Research governance and change in research ethics practices at a major Australian university.

Recent revisions of the National Statement on Ethical Conduct in Human Research and the Australian Code for the Responsible Conduct of Research put a great emphasis on research governance. Institutional responsibility for the governance of the research is not limited only to the ethical review by the Human Research Ethics Committee (HREC), but also to the accountability for quality, safety, privacy, risk management and financial management of the research. Despite the development of proposed research governance frameworks, many Australian institutions do not have such structures in place and rely excessively on HRECs to perform administrative functions that are not their responsibility. In this paper we report on implementation of a research governance framework at University of New South Wales which led to reduced HREC workload and allowed more attention to its core functions. We present the approach undertaken by the university to separate the ethical review process by HREC from the research governance. We recommend that with proper research governance frameworks in place, the role of HRECs and the institutional responsibility of governance of the research can be defined clearly.