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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...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2020
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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. |
format | Online Article Text |
id | pubmed-6984058 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
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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