NOTE: This procedure is consistent with the Tri-Council Policy Statement TCPS2: Chapter 4 Fairness and Equity in Research Participation.
The JIBC supports inclusion in research based on the principle of equal moral status, which holds that particular individuals or groups in society should neither bear an unfair share of the direct burdens of participating in research, nor should they be unfairly excluded from the potential benefits of research participation by virtue of gender and diversity. Inclusiveness in research must be of concern to researchers, Research Ethics Board (REB), and other research partner institutions.
Researchers must not exclude individuals from participation in research on the basis of attributes such as culture, religion, race, disability, sexual orientation, ethnicity, sex or age unless there is an ethically defensible reason for the exclusion. This includes:
1. Research Involving Women
Women must not be automatically excluded from research solely on the basis of sex or reproductive capacity.
2. Research Involving Children
Researchers should not exclude children from research unless there is a valid reason for doing so. Participation of children in research is justifiable when the research objective cannot be achieved with adult participants only. When considering the inclusion of children in research, researchers and REB’s shall consider a child’s stage of physical, physiological, psychological, and social development to ensure adequate protections for the child’s welfare. Where children have not yet attained the capacity to consent for themselves to participate in research, researchers shall seek consent from an authorized third party while ascertaining the child’s assent or dissent, as outlined in Chapter 3.
Note that Article 4 equally applies to children.
3. Research Involving the Elderly
Researchers should not exclude elderly people from research unless there is a valid reason for doing so. When considering the inclusion of elderly people in research, researchers and REBs shall consider their physical and social needs to ensure adequate protections. Depending on their social circumstances, elderly people may require some reasonable accommodation for mobility, transportation support and other types of assistance to facilitate their participation in research. The principle of Justice requires that such accommodations for the natural processes of aging be considered by REBs and researchers. Exclusion of the elderly shall not be based on easily remediable issues that are not germane to the research question.
4. Research Involving Participants Who Lack the Capacity to Consent for Themselves
Where a researcher seeks to involve individuals in research who do not have capacity to give free and informed consent, the researcher must satisfy the Research Ethics Board that:
a. The research question can be addressed only with the participation of individuals who do not have capacity to consent; andb. If the research involves more than minimal risk, it has the potential to provide direct benefits for participants or a group to which they belong.
To be ethically acceptable, the participation of those who lack capacity to consent for themselves shall be necessary and appropriate to address the research question. Researchers and REBs shall consider the level of risk to which participants who lack capacity to consent are exposed, and the prospect of direct benefits to accruing to the participants. Their participation should generally be limited to research of minimal risk.
Individuals who are not proficient in the language used by the researchers should not be automatically excluded from the opportunity to participate in research. Where appropriate, or necessary for purposes of the research model, the researcher may be requested to accommodate language differences.
6. Vulnerable individuals
Vulnerable individuals or groups must not be automatically excluded from research that may benefit them or a group to which they belong.
Last updated July 30, 2015
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