B17 Trends in clinical research governance

Governance of health research has been the subject of much discussion, particularly since the introduction of single ethical review. However, the complexity of this exiting area is difficult to capture in single definition. Broadly speaking, it includes structure and strategy as well as mechanisms of implementation and feedback. In this session we explore some current trends in clinical research governance, including examining directions in education, analysis and feedback.

Governance and Ethics

Research Governance” is currently in the spotlight for the impact that it has on study start up times.  The research sector typically sees governance as bureaucracy. Anecdotally, it seems this view is related to a lack of understanding of the process, despite efforts by regulators, institutions and education providers to demystify it.  This presentation aims to provide clarity around the role of the HREC within this process.

 

Exploring the hospital voice: public hospital perspective on research governance 
This presentation looks at what influences research governance practices in Victoria from the perspective of public health system. Hospitals are viewed as social entities that respond to the environment around them. Three areas of influence will be examined: the power of the stakeholders, especially government; peer affect; and professionalisation. The particular focus of the enquiry is on the National Mutual Acceptance (NMA), which involves a system of single ethical review across Australia. Although the number of ethic reviews has decreased, concerns regarding the timeliness of study start-up persist.

Governance in an institution
This presentation will present the view from with the Governance Office of a public health institution.  The presentation will cover Governance with a “big G”: ie the overall process of study start up, conduct and closeout, and the steps along the way (including ethics, commercial and clinical considerations, as well as site specific assessment).

Chairperson: Kylie Sproston, Bellberry