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Developing a community of practice for trainers: towards a culture of conscience in clinical research

By Marie McKenzie-Mills


This developmental research study concerned how trainers, drawn mainly from the\ud commercial (pharmaceutical) sector of the field of clinical research, shared understandings of\ud practice in a professionally localised community, as part of their continuing professional\ud development. Trainers in this community had a heterogeneous range of identities including\ud full-time and part-time trainers: clinical research trainers, training managers; clinical research\ud managers, clinical research associates, compliance managers, auditors and others. The main\ud aim was to explain conditions shaping this community and its concept of practice.\ud The study involved observing practice from an interlocutory position, using Cultural-\ud Historical Activity Theory (CHAT), to reveal the cultural complexity of the concept of\ud practice within this community.\ud Two competing rationalities, expressed within contrasting pedagogies with associated cultural\ud standards of compliance or conscience, were established for training:-\ud • as a restricted technical function focussed on the transmissive delivery of content, or\ud • as an expansive approach to organisational learning focussed on deliberative enquiry.\ud These competing rationalities reflected the struggle of an emergent profession to establish\ud autonomy of standards, with implications for the field of practice and wider society:\ud establishing the moral order through a culture of conscience, based on standards of excellence\ud or because a system of regulatory governance dominates the drive to uphold standards\ud through a culture of compliance.\ud A conceptual-analytical framework, substantiated by empirical evidence, was proposed to\ud describe and analyse the concept of practice embodied in the community’s object of activity.\ud Through demonstrating CHAT at the level of declarative conceptions, procedural models, and\ud social discourses/interactions, a link was established between the dominant concept of\ud practice (expressed within a transmissive pedagogy) in the community and the larger sociocultural\ud context (compliance culture rooted in the system of regulatory governance).\ud The contribution of this study is to show how CHAT can be applied with theoretically\ud formulated and empirically tested evaluative tools, to reveal the richness of human experience\ud and the complexity of human activity in terms of its cognitive and cooperative social\ud elements, identified as objective regularities unique to the activity system under investigation

Topics: HD, RM
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