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

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 to 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 the key missing distinction in current guidance is that 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.SIW and RJL are funded by the NIHR Global Health Research Unit on Improving Health in Slums. CT, PJC and RJL are also supported by the National Institute for Health Research (NIHR) Collaboration for Leadership for Applied Health Research Care (CLAHRC) West Midlands initiative. EBW and ELD are employed by Partners In Health. MD-W 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 health care for people in the UK. This work was also supported by MDW’s Wellcome Trust Investigator award WT09789. MDW is a National Institute for Health Research (NIHR) Senior Investigator. 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 Healt