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Revising ethical guidance for the evaluation of programmes and interventions not initiated by researchers

Public health and service delivery programmes, interventions and policies (collectively, ‘programmes’) are typically developed and implemented for the primary purpose of effecting change rather than generating knowledge. Nonetheless, evaluations of these programmes may produce valuable learning that...

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Autores principales: Watson, Samuel I, Dixon-Woods, Mary, Taylor, Celia A, Wroe, Emily B, Dunbar, Elizabeth L, Chilton, Peter J, Lilford, Richard J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6984058/
https://www.ncbi.nlm.nih.gov/pubmed/31481472
http://dx.doi.org/10.1136/medethics-2018-105263
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author Watson, Samuel I
Dixon-Woods, Mary
Taylor, Celia A
Wroe, Emily B
Dunbar, Elizabeth L
Chilton, Peter J
Lilford, Richard J
author_facet Watson, Samuel I
Dixon-Woods, Mary
Taylor, Celia A
Wroe, Emily B
Dunbar, Elizabeth L
Chilton, Peter J
Lilford, Richard J
author_sort Watson, Samuel I
collection PubMed
description Public health and service delivery programmes, interventions and policies (collectively, ‘programmes’) are typically developed and implemented for the primary purpose of effecting change rather than generating knowledge. Nonetheless, evaluations of these programmes may produce valuable learning that helps determine effectiveness and costs as well as informing design and implementation of future programmes. Such studies might be termed ‘opportunistic evaluations’, since they are responsive to emergent opportunities rather than being studies of interventions that are initiated or designed by researchers. However, current ethical guidance and registration procedures make little allowance for scenarios where researchers have played no role in the development or implementation of a programme, but nevertheless plan to conduct a prospective evaluation. We explore the limitations of the guidance and procedures with respect to opportunistic evaluations, providing a number of examples. We propose that one key missing distinction in current guidance is moral responsibility: researchers can only be held accountable for those aspects of a study over which they have control. We argue that requiring researchers to justify an intervention, programme or policy that would occur regardless of their involvement prevents or hinders research in the public interest without providing any further protections to research participants. We recommend that trial consent and ethics procedures allow for a clear separation of responsibilities for the intervention and the evaluation.
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spelling pubmed-69840582020-02-06 Revising ethical guidance for the evaluation of programmes and interventions not initiated by researchers Watson, Samuel I Dixon-Woods, Mary Taylor, Celia A Wroe, Emily B Dunbar, Elizabeth L Chilton, Peter J Lilford, Richard J J Med Ethics Original Research Public health and service delivery programmes, interventions and policies (collectively, ‘programmes’) are typically developed and implemented for the primary purpose of effecting change rather than generating knowledge. Nonetheless, evaluations of these programmes may produce valuable learning that helps determine effectiveness and costs as well as informing design and implementation of future programmes. Such studies might be termed ‘opportunistic evaluations’, since they are responsive to emergent opportunities rather than being studies of interventions that are initiated or designed by researchers. However, current ethical guidance and registration procedures make little allowance for scenarios where researchers have played no role in the development or implementation of a programme, but nevertheless plan to conduct a prospective evaluation. We explore the limitations of the guidance and procedures with respect to opportunistic evaluations, providing a number of examples. We propose that one key missing distinction in current guidance is moral responsibility: researchers can only be held accountable for those aspects of a study over which they have control. We argue that requiring researchers to justify an intervention, programme or policy that would occur regardless of their involvement prevents or hinders research in the public interest without providing any further protections to research participants. We recommend that trial consent and ethics procedures allow for a clear separation of responsibilities for the intervention and the evaluation. BMJ Publishing Group 2020-01 2019-09-03 /pmc/articles/PMC6984058/ /pubmed/31481472 http://dx.doi.org/10.1136/medethics-2018-105263 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle Original Research
Watson, Samuel I
Dixon-Woods, Mary
Taylor, Celia A
Wroe, Emily B
Dunbar, Elizabeth L
Chilton, Peter J
Lilford, Richard J
Revising ethical guidance for the evaluation of programmes and interventions not initiated by researchers
title Revising ethical guidance for the evaluation of programmes and interventions not initiated by researchers
title_full Revising ethical guidance for the evaluation of programmes and interventions not initiated by researchers
title_fullStr Revising ethical guidance for the evaluation of programmes and interventions not initiated by researchers
title_full_unstemmed Revising ethical guidance for the evaluation of programmes and interventions not initiated by researchers
title_short Revising ethical guidance for the evaluation of programmes and interventions not initiated by researchers
title_sort revising ethical guidance for the evaluation of programmes and interventions not initiated by researchers
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6984058/
https://www.ncbi.nlm.nih.gov/pubmed/31481472
http://dx.doi.org/10.1136/medethics-2018-105263
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