The principle of Justice holds that particular individuals, groups or communities 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. Inclusiveness in research and fair distribution of benefits and burdens should be important considerations for researchers, research ethics boards (REBs), research institutions and sponsors. Issues of fair and equitable treatment arise in deciding whether and how to include individuals, groups or communities in research, and the basis for the exclusion of some.
This chapter addresses inclusion in research of individuals and groups that might be inappropriately excluded on the basis of attributes such as culture, language, gender, race, ethnicity, age and disability. It provides guidance relevant to inclusion in research of specific groups such as women, children, the elderly and those who lack capacity to consent to participate in research. Historically, these groups have often been inappropriately excluded from research.
This chapter also addresses the fair inclusion and equitable treatment of individuals, groups and communities whose situation or circumstances make them vulnerable in the context of a specific research project. These individuals run the risk of being included in research in ways that may be unfair and inequitable. This chapter provides guidance relevant to the equitable distribution of the risks and benefits of research.
Over-protectionist attitudes or practices of researchers or REBs, whether intentional or inadvertent, can exclude some members of society from participating in research. The exclusion of individuals, groups or communities may constitute a failure to treat them justly. For example, age has been used to exclude individuals from participation in research, particularly health research (e.g., studies that only accept participants between the ages of 18 to 35). As a result, sufficient research may not be done on groups that fall outside of narrow age criteria. The inclusion of the young and the elderly in research, for example, ensures that treatments frequently given to these populations are effective and safe.
Researchers, institutions and REBs all have important roles to play in advancing that societal commitment, and ensuring a fair distribution of the benefits and burdens of research. Researchers and REBs must navigate between the dangers of imposing unfair burdens on particular participants, groups and communities, and overprotecting them. In assessing fairness and equity issues in the research ethics process, REBs should not intervene in the choice of research topics.
Article 4.1 Taking into account the scope and objectives of their research, researchers should be inclusive in selecting participants. Researchers shall not exclude individuals from the opportunity to participate in research on the basis of attributes such as culture, language, religion, race, disability, sexual orientation, ethnicity, linguistic proficiency, gender or age, unless there is a valid reason for the exclusion.
Application Article 4.1 is based on the principle of Justice. It imposes a duty on researchers not to exclude individuals or groups from participation for reasons that are unrelated to the research. This duty is explicitly stated because groups have been inappropriately excluded from participation in research on the basis of attributes such as gender, race, ethnicity, age and disability.
The focus, objective, nature of research and context in which the research is conducted inform the inclusion and exclusion criteria for a specific research project. Some research may be focused on a certain individual (such as in a biography), or a group of individuals who share a specific characteristic (e.g., an identifiable group of painters who happen to be all of one sex; a religious order that is restricted to one sex). Other examples include research that is focused on specific cultural traditions or languages, or on one age group (e.g., a biomechanical modeling study of posture corrections in adolescents). Such research should not be precluded so long as the selection criteria for those to be included in the research are germane to answering the research question. Researchers who plan to actively exclude particular groups should clarify to their REBs the grounds for the exclusion.
Where a language barrier exists between the researcher and the prospective participant, various measures may be used to ensure effective communication in recruitment and consent discussions. For example, an intermediary who may not be part of the research project or team, but who is competent in the language used by the researchers, as well as that preferred by the participant, may assist with communication between prospective participants and researchers. The selection of an intermediary and their activities will depend on the nature, context and risks of the research.
Research Involving Women
Women have historically been inappropriately excluded from participating in some research. This exclusion of women, where unwarranted, has delayed the advancement of knowledge, denied potential benefits to women, and exposed women to harm when research findings from male-only research projects were generalized inappropriately to women, as has often been the case in clinical drug trials. The inclusion of women in research advances the commitment to Justice, improves the generalizability of research findings to women where that is a goal of the research, and is essential to ensure that women and men benefit equally from research.
Article 4.2 Women shall not be inappropriately excluded from research solely on the basis of gender or sex.
Application Researchers should not exclude women from research unless there is a valid reason for doing so. While some research is properly focused on particular research populations that do not include women, or include very few women, women should generally be represented where there is a reasonable expectation that the results of the research will be generalized to women.
Article 4.2 rejects discriminatory and unethical use of inclusion or exclusion criteria that presumptively or inappropriately exclude women because of their gender or sex.
Article 4.3 Women shall not be inappropriately excluded from research solely on the basis of their reproductive capacity, or because they are pregnant or breastfeeding.
Application Researchers should not exclude women from research on the basis of their reproductive capacity, or their pregnancy, or because they are breastfeeding, unless there is a valid reason for doing so.
Subjecting women of childbearing potential to inappropriate requirements precludes their participation in research. Exclusions should be made on the basis of clear criteria that reflect balanced attention to the potential benefits as well as the foreseeable risks of the research that may affect the welfare of women. For example, researchers should not require participants to use oral contraception, unless there is a valid reason for doing so.
In considering research on pregnant or breastfeeding women, researchers and REBs shall take into account foreseeable risks and potential benefits for the woman and her embryo, fetus or infant, as well as the foreseeable risks and potential benefits of excluding pregnant or breastfeeding women from the research.
Research Involving Children
Children have varying degrees of maturity – metabolically, immunologically and cognitively – that may present important challenges for research design and the consent process, depending on the nature and complexity of the research. In addition to the vulnerability that arises from their developmental stage, children may also lack capacity to consent to participate in research (see Article 4.6). As well, physical or psychological harms a child may experience in a research setting may have long-lasting consequences. As a result, researchers have often avoided the inclusion of children in some research, especially in clinical trials testing new treatments, so as to eliminate any risks. Clinical trials conducted only with adults yield a generally poor understanding of the results that apply to children.
As is the case with women, the inclusion of children in research advances the commitment to justice in research by improving our knowledge of, and ability to respond to, the unique needs of children throughout their development.
Application 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 REBs 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 4.6 equally applies to children.
Research Involving the Elderly
As the population ages, the proportion of elderly people is increasing, and so is their life expectancy. Research designed to improve our understanding of a wide range of aspects of aging and the lives of elderly people is important for ensuring that they stay fully integrated into society and maintain a continuing high quality of life. Medically, elderly patients are the highest consumers of drugs, yet many of these treatments have not been tested adequately on elderly patients. Research that takes into account the differential effects on the elderly and how best to accommodate their needs provides scientific evidence that can inform changes to policies and standards of care for the elderly.
Article 4.5 Elderly people shall not be inappropriately excluded from research solely on the basis of their age.
Application 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.
Research Involving Participants Who Lack the Capacity to Consent for Themselves
The core principles of Justice and Concern for Welfare entail special ethical obligations toward individuals who lack capacity to consent to participate in research. This section sets out conditions that apply to research involving those who cannot consent for themselves. It should be read in conjunction with Section C of Chapter 3.
Article 4.6 Subject to applicable legal requirements, individuals who lack capacity to consent to participate in research shall not be inappropriately excluded from research. Where a researcher seeks to involve individuals in research who do not have capacity to consent for themselves, the researcher shall, in addition to fulfilling the conditions in Articles 3.9 and 3.10, satisfy the REB that:
(a) the research question can be addressed only with participants within the identified group; and
(b) the research does not expose the participants to more than minimal risk without the prospect of direct benefits for them; or
(c) where the research entails only minimal risk, it should at least have the prospect of providing benefits to participants or to a group that is the focus of the research and to which the participants belong.
Application Children and individuals with cognitive impairments or intellectual disabilities may lack capacity to consent to participate in particular research initiatives. As a result, they have, historically, experienced both over-inclusion as populations of convenience for some research and unjustified exclusion from other research. Yet the advancement of knowledge about their social, psychological, and health experiences and needs may depend on their appropriate participation in research. Their inclusion in research requires special considerations as outlined in this article.
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 as defined in this Policy (see Chapter 2 for the definition of minimal risk).
Where the research presents more than minimal risk, it should have appropriate justification aimed at generating knowledge of sufficient importance to addressing the participants’ disorder, condition, interest or situation. Such research should have the prospect of direct benefits for the participants themselves commensurate with the level of foreseeable risk to participants. The relation of the potential benefit to the foreseeable risk presented by the research should be at least as favourable to the participants as that provided by available alternative approaches.
Where the research entails only minimal risk, it is sufficient if the research presents the prospect of benefits to participants or to a group that is the focus of the research and to which the participants belong.
The research design should take into account factors that may affect the capacity of prospective participants to receive information, to consent to the research at some stage, or to participate in it. These factors may be permanent or may vary over time (e.g., the participant’s capacity to consent may fluctuate over time). Articles 3.9 and 3.10 in Chapter 3 establish other conditions regarding research that involve individuals who lack capacity to consent. This includes the involvement of an authorized third party to consent on their behalf, and adequate provisions to ascertain the wishes of the individuals concerning their participation.
Participants’ Vulnerability and Research
Article 4.7 Individuals or groups whose circumstances may make them vulnerable in the context of research should not be inappropriately included or automatically excluded from participation in research on the basis of their circumstances.
Application The core principles of Respect for Persons, Concern for Welfare, and Justice entail special ethical obligations toward individuals or groups whose circumstances may lead to their vulnerability in the context of a specific research project and limit their ability to fully safeguard their own interests. Those who are owed special ethical obligations may include individuals who are institutionalized, those in dependent situations, or those whose circumstances (e.g., poverty or poor health status) may render even modest participation incentives so attractive as to constitute an inducement to take risks they would otherwise not take. Their situation may also compromise the voluntariness of consent in other ways. However, individuals should not automatically be considered vulnerable simply because of assumptions made about the vulnerability of the group to which they belong. Their particular circumstances shall be considered in the context of the proposed research project.
REBs and researchers shall carefully examine the relationship between the circumstances of the individuals and groups they aim to recruit, and the proposed research question. They should not presume that these circumstances will automatically result in the inclusion or exclusion of individuals or groups as prospective participants. Participation should be based on inclusion or exclusion criteria that are justified by the research question. Researchers and REBs should recognize and address changes in a participant’s circumstances that may create, heighten, or attenuate their vulnerability, and provide special protections or consideration.
In general, researchers should be familiar with the cultural, social and economic circumstances of prospective participants, groups or communities. Researchers should anticipate, to the best of their ability, needs of participants, groups and their communities that might arise in any given research project. Especially when groups, and their communities, have a wide range of pressing needs due to their low socioeconomic circumstances, these needs can present significant ethical challenges for researchers. An equitable distribution of research benefits (discussed below) can help ensure that individuals, groups and communities whose circumstances may make them vulnerable in the context of research are not inappropriately included in research based on these circumstances.
Equitable Distribution of Research Benefits
Researchers should consider ways to ensure the equitable distribution of any benefits of participation in research. Benefits of research participation may be direct, where, for example, an individual participant experiences amelioration of a health condition as a result of an experimental therapy, or learns new information about social issues as a result of participation in a research focus group. In a community hosting research, benefits may take the form of information sharing, training for local personnel, the establishment of health care or similar services. Benefits may be indirect, where the participation in research of an individual or group, or in a research project involving a community contributes to the advancement of knowledge that may lead to improved conditions for a group to which the participant belongs. Such knowledge may also inform other communities or society in general.
Researchers should also be sensitive to the expectations and opinions of participants regarding potential benefits of the research. Prior to the commencement of the research, researchers should formally or informally discuss these expectations with individuals and/or groups, and outline the scope and nature of potential benefits that may accrue to participants during and after the research (see Article 9.13). REBs should be vigilant to ensure that the proposed distribution of benefits is fair, without imposing undue burdens on the researcher that would make it too difficult or costly to complete research.
Researchers should normally provide copies of publications, or other research reports or products, arising from the research to the institution or organization – normally the host institution – that is best suited to act as a repository and disseminator of the results within the participating communities. This may not be necessary in jurisdictions where the results are readily available in print or electronically. In general, researchers should ensure that participating individuals, groups and communities are informed of how to access the results of the research. Results of the research should be made available to them in a culturally appropriate and meaningful format, such as reports in plain language in addition to technical reports.