variability in the interpretation of what constitutes research across different research committees and national legislations,11 as illustrated in Case Study 1 and 2 and will be expanded in the next section. When in doubt, it is recommended that patient safety projects are submitted to ethics committees at an early stage, to determine whether or not they consider them as research that should receive their oversight. EXISTING GUIDELINES The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins. This committee must be independent of the researcher, the sponsor and any other undue influence. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration. The committee must have the right to monitor on-going studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No change to the protocol may be made without consideration and approval by the committee. Ethical Principles for Medical Research Involving Human Subjects, World Medical Association Declaration of Helsinki, 2008 paragraph 15 An important criterion to bear in mind is whether or not the proposed intervention is evidence based. If it is not evidence-based, then it is recommended that the activity be developed within a research framework. 12Ethical issues in Patient Safety Research Dovey S, Hall K, Makeham M, et. al. Seeking ethical approval for an international study in primary care patient safety. Br J Gen Pract 2011; 61: 197-204 Seeking ethics committee approval for research can be challenging even for relatively simple studies occurring in single settings. Complicating factors such as multicentre studies and/or contentious research issues can challenge review processes, and conducting such studies internationally adds a further layer of complexity. This paper drew on the experiences of the LINNAEUS Collaboration, an international group of primary care researchers, in obtaining ethics approval to conduct an international study investigating medical error in general practice in six countries. It describes the ethics review processes applied to exactly the same research protocol for a study run in Australia, Canada, England, the Netherlands, New Zealand, and the US. Wide variations in ethics review responses to the research proposal occurred, from no approval being deemed necessary to the study plan narrowly avoiding rejection. The ethics committees in each country had different concerns about the study protocol they were presented with, which was exactly the same in each country. The authors’ experiences demonstrated that ethics committees operate in their own historical and cultural context, which can lead to radically different subjective interpretations of commonlyheld ethical principles, and raised further issues such as ‘what is research?’ Case study 1 – Obtaining research ethics oversight 13Interpreting existing guidance EXISTING GUIDELINES The “generalizable knowledge” definition works well for medical and behavioural studies pertaining to human health, which are commonly denominated “biomedical research” to indicate its relation to health. But the definition works less well in separating practice from research in the field of epidemiology. Many studies using the tools of epidemiology which are performed on a regular basis by public health agencies, such as routine surveillance for disease outbreaks, are correctly viewed as “practice” even though the information produced may contribute to generalizable knowledge. Thus, in carrying out their activities, epidemiologists (and others examining the activities) need to apply careful judgment to determine whether the activity should be classified as research or practice. Of course, it does not necessarily follow that everything placed in the former category is problematic or is even subject to all the requirements for advanced approval and