Warwick Medical School, University of Warwick, Coventry, UK
THIS Institute, University of Cambridge, Cambridge, UK.
J Med Ethics. 2020 Jan;46(1):26-30. doi: 10.1136/medethics-2018-105263. Epub 2019 Sep 3.
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.
公共卫生和服务提供计划、干预措施和政策（统称为“计划”）通常是为了实现变革而制定和实施的，而不是为了产生知识。然而，这些计划的评估可能会产生有价值的学习，有助于确定效果和成本，并为未来计划的设计和实施提供信息。此类研究可以称为“机会性评估”，因为它们对新出现的机会做出反应，而不是对研究人员发起或设计的干预措施进行研究。然而，目前的伦理指导和注册程序几乎没有考虑到这样的情况：研究人员在计划进行前瞻性评估的情况下，在计划的制定或实施中没有发挥任何作用。我们探讨了指导方针和程序在机会性评估方面的局限性，并提供了一些示例。我们提出，当前指导方针中缺失的一个关键区别是道德责任：研究人员只能对他们能够控制的研究的各个方面负责。我们认为，要求研究人员证明一项干预措施、计划或政策的合理性，而无论他们是否参与其中，这会在没有为研究参与者提供任何进一步保护的情况下，阻止或阻碍符合公众利益的研究。我们建议试验同意和伦理程序允许对干预措施和评估明确划分责任。
