The use of electronic patient records for medical research: conflicts and contradictions

BACKGROUND: The use of electronic patient records for medical research is extremely topical. The Clinical Practice Research Datalink (CRPD), the English NHS observational data and interventional research service, was launched in April 2012. The CPRD has access to, and facilities to link, many healthcare related datasets. The CPRD is partially based on learning from the Health Research Support Service (HRSS), which was used to test the technical and practical aspects of downloading and linking electronic patient records for research. Questions around the feasibility and acceptability of implementing and integrating the processes necessary to enable electronic patient records to be used for the purposes of research remain. METHODS: Focus groups and interviews were conducted with a total of 50 patients and 7 staff from the two English GP practices involved in piloting the HRSS, supplemented with 11 interviews with key stakeholders. Emergent themes were mapped on to the constructs of normalization process theory (NPT) to consider the ways in which sense was made of the work of implementing and integrating the HRSS. RESULTS: The NPT analysis demonstrated a lack of commitment to, and engagement with, the HRSS on the part of patients, whilst the commitment of doctors and practice staff was to some extent mitigated by concerns about issues of governance and consent, particularly in relation to downloading electronic patient records with associated identifiers. CONCLUSIONS: Although the CPRD is presented as a benign, bureaucratic process, perceptions by patients and staff of inherent contradictions with centrally held values of information governance and consent in downloading and linking electronic patient records for research remains a barrier to implementation. It is likely that conclusions reached about the problems of balancing the contradictions inherent in sharing what can be perceived as a private resource for the public good are globally transferrable.