Research governance as a facilitator for ethical and timely research? Learning from the experience of a large government-funded multisite research project

Abstract

The processes of research ethics and research governance are core to the conduct of research in health. Each aims to facilitate research that is both ethical and practical in order to produce new knowledge about the health system and improve the lives of those who use it. However, our experience has demonstrated that the process of obtaining ethical approval for a low-risk and low-resource research project was severely confounded by the multiple layers of research governance in operation at hospitals in Queensland (Qld) and New South Wales (NSW). We analysed our own experience of gaining research governance approval with the aim of improving governance processes for multicentre research projects. Our project aimed to interview and survey one person at each of 57 hospitals in NSW and 18 in Qld. We recorded and compared the steps, documents and time-frame related to research governance approval at each of these research sites. We found that the progress of our project was significantly impeded by the multiple steps related to research governance processes in hospitals. Research governance approval took an average of 160 days in NSW and 316 in Qld. There was inconsistency between hospitals regarding documentation and significant duplication of documentation already approved through ethical review processes. The necessity for separate research contracts for all Qld research sites also added to research delays. Based on our experiences we make recommendations about changes to research governance including clarification of responsibility, reform of areas of duplication and inconsistency, time limitations for approval and, in Qld, reform of financial and legal oversight.