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Draft 2nd Edition of the TCPS (December 2008)

Chapter 4

INCLUSION IN RESEARCH

A. Introduction

An important aspect of the principle of equal moral status is the fair distribution of benefits and burdens in research. 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. Benefits may be indirect, where an individual’s research participation contributes to advancement in knowledge that may lead to improved conditions for a group to which the participant belongs or to society in general. Historically, concern for justice in research involving human participants focused on whether research participants were treated fairly: were they overburdened relative to the direct benefits they received from their participation in research? Contemporary concerns with justice in research have broadened: are the overall benefits and burdens of research distributed fairly, and have disadvantaged individuals and groups received a fair share of the benefits of research?

The above two concerns flow from 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. Inclusiveness in research and fair distribution of benefits and burdens should be of concern to researchers, research ethics boards (REBs), research institutions and sponsors.

Overprotectionist attitudes or practices of researchers or REBs that intentionally exclude some members of society from participating in research may, in fact, fail to respect the equal moral status of those individuals and deprive them of the potential benefits of research. 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 involving the young and the elderly.

Whether intentional or inadvertent, the exclusion of some from the potential benefits of research violates the principle of equal moral status of all humans. 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. Research should navigate somewhere between the dangers of exploitation and the dangers of overprotection of research participants.

B. General Inclusivity of Research

Article 4.1 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 a valid reason for the exclusion.

Application Article 4.1 is based on the principles of equal moral status and just distribution of benefits of research participation across all groups in society. It imposes a duty on researchers not to discriminate against individuals or groups for reasons that are unrelated to the research inquiry. Groups have been disadvantaged in the context of research on the basis of characteristics such as sex, colour, ethnicity, age and disability. Among those who have been disadvantaged in the context of research, women warrant special consideration, as elaborated on in Article 4.3.

Article 4.1 is not intended to preclude research focused on a single living individual (such as in a biography) or on 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).

Researchers who plan to actively exclude particular groups from research must explain the exclusion to the REB. The REB will assess the validity and reasonableness of the exclusion, based on the nature of the research inquiry, the context in which the research is conducted, and other objective grounds for the inclusion and exclusion criteria.

Article 4.2 Individuals who are not proficient in the language used by the researchers should not be automatically excluded from the opportunity to participate in research.

Application The exclusion of potential research participants on the basis of language proficiency may undermine the objective of Article 4.1 to avoid exclusions based on culture, race or ethnicity. With appropriate measures to ensure effective communication between potential participants and researchers, language proficiency should not bar inclusion in research. Where a language barrier exists, various measures may be used to ensure effective communication between potential participants and researchers in recruitment and informed consent discussions. For example, an intermediary who is not part of the research study or team, but who is competent in the language used by the researchers as well as that chosen by the research participant may assist with communication between potential participants and researchers. The intermediary’s activities will depend on the nature and risks of the research. For example, where risks are minimal and researchers intend to seek oral consent from participants, an intermediary may help facilitate oral communication. In other situations involving written consent materials, the intermediary may translate or approve an existing translation of consent documents and any other information relevant to participation in the study. The intermediary should not be in a role or relationship that may influence the potential participant’s free and informed consent.

C. Research Involving Women

Women have historically been inappropriately excluded from participating in some research. Exclusion of women, where unwarranted, delays advancement of knowledge, denies potential benefits to women, and may expose them to harm if research findings from male-only studies are generalized inappropriately to women. The inclusion of women in research advances the commitment to equal moral status, 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 4.3 Women must not be automatically excluded from research solely on the basis of sex or reproductive capacity.

Application Like Article 4.1, Article 4.3 imposes obligations on REBs and researchers to ensure equitable treatment of potential participants. While some research is properly focused on particular research populations that do not include women or include very few women, women should be represented in most studies.

Article 4.3 rejects discriminatory and unethical use of inclusion or exclusion criteria that presumptively or automatically exclude women because of their sex or reproductive capacity. In considering research on pregnant or breastfeeding women, researchers and REBs must, however, take into account potential harms and benefits for the woman and her embryo, fetus or infant.

D. Research Involving Vulnerable Persons or Groups

Respect for equal moral status and welfare entails special ethical obligations toward individuals or groups who may be vulnerable in the context of research, such as children and individuals who are institutionalized, or those in dependent situations or other situations that may compromise voluntariness of consent. Researchers and REBs should be mindful of the fact that poverty may also impede an autonomous choice to participate in research.

Article 4.4 Vulnerable individuals or groups must not be automatically excluded from research that may benefit them or a group to which they belong.

Application Characteristics that may make an individual or group vulnerable in the context of research may vary over time and with changing circumstances. Also, individuals should not automatically be considered vulnerable because of a group with which they may be identified. Researchers and REBs should recognize and address changes in a participant’s circumstances that may create, heighten or attenuate vulnerability and provide special protections for those who are vulnerable to abuse, exploitation or discrimination. Researchers and REBs should also be aware of applicable laws, regulations and other requirements that establish rules regarding participation of vulnerable individuals in research.

Children may be particularly vulnerable as research participants because of their developmental status. Researchers and REBs must consider a child’s stage of physical, physiological, psychological and social development to ensure adequate protections for a child’s welfare. Physical or psychological harms a child experiences in a research setting may have long-lasting effects. In addition to vulnerability that arises from their developmental status, children may also lack capacity to give consent to participate in research.

Similarly, adults who are institutionalized may be vulnerable because they live under the care of others, but they may also lack capacity to consent due to cognitive disability or other impairment. The following section provides further guidance on the ethical conduct of research with participants who cannot give consent for themselves.

E. Research Involving Those Who Lack Capacity to Consent for Themselves

Respect for equal moral status and concern for welfare entails special ethical obligations toward individuals who do not have capacity to give free and informed consent for research participation. Individuals who do not have capacity to give consent to participate in research should not be automatically excluded from research. Based on the core principle of concern for welfare, however, this section sets out conditions that apply to research involving those who cannot give consent for themselves. This section should be read in conjunction with Section C (“Capacity”) of Chapter 3 (“Free and Informed Consent”).

Article 4.5 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:

  1. The research question can be addressed only with the participation of individuals who do not have capacity to consent; and
  2. 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.

Application This Policy recognizes the need to include individuals or groups in research who have historically been excluded, including those who lack capacity to give consent for themselves. For example, young children and individuals with cognitive or intellectual disabilities may lack capacity to give consent to participate in particular research initiatives. Yet the advancement of knowledge about their social, psychological and health experiences and needs may depend on their participation in research.

Article 4.5 and Article 3.10 in Chapter 3 (“Free and Informed Consent”) establish conditions regarding research that involves individuals who lack capacity to give consent. Researchers and REBs must consider the degree of risk to which participants are exposed and the potential of direct benefits to the participant or a group to which they belong.

Note: The World Medical Association Declaration Of Helsinki: Ethical Principles For Medical Research Involving Human Subjects (October 2008), s. 27, states, with respect to research involving those who lack capacity, that “these individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the population represented by the potential subject, the research cannot instead be performed with competent individuals, and entails only minimal risk and minimal burden.” The Panel presents this statement here as a point of comparison in the discussion of proposed Article 4.5.