Fitting a square peg in a round hole? A mixed-methods study on research ethics and collaborative health and social care research involving 'vulnerable' groups

Abstract

Background: 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.

Methods: 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.

Results: 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).

Conclusions: 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.

Keywords: Co-creation; Co-design; Co-production; Collaborative research; Institutional review board; Participatory research; Procedural ethics; Research ethics; Research ethics committee; ‘Vulnerable’ groups.

Fig. 1

Final set of recommendations and their expected impact in ascending order