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J Med Ethics. 2020 Jan;46(1):26-30. doi: 10.1136/medethics-2018-105263. Epub 2019 Sep 3.

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

Author information

1
Warwick Medical School, University of Warwick, Coventry, UK s.watson.1@warwick.ac.uk.
2
THIS Institute, University of Cambridge, Cambridge, UK.
3
Warwick Medical School, University of Warwick, Coventry, UK.
4
Partners In Health, Boston, Massachusetts, USA.
5
Warwick Business School, University of Warwick, Coventry, UK.

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.

KEYWORDS:

Research ethics; clinical trials; policy guidelines

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