Please consider the following when designing studies that involve data access, sharing and linking activities. While some of these challenges stem from legislative constraints, others are due to policy choices and may change over time. We aim to streamline data access and sharing across Canada for research purposes so please check back here regularly to view updated recommendations and advice.
Data disclosures for research use
- Disclosure of personal health information (PHI) and de-identified data are subject to specific jurisdictional legislation and requirements set out in each HDRN Canada data centre’s agreements under which the data was originally provided.
- De-identified data refers to personal health information that has been modified using appropriate de-identification processes so that the identity of the individual cannot be determined by a reasonably foreseeable method.
- In many Canadian jurisdictions, there may be legislative or policy limitations to 1) the disclosure of patient level data, and 2) the transfer and/or sharing of data across jurisdictional boundaries for research use. This can have implications for research designed for data to be hosted / centralized in one location for analysis.
- DASH can support researchers in navigating these challenges and identify potential options early on in the research design process. DASH can also provide researchers with feedback as data sharing and/or access agreements are being drafted.
Consent-based research studies
- For research studies where the intent is to link study data with data at our HDRN Canada data centres, study participant consent is typically required for:
- the research team to provide identifying information (for example, health care number) to conduct linkage, and
- linked data to be subsequently disclosed to the research team.
- It may surprise you to learn that even with study participant consent, some jurisdictions have issues with sharing patient-level data outside of province, especially if agreements are in place between the HDRN data centres and the original data providers that stipulate only releasing aggregate data. In some cases, informed consent of participants will be overruled by these existing agreements and polices.
- DASH can support researchers to ensure that informed consent contains language that is appropriate and sufficient for linkage and disclosures to be conducted by HDRN Canada data centres.
Outside of Canada
- Disclosure of personal health information or de-identified data outside of Canada is prohibited in many Canadian jurisdictions. DASH can identify these challenges early on in the research design process.
If your research involves any of the scenarios described above, we encourage you to contact DASH as early as possible by completing a DASH Intake Form. We will work with you to identify any potential barriers early on and work with you to determine options.
We suggest that researchers follow this checklist when developing research projects:
- Connect with DASH early and often in research design process on subjects such as linkage, disclosures, hosting and access to linked data, informed consent and data sharing agreements
- Seek consent from study participants to link their study data to their pseudonymous, administrative and personal health information. Seek support from DASH to ensure informed consent wording is appropriate and sufficient for the linkage and disclosure.
- Develop a data flow diagram to describe how data will flow between each entity (i.e. research team, data centres, analytical site), where specific data linkages would occur and where analysis would take place
- Clearly identify the dataset name, included variables and the data business owner of all datasets you are requesting to link to data held by HDRN Canada research centres.