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

OBJECTIVE: 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). METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Perceived practice change in Australian doctors as a result of medicolegal concerns.

OBJECTIVES: To explore the perceived impact of medicolegal concerns on how Australian doctors practise medicine and to compare doctors who have experienced a medicolegal matter with those who have not. DESIGN AND SETTING: Cross-sectional survey (posted in September 2007, with reminder 4 weeks later) of Australian doctors from all major specialty groups, trainees and a sample of general practitioners who were insured with a medical insurance company. PARTICIPANTS: 2999 respondents of 8360 who were sent the survey. MAIN OUTCOME MEASURES: Perceived practice changes due to concerns about medicolegal issues, beliefs about medicolegal issues, and the influence of medicolegal issues on both career choices and how doctors relate to their patients. RESULTS: Respondents reported changes in practice behaviour due to medicolegal concerns, with 43% of doctors stating that they referred patients more than usual, 55% stating that they ordered tests more than usual, and 11% stating that they prescribed medications more than usual. Respondents also reported improved communication of risk (66%), increased disclosure of uncertainty (44%), developed better systems for tracking results (48%) and better methods for identifying non-attenders (39%) and for auditing clinical practice (35%). Concerns about medicolegal issues led to 33% considering giving up medicine, 32% considering reducing their working hours and 40% considering retiring early. These proportions were all significantly greater for doctors who had previously experienced a medicolegal matter compared with those who had not. CONCLUSIONS: This Australian study, like international studies, confirms that doctors' concerns about medicolegal issues impact on their practice in a variety of ways. There is a greater perceived impact on those doctors who have previously experienced a medicolegal matter.

Developing a national patient safety education framework for Australia.

BACKGROUND: In 2004, The Australian Council for Safety and Quality in Health Care recognised that the lack of a comprehensive framework describing competencies for patient safety was a barrier to achieving a competent and safe health workforce. This article describes the building of a national patient safety education framework that describes the competencies for healthcare workers. AIM: Develop an educational framework that was patient centred and identified the knowledge, skills and behaviours required by healthcare workers irrespective of their profession, position or location. METHODS: The content of the framework was developed using a four-staged approach: literature review, development of learning areas and topics, classification into learning domains and, lastly, converting into a performance-sbased format. An extensive consultation and validation process was also undertaken. RESULTS: A national patient safety education framework was endorsed by The Australian Council for Safety and Quality in Health Care in 2005. The framework is already being used to develop curricula and train the trainer programmes in patient safety. CONCLUSIONS: The framework, which draws its educational approach from adult learning principles, was extensively researched and built on the experience of healthcare workers. The next challenge is to test different strategies for implementing the framework.

Improving safety and quality: how can education help?

National efforts to improve the quality and safety of health care present challenges for medical education and training. Today's doctors need to be skilled communicators who know how to identify, prevent and manage adverse events and near misses, how to use evidence and information, how to work safely in a team, how to practise ethically, and how to be workplace teachers and learners. These competencies (knowledge, skills and attitudes) are set out in the National Patient Safety Education Framework (NPSF) of the Australian Council for Safety and Quality in Health Care. The NPSF is designed to help medical schools, vocational colleges, health organisations and private practitioners develop curricula to enable health professionals to work safely. The NPSF describes what doctors (depending on their level of knowledge and experience) can do to demonstrate competencies in a range of quality and safety activities. Medical schools, vocational colleges, health organisations and private practitioners need to work collaboratively with one another and with other health professionals to ensure that patient safety and quality curricula are implemented and evaluated, and that valid and reliable assessments of learning outcomes are developed. Interdisciplinary and vertically integrated education and training are needed, incorporating innovative methods, to create a safer health care system.