With input from multiple stakeholder groups, Health Data Research Network Canada (HDRN Canada) has compiled a set of guidelines for researchers on what should be included in consent forms for projects where new study data will be linked to existing administrative data.
Data linkage refers to the process of connecting data about the same person, from two or more different sets of data (e.g. health information and education information).
The linkage may be one-time (e.g. data collected for a vaccine study is linked to administrative data so that results from the vaccine study can be contextualized) or ongoing (e.g. a genomic study dataset is integrated into a data platform so the data can be used in the future for multiple studies).
When conducting research that proposes linking an individual’s existing administrative data to the new data obtained through the study, researchers must obtain Research Ethics Board (REB) approval, among other potential requirements and approvals, before undertaking any study activities.
HDRN Canada’s Privacy Team is made up of privacy officers who advise researchers on data privacy and ethics practices with respect to administrative data. The Privacy Team noticed that researchers were not always familiar with the requirement of consent from participants to link study findings to administrative data, or what information was required to ensure patients were fully informed about what data linking means.
Working collaboratively, members of the Privacy Team identified the most common scenarios they encountered regarding patient consent and guidance needed for researchers. By gathering feedback from HDRN Canada’s member organizations and Public Advisory Council (PAC), REBs, and researchers across Canada, the Privacy Team developed a set of guidelines to assist researchers when preparing their data consent forms.
These guidelines outline key topics that should be included in the consent form that is presented to research participants when seeking their consent for data linkage, as well as sample text in plain language.
“Building a shared understanding of requirements for informed consent allows researchers to not only inform patient participants appropriately, but also allows regions to learn from one another,” said Donna Curtis Maillet, Chair of the Privacy Team. “Shared practices and understanding across regions allows us to establish harmonized best practices, resulting in more equitable outcomes for patient partners.”