The scope of this Policy is restricted to the review of the ethical conduct of research involving humans. This applies to materials derived from living and deceased individuals. human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells.The following requires ethics review and approval by an REB before the research commences. Research Requiring Research Ethics Board Review Article 2.1 Non-research activities do not require REB review even if they employ methods and techniques similar to those in research ( Articles 2.5 and 2.6). Some research is exempt from REB review where protections are available by other means ( Articles 2.2 to 2.4). The general categories of research that require REB review in accordance with this Policy are defined in Article 2.1. The establishment, governance, jurisdiction and composition of REBs, and operational issues related to their functioning are addressed in Chapter 6. The research ethics board (REB) tailors the level of scrutiny by an REB to the level of risk presented by the research, and assesses the ethical acceptability of the research through consideration of the foreseeable risks, the potential benefits and the ethical implications of the research, both at the stage of the initial REB review and throughout the life of the project (continuing ethics review). The preferred approach to research ethics review is a proportionate approach. This chapter outlines the scope of application of the Policy and the approach to research ethics review that flows from the core principles – Respect for Persons, Concern for Welfare, and Justice.
The purpose of this Policy, as set out in Chapter 1, is to establish principles to guide the design, ethical conduct and ethics review process of research involving humans. TCPS 2 (2018) – Chapter 2: Scope and Approach
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