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Revising ethical guidance for the evaluation of programmes and interventions not initiated by researchers
  1. Samuel I Watson1,
  2. Mary Dixon-Woods2,
  3. Celia A Taylor1,
  4. Emily B Wroe3,
  5. Elizabeth L Dunbar3,
  6. Peter J Chilton4,
  7. Richard J Lilford1
  1. 1 Warwick Medical School, University of Warwick, Coventry, UK
  2. 2 THIS Institute, University of Cambridge, Cambridge, UK
  3. 3 Partners In Health, Boston, Massachusetts, USA
  4. 4 Warwick Business School, University of Warwick, Coventry, UK
  1. Correspondence to Dr Samuel I Watson, Warwick Medical School, University of Warwick, Coventry CV4 7AL, UK; s.watson.1{at}warwick.ac.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.

  • Research ethics
  • clinical trials
  • policy guidelines
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/.

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Footnotes

  • Contributors SIW, CAT and RJL conceived the idea for the manuscript on the basis of work conducted evaluating service delivery interventions in multiple countries. This work includes being at the forefront of the development of stepped-wedge randomised trials, the design of data collection for the evaluation of service delivery interventions, the development of statistical methods for extrapolating from this evidence, multiple service delivery intervention evaluations in both high-income and low-income countries, as well as publishing on the ethics of randomised controlled trials. MDW leads a programme of work that studies improvement in healthcare organisation and delivery and the ethics of studying improvement programmes; she provided substantial input into the development of the manuscript. EBW and ELD work for Partners In Health, represent the ‘service manager and policymaker side’ and are involved with the other authors in ongoing evaluations of health service interventions in Malawi and helped the development of these arguments. SIW wrote the first draft of the manuscript and all authors reviewed, edited and approved subsequent versions including the final version. RJL is the guarantor of the study.

  • Funding SIW and RJL are funded by the National Institute for Health Research (NIHR) Global Health Research Unit on Improving Health in Slums. CT, PJC and RJL are also supported by the NIHR Collaboration for Leadership for Applied Health Research Care (CLAHRC) West Midlands initiative. EBW and ELD are employed by Partners In Health. MDW is supported by the Health Foundation’s grant to the University of Cambridge for The Healthcare Improvement Studies (THIS) Institute. THIS Institute is supported by the Health Foundation—an independent charity committed to bringing about better health and healthcare for people in the UK. This work was also supported by MDW’s Wellcome Trust Investigator award (WT09789). MDW is an NIHR senior investigator.

  • Disclaimer This paper presents independent research and the views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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