Regulating the regulators. An empirical study of the influences on the research governance practices in Victorian public healthcare agencies

This thesis investigated how the National Mutual Acceptance (NMA) model of single ethical review has currently impacted, and how it is likely to impact the future, on the research governance practices of public healthcare agencies participating in multi-site clinical trials.\ud This study sought to describe the variables associated with the impact of the NMA through the theory of Institutional Isomorphism proposed by DiMaggio and Powell , which proposes that comparable organisations develop similarities in order to appear legitimate to their stakeholders. Consolidation is influenced by: coercive isomorphism, which involves pressures from other entities on which they are dependent; mimetic isomorphism, which refers to the tendency of an organisation to imitate a more successful organisation; and normative isomorphism, which is driven by professional pressures. Data was collected in two phases.\ud Phase One focused on the collection of quantitative data relating to perceptions of the importance of research and the impact of the NMA. Phase Two involved collection of qualitative data to explore the reasons behind current irregularities in the NMA and expectations of the future.\ud Although participants agreed that the NMA could provide isomorphic pressures, there were concerns regarding bureaucratic inconsistency that created uncertainty in the processes. The strongest isomorphic influence provided by the NMA was coercive pressure, which was also identified as a possible future mechanism. In contrast to findings in other literature, neither mimetic nor normative pressures were perceived as influential because emphasis on the practices of individual agencies prevented a coherent system from developing.\ud The study made three contributions to Institutional Isomorphism theory. It identified the importance of robust coercive forces to allowing mimetic and normative forces to emerge. It also highlighted the need for agencies to recognise implications of research governance beyond their own organisational boundaries and the need to quantify the responsibilities of governance personnel to strengthen coercive impact.\ud Recommendation included the need to address: organisational leadership of the NMA, to strengthen the knowledge base through education and training, the development of a stakeholder engagement framework and opportunities to expand the NMA.\ud This research provides new insight into understanding research governance in the context of the Australian public healthcare sector and provides a model though which further exploration may be undertaken