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Revising ethical guidance for the evaluation of programmes and interventions not initiated by researchers
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Watson, Samuel I., Dixon-Woods, Mary, Taylor, Celia A., Wroe, Emily B., Dunbar, Elizabeth L, Chilton, Peter J. and Lilford, Richard (2019) Revising ethical guidance for the evaluation of programmes and interventions not initiated by researchers. Journal of Medical Ethics . doi:10.1136/medethics-2018-105263
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Official URL: https://doi.org/10.1136/medethics-2018-105263
Abstract
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.
| Item Type: | Journal Article | ||||||||||||
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| Subjects: | Q Science > Q Science (General) R Medicine > R Medicine (General) R Medicine > RA Public aspects of medicine |
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| Divisions: | Faculty of Social Sciences > Warwick Business School Faculty of Medicine > Warwick Medical School |
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| SWORD Depositor: | Library Publications Router | ||||||||||||
| Library of Congress Subject Headings (LCSH): | Public health -- Research, Public health -- Research -- Moral and ethical aspects, Research -- Moral and ethical aspects, Clinical trials -- Reporting | ||||||||||||
| Journal or Publication Title: | Journal of Medical Ethics | ||||||||||||
| Publisher: | BMJ Publishing Group | ||||||||||||
| ISSN: | 1473-4257 | ||||||||||||
| Official Date: | 3 September 2019 | ||||||||||||
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| DOI: | 10.1136/medethics-2018-105263 | ||||||||||||
| Status: | Peer Reviewed | ||||||||||||
| Publication Status: | Published | ||||||||||||
| Access rights to Published version: | Open Access | ||||||||||||
| RIOXX Funder/Project Grant: |
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