De Poli Chiara, Oyebode Jan, Airoldi Mara, Stevens Martin, Capstick Andrea, Mays Nicholas, Clark Michael, Driessen Annelieke, Rivas Carol, Penhale Bridget, Fletcher James R, Russell Amy M
Care Policy and Evaluation Centre, London School of Economics and Political Science, Houghton Street, London, WC2A 2AE, United Kingdom.
Centre for Applied Dementia Studies, Faculty of Health Studies, University of Bradford, Richmond Road, Bradford, BD7 1DP, United Kingdom.
Health Res Policy Syst. 2025 Apr 1;23(1):40. doi: 10.1186/s12961-025-01290-3.
Current research ethics frameworks that oversee health and social care research, in the United Kingdom and internationally, originated in biomedical research, having positivist underpinnings and an orientation towards experimental research. Limitations of these frameworks have been extensively documented including with regard to health and social care research that adopts collaborative approaches. This article contributes to debates about how the research ethics system deals with collaborative research with groups labelled or potentially perceived as vulnerable, and identifies practical recommendations to ensure a better fit between principles and practices of research ethics and those of collaborative research.
We conducted a two-round online Delphi study with 35 academic researchers with experience of collaborative research involving vulnerable groups and of seeking research ethics approval in England (United Kingdom), followed by a focus group with eight members of the Delphi panel. The Delphi questionnaire, organised in 12 themes, comprised 66 statements about how researchers experience research ethics review and how the research ethics system could be improved. The focus group discussed the results of the Delphi study to generate practical recommendations.
By the end of the second Delphi round, only one statement relating to the experience of the current research ethics system reached consensus, signalling heterogeneous experiences among researchers working in this field. A total of 32 statements on potential improvements reached consensus. The focus group discussed the 14 Delphi statements with the highest levels of consensus and generated 12 practical recommendations that we grouped into three clusters (1. Endorsing the 'collaborative' dimension of collaborative research; 2. Allowing flexibility; and 3. Strengthening the relational and ongoing nature of ethical research practice).
This work provides further empirical evidence of how the research ethics system deals with collaborative research involving 'vulnerable' groups. It also offers practical recommendations to ensure that the collaborative dimension of such research receives proper ethical scrutiny, to introduce a degree of flexibility in research ethics processes and supporting documents, and to replace formal, one-off research ethics approvals with ongoing, situated, relational ethical processes and practices.
在英国及国际上，目前监督健康与社会关怀研究的研究伦理框架起源于生物医学研究，具有实证主义基础且倾向于实验性研究。这些框架的局限性已有大量文献记载，包括在采用协作方法的健康与社会关怀研究方面。本文有助于就研究伦理体系如何处理与被标记或可能被视为弱势群体的协作研究展开辩论，并确定切实可行的建议，以确保研究伦理的原则与实践和协作研究的原则与实践之间能更好地契合。
我们对35名学术研究人员进行了两轮在线德尔菲研究，这些研究人员有涉及弱势群体的协作研究经验，并在英国英格兰寻求过研究伦理批准，随后与德尔菲小组的八名成员进行了焦点小组讨论。德尔菲问卷按12个主题组织，包含66条关于研究人员如何体验研究伦理审查以及研究伦理体系如何改进的陈述。焦点小组讨论了德尔菲研究的结果以提出切实可行的建议。
在德尔菲第二轮结束时，关于当前研究伦理体系体验的陈述中只有一条达成了共识，这表明该领域研究人员的体验存在异质性。关于潜在改进的32条陈述达成了共识。焦点小组讨论了共识程度最高的14条德尔菲陈述，并提出了12条切实可行的建议，我们将其分为三类（1. 认可协作研究的“协作”维度；2. 允许灵活性；3. 加强伦理研究实践的关系性和持续性）。
这项工作为研究伦理体系如何处理涉及“弱势群体”的协作研究提供了进一步的实证证据。它还提供了切实可行的建议，以确保此类研究的协作维度得到适当的伦理审查，在研究伦理流程和支持文件中引入一定程度的灵活性，并用持续的、情境化的、关系性的伦理流程和实践取代正式的一次性研究伦理批准。
