Background to the study
Ethical regulation in general and ethics review more specifically are perceived as challenging for researchers and have been subject to critique from both qualitative and quantitative research paradigms. Existing critique clusters around the following themes:
Bureaucracy and its impact on research.
Authors here suggest that there are unacceptable delays in receiving decisions on ethics in review or that the requirements of review are excessive, unachievable and constitute a barrier to research. (Dingwall, 2006; Hammersley, 2010; Stewart et al (2008).
Dominance of quantitative research paradigms.
There is perceived lack of understanding of qualitative research and quantitative ‘bias’ (Burrr and Reynolds (2010); Murphy and Dingwall, 2007; Hammersley, 2009, 2010). Alongside critics of the system, particularly in the social sciences, other commentators have identified the potential educative value of engaging with review systems (Wiles,2012; Guillemin and Gillam, 2004; Israel and Hay, 2006) despite acknowledging some of the (historic) limitations in relation to qualitative research paradigms.
Centrality of the informed consent requirement.
This has been problematised from a range of perspectives which view it as unachievable in some methodologies, as necessary but problematic, or as an overly bureaucratic requirement which makes it informed but not necessarily genuine (O’Neill, 2003). The shortcomings of procedural consent in medicine and biomedical contexts and which also relate to consent in research ethics have been highlighted by philosophers (O’Neill 2003; Kittay, 2007; Manson and O’Neil, 2007) while sociologists have commented on the potential privileging of consent over other ethical considerations and described informed consent as an ‘ethical panacea’ (Corrigan, 2003). Furthermore, the importance of context in consent (Greenhough, 2007) and the need for it to be seen as an ongoing process rather than a ‘on-off’ event (Corrigan, 2016) has also been highlighted.
Procedure and principles.
Concerns with the overly-procedural nature of review in general is criticism of the principlist approaches which inform the review process. Hammersley (2015) claims that judgements are derived in a ‘quasi- logical way from given principles’ (p445).
Gaps in existing research
The literature review evidenced the paucity of discussion about and inquiry into how reviewers in RECs are involved in the review process. Existing accounts of review and the role of consent have not explored how reviewers’ activities are carried out, where procedures and principles are enacted and where judgements about research take place. Exceptions are Hedgecoe (2008; 2009; 2012) in the United Kingdom and Laura Stark on Institutional Review Boards (IRBs) (2012 and 2013) in the United States.
Much is claimed about the barriers and limitations which the review of ethics presents to researchers, however, there is little evidence which starts from the standpoint of committee members and explores how the work of review is accomplished in the everyday contexts in which decisions are made. Sheehan (2013) has responded to criticisms of the functioning of RECs as over-generalised and therefore inaccurate. He argues that critique requires evidence and this is not always apparent in the arguments for changes in the current system of ethics review. This research provides detailed investigation into RECs to discover how their work is achieved.
The focus of the study was NHSRECs which are ‘flagged’ to review studies which involved participants who may lack capacity to consent. This meant that reviewers had undertaken additional training on the Mental Capacity Act 2005.
Morton, JW 2017, Summary of research for participants and the Health Research Authority ‘An ethnographic study of National Health Service Research Ethics Committees : mapping ethics review’ Dr Julie Morton, April 2017 , Project Report, University of Salford. (Unpublished)
Institutional reprint (Open Access): http://usir.salford.ac.uk/45160/