Seeking ethical approval for an international study in primary care patient safety

Authors: Dovey, Susan1; Hall, Katherine2; Makeham, Meredith3; Rosser, Walter4; Kuzel, Anton5; Van Weel, Chris6; Esmail, Aneez7; Phillips, Robert8

Source: British Journal of General Practice, 1 April 2011, vol. 61, no. 585, pp. e197-e204(8)

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Abstract:

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 draws 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 variation in ethics review responses to the research proposal occurred, from no approval being deemed necessary to the study plan narrowly avoiding rejection. The authors' experiences demonstrated that ethics committees operate in their own historical and cultural context, which can lead to radically different subjective interpretations of commonly-held ethical principles, and raised further issues such as ‘what is research?’. This first LINNAEUS study started when patient safety was a particularly sensitive subject. Although it is now a respectable area of inquiry, patient safety is still a topic that can excite emotions and prejudices. The LINNAEUS Collaboration now extends to more countries and continues to pursue an international research agenda, so reflection on the influences of history, social context, and structure of each country's ethical review processes is timely.

Keywords: ethics; patient safety; primary care; regulation

Document Type: Research Article

DOI: http://dx.doi.org/10.3399/bjgp11X567144

Affiliations: 1: Department of General Practice and Rural Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand 2: Maori Hill Clinic, Dunedin, New Zealand 3: School of Public Health and Community Medicine, University of New South Wales, Sydney, Australia 4: Queens University, Kingston, Ontario, Canada 5: Virginia Commonwealth University, Richmond, VA, US 6: Radboud University of Nijmegen Medical Centre, the Netherlands 7: University of Manchester, UK 8: The Robert Graham Center, American Academy of Family Physicians,Washington, DC, US

Publication date: April 1, 2011

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