What is considered minimal risk?

In accordance with the Tri-Council Policy Statement on the Ethical Conduct for Research Involving Humans, the REB relies on the principle that more invasive or hazardous research requires a more careful ethical analysis afforded by a full-board review. In contrast, research proposals with no more than minimal risk to the participants (research subjects and personnel) may be expedited. Expedited review means that the research proposal is reviewed by a subset of the full board. Researchers may recommend an expedited review, but the decision rests with the Chair of the REB or their designate.

The Tri-Council has recognized the difficulty in assessing risk. To help determine what constitutes minimal risk research, the Tri-Council has defined the term:

For the purposes of this Policy, “minimal risk” research is defined as research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research (p. 23 TCPS2).

The Tri-Council Policy indicates that researchers and REBs must take into account (A) the type of risk; (B) the extent and likelihood of experiencing harm; and (C) known pre-existing individual or group vulnerabilities that might exacerbate or alter the likelihood or extent of harm. Each of these is described below.

A) Type of risk has been interpreted as risk that is physical (e.g., risk of harm through bodily contact or administration of a substance, or by administering a painful stimulus), psychological or emotional (e.g., feeling uncomfortable, embarrassed, anxious, or upset), and social risk (e.g., risk of loss of status, reputation, or privacy, financial loss, legal risk following disclosure of duty-to-report events).

B) The extent and likelihood of experiencing one of these harms (physical, psychological, social) must also be taken into account. The magnitude of the harm (e.g., a little emotional discomfort, loss of reputation, experience of pain) and the likelihood of harm (very unlikely to certain) are independent constructs.

C) With respect to individual and group vulnerabilities, the Tri-Council has indicated that REBs (and researchers) “have special ethical obligations to individuals or groups whose situation or circumstances make them vulnerable in the context of a specific research project, and to those who live with relatively high levels of risk on a daily basis. Their inclusion in research should not exacerbate their vulnerability (see Article 4.7)” (p. 23 TCPS 2). This does not imply that any research involving a vulnerable group should necessarily require full board review. To qualify for minimal risk, however, researchers must make the case that participation in the research is unlikely to exacerbate the participant’s (or group’s) vulnerability or increase their risk of physical, psychological, or social harm.

Designating a group as vulnerable presumes that the researcher or the REB believes that there is a reasonable expectation that at least one member of the group will experience a physical, psychological, or social harm in the course of or as a result of participating in the study or experiment. This is a question of probabilities that should be substantiated with empirical evidence or advice from those with extensive and direct experience with the group (e.g., clinicians for those with a disorder, teachers for children). Such evidence or advice must take into account the nature of the study or experiment being proposed. Where there is a reasonable expectation that at least one member of the group will experience harm in the course of or as a result of participating in the study or experiment, researchers must have a plan for mitigating the harmful consequence.

Deception: Experiments involving serious deception (e.g., giving false negative feedback about an important aspect of self; creating a fearful environment; convincing someone they have a serious medical condition; covert recording of individuals with the intent of obtaining consent after the fact) should be considered more than minimal risk if there is a reasonable expectation that at least one member of the sample will experience a physical, psychological (e.g., feelings of emotional upset or anxiety), or social harm.

Stress induction: Experiments involving the instigation of stress or anxiety (e.g., where the Trier Stress Test is used) should be considered more than minimal risk if there is a reasonable expectation that at least one member of the sample will experience a physical, psychological (e.g., feelings of emotional upset or anxiety), or social harm.

The Tri-Council Policy notes that, in assessing risk, special attention must be given to the culture, values, and beliefs of the population being studied. Where expertise is lacking, REBs should consult ad hoc advisors as needed (p. 24 TCPS 2).