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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

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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
Subjects: Q Science > Q Science (General)
R Medicine > R Medicine (General)
R Medicine > RA Public aspects of medicine
Divisions: Faculty of Social Sciences > Warwick Business School
Faculty of Medicine > Warwick Medical School
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
Dates:
DateEvent
3 September 2019Published
13 August 2019Accepted
DOI: 10.1136/medethics-2018-105263
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access
RIOXX Funder/Project Grant:
Project/Grant IDRIOXX Funder NameFunder ID
UNSPECIFIED[NIHR] National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
UNSPECIFIEDHealth Foundationhttp://dx.doi.org/10.13039/501100000724
WT09789Wellcome Trusthttp://dx.doi.org/10.13039/100010269
Related URLs:
  • https://creativecommons.org/licenses/by/...

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