Part of creating and implementing research data management, especially when considering data deposits of clinical biomedical research, involves patient consent. Canada’s clinical community has yet to harmonize consent language considering shifting data management and deposit mandates.
Research ethics considerations in RDM
Below we present an infographic developed for use as a training tool. The collaboration between Research Ethics Boards and researchers will help better equip research communities in effectively and efficiently complying with new and incoming research data management requirements, including that of the Tri-Agency Research Data Management policy.
Harmonized consent language for data sharing
These templates provide guidance that can be adapted to the research team's study and goals. These documents have been reviewed and revised through many processes including from legal and bioethical perspectives by lawyers from different jurisdictions in Canada, privacy and security professionals and patients and caregivers in Canada.
Last updated: 2025-03-20
Please view the data sharing consent templates for use in four different scenarios for clinical study data to be shared:
- Prospective consent – open data sharing
- Retrospective consent – open data sharing
- Prospective consent – controlled data sharing
- Retrospective – controlled data sharing
Consent is critical to clarify factors of what a participant may expect for how their data will be collected, handled, stored, and/or shared to be used in the future.
Here, we present templates for consent for REBs for data sharing, illustrating the continuum of consent language for controlled access to open data sharing, as well as obtaining consent retrospectively.
Building Community to Support Data Sharing in Health Research Event
The goal of the workshop was to learn, discuss and build community among experts and professionals working in research ethics, privacy, and open science spaces around best practices to support health research data sharing.
This event took place at The University of Ottawa Heart Institute on March 21st, 2025.
Please view the recording of the event and presentation slides below.