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Fairness and Equity

1. Can a researcher justify conducting research in a specific language(s) only?

It is “the focus, objective, nature of research and context in which the research is conducted [that] inform the inclusion and exclusion criteria for a specific research project” (Application of Article 4.1). If the research is focused on a community or group that communicates in a specific language, it would be justifiable to have the research conducted and material provided in that specific language only. However, if the objective of the research is, for example, to gather the views of a cross-section of parents of hockey players in a bilingual community, then the research material and resources (including consent information and other communications addressed to participants) should be available in both languages.  Making this decision is based on the extent that the inclusion of the linguistic groups is germane to answering the research question and guided by the principle of Respect for Persons in TCPS 2.  Researchers must provide information in a language that participants can understand to be able to make an informed decision to participate in a research project in accordance with Articles 3.2 and 3.3 of TCPS 2.

In general, researchers should do exploratory work before conducting the research to understand the make-up of the community they wish to involve in their research. They should also inform the REB of “their strategies to familiarize themselves with the relevant norms and cultural practices…” (Application of Article 8.3). Though this article deals with research conducted in other countries, it applies equally to any community or participant population in any jurisdiction.  It is equally important that in their reviews, REBs should have the relevant expertise and knowledge for a competent review of research material in those languages (see Article 6.5).

2. If research material will be offered to participants in more than one language, how do researchers and REBs decide what research material should be made available in those language(s)?

Deciding upon the language(s) in which research material should be made available must be determined on a case-by-case basis, based on the context of the research and the extent to which the inclusion of all linguistic groups is germane to answering the research question.  This determination should be guided by the principle of Respect for Persons in TCPS 2.  Researchers should provide all information necessary in the language that participants understand to allow them to make informed decisions regarding their participation in research.  This means making recruitment, consent and other material, if any, available in the relevant language(s).  If the research has a more involved process requiring participant feedback and discussion and/or if the topic is sensitive it may also be necessary to provide translators. As stated in the Application of Article 4.1 of TCPS 2, where a language barrier exists between the prospective participant and the researcher, various measures, for  example an intermediary, may be used to ensure effective communication in recruitment and consent discussions.

The onus is on researchers to provide a rationale regarding their plans for the provision of material or resources in any language(s) – based on the research question. The onus is also on the researcher to satisfy the REB that the proposed research material in other language(s) is accurate, appropriate and understandable for potential participants.  The researcher may do so, for example, by having the material translated by a certified translator, or by having the material presented by a translator to the REB, or by attestation of a member of the participant community or by the researcher.  The REB may also solicit input from an ad hoc member with the ability to understand and review the proposed material in the other language (see Article 6.5).  It is then the REBs’ responsibility to assess the ethical acceptability of these plans on a case-by-case basis.

3. Within the context of TCPS 2, what are the ethical implications where research participants are funders of the research? NEW

TCPS 2 applies to all research within the jurisdiction or under the auspices of any institution eligible to administer funding from any of the federal research Agencies (CIHR, NSERC, and SSHRC) regardless of the source of funding. TCPS 2 makes reference to “funding” in general. It acknowledges that the source of funding may raise ethics issues. These include issues of conflicts of interest at the institutional level, as well as at the level of researchers. TCPS 2 advises that “researchers should not benefit financially from … sponsors” and that “REBs shall consider the potential for conflicts of interest in clinical trials because it has been empirically established as a risk of some sponsored research and can undermine the ethical conduct of research” (Application of Article 11.10).

TCPS 2 does not specifically address situations when participants fund the research. In the absence of specific guidance, researchers and REBs should be guided by the Policy’s three core principles: Justice, Concern for Welfare, and Respect for Persons (Chapter 1B. Core Principles).

Funders of research may be a group of participants (for example, individuals with a common condition) who provide all or part of the funding of a research project as sponsors through a charitable organization, or based on their individual efforts to seek donations. In those cases, eligibility for participation in the study is likely not tied to payment, and not all funders are or become participants in the research. This model does not seem to raise new ethical issues beyond what is already addressed in TCPS 2 in relation to funding.

A more direct form of participants’ funding research is when a researcher makes payment a condition of participation in the research. This funding model raises ethical issues with respect to inclusion and exclusion criteria.  It raises new ethical issues or exacerbates existing risks, and presents key challenges to the obligation to treat people fairly and equitably – an obligation that stems from the core principle of Justice.  The principle of Justice holds that particular individuals, groups or communities should not be unfairly excluded from the potential benefits of research participation, and that the criteria for inclusion in research must be relevant to answering the research question (Chapter 4). Exclusion from research solely on the basis of inability or refusal to contribute financially to the research contravenes the principle of Justice.  Limiting access to the research to those able to pay may lead to preferential treatment. It may influence eligibility for participation in a study by introducing biases in recruitment and selection. Researchers may feel pressured to include participants who want to pay to participate, but who are ineligible to participate based on the inclusion and exclusion criteria of the research.  This may possibly result in skewing the results of research and constraining its scientific validity.

Paying to participate in research may also result in undue pressure on participants to harness their fundraising ability, and risk unnecessary psychological and financial pressures. Concern for Welfare, another core principle of TCPS 2, requires researchers and REBs to protect the participants’ welfare including impacts on individuals’ mental and spiritual health as well as economic and social circumstances (Chapter 1B., Core Principles).

The core principle of Respect for Persons implies that individuals who participate in research should do so voluntarily, based on as full an understanding as possible of the research, its risks, and potential benefits (Chapter 3, The Consent Process). Considering these issues is of particular importance in the pay-to-participate funding model.  This model may raise unrealistic expectations in that prospective participants will incur direct benefits from the research having paid for it, may exaggerate benefits of the research, or may increase the risk that the research will be confused/conflated with treatment (therapeutic misconception – Article 11.6). It may undermine voluntariness to consent by presenting an undue inducement to continue in a study rather than withdraw, as withdrawal may be perceived by a participant as a loss of his/her investment.  This would undermine the core principle of Respect for Persons, by diminishing the voluntariness of ongoing consent.

In their review of pay-to-participate research, REBs have an ethical obligation to take into account the additional risks that may be introduced by this funding model in light of the issues discussed above. As with all ethics review, the level of scrutiny shall be proportionate to the level of risk posed to participants (Article 2.9). This scrutiny may include greater initial review, more extensive continuing ethics review, and/or more frequent reporting to the REB and monitoring (Application of Article 6.14).  Also, “[i]n addition to the principles and guidelines in this Policy,  researchers are responsible for ascertaining and complying with all applicable legal and regulatory requirements” (Chapter 1, Research Ethics and Law).

 

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