NOTE: This procedure is consistent with the Tri-Council Policy Statement TCPS2: Chapter 2 Scope and Approach of Ethics Review.
1. Research Requiring Research Ethics Board Review
Research Ethics Board (REB) will review:
a. All research that involves human participants requires approval by the REB before the research commences, except as stipulated in section 2;
b. Research involving human or animal* remains, cadavers, tissues, biological fluids, embryos or fetuses and shall also be reviewed by the REB; *Animal research will operate in accordance with Tri-council policy.
c. Researchers who intend to secure identifiable personal information about participants shall secure REB approval.
2. Research Not Requiring REB Review
REB will not review:
a. Research that relies exclusively on publicly available information, including secondary data sets. This includes research on living individuals and research on organizations such as governments or corporations, so long as the research is based entirely on material to which the public has access;
b. Research involving public policy issues, the writing of modern history, or literary or artistic criticism;
c. Quality assurance and quality improvement studies, program evaluation, and performance reviews or testing within normal educational requirements;
d. Research involving observation of people in public places that does not allow for the identification of the individuals in research material and that is not staged by the researchers;
e. Creative practice activities in and of themselves and having no identified application.
3. REB Review Shall be Proportionate
REB will adopt a proportionate approach to ethics review, based on the principle that as the risk to participants increases, so will the level of scrutiny in assessing the research and the level of expertise involved in the review process. An evaluation of the risks associated with a human participant’s participation in an applied research initiative relative to the assumed benefits to the participant and society at large is a central ethical consideration for both the researcher and the REB. Determining risk should be made using a person centered approach and must take into account agreed upon benchmarks for normally accepted risk.
Typically, there are two levels of risk:
a. Minimal Risk – occurs when potential participants can reasonably be expected to regard the probability of possible harms to be no greater than those encountered by the participant in those aspects of her or her everyday life. Methodologies most associated with minimal risk include surveys, questionnaires, face-to-face interviews and focus group discussions;
b. Non-Minimal Risk – occurs when the potential participants may be at risk of possible harm due to the nature of the research activities. Methodologies most associated with non-minimal risk include specific preventative or therapeutic measures and/or invasive procedures, as well as studies concerning human health related behaviours and/or experiences in a variety of circumstances and environments that may place the participants at some risk.
All researchers engaged in activities at the JIBC are expected to assess all reasonably predictable risk involved in and the benefits expected to arise from their activities. In considering possible risks, researchers should take the following factors into consideration when conducting their risk analysis. Is there a likelihood of causing:
a. Physical harm;
b. Psychological harm;
c. Injury to reputation and privacy;
d. A breach of any relevant law.
4. Ongoing REB Review
Further to the initial review of research that falls within the scope of these Procedures, the REB will review ongoing research throughout the life of the project. This includes review of departures from approved research that result in a change in the level of risk of research, or other ethical implications that have an impact on the welfare, autonomy and equal moral status of all humans. As with initial review, continuing ethics review will be based on a proportionate approach. In order to facilitate a further ethics review, researchers will be required to report to the REB, in a timely manner, events or issues that have ethical implications or that change the risk to participants.
5. Scholarly Review as Part of REB Review
As part of research ethics review, the REB shall review the ethical implications of the methods and design of the research.
REB requires that research posing more than minimal risk must undergo scholarly review. The REB may require ad hoc specialists, including experts external to the JIBC, to assist in evaluating research in specialized disciplines with which REB membership is unfamiliar.
In ethics review and the conduct of research, the REB and researchers have an obligation to be aware of applicable laws.
Last updated June 23, 2015
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