• Sara Shaw, Petra M Boynton, and Trisha Greenhalgh.
• Open Learning Unit, Department of Primary Care and Population Sciences, University College London, Holborn Union Building, Highgate Hill, London N19 5LW, UK. s.shaw@psps.ucl.ac.uk
• J R Soc Med. 2005 Nov 1; 98 (11): 496-502.

AbstractFor a variety of historical and social reasons, research has become increasingly formalized and regulated. This change has potential benefits (reduction in fraud and misconduct, protection of vulnerable groups, financial probity) but also disadvantages (increased paperwork, time delays, constraints on research freedom). The terms 'research' and 'governance' mean different things in different contexts. Even with explicit guidance, ambiguities must be resolved by human judgement. Variation in the nature and outcome of approval decisions is therefore a fact of life. The type of approval needed for a research study depends on the official remit of the approval body, the question to be addressed; the methods to be used; the context in which the work will take place; the level of analysis and interpretation; and the plans for how the findings will be presented and used.

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