| Summary: | Persuasive arguments exist as to why the harmonisation of tissue banks is important. Yet harmonisation has not happened on a large scale and empirical research has not investigated the reasons for this in detail. This thesis presents the results of ethnographic research using the case study of cancer tissue banks to identify influences on harmonisation. The research involved 40 interviews and over 117 hours of observations with professionals working across 15 organisations. Data analysis was based on the constant comparative method with use of sensitising constructs from literatures on standards and diffusion of innovation. A new model of the tissue supply chain was developed and refined against the findings. Harmonisation depends on the creation, implementation and outcome of standards. The empirical work showed that a complex picture of harmonisation emerges when the creation, implementation and outcome of standards are considered separately. Different factors act as barriers or facilitators, or as both, at each stage. Standard creation in cancer tissue banks is obstructed by a lack of agreement between organisations and professionals, who may have differing interests and views on the appropriate type and scope of standards, who should create them and how. Standard implementation can be enabled or hindered by standard design, the actions and features of organisations, and individual and professional factors. Critically, the outcome of implementing standards has not always increased harmonisation; in some cases the result is fragmentation, duplication or exclusion. The thesis describes cross-cutting political, social and technical issues that arise during the tissue supply chain and throughout the stages of standard creation and implementation, making harmonisation complicated and difficult to achieve. Eight recommendations are offered for how harmonisation can be facilitated in practice.
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