CAN/HRSO – 200.01 – 2021

This NSC applies to all individuals, as well as all for-profit and not-for-profit, public and private organizations, engaged in the ethical review and oversight of human research, such as: • those involved in establishing, administering, and ensuring effective REB operations • regulatory authorities and other organizations that evaluate REBs. By reducing the variability of interpretation of regulations, policies, and guidelines, this NSC provides a basis for the establishment of unambiguous procedural documents that are informed by Canadian and other commonly used normative references. Human research is defined as a systematic, rigorous investigation involving human beings. Human research includes, but is not limited to, the following disciplines: health research, social sciences and humanities research, creative and arts-based research, and engineering research. Human research includes, but is not limited to, the following methodologies: interventional research, observational research, qualitative research, social and behavioural research, health services research, public health research, educational research, research involving existing human data, research with deceased individuals, and research involving human biological materials and their derivatives. “Shall” vs “Should” In this NSC, “shall” indicates that the requirement is mandatory and is supported by normative references, whereas “should” indicates that the requirement is recommended, or a best practice statement.