CAN/DGSI 100-10 / HRSO 300.03, Data Governance in Human Research

The NSC applies to all individuals engaged in the conduct of human research. It also applies to for-profit and not-for-profit, public, and private organizations. In this document, any entity that conducts or facilitates human research is called a Research Enterprise (RE). An RE may exist as a component of a larger institution (e.g., a university) or corporation, or as a component of a Human Research Protection Program (HRPP).

By reducing the variability of interpretation of regulations, policies, and guidelines, this NSC provides a basis for the establishment of unambiguous procedural documents that adhere to Canadian and international normative references.

Human research incorporates various types of qualitative and quantitative methods, disciplines (health, social sciences and humanities, arts, engineering), and approaches (interventional, observational) conducted in a variety of domains (biomedical, social, legal, behavioural). Human research may involve the use of existing or prospectively collected data, specimens, images, observations, or audio/video recordings, both digital and analog. This standard applies to all digitized and digital data.

Because of the diversity of research disciplines and methods, this NSC covers data governance issues, practices, and processes held in common and acknowledges where there may be discipline-specific requirements or norms with which the reader should conform.

DATE POSTED: January 22, 2025

DEADLINE FOR COMMENTS: March 24, 2025