With rare diseases, sufficient patient numbers are not available at any one site; data needs to be centralized, integrated and broadly accessible to drive rare disease research for gene identification and understanding. To do so, a broad, actionable and ethically grounded policy toolkit will develop a data governance framework for clinical consent and genomic data sharing in Canada. It is funded as part of the All for One initiative, the goal of which is to improve the health and wellness of Canadians with serious genetic conditions by enabling access to a timely and accurate genomic-based diagnosis. Moreover, All for One will enable patients to benefit while helping others through the sharing of their clinical and genomic data within a learning health system. It lays a foundation for precision health in Canada.
The development of this project’s policy tools will require a three-stage approach: 1) assessment of the rare disease policy ecosystem to identify commonalities, differences and limitations to inter-provincial data sharing; 2) consensus-building activities to identify the policy needs of the rare diseases research community; and 3) development of an overarching governance framework. Resulting resources aim to be interoperable and standardized to meet the needs of different clinical and research sites – for approval and use in the clinical implementation stage, as well as future sites.
Part of Genome Canada’s All for One initiative. The framework will support connecting projects and institutions within the All for One initiative and enable partnership with other national initiatives. Through tailored to the rare disease clinical research community, the tools developed by All for One Policy Toolkit can be adapted and used as models for more common diseases as precision medicine advances.