Search

Digital data generated in the course of clinical care are increasingly being leveraged for a wide range of secondary purposes. Researchers need to develop governance policies that can assure the public that their information is being used responsibly. Our aim was to develop a generalisable model for governance of research emanating from health data repositories that will invoke the trust of the patients and the healthcare professionals whose data are being accessed for health research. We developed our governance principles and processes through literature review and iterative consultation with key actors in the research network including: a data governance working group, the lead investigators and patient advisors. We then recruited persons to participate in the governing and advisory bodies. Our governance process is informed by eight principles: (1) transparency; (2) accountability; (3) follow rule of law; (4) integrity; (5) participation and inclusiveness; (6) impartiality and independence; (7) effectiveness, efficiency and responsiveness and (8) reflexivity and continuous quality improvement. We describe the rationale for these principles, as well as their connections to the subsequent policies and procedures we developed. We then describe the function of the Research Governing Committee, the majority of whom are either persons living with diabetes or physicians whose data are being used, and the patient and data provider advisory groups with whom they consult and communicate. In conclusion, we have developed a values-based information governance framework and process for Diabetes Action Canada that adds value over-and-above existing scientific and ethics review processes by adding a strong patient perspective and contextual integrity. This model is adaptable to other secure data repositories., Competing Interests: Competing interests: The Institute of Health Policy, Management and Evaluation received funds from Diabetes Action Canada SPOR Network towards a partial secondment of DJW time for the development of the governance process for the diabetes data repository. The Department of Family and Community Medicine, University of Toronto, received funds from Diabetes Action Canada SPOR Network towards a partial secondment of MG time for the development of the Diabetes data repository. KK received personal fees from InfoClin during the conduct of the study towards designing the architecture of the Diabetes data repository. In addition, KK has a patent ‘Prediction of Diabetes Mellitus Type 2 Using Biomarkers in Electronic Health Records and Differential Calculus’, pending., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: Deceased donation data requires standardization to enable accurate interprovincial and international comparisons of deceased donation performance. In Canada, most provincial organ donation organizations (ODOs) have developed different processes and infrastructures for referring potential donors and subsequent data collection. This has led to differing definitions of the performance measures used for each step in the donation process, from potential donor identification to consent to transplantation. The Deceased Donation Data Working Group (DDDWG), comprised of representatives from ODOs across Canada, was therefore convened by Canadian Blood Services to develop a national, comprehensive, standardized deceased donation minimum data set., Methods: The DDDWG's scope encompassed considering all potential deceased organ donation data elements, including operational and performance data collected along the deceased donor pathway from donation potential to donation and disposition of organs. An environmental scan was conducted of other existing deceased donation registries from the Canadian and the international community. The DDDWG then engaged in regular face-to-face meetings and teleconferences to develop recommendations for the minimum data set that would satisfy key considerations, including the impact on existing ODO data collection processes, financial impact on stakeholders, the clinical and operational needs of multiple healthcare professionals involved in the deceased donation pathway, and availability of other existing national data sets that could be leveraged to reduce data collection burden., Results: The key deceased donation data elements identified by the DDDWG are contained in an inverted pyramid framework that was derived from similar work conducted in other countries., Conclusion: The DDDWG developed recommendations for proposed definitions and data sources that should be adopted nationally to guide the collection of deceased donation data. The ultimate purpose of the final minimum data set is to harmonize and standardize donation data definitions in Canada and align with international standards; inform the development of operational and clinical practice standards at the provincial and national levels; develop a framework for deceased donation performance measures; and advance the science of deceased donation.

Medical Emergency Datasets (MEDs) are brief summarizations of an individual's medical history, providing vital patient information to emergency medical providers. A recent German study [1] evaluated whether MEDs are useful to local emergency physicians and paramedics, and which health data were relevant to their medical management. To validate of the German study internationally, Canadian physicians and paramedics were recruited to provide feedback on the utility of the German MEDs as well as their specific content. Original documents and surveys were translated to English directly, with a goal of collecting quantitative and qualitative feedback. Overall, physicians and paramedics found the MEDs to be useful in their evaluation of hypothetical medical scenarios. Most of the MED content was very useful, with some items appearing extraneous. The findings of this study will be used to inform future development of MEDs as well as to drive future research.