Ethical issues in implementation research: a discussion of the problems in achieving informed consent

Jane L Hutton*1, Martin P Eccles2 and Jeremy M Grimshaw3 Address: 1Department of Statistics, University of Warwick, Coventry, CV4 7AL, UK, 2Institute of Health and Society, University of Newcastle, Newcastle upon Tyne, NE2 4AA, UK and 3Clinical Epidemiology Programme, Ottawa Health Research Institute, Ottawa, Canada Email: Jane L Hutton* - ; Martin P Eccles - ; Jeremy M Grimshaw - jgrimshaw@ * Corresponding author | Implementation Science BioMed Central Open Access Debate Ethical issues in implementation research a discussion of the problems in achieving informed consent Jane L Hutton 1 Martin P Eccles2 and Jeremy M Grimshaw3 Address Department of Statistics University of Warwick Coventry CV4 7AL UK institute of Health and Society University of Newcastle Newcastle upon Tyne NE2 4AA UK and 3Clinical Epidemiology Programme Ottawa Health Research Institute Ottawa Canada Email Jane L Hutton - Martin P Eccles - Jeremy M Grimshaw - jgrimshaw@ Corresponding author Published 17 December 2008 Received 31 August 2006 Accepted 17 December 2008 Implementation Science 2008 3 52 doi l748-5908-3-52 This article is available from http content 3 1 52 2008 Hutton et al licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License http licenses by which permits unrestricted use distribution and reproduction in any medium provided the original work is properly cited. Abstract Background Improved quality of care is a policy objective of health care systems around the world. Implementation research is the scientific study of methods to promote the systematic uptake of clinical research findings into routine clinical practice and hence to reduce inappropriate care. It includes the study of influences on healthcare professionals behaviour and methods to enable them to use research findings more effectively. Cluster randomized trials represent the optimal design for evaluating the effectiveness of implementation strategies. Various codes of medical ethics such as the Nuremberg Code and the Declaration of Helsinki inform medical research but their relevance to cluster randomised trials in implementation research is unclear. This paper discusses the applicability of various ethical codes to obtaining consent in cluster

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