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CAN/DGSI 131 / HRSO 200.01, Ethical Review and Oversight of Human Research

Public Review

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 documented procedures that are informed by Canadian and international 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.

DATE POSTED: November 12, 2025

DEADLINE FOR COMMENTS: January 12, 2026
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dquesnel Dec 31 2025 at 8:06PM on page 25

Editorial
A new yet pressing reality is the use of generative artificial intelligence / LLM models by researchers/institutions in the creation of research documents (including those intended for research ethics board approval), and the potential risks in data analysis. How much oversight does a REB have in this?

dquesnel Dec 31 2025 at 7:56PM on page 10

Editorial
Recommend definition of participatory/community and patient oriented research to refer to.

dquesnel Dec 31 2025 at 6:11PM on page 12

Editorial
Clarity in role is needed. Investigator/Researcher are not synonymous terms.

dquesnel Dec 31 2025 at 5:57PM on page 23

Editorial
Requires mention that Research Participants can also have a dual role, as Individuals who Play a Role in the RE.

Denise Dec 31 2025 at 5:30PM on page 34

Editorial
Section needs to emphasize contextual detail: how much methodological detail is reasonable at initial submission and what counts as a “material” change from the initial protocol is context specific. It is important to consider that what is proposed during initial REB submission may need to change, because community-research partnerships are dynamic, and reciprocity and trust with community members emerges over time.

Denise Dec 31 2025 at 5:16PM on page 26

Editorial
Flexibility in what counts as a “material” change (vs minor iterative refinements) requiring formal amendment is needed for the standard to truly be congruent with community-engaged, engagement/partnership with communities, participatory, co-production, and other emergent designs.
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