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Consent, including advanced consent, of older adults to research in care homes: a qualitative study of stakeholders' views in South Wales

Consent, including advanced consent, of older adults to research in care homes: a qualitative study of stakeholders' views in South Wales
Consent, including advanced consent, of older adults to research in care homes: a qualitative study of stakeholders' views in South Wales

Background: Care home residents, especially those lacking capacity to provide consent for themselves, are frequently excluded from research, thus limiting generalisability of study findings. We set out to explore stakeholders' views about the ethical and practical challenges associated with recruiting care home residents into research studies.Methods: Qualitative individual interviews with care home residents (n = 14), their relatives (n = 14), and general practitioners (GPs) (n = 10), and focus groups (n = 2) with care home staff. Interviews focused on the issues of older adults consenting to research in care homes, including advanced consent, in general and through reference to a particular study on the use of probiotics to prevent Antibiotic Associated Diarrhoea. Data were analysed using a thematic approach incorporating themes that had been identified in advance, and themes derived from the data. Researchers discussed evidence for themes, and reached consensus on the final themes.Results: Respondents were generally accepting of low risk observational studies and slightly less accepting of low risk randomised trials of medicinal products. Although respondents identified some practical barriers to informed consent, consenting arrangements were considered workable. Residents and relatives varied in the amount of detail they wanted included in information sheets and consent discussions, but were generally satisfied that an advanced consent model was acceptable and appropriate. Opinions differed about what should happen should residents lose capacity during a research study.Conclusions: Research staff should be mindful of research guidance and ensure that they have obtained an appropriate level of informed consent without overwhelming the participant with unnecessary detail. For research involving medicinal products, research staff should also be more explicit when recruiting that consent is still valid should an older person lose capacity during a trial provided the individual did not previously state a wish to be withdrawn if they lose capacity, and provided they do not indicate objection or resistance after loss of capacity.

Common infections, Consent, Ethics, Mental capacity, Older adults, Qualitative research, Recruitment
1745-6215
Wood, Fiona
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Prout, Hayley
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Bayer, Antony
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Duncan, Donna
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Nuttall, Jacqueline
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Hood, Kerenza
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Butler, Christopher C.
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Aawar, Nadine
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Allen, Steve
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Archarjya, Arun
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Carter, Ben
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Cohen, David
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Evans, Judith
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Evans, Meirion
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Francis, Nick
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Gillespie, David
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Groves, Samantha
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Howe, Robin
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Johansen, Antony
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Toghill, Alun
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Townson, Julia
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Wood, Fiona
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Prout, Hayley
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Bayer, Antony
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Duncan, Donna
f23b1ac8-25ff-48ae-9a28-80238a9c1ef8
Nuttall, Jacqueline
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Hood, Kerenza
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Butler, Christopher C.
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Aawar, Nadine
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Allen, Steve
b555ec39-a221-47b9-96e0-49809ef7f092
Archarjya, Arun
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Carter, Ben
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Cohen, David
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Evans, Judith
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Evans, Meirion
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Francis, Nick
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Gillespie, David
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Groves, Samantha
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Howe, Robin
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Johansen, Antony
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Toghill, Alun
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Townson, Julia
bbbf583d-fd5e-4750-b3dc-02b7f2dac204

Wood, Fiona, Prout, Hayley, Bayer, Antony, Duncan, Donna, Nuttall, Jacqueline, Hood, Kerenza, Butler, Christopher C., Aawar, Nadine, Allen, Steve, Archarjya, Arun, Carter, Ben, Cohen, David, Evans, Judith, Evans, Meirion, Francis, Nick, Gillespie, David, Groves, Samantha, Howe, Robin, Johansen, Antony, Toghill, Alun and Townson, Julia (2013) Consent, including advanced consent, of older adults to research in care homes: a qualitative study of stakeholders' views in South Wales. Trials, 14 (1), [247]. ().

Record type: Article

Abstract

Background: Care home residents, especially those lacking capacity to provide consent for themselves, are frequently excluded from research, thus limiting generalisability of study findings. We set out to explore stakeholders' views about the ethical and practical challenges associated with recruiting care home residents into research studies.Methods: Qualitative individual interviews with care home residents (n = 14), their relatives (n = 14), and general practitioners (GPs) (n = 10), and focus groups (n = 2) with care home staff. Interviews focused on the issues of older adults consenting to research in care homes, including advanced consent, in general and through reference to a particular study on the use of probiotics to prevent Antibiotic Associated Diarrhoea. Data were analysed using a thematic approach incorporating themes that had been identified in advance, and themes derived from the data. Researchers discussed evidence for themes, and reached consensus on the final themes.Results: Respondents were generally accepting of low risk observational studies and slightly less accepting of low risk randomised trials of medicinal products. Although respondents identified some practical barriers to informed consent, consenting arrangements were considered workable. Residents and relatives varied in the amount of detail they wanted included in information sheets and consent discussions, but were generally satisfied that an advanced consent model was acceptable and appropriate. Opinions differed about what should happen should residents lose capacity during a research study.Conclusions: Research staff should be mindful of research guidance and ensure that they have obtained an appropriate level of informed consent without overwhelming the participant with unnecessary detail. For research involving medicinal products, research staff should also be more explicit when recruiting that consent is still valid should an older person lose capacity during a trial provided the individual did not previously state a wish to be withdrawn if they lose capacity, and provided they do not indicate objection or resistance after loss of capacity.

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More information

Published date: 9 August 2013
Keywords: Common infections, Consent, Ethics, Mental capacity, Older adults, Qualitative research, Recruitment

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Local EPrints ID: 445009
URI: http://eprints.soton.ac.uk/id/eprint/445009
DOI:
ISSN: 1745-6215
PURE UUID: 0819e07b-9e4d-41aa-a20c-52a7a3793b69
ORCID for Nick Francis:

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Date deposited: 18 Nov 2020 13:16
Last modified: 18 Nov 2020 13:16

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Contributors

Author: Fiona Wood
Author: Hayley Prout
Author: Antony Bayer
Author: Donna Duncan
Author: Jacqueline Nuttall
Author: Kerenza Hood
Author: Christopher C. Butler
Author: Nadine Aawar
Author: Steve Allen
Author: Arun Archarjya
Author: Ben Carter
Author: David Cohen
Author: Judith Evans
Author: Meirion Evans
Author:
Author: David Gillespie
Author: Samantha Groves
Author: Robin Howe
Author: Antony Johansen
Author: Alun Toghill
Author: Julia Townson

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