Micaela, Francis, Nicholas Andrew, Hood, Kerenza, Watkins, Angela, Turner, Jill, Moore, Ronald, Webb, Steve A. R., Butler, Christopher Collett and Nichol, Alistair (2015) Key stakeholder perceptions about consent to participate in acute illness research: a rapid, systematic review to inform epi/pandemic research preparedness. Trials, 16, 1-21. (doi:10.1186/s13063-015-1110-6).

Record type: Article

Abstract

Background A rigorous research response is required to inform clinical and public health decision-making during an epi/pandemic. However, the ethical conduct of such research, which often involves critically ill patients, may be complicated by the diminished capacity to consent and an imperative to initiate trial therapies within short time frames. Alternative approaches to taking prospective informed consent may therefore be used. We aimed to rapidly review evidence on key stakeholder (patients, their proxy decision-makers, clinicians and regulators) views concerning the acceptability of various approaches for obtaining consent relevant to pandemic-related acute illness research. Methods We conducted a rapid evidence review, using the Internet, database and hand-searching for English language empirical publications from 1996 to 2014 on stakeholder opinions of consent models (prospective informed, third-party, deferred, or waived) used in acute illness research. We excluded research on consent to treatment, screening, or other such procedures, non-emergency research and secondary studies. Papers were categorised, and data summarised using narrative synthesis. Results We screened 689 citations, reviewed 104 full-text articles and included 52. Just one paper related specifically to pandemic research. In other emergency research contexts potential research participants, clinicians and research staff found third-party, deferred, and waived consent to be acceptable as a means to feasibly conduct such research. Acceptability to potential participants was motivated by altruism, trust in the medical community, and perceived value in medical research and decreased as the perceived risks associated with participation increased. Discrepancies were observed in the acceptability of the concept and application or experience of alternative consent models. Patients accepted clinicians acting as proxy-decision makers, with preference for two decision makers as invasiveness of interventions increased. Research regulators were more cautious when approving studies conducted with alternative consent models; however, their views were generally under-represented. Conclusions Third-party, deferred, and waived consent models are broadly acceptable to potential participants, clinicians and/or researchers for emergency research. Further consultation with key stakeholders, particularly with regulators, and studies focused specifically on epi/pandemic research, are required. We highlight gaps and recommendations to inform set-up and protocol development for pandemic research and institutional review board processes.

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More information

Published date: 1 December 2015
Additional Information: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Identifiers

Local EPrints ID: 435847
URI: http://eprints.soton.ac.uk/id/eprint/435847
ISSN: 1745-6215
PURE UUID: 0794eda6-fb56-43cf-9b09-c203661b5018
ORCID for Nicholas Andrew Francis: ORCID iD orcid.org/0000-0001-8939-7312

Catalogue record

Date deposited: 21 Nov 2019 17:30
Last modified: 26 Nov 2021 03:20

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Contributors

Author: Nina Helene Gobat
Author: Micaela Gal
Author: Kerenza Hood
Author: Angela Watkins
Author: Jill Turner
Author: Ronald Moore
Author: Steve A. R. Webb
Author: Christopher Collett Butler
Author: Alistair Nichol

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