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Revised Draft 2nd Edition of the TCPS (December 2009)

Chapter 4


A. Introduction

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 an important consideration 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, the basis for exclusion of some, and social justice issues such as how research differentially impacts groups and communities in society.

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 certain groups such as women, children, the elderly, and those who lack capacity to consent to participate in research. Historically, these groups have been inappropriately excluded from research. This chapter also addresses the fair inclusion and equitable treatment of individuals and communities whose situation or circumstances makes them vulnerable in the context of a specific research project. Such individuals run the risk of being included in research in ways that may be unfair and inequitable.

Benefits of research participation may be direct, where, for example, an individual participant experiences amelioration of a health condition because of an experimental therapy or learns new information about social issues by participating in a research focus group. In a community hosting the 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 an individual’s research participation or a study involving a community contributes to advancement in knowledge that may lead to improved conditions for a group to which the participant belongs. Such knowlege may inform other communities or society in general.

Over-protectionist attitudes or practices of researchers or REBs, whether intentional or inadvertent, exclude some members of society or communities from participating in research, and may therefore fail to treat those individuals or communities justly. For example, age has been used to exclude individuals from participation in research, particularly health research. The result of such exclusion is that insufficient research has been done to ensure treatments that are frequently given to the young and the elderly are effective and safe in these populations.

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 research participants, groups, and communities and overprotecting them.

B. Appropriate Inclusion

Article 4.1 Taking into account the scope and objectives of their research, researchers should be inclusive in selecting research 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. 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 or study. Some research may be focused on a certain individual (such as in a biography) or a group of individuals who share a specific characteristic (as in a study of an identifiable group of painters who happen to be all of one sex, race or religion, or of a religious order that is restricted to one sex, or research focused on certain cultural traditions or languages). 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 potential participant, various measures may be used to ensure effective communication between them in recruitment and consent discussions. For example, an intermediary who may not be part of the research study or team, but who is competent in the language used by the researchers as well as that preferred by the research participant, may assist with communication between potential participants and researchers. The selection of the intermediary and the intermediary’s activities will depend on the nature, context, and risks of the research.

C. Inappropriate Exclusion

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 studies have been generalized inappropriately to women, as has often been the case in clinical drug trials, for example. The inclusion of women in research advances the commitment to justice, improves the generalizability of research results 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 reproductive capacity.

Application 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 reproductive capacity. In considering research on pregnant or breastfeeding women, researchers and REBs shall, however, take into account risks and potential benefits for the woman and her embryo, fetus or infant.

Research Involving Children

Children have varying degrees of maturity, metabolically, immunologically and cognitively, which presents important challenges for research design and consent, depending on the nature and complexity of the research. In addition to vulnerability that arises from their developmental status, children may also lack capacity to consent to participate in research. (See Article 4.5).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 simply avoided the inclusion of children in some research, especially in clinical trials testing new treatments, so as to eliminate any risks. The result is a generally poor understanding of how the results of clinical trials conducted with adults only 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.

Article 4.3 Children shall not be inappropriately excluded from research solely on the basis of their age or development status.

Application Researchers should not automatically exclude children from research, unless there is a valid reason for doing so. 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 4.5 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 4.4 Elderly people shall not be inappropriately excluded from research solely on the basis of their age.

Application REBs and researchers should ensure that elderly people are not automatically excluded 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 that would otherwise preclude their participation in research. The principle of justice requires that such accommodations for the natural processes of aging be considered by REBs and researchers to ensure that exclusion of the elderly is not based on easily remediable issues that are not germane to the research question.

Research Involving Those Who Lack 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 4.5 Subject to conditions in Articles 3.9 and 3.10, 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 satisfy the REB that:

(a) the research question can be addressed only with participants within the identified group; and

(b) the research involves minimal risk or a minor increase above minimal risk with appropriate justification; and

(c) the research maintains an appropriate balance of risks commensurate with the potential to provide direct benefits to the participants or the relevant group to which they belong.

Application Individuals with cognitive impairments or intellectual disabilities and children 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 also 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 potential for benefits accruing directly to the participants or to a group to which they belong. 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). The prospect of benefits for participants should be commensurate with the level of risk entailed by the research.

Where the research entails only minimal risk, it should at least have the potential to provide benefits to participants or to a group to which they belong. Where the research presents a minor increase above minimal risk, it should have appropriate justification and the potential for direct benefits for the participants themselves. Where the research presents a minor increase above minimal risk but no prospect for direct benefits to the participants themselves, it should have the potential to yield generalizable knowledge that is likely to benefit the population from which the participants are recruited.

The research design should take into account factors that may affect the capacity of potential research 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. 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.

D. Inappropriate Inclusion

The core principles of respect for persons and concern for welfare entail special ethical obligations toward individuals or groups whose circumstances may lead to their vulnerability in the context of a specific research project or study and limit their ability to fully safeguard their own interests. These may include individuals who are institutionalized, those in dependent situations, or those whose circumstances, such as poverty or poor health status, may render even modest incentives to participate 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, such individuals should not automatically be considered vulnerable simply because of assumptions about the vulnerability of the group to which they belong. Their particular circumstances shall be considered in the context of the proposed research project.

Article 4.6 Individuals or groups whose circumstances may make them especially convenient for researchers to recruit into research projects shall not be included in research solely on the basis of these convenient circumstances.

Application REBs and researchers shall carefully examine the relationship between the circumstances of the individuals and communities they aim to recruit and the research questions they aim to answer. They should not presume that these circumstances will either automatically preclude or qualify individuals or communities for participation. 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. This may be the case for individuals or communities who are vulnerable to abuse, unfair treatment or discrimination.

In general, researchers should be familiar with the cultural, social and economic circumstances of prospective individual research participants or host communities. Researchers should anticipate, to the best of their ability, needs of participants and their communities that might arise in any given research project. Especially when participants and their communities have a wide range of pressing needs as a result of their low socioeconomic circumstances, these needs can present significant ethical challenges for researchers.

Researchers should also be sensitive to the expectations and opinions of participants regarding potential benefits of the research, and, where possible, they should arrive at agreements with the community about the scope and nature of the potential benefits that will be provided to participants and/or their communities during and after the research. The agreements should, to the extent possible, be explicit about the planned division of responsibilities for realizing these benefits. In many cases, benefits may be delivered most effectively in partnership with local organizations to better ensure balance in the relationship between researchers and participants and mutual benefit in researcher-community relations. (See Article 9.13 on mutual benefits in collaborative research as it pertains to research involving Aboriginal peoples in Canada).

Researchers shall ensure that any potential benefits for participants or their communities are not only commensurate with the risks of participation, but also fair in terms of the overall distribution of benefits between participants and researchers. A fair distribution of benefits can help ensure that individuals and communities are not included in research merely because their circumstances make their recruitment more convenient or efficient for researchers.

Benefits may, for example, take the form of information sharing, training for local personnel, or health care or similar services. Where applicable, these research agreements outlining expectations and other considerations, whether formal or informal, should be submitted to the REB under the auspices of which the research is being conducted and by the REB or other responsible body or bodies where such exists at the host research site or country for review. (See Article 8.3).

Since researchers are not aid agencies, 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 the research reliably.

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 when the results are readily available in print or electronically. In all cases, researchers should ensure that participating communities are informed of how to access the results of the research that should be made available to them in a culturally appropriate and meaningful format, such as reports in plain language in addition to technical reports.

Respect for Communities and Minimizing Social Disruption

Researchers should recognize that communities, as well as individuals within those communities, can be put at risk or their vulnerability may be exacerbated by research activities. They should be aware of the implications of their research for local communities and should be attentive to social changes that might be introduced by their research projects. Researchers should also take care not to create unrealistic expectations among participants within those communities with respect to the potential benefits of the research. They should demonstrate respect for the communities they engage in research by exercising due diligence to anticipate and minimize any risk and social disruption that might be created by the research.