Grant: Operating Grant

Our objective is to identify the conditions under which scientifically valid health research using data and biological samples may proceed using: the evolving Canadian interoperable electronic health record system; registries, biobanks, and longitudinal cohort studies; and archived pathology samples and records. Through a series of evidence-informed deliberative dialogues, we will identify areas of consensus and divergence on the topics relevant to key conditions of use: (a) the role of consent and privacy, (b) models of governance, and (c) necessary safeguards. Deliberations will be grounded in real-world research scenarios and informed by relevant ethical, legal, philosophical, technical, and empirical literature. Following the dialogues, findings and policy recommendations will be fed back to the affected stakeholders for their comments. A series of workshops will be prepared for the annual meetings of the associations of research ethics board chairs, ethicists, privacy commissioners, public health researchers, health services and policy researchers, and informatics researchers. The evidence syntheses will be published as a book and the results of the dialogues in peer-reviewed journals. Through our literature syntheses, legal analysis, and dialogues, we will be well positioned to make statements about what an ideal framework for research use of electronic health information ought to be and the values and principles that should be taken into consideration when making policy decisions around use of personal information and biosamples for health research. By working closely with policy makers at all stages, we expect to have an impact on future legislative and policy development, including future revisions to the TCPS. This work will be ground-breaking internationally, and could make Canada a leader in the use of research data to improve the health care system and the population's health.