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 po-tential 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 es-sential to ensure that women and men benefit equally from research.
Chapter 4 – Fairness and Equity in Research Participation
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 pop-ulations 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 repro-ductive 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 pre-cludes 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 exam-ple, 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 Ar-ticle 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 jus-tice in research by improving our knowledge of, and ability to respond to, the unique needs of children throughout their development.
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Article 4.4 Children shall not be inappropriately excluded from research solely on the basis of their age or developmental stage. The inclusion of children in research is subject to Article 4.6.
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 ex-pectancy. 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. Re-search 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 ad-equate 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.
Chapter 4 – Fairness and Equity in Research Participation
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 ca-pacity 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 iden-tified 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 re-search 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 conven-ience for some research and unjustified exclusion from other research. Yet the advancement of knowledge about their social, psychological, and health experi-ences 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
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over time (e.g., the participant’s capacity to consent may fluctuate over time). Ar-ticles 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 con-text 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 induce-ment 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 circum-stances of the individuals and groups they aim to recruit, and the proposed research question. They should not presume that these circumstances will automatically re-sult 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 at-tenuate 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 so-cioeconomic 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 in-cluded in research based on these circumstances.
Chapter 4 – Fairness and Equity in Research Participation
Equitable Distribution of Research Benefits
Researchers should consider ways to ensure the equitable distribution of any benefits of partici-pation in research. Benefits of research participartici-pation 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 in-volving 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 commu-nities. 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 com-munities 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.
Chapter 5
PRIVACY AND CONFIDENTIALITY
Introduction
There is widespread agreement about the interests of participants in protection of privacy, and the corresponding duties of researchers to treat personal information in a confidential manner. Indeed, the respect for privacy in research is an internationally recognized norm and ethical standard. Fun-damental rights and freedoms in the Canadian Constitution have been interpreted by the courts to include privacy protections. Privacy rights are protected in federal and provincial/territorial leg-islation. Model voluntary codes1have also been adopted to govern access to, and the protection of, personal information. Some professional organizations have established codes that set out the conditions and obligations of their members regarding the collection, use and disclosure of personal information.
Privacy risks in research relate to the identifiability of participants, and the potential harms they, or groups to which they belong, may experience from the collection, use and disclosure of personal information. Privacy risks arise at all stages of the research life cycle, including initial collection of information, use and analysis to address research questions, dissemination of findings, storage and retention of information, and disposal of records or devices on which information is stored.
This Policy is based on a proportionate approach to the assessment of the ethical acceptability of research. Researchers and research ethics boards (REBs) are expected to identify and minimize privacy risks, keeping in mind that a matter that is not sensitive or embarrassing for the researcher may be so for the participant.
In addition to following the guidance provided in this Policy, researchers are responsible for com-pliance with all applicable legal and regulatory requirements with respect to protection of privacy, and consent for the collection, use or disclosure of information about participants. These require-ments may vary by jurisdiction and, depending on who is funding or conducting the research, may include obligations under the Constitution (including the Canadian Charter of Rights and Free-doms), and federal or provincial privacy legislation, among other legal and regulatory requirements.