79C3C34C52B45572883A05D425EB0F82
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans
https://leaux.net/URLS/General/MR21-18-2010-eng.pdf
http://leaux.net/URLS/ConvertAPI Text Files/0F04AE079D8F8081644A7F53C76ECB70.en.txt
Examining the file media/Synopses/0F04AE079D8F8081644A7F53C76ECB70.html:
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator prisoners:
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p.000199: Justice
p.000199: Justice refers to the obligation to treat people fairly and equitably. Fairness entails treating all peo- ple with
p.000199: equal respect and concern. Equity requires distributing the benefits and burdens of research participation in such a
p.000199: way that no segment of the population is unduly burdened by the harms of research or denied the benefits of the
p.000199: knowledge generated from it.
p.000199: Treating people fairly and equitably does not always mean treating people in the same way. Dif- ferences in treatment
p.000199: or distribution are justified when failures to take differences into account may result in the creation or
p.000199: reinforcement of inequities. One important difference that must be considered for fairness and equity is vulnerability.
p.000199: Vulnerability is often caused by limited capacity, or limited access to social goods, such as rights, opportunities and
p.000199: power. Individuals or groups in vulnerable circumstances have historically included children, the elderly, women,
p.000199: prisoners, those with mental health issues and those with diminished capacity for self-determination. Ethno- cultural
p.000199: minorities and those who are institutionalized are other examples of groups who have, at times, been treated unfairly
p.000199: and inequitably in research, or have been excluded from research op- portunities. People or groups whose circumstances
p.000199: cause them to be vulnerable or marginalized may need to be afforded special attention in order to be treated justly in
p.000199: research.
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p.000199: 10 TCPS 2
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p.000199: Chapter 1 – Ethics Framework
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p.000199: The recruitment process, both of participants who may become directly involved in research and those who participate as
p.000199: the source of information or biological materials to be used in research, is an important component of the fair and
p.000199: equitable conduct of research. Participation should be based on inclusion criteria that are justified by the research
p.000199: question. Inequity is created when par- ticular groups fail to receive fair benefits of research or when
p.000199: groups, or their data or their biological materials, are excluded from research arbitrarily or for reasons
p.000199: unrelated to the research question.
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p.000199: biological materials.
p.000199: Application (a) The voluntariness of consent is important because it respects human dignity and means that
p.000199: individuals have chosen to participate in research according to their own values, preferences and wishes.
p.000199: The approach to recruitment is an important element in assuring voluntariness. In particular, how, when and where
p.000199: participants are approached, and who re- cruits them are important elements in assuring (or undermining) voluntariness.
p.000199: In considering the voluntariness of consent, REBs and researchers should be cognizant of situations where undue
p.000199: influence, coercion or the offer of incen- tives may undermine the voluntariness of a participant’s consent to
p.000199: participate in research.
p.000199: UndueXInfluence
p.000199: Undue influence and manipulation may arise when prospective participants are recruited by individuals in a position of
p.000199: authority. The influence of power re- lationships (e.g., employers and employees, teachers and students, commanding
p.000199: officers and members of the military or correctional officers and prisoners) on the voluntariness of consent should be
p.000199: judged from the perspective of prospec- tive participants, since the individuals being recruited may feel constrained
p.000199: to follow the wishes of those who have some form of control over them. This con- trol may be physical, psychological,
p.000199: financial or professional, for example, and may involve offering some form of inducement or threatening some form of
p.000199: deprivation. In such situations, the control exerted in a power relationship may place undue pressure on the
p.000199: prospective participants. At the extreme, there can be no voluntariness if consent is secured by the order of
p.000199: authorities.
p.000199: REBs and researchers should also pay particular attention to elements of trust and dependency in relationships (e.g.,
p.000199: between physician and patient or between professor and student). These relationships can impose undue influence on the
p.000199: individual in the position of dependence to participate in research projects. Any relationship of dependency, even a
p.000199: nurturing one, may give rise to undue in- fluence even if it is not applied overtly. There may be a greater risk of
p.000199: undue influence in situations of ongoing or significant dependency.
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p.000199: that their inquiries may give rise to an ethical or legal reason to disclose information obtained in the research
p.000199: context shall advise the REB and prospective participants about the possibility of compelled disclosure. Advising
p.000199: participants of reasonably foreseeable disclosure requirements is an important aspect of the consent process.
p.000199: Situations may arise where researchers unexpectedly acquire information that gives rise to a reason for disclosure to a
p.000199: third party, or researchers may receive a disclo- sure demand from a third party. In such cases, advising a participant
p.000199: about the disclosure may be important to respect the trust relationship with the participant, and to ensure the
p.000199: validity of the participant’s ongoing consent. Decisions about whether, how and when to advise a participant of
p.000199: disclosure should be guided by any applicable disciplinary standards and consultation with the REB, colleagues,
p.000199: relevant professional body and/or legal counsel.
p.000199: Researchers shall also inform participants and seek their consent if their personal information may be shared with
p.000199: government departments or agencies, community partners in the research, personnel from an agency that monitors the
p.000199: research, a re- search sponsor (such as a pharmaceutical company), the REB or a regulatory agency.
p.000199: Researchers shall avoid being put in a position of becoming informants for author- ities or leaders of
p.000199: organizations. For example, when records of prisoners, employees, students or others are used for research
p.000199: purposes, the researcher shall not provide authorities with results that could identify individuals unless the prior
p.000199: written consent of the participants has been given. Researchers may, however, pro- vide administrative bodies with
p.000199: aggregated data that cannot be linked to individuals for purposes such as policy-making or program evaluation. When
p.000199: seeking consent, researchers shall advise prospective participants if aggregated data from a project
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p.000199: TCPS 2 59
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p.000199: Chapter 5 – Privacy and Confidentiality
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p.000199: may be disclosed, particularly where such disclosure may pose a risk to the partic- ipants. For example, aggregate data
p.000199: provided to authorities about research on illicit drug use in a penitentiary may pose risks of reprisal to the
p.000199: prisoners, even though they are not identified individually.
p.000199: When planning a study, researchers should incorporate any applicable statute-based or other legal principles that may
p.000199: afford protection for the privacy of participants and the confidentiality of research information.
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p.000199: C. Safeguarding Information
p.000199: Article 5.3 Researchers shall provide details to the REB regarding their proposed measures for safeguarding
p.000199: information, for the full life cycle of information: its collection, use, dissemination, retention and/or disposal.
p.000199: Application Researchers shall assess privacy risks and threats to the security of information for all stages of the
p.000199: research life cycle, and implement appropriate measures to protect information. Safeguarding information helps respect
p.000199: the privacy of participants and helps researchers fulfil their confidentiality obligations. In adopting measures to
p.000199: safeguard information, researchers should follow disciplinary standards and prac- tices for the collection and
p.000199: protection of information gathered for research purposes. Formal privacy impact assessments are required in some
p.000199: institutions and may also be required under legislation or policy in some jurisdictions. Security measures should take
p.000199: into account the nature, type and state of data: the data’s form (e.g., paper or electronic records); content (e.g.,
p.000199: presence of direct or indirect identifiers); mobility (e.g., kept in one location or subject to physical or electronic
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Political / Illegal Activity
Searching for indicator illegal:
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p.000199: of identification (see Article 2.4 or Article 9.22).
p.000199: Where it is not feasible to use anonymous or anonymized data for research (and there are many reasons why data may need
p.000199: to be gathered and retained in an identifiable form), the ethical duty of confidentiality and the use of appropriate
p.000199: measures to safeguard information become para- mount. This Policy generally requires more stringent protections in
p.000199: research involving identifiable information. Researchers are expected to consult their REB if they are uncertain about
p.000199: whether information proposed for use in research is identifiable (e.g., when proposing to link anonymized or coded
p.000199: datasets).
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p.000199: TCPS 2 57
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p.000199: Chapter 5 – Privacy and Confidentiality
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p.000199: B. Ethical Duty of Confidentiality
p.000199: Article 5.1 Researchers shall safeguard information entrusted to them and not misuse or wrongfully
p.000199: disclose it. Institutions shall support their researchers in maintaining promises of confidentiality.
p.000199: Application When researchers obtain information with a promise of confidentiality, they assume an ethical duty that
p.000199: is central to respect for participants and the integrity of the re- search project. Breaches of confidentiality may
p.000199: harm the participant, the trust relationship between the researcher and the participant, other individuals or groups,
p.000199: and/or the reputation of the research community. Research that probes sensitive topics (e.g., illegal activities)
p.000199: generally depends on strong promises of confiden- tiality to establish trust with participants.
p.000199: The ethical duty of confidentiality applies to information obtained directly from participants, or from other
p.000199: researchers or organizations that have legal, professional or other obligations to maintain confidentiality.
p.000199: The ethical duty of confidentiality must, at times, be balanced against competing ethical considerations or legal or
p.000199: professional requirements that call for disclosure of information obtained or created in a research context. For
p.000199: example, in excep- tional and compelling circumstances, researchers may be subject to obligations to report information
p.000199: to authorities to protect the health, life or safety of a participant or a third party. Researchers are expected to be
p.000199: aware of ethical codes (such as pro- fessional codes of conduct) or laws (e.g., those requiring the reporting of
p.000199: children in need of protection) that may require disclosure of information they obtain in a research context. In other
p.000199: situations, a third party may seek access to information obtained and/or created in confidence in a research context.
p.000199: An access request may seek voluntary disclosure of information, or may seek to compel disclosure through force of law
p.000199: (e.g., by subpoena). Chapter 1, Section C, elaborates on the relationship between research ethics and law.
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Political / Indigenous
Searching for indicator indigenous:
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p.000105: and the ongoing development of community codes of research practice by these communities at the local, regional and
p.000105: national level, ethical review of a proposed project shall be attentive to the specific context of the project and the
p.000105: community involved (see Articles 9.8 and 9.9).
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p.000105: A. Key Concepts and Definitions
p.000105: Definitions of key concepts used in this chapter are provided to assist in applying the guidance in this Policy (see
p.000105: Chapter 1 regarding the scope of definitions used in this Policy) and to facilitate dialogue between researchers and
p.000105: Aboriginal communities. Since there is not universal agreement on the meaning of some terms, the definitions provided
p.000105: are intended for the purposes of this Policy only. This terminology will require periodic revision, particularly in
p.000105: light of the ongoing debate on the terms of art used in international and domestic contexts. This is in
p.000105: keeping with a commitment to the continued evolution of this Policy.
p.000105: • Aboriginal peoples – include persons of Indian, Inuit or Métis descent regardless of where they reside and
p.000105: whether or not their names appear on an official register. The term “Aboriginal” fails to reflect the
p.000105: distinctions among First Nations, Inuit and Métis peoples, who have their own histories, cultures and languages, so an
p.000105: attempt has been made to limit use of the term in this Policy to instances where a global term is appropriate. Indian
p.000105: peoples commonly identify themselves by distinct nation names such as Mi’kmaq, Dene or Haida, and as First Nations. In
p.000105: the international context, the term comparable to Aboriginal peoples is Indigenous peoples.
p.000105: • Community – describes a collectivity with shared identity or interests, that has the capacity to act or express
p.000105: itself as a collective. In this Policy, a community may include members from multiple cultural groups. A community may
p.000105: be territorial, organizational or a com- munity of interest. “Territorial communities” have governing bodies exercising
p.000105: local or regional jurisdiction (e.g., members of a First Nations resident on reserve lands). “Organi- zational
p.000105: communities” have explicit mandates and formal leadership (e.g., a regional Inuit association or a friendship centre
p.000105: serving an urban Aboriginal community). In both terri- torial and organizational communities, membership is defined and
p.000105: the community has designated leaders. “Communities of interest” may be formed by individuals or organiza- tions who
p.000105: come together for a common purpose or undertaking, such as a commitment to conserving a First Nations language.
p.000105: Communities of interest are informal communities
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p.000105: TCPS 2
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p.000107: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
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p.000107: whose boundaries and leadership may be fluid and less well-defined. They may exist tem- porarily or over the long term,
p.000107: within or outside of territorial or organizational communities.
p.000107: An individual may belong to multiple communities, both Aboriginal and non-Aboriginal (e.g., as a member of a local
p.000107: Métis community, a graduate students’ society and a coalition in support of Aboriginal rights). An individual may
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p.000107: research project being proposed.
p.000107: • Community customs and codes of research practice – may be expressed in written or oral form. Consistent with the
p.000107: world views of particular First Nations, Inuit and Métis peoples, community customs and codes of research practice may
p.000107: embody kinship networks and responsibilities that include multi-generational obligations to ancestors and
p.000107: future generations. Ethical obligations often extend to respectful relations with plant, animal and marine life.
p.000107: • Community engagement – is a process that establishes interaction between a researcher or research team, and the
p.000107: Aboriginal community relevant to the research project. It signifies a collaborative relationship between researchers
p.000107: and communities, although the degree of collaboration may vary depending on the community context and the nature of the
p.000107: research. The engagement may take many forms including review and approval from formal leadership to conduct
p.000107: research in the community, joint planning with a responsible agency, commitment to a partnership formalized in a
p.000107: research agreement, or dialogue with an advisory group expert in the customs governing the knowledge being
p.000107: sought. The engagement may range from information sharing to active participation and collaboration, to empowerment
p.000107: and shared leadership of the research project. Communities may also choose not to engage actively in a research
p.000107: project, but simply to acknowledge it and register no objection to it.
p.000107: • First Nations, Inuit and Métis lands – include Indian reserves, Métis settlements, and lands governed under a
p.000107: self-government agreement or an Inuit or First Nations land claim agreement.
p.000107: • Indigenous knowledge – see traditional knowledge, below.
p.000107: • Indigenous peoples – a term used in international or scholarly discourse; there is no consensus on
p.000107: the definition of the term “indigenous.” In some countries, other terms may be used. Self-identification is a
p.000107: fundamental criterion for defining Indigenous peoples.4
p.000107: • Traditional knowledge – the knowledge held by First Nations, Inuit and Métis peoples, the Aboriginal peoples of
p.000107: Canada. Traditional knowledge is specific to place, usually transmitted orally, and rooted in the experience of
p.000107: multiple generations. It is determined by an Aboriginal community’s land, environment, region, culture and language.
p.000107: Traditional knowledge is usually described by Aboriginal peoples as holistic, involving body, mind, feelings and
p.000107: spirit. Knowledge may be expressed in symbols, arts, ceremonial and everyday practices, narratives and, especially, in
p.000107: relationships. The word tradition is not necessarily
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p.000107: 108 TCPS 2
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p.000107: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
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p.000107: synonymous with old. Traditional knowledge is held collectively by all members of a community, although some
p.000107: members may have particular responsibility for its transmission. It includes preserved knowledge
p.000107: created by, and received from, past generations and innovations and new knowledge transmitted to subsequent
p.000107: generations. In international or scholarly discourse, the terms traditional knowledge and Indigenous knowledge are
p.000107: sometimes used interchangeably.
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p.000107: B. Interpreting the Ethics Framework in Aboriginal Contexts
p.000107: Chapter 1 identifies three principles that express the core ethical value of respect for human dignity
p.000107: – Respect for Persons, Concern for Welfare, and Justice. The three core principles are interpreted in this chapter as
p.000107: follows:
p.000107: Respect for Persons is expressed principally through the securing of free, informed and ongoing consent of
p.000107: participants. The concerns of First Nations, Inuit and Métis for their continuity as peoples with distinctive cultures
p.000107: and identities have led to the development of codes of research practice that are in keeping with their world views.
p.000107: Aboriginal codes of research practice go beyond the scope of ethical protections for individual participants, and
p.000107: extend to the interconnection between humans and the natural world, and include obligations to maintain, and pass on to
p.000107: future generations, knowledge received from ancestors as well as innovations devised in the present generation.
p.000107: Historically, the well-being of individual participants has been the focus of research ethics guidelines.
p.000107: In this Policy, the principle of Concern for Welfare is broader, requiring consideration of participants and
p.000107: prospective participants in their physical, social, economic and cultural environments, where applicable, as
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p.000107: Aboriginal peoples’ knowledge as primitive or superstitious; violation of community norms regarding the use of human
p.000107: tissue and remains; failure to share data and resulting benefits; and dissemination of information that has
p.000107: misrepresented or stigmatized entire communities.
p.000107: Where the social, cultural or linguistic distance between the community and researchers from outside the community is
p.000107: significant, the potential for misunderstanding is likewise significant. Engagement between the community involved
p.000107: and researchers, initiated prior to recruiting
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p.000107: TCPS 2
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p.000109: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
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p.000109: participants and maintained over the course of the research, can enhance ethical practice and the quality of
p.000109: research. Taking time to establish a relationship can promote mutual trust and communication, identify
p.000109: mutually beneficial research goals, define appropriate research collaborations or partnerships, and ensure that
p.000109: the conduct of research adheres to the core principles of Respect for Persons, Concern for Welfare – which in this
p.000109: context includes welfare of the collective, as understood by all parties involved – and Justice.
p.000109: Research Involving Indigenous Peoples in Other Countries
p.000109: Although the present chapter addresses research involving Aboriginal peoples in Canada, researchers, REBs, participants
p.000109: and the research community at large may find the guidance articulated here useful when undertaking research or
p.000109: reviewing a proposal involving Indigenous peoples in other countries who endorse collective decision making as a
p.000109: complement to individual consent. It is critically important, however, to seek local guidance in the
p.000109: application or adaptation of this Policy to Indigenous peoples outside of Canada.
p.000109: For considerations that apply to research conducted in another country, see Chapter 8, Section B.
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p.000109: C. Applying Provisions of This Policy in Aboriginal Contexts
p.000109: Requirement of Community Engagement in Aboriginal Research
p.000109: Article 9.1 Where the research is likely to affect the welfare of an Aboriginal community, or communities, to
p.000109: which prospective participants belong, researchers shall seek engagement with the relevant community. The
p.000109: conditions under which engagement is required include, but are not limited to:
p.000109: (a) research conducted on First Nations, Inuit or Métis lands;
p.000109: (b) recruitment criteria that include Aboriginal identity as a factor for the entire study or for a subgroup in the
p.000109: study;
p.000109: (c) research that seeks input from participants regarding a community’s cultural heritage, artefacts, traditional
p.000109: knowledge or unique characteristics;
p.000109: (d) research in which Aboriginal identity or membership in an Aboriginal community is used as a variable for
p.000109: the purpose of analysis of the research data; and
p.000109: (e) interpretation of research results that will refer to Aboriginal communities, peoples, language, history or
p.000109: culture.
p.000109: Application Paragraph (a) refers to First Nations, Inuit and Métis lands that include Indian reserves, Métis
p.000109: settlements and lands governed under a self-government agreement or an Inuit or First Nations land claim agreement.
p.000109: Researchers should become informed about formal rules or oral customs that may apply in accordance with a particular
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p.000185: (GWAS) Data Access, August 28, 2008, http://grants.nih.gov/grants/gwas/data_sharing_policy_modifications_20080828.pdf
p.000185: 2 Assisted Human Reproduction Act (2004, c. 2). http://laws.justice.gc.ca/eng/A-13.4
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p.000185: TCPS 2
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p.000187: Glossary
p.000187:
p.000187: This glossary is intended to assist readers in their understanding of the Tri-Council Policy Statement: Ethical Conduct
p.000187: for Research Involving Humans (TCPS), also referred to as “the Policy.” Definitions that have been provided in the main
p.000187: text of the Policy are also repeated here. Additional terms are defined in accordance with the purposes of the Policy.
p.000187: For more detailed descriptions of many terms it is best to read them in the context of the chapters in which they
p.000187: appear – consult the Index for the appropriate reference.
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p.000187: Aboriginal peoples – Persons of Indian (First Nations), Inuit, or Métis descent, regardless of where they reside and
p.000187: whether or not their names appear on an official register. In the international context, the term comparable to
p.000187: Aboriginal peoples is Indigenous peoples.
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p.000187: Academic freedom – The collective freedom of faculty and students to conduct research, and to disseminate ideas or
p.000187: facts without religious, political, or institutional restrictions. It includes freedom of inquiry, freedom to challenge
p.000187: conventional thought, freedom to express one’s opinion about the institution, its administration, or the system in
p.000187: which one works, and freedom from institutional censorship.
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p.000187: Ad hoc advisor – A person with relevant and competent knowledge and expertise consulted by a research ethics board for
p.000187: a specific research ethics review, and for the duration of that review. The ad hoc advisor is not a member of the
p.000187: research ethics board.
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p.000187: Agencies, the – Canada’s three federal research agencies: the Canadian Institutes of Health Research (CIHR); the
p.000187: Natural Sciences and Engineering Research Council of Canada (NSERC); and the Social Sci- ences and Humanities Research
p.000187: Council of Canada (SSHRC).
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p.000187: Appeal – A process that allows a researcher to request a review of a research ethics board (REB) decision when, after
p.000187: reconsideration, the REB has refused ethics approval of the research.
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p.000187: Appeal mechanism – A procedure established by an institution to promptly handle a researcher’s appeal of a research
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p.000191: name, social insurance number, personal health number).
p.000191: Indirectly identifying information – The information can reasonably be expected to identify an individual through a
p.000191: combination of indirect identifiers (e.g. date of birth, place of residence, or unique personal characteristic).
p.000191: Coded information – Direct identifiers are removed from the information and replaced with a code. Depending on access
p.000191: to the code, it may be possible to re-identify specific participants (e.g. the principal investigator retains a list
p.000191: that links the participants’ code names with their actual name so data can be re-linked if necessary).
p.000191: Anonymized information – The information is irrevocably stripped of direct identifiers, a code is not kept to allow
p.000191: future re-linkage, and risk of re-identification of individuals from remaining in- direct identifiers is low or very
p.000191: low.
p.000191: Anonymous information – The information never had identifiers associated with it (e.g. anony- mous surveys) and risk of
p.000191: identification of individuals is low or very low.
p.000191: Impracticable – Incapable of being put into practice due to a degree of hardship or onerousness that jeop- ardizes the
p.000191: conduct of the research; it does not mean mere inconvenience.
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p.000191: Incentive – Anything offered to participants, monetary or otherwise, to encourage participation in research.
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p.000191: Incidental findings – Unanticipated discoveries made in the course of research that are outside the scope of the
p.000191: research.
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p.000191: Indigenous knowledge – See “Traditional knowledge.”
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p.000191: Indigenous peoples – See “Aboriginal peoples.”
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p.000191: Institutions – The universities, hospitals, colleges, research institutes, centres and other organizations eligible to
p.000191: receive and manage Agency grant funds on behalf of the grant holders and the Agencies.
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p.000191: Intermediary – An individual with the necessary language skills to ensure effective communication between the research
p.000191: team and participants, should any language barriers exist.
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p.000191: Institutional conflicts of interest – An incompatibility between two or more substantial institutional obligations
p.000191: that cannot be adequately fulfilled without compromising one or another of the obligations.
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p.000191: TCPS 2
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p.000193: Glossary
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p.000193: Justice – A core principle of this Policy that refers to the obligation to treat people fairly and equitably. Fairness
p.000193: entails treating all people with equal respect and concern. Equity requires distributing the benefits and burdens of
p.000193: research participation in such a way that no segment of the population is unduly burdened by the harms of research or
p.000193: denied the benefits of the knowledge generated from it.
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p.000193: Medical device trials – Clinical trials that test the safety and/or efficacy of one or more instruments used in the
p.000193: prevention, diagnosis, mitigation, or treatment of a disease or abnormal physical condition or the restoration,
p.000193: correction or modification of body function or structure.
p.000193:
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p.000195: individuals and/or groups of factors such as their physical, mental and spiritual health, as well as their physical,
p.000195: economic and social circumstances.
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p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195: TCPS 2
p.000195:
p.000197: 197
p.000197:
p.000197:
p.000197:
p.000197: Index
p.000197: The Index seeks to direct the reader to meaningful references to key concepts in TCPS 2. Main references to a term are
p.000197: indicated with bold type.
p.000197:
p.000197: The Index is not a record of all occurrences of the listed topics. Readers who wish to check all occurrences of these
p.000197: topics or specific terms may do so through the Adobe search tool available online in the PDF version of the Policy
p.000197: found at www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2- eptc2/Default/.
p.000197:
p.000197: A
p.000197: Aboriginal peoples
p.000197: collaborative research, 123-124, 125-126, 128
p.000197: communities, 107-108, 109
p.000197: community customs, 108, 117-119
p.000197: community engagement, 108, 110-117, 121-125
p.000197: confidentiality, 126-128
p.000197: consent, 109, 119, 123, 131
p.000197: cultural heritage, 110-111
p.000197: definition, 107
p.000197: Elders, 119, 126
p.000197: First Nations, 105, 107, 108, 110, 114, 115, 117, 121, 127
p.000197: governing authorities, 114
p.000197: human biological materials, 119, 129-132
p.000197: Indigenous knowledge (see Aboriginal peoples: traditional knowledge)
p.000197: Indigenous peoples, 107, 108, 110
p.000197: intellectual property, 128-129
p.000197: interpretation and dissemination of research results, 128 interpretation of ethics framework, 109-110
p.000197: Inuit, 105, 107, 108, 110, 114, 115, 117, 118, 121
p.000197: Métis, 105, 107, 108, 110, 114, 115, 117, 121
p.000197: mutual benefits, 124-125
p.000197: privacy, 126-128
p.000197: research agreements, 121, 122-123, 126-127, 128-130, 131
p.000197: research ethics review - research ethics boards and community, 115, 119-122 secondary use of information or human
p.000197: biological materials, 119-121, 130-132 strengthening research capacity, 125-126
p.000197: traditional knowledge, 108-109, 110-111, 126
p.000197: Academic freedom, 7, 11
p.000197: Ad hoc advisors, 24, 72, 73, 75, 120, 150
p.000197: Agencies, 5 Anonymity
p.000197: anonymized human biological materials, 170 anonymized information, 57
p.000197: anonymous human biological materials, 19, 131-132, 170
p.000197: anonymous information, 19, 57, 131-132
p.000197:
p.000197:
p.000197: TCPS 2
p.000199: 199
p.000199:
p.000199: Index
p.000199:
p.000199: Appeals, 83-85
p.000199: Assisted human reproduction (see Human reproduction, materials related to) Authorized third parties, 27, 41-44
p.000199: Autonomy, 8-9, 27, 40
p.000199:
p.000199: B
p.000199: Benefits, research
p.000199: equitable distribution, 10, 53
p.000199: mutual, 124-125
p.000199: and risk, 10, 11, 22-25, 41-42, 51, 157-158
p.000199: Biobanks, 175-176, 186
...
p.000201: definition, 16-17, 169
p.000201: identified, 170
p.000201: secondary use, 62-64, 119-121, 130-132, 172-175, 186
p.000201: storage and banking, 175-176 types, 169-170
p.000201: withdrawal, 28-30, 31, 172
p.000201: (see also Human reproduction, materials related to) Human dignity, respect for, 8-11, 28
p.000201: Human genetic research
p.000201: application of core principles, 181-182 definition, 181
p.000201: gene alteration, 186-187
p.000201: gene transfer, 186-187
p.000201: genetic counselling, 184 genetic material banks, 186
p.000201: involving communities and groups, 181, 183-184, 185
p.000201: involving families, 181, 183-184, 184-185
p.000201: managing information concerning, 182-184 Human participants (see Participants)
p.000201: Human reproduction, materials related to
p.000201: Assisted Human Reproduction Act, 177, 178, 179, 186
p.000201: consent, 177-179
p.000201: definition, 16-17, 176-177
p.000201: embryos, 15-17, 49, 176, 177-178
p.000201: fetal tissue, 15-17, 177, 178-179
p.000201: fetuses, 15-17, 49, 177, 178, 178-179
p.000201: human reproductive materials, 15-17, 177
p.000201: pluripotent stem cells, 179
p.000201: (see also Human biological materials) Hybrids, 179
p.000201:
p.000201:
p.000201:
p.000201:
p.000201:
p.000201:
p.000201: TCPS 2
p.000201:
p.000203: 203
p.000203:
p.000203: Index
p.000203:
p.000203: I
p.000203: Incentives for participation in research
p.000203: conflicts of interest, 29-30, 52, 151, 164
p.000203: consent, 29-30, 31, 151
p.000203: Incidental findings, 34, 171-172
p.000203: Indigenous peoples, 107, 108, 110 (see also Aboriginal peoples)
p.000203: Information
p.000203: anonymized, 57
p.000203: anonymous, 19, 57, 131-132
p.000203: coded, 57
p.000203: data linkage, 18, 19, 64-65, 131-132
p.000203: directly identifying, 56
p.000203: disclosure, 30-33, 59-61, 126-128
p.000203: dissemination, 18-19, 31, 128, 143-144, 164-167
p.000203: identifiable, 19, 56
p.000203: indirectly identifying, 56
p.000203: personal (see Information: identifiable) publicly available, 17-18, 64-65, 131 reporting new, in clinical trials,
p.000203: 159-163 safeguarding, 60-61
p.000203: secondary use of identifiable (see Secondary use of identifiable information) security, 56, 60-61, 64-65
p.000203: sharing, 159-163, 182-184
p.000203: types, 56-57 (see also Data)
p.000203: Informed consent (see Consent)
p.000203: Institutions
p.000203: appointment of appeal boards, 84-85 compliance with Policy, 5-6 conflicts of interest, 89-90, 91-93
p.000203: multi-jurisdictional review, 97-99, 100-103
p.000203: senior administrators, 70-71, 93-94
p.000203: support of research ethics boards, 68-70, 74, 77, 80
p.000203: support of researchers, 5, 58-59
p.000203: Intellectual property, 128-129
p.000203: Intermediaries, 32, 48
p.000203: Inuit, 105, 107, 108, 110, 114, 115, 117, 118, 121
p.000203: (see also Aboriginal peoples)
p.000203:
p.000203: J
p.000203: Justice, 8, 10-11, 47, 109-110
p.000203:
p.000203: K
p.000203: Knowledge, traditional, 108-109, 110-111, 126
p.000203:
p.000203:
p.000203:
p.000203:
p.000203: 204 TCPS 2
p.000203:
p.000203: Index
p.000203:
p.000203:
...
Searching for indicator native:
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p.000115: expanding the coverage of a project to multiple communities. In some cases, the risks to participants and communities
p.000115: involved with, or affected by, the proposed research outweigh the potential benefits likely to be gained, and the
p.000115: research should not be undertaken.
p.000115: Critical Inquiry
p.000115: Article 9.7 Research involving Aboriginal peoples that critically examines the conduct of public institutions,
p.000115: First Nations, Inuit and Métis governments, institutions or organizations or persons exercising authority over First
p.000115: Nations, Inuit or Métis individuals may be conducted ethically, notwithstanding the usual requirement of engaging
p.000115: community leaders.
p.000115: Application Considerations in conducting critical inquiry are discussed more fully in Article
p.000115: 3.6. As in the case of research involving groups whose circumstances make them vulnerable, or communities of interest
p.000115: within an Aboriginal community (see Article 9.6), researchers undertaking critical inquiry research will need to adopt
p.000115: appropriate approaches to ensure that cultural norms are respected, that the safety of participants is protected, and
p.000115: that potential harms to the welfare of the larger community are minimized to the extent possible. Researchers may
p.000115: need to consult culturally relevant regional or national Aboriginal organizations for guidance.
p.000115: For example, the Sisters in Spirit project of the Native Women’s Association of Canada (NWAC) that was launched in
p.000115: 2005 for a five-year period illustrates research of a national scope that incorporated a critical dimension. The
p.000115: project involved interviewing families of missing and murdered First Nations, Métis or Inuit women in urban and rural
p.000115: settings, and on First Nations territory. It examined, among other matters, the adequacy of public institutions and
p.000115: services, Aboriginal and non-Aboriginal, to protect the women’s well-being and support families in their efforts to
p.000115: deal with their losses. The objective was to effect policy change and improve the safety and well-being of Aboriginal
p.000115: women in Canada. NWAC has published its commitment to participatory research and the principles and practices that
p.000115: protect the privacy and well-being of participants. The project built on NWAC’s ongoing efforts to develop meaningful
p.000115: research relationships reflecting Aboriginal ways of knowing.
p.000115: Respect for Community Customs and Codes of Practice
p.000115: Article 9.8 Researchers have an obligation to become informed about, and to respect, the relevant customs and
p.000115: codes of research practice that apply in the particular community or communities affected by their research.
p.000115: Inconsistencies between community custom and this Policy should be identified and addressed in advance of initiating
p.000115: the research, or as they arise.
p.000115:
p.000115:
p.000115: TCPS 2
p.000117: 117
p.000117:
...
Political / criminal
Searching for indicator criminal:
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p.000199: The ethical duty of confidentiality must, at times, be balanced against competing ethical considerations or legal or
p.000199: professional requirements that call for disclosure of information obtained or created in a research context. For
p.000199: example, in excep- tional and compelling circumstances, researchers may be subject to obligations to report information
p.000199: to authorities to protect the health, life or safety of a participant or a third party. Researchers are expected to be
p.000199: aware of ethical codes (such as pro- fessional codes of conduct) or laws (e.g., those requiring the reporting of
p.000199: children in need of protection) that may require disclosure of information they obtain in a research context. In other
p.000199: situations, a third party may seek access to information obtained and/or created in confidence in a research context.
p.000199: An access request may seek voluntary disclosure of information, or may seek to compel disclosure through force of law
p.000199: (e.g., by subpoena). Chapter 1, Section C, elaborates on the relationship between research ethics and law.
p.000199: Certain areas of research (such as research involving children at risk of abuse or studies of criminal behaviour) are
p.000199: more likely to put researchers in positions where they may experience tension between the ethical duty of
p.000199: confidentiality and dis- closure to third parties. Researchers shall maintain their promise of confidentiality to
p.000199: participants within the extent permitted by ethical principles and/or law. This may involve resisting requests for
p.000199: access, such as opposing court applications seek- ing disclosure. Researchers’ conduct in such situations should be
p.000199: assessed on a case-by-case basis and guided by consultation with colleagues, any relevant pro- fessional body, the REB
p.000199: and/or legal counsel.
p.000199: In some instances, participants may waive anonymity (e.g., if they wish to be iden- tified for their contributions to
p.000199: the research). Researchers should obtain the consent of these participants, and negotiate agreements with them that
p.000199: specify how they may be identified or recognized for their contribution. Where an individual partic-
p.000199:
p.000199: 58 TCPS 2
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: ipant waives anonymity but other members of the participant group object because identification may cause harm to the
p.000199: group, researchers shall maintain anonymity for all members of the participant group (see Article 3.2[f] and Article
p.000199: 10.4).
p.000199: Article 5.2 Researchers shall describe measures for meeting confidentiality obligations and explain any reasonably
p.000199: foreseeable disclosure requirements:
p.000199: (a) in application materials they submit to the REB; and
...
p.000141: research, the expectations of privacy that prospective participants might have, the means of recording the
p.000141: observations, whether the research records or published reports involve identification of the participants, and any
p.000141: means by which those participants may give permission to be identified. REBs shall ensure that the proposal contains
p.000141: measures to protect the privacy of the individual in accordance with the law.
p.000141: Researchers and REBs should consult Chapters 3 and 5 for additional details and considerations regarding consent, and
p.000141: privacy and confidentiality.
p.000141: For observational research in which consent is not sought, researchers shall demonstrate to the REB that
p.000141: necessary precautions and measures have been taken to address privacy and confidentiality issues.
p.000141: Because the knowledge that one is being observed can be expected to influence behaviour, research involving
p.000141: non-participant or covert observation generally requires that the participants not know that they are being
p.000141: observed for research purposes. Typically the researcher has no direct interaction with the individuals being observed
p.000141: and therefore their consent is not sought. Covert observation of queuing behaviours in shopping malls is one example of
p.000141: a study where the research could not be completed if shoppers knew that they were being observed. Some forms of
p.000141: qualitative research seek to observe and study criminal behaviours, violent groups, or groups with restricted
p.000141: membership or access using covert participant observation. For example, some social science research that critically
p.000141: probes the inner workings of criminal organizations might never be conducted if the participants know in
p.000141: advance that they are being observed. Other observational studies may be anonymous but involve intervention by the
p.000141: researcher (e.g., studying the propensity of bystanders to help in an emergency normally requires a staged emergency).
p.000141: These methodological approaches may require the researcher seeking an exception to the general requirement for consent.
p.000141:
p.000141:
p.000141:
p.000141:
p.000141: 142 TCPS 2
p.000141:
p.000141: Chapter 10 – Qualitative Research
p.000141:
p.000141: Where no personal information is collected, consent is not required. Where personal information will be collected,
p.000141: researchers should explain whether the need for such covert research justifies an exception to the general
p.000141: requirement for seeking consent, and REBs should exercise their judgment taking into consideration the methodological
p.000141: requirements (see Article 3.7). Researchers and REBs shall take the necessary steps to ensure that the privacy of the
p.000141: individual is protected in accordance with the law in the absence of consent. Where no consent is sought, researchers
p.000141: and REBs may also consider whether debriefing is possible or necessary. Chapter 5 on privacy and
p.000141: confidentiality provides additional information.
...
Political / political affiliation
Searching for indicator party:
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p.000199: The people of Canada, through Acts of Parliament,1 have created and funded the Agencies to promote and assist research
p.000199: within their respective legislative mandates. In discharging their mandates, the Agencies wish to promote research that
p.000199: is conducted according to the highest ethical standards. The Agencies have therefore adopted this Policy as a benchmark
p.000199: for the ethical conduct of research involving humans. As a condition of funding, the Agencies require that researchers
p.000199: and their institutions apply the ethical principles and the articles of this Policy and be guided by the application
p.000199: sections of the articles.
p.000199:
p.000199: Compliance with the Policy
p.000199: To be eligible to receive and administer research funds from the Agencies, institutions must agree to comply with a
p.000199: number of Agency policies set out as schedules to a Memorandum of Under- standing (MOU) between the Agencies and
p.000199: institutions.2 This Policy is referenced in Schedule 2 to that MOU. Institutions must therefore ensure that research
p.000199: conducted under their auspices adhere to this Policy. Researchers are expected, as a condition of funding, to adhere to
p.000199: the TCPS. Institu- tions should support their efforts to do so.
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 5
p.000199:
p.000199: In addition to this Policy on the ethics of research involving humans, institutions and their researchers
p.000199: must adhere to the other policies referenced in the MOU, which include policies on research integrity, peer review and
p.000199: conflicts of interest in research.3
p.000199: Organizations and entities not party to the MOU are welcome to adopt this Policy to guide the ethical aspects of the
p.000199: design, review and conduct of research involving humans. Since the adoption of the original Policy in 1998, many bodies
p.000199: in Canada and abroad have adopted, adapted and been guided by this document. The Agencies hope that this Policy will
p.000199: continue to serve as a model and guide for the ethical conduct of research involving humans.
p.000199: The Agencies recognize that considerations around the ethical conduct of research involving humans are complex and
p.000199: continually evolving. We therefore welcome comments and discussion, and commit to the continued evolution of this
p.000199: document.
p.000199: The online version of the Policy, which will include all updates and revisions, shall be considered the official
p.000199: version.
p.000199:
p.000199: Endnotes
p.000199:
p.000199:
p.000199: 1 See Canadian Institutes of Health Research Act, Statutes of Canada, 2000, Chapter 6; Natural Sciences and Engineering
p.000199: Research Council Act, Revised Statutes of Canada, 1985, Chapter N-21; Social Sciences and Humanities Research Council
p.000199: Act, Revised Statutes of Canada, 1985, Chapter S-12.
p.000199: 2 Memorandum of Understanding (MOU) on the Roles and Responsibilities in the Management of Federal Grants and Awards.
p.000199: www.nserc-crsng.gc.ca/NSERC-CRSNG/Policies-Politiques/MOURoles- ProtocolRoles/index_eng.asp
p.000199: 3 Schedules 4 (research integrity), 6 (peer review) and 14 (conflicts of interest).
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: 6 TCPS 2
p.000199:
p.000199: Chapter 1
...
p.000199: may include the fear of alienating those in positions of authority, such as professional or personal caregivers,
p.000199: researchers, leaders, larger groups, or a community to which one belongs. Other constraints may consist of barriers to
p.000199: accessing resources or knowledge outside the research context. These factors and constraints should be addressed prior
p.000199: to any research being carried out, so as to ensure participants are sufficiently protected.
p.000199: Some people may be incapable of exercising autonomy because of youth, cognitive impairment, other mental health issues
p.000199: or illness. While autonomy may be considered a necessary condition for participation in research, involving those who
p.000199: lack capacity to make their own decisions to participate can be valuable, just and even necessary. For those
p.000199: prospective participants, additional measures are needed to protect their interests and to ensure that their wishes (to
p.000199: the extent that these are known) are respected. These measures will generally include seeking consent from an
p.000199: authorized third party who is entrusted to make decisions on behalf of the prospective participant, based on knowledge
p.000199: of that person and that person’s wishes or, if such wishes are unknown, on consideration of that person’s welfare. Even
p.000199: when the requirements of free, informed and ongoing consent cannot be met, Respect for Persons requires involving
p.000199: individuals in circumstances of vulnerability in decision making where possible. This may include asking about their
p.000199: feelings re- garding participation and/or for their assent.
p.000199: Where it is foreseeable that a participant may lose capacity during a research project, for example in studies of
p.000199: cognitive impairment, it may be appropriate to ask participants to express their pref- erences and ensure that they
p.000199: have authorized a trusted person to make decisions on their behalf should they lose the capacity to provide ongoing
p.000199: consent (see Article 3.11 for guidance on research directives for individuals who lack capacity).
p.000199:
p.000199: Concern for Welfare
p.000199:
p.000199: The welfare of a person is the quality of that person’s experience of life in all its aspects. Welfare consists of the
...
p.000199: records, may also be considered publicly available for the purposes of this Policy.
p.000199: Research that relies exclusively on information that is publicly available, or made accessible through legislation
p.000199: or regulation, does not require REB review. Exemption from REB review for research involving information that is
p.000199: legally accessible to the public is based on the presence of a legally designated custodian/steward who
p.000199: protects its privacy and proprietary interests (e.g., an access to information and privacy coordinator or a guardian of
p.000199: Canadian census data).
p.000199: REB review is also not required where research uses exclusively publicly available information that may contain
p.000199: identifiable information, and for which there is no
p.000199:
p.000199:
p.000199: TCPS 2 17
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
p.000199: reasonable expectation of privacy. For example, identifiable information may be disseminated in the public domain
p.000199: through print or electronic publications; film, audio or digital recordings; press accounts; official publications of
p.000199: private or public institutions; artistic installations, exhibitions or literary events freely open to the public; or
p.000199: publications accessible in public libraries. Research that is non-intrusive, and does not involve direct interaction
p.000199: between the researcher and individuals through the Internet, also does not require REB review. Cyber-material such as
p.000199: documents, records, performances, online archival materials or published third party interviews to which the public is
p.000199: given uncontrolled access on the Internet for which there is no expectation of privacy is considered to be publicly
p.000199: available information.
p.000199: Exemption from REB review is based on the information being accessible in the public domain, and that the individuals
p.000199: to whom the information refers have no reasonable expectation of privacy. Information contained in publicly accessible
p.000199: material may, however, be subject to copyright and/or intellectual property rights protections or dissemination
p.000199: restrictions imposed by the legal entity controlling the information.
p.000199: However, there are situations where REB review is required.
p.000199: There are publicly accessible digital sites where there is a reasonable expectation of privacy. When accessing
p.000199: identifiable information in publicly accessible digital sites, such as Internet chat rooms, and self-help groups with
p.000199: restricted membership, the privacy expectation of contributors of these sites is much higher. Researchers shall submit
p.000199: their proposal for REB review (see Article 10.3).
p.000199: Where data linkage of different sources of publicly available information is involved, it could give rise to
p.000199: new forms of identifiable information that would raise issues of privacy and confidentiality when used in
p.000199: research, and would therefore require REB review (see Article 5.7).
p.000199: When in doubt about the applicability of this article to their research, researchers should consult their REBs.
p.000199: Article 2.3 REB review is not required for research involving the observation of people in public places where:
...
p.000199: “voluntary” are used interchangeably.
p.000199: Respect for Persons implies that individuals who participate in research should do so voluntarily, understanding the
p.000199: purpose of the research, and its risks and potential benefits, as fully as reasonably possible. Where a person has the
p.000199: capacity to understand this information, and the ability to act on it voluntarily, the decision to participate is
p.000199: generally seen as an expression of autonomy. The Policy refers to the process of seeking consent from prospective
p.000199: participants, which may result in either agreement or refusal to participate. This process is meant to emphasize
p.000199: Respect for Persons. Under no circumstances may researchers proceed to conduct research with anyone who has refused to
p.000199: participate. Subject to exceptions set out in this Policy, consent must be obtained from participants prior to the
p.000199: conduct of research.
p.000199: Equally, Respect for Persons implies that those who lack the capacity to decide for themselves should nevertheless have
p.000199: the opportunity to participate in research that may be of benefit to themselves or others. Authorized third parties
p.000199: acting on behalf of these individuals decide whether participation would be appropriate. For the purposes of this
p.000199: Policy, the term “authorized third party” (also known as “authorized third party decision makers”) refers to any person
p.000199: with the necessary legal authority to make decisions on behalf of an individual who lacks the capacity to consent to
p.000199: participate or to continue to participate in a particular research project. These decisions involve considerations of
p.000199: Concern for Welfare and Justice.
p.000199: Certain types of research require alternate processes for seeking consent. These are also described in this chapter.
p.000199: Where elements of the consent process may need to be adapted to the requirements of a particular research project, the
p.000199: research ethics board (REB) can play an educational and consultative role in determining the appropriate process for
p.000199: seeking and maintaining consent.
p.000199: The head of the research team, also known as the principal investigator, is responsible for ensuring that the consent
p.000199: process is followed. This person is also responsible for the actions of any member of the research team involved in the
p.000199: consent process.
p.000199: In addition to this Policy, researchers are responsible for ensuring that all applicable legal and regulatory
...
p.000199: provide participants with all information relevant to their ongoing consent to participate in the research.
p.000199: Application Consent encompasses a process that begins with the initial contact (e.g., recruit- ment) and carries
p.000199: through to the end of participants’ involvement in the project. Throughout the process, researchers have an ongoing
p.000199: duty to provide participants and REBs with all information relevant to participants’ ongoing consent to partic- ipate
p.000199: in the research. The researcher has an ongoing ethical and legal obligation to
p.000199:
p.000199:
p.000199: TCPS 2 33
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: bring to participants’ attention any changes to the research project that may affect them. These changes may have
p.000199: ethical implications, or may be germane to their decision to continue research participation, or may be relevant to the
p.000199: particular cir- cumstances of individual participants. In particular, researchers shall disclose changes to the
p.000199: risks or potential benefits of the research. This gives participants the opportunity to reconsider the basis for their
p.000199: consent in light of the new infor- mation.
p.000199: In the case of children who begin participation in a project on the basis of consent from an authorized third party,
p.000199: the researcher must seek their autonomous consent if they reach the age of majority during the research, in order for
p.000199: their participation to continue.
p.000199: Incidental Findings
p.000199:
p.000199: Article 3.4 Researchers have an obligation to disclose to the participant any material incidental findings
p.000199: discovered in the course of research.
p.000199: Application “Incidental findings” is a term that describes unanticipated discoveries made in the course of research
p.000199: but that are outside the scope of the research. Material incidental findings are findings that have been interpreted as
p.000199: having significant welfare im- plications for the participant, whether health-related, psychological or social. If, in
p.000199: the course of research, material incidental findings are discovered, researchers have an obligation to inform the
p.000199: participant.
p.000199: In some areas of research, such as medical and genetic research, there is a greater likelihood of material incidental
p.000199: findings. When material incidental findings are likely, researchers should develop a plan indicating how they will
p.000199: disclose such findings to participants, and submit this plan to the REB. If there is uncertainty as to whether a
p.000199: research project warrants such a plan, researchers and REBs can make this determination on a case-by-case basis.
p.000199: If researchers are unsure of how to interpret findings or uncertain whether findings are material, they should consult
p.000199: with colleagues or refer to standards in the disci- pline. If researchers are unsure of the most appropriate method for
...
p.000199: conclusion of the project, following debriefing. In cases where participants express concerns about their
p.000199: participation in a project, the researcher may give participants the option of removing their data from the project.
p.000199: Where the terms of the research proposal do not permit the participants to withdraw their data, in the absence
p.000199: of the consent of the participant, the identity of the participants shall be protected at all times during and
p.000199: following completion of the project. Participants who express concern about the conduct of the project at the time of
p.000199: debriefing, or who contest the limits imposed
p.000199:
p.000199:
p.000199: 38 TCPS 2
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: on withdrawing their data, should be given the contact information for the REB that approved the research. Researchers
p.000199: must report to the REB concerns about the conduct of the project raised by participants at the time of debriefing.
p.000199: Consent for Research in Individual Medical Emergencies
p.000199: This section addresses the exception to consent in situations where an individual who requires urgent medical care is
p.000199: unable to provide consent for research due to loss of consciousness or capacity – and the delay to seek authorized
p.000199: third party consent could seriously compromise that individual’s health. Certain types of medical emergency practices
p.000199: can be evaluated only when they occur, hence the need for this exception.
p.000199: This section is to be distinguished, however, from situations where there is a publicly declared emergency (such as the
p.000199: SARS crisis or a major flood) that disrupts the ordinary system for obtaining REB approval for research. For guidance
p.000199: on research ethics review during a publicly declared emergency, see Articles 6.21 and 6.22.
p.000199: Article 3.8 Subject to all applicable legal and regulatory requirements, research involving medical emergencies
p.000199: shall be conducted only if it addresses the emergency needs of the individuals involved, and then only in accordance
p.000199: with criteria established in advance of such research by the REB. The REB may allow research that involves medical
p.000199: emergencies to be carried out without the consent of participants, or of their authorized third party, if all of the
p.000199: following apply:
p.000199: (a) a serious threat to the prospective participant requires immediate intervention;
p.000199: (b) either no standard efficacious care exists or the research offers a realistic possibility of direct
p.000199: benefit to the participant in comparison with standard care;
p.000199: (c) either the risk is not greater than that involved in standard efficacious care, or it is clearly justified by the
p.000199: prospect for direct benefits to the participant;
p.000199: (d) the prospective participant is unconscious or lacks capacity to understand the risks, methods and purposes of the
p.000199: research project;
p.000199: (e) third party authorization cannot be secured in sufficient time, despite diligent and documented efforts to do so;
p.000199: and
p.000199: (f) no relevant prior directive by the participant is known to exist.
p.000199: When a previously incapacitated participant regains capacity, or when an authorized third party is found, consent
p.000199: shall be sought promptly for continuation in the project, and for subsequent examinations or tests related to
p.000199: the research project.
p.000199: Application For purposes of studying potential improvement in the treatment of life-threatening conditions, Article
p.000199: 3.8 outlines an exception (in addition to that in Article 3.7) to the general obligation of seeking consent from those
p.000199: participating in research.
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 39
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: It is the responsibility of researchers to justify to the REB the need for this exception. The underlying
p.000199: assumption of Article 3.8 is that participants could not receive any direct benefits of the research without setting
p.000199: aside the need for the researcher to seek the prior consent of participants, or of their authorized third party.
p.000199: Article 3.8 indicates that research in emergency medicine must be reviewed by the REB, be restricted to the emergency
p.000199: needs of the participants, and be conducted under criteria designated by the REB.
p.000199: It is unethical to expose participants to any additional risk without their consent if standard efficacious care
p.000199: exists, unless it can clearly be shown that there is a realistic possibility of meaningful improvement of the
p.000199: participant’s condition. Accordingly, paragraphs (b) and (c) of Article 3.8 indicate that researchers and REBs must
p.000199: assess the risks and potential benefits of proposed research against existing standard efficacious care.
p.000199: To respect the autonomy of the participant, Article 3.8(e) requires researchers to undertake diligent efforts to
p.000199: contact authorized third parties, if reasonably feasible, and to document such efforts for the benefit of both
p.000199: the participant and the continuing ethics review functions of the REB. The article also requires that
p.000199: participants who regain capacity be promptly afforded the opportunity to consent to their continued participation.
p.000199: Concern for the patient’s welfare is paramount and should be informed by ethical and professional judgment.
...
p.000199: Chapter 4).
p.000199: As indicated in Chapter 1, Respect for Persons and Concern for Welfare entails particular ethical obligations to
p.000199: individuals in vulnerable circumstances. Such obligations often translate into special procedures to promote and
p.000199: protect their interests. This may include the development of consent materials that are appropriate to the
p.000199: cognitive and communication abilities of prospective participants. Articles 3.9, 3.10 and 3.11 describe
p.000199: special procedures for research involving individuals who lack the capacity to consent on their own behalf.
p.000199: Article 3.9 For research involving individuals who lack the capacity, either permanently or temporarily, to decide
p.000199: for themselves whether to participate, the REB shall ensure that, as a minimum, the following conditions are met:
p.000199: (a) the researcher involves participants who lack the capacity to consent on their own behalf to the greatest extent
p.000199: possible in the decision-making process;
p.000199: (b) the researcher seeks and maintains consent from authorized third parties in accordance with the best interests of
p.000199: the persons concerned;
p.000199: (c) the authorized third party is not the researcher or any other member of the research team;
p.000199: (d) the researcher demonstrates that the research is being carried out for the participant’s direct benefit,
p.000199: or for the benefit of other persons in the same category. If the research does not have the potential for direct
p.000199: benefit to the participant but only for the benefit of the other persons in the same category, the researcher shall
p.000199: demonstrate that the research will expose the participant to only a minimal risk and minimal burden, and demonstrate
p.000199: how the participant’s welfare will be protected throughout the participation in research; and
p.000199: (e) when authorization for participation was granted by an authorized third party, and a participant acquires or
p.000199: regains capacity during the course of the research, the researcher shall promptly seek the participant’s consent as a
p.000199: condition of continuing participation.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 41
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: Application The decision of authorized third parties should be based on their knowledge of the prospective
p.000199: participants, and on consideration of the prospective participants’ welfare. The third parties should not be in
p.000199: a position of conflict of interest when making their decision.
p.000199: Article 3.9 outlines other safeguards to protect those who lack the capacity to consent to participate in research. The
p.000199: article details several considerations relevant to the use of third party authorization. Beyond the legal and
p.000199: regulatory requirements for seeking consent from authorized third parties, family members and friends may also provide
p.000199: information to the authorized third party about the interests and previous wishes of prospective
p.000199: participants. An authorized third party should take into account any research directives given in accordance with
p.000199: Article 3.11.
p.000199: Article 3.10 Where an authorized third party has consented on behalf of an individual who lacks legal capacity, but
p.000199: that person has some ability to understand the significance of the research, the researcher shall ascertain the wishes
p.000199: of that individual with respect to participation. Prospective participants’ dissent will preclude their participation.
p.000199: Application Many individuals who lack legal capacity to make decisions may still be able to express their wishes in
p.000199: a meaningful way, even if such expression may not fulfil all of the requirements for consent. Prospective participants
p.000199: may be capable of verbally or physically assenting to, or dissenting from, participation in research. Those who may be
p.000199: capable of assent or dissent include:
p.000199: (a) those whose capacity is in the process of development, such as children whose capacity for judgment and
p.000199: self-direction is maturing;
p.000199: (b) those who once were capable of making an autonomous decision regarding consent but whose capacity is diminishing or
p.000199: fluctuating; and
p.000199: (c) those whose capacity remains only partially developed, such as those living with permanent cognitive impairment.
p.000199: While their assent would not be sufficient to permit them to participate in the absence of consent by an authorized
p.000199: third party, their expression of dissent or signs suggesting they do not wish to participate must be respected.
p.000199: Research Directives
p.000199: Although advance directives for treatment are recognized as a legitimate tool in health care, the use of directives in
p.000199: the context of research is not well developed and they have no legal status. For the purposes of this Policy, research
p.000199: directives should be understood to express an individual’s preferences for participation in future research in the
p.000199: event that the individual loses capacity. Research directives are written instructions to be used by the authorized
p.000199: third party as information about a prospective participant’s preferences when the third party is asked to provide
p.000199: substitute consent.
p.000199:
p.000199:
p.000199:
p.000199: 42 TCPS 2
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: The efficacy of research directives is unknown and their legal status has not yet been recognized or tested. Research
p.000199: directives, nevertheless, are congruent with this Policy’s core principle of Respect for Persons. The use of research
p.000199: directives respects the right of individuals to express their preference regarding participation in research and
p.000199: respects privacy by allowing individuals to control information about themselves and materials from their bodies.
p.000199: Authorized third parties should consult with an individual’s research directive when deciding whether to
p.000199: consent to participation in research on behalf of that individual.
p.000199: Article 3.11 Where individuals have signed a research directive indicating their preferences about future
p.000199: participation in research in the event that they lose capacity or upon death, researchers and authorized third parties
p.000199: should be guided by these directives during the consent process.
p.000199: Application Research directives allow individuals with capacity to express preferences about their future
p.000199: participation in research should they ever lose capacity. Researchers and authorized third parties should take these
...
p.000199:
p.000199:
p.000199: TCPS 2 49
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: Article 4.4 Children shall not be inappropriately excluded from research solely on the basis of their age or
p.000199: developmental stage. The inclusion of children in research is subject to Article 4.6.
p.000199: Application Researchers should not exclude children from research unless there is a valid reason for doing so.
p.000199: Participation of children in research is justifiable when the research objective cannot be achieved with adult
p.000199: participants only. When considering the inclusion of children in research, researchers and REBs shall consider a
p.000199: child’s stage of physical, physiological, psychological, and social development to ensure adequate protections for the
p.000199: child’s welfare. Where children have not yet attained the capacity to consent for themselves to participate in
p.000199: research, researchers shall seek consent from an authorized third party while ascertaining the child’s assent or
p.000199: dissent, as outlined in Chapter 3. Note that Article 4.6 equally applies to children.
p.000199: Research Involving the Elderly
p.000199: As the population ages, the proportion of elderly people is increasing, and so is their life ex- pectancy. Research
p.000199: designed to improve our understanding of a wide range of aspects of aging and the lives of elderly people is important
p.000199: for ensuring that they stay fully integrated into society and maintain a continuing high quality of life. Medically,
p.000199: elderly patients are the highest consumers of drugs, yet many of these treatments have not been tested adequately on
p.000199: elderly patients. Re- search that takes into account the differential effects on the elderly and how best to
p.000199: accommodate their needs provides scientific evidence that can inform changes to policies and standards of care for the
p.000199: elderly.
p.000199: Article 4.5 Elderly people shall not be inappropriately excluded from research solely on the basis of their age.
p.000199: Application Researchers should not exclude elderly people from research unless there is a valid reason for doing
...
p.000199: foreseeable risk to participants. The relation of the potential benefit to the foreseeable risk presented by the
p.000199: research should be at least as favourable to the participants as that provided by available alternative approaches.
p.000199: Where the research entails only minimal risk, it is sufficient if the research presents the prospect of benefits to
p.000199: participants or to a group that is the focus of the research and to which the participants belong.
p.000199: The research design should take into account factors that may affect the capacity of prospective participants to
p.000199: receive information, to consent to the research at some stage, or to participate in it. These factors may be permanent
p.000199: or may vary
p.000199:
p.000199:
p.000199: TCPS 2 51
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: over time (e.g., the participant’s capacity to consent may fluctuate over time). Ar- ticles 3.9 and 3.10 in Chapter 3
p.000199: establish other conditions regarding research that involve individuals who lack capacity to consent. This includes the
p.000199: involvement of an authorized third party to consent on their behalf, and adequate provisions to ascertain the wishes of
p.000199: the individuals concerning their participation.
p.000199: Participants’ Vulnerability and Research
p.000199: Article 4.7 Individuals or groups whose circumstances may make them vulnerable in the con- text of research should
p.000199: not be inappropriately included or automatically excluded from participation in research on the basis of their
p.000199: circumstances.
p.000199: Application The core principles of Respect for Persons, Concern for Welfare, and Justice entail special ethical
p.000199: obligations toward individuals or groups whose circumstances may lead to their vulnerability in the context of a
p.000199: specific research project and limit their ability to fully safeguard their own interests. Those who are owed special
p.000199: ethical obligations may include individuals who are institutionalized, those in dependent situations, or those whose
p.000199: circumstances (e.g., poverty or poor health status) may render even modest participation incentives so attractive as to
p.000199: constitute an induce- ment to take risks they would otherwise not take. Their situation may also compromise
...
p.000199: list that links the participants’ code names with their actual name so data can be re-linked if necessary).
p.000199: • Anonymized information – the information is irrevocably stripped of direct identifiers, a code is not kept to
p.000199: allow future re-linkage, and risk of re-identification of individuals from remaining indirect identifiers is low or
p.000199: very low.
p.000199: • Anonymous information – the information never had identifiers associated with it (e.g., anonymous surveys) and
p.000199: risk of identification of individuals is low or very low.
p.000199: Ethical concerns regarding privacy decrease as it becomes more difficult (or impossible) to asso- ciate information
p.000199: with a particular individual. These concerns also vary with the sensitivity of the information and the extent to which
p.000199: access, use or disclosure may harm an individual or group.
p.000199: The easiest way to protect participants is through the collection and use of anonymous or anonymized
p.000199: data, although this is not always possible or desirable. For example, after information is anonymized, it is not
p.000199: possible to link new information to individuals within a dataset, or to return results to participants. A “next best”
p.000199: alternative is to use de-identified data: the data are pro- vided to the researcher in de-identified form and the
p.000199: existing key code is accessible only to a custodian or trusted third party who is independent of the researcher. The
p.000199: last alternative is for re- searchers to collect data in identifiable form and take measures to de-identify the data as
p.000199: soon as possible. Although these measures are effective ways to protect participants from identification, the use of
p.000199: indirectly identifying, coded or anonymized information for research may still present risks of re-identification.
p.000199: Technological developments have increased the ability to access, store and analyze large volumes of data. These
p.000199: activities may heighten risks of re-identification, such as when researchers link datasets (see Section E, this
p.000199: chapter), or where a dataset contains information about a population in a small geographical area, or about individuals
p.000199: with unique characteristics (e.g., uncommon field of occupational specialization, diagnosis of a very rare disease).
p.000199: Various factors can affect the risks of re-identification, and researchers and REBs should be vigilant in their efforts
p.000199: to rec- ognize and reduce these risks. Data linkage of two or more datasets of anonymous information may present risks
p.000199: of identification (see Article 2.4 or Article 9.22).
p.000199: Where it is not feasible to use anonymous or anonymized data for research (and there are many reasons why data may need
p.000199: to be gathered and retained in an identifiable form), the ethical duty of confidentiality and the use of appropriate
p.000199: measures to safeguard information become para- mount. This Policy generally requires more stringent protections in
p.000199: research involving identifiable information. Researchers are expected to consult their REB if they are uncertain about
...
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: B. Ethical Duty of Confidentiality
p.000199: Article 5.1 Researchers shall safeguard information entrusted to them and not misuse or wrongfully
p.000199: disclose it. Institutions shall support their researchers in maintaining promises of confidentiality.
p.000199: Application When researchers obtain information with a promise of confidentiality, they assume an ethical duty that
p.000199: is central to respect for participants and the integrity of the re- search project. Breaches of confidentiality may
p.000199: harm the participant, the trust relationship between the researcher and the participant, other individuals or groups,
p.000199: and/or the reputation of the research community. Research that probes sensitive topics (e.g., illegal activities)
p.000199: generally depends on strong promises of confiden- tiality to establish trust with participants.
p.000199: The ethical duty of confidentiality applies to information obtained directly from participants, or from other
p.000199: researchers or organizations that have legal, professional or other obligations to maintain confidentiality.
p.000199: The ethical duty of confidentiality must, at times, be balanced against competing ethical considerations or legal or
p.000199: professional requirements that call for disclosure of information obtained or created in a research context. For
p.000199: example, in excep- tional and compelling circumstances, researchers may be subject to obligations to report information
p.000199: to authorities to protect the health, life or safety of a participant or a third party. Researchers are expected to be
p.000199: aware of ethical codes (such as pro- fessional codes of conduct) or laws (e.g., those requiring the reporting of
p.000199: children in need of protection) that may require disclosure of information they obtain in a research context. In other
p.000199: situations, a third party may seek access to information obtained and/or created in confidence in a research context.
p.000199: An access request may seek voluntary disclosure of information, or may seek to compel disclosure through force of law
p.000199: (e.g., by subpoena). Chapter 1, Section C, elaborates on the relationship between research ethics and law.
p.000199: Certain areas of research (such as research involving children at risk of abuse or studies of criminal behaviour) are
p.000199: more likely to put researchers in positions where they may experience tension between the ethical duty of
p.000199: confidentiality and dis- closure to third parties. Researchers shall maintain their promise of confidentiality to
p.000199: participants within the extent permitted by ethical principles and/or law. This may involve resisting requests for
p.000199: access, such as opposing court applications seek- ing disclosure. Researchers’ conduct in such situations should be
p.000199: assessed on a case-by-case basis and guided by consultation with colleagues, any relevant pro- fessional body, the REB
p.000199: and/or legal counsel.
p.000199: In some instances, participants may waive anonymity (e.g., if they wish to be iden- tified for their contributions to
p.000199: the research). Researchers should obtain the consent of these participants, and negotiate agreements with them that
...
p.000199: 10.4).
p.000199: Article 5.2 Researchers shall describe measures for meeting confidentiality obligations and explain any reasonably
p.000199: foreseeable disclosure requirements:
p.000199: (a) in application materials they submit to the REB; and
p.000199: (b) during the consent process with prospective participants.
p.000199: Application This article recognizes that some research projects are more likely to put researchers in a position
p.000199: where they may have a requirement to disclose information to third parties. The reasonable foreseeability of disclosure
p.000199: requirements can be assessed by considering the nature and objectives of the research inquiry. For example, re- search
p.000199: that involves interviewing high-risk families about intergenerational violence raises a reasonably foreseeable
p.000199: prospect that researchers may acquire in- formation that a child is being abused. Researchers who reasonably foresee
p.000199: that their inquiries may give rise to an ethical or legal reason to disclose information obtained in the research
p.000199: context shall advise the REB and prospective participants about the possibility of compelled disclosure. Advising
p.000199: participants of reasonably foreseeable disclosure requirements is an important aspect of the consent process.
p.000199: Situations may arise where researchers unexpectedly acquire information that gives rise to a reason for disclosure to a
p.000199: third party, or researchers may receive a disclo- sure demand from a third party. In such cases, advising a participant
p.000199: about the disclosure may be important to respect the trust relationship with the participant, and to ensure the
p.000199: validity of the participant’s ongoing consent. Decisions about whether, how and when to advise a participant of
p.000199: disclosure should be guided by any applicable disciplinary standards and consultation with the REB, colleagues,
p.000199: relevant professional body and/or legal counsel.
p.000199: Researchers shall also inform participants and seek their consent if their personal information may be shared with
p.000199: government departments or agencies, community partners in the research, personnel from an agency that monitors the
p.000199: research, a re- search sponsor (such as a pharmaceutical company), the REB or a regulatory agency.
p.000199: Researchers shall avoid being put in a position of becoming informants for author- ities or leaders of
p.000199: organizations. For example, when records of prisoners, employees, students or others are used for research
p.000199: purposes, the researcher shall not provide authorities with results that could identify individuals unless the prior
p.000199: written consent of the participants has been given. Researchers may, however, pro- vide administrative bodies with
p.000199: aggregated data that cannot be linked to individuals for purposes such as policy-making or program evaluation. When
p.000199: seeking consent, researchers shall advise prospective participants if aggregated data from a project
p.000199:
p.000199:
p.000199:
...
p.000117: institution from seeking REB approval at their institution, subject to Article 8.1. Prospective research and secondary
p.000117: use of data and human biological materials for research purposes is subject to research ethics review.
p.000117:
p.000117: Application Applying this Policy in a way that accommodates the diversity of First Nations, Inuit and Métis
p.000117: cultures, and mixed Aboriginal communities in urban centres is complex. For example, the fit between
p.000117: institutional policies and community customs and codes of research practice may be unclear, requiring researchers to
p.000117: adapt conventional practice or negotiate a resolution.
p.000117:
p.000117:
p.000117:
p.000117:
p.000117: TCPS 2
p.000119: 119
p.000119:
p.000119: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000119:
p.000119: Consistent with Article 8.3(b), research conducted outside the jurisdiction of the researcher’s institution shall
p.000119: undergo prior research ethics review by both “(i) the REB at the Canadian institution under the auspices of which the
p.000119: research is being conducted, and (ii) the REB or other responsible review body or bodies, if any, at the research
p.000119: site.”
p.000119: Article 8.1 permits review models for multi-site research that do not require separate research ethics
p.000119: review by each site involved in a research project. In cases where the community is the direct recipient of funding and
p.000119: has constituted a local REB that is party to an agreement with the researcher’s institution, review by the
p.000119: institution’s REB may not be required.
p.000119: In accordance with Article 8.4, communication between the institutional REB and the responsible agency in the community
p.000119: may assist in resolving inconsistencies between institutional policy and community customs and codes of research
p.000119: practice. Where a community research ethics review is required in addition to the mandatory institutional REB review,
p.000119: reconciling differences may require resubmission to one or both review bodies.
p.000119: Researchers and REBs should recognize that research ethics review by community bodies will often pursue purposes and
p.000119: apply criteria that differ from the provisions of this Policy. The express purpose of most Aboriginal community
p.000119: codes of research practice is to ensure the relevance of research undertakings to community needs and priorities,
p.000119: and respect for First Nations, Inuit and Métis identities, cultures and knowledge systems. While community
p.000119: codes of practice and research agreements typically share many of the goals of institutional policies, the
p.000119: approaches to achieving those goals may differ significantly. It is therefore inappropriate to insist on
p.000119: uniformity between community practices and institutional policies. For example, when researchers seek to interview
p.000119: Elders willing to share their knowledge according to traditional customs of consent, REBs should not impose language
...
p.000169: non-identifiable human biological materials also precludes withdrawal of a participant’s material from research
p.000169: use, even at the participant’s request.
p.000169:
p.000169: B. Collection of Human Biological Materials
p.000169: Human biological materials may be obtained in different ways:
p.000169: 1. they may be collected expressly for a specific research purpose;
p.000169: 2. they may be collected incidentally to medical or diagnostic procedures with no initial intent to be used in
p.000169: research; or
p.000169:
p.000169:
p.000169: 170 TCPS 2
p.000169:
p.000169: Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction
p.000169:
p.000169: 3. they may be collected for research or medical or diagnostic purposes with some expectation that they
p.000169: may, or will, also be used in future research, although the precise research project(s) may not be known at the time.
p.000169: The first category above refers to the initial collection of human biological materials for research, which is
p.000169: described in this section. The latter two categories are relevant to subsequent, secondary uses of human biological
p.000169: materials for research that may not have been conceived at the time the tissue was taken. Secondary use of biological
p.000169: materials is described in Section C.
p.000169: Article 12.1 Research involving collection and use of human biological materials requires REB review and:
p.000169: (a) consent of the participant who will donate biological materials; or
p.000169: (b) consent of an authorized third party on behalf of a participant who lacks capacity, taking into account any
p.000169: research directive that applies to the participant; or
p.000169: (c) consent of a deceased participant through a donation decision made prior to death, or by an authorized third
p.000169: party.
p.000169: Application Article 12.1 applies prospectively, that is, prior to the collection of human biological materials for
p.000169: research purposes. It applies the general elements of consent in Chapter 3 to the collection and use of human
p.000169: biological materials. During the consent process, a clear distinction should be made between consent to research
p.000169: participation and consent for any clinical procedure or test. In practice, this may mean separate consent information
p.000169: and forms, but in any event the different uses must be clearly explained. Individuals who do not wish to
p.000169: contribute human biological materials for research are free to withhold consent without penalty, and without
p.000169: prejudicing access to any treatment they would otherwise receive. For individuals who lack capacity to consent, the
p.000169: guidance developed in Chapter 3 regarding authorized third parties shall be observed.
p.000169: Where a participant has expressed preferences for future research participation in a research directive before losing
p.000169: capacity, researchers and authorized third parties shall take such directives into account during the consent
...
p.000181: participants, or notifi- cation of general, non-identifiable research results through newsletters, websites or other
p.000181: means. In regard to release or publication of research findings, the provi- sions of Chapter 5 apply.
p.000181: Article 13.3 Where researchers plan to share findings with individuals, researchers shall provide participants with
p.000181: an opportunity to:
p.000181: (a) make informed choices about whether they wish to receive information about themselves; and
p.000181: (b) express preferences about whether information will be shared with biological relatives, or others with whom the
p.000181: participants have a family, community or group relationship.
p.000181: Application The core principles on which this Policy is based emphasize autonomous choices regarding research
p.000181: participation. Researchers shall explain to participants the types of findings that may be revealed (as discussed in
p.000181: the Application of Article 13.2), and the potential implications of these findings, to permit participants to make in-
p.000181: formed choices about whether or not to receive information. Since the right to pri- vacy includes a right not to know,
p.000181: researchers shall give participants options for receiving or refusing different types of information.
p.000181: Where individual findings will be shared with participants, researchers must de- velop appropriate procedures for
p.000181: communicating findings in accordance with the participant’s preferences or instructions. These procedures shall be
p.000181: clearly described in the researcher’s plan. This may include direct communication of findings to the participant, or
p.000181: communication to a specified health care provider or other party au- thorized to receive the information. As discussed
p.000181: below, sharing research findings with individuals may give rise to a need for genetic counselling.
p.000181: Participants in genetic research shall have an opportunity to express their prefer- ences about the sharing of
p.000181: information with relatives or others. These preferences may be subject to overriding considerations that may warrant
p.000181: disclosure of infor- mation to relatives in exceptional circumstances (e.g., if genetic research reveals information
p.000181: about a serious or life-threatening condition that can be prevented or treated through intervention). Articles 5.1 and
p.000181: 5.2 provide guidance on researchers’ ethical duty of confidentiality, and situations where researchers may have a
p.000181: require- ment to disclose information to third parties.
p.000181: Chapter 5 also requires researchers to provide details to the REB regarding their proposed measures for safeguarding
p.000181: information throughout its life cycle, including dissemination, and to guard against risks of re-identification.
p.000181: Funders of human genomics research may have policies requiring researchers to make genome se-
p.000181:
p.000181:
p.000181:
p.000181:
p.000181:
p.000181: TCPS 2
p.000183: 183
p.000183:
p.000183: Chapter 13 – Human Genetic Research
p.000183:
p.000183: quence data publicly accessible. Where such policies apply, researchers must advise the REB and participants of
p.000183: data-sharing requirements, and measures for protection of personal information (see Articles 5.2 and 5.3 for further
p.000183: guidance). Publication of aggregated data from genome-wide association studies has raised concerns about individual
p.000183: re-identification.1 This underscores the need for researchers and REBs to ensure that measures for safeguarding
...
p.000183: information. For example, genetic counselling can help explain the clinical significance of the information, whether
p.000183: health care interventions or lifestyle changes are recommended, and any implica- tions of the information for
p.000183: biological relatives. Researchers should explain differ- ences between genetic testing in a research context and
p.000183: testing in a clinical context. Clinical genetic testing may be needed to clarify or confirm findings obtained in
p.000183: research. Where researchers share information with biological relatives or other family, community or group members,
p.000183: genetic counselling should be made avail- able to them as well as the participants. The counselling service provider
p.000183: must have the appropriate experience or training to provide genetic counselling, but need not necessarily hold a
p.000183: diploma, degree or professional designation in genetic coun- selling.
p.000183: D. Genetic Research Involving Families
p.000183: Article 13.5 Researchers who seek to recruit members of a family to participate in genetic re- search shall:
p.000183: (a) ensure recruitment processes respect privacy and other personal interests of family members; and
p.000183: (b) seek consent from individual family members.
p.000183: Application Recruitment of members of a family may take place in various ways: through (a) the researcher, (b) an
p.000183: individual participant, or (c) a third party on behalf of an individual participant. A family group, such as parents
p.000183: and a child, or several adult siblings, may all receive an invitation at the same time from the researcher to
p.000183: participate in genetic research. Alternatively, researchers may seek permission from an individual participant to
p.000183: contact family members to invite participation. It may be preferable for the participant to make initial contact with
p.000183: the family member, in
p.000183:
p.000183:
p.000183: 184 TCPS 2
p.000183:
p.000183: Chapter 13 – Human Genetic Research
p.000183:
p.000183: order to respect privacy interests or known sensitivities. The participant may prefer to identify a third party to
p.000183: inform family members about the opportunity to participate in genetic research. However, an approach by someone
p.000183: in a position of authority over family members may raise concerns about undue influence or manipulation.
p.000183: Refer to Chapter 3 for further guidance in regard to the voluntariness of consent.
p.000183: Family members may have conflicting views about participation in research, and some may have specific sensitivities or
p.000183: objections. Researchers should recognize the potential for conflict within families and be respectful of any known
p.000183: sensitivi- ties. Where researchers seek participation from children or other members of a fam- ily who may lack
p.000183: capacity to consent, the applicable provisions in Chapter 3 shall be followed.
p.000183: E. Genetic Research Involving Communities and Groups
p.000183: Article 13.6 Where researchers intend to recruit participants for genetic research based on their membership in
p.000183: specific communities or groups, it may be appropriate for re- searchers to discuss the research with community
p.000183: or group members, and/or their leaders, in addition to seeking consent from individual participants. In these cases,
p.000183: researchers shall provide details to the REB about their proposed methods for en- gaging in discussion.
...
p.000187: conventional thought, freedom to express one’s opinion about the institution, its administration, or the system in
p.000187: which one works, and freedom from institutional censorship.
p.000187:
p.000187: Ad hoc advisor – A person with relevant and competent knowledge and expertise consulted by a research ethics board for
p.000187: a specific research ethics review, and for the duration of that review. The ad hoc advisor is not a member of the
p.000187: research ethics board.
p.000187:
p.000187: Agencies, the – Canada’s three federal research agencies: the Canadian Institutes of Health Research (CIHR); the
p.000187: Natural Sciences and Engineering Research Council of Canada (NSERC); and the Social Sci- ences and Humanities Research
p.000187: Council of Canada (SSHRC).
p.000187:
p.000187: Appeal – A process that allows a researcher to request a review of a research ethics board (REB) decision when, after
p.000187: reconsideration, the REB has refused ethics approval of the research.
p.000187:
p.000187: Appeal mechanism – A procedure established by an institution to promptly handle a researcher’s appeal of a research
p.000187: ethics board (REB) decision. An ad hoc or permanent appeal committee, which reflects a range of expertise and knowledge
p.000187: similar to that of the REB, is established or appointed by the same authority that established the REB.
p.000187:
p.000187: Authorized third party – Any person with the necessary legal authority to make decisions on behalf of a prospective
p.000187: participant who lacks the capacity to consent to participate, or to continue to participate, in a particular research
p.000187: project. In other policies/guidance they are also known as “authorized third party deci- sion makers.”
p.000187:
p.000187: Autonomy – The capacity to understand information and to be able to act on it voluntarily; the ability of individuals
p.000187: to use their own judgement to make decisions about their own actions, such as the decision to consent to participate in
p.000187: research.
p.000187:
p.000187:
p.000187:
p.000187: TCPS 2
p.000189: 189
p.000189:
p.000189: Glossary
p.000189:
p.000189: Biobank – A collection of human biological materials. It may also include associated information about individuals from
p.000189: whom biological materials were collected.
p.000189:
p.000189: Capacity – The ability of prospective or actual participants to understand relevant information presented (e.g. purpose
p.000189: of the research, foreseeable risks, and potential benefits), and to appreciate the potential con- sequences of any
p.000189: decision they make based upon this information.
p.000189:
p.000189: Clinical equipoise – The existence of a genuine uncertainty on the part of the relevant expert community about what
p.000189: therapy or therapies are most effective for a given condition.
p.000189:
p.000189: Clinical trial – Any investigation involving participants that evaluates the effects of one or more health- related
p.000189: interventions on health outcomes.
p.000189:
p.000189: Coercion – An extreme form of undue influence, involving a threat of harm or punishment for failure to participate in
...
p.000193: in it. This approach requires researchers to understand phenomena based on discourse, actions, and documents, and how
p.000193: and why individuals interpret and ascribe meaning to what they say and do, and to other aspects of the world (including
p.000193: other people) they encounter.
p.000193:
p.000193: Reciprocal research ethics board (REB) review – An official agreement between two or more institutions, in which they
p.000193: accept, with an agreed level of oversight, the research ethics reviews of each other’s REBs.
p.000193:
p.000193: Reimbursement – Payment to participants to ensure that they are not put at a direct, or indirect, financial
p.000193: disadvantage for the time and inconvenience of participation in research. Direct expenses refer to the costs incurred,
p.000193: and indirect expenses refer to losses that arise, because of research participation.
p.000193:
p.000193:
p.000193:
p.000193: TCPS 2
p.000195: 195
p.000195:
p.000195: Glossary
p.000195:
p.000195: Research – An undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation.
p.000195:
p.000195: Research agreement – A document that serves as a primary means of clarifying and confirming mutual expectations and,
p.000195: where appropriate, commitments between researchers and communities.
p.000195:
p.000195: Research directive – Written instructions used to express an individual’s preferences for participation in future
p.000195: research, in the event that the individual loses capacity. It is intended to guide the individual’s authorized third
p.000195: party in deciding whether or not to give substitute consent for the individual to participate in research.
p.000195:
p.000195: Research ethics board (REB) – A body of researchers, community members, and others with specific ex- pertise (e.g. in
p.000195: ethics, in relevant research disciplines) established by an institution to review the ethical acceptability of all
p.000195: research involving humans conducted within the institution’s jurisdiction or under its auspices.
p.000195:
p.000195: Research ethics education and training – The provision of materials and corresponding instruction by an institution to
p.000195: research ethics board (REB) members or researchers with regard to the core principles and understanding of this Policy,
p.000195: basic ethics standards, applicable institutional policies, and legal or regulatory requirements. This term also
p.000195: includes an understanding of the role and mandate of REBs and responsibilities of REB members.
p.000195:
p.000195: Research involving partial disclosure or deception – A type of research, in which the participant may not know that
p.000195: they are part of a project until it is over or is not informed of the true purpose of the research in advance. See
p.000195: “Debriefing.”
p.000195:
p.000195: Respect for Persons – A core principle of this Policy that recognizes the intrinsic value of human beings and the
...
p.000207: procedures, 76-83
p.000207: proportionate approach, 11, 22, 24-25, 77-79, 82, 148
p.000207: reconsideration, 83-85
p.000207: record keeping, 82-83
p.000207: research conducted outside the institution, 101-104 research exempt from, 17-19
p.000207: research requiring, 15-17, 119-121 scholarly review and, 20-21 scope, 15-22
p.000207: timing, 15, 76, 139
p.000207: Research participants (see Participants)
p.000207: Researchers
p.000207: academic freedom, 7, 11
p.000207: conflicts of interest, 91, 94-96
p.000207: dual roles, 95, 149, 158
p.000207: multiple affiliations, 68, 97-101
p.000207: Respect for Persons, 8-9, 27, 109 Risk
p.000207: and benefits, 10, 11, 22-25, 41-42, 51, 157-158
p.000207: in clinical trials, 148, 157-159
p.000207: definition, 22-23
p.000207: minimal, 11, 23, 24-25, 37-39, 41, 51, 77-79
p.000207: to researchers, 25
p.000207:
p.000207:
p.000207: 208 TCPS 2
p.000207:
p.000207: Index
p.000207:
p.000207: S
p.000207: Scholarly review, 20-21
p.000207: Secondary use of human biological materials, 62-64, 119-121, 130-132, 172-175, 186 Secondary use of identifiable
p.000207: information
p.000207: Aboriginal peoples, 119-121, 130-132
p.000207: anonymous, 19
p.000207: consent, 62-64, 130-132
p.000207: definition, 19, 62
p.000207: genetic material, 186
p.000207: privacy, 62-64
p.000207: Security of information, 56, 60-61, 64-65 StemXcells
p.000207: Guidelines for Human Pluripotent Stem Cell Research, 179 pluripotent, 179
p.000207: Students, 25, 67-68, 77-79 Subjects (see Participants)
p.000207: T
p.000207: Therapeutic misconception, 148, 149, 158-159
p.000207: Third party consent (see Consent: authorized third parties) Trials (see Clinical trials)
p.000207: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) application, 11-13
p.000207: compliance with, 5-6
p.000207: interpretation, 13
p.000207:
p.000207: U
p.000207: Unanticipated issues, 22, 34, 81, 161-163
p.000207: Undue influence, 28-29
p.000207:
p.000207: V
p.000207: Vulnerability, 9, 10, 23, 47, 52, 116, 137, 148
p.000207:
p.000207: W
p.000207: Welfare (see Concern for Welfare)
p.000207: Withdrawal
p.000207: of consent, 28-30, 31
p.000207: of data, 28-30, 31
p.000207: of human biological materials, 28-30, 31, 172
p.000207: from research, 28-30, 31, 61, 140, 186
p.000207: Women
p.000207: as research participants, 10, 47, 48-49, 116, 178-179 pregnant, inclusion in research, 49
p.000207:
p.000207:
p.000207:
p.000207:
p.000207:
p.000207:
p.000207: TCPS 2
p.000209: 209
p.000209:
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p.000199: informed about the views of the organization re- garding the research, if these are known. Researchers shall inform
p.000199: participants when the permission of the organization has not been obtained. Researchers engaging in critical inquiry
p.000199: need to be attentive to risks, both of stigmatization or breach of pri- vacy, to those who participate in research
p.000199: about their organization. In particular, prospective participants should be fully informed of the possible consequences
p.000199: of participation.
p.000199: REBs should, however, legitimately concern themselves with the welfare of participants and the security of research
p.000199: materials in such circumstances. When participants are vul- nerable to risks from third parties (e.g., authoritarian
p.000199: regimes, gang leaders, employers) on account of their involvement in research, researchers should ensure that copies of
p.000199: field materials are kept in secure locations. When sharing research materials such as consent forms or transcripts of
p.000199: field notes with participants, researchers must honour their commitment to protect the anonymity and confidentiality of
p.000199: participants to ensure that their human rights, and the ethical principles set out in this Policy, are not compro-
p.000199: mised. In general, regardless of where the researchers conduct their research, researchers and REBs should
p.000199: concern themselves with safeguarding information while it is in transit (see Articles 5.1 to 5.4).
p.000199: REBs should also be aware that some research, involving critical assessments of public, political or corporate
p.000199: institutions and associated public figures, for example, may be legitimately critical and/or opposed to the welfare of
p.000199: those individuals in a position of power, and may cause them some harm. There may be a compelling public interest in
p.000199: this research. Therefore, it should not be blocked through the use of risk-benefit analysis. Such research should be
p.000199: carried out according to the pro- fessional standards of the relevant discipline(s) or field(s) of research. Where an
p.000199: individual in a position of power is invited to be interviewed or gives access to pri- vate papers and thus becomes a
p.000199: participant as defined by this Policy, Article 3.2 applies (see also Article 3.12, Article 9.7 and Article 10.2). In
p.000199: such cases, the bal- ance of risks to those who are the object of the research is mainly considered along with the
p.000199: potential benefit of new knowledge to society and the indirect benefits to the population affected by the public,
p.000199: political or corporate institutions to which the participant belongs.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: 36 TCPS 2
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: B. Departures from General Principles of Consent
p.000199: Alteration of Consent in Minimal Risk Research
p.000199: Article 3.7 The REB may approve research without requiring that the researcher obtain the participant’s consent in
p.000199: accordance with Articles 3.1 to 3.5 where the REB is sat- isfied, and documents, that all of the following apply:
p.000199:
p.000199: (a) the research involves no more than minimal risk to the participants;
p.000199: (b) the lack of the participant’s consent is unlikely to adversely affect the welfare of the participant;
p.000199: (c) it is impossible or impracticable to carry out the research and to answer the research question properly, given
p.000199: the research design, if the prior consent of the participant is required;
p.000199: (d) whenever possible and appropriate, after participation, or at a later time during the study, participants will
p.000199: be debriefed and provided with additional pertinent information in accordance with Articles 3.2 and 3.4, at which point
...
p.000111: Albert, Saskatchewan.
p.000111: • First Nations in the district, represented by their tribal council, the local Métis association, and urban
p.000111: Aboriginal and women’s organizations may partner with the Prince Albert city council to sponsor, implement and use the
p.000111: results of the housing study.
p.000111: 3) Research focusing on a larger community that is known to include Aboriginal people (regardless of their
p.000111: proportion), and where Aboriginal-specific conclusions are anticipated. For example, a study of student retention
p.000111: in high schools in the Sault Ste. Marie district of Ontario.
p.000111: • A committee representing First Nations, Métis organizations and urban Aboriginal people whose children may
p.000111: be affected by the study may be convened to advise the District Board of Education and the researchers involved.
p.000111: 4) Research involving Aboriginal people who comprise a sizeable proportion of the larger community that is the
p.000111: subject of research even if no Aboriginal- specific conclusions will be made. For example, research on
p.000111: employment
p.000111:
p.000111: 112 TCPS 2
p.000111:
p.000111: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000111:
p.000111: development programs serving residents of the inner city of Winnipeg in Manitoba.
p.000111: • Aboriginal service agencies or political organizations may be engaged to help recruit Aboriginal participants and
p.000111: secure community representation on an oversight committee, and to ensure cultural sensitivity in collecting and
p.000111: interpreting data on employment program impacts.
p.000111: 5) Interviewing a sample of individuals of Aboriginal ancestry across Canada on the impact of a policy on their
p.000111: lives, where the results are not attributable to, or likely to affect, the community or communities with which they may
p.000111: identify. For example, survey research on the implementation of Indian Act provisions requiring ministerial approval of
p.000111: an “Indian’s” will.
p.000111: • First Nations, Inuit and Métis persons, whether or not they identify as members of an Aboriginal
p.000111: community, enjoy freedom of expression as does any citizen. They are free to consent and to participate in research
p.000111: projects that they consider to be of personal or social benefit. If the project is unlikely to affect the welfare
p.000111: of the individuals’ communities, local community engagement is not required under this Policy. The necessity or
p.000111: desirability of engaging regional or national representatives of Aboriginal communities in policy research may,
p.000111: however, be determined by other considerations.
p.000111: 6) Natural sciences research on First Nations, Inuit or Métis lands where Aboriginal people may act as
p.000111: co-investigators, or benefit from findings. For example, research focusing exclusively on contaminants in animals or
p.000111: plants in Nunavik that does not make inferences regarding food intake.
...
p.000113: Research involving multiple geographic communities raises complex issues of review and approval. Regional bodies
p.000113: or national organizations may facilitate research ethics review and make recommendations, but the decision to
p.000113: participate normally rests with the local communities.
p.000113: Engagement with formal leadership is not a substitute for seeking consent from individual participants, as required by
p.000113: Chapter 3.
p.000113:
p.000113:
p.000113: 114 TCPS 2
p.000113:
p.000113: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000113:
p.000113: Engagement with Organizations and Communities of Interest
p.000113: Article 9.4 For the purposes of community engagement and collaboration in research undertakings,
p.000113: researchers and REBs shall recognize Aboriginal organizations, including First Nations, Inuit and Métis
p.000113: representative bodies, and service organizations and communities of interest, as communities. They shall
p.000113: also recognize these groups through representation of their members on ethical review and oversight of projects, where
p.000113: appropriate.
p.000113: Application Organizational communities and communities of interest may exist within the boundaries of territorial
p.000113: communities. Overlapping interests in these cases are considered in Articles 9.5 and 9.6. A majority of persons who
p.000113: self-identify as Aboriginal live in rural and urban communities outside of discrete First Nations, Métis or Inuit
p.000113: communities. Political organizations, friendship centres, housing associations, health access centres and other groups
p.000113: operating in rural or urban centres have been created to enhance the welfare of their own members or the populations
p.000113: that they serve. Organizations and communities of interest are potential partners in research on issues relevant
p.000113: to their communities, and are to be recognized as communities for the purposes of community engagement under this
p.000113: Policy.
p.000113: An organization may participate in research focusing on its members (e.g., the board and staff of a friendship centre),
p.000113: or it may facilitate ethical engagement with the population that it serves (e.g., the clientele of a health
p.000113: access centre). A community of interest (e.g., Aboriginal youth who use an urban service program) may designate a
p.000113: local organization to provide advice and ethical protection for a project in which they participate.
p.000113: Prospective participants may not necessarily recognize organizational communities or communities of interest as
p.000113: representing their interests. Where researchers and organizational communities or communities of interest collaborate
p.000113: in research (e.g., through a research agreement), prospective participants shall be informed about the extent of such
p.000113: collaboration (including how data will be shared) as part of the initial and ongoing consent process (see Article
p.000113: 3.2[i]).
p.000113: Complex Authority Structures
p.000113: Article 9.5 Where alternatives to securing the agreement of formal leadership are proposed for research on First
p.000113: Nations, Inuit or Métis lands or in organizational communities, researchers should engage community processes and
p.000113: document measures taken, to enable the REB to review the proposal with due consideration of complex
p.000113: community authority structures.
p.000113: Application Researchers and REBs should not assume that approval of a project by formal leaders is the only avenue
p.000113: for endorsing a project. In some communities and some domains of knowledge, authority to permit and monitor
p.000113: research rests with knowledge keepers designated by custom rather than by election or appointment.
p.000113:
p.000113:
p.000113:
p.000113: TCPS 2
p.000115: 115
p.000115:
p.000115: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000115:
p.000115: In First Nations settings, a confederacy council spanning several communities may be recognized as having authority
p.000115: over its members’ traditional knowledge. In an Inuit community, the hamlet council, an Elders’ circle, and a hunters
p.000115: and trappers organization may have overlapping responsibility and expertise with respect to the knowledge being sought.
p.000115: Métis Elders dedicated to conserving Michif language may assert their autonomy from political leaders, but choose to
p.000115: collaborate with educational or cultural agencies (see also Article 9.15).
p.000115: The preferred course is to secure approval for research from both formal leaders of a community and customary
p.000115: authority. This is especially important for outsiders to communities, whose presence or intentions might be challenged
p.000115: as inappropriate. Researchers should engage community processes, including the guidance of moral authorities such as
p.000115: Elders, to avert potential conflict. These measures should be documented to assist the REB in considering the community
p.000115: engagement processes proposed (see Article 9.10). Where no agreement exists between formal community leadership and
p.000115: customary authority regarding the conduct of the proposed research, researchers should inform the REB. When alternative
p.000115: community engagement processes are followed to endorse a project, all other ethical safeguards set out in this chapter
p.000115: remain applicable.
p.000115: Recognizing Diverse Interests within Communities
p.000115: Article 9.6 In engaging territorial or organizational communities, researchers should ensure, to the extent
p.000115: possible, that they take into consideration the views of all relevant sectors – including individuals and subgroups who
p.000115: may not have a voice in the formal leadership. Groups or individuals whose circumstances make them vulnerable
p.000115: may need or desire special measures to ensure their safety in the context of a specific research project. Those who
...
p.000131: Aboriginal Health Organization and Inuit Tapiriit Kanatami, Research and Research Ethics Fact Sheets.
p.000131: www.naho.ca/inuit/e/ethics/factsheets.php
p.000131: • Royal Commission on Aboriginal Peoples. Report of the Royal Commission on Aboriginal Peoples. “Ethical Guidelines
p.000131: for Research.” In Volume 5, Renewal: A Twenty-Year Commitment, Ottawa: Canada Communications Group. 1996. It can also
p.000131: be accessed at www.ainc-inac.gc.ca/ap/rrc-eng.asp
p.000131: • United Nations Educational, Scientific and Cultural Organization. Universal Declaration on Bioethics and Human
p.000131: Rights. Adopted October 19, 2005, by the 33rd session of the General Conference of UNESCO. 2005.
p.000131: http://unesdoc.unesco.org/images/0014/001461/146180e.pdf
p.000131: • United Nations. Convention on Biological Diversity. 1992. www.cbd.int/convention/convention.shtml
p.000131:
p.000131:
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p.000131:
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p.000131:
p.000131: TCPS 2
p.000133: 133
p.000133:
p.000133:
p.000133:
p.000133: Chapter 10
p.000133: QUALITATIVE RESEARCH
p.000133:
p.000133: Introduction
p.000133: Researchers in social sciences and humanities – such as anthropology, sociology, philosophy, psychology, criminology,
p.000133: business administration, political science, communications, education and history – have a common belief in the
p.000133: desirability of trying to understand human action through systematic study and analysis. Some researchers use
p.000133: quantitative research approaches, others opt for qualitative research methods, and some use a combination of both.
p.000133: Qualitative research has a long history in many established disciplines in the social sciences and humanities, as well
p.000133: as many areas in the health sciences (e.g., nursing, occupational therapy). The use of qualitative approaches is
p.000133: increasing, whether in health research or in social sciences and humanities disciplines. Within specific disciplines,
p.000133: ethics guidelines have been created to address the issues inherent in the use of, for example, particular methods,
p.000133: technologies and settings. Qualitative research approaches are inherently dynamic and may be grounded in
p.000133: different assumptions than those that shape quantitative research approaches. Many of the research practices and
p.000133: methodological requirements that characterize qualitative research approaches parallel those that characterize
p.000133: quantitative approaches such as concerns regarding research quality. However, as is the case with all research
p.000133: involving humans, the criteria are adapted to the specific subject matter, context and epistemological assumptions
p.000133: about the nature of knowledge in the specific area of research of the specific project.
p.000133: This chapter seeks to provide specific guidance on some issues that are particularly germane to qualitative research,
...
p.000135: time of the initial consent discussion, researchers inform prospective participants about the confidentiality of the
p.000135: data and discuss the expectations of participants (see Articles 3.2 and 5.2).
p.000135: (f) Research Goals and Objectives: The aims of qualitative research are very diverse, both within and across
p.000135: disciplines. The intended goals of qualitative projects may include “giving voice” to a particular population, engaging
p.000135: in research that is critical of settings and systems, or the power of those being studied, affecting change in a
p.000135: particular social environment, or exploring previously understudied phenomena to develop new theoretical approaches to
p.000135: research.
p.000135: (g) Dynamic, Negotiated and Ongoing Consent Process: Entry into a particular setting for research purposes sometimes
p.000135: requires negotiation with the population of interest; sometimes the researcher cannot ascertain the process in
p.000135: advance of the research, in part because the relevant contexts within which the research occurs evolve over time.
p.000135:
p.000135:
p.000135:
p.000135:
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p.000137: 137
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p.000137: Chapter 10 – Qualitative Research
p.000137:
p.000137: In some cases, participants hold equal or greater power in the researcher-participant rela- tionship, such as in
p.000137: community-based and/or organizational research when a collaborative process is used to define and design the research
p.000137: project and questions, or where partici- pants are public figures or hold other positions of power (e.g., research
p.000137: involving economic, social, political or cultural elites). In other cases, researchers themselves may hold greater
p.000137: power when access to prospective participant populations is gained through gatekeepers with whom the researcher has
p.000137: established a relationship (e.g., when a researcher engages with the police to do research in relation to a problem
p.000137: population, or when researchers en- gage with prison authorities to do research with offenders).
p.000137: (h) Research Partnerships: Access to particular settings and populations is sometimes developed over time, and
p.000137: the relationships that are formed may well exist outside the research setting per se, which sometimes makes it
p.000137: difficult to determine exactly where the “research” relationship begins and ends. In many cases, despite
p.000137: in-depth, advance preparation, a researcher may not know until the actual data collecting starts just where the search
p.000137: will lead. Indeed, the emergent nature of many qualitative studies makes the achievement of rapport with participants
p.000137: and feelings of interpersonal trust crucial to the generation of questions considered important or interesting by both
p.000137: parties, and to the collection of dependable data. Research often becomes a collaborative process negotiated between
p.000137: the participant(s) and the researcher, requiring considerable time spent initially simply figuring out the focus of the
p.000137: research.
p.000137: In certain cases, contacts between researchers and participants can extend over a lifetime, and these individuals may
...
p.000139: The consent process should be based on mutual understanding of the project goals and objectives between the
p.000139: participants and the researcher. The participant may perceive attempts to legalize or formalize the process as a
p.000139: violation of that trust. Qualitative researchers use a range of procedures to seek and document consent, including oral
p.000139: consent documented in field notes, and other forms of recording (a consent log, audio or video recordings, or other
p.000139: electronic means) Evidence of consent may also be documented via completed questionnaires (in person, by mail, or by
p.000139: email or other electronic means).
p.000139: REBs may need to consider the power relationship that might exist between researchers and participants, and
p.000139: whether a waiver of the requirement for signed written consent may affect the welfare of the participants. In cases
p.000139: where the participant holds a position of power, or routinely engages in communicative interactions similar
p.000139: to those involved in the research by virtue of their position or profession (e.g., a communications officer or
p.000139: spokesperson for an organization), consent can be inferred by the participant’s agreeing to interact with the
p.000139: researcher for the purpose of the research. For example, some political science research focuses on power
p.000139: structures and individuals in positions of power (e.g., a senior partner in a law firm, a cabinet minister or a senior
p.000139: corporate officer). In this type of research, where a prospective participant agrees to be interviewed on the basis of
p.000139: sufficient information provided by the researcher, it may be sufficient for the participant to signify consent to
p.000139: participate in the research. The researcher should record this in an appropriate way. Researchers shall demonstrate to
p.000139: the REB that the participant will be informed about the research including the option not to participate, or to
p.000139: withdraw from the study at any time. Nothing in this article should be interpreted to mean that prospective
p.000139: participants need not be informed about the study prior to their participation.
p.000139: Researchers and REBs should consult Chapter 3, and Articles 3.1, 3.2, 3.3 and 3.12 in particular, for additional
p.000139: details and considerations on consent, and how to document consent.
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139: 140 TCPS 2
p.000139:
p.000139: Chapter 10 – Qualitative Research
p.000139:
p.000139: Observational Studies
p.000139: In qualitative research, observation is used to study behaviour in a natural environment. It often takes
p.000139: place in living, natural and complex communities or settings, in physical environments, or in virtual settings.
...
p.000141: example, a photograph taken in a public place, but focused on a private individual who was not expecting this
p.000141: action – may be interpreted in a civil suit as an invasion of privacy.
p.000141:
p.000141: Privacy and Confidentiality in the Dissemination of Research Results
p.000141: Article 10.4 In some research contexts, the researcher may plan to disclose the identity of participants. In such
p.000141: projects, researchers shall discuss with prospective participants or participants whether they wish to have their
p.000141: identity disclosed in publications or other means of dissemination. Where participants consent to have their identity
p.000141: disclosed, researchers shall record each participant’s consent.
p.000141: Application In some types of qualitative research (e.g., oral history, a biographical study or a study involving
p.000141: specific personalities) respect for the participant’s contribution is shown by identifying the individual in research
p.000141: publications, or other means of dissemination of the results from the research. For instance, in an interview study
p.000141: with visual artists concerning some aspect of the way they work, it might be appropriate and respectful
p.000141: to identify the respondents. If failing to identify participants would be unethical because of any disrespect it
p.000141: would represent, or if informed participants assert their desire to be named, then researchers should do so, according
p.000141: to the practices of their discipline. For example, social historians seek to document and archive the lives of
p.000141: individuals, or highlight the contributions that ordinary people make in social and political life. In oral history,
p.000141: anonymity is the exception. Researchers make the option for anonymity known to participants as part of the discussion
p.000141: around the nature and conditions of their consent.
p.000141: In some types of critical inquiry, anonymity would result in individuals in positions of power not being held
p.000141: accountable for their actions, and for how their exercise of power has implications for others. The safeguards for
p.000141: those in the public arena are through public debate and discourse, and through action in the courts for libel.
p.000141: In much other social science and some humanities research, it is primarily the harm that can result from violations of
p.000141: confidentiality that REBs and researchers need to address. This can pose a particular challenge in qualitative research
p.000141: because of
p.000141:
p.000141:
p.000141:
p.000141:
p.000141: TCPS 2
p.000143: 143
p.000143:
p.000143: Chapter 10 – Qualitative Research
p.000143:
p.000143: the depth, detail, sensitivity and uniqueness of information obtained. The default approach is to maintain
p.000143: confidentiality of the research data. In some instances, participants may waive anonymity (e.g., if they wish to be
p.000143: identified for their contributions to the research). The researcher may accept the waiver of anonymity by the
p.000143: participant as long as such a waiver does not compromise the welfare of other participants (see Article 3.2(f) and the
p.000143: Application of Article 5.1). In some cases, the researcher may decide to maintain the anonymity of the participant in
p.000143: publications or dissemination of research results to ensure confidentiality of the data and anonymity of other
p.000143: participants.
...
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p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
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p.000185:
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p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185: TCPS 2
p.000187: 187
p.000187:
p.000187:
p.000187:
p.000187: Glossary
p.000187:
p.000187: This glossary is intended to assist readers in their understanding of the Tri-Council Policy Statement: Ethical Conduct
p.000187: for Research Involving Humans (TCPS), also referred to as “the Policy.” Definitions that have been provided in the main
p.000187: text of the Policy are also repeated here. Additional terms are defined in accordance with the purposes of the Policy.
p.000187: For more detailed descriptions of many terms it is best to read them in the context of the chapters in which they
p.000187: appear – consult the Index for the appropriate reference.
p.000187:
p.000187: Aboriginal peoples – Persons of Indian (First Nations), Inuit, or Métis descent, regardless of where they reside and
p.000187: whether or not their names appear on an official register. In the international context, the term comparable to
p.000187: Aboriginal peoples is Indigenous peoples.
p.000187:
p.000187: Academic freedom – The collective freedom of faculty and students to conduct research, and to disseminate ideas or
p.000187: facts without religious, political, or institutional restrictions. It includes freedom of inquiry, freedom to challenge
p.000187: conventional thought, freedom to express one’s opinion about the institution, its administration, or the system in
p.000187: which one works, and freedom from institutional censorship.
p.000187:
p.000187: Ad hoc advisor – A person with relevant and competent knowledge and expertise consulted by a research ethics board for
p.000187: a specific research ethics review, and for the duration of that review. The ad hoc advisor is not a member of the
p.000187: research ethics board.
p.000187:
p.000187: Agencies, the – Canada’s three federal research agencies: the Canadian Institutes of Health Research (CIHR); the
p.000187: Natural Sciences and Engineering Research Council of Canada (NSERC); and the Social Sci- ences and Humanities Research
p.000187: Council of Canada (SSHRC).
p.000187:
p.000187: Appeal – A process that allows a researcher to request a review of a research ethics board (REB) decision when, after
p.000187: reconsideration, the REB has refused ethics approval of the research.
p.000187:
p.000187: Appeal mechanism – A procedure established by an institution to promptly handle a researcher’s appeal of a research
p.000187: ethics board (REB) decision. An ad hoc or permanent appeal committee, which reflects a range of expertise and knowledge
p.000187: similar to that of the REB, is established or appointed by the same authority that established the REB.
p.000187:
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p.000105: collective interests. In light of the diversity within and among First Nations, Inuit and Métis communities,
p.000105: and the ongoing development of community codes of research practice by these communities at the local, regional and
p.000105: national level, ethical review of a proposed project shall be attentive to the specific context of the project and the
p.000105: community involved (see Articles 9.8 and 9.9).
p.000105:
p.000105: A. Key Concepts and Definitions
p.000105: Definitions of key concepts used in this chapter are provided to assist in applying the guidance in this Policy (see
p.000105: Chapter 1 regarding the scope of definitions used in this Policy) and to facilitate dialogue between researchers and
p.000105: Aboriginal communities. Since there is not universal agreement on the meaning of some terms, the definitions provided
p.000105: are intended for the purposes of this Policy only. This terminology will require periodic revision, particularly in
p.000105: light of the ongoing debate on the terms of art used in international and domestic contexts. This is in
p.000105: keeping with a commitment to the continued evolution of this Policy.
p.000105: • Aboriginal peoples – include persons of Indian, Inuit or Métis descent regardless of where they reside and
p.000105: whether or not their names appear on an official register. The term “Aboriginal” fails to reflect the
p.000105: distinctions among First Nations, Inuit and Métis peoples, who have their own histories, cultures and languages, so an
p.000105: attempt has been made to limit use of the term in this Policy to instances where a global term is appropriate. Indian
p.000105: peoples commonly identify themselves by distinct nation names such as Mi’kmaq, Dene or Haida, and as First Nations. In
p.000105: the international context, the term comparable to Aboriginal peoples is Indigenous peoples.
p.000105: • Community – describes a collectivity with shared identity or interests, that has the capacity to act or express
p.000105: itself as a collective. In this Policy, a community may include members from multiple cultural groups. A community may
p.000105: be territorial, organizational or a com- munity of interest. “Territorial communities” have governing bodies exercising
p.000105: local or regional jurisdiction (e.g., members of a First Nations resident on reserve lands). “Organi- zational
p.000105: communities” have explicit mandates and formal leadership (e.g., a regional Inuit association or a friendship centre
p.000105: serving an urban Aboriginal community). In both terri- torial and organizational communities, membership is defined and
p.000105: the community has designated leaders. “Communities of interest” may be formed by individuals or organiza- tions who
p.000105: come together for a common purpose or undertaking, such as a commitment to conserving a First Nations language.
p.000105: Communities of interest are informal communities
p.000105:
p.000105:
p.000105:
p.000105:
p.000105: TCPS 2
p.000107: 107
p.000107:
p.000107: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000107:
p.000107: whose boundaries and leadership may be fluid and less well-defined. They may exist tem- porarily or over the long term,
p.000107: within or outside of territorial or organizational communities.
...
p.000115: research relationships reflecting Aboriginal ways of knowing.
p.000115: Respect for Community Customs and Codes of Practice
p.000115: Article 9.8 Researchers have an obligation to become informed about, and to respect, the relevant customs and
p.000115: codes of research practice that apply in the particular community or communities affected by their research.
p.000115: Inconsistencies between community custom and this Policy should be identified and addressed in advance of initiating
p.000115: the research, or as they arise.
p.000115:
p.000115:
p.000115: TCPS 2
p.000117: 117
p.000117:
p.000117: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000117:
p.000117: Application First Nations, Inuit and Métis codes of research practice derive from procedures and customs of
p.000117: predominantly oral cultures. While some rules may be in written form, their interpretation is dependent on experiential
p.000117: knowledge acquired through interactions in the community. An example is the strict limitation on making
p.000117: publicly available sacred knowledge that might be revealed within a trusting relationship. In academic
p.000117: culture, rules regarding limits on disclosure of information would reasonably be incorporated into a research
p.000117: proposal, and should be integrated into research agreements between communities and researchers where such exists.
p.000117: The absence, or perceived absence, of a formal local research code or guidelines does not relieve the researcher of the
p.000117: obligation to seek community engagement in order to identify local customs and codes of research practice.
p.000117: First Nation, Inuit and Métis customs and codes of behaviour distinguish among knowledge that can be publicly
p.000117: disclosed, disclosed to a specific audience, or disclosed under certain conditions. Determination of what information
p.000117: may be shared, and with whom, will depend on the culture of the community involved. Any restrictions on access to, or
p.000117: use of, traditional or sacred knowledge shared in the course of the research project should be addressed in the
p.000117: research agreement.
p.000117: In Aboriginal communities, custom may restrict the observation, recording, or reporting of ceremonies or certain
p.000117: performances, and require approval of appropriate individuals. Article 10.3 addresses the requirement for ethics
p.000117: review of research involving observational studies, and associated ethical implications, which may include infringement
p.000117: on consent and privacy.
p.000117: Many First Nations communities across Canada have adopted an ethics code originally developed to govern
p.000117: practice in the First Nations Regional Longitudinal Health Survey. The code asserts ownership of, control of, access
p.000117: to, and possession (OCAP) of research processes affecting participant communities, and the resulting data. OCAP
p.000117: addresses issues of privacy, intellectual property, data custody and secondary use of data, which are also covered
p.000117: later in this chapter.
p.000117: Inuit communities and organizations are considering addressing similar concerns, including adoption or adaptation of
...
p.000125: accommodate in the programs of students. Mentorship by experienced researchers who introduce students to
p.000125: communities and monitor their ethical practice can facilitate the trust- building process and advance student progress.
p.000125: Recognition of the Role of Elders and Other Knowledge Holders
p.000125: Article 9.15 Researchers should engage the community in identifying Elders or other recognized knowledge holders to
p.000125: participate in the design and execution of research, and the interpretation of findings in the context of cultural
p.000125: norms and traditional knowledge. Community advice should also be sought to determine appropriate recognition for the
p.000125: unique advisory role fulfilled by these persons.
p.000125: Application Within First Nations, Inuit and Métis communities, persons with special gifts carry varied roles and
p.000125: responsibilities in conserving and transmitting traditional knowledge and expressions of culture. They often are
p.000125: fluent in their traditional language. They model respectful relationships and may conduct ceremonies, pass on oral
p.000125: history, and offer guidance in community affairs. Their gifts are normally refined over a lifetime. Thus, Elders who
p.000125: have followed a rigorous path of learning over a long period are highly respected. Younger persons may also gain
p.000125: recognition as gifted knowledge holders.
p.000125: High regard by the community that knows the Elder or other knowledge holder is the most reliable indicator of an
p.000125: individual’s authority. Each community or nation has particular ways of approaching Elders or knowledge holders
p.000125: respectfully. In many First Nations this involves the presentation and acceptance of tobacco to symbolize entering into
p.000125: a relationship. In some communities, feasting or gift-giving is appropriate.
p.000125: Elders are now being recognized in research proposals and grant applications as providers of access to community
p.000125: networks, ethical guidance to researchers, and advice in interpreting findings in the context of traditional knowledge
p.000125: (see Article 9.17). Researchers should seek advice from the community and the Elders regarding the appropriate
p.000125: recognition of the contribution of Elders and knowledge holders, which may include providing honoraria, acknowledging
p.000125: contributions by name or, as directed, withholding the Elder’s identity in reports and publications.
p.000125: Privacy and Confidentiality
p.000125: Article 9.16 Researchers and community partners shall address privacy and confidentiality for communities and
p.000125: individuals early on in the community engagement process. The extent to which limited or full disclosure of personal
p.000125: information related to the research is to be disclosed to community partners shall be addressed in research
p.000125:
p.000125:
p.000125:
p.000125: 126 TCPS 2
p.000125:
p.000125: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000125:
p.000125: agreements where these exist. Researchers shall not disclose personal information to community partners without the
p.000125: participant’s consent, as set out in Article 3.2(i).
...
p.000129: collect additional information from identified communities or individuals, REB review is required. The provisions set
p.000129: out in Article 5.6 apply for new initiatives of this kind.
p.000129: Article 9.22 REB review is required where the researcher seeks data linkage of two or more anonymous datasets or
p.000129: data associated with human biological materials and there
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129: TCPS 2
p.000131: 131
p.000131:
p.000131: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000131:
p.000131: is a reasonable prospect that this could generate information identifiable as originating from a specific
p.000131: Aboriginal community or a segment of the Aboriginal community at large.
p.000131: Application The REB may determine that community engagement is required to seek guidance on secondary use. Articles
p.000131: 5.5 and 5.6 or Articles 12.3 and 12.4 may apply.
p.000131: Consistent with Article 2.4, REB review is not required for research involving only anonymous datasets or anonymous
p.000131: human biological materials, and associated data, that cannot be identified as originating from a specific Aboriginal
p.000131: community or a segment of the Aboriginal community at large. Community engagement is not possible given that the data
p.000131: or human biological materials cannot be linked to a specific Aboriginal community or specific individuals. Where the
p.000131: researcher seeks data linkage of two or more anonymous sets of information or human biological materials and there is a
p.000131: reasonable prospect that this could generate identifiable information, then REB review is required.
p.000131:
p.000131: Endnotes
p.000131:
p.000131:
p.000131: 1 Indian peoples commonly identify themselves as “First Nations.” First Nation: A term that came into common usage in
p.000131: the 1970s to replace the word “Indian,” which some people found offensive. Although the term First Nation is widely
p.000131: used, no legal definition of it exists. Among its uses, the term “First Nations peoples” refers to the Indian peoples
p.000131: in Canada, both Status and non-Status. Some Indian peoples have also adopted the term “First Nation” to replace the
p.000131: word “band” in the name of their community. See Indian and Northern Affairs Canada, Terminology, available at www.ainc-
p.000131: inac.gc.ca/ap/tln-eng.asp.
p.000131: 2 www.nserc-crsng.gc.ca/NSERC-CRSNG/Policies-Politiques/MOURoles-ProtocolRoles/index_eng.asp
p.000131: 3 Constitution Act, 1982, s. 35. http://laws.justice.gc.ca/en/const/9.html#anchorsc:7-bo-ga:l_II
p.000131: 4 www.wipce2008.com/enews/pdf/wipce_fact_sheet_21-10-07.pdf
p.000131:
p.000131: References
p.000131:
p.000131:
p.000131: • Canadian Institutes of Health Research. CIHR Guidelines for Health Research Involving Aboriginal People. May
p.000131: 2007. www.cihr-irsc.gc.ca/e/29134.html
p.000131: • ———. CIHR Best Practices for Protecting Privacy in Health Research. September 2005.
p.000131: www.cihr-irsc.gc.ca/e/29072.html
p.000131: • First Nations Centre. OCAP: Ownership, Control, Access and Possession. Sanctioned by the First Nations
p.000131: Information Governance Committee, Assembly of First Nations. Ottawa: National Aboriginal Health Organization
p.000131: www.naho.ca/english/pub_research.php
p.000131: • First Nations Regional Longitudinal Health Survey (RHS). www.rhs-ers.ca/english
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: 132 TCPS 2
p.000131:
p.000131: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000131:
p.000131: • Interagency Advisory Panel on Research Ethics. Aboriginal Research Ethics Initiative. “Issues and Options for
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p.000199: on the nature of the research being undertaken, and the individuals or group in question. This consideration does not
p.000199: imply, however, that the welfare of a group should be given priority over the welfare of individuals.
p.000199: Justice
p.000199: Justice refers to the obligation to treat people fairly and equitably. Fairness entails treating all peo- ple with
p.000199: equal respect and concern. Equity requires distributing the benefits and burdens of research participation in such a
p.000199: way that no segment of the population is unduly burdened by the harms of research or denied the benefits of the
p.000199: knowledge generated from it.
p.000199: Treating people fairly and equitably does not always mean treating people in the same way. Dif- ferences in treatment
p.000199: or distribution are justified when failures to take differences into account may result in the creation or
p.000199: reinforcement of inequities. One important difference that must be considered for fairness and equity is vulnerability.
p.000199: Vulnerability is often caused by limited capacity, or limited access to social goods, such as rights, opportunities and
p.000199: power. Individuals or groups in vulnerable circumstances have historically included children, the elderly, women,
p.000199: prisoners, those with mental health issues and those with diminished capacity for self-determination. Ethno- cultural
p.000199: minorities and those who are institutionalized are other examples of groups who have, at times, been treated unfairly
p.000199: and inequitably in research, or have been excluded from research op- portunities. People or groups whose circumstances
p.000199: cause them to be vulnerable or marginalized may need to be afforded special attention in order to be treated justly in
p.000199: research.
p.000199:
p.000199:
p.000199:
p.000199: 10 TCPS 2
p.000199:
p.000199: Chapter 1 – Ethics Framework
p.000199:
p.000199: The recruitment process, both of participants who may become directly involved in research and those who participate as
p.000199: the source of information or biological materials to be used in research, is an important component of the fair and
p.000199: equitable conduct of research. Participation should be based on inclusion criteria that are justified by the research
p.000199: question. Inequity is created when par- ticular groups fail to receive fair benefits of research or when
p.000199: groups, or their data or their biological materials, are excluded from research arbitrarily or for reasons
p.000199: unrelated to the research question.
p.000199: An important threat to Justice is the imbalance of power that may exist in the relationship between researcher and
p.000199: participant. Participants will generally not understand the research in the same way and in the same depth as does the
p.000199: researcher. Historically, there have been instances in which this power imbalance has been abused, with resulting harm
p.000199: to participants.
p.000199: The Core Principles – Conclusion
p.000199: The importance of research and the need to ensure the ethical conduct of research requires both researchers and REB
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p.000199: application of the articles and principles to particular circumstances will always be a part of the exercise. The
p.000199: articles in this Policy are intended to provide guidance, and in some cases, to set out certain requirements. The
p.000199: application sections are intended to supplement the articles with further explanation and examples. Although they
p.000199: cannot guarantee identical decisions across REBs, they can ensure that researchers and REBs employing this Policy are
p.000199: operating within the same parameters and taking into account the same considerations as they design and evaluate
p.000199: research involving humans.
p.000199: At the end of some chapters, a section entitled “References” provides links to documents that contain further guidance
p.000199: on specific topics addressed in the chapter. These references are not meant to be exhaustive, but are offered to assist
p.000199: the reader who wishes to explore certain topics in greater detail.
p.000199: This Policy will continue to evolve in response to the emerging needs and suggestions of all those whom this Policy is
p.000199: intended to serve, including the research community, participants and the public.
p.000199: Definitions
p.000199: The definitions provided in this Policy are intended specifically and solely for the purposes of this Policy.
p.000199: Endnote
p.000199:
p.000199:
p.000199: 1 The three core principles incorporate within them the eight guiding ethical principles set out in the 1998 TCPS.
p.000199: Respect for Human Dignity is expressed through the three core principles. Respect for Free and Informed Consent and
p.000199: Respect for Vulnerable Persons are both reflected in the principle of Respect for Persons, while Respect for Vulnerable
p.000199: Persons is also reflected in the principle of Justice. Respect for Privacy and Confidentiality is an element of Concern
p.000199: for Welfare. Respect for Justice and Inclusiveness is covered in the core principle of Justice. Balancing Harms and
p.000199: Benefits, Minimizing Harm and Maximizing Benefit are, in fact, not principles, but are the means by which the principle
p.000199: of Concern for Welfare is put into effect. Each of these elements is addressed in greater detail in a chapter or
p.000199: section of this Policy.
p.000199:
p.000199: By using these broader and more encompassing core principles, this Policy seeks to provide a more focused framework for
p.000199: the ethical guidance that follows. It is also a framework that harmonizes with other national and international ethics
p.000199: policies.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 13
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: Introduction
p.000199: Chapter 2
p.000199: SCOPE AND APPROACH
p.000199: The purpose of this Policy, as set out in Chapter 1, is to establish principles to guide the design, ethical conduct
p.000199: and ethics review process of research involving humans. This chapter outlines the scope of application of the Policy
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p.000199: probability may be based on the researcher’s past experience conducting such studies, the review of existing
p.000199: publications that provide rates of the relevant harms in similar issues, or on other empirical evidence. And while
p.000199: researchers should attempt to estimate the occurrence of the relevant harms, this may be more difficult, or not
p.000199: possible, for new or emerging areas of research where no prior experience, comparable research or publications exist.
p.000199: Certain accepted research paradigms bring inherent limitations to the prior identification of risk. For example, when
p.000199: research in the social sciences employs emergent design, the manner in which the research project will proceed and any
p.000199: associated risks may be known only as it unfolds (see Chapters 3 and 10).
p.000199: Minimal Risk
p.000199: Minimal risk research that falls within the scope of this Policy requires REB review. It is generally eligible for
p.000199: delegated review – described in Article 6.12.
p.000199: For the purposes of this Policy, “minimal risk” research is defined as research in which the probability and magnitude
p.000199: of possible harms implied by participation in the research is no greater than those encountered by participants in
p.000199: those aspects of their everyday life that relate to the research.
p.000199: In their assessment of the acceptable threshold of minimal risk, REBs have special ethical obligations to
p.000199: individuals or groups whose situation or circumstances make them vulnerable in the context of a specific research
p.000199: project, and to those who live with relatively high levels of risk on a daily basis. Their inclusion in research should
p.000199: not exacerbate their vulnerability (see Article 4.7).
p.000199:
p.000199:
p.000199:
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p.000199: TCPS 2 23
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
p.000199: Balancing Risks and Potential Benefits
p.000199: The analysis, balance, and distribution of risks and potential benefits are critical to the ethics of research
p.000199: involving humans. The principle of Concern for Welfare imposes an ethical obligation to design, assess and conduct
p.000199: research in a way that protects participants from any unnecessary or avoidable risks. In their review, REBs should be
p.000199: concerned with an assessment that the potential research outcomes and potential benefits merit the risks.
p.000199: Risks and potential benefits may be perceived differently by different individuals and groups in society. Researchers
p.000199: and REBs should take this into account in designing and reviewing research. They should also recognize that researchers
p.000199: and participants may not always see the risks and potential benefits of a research project in the same way. In
p.000199: assessing risks and potential benefits for specific populations, researchers and REBs should understand the role of the
p.000199: culture, values and beliefs of the populations to be studied. In this regard REBs may consult ad hoc advisors as
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p.000199: needs of the participants, and be conducted under criteria designated by the REB.
p.000199: It is unethical to expose participants to any additional risk without their consent if standard efficacious care
p.000199: exists, unless it can clearly be shown that there is a realistic possibility of meaningful improvement of the
p.000199: participant’s condition. Accordingly, paragraphs (b) and (c) of Article 3.8 indicate that researchers and REBs must
p.000199: assess the risks and potential benefits of proposed research against existing standard efficacious care.
p.000199: To respect the autonomy of the participant, Article 3.8(e) requires researchers to undertake diligent efforts to
p.000199: contact authorized third parties, if reasonably feasible, and to document such efforts for the benefit of both
p.000199: the participant and the continuing ethics review functions of the REB. The article also requires that
p.000199: participants who regain capacity be promptly afforded the opportunity to consent to their continued participation.
p.000199: Concern for the patient’s welfare is paramount and should be informed by ethical and professional judgment.
p.000199: Because their incapacity to exercise consent makes them vulnerable, prospective participants for emergency research
p.000199: are owed special ethical obligations and protection commensurate with the risks involved. Their welfare should be
p.000199: protected by additional safeguards, where feasible and appropriate. These might include: additional scientific,
p.000199: medical or REB consultation; procedures to identify prospective participants in advance so that consent may be
p.000199: sought prior to the occurrence of the emergency situation; consultation with former and prospective participants; and
p.000199: special monitoring procedures to be followed by data safety and monitoring boards.
p.000199: C. Capacity
p.000199: Capacity refers to the ability of prospective or actual participants to understand relevant information
p.000199: presented about a research project, and to appreciate the potential consequences of their decision to participate or
p.000199: not participate. This ability may vary according to the complexity of the choice being made, the circumstances
p.000199: surrounding the decision, or the point in time at which consent is sought. The determination of capacity to participate
p.000199: in research, then, is not a static determination. It is a process that may change over time, depending on the nature of
p.000199: the decision the prospective participant needs to make, and on any changes in the participant’s condition. Assessing
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p.000199:
p.000199: One may therefore have diminished capacity but still be able to decide whether to participate in certain types of
p.000199: research. Researchers should be aware of all applicable legal and regulatory requirements with respect to capacity.
p.000199: These may vary among jurisdictions. Authorized third parties who are asked to make a consent decision on behalf of a
p.000199: prospective participant should also be aware of their legal responsibilities.
p.000199: In keeping with the principle of Justice, those who lack the capacity to consent on their own behalf must neither be
p.000199: unfairly excluded from the potential benefits of research participation, nor may their lack of capacity to consent be
p.000199: used to inappropriately include them in research. REBs and researchers should be aware of these ethical considerations
p.000199: and seek to find a balance between them for the benefit of prospective participants who lack capacity to consent (see
p.000199: Chapter 4).
p.000199: As indicated in Chapter 1, Respect for Persons and Concern for Welfare entails particular ethical obligations to
p.000199: individuals in vulnerable circumstances. Such obligations often translate into special procedures to promote and
p.000199: protect their interests. This may include the development of consent materials that are appropriate to the
p.000199: cognitive and communication abilities of prospective participants. Articles 3.9, 3.10 and 3.11 describe
p.000199: special procedures for research involving individuals who lack the capacity to consent on their own behalf.
p.000199: Article 3.9 For research involving individuals who lack the capacity, either permanently or temporarily, to decide
p.000199: for themselves whether to participate, the REB shall ensure that, as a minimum, the following conditions are met:
p.000199: (a) the researcher involves participants who lack the capacity to consent on their own behalf to the greatest extent
p.000199: possible in the decision-making process;
p.000199: (b) the researcher seeks and maintains consent from authorized third parties in accordance with the best interests of
p.000199: the persons concerned;
p.000199: (c) the authorized third party is not the researcher or any other member of the research team;
p.000199: (d) the researcher demonstrates that the research is being carried out for the participant’s direct benefit,
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p.000199: of the direct burdens of participating in research, nor should they be unfairly excluded from the potential benefits of
p.000199: research participation. Inclusiveness in research and fair distribution of benefits and burdens should be important
p.000199: considerations for researchers, research ethics boards (REBs), research institutions and sponsors. Issues of fair and
p.000199: equitable treatment arise in deciding whether and how to include individuals, groups or communities in research, and
p.000199: the basis for the exclusion of some.
p.000199: This chapter addresses inclusion in research of individuals and groups that might be inappropriately excluded on the
p.000199: basis of attributes such as culture, language, gender, race, ethnicity, age and dis- ability. It provides guidance
p.000199: relevant to inclusion in research of specific groups such as women, children, the elderly and those who lack capacity
p.000199: to consent to participate in research. Historically, these groups have often been inappropriately excluded from
p.000199: research.
p.000199: This chapter also addresses the fair inclusion and equitable treatment of individuals, groups and communities whose
p.000199: situation or circumstances make them vulnerable in the context of a specific research project. These individuals run
p.000199: the risk of being included in research in ways that may be unfair and inequitable. This chapter provides guidance
p.000199: relevant to the equitable distribution of the risks and benefits of research.
p.000199: Over-protectionist attitudes or practices of researchers or REBs, whether intentional or inadvertent, can exclude some
p.000199: members of society from participating in research. The exclusion of individuals, groups or communities may constitute a
p.000199: failure to treat them justly. For example, age has been used to exclude individuals from participation in research,
p.000199: particularly health research (e.g., studies that only accept participants between the ages of 18 to 35). As a result,
p.000199: sufficient research may not be done on groups that fall outside of narrow age criteria. The inclusion of the young and
p.000199: the elderly in research, for example, ensures that treatments frequently given to these populations are effective and
p.000199: safe.
p.000199: Researchers, institutions and REBs all have important roles to play in advancing that societal com- mitment, and
p.000199: ensuring a fair distribution of the benefits and burdens of research. Researchers and REBs must navigate between the
p.000199: dangers of imposing unfair burdens on particular participants, groups and communities, and overprotecting them. In
p.000199: assessing fairness and equity issues in the research ethics process, REBs should not intervene in the choice of
p.000199: research topics.
p.000199:
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p.000199: participants or to a group that is the focus of the research and to which the participants belong.
p.000199: The research design should take into account factors that may affect the capacity of prospective participants to
p.000199: receive information, to consent to the research at some stage, or to participate in it. These factors may be permanent
p.000199: or may vary
p.000199:
p.000199:
p.000199: TCPS 2 51
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p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: over time (e.g., the participant’s capacity to consent may fluctuate over time). Ar- ticles 3.9 and 3.10 in Chapter 3
p.000199: establish other conditions regarding research that involve individuals who lack capacity to consent. This includes the
p.000199: involvement of an authorized third party to consent on their behalf, and adequate provisions to ascertain the wishes of
p.000199: the individuals concerning their participation.
p.000199: Participants’ Vulnerability and Research
p.000199: Article 4.7 Individuals or groups whose circumstances may make them vulnerable in the con- text of research should
p.000199: not be inappropriately included or automatically excluded from participation in research on the basis of their
p.000199: circumstances.
p.000199: Application The core principles of Respect for Persons, Concern for Welfare, and Justice entail special ethical
p.000199: obligations toward individuals or groups whose circumstances may lead to their vulnerability in the context of a
p.000199: specific research project and limit their ability to fully safeguard their own interests. Those who are owed special
p.000199: ethical obligations may include individuals who are institutionalized, those in dependent situations, or those whose
p.000199: circumstances (e.g., poverty or poor health status) may render even modest participation incentives so attractive as to
p.000199: constitute an induce- ment to take risks they would otherwise not take. Their situation may also compromise
p.000199: the voluntariness of consent in other ways. However, individuals should not automatically be considered vulnerable
p.000199: simply because of assumptions made about the vulnerability of the group to which they belong. Their particular
p.000199: circumstances shall be considered in the context of the proposed research project.
p.000199: REBs and researchers shall carefully examine the relationship between the circum- stances of the individuals and groups
p.000199: they aim to recruit, and the proposed research question. They should not presume that these circumstances will
p.000199: automatically re- sult in the inclusion or exclusion of individuals or groups as prospective participants.
p.000199: Participation should be based on inclusion or exclusion criteria that are justified by the research question.
p.000199: Researchers and REBs should recognize and address changes in a participant’s circumstances that may create, heighten,
p.000199: or at- tenuate their vulnerability, and provide special protections or consideration.
p.000199: In general, researchers should be familiar with the cultural, social and economic circumstances of prospective
p.000199: participants, groups or communities. Researchers should anticipate, to the best of their ability, needs of
p.000199: participants, groups and their communities that might arise in any given research project. Especially when groups, and
p.000199: their communities, have a wide range of pressing needs due to their low so- cioeconomic circumstances, these needs can
p.000199: present significant ethical challenges for researchers. An equitable distribution of research benefits (discussed
p.000199: below) can help ensure that individuals, groups and communities whose circumstances may make them vulnerable in the
p.000199: context of research are not inappropriately in- cluded in research based on these circumstances.
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p.000199: Chapter 4 – Fairness and Equity in Research Participation
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p.000199: Equitable Distribution of Research Benefits
p.000199: Researchers should consider ways to ensure the equitable distribution of any benefits of partici- pation in research.
p.000199: Benefits of research participation may be direct, where, for example, an individual participant experiences
p.000199: amelioration of a health condition as a result of an experimental therapy, or learns new information about social
p.000199: issues as a result of participation in a research focus group. In a community hosting research, benefits may take the
p.000199: form of information sharing, training for local personnel, the establishment of health care or similar services.
p.000199: Benefits may be indirect, where the participation in research of an individual or group, or in a research project in-
p.000199: volving a community contributes to the advancement of knowledge that may lead to improved conditions for a group to
p.000199: which the participant belongs. Such knowledge may also inform other communities or society in general.
p.000199: Researchers should also be sensitive to the expectations and opinions of participants regarding potential benefits of
p.000199: the research. Prior to the commencement of the research, researchers should formally or informally discuss these
p.000199: expectations with individuals and/or groups, and outline the scope and nature of potential benefits that may accrue to
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p.000199: An understanding of relevant legal issues and contexts is advisable for all REBs, although for non-biomedical research
p.000199: such insights may be sought from an ad hoc advisor whom the REB consults only for specific research projects. Where
p.000199: REBs review research on complex topics that regularly requires advice on legal issues, they should appoint a member
p.000199: knowledgeable in the relevant law. In some in- stances, the legal issues that may be identified by the REB will
p.000199: necessitate further scrutiny and even formal legal advice by the legal counsel to the institution. Legal liability is a
p.000199: separate issue for institutions to handle through mechanisms other than the REB.
p.000199: Community Member
p.000199: The community member shall not be affiliated with the institution. The community member requirement (Article 6.4[d]) is
p.000199: essential to help broaden the perspective and value base of the REB, and thus advances dialogue with, and
p.000199: accountability to, relevant communities. In addition to a broad-based representation from the com- munity, it is highly
p.000199: desirable that institutions seek to appoint former participants on REBs. Their experience as participants provides the
p.000199: REB with a vital perspective and an important contribution to the research ethics review process. It is advisable that
p.000199: members are not currently engaged in research or legal work as their principal activities.
p.000199: The role of community members on REBs during the ethics review process is unique and at arm’s length from the
p.000199: institution. Their primary role is to reflect the perspective of the participant. This is particularly important when
p.000199: participants are vulnerable and/or risks to participants are high.
p.000199: To maintain effective community representation, the number of community mem- bers should be commensurate with the size
p.000199: of an REB and should increase as the size of an REB increases. Institutions should provide training opportunities to
p.000199: com- munity members (see Article 6.7).
p.000199: Substitute Members
p.000199: Institutions should consider the nomination of substitute REB members so that REBs can continue to function when
p.000199: regular members are unable to attend due to illness or other unforeseen eventualities. The appointment of substitute
p.000199: members
p.000199:
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p.000199: 72 TCPS 2
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p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: should not, however, alter the REB membership composition as set out in this article. Substitute members should have
p.000199: the appropriate knowledge, expertise and training to contribute to the research ethics review process.
p.000199: Ad Hoc Advisors
p.000199: Article 6.5 The REB should have provisions for consulting ad hoc advisors in the event that it lacks the specific
p.000199: expertise or knowledge to review the ethical acceptability of a research proposal competently.
p.000199: Application In the event that the REB is reviewing a project that requires particular community or participant
p.000199: representation or specific disciplinary or methodological expertise not available from its members, it should have
p.000199: provisions for consulting ad hoc ad- visors. Consultation with an ad hoc advisor shall not alter the composition and
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p.000199: efforts
p.000199:
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p.000199: 86 TCPS 2
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p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: and research ethics review processes within and across institutions. REB members may become unavailable (e.g., due to
p.000199: illness, relocation, or quarantine by public authorities). Institutions and REBs should explore the nomination of
p.000199: substitute REB members and consultation with ad hoc advisors with relevant expertise (see Articles
p.000199: 6.4 and 6.5), negotiate reciprocity agreements with other institutions for REB re- views (see Article 8.1), and revisit
p.000199: how scholarly review (see Article 2.7) would be applied in emergency situations.
p.000199: Research ethics review should be commensurate with the necessities occasioned by the emergency because of the
p.000199: critical interplay between public urgencies, essential research and a continuing commitment to the core principles
p.000199: even in the face of acute public necessity. Indeed, research ethics review during publicly declared
p.000199: emergencies is even more important than under normal circumstances, and may require even greater care, since everyone
p.000199: (participants, researchers and REB members themselves) may be rendered more vulnerable by the nature of the emergency.
p.000199: Research Ethics Review Policy and Procedures during Publicly Declared Emergencies Article 6.22 Research ethics
p.000199: policies and procedures for emergencies take effect once an emer-
p.000199: gency has been publicly declared. They should cease to apply as soon as is feasible after the end of the publicly
p.000199: declared emergency.
p.000199: Application Because emergencies present extraordinary public risks that warrant special re- sponses, legislation
p.000199: or public policies usually require that they be officially proclaimed or declared. Research ethics review
p.000199: procedures that have been estab- lished for use during publicly declared emergencies should be applied only after an
p.000199: authorized public official declares a public emergency. These procedures there- fore apply to very narrow, limited and
p.000199: exceptional circumstances. Institutions and REBs must endeavour to return to normal operating procedures as soon as
p.000199: possible after public officials have declared that the emergency is over.
p.000199: Respecting Core Principles: Limiting Exceptions
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p.000199: Endnote
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p.000199: Where exceptions to or infringements of ethics principles and REB procedures are justified, they should be narrowly
p.000199: tailored to address the necessities occasioned by the publicly declared emergency, such that they rely on the most
p.000199: restrictive or least intrusive means necessary to achieve the Policy goal: the promotion and guidance of ethical
p.000199: conduct in research. This approach – consistent with international bioethics and human rights norms – maximizes
p.000199: respect for ethical principles and helps to ensure that exceptions and the means to implement them are not unduly
p.000199: broad, overreaching or unjustifiably invasive.
p.000199: Recognizing and respecting the principle of Justice means that research ethics re- view policies and procedures for
p.000199: publicly declared emergencies shall be used in a manner that is not discriminatory or arbitrary. The commitment to
p.000199: justice advances a fair and balanced distribution of risks and potential benefits even in the face of public
p.000199: emergencies.
p.000199: REBs and researchers should be aware that individuals, prospective participants, researchers, and institutions may not
p.000199: normally be considered vulnerable, but may become so by the very nature of public emergencies. Those already vulnerable
p.000199: may become acutely so (see Article 4.7). The increased public risks and devastation that cause public emergencies to be
p.000199: declared can threaten autonomy and physical, emo- tional, institutional and social welfare or safety. They also bring
p.000199: inherent tensions and pressures that may impact deliberative decision making. Taking all of this into consideration,
p.000199: REBs and researchers should ensure that the risks and potential ben- efits posed by any proposed research are
p.000199: appropriately evaluated, including provisions for greater-than-normal attention to risk, where applicable.
p.000199:
p.000199:
p.000199: 1 Memorandum of Understanding on the Roles and Responsibilities in the Management of Federal Grants and Awards.
p.000199: www.nserc-crsng.gc.ca/NSERC-CRSNG/Policies-Politiques/MOURoles-Protocol- Roles/index_eng.asp
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p.000199: 88 TCPS 2
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p.000199:
p.000199: Introduction
p.000199: Chapter 7
p.000199: CONFLICTS OF INTEREST
p.000199: This chapter addresses ethical issues that can arise when research activities and other activities conflict. A conflict
p.000199: of interest may arise when activities or situations place an individual or insti- tution in a real, potential or
p.000199: perceived conflict between the duties or responsibilities related to research, and personal, institutional or other
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p.000115: collaborate with educational or cultural agencies (see also Article 9.15).
p.000115: The preferred course is to secure approval for research from both formal leaders of a community and customary
p.000115: authority. This is especially important for outsiders to communities, whose presence or intentions might be challenged
p.000115: as inappropriate. Researchers should engage community processes, including the guidance of moral authorities such as
p.000115: Elders, to avert potential conflict. These measures should be documented to assist the REB in considering the community
p.000115: engagement processes proposed (see Article 9.10). Where no agreement exists between formal community leadership and
p.000115: customary authority regarding the conduct of the proposed research, researchers should inform the REB. When alternative
p.000115: community engagement processes are followed to endorse a project, all other ethical safeguards set out in this chapter
p.000115: remain applicable.
p.000115: Recognizing Diverse Interests within Communities
p.000115: Article 9.6 In engaging territorial or organizational communities, researchers should ensure, to the extent
p.000115: possible, that they take into consideration the views of all relevant sectors – including individuals and subgroups who
p.000115: may not have a voice in the formal leadership. Groups or individuals whose circumstances make them vulnerable
p.000115: may need or desire special measures to ensure their safety in the context of a specific research project. Those who
p.000115: have been excluded from participation in the past may need special measures to ensure their inclusion in research.
p.000115: Application Groups or individuals whose circumstances may make them vulnerable or marginalized within
p.000115: territorial or organizational communities should not be deprived of opportunities to participate in, and
p.000115: influence, research affecting their welfare. For example, people living with HIV/AIDS, impoverished youth or
p.000115: women who have suffered abuse may experience barriers to participation.
p.000115: Gender-based analysis is being applied in First Nations, Inuit and Métis organizations and communities to
p.000115: promote or restore recognition of women’s responsibilities in the conduct of community life – including decision
p.000115: making that directly affects their welfare. The legacy of patriarchal governance structures continues to pose
p.000115: challenges to women’s full participation. Approaches that are attentive to cultural considerations help to ensure the
p.000115: equitable participation and benefit of women throughout the life cycle of a research project (see Article 4.2).
p.000115: Research undertaken secretly or as a direct challenge to legitimate authority may increase risks to participants whose
p.000115: circumstances make them vulnerable, may deepen rifts within the community, and actually impede the advancement of
p.000115: social
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p.000115: 116 TCPS 2
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p.000115: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000115:
p.000115: justice. Strategies that have proven effective to secure the inclusion and promote the safety of diverse sectors within
p.000115: a community include: advocacy by moral authorities in the community; special measures to protect the identity of
p.000115: participants in small communities; identifying research questions that include rather than divide interest groups; or
p.000115: expanding the coverage of a project to multiple communities. In some cases, the risks to participants and communities
p.000115: involved with, or affected by, the proposed research outweigh the potential benefits likely to be gained, and the
p.000115: research should not be undertaken.
p.000115: Critical Inquiry
p.000115: Article 9.7 Research involving Aboriginal peoples that critically examines the conduct of public institutions,
p.000115: First Nations, Inuit and Métis governments, institutions or organizations or persons exercising authority over First
p.000115: Nations, Inuit or Métis individuals may be conducted ethically, notwithstanding the usual requirement of engaging
p.000115: community leaders.
p.000115: Application Considerations in conducting critical inquiry are discussed more fully in Article
p.000115: 3.6. As in the case of research involving groups whose circumstances make them vulnerable, or communities of interest
p.000115: within an Aboriginal community (see Article 9.6), researchers undertaking critical inquiry research will need to adopt
p.000115: appropriate approaches to ensure that cultural norms are respected, that the safety of participants is protected, and
p.000115: that potential harms to the welfare of the larger community are minimized to the extent possible. Researchers may
p.000115: need to consult culturally relevant regional or national Aboriginal organizations for guidance.
p.000115: For example, the Sisters in Spirit project of the Native Women’s Association of Canada (NWAC) that was launched in
p.000115: 2005 for a five-year period illustrates research of a national scope that incorporated a critical dimension. The
p.000115: project involved interviewing families of missing and murdered First Nations, Métis or Inuit women in urban and rural
p.000115: settings, and on First Nations territory. It examined, among other matters, the adequacy of public institutions and
p.000115: services, Aboriginal and non-Aboriginal, to protect the women’s well-being and support families in their efforts to
p.000115: deal with their losses. The objective was to effect policy change and improve the safety and well-being of Aboriginal
p.000115: women in Canada. NWAC has published its commitment to participatory research and the principles and practices that
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p.000123: personnel in research methods, project management, and ethical review and oversight.
p.000123: Application Collaborative research approaches provide for reciprocal learning and for transfer of skills and
p.000123: knowledge between the community and the researcher. Researchers should foster education and training of community
p.000123: members to enhance their participation in research projects. Employing Aboriginal research assistants and
p.000123: translators is already common practice in community-based projects. Extending skills transfer through a program of
p.000123: training will support collaboration with institutions, and advance the capacity of communities to initiate and
p.000123: implement their own research. Collaborative research can also support building capacity of the research community to
p.000123: conduct culturally relevant research.
p.000123: Lack of engagement by communities may be due to inadequate financial or human resources. Communities vary widely in the
p.000123: level of human and material resources they have available to collaborate with research initiatives. Structural barriers
p.000123: may prevent access to, and participation in, research. For example, small, remote communities and many urban
p.000123: communities of interest have limited organizational resources to advise or collaborate in research. The least
p.000123: organizationally developed communities are the most vulnerable to exploitation. Research undertaken in these
p.000123: circumstances should strive to enhance capacity for participation.
p.000123: Funding programs that target the development of Aboriginal research and capacity building seek to generate
p.000123: significant research training opportunities. Funding criteria allow researchers to include in their grant
p.000123: applications stipends for
p.000123:
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p.000123: TCPS 2
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p.000125: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
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p.000125: undergraduate, master’s or doctoral students, or post-doctoral researchers, as appropriate, with priority given
p.000125: to Aboriginal candidates. The time required to establish collaborative relationships may be difficult to
p.000125: accommodate in the programs of students. Mentorship by experienced researchers who introduce students to
p.000125: communities and monitor their ethical practice can facilitate the trust- building process and advance student progress.
p.000125: Recognition of the Role of Elders and Other Knowledge Holders
p.000125: Article 9.15 Researchers should engage the community in identifying Elders or other recognized knowledge holders to
p.000125: participate in the design and execution of research, and the interpretation of findings in the context of cultural
p.000125: norms and traditional knowledge. Community advice should also be sought to determine appropriate recognition for the
p.000125: unique advisory role fulfilled by these persons.
p.000125: Application Within First Nations, Inuit and Métis communities, persons with special gifts carry varied roles and
...
p.000135: to engage with particular social environments. Methodological approaches include, but are not limited to,
p.000135: ethnography, participatory action research, oral history, phenomenology, narrative inquiry, grounded theory and
p.000135: discourse analysis. The term “qualitative research” covers a wide range of overlapping paradigms or perspectives.
p.000135: (c) Dynamic, Reflective and Continuous Research Process: The emergence during the course of the research itself of
p.000135: questions, concepts, strategies, theories and ways to gather and engage with the data (e.g., emergent design research,
p.000135: see Article 10.5) requires a constant reflective approach and questioning by the researcher. Such flexibility,
p.000135: reflexivity and responsiveness contribute to the overall strength and rigour of data collection and analysis.
p.000135: (d) Diverse, Multiple and Often Evolving Contexts: Qualitative research takes place in a variety of contexts, each
p.000135: of which presents unique ethical issues. As knowledge is considered to be context-contingent in qualitative
p.000135: research, these studies tend to focus on particular individuals, sites or concepts that are empirically derived from
p.000135: other social settings. The researcher’s priority is to answer the research question stemming from the study of those
p.000135: individuals in a specific social setting at a specific time.
p.000135:
p.000135:
p.000135:
p.000135: 136 TCPS 2
p.000135:
p.000135: Chapter 10 – Qualitative Research
p.000135:
p.000135: Researchers sometimes engage in research that questions social structures and activities that create, or result in,
p.000135: inequality and injustice. Studies may involve participants who are in highly vulnerable circumstances because of the
p.000135: social and/or legal stigmatization that is associated with their activity or identity, and who may have little trust in
p.000135: the law, social agencies or institutional authorities. Regardless of the methodological approach, researchers
p.000135: who question social structures, or deal with the disempowered, may face pressures from authority figures. Research may
p.000135: also involve participants, such as business executives or government officials, who may be more powerful than the
p.000135: researchers.
p.000135: (e) Data Collection and Sample Size: There is generally a greater emphasis placed on depth of research than on
p.000135: breadth. Most qualitative researchers would emphasize gathering diverse but overlapping data on a limited number of
p.000135: cases or situations to the point of data saturation or thematic redundancy. Samples and research sites in these studies
p.000135: are chosen because they are viewed as particularly useful or rich sources of information for furthering one’s
p.000135: understanding of phenomena of interest, and not because the results may prove statistically significant. Participants
p.000135: are selected for their potential to inform theory development, and often selection of participants is guided by
p.000135: emerging patterns over the course of the data collection.
p.000135: A researcher may rely on multiple sources of information and data gathering strategies to enhance data quality.
p.000135: Researchers use a variety of methods for data gathering, including interviews, participant observation, focus groups
p.000135: and other techniques. In some cases, gathering of trustworthy data is best achieved by closeness and extended contact
...
p.000145: additional guidance on principles, norms and practices applicable to all research.
p.000145: This chapter will require periodic revision, particularly in light of the ongoing efforts to develop provincial,
p.000145: national and international guidance for new methods and emerging areas of clinical re- search, including, but not
p.000145: limited to, clinical trials. Though much clinical research is observational and evaluative such that previous chapters
p.000145: provide relevant guidance, there are plans to develop additions to the Policy that include both interventional clinical
p.000145: research (i.e., clinical trials) and encompass the fuller spectrum of non-interventional clinical research (e.g.,
p.000145: public health research, epidemiology). This is in keeping with a commitment to the continued evolution of this Policy.
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: TCPS 2
p.000147: 147
p.000147:
p.000147: Chapter 11 – Clinical Trials
p.000147:
p.000147: A. Key Concepts
p.000147: Risk and Proportionate Approach
p.000147: Clinical trials, like other research covered by this Policy, are subject to a proportionate approach to research ethics
p.000147: review: trials that pose greater foreseeable risk to participants will receive proportionately greater scrutiny (see
p.000147: Chapters 1 and 2). Not all clinical trials are high risk and care should be taken to avoid an automatic classification
p.000147: of this nature. However, because clinical trials often involve large numbers of people, and may include people
p.000147: who are in vulnerable circumstances due to health issues, the risk of serious harm or death must be considered. The
p.000147: majority of clinical trials are classified as above minimal risk, and are reviewed accordingly. This is consistent with
p.000147: the principle of Concern for Welfare.
p.000147: As discussed in Chapter 2, Section B, the evaluation of possible harms that participants may experience due to their
p.000147: involvement in research is of primary importance. The magnitude and probability of these harms are described as
p.000147: foreseeable risks. In keeping with the principle of Respect for Persons, it is the responsibility of researchers to
p.000147: clearly describe all foreseeable risks and potential benefits of their research to prospective participants in the
p.000147: consent process (see Articles 11.4 and 11.5). It is the responsibility of the REB to weigh the foreseeable risks to
p.000147: participants against the potential benefits of the trial in the context of a proportionate approach to research ethics
p.000147: review, and to discuss with the researcher additional ways to eliminate or minimize risks.
p.000147:
p.000147: Clinical Equipoise
p.000147: In trials where participants are randomly assigned to different groups (e.g., treatment A; treatment B; no treatment),
p.000147: ethical issues relevant to the principle of Justice arise when one group may fare better or worse than another (see
...
p.000157: The REB may approve clinical trials involving participants who are exposed to risk in their usual clinical care, where
p.000157: the REB finds a favourable balance between the foreseeable risks attributable to the research and the potential
p.000157: benefits.
p.000157:
p.000157: In addition to describing any other available treatments (including no treatment), researchers must ensure that
p.000157: prospective participants are informed of the foreseeable risks and potential benefits attributable to the
p.000157: research, as distinct from those arising from their clinical care. REBs should ensure that all consent materials
p.000157: reflect this distinction.
p.000157: Article 11.6 REBs and clinical trial researchers should be conscious of the phenomenon of therapeutic misconception,
p.000157: and ensure that procedures for recruitment and consent emphasize which specific elements of a clinical trial are
p.000157: required for research purposes, as well as the differences between research and the standard clinical care patients
p.000157: might otherwise receive.
p.000157: Application When treating clinicians conduct research with their patients, special efforts may be required, as part
p.000157: of the consent process, to distinguish between their dual role
p.000157: – clinician and researcher – and to ensure that patients who become participants understand the differences between
p.000157: the goals of health care and the goals of research.
p.000157: It is important that clinician-researchers take care not to overplay the benefits of research participation to patients
p.000157: in vulnerable circumstances, who may be misled
p.000157:
p.000157:
p.000157: 158 TCPS 2
p.000157:
p.000157: Chapter 11 – Clinical Trials
p.000157:
p.000157: to enter trials with false hopes. Research has shown that clinicians can affect how well their patients appreciate
p.000157: the uncertainty of research, the seriousness and magnitude of risks, and the possibility that participation may
p.000157: not result in any direct benefits to their own health status.
p.000157: Article 3.2 describes the requirements for consent to research participation. It indicates that participants shall be
p.000157: provided with relevant information, including a clear description of those elements of participation that are
p.000157: experimental in nature and those not primarily intended to benefit the participant directly.
p.000157: In general, therapeutic misconception can be minimized by ensuring that the clinicians who provide the
p.000157: patient’s regular care are involved as little as possible in recruitment and the consent process. Ideally, treatment
p.000157: and research functions should be performed by different people. However, there may be instances in which participants’
p.000157: best interests are served by having their primary care clinician involved in recruitment and consent. In these
p.000157: cases, the research proposal shall indicate what other measures will be taken to minimize therapeutic misconception.
p.000157:
p.000157: Monitoring Safety and Reporting New Information
p.000157: In accordance with the core principle of Concern for Welfare, it is a key responsibility of researchers
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Searching for indicator vulnerability:
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p.000199: to any research being carried out, so as to ensure participants are sufficiently protected.
p.000199: Some people may be incapable of exercising autonomy because of youth, cognitive impairment, other mental health issues
p.000199: or illness. While autonomy may be considered a necessary condition for participation in research, involving those who
p.000199: lack capacity to make their own decisions to participate can be valuable, just and even necessary. For those
p.000199: prospective participants, additional measures are needed to protect their interests and to ensure that their wishes (to
p.000199: the extent that these are known) are respected. These measures will generally include seeking consent from an
p.000199: authorized third party who is entrusted to make decisions on behalf of the prospective participant, based on knowledge
p.000199: of that person and that person’s wishes or, if such wishes are unknown, on consideration of that person’s welfare. Even
p.000199: when the requirements of free, informed and ongoing consent cannot be met, Respect for Persons requires involving
p.000199: individuals in circumstances of vulnerability in decision making where possible. This may include asking about their
p.000199: feelings re- garding participation and/or for their assent.
p.000199: Where it is foreseeable that a participant may lose capacity during a research project, for example in studies of
p.000199: cognitive impairment, it may be appropriate to ask participants to express their pref- erences and ensure that they
p.000199: have authorized a trusted person to make decisions on their behalf should they lose the capacity to provide ongoing
p.000199: consent (see Article 3.11 for guidance on research directives for individuals who lack capacity).
p.000199:
p.000199: Concern for Welfare
p.000199:
p.000199: The welfare of a person is the quality of that person’s experience of life in all its aspects. Welfare consists of the
p.000199: impact on individuals of factors such as their physical, mental and spiritual health, as well as their physical,
p.000199: economic and social circumstances. Thus, determinants of welfare can include housing, employment, security, family
p.000199: life, community membership, and social participation, among other aspects of life. Other contributing factors to
...
p.000199: research and indicate where any neg- ative impact on welfare can be minimized. Researchers must also consider the risks
p.000199: and potential benefits of their research and the knowledge it might generate for the welfare of society as a whole.
p.000199: Where research on individuals may affect the welfare of a group(s), the weight given to the group’s welfare will depend
p.000199: on the nature of the research being undertaken, and the individuals or group in question. This consideration does not
p.000199: imply, however, that the welfare of a group should be given priority over the welfare of individuals.
p.000199: Justice
p.000199: Justice refers to the obligation to treat people fairly and equitably. Fairness entails treating all peo- ple with
p.000199: equal respect and concern. Equity requires distributing the benefits and burdens of research participation in such a
p.000199: way that no segment of the population is unduly burdened by the harms of research or denied the benefits of the
p.000199: knowledge generated from it.
p.000199: Treating people fairly and equitably does not always mean treating people in the same way. Dif- ferences in treatment
p.000199: or distribution are justified when failures to take differences into account may result in the creation or
p.000199: reinforcement of inequities. One important difference that must be considered for fairness and equity is vulnerability.
p.000199: Vulnerability is often caused by limited capacity, or limited access to social goods, such as rights, opportunities and
p.000199: power. Individuals or groups in vulnerable circumstances have historically included children, the elderly, women,
p.000199: prisoners, those with mental health issues and those with diminished capacity for self-determination. Ethno- cultural
p.000199: minorities and those who are institutionalized are other examples of groups who have, at times, been treated unfairly
p.000199: and inequitably in research, or have been excluded from research op- portunities. People or groups whose circumstances
p.000199: cause them to be vulnerable or marginalized may need to be afforded special attention in order to be treated justly in
p.000199: research.
p.000199:
p.000199:
p.000199:
p.000199: 10 TCPS 2
p.000199:
p.000199: Chapter 1 – Ethics Framework
p.000199:
...
p.000199: possible, for new or emerging areas of research where no prior experience, comparable research or publications exist.
p.000199: Certain accepted research paradigms bring inherent limitations to the prior identification of risk. For example, when
p.000199: research in the social sciences employs emergent design, the manner in which the research project will proceed and any
p.000199: associated risks may be known only as it unfolds (see Chapters 3 and 10).
p.000199: Minimal Risk
p.000199: Minimal risk research that falls within the scope of this Policy requires REB review. It is generally eligible for
p.000199: delegated review – described in Article 6.12.
p.000199: For the purposes of this Policy, “minimal risk” research is defined as research in which the probability and magnitude
p.000199: of possible harms implied by participation in the research is no greater than those encountered by participants in
p.000199: those aspects of their everyday life that relate to the research.
p.000199: In their assessment of the acceptable threshold of minimal risk, REBs have special ethical obligations to
p.000199: individuals or groups whose situation or circumstances make them vulnerable in the context of a specific research
p.000199: project, and to those who live with relatively high levels of risk on a daily basis. Their inclusion in research should
p.000199: not exacerbate their vulnerability (see Article 4.7).
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 23
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
p.000199: Balancing Risks and Potential Benefits
p.000199: The analysis, balance, and distribution of risks and potential benefits are critical to the ethics of research
p.000199: involving humans. The principle of Concern for Welfare imposes an ethical obligation to design, assess and conduct
p.000199: research in a way that protects participants from any unnecessary or avoidable risks. In their review, REBs should be
p.000199: concerned with an assessment that the potential research outcomes and potential benefits merit the risks.
p.000199: Risks and potential benefits may be perceived differently by different individuals and groups in society. Researchers
p.000199: and REBs should take this into account in designing and reviewing research. They should also recognize that researchers
p.000199: and participants may not always see the risks and potential benefits of a research project in the same way. In
p.000199: assessing risks and potential benefits for specific populations, researchers and REBs should understand the role of the
p.000199: culture, values and beliefs of the populations to be studied. In this regard REBs may consult ad hoc advisors as
p.000199: needed. Researchers and REBs may also consult guidelines that exist for conducting research with these populations (see
p.000199: Chapters 8, 9 and 10). Researchers shall demonstrate to their REBs that they have a reasonable understanding of the
p.000199: culture, values and beliefs of the population to be studied, and the likely effects of their research upon
...
p.000199: Exclusions should be made on the basis of clear criteria that reflect balanced attention to the potential benefits as
p.000199: well as the foreseeable risks of the research that may affect the welfare of women. For exam- ple, researchers should
p.000199: not require participants to use oral contraception, unless there is a valid reason for doing so.
p.000199: In considering research on pregnant or breastfeeding women, researchers and REBs shall take into account foreseeable
p.000199: risks and potential benefits for the woman and her embryo, fetus or infant, as well as the foreseeable risks and
p.000199: potential benefits of excluding pregnant or breastfeeding women from the research.
p.000199: Research Involving Children
p.000199: Children have varying degrees of maturity – metabolically, immunologically and cognitively – that may present important
p.000199: challenges for research design and the consent process, depending on the nature and complexity of the research. In
p.000199: addition to the vulnerability that arises from their developmental stage, children may also lack capacity to consent to
p.000199: participate in research (see Ar- ticle 4.6). As well, physical or psychological harms a child may experience in a
p.000199: research setting may have long-lasting consequences. As a result, researchers have often avoided the inclusion of
p.000199: children in some research, especially in clinical trials testing new treatments, so as to eliminate any risks. Clinical
p.000199: trials conducted only with adults yield a generally poor understanding of the results that apply to children.
p.000199: As is the case with women, the inclusion of children in research advances the commitment to jus- tice in research by
p.000199: improving our knowledge of, and ability to respond to, the unique needs of children throughout their development.
p.000199:
p.000199:
p.000199: TCPS 2 49
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: Article 4.4 Children shall not be inappropriately excluded from research solely on the basis of their age or
...
p.000199: research should be at least as favourable to the participants as that provided by available alternative approaches.
p.000199: Where the research entails only minimal risk, it is sufficient if the research presents the prospect of benefits to
p.000199: participants or to a group that is the focus of the research and to which the participants belong.
p.000199: The research design should take into account factors that may affect the capacity of prospective participants to
p.000199: receive information, to consent to the research at some stage, or to participate in it. These factors may be permanent
p.000199: or may vary
p.000199:
p.000199:
p.000199: TCPS 2 51
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: over time (e.g., the participant’s capacity to consent may fluctuate over time). Ar- ticles 3.9 and 3.10 in Chapter 3
p.000199: establish other conditions regarding research that involve individuals who lack capacity to consent. This includes the
p.000199: involvement of an authorized third party to consent on their behalf, and adequate provisions to ascertain the wishes of
p.000199: the individuals concerning their participation.
p.000199: Participants’ Vulnerability and Research
p.000199: Article 4.7 Individuals or groups whose circumstances may make them vulnerable in the con- text of research should
p.000199: not be inappropriately included or automatically excluded from participation in research on the basis of their
p.000199: circumstances.
p.000199: Application The core principles of Respect for Persons, Concern for Welfare, and Justice entail special ethical
p.000199: obligations toward individuals or groups whose circumstances may lead to their vulnerability in the context of a
p.000199: specific research project and limit their ability to fully safeguard their own interests. Those who are owed special
p.000199: ethical obligations may include individuals who are institutionalized, those in dependent situations, or those whose
p.000199: circumstances (e.g., poverty or poor health status) may render even modest participation incentives so attractive as to
p.000199: constitute an induce- ment to take risks they would otherwise not take. Their situation may also compromise
p.000199: the voluntariness of consent in other ways. However, individuals should not automatically be considered vulnerable
p.000199: simply because of assumptions made about the vulnerability of the group to which they belong. Their particular
p.000199: circumstances shall be considered in the context of the proposed research project.
p.000199: REBs and researchers shall carefully examine the relationship between the circum- stances of the individuals and groups
p.000199: they aim to recruit, and the proposed research question. They should not presume that these circumstances will
p.000199: automatically re- sult in the inclusion or exclusion of individuals or groups as prospective participants.
p.000199: Participation should be based on inclusion or exclusion criteria that are justified by the research question.
p.000199: Researchers and REBs should recognize and address changes in a participant’s circumstances that may create, heighten,
p.000199: or at- tenuate their vulnerability, and provide special protections or consideration.
p.000199: In general, researchers should be familiar with the cultural, social and economic circumstances of prospective
p.000199: participants, groups or communities. Researchers should anticipate, to the best of their ability, needs of
p.000199: participants, groups and their communities that might arise in any given research project. Especially when groups, and
p.000199: their communities, have a wide range of pressing needs due to their low so- cioeconomic circumstances, these needs can
p.000199: present significant ethical challenges for researchers. An equitable distribution of research benefits (discussed
p.000199: below) can help ensure that individuals, groups and communities whose circumstances may make them vulnerable in the
p.000199: context of research are not inappropriately in- cluded in research based on these circumstances.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: 52 TCPS 2
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: Equitable Distribution of Research Benefits
p.000199: Researchers should consider ways to ensure the equitable distribution of any benefits of partici- pation in research.
p.000199: Benefits of research participation may be direct, where, for example, an individual participant experiences
p.000199: amelioration of a health condition as a result of an experimental therapy, or learns new information about social
p.000199: issues as a result of participation in a research focus group. In a community hosting research, benefits may take the
...
p.000199: prisoners, even though they are not identified individually.
p.000199: When planning a study, researchers should incorporate any applicable statute-based or other legal principles that may
p.000199: afford protection for the privacy of participants and the confidentiality of research information.
p.000199:
p.000199: C. Safeguarding Information
p.000199: Article 5.3 Researchers shall provide details to the REB regarding their proposed measures for safeguarding
p.000199: information, for the full life cycle of information: its collection, use, dissemination, retention and/or disposal.
p.000199: Application Researchers shall assess privacy risks and threats to the security of information for all stages of the
p.000199: research life cycle, and implement appropriate measures to protect information. Safeguarding information helps respect
p.000199: the privacy of participants and helps researchers fulfil their confidentiality obligations. In adopting measures to
p.000199: safeguard information, researchers should follow disciplinary standards and prac- tices for the collection and
p.000199: protection of information gathered for research purposes. Formal privacy impact assessments are required in some
p.000199: institutions and may also be required under legislation or policy in some jurisdictions. Security measures should take
p.000199: into account the nature, type and state of data: the data’s form (e.g., paper or electronic records); content (e.g.,
p.000199: presence of direct or indirect identifiers); mobility (e.g., kept in one location or subject to physical or electronic
p.000199: transport); and vulnerability to unauthorized access (e.g., use of encryption or password pro- tection). Measures for
p.000199: safeguarding information apply both to original documents and copies of information.
p.000199: Factors relevant to the REB’s assessment of the adequacy of the researchers’ pro- posed measures for safeguarding
p.000199: information include:
p.000199: (a) the type of information to be collected;
p.000199: (b) the purpose for which the information will be used, and the purpose of any secondary use of identifiable
p.000199: information;
p.000199: (c) limits on the use, disclosure and retention of the information;
p.000199: (d) risks to participants should the security of the data be breached, including risks of re-identification of
p.000199: individuals;
p.000199: (e) appropriate security safeguards for the full life cycle of information;
p.000199: (f) any recording of observations (e.g., photographs, videos, sound recordings) in the research that may allow
p.000199: identification of particular participants;
p.000199:
p.000199:
p.000199: 60 TCPS 2
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: (g) any anticipated uses of personal information from the research; and
p.000199: (h) any anticipated linkage of data gathered in the research with other data about participants, whether those data
p.000199: are contained in public or personal records (see also Section E of this chapter).
p.000199: In considering the adequacy of proposed measures for safeguarding information during its full life cycle, REBs should
p.000199: not automatically impose a requirement that researchers destroy the research data. Stored information may be useful for
...
p.000199: institution.
p.000199: Application Sensitivity to context is a key issue in the application of the core principles of this Policy to the
p.000199: ethics review of research involving multiple institutions and/or REBs. Researchers should consider the alternative
p.000199: research ethics review models at the planning and design stage of their research, and should consult with their REB to
p.000199: facilitate the selection and coordination of the appropriate review model. In choos- ing the appropriate research
p.000199: ethics review model, the researcher and the REB should pay attention to the research context, and the characteristics
p.000199: of the popula- tions targeted by the research. The final decision regarding the selection of the appropriate model is
p.000199: the responsibility of the principal REB.
p.000199: When selecting from among research ethics review models authorized by their in- stitution, researchers and REBs should
p.000199: consider the following:
p.000199:
p.000199:
p.000199: 100 TCPS 2
p.000199:
p.000199: Chapter 8 – Multi-Jurisdictional Research
p.000199:
p.000199: • the discipline and content area of the research, and the availability of appropri- ate experience and expertise
p.000199: within, or available to, the reviewing REB;
p.000199: • the scope of the project to be reviewed and appropriateness of the proposed re- search ethics review model;
p.000199: • the vulnerability of the study population overall and/or the particular charac- teristics of the local population
p.000199: at individual sites, differences in values and cultural norms, and the level of risk associated with the research under
p.000199: review;
p.000199: • any relevant differences in laws and/or guidelines pertaining to the research in question if the institutions are
p.000199: in different provinces, territories and/or coun- tries;
p.000199: • relationships between institutions and REBs, and conflict resolution mecha- nisms related to REB decisions;
p.000199: • the potential for conflicts of interest and undue influence, including those that may arise from funding sources;
p.000199: • any differences in the standard of care normally followed, or access to services at the participating
p.000199: institutions that might be relevant to the conduct of the re- search; and
p.000199: • any operational issues that might affect the research.
p.000199:
p.000199: B. Ethics Review of Research Conducted outside the Institution
p.000199: Researchers affiliated with Canadian institutions are undertaking research at numerous sites within Canada and in
p.000199: countries around the world. Such research may be carried out with or without any collaboration with host institutions
p.000199: and local researchers. Most middle-income countries, and many low-income countries, have laws, policies or guidelines
p.000199: governing the ethical conduct of research involving humans, but some parts of the world do not have developed or
...
p.000155: unblinding.
p.000155:
p.000155:
p.000155:
p.000155:
p.000155: TCPS 2
p.000157: 157
p.000157:
p.000157: Chapter 11 – Clinical Trials
p.000157:
p.000157: Article 11.5 When describing the foreseeable risks and potential benefits of research involving participants who are
p.000157: undergoing high-risk therapies, researchers should clearly indicate which risks are attributable to the research
p.000157: (including cumulative risks), and which risks the participants would normally be exposed to in the course of their
p.000157: clinical care.
p.000157: In their evaluation of risk, REBs should ensure that they are evaluating only those risks that are attributable to the
p.000157: research (including cumulative risks), and not compounding them with the risks attributable to clinical care.
p.000157: Application The evaluation of foreseeable risk to participants in a clinical trial can be complicated
p.000157: if the prospective participants are already exposed to risks in the course of their clinical care. It is the
p.000157: researcher’s responsibility to clearly distinguish in their research proposal between the risks due to clinical care
p.000157: from the foreseeable risks of the clinical trial.
p.000157: The REB must take into consideration the ethical implications of recruiting patients, particularly those
p.000157: receiving high-risk therapies, into clinical trials that may offer additional risk. In accordance with Articles 4.1 and
p.000157: 4.7 on vulnerability and inclusion/exclusion criteria, patients who are receiving high-risk clinical care should not
p.000157: be inappropriately included in, or excluded from, participating in research.
p.000157: The REB may approve clinical trials involving participants who are exposed to risk in their usual clinical care, where
p.000157: the REB finds a favourable balance between the foreseeable risks attributable to the research and the potential
p.000157: benefits.
p.000157:
p.000157: In addition to describing any other available treatments (including no treatment), researchers must ensure that
p.000157: prospective participants are informed of the foreseeable risks and potential benefits attributable to the
p.000157: research, as distinct from those arising from their clinical care. REBs should ensure that all consent materials
p.000157: reflect this distinction.
p.000157: Article 11.6 REBs and clinical trial researchers should be conscious of the phenomenon of therapeutic misconception,
p.000157: and ensure that procedures for recruitment and consent emphasize which specific elements of a clinical trial are
p.000157: required for research purposes, as well as the differences between research and the standard clinical care patients
p.000157: might otherwise receive.
p.000157: Application When treating clinicians conduct research with their patients, special efforts may be required, as part
p.000157: of the consent process, to distinguish between their dual role
p.000157: – clinician and researcher – and to ensure that patients who become participants understand the differences between
...
p.000195: of clinical trials. Often participants do not understand that research is aimed primarily at producing knowledge and
p.000195: may not provide any therapeutic benefit to them.
p.000195:
p.000195: Traditional knowledge – The knowledge held by First Nations, Inuit and Métis peoples, the Aboriginal peoples of
p.000195: Canada. Traditional knowledge is specific to place, usually transmitted orally, and rooted in the experience of
p.000195: multiple generations. It is determined by an Aboriginal community’s land, environment, region, culture, and language.
p.000195: It may also include new knowledge transmitted to subsequent generations.
p.000195:
p.000195: Unanticipated issues – Issues that: occur during the conduct of research; may increase the level of risk to
p.000195: participants or have other ethical implications that may affect participants’ welfare; and were not anticipated by the
p.000195: researcher in the research proposal submitted for research ethics review.
p.000195:
p.000195: Undue influence – The impact of an unequal power relationship on the voluntariness of consent. This may occur when
p.000195: prospective participants are recruited by individuals in a position of authority over them (e.g. doctor/patient,
p.000195: teacher/student, employer/employee). See “Coercion.”
p.000195:
p.000195: Vulnerability – A diminished ability to fully safeguard one’s own interests in the context of a specific research
p.000195: project. This may be caused by limited capacity or limited access to social goods, such as rights, opportunities and
p.000195: power. Individuals or groups may experience vulnerability to different degrees and at different times, depending on
p.000195: their circumstances. See also “Autonomy.”
p.000195:
p.000195: Welfare – The quality of a person’s experience of life in all its aspects. Welfare consists of the impact on
p.000195: individuals and/or groups of factors such as their physical, mental and spiritual health, as well as their physical,
p.000195: economic and social circumstances.
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195: TCPS 2
p.000195:
p.000197: 197
p.000197:
p.000197:
p.000197:
p.000197: Index
p.000197: The Index seeks to direct the reader to meaningful references to key concepts in TCPS 2. Main references to a term are
p.000197: indicated with bold type.
p.000197:
p.000197: The Index is not a record of all occurrences of the listed topics. Readers who wish to check all occurrences of these
p.000197: topics or specific terms may do so through the Adobe search tool available online in the PDF version of the Policy
p.000197: found at www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2- eptc2/Default/.
p.000197:
p.000197: A
p.000197: Aboriginal peoples
p.000197: collaborative research, 123-124, 125-126, 128
p.000197: communities, 107-108, 109
p.000197: community customs, 108, 117-119
p.000197: community engagement, 108, 110-117, 121-125
p.000197: confidentiality, 126-128
...
p.000203: privacy, 12, 17-18, 55, 63, 64, 142, 143, 174
p.000203: research ethics, 12
p.000203: Medical emergencies (see Emergencies)
p.000203: Memorandum of Understanding on the Roles and Responsibilities in the Management of Federal Grants and Awards, 5, 67,
p.000106: 106
p.000106: Métis, 105, 107, 108, 110, 114, 115, 117, 121
p.000106: (see also Aboriginal peoples)
p.000106: Minimal risk research, 11, 23, 24-25, 37-39, 41, 51, 77-79 Multi-jurisdictional research
p.000106: official agreements, 98, 100
p.000106: research ethics review models, 99-101 review mechanisms, 97-101
p.000106:
p.000106: O
p.000106: Observational research, 18-19, 118, 141-143
p.000106:
p.000106: P
p.000106: Participants
p.000106: autonomy, 8-9, 27, 40 capacity (see Capacity)
p.000106: children, 10, 34, 41-42, 47, 49-50, 51, 185, 187
p.000106: confidentiality, 56, 58-60, 126-128, 143-144, 186
p.000106: definition, 16
p.000106: elderly, 10, 47, 50
p.000106: as members of research ethics boards, 72 perspective, 12, 23, 28, 72, 161
p.000106: privacy, 55-56, 58-60, 126-128, 143-144, 171-172, 186
p.000106: recruitment, 11, 28, 76-77, 110, 158-159, 164, 184-185
p.000106: removal from research, 31, 33, 160 as research partners, 138
p.000106: vulnerability, 9, 10, 23, 47, 52, 116, 137, 148
p.000106: withdrawal from research, 28-30, 31, 61, 140, 186
p.000106: women, 10, 47, 48-49, 116, 178-179
p.000106: Participatory research, 123-125
p.000106: Performance review, 20
p.000106:
p.000106:
p.000106: TCPS 2
p.000205: 205
p.000205:
p.000205: Index
p.000205:
p.000205: Pilot studies, 76-77, 139
p.000205: Pluripotent stem cells, 179
p.000205: Policy, the (see Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans) Principal investigators,
p.000205: 27, 99, 153-154, 159, 162, 165-166
p.000205: Principles (see Core principles) Privacy and confidentiality
p.000205: Aboriginal peoples, 126-128
p.000205: data linkage, 18, 19, 64-65, 131-132
p.000205: definition, 55-56
p.000205: ethical duty, 56, 58-60
p.000205: identifiability of information, 56-57
p.000205: participant, 55-56, 58-60, 126-128, 143-144, 171-172, 186
p.000205: qualitative research, 138, 143-144
p.000205: research involving Aboriginal peoples, 126-128 safeguarding information, 60-61
p.000205: security, 56, 60-61, 64-65
p.000205: (see also Secondary use of human biological materials; Secondary use of identifiable information)
p.000205: Program evaluation, 20
p.000205: Proportionate approach to research ethics review, 11, 22, 24-25, 77-79, 82, 148
p.000205: Publicly available information, 17-18, 64-65, 131 Publicly declared emergencies, 85-88
p.000205: exceptions during, 87-88
p.000205: preparedness plans, 85-86
p.000205: research ethics review during, 87-88
p.000205:
p.000205: Q
p.000205: Qualitative research
...
p.000207: and benefits, 10, 11, 22-25, 41-42, 51, 157-158
p.000207: in clinical trials, 148, 157-159
p.000207: definition, 22-23
p.000207: minimal, 11, 23, 24-25, 37-39, 41, 51, 77-79
p.000207: to researchers, 25
p.000207:
p.000207:
p.000207: 208 TCPS 2
p.000207:
p.000207: Index
p.000207:
p.000207: S
p.000207: Scholarly review, 20-21
p.000207: Secondary use of human biological materials, 62-64, 119-121, 130-132, 172-175, 186 Secondary use of identifiable
p.000207: information
p.000207: Aboriginal peoples, 119-121, 130-132
p.000207: anonymous, 19
p.000207: consent, 62-64, 130-132
p.000207: definition, 19, 62
p.000207: genetic material, 186
p.000207: privacy, 62-64
p.000207: Security of information, 56, 60-61, 64-65 StemXcells
p.000207: Guidelines for Human Pluripotent Stem Cell Research, 179 pluripotent, 179
p.000207: Students, 25, 67-68, 77-79 Subjects (see Participants)
p.000207: T
p.000207: Therapeutic misconception, 148, 149, 158-159
p.000207: Third party consent (see Consent: authorized third parties) Trials (see Clinical trials)
p.000207: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) application, 11-13
p.000207: compliance with, 5-6
p.000207: interpretation, 13
p.000207:
p.000207: U
p.000207: Unanticipated issues, 22, 34, 81, 161-163
p.000207: Undue influence, 28-29
p.000207:
p.000207: V
p.000207: Vulnerability, 9, 10, 23, 47, 52, 116, 137, 148
p.000207:
p.000207: W
p.000207: Welfare (see Concern for Welfare)
p.000207: Withdrawal
p.000207: of consent, 28-30, 31
p.000207: of data, 28-30, 31
p.000207: of human biological materials, 28-30, 31, 172
p.000207: from research, 28-30, 31, 61, 140, 186
p.000207: Women
p.000207: as research participants, 10, 47, 48-49, 116, 178-179 pregnant, inclusion in research, 49
p.000207:
p.000207:
p.000207:
p.000207:
p.000207:
p.000207:
p.000207: TCPS 2
p.000209: 209
p.000209:
...
Health / Cognitive Impairment
Searching for indicator cognitive:
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p.000199: participation through the use of one’s data or biological materials, should be a matter of choice and that, to be
p.000199: meaningful, the choice must be informed. An informed choice is one that is based on as complete an understanding as is
p.000199: reasonably possible of the purpose of the research, what it entails, and its foreseeable risks and potential benefits,
p.000199: both to the partic- ipant and to others. Respect for Persons also includes a commitment to accountability
p.000199: and transparency in the ethical conduct of research.
p.000199: Certain factors may diminish a person’s ability to exercise their autonomy, such as inadequate information or
p.000199: understanding for deliberation, or a lack of freedom to act due to controlling influences or coercion. Such constraints
p.000199: may include the fear of alienating those in positions of authority, such as professional or personal caregivers,
p.000199: researchers, leaders, larger groups, or a community to which one belongs. Other constraints may consist of barriers to
p.000199: accessing resources or knowledge outside the research context. These factors and constraints should be addressed prior
p.000199: to any research being carried out, so as to ensure participants are sufficiently protected.
p.000199: Some people may be incapable of exercising autonomy because of youth, cognitive impairment, other mental health issues
p.000199: or illness. While autonomy may be considered a necessary condition for participation in research, involving those who
p.000199: lack capacity to make their own decisions to participate can be valuable, just and even necessary. For those
p.000199: prospective participants, additional measures are needed to protect their interests and to ensure that their wishes (to
p.000199: the extent that these are known) are respected. These measures will generally include seeking consent from an
p.000199: authorized third party who is entrusted to make decisions on behalf of the prospective participant, based on knowledge
p.000199: of that person and that person’s wishes or, if such wishes are unknown, on consideration of that person’s welfare. Even
p.000199: when the requirements of free, informed and ongoing consent cannot be met, Respect for Persons requires involving
p.000199: individuals in circumstances of vulnerability in decision making where possible. This may include asking about their
p.000199: feelings re- garding participation and/or for their assent.
p.000199: Where it is foreseeable that a participant may lose capacity during a research project, for example in studies of
p.000199: cognitive impairment, it may be appropriate to ask participants to express their pref- erences and ensure that they
p.000199: have authorized a trusted person to make decisions on their behalf should they lose the capacity to provide ongoing
p.000199: consent (see Article 3.11 for guidance on research directives for individuals who lack capacity).
p.000199:
p.000199: Concern for Welfare
p.000199:
p.000199: The welfare of a person is the quality of that person’s experience of life in all its aspects. Welfare consists of the
p.000199: impact on individuals of factors such as their physical, mental and spiritual health, as well as their physical,
p.000199: economic and social circumstances. Thus, determinants of welfare can include housing, employment, security, family
p.000199: life, community membership, and social participation, among other aspects of life. Other contributing factors to
p.000199: welfare are privacy and the control of information about the person, and the treatment of human biological materials
p.000199: according to the free, informed and ongoing consent of the person who was the source of the information or materials. A
...
p.000199: These may vary among jurisdictions. Authorized third parties who are asked to make a consent decision on behalf of a
p.000199: prospective participant should also be aware of their legal responsibilities.
p.000199: In keeping with the principle of Justice, those who lack the capacity to consent on their own behalf must neither be
p.000199: unfairly excluded from the potential benefits of research participation, nor may their lack of capacity to consent be
p.000199: used to inappropriately include them in research. REBs and researchers should be aware of these ethical considerations
p.000199: and seek to find a balance between them for the benefit of prospective participants who lack capacity to consent (see
p.000199: Chapter 4).
p.000199: As indicated in Chapter 1, Respect for Persons and Concern for Welfare entails particular ethical obligations to
p.000199: individuals in vulnerable circumstances. Such obligations often translate into special procedures to promote and
p.000199: protect their interests. This may include the development of consent materials that are appropriate to the
p.000199: cognitive and communication abilities of prospective participants. Articles 3.9, 3.10 and 3.11 describe
p.000199: special procedures for research involving individuals who lack the capacity to consent on their own behalf.
p.000199: Article 3.9 For research involving individuals who lack the capacity, either permanently or temporarily, to decide
p.000199: for themselves whether to participate, the REB shall ensure that, as a minimum, the following conditions are met:
p.000199: (a) the researcher involves participants who lack the capacity to consent on their own behalf to the greatest extent
p.000199: possible in the decision-making process;
p.000199: (b) the researcher seeks and maintains consent from authorized third parties in accordance with the best interests of
p.000199: the persons concerned;
p.000199: (c) the authorized third party is not the researcher or any other member of the research team;
p.000199: (d) the researcher demonstrates that the research is being carried out for the participant’s direct benefit,
p.000199: or for the benefit of other persons in the same category. If the research does not have the potential for direct
p.000199: benefit to the participant but only for the benefit of the other persons in the same category, the researcher shall
p.000199: demonstrate that the research will expose the participant to only a minimal risk and minimal burden, and demonstrate
...
p.000199: Article 3.11.
p.000199: Article 3.10 Where an authorized third party has consented on behalf of an individual who lacks legal capacity, but
p.000199: that person has some ability to understand the significance of the research, the researcher shall ascertain the wishes
p.000199: of that individual with respect to participation. Prospective participants’ dissent will preclude their participation.
p.000199: Application Many individuals who lack legal capacity to make decisions may still be able to express their wishes in
p.000199: a meaningful way, even if such expression may not fulfil all of the requirements for consent. Prospective participants
p.000199: may be capable of verbally or physically assenting to, or dissenting from, participation in research. Those who may be
p.000199: capable of assent or dissent include:
p.000199: (a) those whose capacity is in the process of development, such as children whose capacity for judgment and
p.000199: self-direction is maturing;
p.000199: (b) those who once were capable of making an autonomous decision regarding consent but whose capacity is diminishing or
p.000199: fluctuating; and
p.000199: (c) those whose capacity remains only partially developed, such as those living with permanent cognitive impairment.
p.000199: While their assent would not be sufficient to permit them to participate in the absence of consent by an authorized
p.000199: third party, their expression of dissent or signs suggesting they do not wish to participate must be respected.
p.000199: Research Directives
p.000199: Although advance directives for treatment are recognized as a legitimate tool in health care, the use of directives in
p.000199: the context of research is not well developed and they have no legal status. For the purposes of this Policy, research
p.000199: directives should be understood to express an individual’s preferences for participation in future research in the
p.000199: event that the individual loses capacity. Research directives are written instructions to be used by the authorized
p.000199: third party as information about a prospective participant’s preferences when the third party is asked to provide
p.000199: substitute consent.
p.000199:
p.000199:
p.000199:
p.000199: 42 TCPS 2
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: The efficacy of research directives is unknown and their legal status has not yet been recognized or tested. Research
p.000199: directives, nevertheless, are congruent with this Policy’s core principle of Respect for Persons. The use of research
...
p.000199: collected. Researchers who collect information or human biological materials for a specific research project may
p.000199: anticipate subsequent research uses. Some types of research initiatives (e.g., the creation of large databases
p.000199: sometimes known as research plat- forms) involve long-term retention and use of information or human biological
p.000199: materials for research purposes (e.g., longitudinal studies that involve biobanking).
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 43
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: When data for these platforms are initially collected, it is not typically possible to specify every research that
p.000199: could be carried out using the participants’ information or human biological materials. Research directives may be used
p.000199: in these contexts to give participants the opportunity to express their preferences about future research should they
p.000199: lose capacity (see Article 5.5[d] for expression of preferences in the con- text of secondary use of data).
p.000199: In long-term projects, research directives may be used to allow participants to make choices about other aspects of
p.000199: research participation. For example, participants could specify preferences about receiving findings, or allowing the
p.000199: continued use of their information or samples in the event that they lose capacity, or after they die.
p.000199: Individuals can also use research directives to express preferences concerning par- ticipation in future research. For
p.000199: example, individuals in an early stage of cognitive impairment may use a research directive to express their
p.000199: preferences for future par- ticipation in research that, due to diminishing capacity, they would not otherwise be able
p.000199: to consent to on their own. They also allow existing participants to express their preference to continue to
p.000199: participate in research should they lose capacity. Research directives should be as specific as possible, and in the
p.000199: event of ambiguity or imprecision, should be interpreted narrowly. Individuals should be encouraged to periodically
p.000199: update their research directives and, if possible, construct directives in contemplation of specific types of research
p.000199: interventions. Research directives should be written, dated and witnessed, and include a declaration about the capacity
p.000199: of the individual at the time the directive was made.
p.000199:
p.000199: D. Consent Shall Be Documented
p.000199:
p.000199: Article 3.12 Evidence of consent shall be contained either in a signed consent form or in documentation
p.000199: by the researcher of another appropriate means of consent.
p.000199: Application Written consent in a signed statement from the participant is a common means of demonstrating consent,
...
p.000199: who cannot consent for themselves. It should be read in conjunction with Section C of Chapter 3.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: 50 TCPS 2
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: Article 4.6 Subject to applicable legal requirements, individuals who lack capacity to consent to participate in
p.000199: research shall not be inappropriately excluded from research. Where a researcher seeks to involve individuals in
p.000199: research who do not have ca- pacity to consent for themselves, the researcher shall, in addition to fulfilling the
p.000199: conditions in Articles 3.9 and 3.10, satisfy the REB that:
p.000199: (a) the research question can be addressed only with participants within the iden- tified group; and
p.000199: (b) the research does not expose the participants to more than minimal risk without the prospect of direct benefits for
p.000199: them; or
p.000199: (c) where the research entails only minimal risk, it should at least have the prospect of providing benefits to
p.000199: participants or to a group that is the focus of the re- search and to which the participants belong.
p.000199: Application Children and individuals with cognitive impairments or intellectual disabilities may lack capacity to
p.000199: consent to participate in particular research initiatives. As a result, they have, historically, experienced both
p.000199: over-inclusion as populations of conven- ience for some research and unjustified exclusion from other research. Yet the
p.000199: advancement of knowledge about their social, psychological, and health experi- ences and needs may depend on their
p.000199: appropriate participation in research. Their inclusion in research requires special considerations as outlined in this
p.000199: article.
p.000199: To be ethically acceptable, the participation of those who lack capacity to consent for themselves shall be necessary
p.000199: and appropriate to address the research question. Researchers and REBs shall consider the level of risk to which
p.000199: participants who lack capacity to consent are exposed, and the prospect of direct benefits to accruing to the
p.000199: participants. Their participation should generally be limited to research of minimal risk as defined in this Policy
p.000199: (see Chapter 2 for the definition of minimal risk).
p.000199: Where the research presents more than minimal risk, it should have appropriate justification aimed at generating
...
Searching for indicator impaired:
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p.000199: inherent worth of all human beings and the respect and consideration that they are due. In this Policy, respect for
p.000199: human dignity is expressed through three core principles – Re- spect for Persons, Concern for Welfare, and Justice.
p.000199: These core principles transcend disciplinary boundaries and, therefore, are relevant to the full range of research
p.000199: covered by this Policy.1
p.000199: Article 1.1 The guidelines in this Policy are based on the following three core principles:
p.000199: • Respect for Persons
p.000199: • Concern for Welfare
p.000199: • Justice
p.000199: These principles are complementary and interdependent. How they apply and the weight accorded to each will depend on
p.000199: the nature and context of the research being undertaken. Specific applica- tions are addressed in the following
p.000199: chapters.
p.000199: Respect for Persons
p.000199: Respect for Persons recognizes the intrinsic value of human beings and the respect and consider- ation that they are
p.000199: due. It encompasses the treatment of persons involved in research directly as participants and those who are
p.000199: participants because their data or human biological materials, which for the purposes of this Policy include materials
p.000199: related to human reproduction, are used in re- search. Respect for Persons incorporates the dual moral obligations to
p.000199: respect autonomy and to protect those with developing, impaired or diminished autonomy.
p.000199: Autonomy includes the ability to deliberate about a decision and to act based on that deliberation. Respecting autonomy
p.000199: means giving due deference to a person’s judgment and ensuring that the person is free to choose without
p.000199: interference. Autonomy is not exercised in isolation but is influenced by a person’s various connections to
p.000199: family, to community, and to cultural, social, linguistic, religious and other groups. Likewise, a person’s decisions
p.000199: can have an impact on any of these connections.
p.000199:
p.000199: 8 TCPS 2
p.000199:
p.000199: Chapter 1 – Ethics Framework
p.000199:
p.000199: An important mechanism for respecting participants’ autonomy in research is the requirement to seek their free,
p.000199: informed and ongoing consent. This requirement reflects the commitment that par- ticipation in research, including
p.000199: participation through the use of one’s data or biological materials, should be a matter of choice and that, to be
p.000199: meaningful, the choice must be informed. An informed choice is one that is based on as complete an understanding as is
...
p.000195: ethics, in relevant research disciplines) established by an institution to review the ethical acceptability of all
p.000195: research involving humans conducted within the institution’s jurisdiction or under its auspices.
p.000195:
p.000195: Research ethics education and training – The provision of materials and corresponding instruction by an institution to
p.000195: research ethics board (REB) members or researchers with regard to the core principles and understanding of this Policy,
p.000195: basic ethics standards, applicable institutional policies, and legal or regulatory requirements. This term also
p.000195: includes an understanding of the role and mandate of REBs and responsibilities of REB members.
p.000195:
p.000195: Research involving partial disclosure or deception – A type of research, in which the participant may not know that
p.000195: they are part of a project until it is over or is not informed of the true purpose of the research in advance. See
p.000195: “Debriefing.”
p.000195:
p.000195: Respect for Persons – A core principle of this Policy that recognizes the intrinsic value of human beings and the
p.000195: respect and consideration that they are due. It incorporates the dual moral obligations to respect autonomy and to
p.000195: protect those with developing, impaired, or diminished autonomy.
p.000195:
p.000195: Risk – The possibility of the occurrence of harm. The level of foreseeable risk posed to participants by their
p.000195: involvement in research is assessed by considering the magnitude or seriousness of the harm and the probability that it
p.000195: will occur, whether to participants or to third parties.
p.000195:
p.000195: Secondary use – The use in research of information or human biological materials originally collected for a purpose
p.000195: other than the current research purpose.
p.000195:
p.000195: Security – Measures taken to protect information. It includes physical, administrative, and technical safe- guards.
p.000195:
p.000195: Shall – Indicates a mandatory provision.
p.000195:
p.000195: Should – Indicates guidance for the interpretation of the core principles.
p.000195:
p.000195: Stopping rules – Statistically significant end points and safety considerations for a clinical trial that are
p.000195: determined in advance, and, once reached, dictate that the trial must be terminated.
p.000195:
p.000195:
p.000195:
p.000195: 196 TCPS 2
p.000195:
p.000195: Glossary
p.000195:
p.000195: Surgical trials – A clinical trial which compares the safety and/or efficacy of different surgical techniques.
p.000195:
p.000195: Therapeutic misconception – A misunderstanding, on the part of participants, of the purpose, benefits, and/or risks
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Searching for indicator impairment:
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p.000199: participation through the use of one’s data or biological materials, should be a matter of choice and that, to be
p.000199: meaningful, the choice must be informed. An informed choice is one that is based on as complete an understanding as is
p.000199: reasonably possible of the purpose of the research, what it entails, and its foreseeable risks and potential benefits,
p.000199: both to the partic- ipant and to others. Respect for Persons also includes a commitment to accountability
p.000199: and transparency in the ethical conduct of research.
p.000199: Certain factors may diminish a person’s ability to exercise their autonomy, such as inadequate information or
p.000199: understanding for deliberation, or a lack of freedom to act due to controlling influences or coercion. Such constraints
p.000199: may include the fear of alienating those in positions of authority, such as professional or personal caregivers,
p.000199: researchers, leaders, larger groups, or a community to which one belongs. Other constraints may consist of barriers to
p.000199: accessing resources or knowledge outside the research context. These factors and constraints should be addressed prior
p.000199: to any research being carried out, so as to ensure participants are sufficiently protected.
p.000199: Some people may be incapable of exercising autonomy because of youth, cognitive impairment, other mental health issues
p.000199: or illness. While autonomy may be considered a necessary condition for participation in research, involving those who
p.000199: lack capacity to make their own decisions to participate can be valuable, just and even necessary. For those
p.000199: prospective participants, additional measures are needed to protect their interests and to ensure that their wishes (to
p.000199: the extent that these are known) are respected. These measures will generally include seeking consent from an
p.000199: authorized third party who is entrusted to make decisions on behalf of the prospective participant, based on knowledge
p.000199: of that person and that person’s wishes or, if such wishes are unknown, on consideration of that person’s welfare. Even
p.000199: when the requirements of free, informed and ongoing consent cannot be met, Respect for Persons requires involving
p.000199: individuals in circumstances of vulnerability in decision making where possible. This may include asking about their
p.000199: feelings re- garding participation and/or for their assent.
p.000199: Where it is foreseeable that a participant may lose capacity during a research project, for example in studies of
p.000199: cognitive impairment, it may be appropriate to ask participants to express their pref- erences and ensure that they
p.000199: have authorized a trusted person to make decisions on their behalf should they lose the capacity to provide ongoing
p.000199: consent (see Article 3.11 for guidance on research directives for individuals who lack capacity).
p.000199:
p.000199: Concern for Welfare
p.000199:
p.000199: The welfare of a person is the quality of that person’s experience of life in all its aspects. Welfare consists of the
p.000199: impact on individuals of factors such as their physical, mental and spiritual health, as well as their physical,
p.000199: economic and social circumstances. Thus, determinants of welfare can include housing, employment, security, family
p.000199: life, community membership, and social participation, among other aspects of life. Other contributing factors to
p.000199: welfare are privacy and the control of information about the person, and the treatment of human biological materials
p.000199: according to the free, informed and ongoing consent of the person who was the source of the information or materials. A
p.000199: person’s or group’s welfare is also affected by the welfare of those
p.000199:
...
p.000199: that person has some ability to understand the significance of the research, the researcher shall ascertain the wishes
p.000199: of that individual with respect to participation. Prospective participants’ dissent will preclude their participation.
p.000199: Application Many individuals who lack legal capacity to make decisions may still be able to express their wishes in
p.000199: a meaningful way, even if such expression may not fulfil all of the requirements for consent. Prospective participants
p.000199: may be capable of verbally or physically assenting to, or dissenting from, participation in research. Those who may be
p.000199: capable of assent or dissent include:
p.000199: (a) those whose capacity is in the process of development, such as children whose capacity for judgment and
p.000199: self-direction is maturing;
p.000199: (b) those who once were capable of making an autonomous decision regarding consent but whose capacity is diminishing or
p.000199: fluctuating; and
p.000199: (c) those whose capacity remains only partially developed, such as those living with permanent cognitive impairment.
p.000199: While their assent would not be sufficient to permit them to participate in the absence of consent by an authorized
p.000199: third party, their expression of dissent or signs suggesting they do not wish to participate must be respected.
p.000199: Research Directives
p.000199: Although advance directives for treatment are recognized as a legitimate tool in health care, the use of directives in
p.000199: the context of research is not well developed and they have no legal status. For the purposes of this Policy, research
p.000199: directives should be understood to express an individual’s preferences for participation in future research in the
p.000199: event that the individual loses capacity. Research directives are written instructions to be used by the authorized
p.000199: third party as information about a prospective participant’s preferences when the third party is asked to provide
p.000199: substitute consent.
p.000199:
p.000199:
p.000199:
p.000199: 42 TCPS 2
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: The efficacy of research directives is unknown and their legal status has not yet been recognized or tested. Research
p.000199: directives, nevertheless, are congruent with this Policy’s core principle of Respect for Persons. The use of research
p.000199: directives respects the right of individuals to express their preference regarding participation in research and
...
p.000199: anticipate subsequent research uses. Some types of research initiatives (e.g., the creation of large databases
p.000199: sometimes known as research plat- forms) involve long-term retention and use of information or human biological
p.000199: materials for research purposes (e.g., longitudinal studies that involve biobanking).
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 43
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: When data for these platforms are initially collected, it is not typically possible to specify every research that
p.000199: could be carried out using the participants’ information or human biological materials. Research directives may be used
p.000199: in these contexts to give participants the opportunity to express their preferences about future research should they
p.000199: lose capacity (see Article 5.5[d] for expression of preferences in the con- text of secondary use of data).
p.000199: In long-term projects, research directives may be used to allow participants to make choices about other aspects of
p.000199: research participation. For example, participants could specify preferences about receiving findings, or allowing the
p.000199: continued use of their information or samples in the event that they lose capacity, or after they die.
p.000199: Individuals can also use research directives to express preferences concerning par- ticipation in future research. For
p.000199: example, individuals in an early stage of cognitive impairment may use a research directive to express their
p.000199: preferences for future par- ticipation in research that, due to diminishing capacity, they would not otherwise be able
p.000199: to consent to on their own. They also allow existing participants to express their preference to continue to
p.000199: participate in research should they lose capacity. Research directives should be as specific as possible, and in the
p.000199: event of ambiguity or imprecision, should be interpreted narrowly. Individuals should be encouraged to periodically
p.000199: update their research directives and, if possible, construct directives in contemplation of specific types of research
p.000199: interventions. Research directives should be written, dated and witnessed, and include a declaration about the capacity
p.000199: of the individual at the time the directive was made.
p.000199:
p.000199: D. Consent Shall Be Documented
p.000199:
p.000199: Article 3.12 Evidence of consent shall be contained either in a signed consent form or in documentation
p.000199: by the researcher of another appropriate means of consent.
p.000199: Application Written consent in a signed statement from the participant is a common means of demonstrating consent,
p.000199: and in some instances, is mandatory (e.g., Health Canada regulations under the Food and Drugs Act, the Civil Code of
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Health / Drug Dependence
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p.000199: authority. The influence of power re- lationships (e.g., employers and employees, teachers and students, commanding
p.000199: officers and members of the military or correctional officers and prisoners) on the voluntariness of consent should be
p.000199: judged from the perspective of prospec- tive participants, since the individuals being recruited may feel constrained
p.000199: to follow the wishes of those who have some form of control over them. This con- trol may be physical, psychological,
p.000199: financial or professional, for example, and may involve offering some form of inducement or threatening some form of
p.000199: deprivation. In such situations, the control exerted in a power relationship may place undue pressure on the
p.000199: prospective participants. At the extreme, there can be no voluntariness if consent is secured by the order of
p.000199: authorities.
p.000199: REBs and researchers should also pay particular attention to elements of trust and dependency in relationships (e.g.,
p.000199: between physician and patient or between professor and student). These relationships can impose undue influence on the
p.000199: individual in the position of dependence to participate in research projects. Any relationship of dependency, even a
p.000199: nurturing one, may give rise to undue in- fluence even if it is not applied overtly. There may be a greater risk of
p.000199: undue influence in situations of ongoing or significant dependency.
p.000199:
p.000199:
p.000199:
p.000199: 28 TCPS 2
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: Pre-existing entitlements to care, education and other services should not be prejudiced by the decision of whether or
p.000199: not to participate in, or to withdraw from, a research project. Accordingly, for example, a physician should ensure
p.000199: that continued clinical care is not linked to research participation. Similarly, where students do not wish to
p.000199: participate in research studies for course credits, they should be offered a comparable alternative.
p.000199: Coercion
p.000199: Coercion is a more extreme form of undue influence, involving a threat of harm or punishment for failure to
...
Searching for indicator dependency:
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p.000199: participate in research.
p.000199: UndueXInfluence
p.000199: Undue influence and manipulation may arise when prospective participants are recruited by individuals in a position of
p.000199: authority. The influence of power re- lationships (e.g., employers and employees, teachers and students, commanding
p.000199: officers and members of the military or correctional officers and prisoners) on the voluntariness of consent should be
p.000199: judged from the perspective of prospec- tive participants, since the individuals being recruited may feel constrained
p.000199: to follow the wishes of those who have some form of control over them. This con- trol may be physical, psychological,
p.000199: financial or professional, for example, and may involve offering some form of inducement or threatening some form of
p.000199: deprivation. In such situations, the control exerted in a power relationship may place undue pressure on the
p.000199: prospective participants. At the extreme, there can be no voluntariness if consent is secured by the order of
p.000199: authorities.
p.000199: REBs and researchers should also pay particular attention to elements of trust and dependency in relationships (e.g.,
p.000199: between physician and patient or between professor and student). These relationships can impose undue influence on the
p.000199: individual in the position of dependence to participate in research projects. Any relationship of dependency, even a
p.000199: nurturing one, may give rise to undue in- fluence even if it is not applied overtly. There may be a greater risk of
p.000199: undue influence in situations of ongoing or significant dependency.
p.000199:
p.000199:
p.000199:
p.000199: 28 TCPS 2
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: Pre-existing entitlements to care, education and other services should not be prejudiced by the decision of whether or
p.000199: not to participate in, or to withdraw from, a research project. Accordingly, for example, a physician should ensure
p.000199: that continued clinical care is not linked to research participation. Similarly, where students do not wish to
p.000199: participate in research studies for course credits, they should be offered a comparable alternative.
p.000199: Coercion
p.000199: Coercion is a more extreme form of undue influence, involving a threat of harm or punishment for failure to
p.000199: participate. Coercion would negate the voluntariness of a decision to participate, or to remain, in a research project.
p.000199: Incentives
p.000199: Incentives are anything offered to participants, monetary or otherwise, for par- ticipation in research (incentives
p.000199: differ from reimbursements and compensation for injury, which are discussed in Article 3.2[j]). Because incentives are
p.000199: used to encourage participation in a research project, they are an important consid- eration in assessing
p.000199: voluntariness. Where incentives are offered to participants, they should not be so large or attractive as to encourage
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Health / Drug Usage
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p.000199: par- ticular groups should clarify to their REBs the grounds for the exclusion.
p.000199: Where a language barrier exists between the researcher and the prospective partic- ipant, various measures may be
p.000199: used to ensure effective communication in recruitment and consent discussions. For example, an intermediary who
p.000199: may not be part of the research project or team, but who is competent in the language used by the researchers, as well
p.000199: as that preferred by the participant, may assist with com- munication between prospective participants and researchers.
p.000199: The selection of an intermediary and their activities will depend on the nature, context and risks of the research.
p.000199:
p.000199: B. Inappropriate Exclusion
p.000199: Research Involving Women
p.000199: Women have historically been inappropriately excluded from participating in some research. This exclusion of women,
p.000199: where unwarranted, has delayed the advancement of knowledge, denied po- tential benefits to women, and exposed women to
p.000199: harm when research findings from male-only research projects were generalized inappropriately to women, as has often
p.000199: been the case in clinical drug trials. The inclusion of women in research advances the commitment to Justice, improves
p.000199: the generalizability of research findings to women where that is a goal of the research, and is es- sential to ensure
p.000199: that women and men benefit equally from research.
p.000199:
p.000199:
p.000199: 48 TCPS 2
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: Article 4.2 Women shall not be inappropriately excluded from research solely on the basis of gender or sex.
p.000199: Application Researchers should not exclude women from research unless there is a valid reason for doing so. While
p.000199: some research is properly focused on particular research pop- ulations that do not include women, or include very few
p.000199: women, women should generally be represented where there is a reasonable expectation that the results of the research
p.000199: will be generalized to women.
p.000199: Article 4.2 rejects discriminatory and unethical use of inclusion or exclusion criteria that presumptively or
...
p.000199: relevant professional body and/or legal counsel.
p.000199: Researchers shall also inform participants and seek their consent if their personal information may be shared with
p.000199: government departments or agencies, community partners in the research, personnel from an agency that monitors the
p.000199: research, a re- search sponsor (such as a pharmaceutical company), the REB or a regulatory agency.
p.000199: Researchers shall avoid being put in a position of becoming informants for author- ities or leaders of
p.000199: organizations. For example, when records of prisoners, employees, students or others are used for research
p.000199: purposes, the researcher shall not provide authorities with results that could identify individuals unless the prior
p.000199: written consent of the participants has been given. Researchers may, however, pro- vide administrative bodies with
p.000199: aggregated data that cannot be linked to individuals for purposes such as policy-making or program evaluation. When
p.000199: seeking consent, researchers shall advise prospective participants if aggregated data from a project
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 59
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: may be disclosed, particularly where such disclosure may pose a risk to the partic- ipants. For example, aggregate data
p.000199: provided to authorities about research on illicit drug use in a penitentiary may pose risks of reprisal to the
p.000199: prisoners, even though they are not identified individually.
p.000199: When planning a study, researchers should incorporate any applicable statute-based or other legal principles that may
p.000199: afford protection for the privacy of participants and the confidentiality of research information.
p.000199:
p.000199: C. Safeguarding Information
p.000199: Article 5.3 Researchers shall provide details to the REB regarding their proposed measures for safeguarding
p.000199: information, for the full life cycle of information: its collection, use, dissemination, retention and/or disposal.
p.000199: Application Researchers shall assess privacy risks and threats to the security of information for all stages of the
p.000199: research life cycle, and implement appropriate measures to protect information. Safeguarding information helps respect
p.000199: the privacy of participants and helps researchers fulfil their confidentiality obligations. In adopting measures to
p.000199: safeguard information, researchers should follow disciplinary standards and prac- tices for the collection and
p.000199: protection of information gathered for research purposes. Formal privacy impact assessments are required in some
p.000199: institutions and may also be required under legislation or policy in some jurisdictions. Security measures should take
p.000199: into account the nature, type and state of data: the data’s form (e.g., paper or electronic records); content (e.g.,
p.000199: presence of direct or indirect identifiers); mobility (e.g., kept in one location or subject to physical or electronic
...
p.000145: CLINICAL TRIALS
p.000145:
p.000145: This chapter focuses on the ethical issues involved in the design, review and conduct of clinical trials (as defined
p.000145: below). In particular, it addresses clinical trial design, therapeutic misconception, research-attributable risk, and
p.000145: other issues that may be unique to clinical trials. As clinical trials are, perhaps, the most regulated type of
p.000145: research – subject to provincial, national and international regulatory bodies – reference will be made to these
p.000145: regulations, where appropriate. However, the emphasis in this chapter is on ethical guidance, grounded in the core
p.000145: principles of this Policy: Respect for Persons, Concern for Welfare, and Justice. As is the case throughout this
p.000145: Policy, the welfare of participants takes precedence over the interests of researchers and sponsors.
p.000145: For the purposes of this Policy, a clinical trial, a form of clinical research (also known as patient- oriented
p.000145: research), is any investigation involving participants that evaluates the effects of one or more health-related
p.000145: interventions on health outcomes. Interventions include, but are not restricted to, drugs, radiopharmaceuticals, cells
p.000145: and other biological products, surgical procedures, radiologic procedures, devices, genetic therapies, natural health
p.000145: products, process-of-care changes, preventive care, manual therapies and psychotherapies. Clinical trials may also
p.000145: include questions that are not directly related to therapeutic goals – for example, drug metabolism – in addition to
p.000145: those that directly evaluate the treatment of participants.
p.000145: Clinical trials are most frequently undertaken in biomedical research, although research that evaluates interventions,
p.000145: usually by comparing two or more approaches, is also conducted in related disciplines, such as psychology. The
p.000145: researcher leading a clinical trial is often (but not always) a clinician, that is, a health care provider (e.g.,
p.000145: physician, dentist, naturopath, nurse, physiotherapist). Although various types and forms of clinical trials have
p.000145: methodological differences, the ethical principles and procedures articulated in this Policy are applicable, and can be
p.000145: adapted as needed. Researchers and research ethics boards (REBs) should consult the other chapters of the Policy for
p.000145: additional guidance on principles, norms and practices applicable to all research.
p.000145: This chapter will require periodic revision, particularly in light of the ongoing efforts to develop provincial,
p.000145: national and international guidance for new methods and emerging areas of clinical re- search, including, but not
p.000145: limited to, clinical trials. Though much clinical research is observational and evaluative such that previous chapters
p.000145: provide relevant guidance, there are plans to develop additions to the Policy that include both interventional clinical
p.000145: research (i.e., clinical trials) and encompass the fuller spectrum of non-interventional clinical research (e.g.,
p.000145: public health research, epidemiology). This is in keeping with a commitment to the continued evolution of this Policy.
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: TCPS 2
p.000147: 147
p.000147:
p.000147: Chapter 11 – Clinical Trials
p.000147:
...
p.000149: trial proposed (and, where relevant, its phase), identify the foreseeable risks and potential benefits to participants,
p.000149: and show how this information will be clearly communicated to participants in the consent process (see Article 3.2).
p.000149: REBs reviewing clinical trials need to be familiar with the ethical issues raised by different phases, and by different
p.000149: types, of clinical trials. If an REB does not have members with the appropriate expertise to review a particular trial,
p.000149: then it shall seek out someone with the necessary expertise to consult as an ad hoc advisor (see Article 6.5).
p.000149: This guidance applies equally to continuing research ethics review, including requests to make changes to the method,
p.000149: statistical procedures, inclusion/exclusion criteria, or other elements of approved research, as required by this
p.000149: Policy (see Article 6.14 and 6.16).
p.000149: Pharmaceutical Trials
p.000149: Clinical trials involving pharmaceutical products are commonly categorized into four phases, each of which gives
p.000149: rise to particular ethical issues. Detailed descriptions of the phases of clinical trials are provided in
p.000149: other guidance documents (see References). The ethical concerns described are most likely to arise in a specific
p.000149: phase of a clinical trial. Some issues may arise at any phase of a clinical trial.
p.000149: Phase I
p.000149: Safety concerns are particularly acute in phase I research because it may be the first time participants are exposed to
p.000149: the new drug (“first-in-human” trials), and there may be little or no experience with the drug. Phase I trials often
p.000149: depend on healthy participants who are offered incentives for their participation, though this
p.000149:
p.000149:
p.000149:
p.000149: 150 TCPS 2
p.000149:
p.000149: Chapter 11 – Clinical Trials
p.000149:
p.000149: is not usually the case in, for example, cancer trials. Increasingly, phase I trials include participants with specific
p.000149: diseases for whom conventional therapy has failed. The combination of clinical risk with uncertain or no likelihood of
p.000149: clinical benefit, and the often substantial incentives offered to participants, raises ethical concerns about safety,
p.000149: the selection and recruitment of participants, and the consent process. For safety, it is important to ensure that the
p.000149: drug is initially given to a small number of participants and that dosing is increased in clearly defined
p.000149: increments only after participants’ responses to the initial dose is known. Recruitment and consent
p.000149: procedures shall ensure that participants are aware of the untested nature of the therapy and that participants do not
p.000149: accept, because of the incentives being offered, risks they would otherwise refuse.
p.000149: Phase II
p.000149: Phase II or combined phase I/II clinical trials raise particular ethical concerns, because they are often conducted
p.000149: with populations whose therapeutic options have been exhausted. Examples include patients with cancer that is incurable
p.000149: by standard therapies and HIV/AIDS, or people with conditions that cause them acute or chronic pain. These
p.000149: circumstances may affect the perceptions of patients and their families as to the balance between the risks and
p.000149: potential benefits of the trial and thus may affect their decision whether to participate. Additionally,
p.000149: because participants in phase II trials may include patients who are unwell and frequently not working, the REB should
p.000149: ensure incentives for participation is not coercive, and patients do not accept risks they would otherwise
p.000149: refuse because of the incentives being offered. Researchers should be encouraged to consult with the REB at an early
p.000149: stage about any recruiting, consent or safety issues that arise.
p.000149: During the course of a phase II clinical trial, patients will have access to a new drug that may be efficacious
p.000149: (provide clinical benefit). Researchers shall: a) as part of the consent process, provide details on access to
p.000149: the new drug upon trial completion; and b) make reasonable efforts to secure continued access to the drug following
p.000149: the phase II trial, for those patients for whom the drugs appear to be efficacious.
p.000149: Phase III
p.000149: The REB should carefully examine phase III clinical trials to ensure that the care of patient-participants is not
p.000149: compromised in the random assignment to any arm of the trial (including the placebo arm – see Article 11.2).
p.000149: Researchers should also provide a plan for interim analysis of data, early unblinding of clinicians and/or patients,
p.000149: and/or ending the trial if the drug should prove effective or harmful. The REB should evaluate such plans with due
p.000149: consideration for the welfare of the participants and the group which is the focus of the research (see Article 3.2
p.000149: [l]).
p.000149: Researchers and the REB should also address the issue of continuing access to the experimental therapy after the trial
p.000149: closes. If the treatment benefits participants
p.000149:
p.000149:
p.000149:
p.000149: TCPS 2
p.000151: 151
p.000151:
p.000151: Chapter 11 – Clinical Trials
p.000151:
p.000151: and is safe, the proposal should state whether it will continue to be provided and under what conditions. REBs should
p.000151: be concerned about what provisions are possible to ensure that participants continue to receive adequate treatment.
p.000151: Phase IV
p.000151: Phase IV trials can be valuable for assessing the long-term safety and effectiveness of marketed drugs and devices.
p.000151: Earlier-stage trials are of limited duration, and subsequent research can identify side effects, toxicities, drug
p.000151: interactions and overall tolerance that may only emerge over time. However, in some cases, phase IV trials may be
p.000151: designed to serve primarily as marketing initiatives to encourage the prescription and continued use of an approved
p.000151: drug. For example, a clinician may be paid a per capita fee by a sponsor to collect data on the side effects and
p.000151: acceptance by patients of a drug being marketed by that drug’s sponsor. REBs should carefully consider the financial
p.000151: terms between sponsors and investigators associated with these trials as they may create problems such as inappropriate
p.000151: prescription practices, billing practices and/or inappropriate utilization of public resources (e.g., diagnostic
p.000151: services and medical imaging). Researchers and REBs must ensure that trials are undertaken for a bona fide scientific
p.000151: purpose, which includes a design and objective(s) that are scientifically, rather than commercially, driven. Phase IV
p.000151: trials designed with the primary goal of increasing sales do not constitute legitimate research.
p.000151:
p.000151: Natural Health Product Trials
p.000151: Natural Health Products (NHPs) may be viewed as safe simply because they are natural. Some NHPs, however, can pose
p.000151: serious health risks. NHPs may also be part of a multi-treatment therapeutic approach (e.g., a herbal medicine added to
p.000151: a conventional medicine or to a complementary alternative therapy). A research proposal for an NHP clinical trial shall
p.000151: clearly identify the known effects of the product under investigation and its possible contraindications. REBs should
p.000151: ensure that NHP clinical trial proposals are reviewed with the appropriate level of scrutiny as indicated by the
p.000151: foreseeable risks to the participants.
p.000151: In evaluating the research design REBs should consider the history of the NHP as provided in the literature review
p.000151: contained in the researcher’s brochure and/or in a monograph (such as those published by Health Canada setting out
p.000151: approved uses and cautionary information). For NHPs with an established safe history of human use, the researcher does
p.000151: not have to present the findings of prior testing with animals, if the proposed conditions of use in the trial do not
...
p.000155: interventions, the potential harms can be physical, psychological or social, and may cause lasting, irreparable damage.
p.000155: In accordance with the core principles, it is the responsibility of researchers and REBs to ensure that (a) foreseeable
p.000155: risks to participants are minimized, and appropriately evaluated alongside potential benefits, (b) participants are
p.000155: clearly informed as to the nature of these foreseeable risks and potential benefits, (c) participant safety is
p.000155: monitored and accurately reported, and (d) any new information that may impact on the welfare of participants, or their
p.000155: decision to remain involved in a trial, be shared appropriately.
p.000155: Article 11.4 Researchers and REBs should ensure that the foreseeable risk to participants in clinical trials is:
p.000155: (a) justified by the potential benefits to be gained; and (b) appropriately minimized.
p.000155: Application The researcher has a responsibility to present the proposed research in the context of a systematic
p.000155: review of the literature on that topic. Clinical trials should not be conducted unnecessarily on questions that have
p.000155: already been definitively answered.
p.000155: The proportionate approach to research ethics review (see Chapter 2, Section B) dictates that trials deemed to be of
p.000155: greater risk should be subject to proportionately greater scrutiny. In all clinical research, the REB should carefully
p.000155: evaluate previous laboratory, animal and human research with a drug or other therapy, and/or have an expert evaluation
p.000155: undertaken on its behalf, to ensure that the foreseeable risk from its use is: (a) justified by the potential
p.000155: benefits to be gained; and (b) appropriately minimized.
p.000155: Where appropriate, based on reports of safety issues arising in the trial, an REB may discontinue the trial at its
p.000155: institution, require the disclosure of relevant safety information to existing and future participants (see Articles
p.000155: 6.3 and 6.15), or take other steps that are reasonably necessary to promote the safety of participants, such as
p.000155: unblinding.
p.000155:
p.000155:
p.000155:
p.000155:
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p.000157: Chapter 11 – Clinical Trials
p.000157:
p.000157: Article 11.5 When describing the foreseeable risks and potential benefits of research involving participants who are
p.000157: undergoing high-risk therapies, researchers should clearly indicate which risks are attributable to the research
p.000157: (including cumulative risks), and which risks the participants would normally be exposed to in the course of their
p.000157: clinical care.
p.000157: In their evaluation of risk, REBs should ensure that they are evaluating only those risks that are attributable to the
p.000157: research (including cumulative risks), and not compounding them with the risks attributable to clinical care.
p.000157: Application The evaluation of foreseeable risk to participants in a clinical trial can be complicated
p.000157: if the prospective participants are already exposed to risks in the course of their clinical care. It is the
...
p.000161: jurisdiction. REBs may advise researchers as to the steps they must take to eliminate or mitigate newly
p.000161: reported risks, and how this information should be shared with participants (see Article 11.8). In exceptional
p.000161: cases, REBs may decide to suspend new recruitment, or to suspend all participant involvement in a trial pending further
p.000161: investigation.
p.000161:
p.000161: D. Financial Conflicts of Interest
p.000161: Clinical trials can be affected by all types of conflict of interest: personal, professional and/or institutional (as
p.000161: described in Chapter 7). Article 11.10 deals specifically with financial conflicts of interest that are of concern for
p.000161: sponsored clinical trials.
p.000161: Sponsored Research
p.000161: Article 11.10 Researchers and REBs should be aware of and consider the possibility of financial conflicts of interest.
p.000161: They should ensure that clinical trials are designed to meet appropriate standards of participant safety in accordance
p.000161: with the core principles of this Policy. Financial considerations shall not affect these standards or the scientific
p.000161: validity and transparency of trial procedures.
p.000161: Application Researchers should not benefit financially from pharmaceutical or biotechnology companies, or other
p.000161: types of sponsors. Financial incentives have the potential to distort researchers’ judgment in ensuring the design and
p.000161: conduct of the trial is ethical. Some clinical trials are conducted under contract with companies that have a profit
p.000161: motive in order to secure marketing approval for the drug, device or product being tested. Because these companies
p.000161: operate on a profit-based model, the financial benefits of demonstrating efficacy and safety in a novel therapy may
p.000161:
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p.000163: Chapter 11 – Clinical Trials
p.000163:
p.000163: have the effect of compromising standards of participant protection and scientific validity (see Chapter 7). Financial
p.000163: conflicts of interest are not a feature of all sponsored research. However, REBs shall consider the potential for
p.000163: conflicts of interest in clinical trials because it has been empirically established as a risk of some sponsored
p.000163: research and can undermine the ethical conduct of research.
p.000163: Clinical Trial Budgets
p.000163: Budgets for clinical trials are usually calculated based on per capita costs – that is, the sponsor pays the researcher
p.000163: a fixed sum for each participant, based on the duration and complexity of the trial and the tests and procedures it
p.000163: requires.
p.000163: Article 11.11 REBs shall ensure that clinical trial budgets are reviewed to ensure that conflicts of interest are
p.000163: identified and minimized, or otherwise managed.
p.000163: Application REBs may delegate the review of clinical trial budgets to an appropriate institutional
p.000163: body. The body should ensure financial conflicts of interest are reported to the REB. When no such
p.000163: institutional body exists, the REBs shall review clinical trial budgets for financial conflicts of interest. As a
p.000163: general guide, payments for clinical trial procedures should be no greater than the usual amounts charged by health
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p.000165: www.science.gc.ca/default.asp?Lang=En&n=9990CB6B-1
p.000165: • Consolidated Standards of Reporting Trials: CONSORT Statement, and Explanation and Elaboration document.
p.000165: www.consort-statement.org
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
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p.000167:
p.000167: Chapter 11 – Clinical Trials
p.000167:
p.000167: • Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to
p.000167: the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. 1997.
p.000167: http://conventions.coe.int/Treaty/EN/Treaties/Html/164.htm
p.000167: • Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for
p.000167: Biomedical Research Involving Human Subjects. Geneva: 2002. www.cioms.ch/publications/layout_guide2002.pdf
p.000167: • Health Canada. Therapeutic Products Directorate. Medical Devices Bureau. Guidance documents.
p.000167: www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/index-eng.php
p.000167: • International Conference on Harmonisation. Guidance for Industry: Good Clinical Practice – Consolidated
p.000167: Guidelines, ICH Topic E6: Technical Requirements for the Registration of Pharmaceuticals for Human Use. 1996. Adopted
p.000167: by Health Canada in 1997.
p.000167: www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-eng.php
p.000167: • Ottawa Hospital Research Institute. Ottawa Statement on Trial Registration. http://ottawagroup.ohri.ca
p.000167: • United States. Food and Drug Administration. Food and Drug Administration Amendments Act of 2007. September 2007.
p.000167: • United States. National Institutes of Health. NIH Policy for Data and Safety Monitoring. Released 1998.
p.000167: www.grants.nih.gov/grants/guide/notice-files/not98-084.html
p.000167: • ———. Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials. Released 2000.
p.000167: www.grants.nih.gov/grants/guide/notice-files/not-od-00-038.html
p.000167: • World Medical Association. Declaration of Helsinki – Ethical Principles of Medical Research Involving Human
p.000167: Subjects. 2008. www.wma.net/en/30publications/10policies/b3/index.html
p.000167:
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p.000167: Chapter 12
p.000167: HUMAN BIOLOGICAL MATERIALS INCLUDING MATERIALS RELATED TO HUMAN REPRODUCTION
p.000167:
p.000167: Introduction
p.000167: The use of materials originating from human bodies for research contributes greatly to the ad- vancement of knowledge.
p.000167: The sources of these materials can be from patients following diagnostic or therapeutic procedures, autopsy specimens,
p.000167: donations of organs or tissue from living or dead humans, body wastes (including urine, saliva, sweat) or abandoned
p.000167: tissue. Biological materials may also be sought from individuals for use in a specific research project. Once
p.000167: collected, biolog- ical materials may be held in biobanks to serve as a research resource for many years.
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p.000199: that may be determined in part by the nature of the research and the jurisdiction in which the research is being
p.000199: conducted.1
p.000199:
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p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: A. General Principles
p.000199: Consent Shall Be Given Voluntarily
p.000199: Article 3.1 (a) Consent shall be given voluntarily.
p.000199: (b) Consent can be withdrawn at any time.
p.000199: (c) If a participant withdraws consent, the participant can also request the with- drawal of their data or human
p.000199: biological materials.
p.000199: Application (a) The voluntariness of consent is important because it respects human dignity and means that
p.000199: individuals have chosen to participate in research according to their own values, preferences and wishes.
p.000199: The approach to recruitment is an important element in assuring voluntariness. In particular, how, when and where
p.000199: participants are approached, and who re- cruits them are important elements in assuring (or undermining) voluntariness.
p.000199: In considering the voluntariness of consent, REBs and researchers should be cognizant of situations where undue
p.000199: influence, coercion or the offer of incen- tives may undermine the voluntariness of a participant’s consent to
p.000199: participate in research.
p.000199: UndueXInfluence
p.000199: Undue influence and manipulation may arise when prospective participants are recruited by individuals in a position of
p.000199: authority. The influence of power re- lationships (e.g., employers and employees, teachers and students, commanding
p.000199: officers and members of the military or correctional officers and prisoners) on the voluntariness of consent should be
p.000199: judged from the perspective of prospec- tive participants, since the individuals being recruited may feel constrained
p.000199: to follow the wishes of those who have some form of control over them. This con- trol may be physical, psychological,
p.000199: financial or professional, for example, and may involve offering some form of inducement or threatening some form of
p.000199: deprivation. In such situations, the control exerted in a power relationship may place undue pressure on the
p.000199: prospective participants. At the extreme, there can be no voluntariness if consent is secured by the order of
p.000199: authorities.
p.000199: REBs and researchers should also pay particular attention to elements of trust and dependency in relationships (e.g.,
p.000199: between physician and patient or between professor and student). These relationships can impose undue influence on the
p.000199: individual in the position of dependence to participate in research projects. Any relationship of dependency, even a
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p.000199: reporting relationship with the REBs, and ensure the REBs are provided with necessary and sufficient ongoing financial
p.000199: and administrative resources to ful- fil their duties. REBs are independent in their decision making and are
p.000199: accountable to the highest body that established them for the process of research ethics review.
p.000199: Application The highest body of the institution that establishes the REB or REBs could be an individual, such as
p.000199: the president, rector or chief executive officer, or an equivalent body, such as a governing council, board of
p.000199: directors, or council of administration. Institutions shall have in place written procedures for the appointment,
p.000199: renewal and removal of REB members.
p.000199: For the integrity of the research ethics review process, and to safeguard public trust in that process, institutions
p.000199: shall ensure that REBs are able to operate effectively and independently in their decision making. Disagreement between
p.000199: the researcher
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p.000199: 68 TCPS 2
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p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: and the REB over a decision that cannot be resolved through discussion and reconsideration can be resolved
p.000199: through the normal appeal process (see Articles 6.18 to 6.20).
p.000199: Institutional policies and procedures shall also support and promote the independ- ence of REBs in their decision
p.000199: making so that REBs may be free of inappropriate influence, including situations of real, potential or perceived
p.000199: conflicts of interest (see Chapter 7).
p.000199: It is critical that institutions provide appropriate administrative resources to REBs (e.g., research ethics
p.000199: administration staff, a research ethics office) for the effective and efficient operation of the REB. The means by
p.000199: which this support may be pro- vided will vary by institution, but may include REB coordination, support in policy
p.000199: development and interpretation, record keeping, and provision of research ethics training opportunities to REB members,
p.000199: researchers and students. The research ethics administration staff may provide important ethics expertise in support of
p.000199: the REB’s ethical analysis and discussion. Research ethics administration staff should also have the necessary
p.000199: qualifications, as well as initial and continuing training, to appropriately perform their roles and responsibilities.
p.000199: Institutions should recognize the integral role of research ethics administration staff and research ethics office(s),
p.000199: as applicable, in supporting the REB in fulfilling its mandate.
p.000199: As an entity that draws its authority and resources from the institution, the REB remains accountable to the highest
p.000199: body of the institution that established it for the integrity of its processes.
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p.000199: It is advisable that each member be appointed to formally fulfil the requirements of only one of the above categories.
p.000199: To ensure the independence of REB decision making, institutional senior adminis- trators shall not serve on the REB.
p.000199: Application This minimum requirement for REB membership brings to bear the necessary basic background, expertise
p.000199: and perspectives to allow informed independent reflection and decision making on the ethics of research involving
p.000199: humans. At a minimum, the REB shall have members appointed in one capacity only for each of the mem- bership
p.000199: categories. Where the size of the REB exceeds the minimum requirements, additional members may fulfil more than one
p.000199: capacity. In any case, REB members can contribute to the review based on their experience, expertise or knowledge in
p.000199: more than one of the categories above (Article 6.4[a] to [d]).
p.000199: As an entity created and supported by the institution, an REB is encouraged to build strong relationships with its host
p.000199: institution and senior administration. The involve- ment of administrative staff dedicated to research ethics functions
p.000199: (e.g., the research ethics office administrator or director) may be relevant and appropriate to support REB procedures.
p.000199: However, an institutional senior administrator (e.g., vice-president of research, director general or director of
p.000199: business development) should not serve on an REB, or directly or indirectly influence the REB decision-making process
p.000199: (see Articles 6.2 and 6.10). The mere presence of a non-voting institutional senior administrator at REB meetings may
p.000199: be a source of real, potential or perceived con-
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p.000199: 70 TCPS 2
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p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: flict of interest, and may therefore undermine the independence of the REB by un- duly influencing REB deliberations
p.000199: and decisions (see Article 7.2).
p.000199: The size of an REB may vary based on the diversity of disciplines, fields of research and methodologies to be covered
p.000199: by the REB, as well as on the needs of the insti- tution. In appointing REB members, institutions should strive
p.000199: for appropriate diversity. Institutions may need to exceed the minimum REB membership require- ments in order to
p.000199: ensure adequate and thorough reviews, reasonable workload for REB members, or to respond to other local,
p.000199: provincial/territorial, or federal legal or regulatory requirements. For example, in the case of REB review of clinical
p.000199: tri- als, provincial/territorial or federal regulations may outline specific membership requirements in addition to the
p.000199: requirements set out in this Policy. Where REBs mainly review student research, they may consider adding a student REB
p.000199: member. Additional community representation should be commensurate with the size of the REB. Institutions are
p.000199: encouraged to establish a pool of substitute members (see below). Where research ethics administration staff have the
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p.000199: eliminate, minimize or otherwise manage real, potential or perceived conflicts of interest. If an REB is reviewing a
p.000199: research project in which a member of the REB has a personal or financial conflict of interest (see Section A of this
p.000199: chapter), the member must disclose the nature of the conflict and absent themselves from any discussion or decision
p.000199: regarding that research project. In the event that a member’s conflict of interest and necessary withdrawal from the
p.000199: meet- ing will threaten the maintenance of quorum, the REB can ensure that a substitute member be in attendance to
p.000199: maintain quorum.
p.000199: Conflict of interest policies should determine a reasonable time period during which an REB member is not allowed to
p.000199: review a proposal involving a recent collaborator, supervisor, student or other colleague (as defined by the
p.000199: institution). The purpose of these policies on time limits is to ensure adequate and continued access to com- petent
p.000199: expertise. In some cases, the scientific expertise of the REB member may still be sought when no other individuals with
p.000199: the scientific expertise relevant to the proposal under review are available to the REB. In such instances, the REB
p.000199: will record this explicitly in the minutes. The member should not be present when the REB makes its decision.
p.000199: REBs and Senior Administrators
p.000199: Institutional senior administrators (e.g., a vice-president of research or business de- velopment) should not serve on
p.000199: an REB, or directly or indirectly influence the REB decision-making process. The mere presence of an institutional
p.000199: senior administrator at REB meetings may undermine the independence of the REB by unduly influ- encing REB
p.000199: deliberations and decisions.
p.000199:
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p.000199: Chapter 7 – Conflicts of Interest
p.000199:
p.000199: REBs and senior administrators should consider other venues to discuss policy is- sues, general issues arising from the
p.000199: REB’s activities, or training and educational needs, to the benefit of the overall operation and mandate of the REB. In
p.000199: the dis- charge of their interdependent roles and duties to participants, effective communications
p.000199: processes should be established between REBs and the relevant officers of institutions. In cases where senior
p.000199: administrators interfere with the REB decision-making process, REBs should invoke the institution’s conflict of
p.000199: interest policies.
p.000199: Compensation for REB members
p.000199: Reasonable compensation by institutions for work done by REB members is ap- propriate. However, in some instances,
p.000199: individual members of the REB may have a conflict of interest in accepting undue or excessive honoraria for their
p.000199: participa- tion in the REB. Institutions should define appropriate levels of compensation.
p.000199: D. Researchers and Conflicts of Interest
p.000199: Article 7.4 Researchers shall disclose in research proposals they submit to the REB any real, potential or
p.000199: perceived individual conflicts of interest, as well as any institutional conflicts of interest of which they are aware
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p.000199: prevent, disclose, minimize or otherwise manage conflicts.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 95
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p.000199: Chapter 7 – Conflicts of Interest
p.000199:
p.000199: The REB should examine budgets to ensure that there are no inappropriate pay- ments to be made or other unexplained
p.000199: expenses that may raise questions about conflict of interest. Further, payment provisions should be scrutinized to
p.000199: ensure they do not create ethically inappropriate incentives to recruit quickly, at the ex- pense of a careful
p.000199: review of the suitability of prospective participants. Unreasonable payments or undue inducements may place
p.000199: the researcher, and some- times the institution, in a conflict between maximizing financial remuneration on the one
p.000199: hand and protecting participants and meeting the scientific requirements of the project on the other. Disclosure of the
p.000199: kinds and amounts of payments and other budgetary details encourages the researcher to identify and appropriately
p.000199: manage potential conflicts of interest and helps the REB to assess them. Manage- ment by institutions and/or REBs
p.000199: may include prohibiting certain forms of payment.
p.000199: The perception of a conflict of interest may, in many cases, be as damaging as a real conflict. The REB should assess
p.000199: the likelihood that the researcher’s judgment may be inappropriately influenced, or perceived to be influenced, by
p.000199: private or per- sonal interests. It should then determine the magnitude of harm that is likely to result from such
p.000199: influence or from the perception of undue influence.
p.000199: In addressing conflicts of interest, disagreements between the REB and the re- searcher may arise about the scope and
p.000199: reach of disclosure, including disclosure of new information to participants, or other aspects of managing the
p.000199: conflict. Reso- lution of disagreements should be guided by the paramount principles of Respect for Persons and Concern
p.000199: for Welfare of participants. If the researcher and the REB cannot resolve their disagreement they should use the
p.000199: institutional conflict of in- terest mechanisms to arrive at a solution.
p.000199:
p.000199: Endnote
p.000199:
p.000199:
p.000199: 1 Definition of “conflict of interest” based on Schedule 14 of the Memorandum of Understanding (MOU) on the Roles and
p.000199: Responsibilities in the Management of Federal Grants and Awards. www.nserc-
p.000199: crsng.gc.ca/NSERC-CRSNG/Policies-Politiques/MOURoles-ProtocolRoles/index_eng.asp
p.000199:
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p.000199:
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p.000199:
p.000199:
p.000199: Introduction
p.000199: Chapter 8
p.000199: MULTI-JURISDICTIONAL RESEARCH
p.000199: This chapter sets out options, procedures and considerations for the ethics review of multi-juris- dictional research
p.000199: either entirely within Canada, or in Canada and other countries. It is intended to facilitate the ethics review process
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p.000115: as inappropriate. Researchers should engage community processes, including the guidance of moral authorities such as
p.000115: Elders, to avert potential conflict. These measures should be documented to assist the REB in considering the community
p.000115: engagement processes proposed (see Article 9.10). Where no agreement exists between formal community leadership and
p.000115: customary authority regarding the conduct of the proposed research, researchers should inform the REB. When alternative
p.000115: community engagement processes are followed to endorse a project, all other ethical safeguards set out in this chapter
p.000115: remain applicable.
p.000115: Recognizing Diverse Interests within Communities
p.000115: Article 9.6 In engaging territorial or organizational communities, researchers should ensure, to the extent
p.000115: possible, that they take into consideration the views of all relevant sectors – including individuals and subgroups who
p.000115: may not have a voice in the formal leadership. Groups or individuals whose circumstances make them vulnerable
p.000115: may need or desire special measures to ensure their safety in the context of a specific research project. Those who
p.000115: have been excluded from participation in the past may need special measures to ensure their inclusion in research.
p.000115: Application Groups or individuals whose circumstances may make them vulnerable or marginalized within
p.000115: territorial or organizational communities should not be deprived of opportunities to participate in, and
p.000115: influence, research affecting their welfare. For example, people living with HIV/AIDS, impoverished youth or
p.000115: women who have suffered abuse may experience barriers to participation.
p.000115: Gender-based analysis is being applied in First Nations, Inuit and Métis organizations and communities to
p.000115: promote or restore recognition of women’s responsibilities in the conduct of community life – including decision
p.000115: making that directly affects their welfare. The legacy of patriarchal governance structures continues to pose
p.000115: challenges to women’s full participation. Approaches that are attentive to cultural considerations help to ensure the
p.000115: equitable participation and benefit of women throughout the life cycle of a research project (see Article 4.2).
p.000115: Research undertaken secretly or as a direct challenge to legitimate authority may increase risks to participants whose
p.000115: circumstances make them vulnerable, may deepen rifts within the community, and actually impede the advancement of
p.000115: social
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p.000119: committee (e.g., an urban community of interest). Where community engagement is not being proposed, perhaps
p.000119: due to the nature of the research and the community context (see Articles 9.1 and 9.2), researchers shall provide a
p.000119: rationale acceptable to the REB.
p.000119: Provision of a research agreement is particularly emphasized in health research funded by CIHR (see CIHR Guidelines for
p.000119: Health Research Involving Aboriginal People in References at end of this chapter).
p.000119: Where a researcher has an ongoing relationship with a community, a letter from formal or customary leaders in the
p.000119: relevant community may signal approval, and suffice to proceed with the research.
p.000119: Where, under the provisions of Articles 6.11 and 10.1, a community signals during preliminary discussions with
p.000119: researchers, prior to REB review, that the research may proceed but that it does not want further community engagement,
p.000119: researchers shall document and present to the REB the steps they took to invite and facilitate engagement by the
p.000119: community. See Article 9.14 on how researchers may assist in capacity building.
p.000119: Although researchers shall offer the option of engagement, a community may choose to engage nominally or not at all,
p.000119: despite being willing to allow the research to proceed. A community may, for example, support a research project
p.000119: carried out
p.000119:
p.000119:
p.000119:
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p.000121: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000121:
p.000121: independent of community influence, or without any further collaboration of the community in the actual implementation
p.000121: of the research in order to use scientifically defensible results to validate a negotiating position.
p.000121: Research Agreements
p.000121: Article 9.11 Where a community has formally engaged with a researcher or research team through a designated
p.000121: representative, the terms and undertakings of both the researcher and the community should be set out in a
p.000121: research agreement before participants are recruited.
p.000121: Application Research agreements serve as a primary means of clarifying and confirming mutual expectations and,
p.000121: where appropriate, commitments between researchers and communities. Research agreements, where applicable, shall
p.000121: precede recruitment of individual participants and collection of, or access to, research data. The scope of the
p.000121: agreement will depend on the level of engagement which the community desires, and the availability of resources to
p.000121: support community participation.
p.000121: At a minimum, the agreement should address the ethical protections that would apply to securing individual consent for
p.000121: a comparable project, and should specify any commitments regarding collective community participation and
p.000121: decision making, sharing of benefits and review, and updating of the agreement. Expanding on information normally
p.000121: provided to an individual participant (see Article 3.2), agreements typically set out the purpose of the
p.000121: research and detail mutual responsibilities in project design, data collection and management (see Article 5.3);
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p.000125:
p.000125: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000125:
p.000125: agreements where these exist. Researchers shall not disclose personal information to community partners without the
p.000125: participant’s consent, as set out in Article 3.2(i).
p.000125: Application Researchers and community partners should consider early in the design of the research how community
p.000125: codes of research practice fit with provisions for privacy and confidentiality as set out in Chapter 5. Where
p.000125: inconsistencies exist, they should be resolved in advance of starting the research. The research agreement should
p.000125: address how inconsistencies will be addressed if they arise over the course of the conduct of the research project.
p.000125: In First Nations communities, privacy and confidentiality of identifiable personal and community information may be
p.000125: affected by the application of the principles of ownership, control, access and possession (OCAP – see definition in
p.000125: Application of Article 9.8). The First Nations Regional Longitudinal Health Survey adminis- tered by regional
p.000125: First Nations organizations has addressed balancing confidentiality and access by having communities
p.000125: designate a regional organization to hold data, while local authorities make decisions on who can access the data, and
p.000125: under what conditions. In practice, the organization that serves as data steward evaluates requests for information,
p.000125: and its recommendations to community author- ities have considerable influence.
p.000125: Whatever the nature of the research, it shall be designed to include safeguards for participant privacy and measures to
p.000125: protect the confidentiality of any data collected. Small Aboriginal communities are characterized by dense
p.000125: networks of relationships. As a result, coding individual data is often not sufficient to mask identities, even
p.000125: when data are aggregated. Some Aboriginal participants are reluctant to speak to interviewers from their own
p.000125: community because of privacy concerns. Communities themselves have distinguishing characteristics, which in some cases
p.000125: have compromised efforts to disguise the research site, and has led to the stigmatization of entire communities.
p.000125: On the other hand, in some social sciences and humanities research, the significance of information is tied to the
p.000125: identity of the source. In these cases individual attribution, with consent, is appropriate. When
p.000125: individual participants waive anonymity, researchers should ensure that this is documented (see Application of
p.000125: Article 5.1 and Article 9.11). Communities partnering in research may wish to be acknowledged (e.g., in the research
p.000125: report) for their contribution to the research effort.
p.000125: Research undertaken with participants who have suffered traumatic experiences (e.g., former residential school
p.000125: students) poses a risk of re-traumatizing participants. Researchers should anticipate such risks in the research
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p.000141: that is not staged by the researcher, and is non- intrusive should normally be regarded as being of minimal risk.
p.000141: REBs and researchers need to consider the methodological requirements of the proposed research project and the ethical
p.000141: implications associated with observational approaches, such as the possible infringement of privacy. They should pay
p.000141: close attention to the ethical implications of such factors as the nature of the activities to be observed, the
p.000141: environment in which the activities are to be observed, whether the activities are staged for the purpose of the
p.000141: research, the expectations of privacy that prospective participants might have, the means of recording the
p.000141: observations, whether the research records or published reports involve identification of the participants, and any
p.000141: means by which those participants may give permission to be identified. REBs shall ensure that the proposal contains
p.000141: measures to protect the privacy of the individual in accordance with the law.
p.000141: Researchers and REBs should consult Chapters 3 and 5 for additional details and considerations regarding consent, and
p.000141: privacy and confidentiality.
p.000141: For observational research in which consent is not sought, researchers shall demonstrate to the REB that
p.000141: necessary precautions and measures have been taken to address privacy and confidentiality issues.
p.000141: Because the knowledge that one is being observed can be expected to influence behaviour, research involving
p.000141: non-participant or covert observation generally requires that the participants not know that they are being
p.000141: observed for research purposes. Typically the researcher has no direct interaction with the individuals being observed
p.000141: and therefore their consent is not sought. Covert observation of queuing behaviours in shopping malls is one example of
p.000141: a study where the research could not be completed if shoppers knew that they were being observed. Some forms of
p.000141: qualitative research seek to observe and study criminal behaviours, violent groups, or groups with restricted
p.000141: membership or access using covert participant observation. For example, some social science research that critically
p.000141: probes the inner workings of criminal organizations might never be conducted if the participants know in
p.000141: advance that they are being observed. Other observational studies may be anonymous but involve intervention by the
p.000141: researcher (e.g., studying the propensity of bystanders to help in an emergency normally requires a staged emergency).
p.000141: These methodological approaches may require the researcher seeking an exception to the general requirement for consent.
p.000141:
p.000141:
p.000141:
p.000141:
p.000141: 142 TCPS 2
p.000141:
p.000141: Chapter 10 – Qualitative Research
p.000141:
...
p.000147: Therapeutic Misconception
p.000147: Although clinical trials may provide benefits to some participants, the purpose of a clinical trial is to evaluate
p.000147: an experimental therapy or intervention, not to provide therapy. Therapeutic misconception occurs when trial
p.000147: participants do not understand that research is aimed primarily at producing knowledge and may not provide any
p.000147: therapeutic benefit to them. It also occurs when participants enter trials without understanding the ways in which
p.000147: elements of a clinical trial design may interfere with their own health care objectives.
p.000147: With the exception of some phase I trials, clinical trials usually involve individuals in need of treatment, for whom
p.000147: the experimental therapy is hoped to be effective. Even when foreseeable risks, potential benefits and treatment
p.000147: alternatives are explained to them, it is common that clinical trial patient-participants do not fully appreciate the
p.000147: differences between clinical care and research participation. As a result, some patient-participants may assume that
p.000147: there must be therapeutic value in the research procedures they are undergoing, or that they have been invited to
p.000147: participate because their clinician believes it would contribute to their health.
p.000147: Dual Roles of Clinician-Researchers
p.000147: Research has shown that clinician-researchers may conflate their clinical practice with their clin- ical trial
p.000147: research. Some may be overly optimistic about the prospects of an experimental intervention and overstate
p.000147: potential benefits or understate foreseeable risks to prospective partic- ipants. This can foster therapeutic
p.000147: misconception among patients and influence the recruitment and consent process (see Chapter 3 and Article 11.6).
p.000147: Clinicians must take care not to create un- realistic expectations among participants with respect to the potential
p.000147: benefits of the research.
p.000147: To preserve the trust on which their professional relationships with patients and colleagues reside, researchers should
p.000147: take all necessary measures to separate their role as researcher from their role as clinician (e.g., enlist associates
p.000147: to recruit participants, rely on colleagues to determine when a patient should be withdrawn). It is important REBs
p.000147: appreciate the potential conflicts between these roles and the possible impact on the welfare of prospective
p.000147: participants.
p.000147:
p.000147: B. Clinical Trial Design and Registration
p.000147: This section discusses ethical issues associated with the design and registration of clinical trials. Guidance for the
p.000147: most common types of clinical trials (pharmaceuticals, medical devices) as well as other types of trials (natural
p.000147: health products, psychotherapy and surgery), is provided in sub- sections of the Application of Article 11.1. Though
p.000147: not all possible clinical trial designs are
p.000147:
p.000147:
p.000147: TCPS 2
p.000149: 149
p.000149:
p.000149: Chapter 11 – Clinical Trials
p.000149:
p.000149: represented in this section, the guidance provided can be applied and adapted as needed. Researchers are
p.000149: advised to consult the relevant provincial, national and international regulatory documents to design their clinical
p.000149: trial (see References at the end of the chapter). In all clinical trials, researchers and REBs should be aware of
...
p.000183: Application Recruitment of members of a family may take place in various ways: through (a) the researcher, (b) an
p.000183: individual participant, or (c) a third party on behalf of an individual participant. A family group, such as parents
p.000183: and a child, or several adult siblings, may all receive an invitation at the same time from the researcher to
p.000183: participate in genetic research. Alternatively, researchers may seek permission from an individual participant to
p.000183: contact family members to invite participation. It may be preferable for the participant to make initial contact with
p.000183: the family member, in
p.000183:
p.000183:
p.000183: 184 TCPS 2
p.000183:
p.000183: Chapter 13 – Human Genetic Research
p.000183:
p.000183: order to respect privacy interests or known sensitivities. The participant may prefer to identify a third party to
p.000183: inform family members about the opportunity to participate in genetic research. However, an approach by someone
p.000183: in a position of authority over family members may raise concerns about undue influence or manipulation.
p.000183: Refer to Chapter 3 for further guidance in regard to the voluntariness of consent.
p.000183: Family members may have conflicting views about participation in research, and some may have specific sensitivities or
p.000183: objections. Researchers should recognize the potential for conflict within families and be respectful of any known
p.000183: sensitivi- ties. Where researchers seek participation from children or other members of a fam- ily who may lack
p.000183: capacity to consent, the applicable provisions in Chapter 3 shall be followed.
p.000183: E. Genetic Research Involving Communities and Groups
p.000183: Article 13.6 Where researchers intend to recruit participants for genetic research based on their membership in
p.000183: specific communities or groups, it may be appropriate for re- searchers to discuss the research with community
p.000183: or group members, and/or their leaders, in addition to seeking consent from individual participants. In these cases,
p.000183: researchers shall provide details to the REB about their proposed methods for en- gaging in discussion.
p.000183: Application Some genetic research seeks to explore genetic variations within specific commu- nities or groups. Such
p.000183: research may raise ethical concerns regarding stigmatization, unfair or inequitable treatment, and social disruption in
p.000183: communities or groups – especially if individual members disagree about participation in research. Discus- sion with
p.000183: formal or informal leaders or other members of the community or group may be appropriate. This determination will
p.000183: depend on factors such as: the objec- tives of the proposed research (in particular, the extent to which membership in,
p.000183: or characteristics of, the community or group are a key aspect of the research); the risks and potential benefits of
p.000183: the research to the community or group; the nature of the community or group from which participants will be recruited;
p.000183: and the com- munity’s or group’s organizational structure.
p.000183: Individuals within a community or group may have conflicting views about par- ticipation in research, including
p.000183: disagreements between leaders and members. Such conflicts may involve attempts by some to influence or coerce choices
p.000183: of others about whether to participate in research. Researchers should recognize the potential for conflict within
p.000183: communities or groups, and ensure that consent and discussion processes facilitate free and informed decisions by
p.000183: individual members. Refer to Chapter 3 for further guidance in regard to voluntariness of consent.
p.000183: Researchers who propose to conduct genetic research involving Aboriginal participants or communities, or to
p.000183: use human biological materials that are identifiable as originating from Aboriginal peoples, should refer to
p.000183: Chapter 9 for further guidance.
p.000183:
p.000183:
p.000183:
p.000183: TCPS 2
p.000185: 185
p.000185:
p.000185: Chapter 13 – Human Genetic Research
p.000185:
p.000185: F. Genetic Material Banks
p.000185: Article 13.7 (a) Researchers who propose research involving the collection and banking of genetic material shall
p.000185: indicate in their research proposal, and in the information they provide to prospective participants, how they plan to
p.000185: address the associated ethical issues, including confidentiality, privacy, storage, use of the data and results,
p.000185: possibility of commercialization of research findings and withdrawal by participants as well as future contact of
p.000185: participants, families, communities and groups.
p.000185: (b) Researchers who propose research involving the secondary use of previously collected and banked genetic material
p.000185: shall, likewise, indicate in their research proposal how they plan to address associated ethical issues.
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p.000193:
p.000193: Observational research – The study of behaviour in a natural environment in which people involved in their normal
p.000193: activities are observed whether with or without their knowledge. This term does not include observational methods used
p.000193: in epidemiological research.
p.000193:
p.000193: Ongoing research – Research that has received REB approval and has not yet been completed.
p.000193:
p.000193: Participant – An individual whose data, or responses to interventions, stimuli, or questions by a researcher are
p.000193: relevant to answering a research question; also referred to as “human participant,” and in other
p.000193: policies/guidance as “subject” or “research subject.”
p.000193:
p.000193: Participatory research – Research that includes the active involvement of those who are the subject of the research.
p.000193: Participatory research is usually action-oriented, where those involved in the research process collaborate to define
p.000193: the research project, collect and analyze the data, produce a final product and act on the results. See
p.000193: “Community-based research” and “Collaborative research.”
p.000193:
p.000193: Principal investigator – The leader of a research team who is responsible for the conduct of the research, and for the
p.000193: actions of any member of the research team.
p.000193:
p.000193:
p.000193:
p.000193:
p.000193: 194 TCPS 2
p.000193:
p.000193: Glossary
p.000193:
p.000193: Personal information – Identifiable information about an individual. See “Identifiable information.”
p.000193: Pharmaceutical trial – A clinical trial designed to test the safety and/or efficacy of a pharmaceutical product.
p.000193: A pharmaceutical product is any chemical substance intended for use in the medical diagnosis, cure, treatment, or
p.000193: prevention of disease, disorders, or other illness.
p.000193: Placebo-controlled trials – A clinical trial in which the safety or efficacy of one or more interventions are compared
p.000193: with a placebo control group.
p.000193: A placebo is an inactive substance or intervention that resembles the comparable active substance or intervention.
p.000193:
p.000193: Privacy – An individual’s right to be free from intrusion or interference by others.
p.000193:
p.000193: Privacy risks – The potential harms that participants, or the groups to which they belong, may experience from the
p.000193: collection, use, and disclosure of personal information for research purposes.
p.000193:
p.000193: Proportionate approach to research ethics review – The assessment of foreseeable risk to determine the level of
p.000193: scrutiny a research proposal will receive (i.e. delegated review for minimal risk research or full REB review for
p.000193: research above minimal risk), as well as the consideration of foreseeable risks, potential benefits, and ethical
p.000193: implications of the research in the context of initial and continuing review.
p.000193:
p.000193: Psychotherapy trials – A clinical trial testing the safety and/or efficacy of one or more psychotherapeutic approaches
p.000193: to behavioural disorders or other mental illness.
p.000193:
p.000193: Publicly declared emergency – An emergency situation which, due to the extraordinary risks it presents, has been
p.000193: proclaimed as such by an authorized public office (in accordance with legislation and/or public policy). Publicly
p.000193: declared emergencies are extraordinary events that arise suddenly or unexpectedly, and require urgent or quick
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p.000129: out in Article 5.6 apply for new initiatives of this kind.
p.000129: Article 9.22 REB review is required where the researcher seeks data linkage of two or more anonymous datasets or
p.000129: data associated with human biological materials and there
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129: TCPS 2
p.000131: 131
p.000131:
p.000131: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000131:
p.000131: is a reasonable prospect that this could generate information identifiable as originating from a specific
p.000131: Aboriginal community or a segment of the Aboriginal community at large.
p.000131: Application The REB may determine that community engagement is required to seek guidance on secondary use. Articles
p.000131: 5.5 and 5.6 or Articles 12.3 and 12.4 may apply.
p.000131: Consistent with Article 2.4, REB review is not required for research involving only anonymous datasets or anonymous
p.000131: human biological materials, and associated data, that cannot be identified as originating from a specific Aboriginal
p.000131: community or a segment of the Aboriginal community at large. Community engagement is not possible given that the data
p.000131: or human biological materials cannot be linked to a specific Aboriginal community or specific individuals. Where the
p.000131: researcher seeks data linkage of two or more anonymous sets of information or human biological materials and there is a
p.000131: reasonable prospect that this could generate identifiable information, then REB review is required.
p.000131:
p.000131: Endnotes
p.000131:
p.000131:
p.000131: 1 Indian peoples commonly identify themselves as “First Nations.” First Nation: A term that came into common usage in
p.000131: the 1970s to replace the word “Indian,” which some people found offensive. Although the term First Nation is widely
p.000131: used, no legal definition of it exists. Among its uses, the term “First Nations peoples” refers to the Indian peoples
p.000131: in Canada, both Status and non-Status. Some Indian peoples have also adopted the term “First Nation” to replace the
p.000131: word “band” in the name of their community. See Indian and Northern Affairs Canada, Terminology, available at www.ainc-
p.000131: inac.gc.ca/ap/tln-eng.asp.
p.000131: 2 www.nserc-crsng.gc.ca/NSERC-CRSNG/Policies-Politiques/MOURoles-ProtocolRoles/index_eng.asp
p.000131: 3 Constitution Act, 1982, s. 35. http://laws.justice.gc.ca/en/const/9.html#anchorsc:7-bo-ga:l_II
p.000131: 4 www.wipce2008.com/enews/pdf/wipce_fact_sheet_21-10-07.pdf
p.000131:
p.000131: References
p.000131:
p.000131:
p.000131: • Canadian Institutes of Health Research. CIHR Guidelines for Health Research Involving Aboriginal People. May
p.000131: 2007. www.cihr-irsc.gc.ca/e/29134.html
p.000131: • ———. CIHR Best Practices for Protecting Privacy in Health Research. September 2005.
p.000131: www.cihr-irsc.gc.ca/e/29072.html
p.000131: • First Nations Centre. OCAP: Ownership, Control, Access and Possession. Sanctioned by the First Nations
p.000131: Information Governance Committee, Assembly of First Nations. Ottawa: National Aboriginal Health Organization
p.000131: www.naho.ca/english/pub_research.php
p.000131: • First Nations Regional Longitudinal Health Survey (RHS). www.rhs-ers.ca/english
p.000131:
p.000131:
p.000131:
p.000131:
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p.000173: relatives and others with shared genetic characteristics.
p.000173:
p.000173:
p.000173:
p.000173:
p.000173:
p.000173: TCPS 2
p.000175: 175
p.000175:
p.000175: Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction
p.000175:
p.000175: Article 12.5 Institutions and researchers that maintain biobanks:
p.000175: (a) shall ensure that they have or use appropriate facilities, equipment, policies and procedures to store human
p.000175: biological materials safely, and in accordance with applicable standards; and
p.000175: (b) shall establish appropriate physical, administrative and technical safeguards to protect human biological materials
p.000175: and any information about participants from unauthorized handling.
p.000175: Application Safe storage of human biological materials is important to maintain their scientific value, and to
p.000175: protect materials and associated information about participants. Procedures for storage and record keeping shall
p.000175: include effective measures to ensure that participants’ identities are protected. Such measures include the security of
p.000175: facilities and effective procedures for data handling, record keeping and regulating access to human
p.000175: biological materials and information. Appropriate governance of biobanks is also important for managing access to
p.000175: and use of stored biological materials. The appropriate governance structure and management of a biobank will vary
p.000175: depending on its size and usage.
p.000175: Organizations that maintain biobanks may have their own policies on privacy of, confidentiality of and access to
p.000175: materials. Researchers should be aware of requirements for compliance with such policies. For example, researchers
p.000175: may be required to apply to the organization for permission to access biological samples, and they may be required to
p.000175: enter into an agreement with the organization that sets out conditions for research access and use of materials in the
p.000175: biobank.
p.000175: Identifiable data derived from human biological materials may be linked to other research or public databases. Such
p.000175: data linking can be a powerful research tool and a valuable resource for monitoring the health of populations,
p.000175: understanding factors influencing disease, and evaluating health services and interventions. However, data linkage also
p.000175: raises separate privacy issues, discussed in Section E of Chapter 5.
p.000175:
p.000175: E. Research Involving Materials Related to Human Reproduction
p.000175: Researchers who conduct research involving human biological materials related to human reproduction shall
p.000175: follow applicable guidance expressed in other chapters of this Policy. This section provides further guidance for
p.000175: research involving embryos, fetuses, fetal tissue, and reproductive materials. For the purposes of this Policy
p.000175: the following definitions apply:3
p.000175: • Embryo means a human organism during the first 56 days of its development following fertilization or creation,
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Health / HIV/AIDS
Searching for indicator HIV:
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p.000115: Elders, to avert potential conflict. These measures should be documented to assist the REB in considering the community
p.000115: engagement processes proposed (see Article 9.10). Where no agreement exists between formal community leadership and
p.000115: customary authority regarding the conduct of the proposed research, researchers should inform the REB. When alternative
p.000115: community engagement processes are followed to endorse a project, all other ethical safeguards set out in this chapter
p.000115: remain applicable.
p.000115: Recognizing Diverse Interests within Communities
p.000115: Article 9.6 In engaging territorial or organizational communities, researchers should ensure, to the extent
p.000115: possible, that they take into consideration the views of all relevant sectors – including individuals and subgroups who
p.000115: may not have a voice in the formal leadership. Groups or individuals whose circumstances make them vulnerable
p.000115: may need or desire special measures to ensure their safety in the context of a specific research project. Those who
p.000115: have been excluded from participation in the past may need special measures to ensure their inclusion in research.
p.000115: Application Groups or individuals whose circumstances may make them vulnerable or marginalized within
p.000115: territorial or organizational communities should not be deprived of opportunities to participate in, and
p.000115: influence, research affecting their welfare. For example, people living with HIV/AIDS, impoverished youth or
p.000115: women who have suffered abuse may experience barriers to participation.
p.000115: Gender-based analysis is being applied in First Nations, Inuit and Métis organizations and communities to
p.000115: promote or restore recognition of women’s responsibilities in the conduct of community life – including decision
p.000115: making that directly affects their welfare. The legacy of patriarchal governance structures continues to pose
p.000115: challenges to women’s full participation. Approaches that are attentive to cultural considerations help to ensure the
p.000115: equitable participation and benefit of women throughout the life cycle of a research project (see Article 4.2).
p.000115: Research undertaken secretly or as a direct challenge to legitimate authority may increase risks to participants whose
p.000115: circumstances make them vulnerable, may deepen rifts within the community, and actually impede the advancement of
p.000115: social
p.000115:
p.000115: 116 TCPS 2
p.000115:
p.000115: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000115:
...
p.000149: depend on healthy participants who are offered incentives for their participation, though this
p.000149:
p.000149:
p.000149:
p.000149: 150 TCPS 2
p.000149:
p.000149: Chapter 11 – Clinical Trials
p.000149:
p.000149: is not usually the case in, for example, cancer trials. Increasingly, phase I trials include participants with specific
p.000149: diseases for whom conventional therapy has failed. The combination of clinical risk with uncertain or no likelihood of
p.000149: clinical benefit, and the often substantial incentives offered to participants, raises ethical concerns about safety,
p.000149: the selection and recruitment of participants, and the consent process. For safety, it is important to ensure that the
p.000149: drug is initially given to a small number of participants and that dosing is increased in clearly defined
p.000149: increments only after participants’ responses to the initial dose is known. Recruitment and consent
p.000149: procedures shall ensure that participants are aware of the untested nature of the therapy and that participants do not
p.000149: accept, because of the incentives being offered, risks they would otherwise refuse.
p.000149: Phase II
p.000149: Phase II or combined phase I/II clinical trials raise particular ethical concerns, because they are often conducted
p.000149: with populations whose therapeutic options have been exhausted. Examples include patients with cancer that is incurable
p.000149: by standard therapies and HIV/AIDS, or people with conditions that cause them acute or chronic pain. These
p.000149: circumstances may affect the perceptions of patients and their families as to the balance between the risks and
p.000149: potential benefits of the trial and thus may affect their decision whether to participate. Additionally,
p.000149: because participants in phase II trials may include patients who are unwell and frequently not working, the REB should
p.000149: ensure incentives for participation is not coercive, and patients do not accept risks they would otherwise
p.000149: refuse because of the incentives being offered. Researchers should be encouraged to consult with the REB at an early
p.000149: stage about any recruiting, consent or safety issues that arise.
p.000149: During the course of a phase II clinical trial, patients will have access to a new drug that may be efficacious
p.000149: (provide clinical benefit). Researchers shall: a) as part of the consent process, provide details on access to
p.000149: the new drug upon trial completion; and b) make reasonable efforts to secure continued access to the drug following
p.000149: the phase II trial, for those patients for whom the drugs appear to be efficacious.
p.000149: Phase III
p.000149: The REB should carefully examine phase III clinical trials to ensure that the care of patient-participants is not
...
p.000169: Due to continuing technological development in genetics, individuals with access to stored human biological materials
p.000169: are increasingly able to use genetic markers to link a non-identifiable sample with an identified sample. For this
p.000169: reason, genetic analysis has made it more difficult to categorize human biological materials as anonymous or
p.000169: anonymized. The definitions above relate to identification of individuals; however, some research involving
p.000169: human biological materials, especially genetic research, may involve identification of groups, even though the human
p.000169: biological materials are non-identifiable at an individual level. Researchers and REBs should be aware of, and guard
p.000169: against, threats to individual privacy and autonomy that arise from re-identification risks, as well as risks to
p.000169: groups, particularly where sensitive research findings will be linked to specific groups.
p.000169: To maintain confidentiality, it may seem desirable to use anonymized or anonymous human biological materials. However,
p.000169: the scientific requirements of many studies may necessitate use of identifiable human biological materials, to link
p.000169: materials with information about participants, and to avoid using different samples from the same individual. Use of
p.000169: anonymized or anonymous human biological materials has the disadvantage of making it impossible to offer the benefits
p.000169: of research findings to participants and their families, or to alert them to relevant clinical findings. This is
p.000169: particularly significant when research may disclose a previously undiagnosed condition, such as HIV infection or an
p.000169: inherited predisposition to breast cancer, for which potentially effective treatments are available. Use of
p.000169: non-identifiable human biological materials also precludes withdrawal of a participant’s material from research
p.000169: use, even at the participant’s request.
p.000169:
p.000169: B. Collection of Human Biological Materials
p.000169: Human biological materials may be obtained in different ways:
p.000169: 1. they may be collected expressly for a specific research purpose;
p.000169: 2. they may be collected incidentally to medical or diagnostic procedures with no initial intent to be used in
p.000169: research; or
p.000169:
p.000169:
p.000169: 170 TCPS 2
p.000169:
p.000169: Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction
p.000169:
p.000169: 3. they may be collected for research or medical or diagnostic purposes with some expectation that they
p.000169: may, or will, also be used in future research, although the precise research project(s) may not be known at the time.
p.000169: The first category above refers to the initial collection of human biological materials for research, which is
p.000169: described in this section. The latter two categories are relevant to subsequent, secondary uses of human biological
p.000169: materials for research that may not have been conceived at the time the tissue was taken. Secondary use of biological
p.000169: materials is described in Section C.
p.000169: Article 12.1 Research involving collection and use of human biological materials requires REB review and:
p.000169: (a) consent of the participant who will donate biological materials; or
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Health / Healthy People
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p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: Pre-existing entitlements to care, education and other services should not be prejudiced by the decision of whether or
p.000199: not to participate in, or to withdraw from, a research project. Accordingly, for example, a physician should ensure
p.000199: that continued clinical care is not linked to research participation. Similarly, where students do not wish to
p.000199: participate in research studies for course credits, they should be offered a comparable alternative.
p.000199: Coercion
p.000199: Coercion is a more extreme form of undue influence, involving a threat of harm or punishment for failure to
p.000199: participate. Coercion would negate the voluntariness of a decision to participate, or to remain, in a research project.
p.000199: Incentives
p.000199: Incentives are anything offered to participants, monetary or otherwise, for par- ticipation in research (incentives
p.000199: differ from reimbursements and compensation for injury, which are discussed in Article 3.2[j]). Because incentives are
p.000199: used to encourage participation in a research project, they are an important consid- eration in assessing
p.000199: voluntariness. Where incentives are offered to participants, they should not be so large or attractive as to encourage
p.000199: reckless disregard of risks. This is a particular consideration in the case of healthy volunteers for the early phases
p.000199: of clinical trials, as discussed in Article 11.1. The offer of incen- tives in some contexts may be perceived by
p.000199: prospective participants as a way for them to gain favour or improve their situation. This may amount to undue
p.000199: inducement and thus negate the voluntariness of participants’ consent.
p.000199: This Policy neither recommends nor discourages the use of incentives. The onus is on the researcher to justify to the
p.000199: REB the use of a particular model and the level of incentives. In considering the possibility of undue influence in re-
p.000199: search involving financial or other incentives, researchers and REBs should be sensitive to issues such as the economic
p.000199: circumstances of those in the pool of prospective participants, the age and capacity of participants, the customs and
p.000199: practices of the community, and the magnitude and probability of harms (see Chapter 4, Section B). Guardians and
p.000199: authorized third parties should not receive incentives for arranging the involvement in research of the individual they
p.000199: rep- resent. However, they may accept reasonable incentives or compensation on behalf of that individual, as long as
p.000199: these are suitable to the circumstances.
p.000199: (b) To maintain the element of voluntariness, participants shall be free to withdraw their consent to participate in
p.000199: the research at any time, and need not offer any reason for doing so. In some cases, however, the physical
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p.000199:
p.000199:
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p.000199:
p.000199:
p.000199:
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p.000199: TCPS 2
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p.000199: iii
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p.000199:
p.000199: Acknowledgements
p.000199: In August 2010, in accordance with its mandate, the Interagency Advisory Panel on Research Ethics (the Panel) submitted
p.000199: its final version of the 2nd edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans
p.000199: (TCPS 2) to the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of
p.000199: Canada (NSERC) and the Social Sciences and Humanities Research Council of Canada (SSHRC), or “the Agencies,” and
p.000199: recommended the Policy’s adoption. The Agencies approved this 2nd edition of the TCPS, which incorporates the changes
p.000199: they deemed appropriate.
p.000199: The Panel’s final version is a collaborative work. Over a period of almost three years, the TCPS was drafted and
p.000199: refined by the Panel and the Secretariat on Research Ethics (the Secretariat). The Policy has benefited from extensive
p.000199: public consultations with, and constructive criticism from, the research community of Canada. It would be impossible to
p.000199: individually thank the hundreds of people who have contributed to the revision process that has produced this Policy.
p.000199: But we would be remiss not to give credit to those volunteers and staff who have devoted countless hours of their
p.000199: attention and concern to develop this document that enhances the ethical conduct of research in Canada – and perhaps
p.000199: beyond.
p.000199: The conception and refinement of the TCPS was carried out by the current and recent members of the Panel and
p.000199: Secretariat, led by Susan Zimmerman, Executive Director of the Secretariat. The enormity of the task they faced was
p.000199: matched by their dedication and tireless commitment to the vigorous collegial process. They warrant special
p.000199: acknowledgement for their efforts.
p.000199: The development of this document has been a long process. The groundwork was laid by the first generation of Panel and
p.000199: Secretariat members led by Derek Jones, former Executive Director of the Secretariat, and the numerous working
p.000199: committee members who began the debate and framing of the issues that are addressed in the new edition.
p.000199: Thanks are also due to the members of the research community who took part in the consultations in 2009 and provided
p.000199: comments on the 2008 and 2009 drafts. This national outreach involved meetings with roughly 2,000 members of the
p.000199: research community and yielded 370 submissions. The Panel found this feedback to be thoughtful, clear and critical to
p.000199: the revision process. As might be expected from such a wide array of independent-minded academics, administrators,
p.000199: practition- ers and members of the general public – their views were not always compatible. Nevertheless, they
p.000199: furnished the grist for what we believe to be substantial improvements to the sequential drafts. Their efforts are
p.000199: deeply appreciated.
p.000199: No document designed to cover the ethical conduct of all types of research involving humans can hope to be definitive.
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Health / Mentally Disabled
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p.000199: institutional policies will organize roles, responsibilities, reporting lines and accountabilities to eliminate,
p.000199: minimize or otherwise manage conflicts of inter- est (see Articles 6.1, 6.2 and 7.2).
p.000199: Measures to manage conflicts of interest should reflect the inherent threat of con- flicts of interest to participants,
p.000199: as well as to the scientific and scholarly integrity
p.000199:
p.000199:
p.000199: TCPS 2 91
p.000199:
p.000199: Chapter 7 – Conflicts of Interest
p.000199:
p.000199: and credibility of research. These measures should also be commensurate with the risks. Institutions should consider
p.000199: the following measures to address conflicts of interest at the institutional level that are germane to research
p.000199: involving humans:
p.000199: • Create central institutional mechanisms, such as a competent institutional au- thority, a conflict of interest
p.000199: committee, or other delegated bodies within the institution to help identify, eliminate, minimize or otherwise manage
p.000199: conflicts of interest.
p.000199: • Refine or redesign roles, responsibilities, and reporting lines to eliminate, min- imize or manage the potential
p.000199: for conflict of interest.
p.000199: • Prevent or minimize conflict of interest in institutional design and structuring when creating new roles,
p.000199: responsibilities or relationships.
p.000199: • Apply barriers to insulate potentially conflicting roles and responsibilities.
p.000199: • Require that individuals involved in the conduct of research withdraw from, or not participate in, roles or
p.000199: functions unduly compromised or disabled by any real, potential or perceived conflict.
p.000199: Conflict of interest policies and procedures should be developed in a transparent manner. The goal of these policies is
p.000199: to eliminate conflict of interest where possible, or alternatively, to identify and disclose real, potential or
p.000199: perceived institutional conflicts of interest, to make them transparent and open to scrutiny, and to provide mechanisms
p.000199: to minimize or otherwise manage them.
p.000199: Article 7.2 Institutions should ensure that real, potential or perceived institutional conflicts of interest that
p.000199: may affect research are reported to the REB through established con- flict of interest mechanisms. The REB shall
p.000199: consider whether the institutional conflict of interest should be disclosed to prospective participants as part of the
p.000199: consent process.
p.000199: Application Any member of an institution, a senior administrator, researcher, REB member or any other individual who
p.000199: is aware of potential sources of institutional conflicts of interest that may affect research should refer to the
p.000199: institutional policy for the ap- propriate steps to inform the REB. Institutional policies shall address when
p.000199: disclosure of conflicts of interest to the REB is required and how these conflicts should be evaluated and managed.
p.000199: Likewise, when a real, potential or perceived institutional conflict of interest is dis- closed and brought to its
p.000199: attention, the REB may be guided by the prescribed institutional mechanisms for managing the conflict. However, it is
p.000199: the REB that is responsible for deciding how these conflicts shall be managed. This includes re- quiring that
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p.000199: sufficient research may not be done on groups that fall outside of narrow age criteria. The inclusion of the young and
p.000199: the elderly in research, for example, ensures that treatments frequently given to these populations are effective and
p.000199: safe.
p.000199: Researchers, institutions and REBs all have important roles to play in advancing that societal com- mitment, and
p.000199: ensuring a fair distribution of the benefits and burdens of research. Researchers and REBs must navigate between the
p.000199: dangers of imposing unfair burdens on particular participants, groups and communities, and overprotecting them. In
p.000199: assessing fairness and equity issues in the research ethics process, REBs should not intervene in the choice of
p.000199: research topics.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 47
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: A. Appropriate Inclusion
p.000199: Article 4.1 Taking into account the scope and objectives of their research, researchers should be inclusive in
p.000199: selecting participants. Researchers shall not exclude individuals from the opportunity to participate in research on
p.000199: the basis of attributes such as culture, language, religion, race, disability, sexual orientation, ethnicity,
p.000199: linguistic proficiency, gender or age, unless there is a valid reason for the exclusion.
p.000199: Application Article 4.1 is based on the principle of Justice. It imposes a duty on researchers not to exclude
p.000199: individuals or groups from participation for reasons that are unrelated to the research. This duty is explicitly stated
p.000199: because groups have been inappropri- ately excluded from participation in research on the basis of attributes such as
p.000199: gender, race, ethnicity, age and disability.
p.000199: The focus, objective, nature of research and context in which the research is con- ducted inform the inclusion and
p.000199: exclusion criteria for a specific research project. Some research may be focused on a certain individual (such as in a
p.000199: biography), or a group of individuals who share a specific characteristic (e.g., an identifiable group of painters who
p.000199: happen to be all of one sex; a religious order that is restricted to one sex). Other examples include research that is
p.000199: focused on specific cultural tra- ditions or languages, or on one age group (e.g., a biomechanical modeling study of
p.000199: posture corrections in adolescents). Such research should not be precluded so long as the selection criteria for those
p.000199: to be included in the research are germane to answering the research question. Researchers who plan to actively exclude
p.000199: par- ticular groups should clarify to their REBs the grounds for the exclusion.
p.000199: Where a language barrier exists between the researcher and the prospective partic- ipant, various measures may be
p.000199: used to ensure effective communication in recruitment and consent discussions. For example, an intermediary who
p.000199: may not be part of the research project or team, but who is competent in the language used by the researchers, as well
p.000199: as that preferred by the participant, may assist with com- munication between prospective participants and researchers.
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Health / Mentally Incapacitated
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p.000199:
p.000199: An important mechanism for respecting participants’ autonomy in research is the requirement to seek their free,
p.000199: informed and ongoing consent. This requirement reflects the commitment that par- ticipation in research, including
p.000199: participation through the use of one’s data or biological materials, should be a matter of choice and that, to be
p.000199: meaningful, the choice must be informed. An informed choice is one that is based on as complete an understanding as is
p.000199: reasonably possible of the purpose of the research, what it entails, and its foreseeable risks and potential benefits,
p.000199: both to the partic- ipant and to others. Respect for Persons also includes a commitment to accountability
p.000199: and transparency in the ethical conduct of research.
p.000199: Certain factors may diminish a person’s ability to exercise their autonomy, such as inadequate information or
p.000199: understanding for deliberation, or a lack of freedom to act due to controlling influences or coercion. Such constraints
p.000199: may include the fear of alienating those in positions of authority, such as professional or personal caregivers,
p.000199: researchers, leaders, larger groups, or a community to which one belongs. Other constraints may consist of barriers to
p.000199: accessing resources or knowledge outside the research context. These factors and constraints should be addressed prior
p.000199: to any research being carried out, so as to ensure participants are sufficiently protected.
p.000199: Some people may be incapable of exercising autonomy because of youth, cognitive impairment, other mental health issues
p.000199: or illness. While autonomy may be considered a necessary condition for participation in research, involving those who
p.000199: lack capacity to make their own decisions to participate can be valuable, just and even necessary. For those
p.000199: prospective participants, additional measures are needed to protect their interests and to ensure that their wishes (to
p.000199: the extent that these are known) are respected. These measures will generally include seeking consent from an
p.000199: authorized third party who is entrusted to make decisions on behalf of the prospective participant, based on knowledge
p.000199: of that person and that person’s wishes or, if such wishes are unknown, on consideration of that person’s welfare. Even
p.000199: when the requirements of free, informed and ongoing consent cannot be met, Respect for Persons requires involving
p.000199: individuals in circumstances of vulnerability in decision making where possible. This may include asking about their
p.000199: feelings re- garding participation and/or for their assent.
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p.000191: Human participant – See “Participant.”
p.000191: Human reproductive materials – A sperm, ovum, or other human cell, or a human gene, including a part of any of them.
p.000191:
p.000191: Identifiable information – Information that may reasonably be expected to identify an individual, alone or in
p.000191: combination with other available information. Also referred to as “personal information.”
p.000191:
p.000191: Directly identifying information – The information identifies a specific individual through direct identifiers (e.g.
p.000191: name, social insurance number, personal health number).
p.000191: Indirectly identifying information – The information can reasonably be expected to identify an individual through a
p.000191: combination of indirect identifiers (e.g. date of birth, place of residence, or unique personal characteristic).
p.000191: Coded information – Direct identifiers are removed from the information and replaced with a code. Depending on access
p.000191: to the code, it may be possible to re-identify specific participants (e.g. the principal investigator retains a list
p.000191: that links the participants’ code names with their actual name so data can be re-linked if necessary).
p.000191: Anonymized information – The information is irrevocably stripped of direct identifiers, a code is not kept to allow
p.000191: future re-linkage, and risk of re-identification of individuals from remaining in- direct identifiers is low or very
p.000191: low.
p.000191: Anonymous information – The information never had identifiers associated with it (e.g. anony- mous surveys) and risk of
p.000191: identification of individuals is low or very low.
p.000191: Impracticable – Incapable of being put into practice due to a degree of hardship or onerousness that jeop- ardizes the
p.000191: conduct of the research; it does not mean mere inconvenience.
p.000191:
p.000191: Incentive – Anything offered to participants, monetary or otherwise, to encourage participation in research.
p.000191:
p.000191: Incidental findings – Unanticipated discoveries made in the course of research that are outside the scope of the
p.000191: research.
p.000191:
p.000191: Indigenous knowledge – See “Traditional knowledge.”
p.000191:
p.000191: Indigenous peoples – See “Aboriginal peoples.”
p.000191:
p.000191: Institutions – The universities, hospitals, colleges, research institutes, centres and other organizations eligible to
p.000191: receive and manage Agency grant funds on behalf of the grant holders and the Agencies.
p.000191:
p.000191: Intermediary – An individual with the necessary language skills to ensure effective communication between the research
p.000191: team and participants, should any language barriers exist.
p.000191:
p.000191: Institutional conflicts of interest – An incompatibility between two or more substantial institutional obligations
p.000191: that cannot be adequately fulfilled without compromising one or another of the obligations.
p.000191:
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p.000191: TCPS 2
p.000191:
p.000193: 193
p.000193:
p.000193: Glossary
p.000193:
p.000193: Justice – A core principle of this Policy that refers to the obligation to treat people fairly and equitably. Fairness
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Health / Motherhood/Family
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p.000199: • Justice
p.000199: These principles are complementary and interdependent. How they apply and the weight accorded to each will depend on
p.000199: the nature and context of the research being undertaken. Specific applica- tions are addressed in the following
p.000199: chapters.
p.000199: Respect for Persons
p.000199: Respect for Persons recognizes the intrinsic value of human beings and the respect and consider- ation that they are
p.000199: due. It encompasses the treatment of persons involved in research directly as participants and those who are
p.000199: participants because their data or human biological materials, which for the purposes of this Policy include materials
p.000199: related to human reproduction, are used in re- search. Respect for Persons incorporates the dual moral obligations to
p.000199: respect autonomy and to protect those with developing, impaired or diminished autonomy.
p.000199: Autonomy includes the ability to deliberate about a decision and to act based on that deliberation. Respecting autonomy
p.000199: means giving due deference to a person’s judgment and ensuring that the person is free to choose without
p.000199: interference. Autonomy is not exercised in isolation but is influenced by a person’s various connections to
p.000199: family, to community, and to cultural, social, linguistic, religious and other groups. Likewise, a person’s decisions
p.000199: can have an impact on any of these connections.
p.000199:
p.000199: 8 TCPS 2
p.000199:
p.000199: Chapter 1 – Ethics Framework
p.000199:
p.000199: An important mechanism for respecting participants’ autonomy in research is the requirement to seek their free,
p.000199: informed and ongoing consent. This requirement reflects the commitment that par- ticipation in research, including
p.000199: participation through the use of one’s data or biological materials, should be a matter of choice and that, to be
p.000199: meaningful, the choice must be informed. An informed choice is one that is based on as complete an understanding as is
p.000199: reasonably possible of the purpose of the research, what it entails, and its foreseeable risks and potential benefits,
p.000199: both to the partic- ipant and to others. Respect for Persons also includes a commitment to accountability
p.000199: and transparency in the ethical conduct of research.
p.000199: Certain factors may diminish a person’s ability to exercise their autonomy, such as inadequate information or
p.000199: understanding for deliberation, or a lack of freedom to act due to controlling influences or coercion. Such constraints
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p.000199: individuals in circumstances of vulnerability in decision making where possible. This may include asking about their
p.000199: feelings re- garding participation and/or for their assent.
p.000199: Where it is foreseeable that a participant may lose capacity during a research project, for example in studies of
p.000199: cognitive impairment, it may be appropriate to ask participants to express their pref- erences and ensure that they
p.000199: have authorized a trusted person to make decisions on their behalf should they lose the capacity to provide ongoing
p.000199: consent (see Article 3.11 for guidance on research directives for individuals who lack capacity).
p.000199:
p.000199: Concern for Welfare
p.000199:
p.000199: The welfare of a person is the quality of that person’s experience of life in all its aspects. Welfare consists of the
p.000199: impact on individuals of factors such as their physical, mental and spiritual health, as well as their physical,
p.000199: economic and social circumstances. Thus, determinants of welfare can include housing, employment, security, family
p.000199: life, community membership, and social participation, among other aspects of life. Other contributing factors to
p.000199: welfare are privacy and the control of information about the person, and the treatment of human biological materials
p.000199: according to the free, informed and ongoing consent of the person who was the source of the information or materials. A
p.000199: person’s or group’s welfare is also affected by the welfare of those
p.000199:
p.000199: TCPS 2 9
p.000199:
p.000199: Chapter 1 – Ethics Framework
p.000199:
p.000199: who are important to them. Harm includes any negative effects on welfare, broadly construed (for the relationship
p.000199: between risk and harm, see Chapter 2, Section B). Note that, for the purposes of this Policy, “group” and “community”
p.000199: are used in their ordinary sense. More detailed types of community as defined in Chapter 9 are specific to Aboriginal
p.000199: contexts.
p.000199: Concern for Welfare means that researchers and REBs should aim to protect the welfare of par- ticipants, and, in some
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p.000199: Where partial disclosure or deception has been used, debriefing is an important mechanism in maintaining the
p.000199: participant’s trust in the research community. The debriefing referred to in Article 3.7(d) should be proportionate to
p.000199: the sensitivity of the issue. Often, debriefing can be a simple and straightforward candid disclosure. In sensitive
p.000199: cases, researchers should also provide a full explanation of why participants were temporarily led to believe
p.000199: that the research, or some aspect of it, had a different purpose, or why participants received less than full
p.000199: disclosure. The researchers should give details about the importance of the research, the necessity of having to use
p.000199: partial disclosure or deception, and express their concern about the welfare of the participants. They should seek to
p.000199: remove any misconceptions that may have arisen and to re-establish any trust that might have been lost, by explaining
p.000199: why these research procedures were necessary to obtain scientifically valid findings.
p.000199: Immediate, full debriefing of all individuals who have contributed data may not be feasible in all cases. In studies
p.000199: with data collection over a longer term, debriefing may have to be deferred until the end of the project. In some cases
p.000199: – for example, in research involving children – it may be more appropriate to debrief the parents, guardians or
p.000199: authorized third parties rather than the participants themselves. In other cases, it may be more appropriate to debrief
p.000199: the entire family or community. When debriefing, researchers should be alert and sensitive to participants’ needs,
p.000199: feelings, reactions and concerns.
p.000199: In studies involving partial disclosure or deception in which an alteration to the requirement for prior consent has
p.000199: been allowed, participants must nevertheless be able to indicate their consent or their refusal at the
p.000199: conclusion of the project, following debriefing. In cases where participants express concerns about their
p.000199: participation in a project, the researcher may give participants the option of removing their data from the project.
p.000199: Where the terms of the research proposal do not permit the participants to withdraw their data, in the absence
p.000199: of the consent of the participant, the identity of the participants shall be protected at all times during and
p.000199: following completion of the project. Participants who express concern about the conduct of the project at the time of
p.000199: debriefing, or who contest the limits imposed
p.000199:
p.000199:
p.000199: 38 TCPS 2
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: on withdrawing their data, should be given the contact information for the REB that approved the research. Researchers
p.000199: must report to the REB concerns about the conduct of the project raised by participants at the time of debriefing.
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p.000199: (e) when authorization for participation was granted by an authorized third party, and a participant acquires or
p.000199: regains capacity during the course of the research, the researcher shall promptly seek the participant’s consent as a
p.000199: condition of continuing participation.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 41
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: Application The decision of authorized third parties should be based on their knowledge of the prospective
p.000199: participants, and on consideration of the prospective participants’ welfare. The third parties should not be in
p.000199: a position of conflict of interest when making their decision.
p.000199: Article 3.9 outlines other safeguards to protect those who lack the capacity to consent to participate in research. The
p.000199: article details several considerations relevant to the use of third party authorization. Beyond the legal and
p.000199: regulatory requirements for seeking consent from authorized third parties, family members and friends may also provide
p.000199: information to the authorized third party about the interests and previous wishes of prospective
p.000199: participants. An authorized third party should take into account any research directives given in accordance with
p.000199: Article 3.11.
p.000199: Article 3.10 Where an authorized third party has consented on behalf of an individual who lacks legal capacity, but
p.000199: that person has some ability to understand the significance of the research, the researcher shall ascertain the wishes
p.000199: of that individual with respect to participation. Prospective participants’ dissent will preclude their participation.
p.000199: Application Many individuals who lack legal capacity to make decisions may still be able to express their wishes in
p.000199: a meaningful way, even if such expression may not fulfil all of the requirements for consent. Prospective participants
p.000199: may be capable of verbally or physically assenting to, or dissenting from, participation in research. Those who may be
p.000199: capable of assent or dissent include:
p.000199: (a) those whose capacity is in the process of development, such as children whose capacity for judgment and
p.000199: self-direction is maturing;
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p.000199: information include:
p.000199: (a) the type of information to be collected;
p.000199: (b) the purpose for which the information will be used, and the purpose of any secondary use of identifiable
p.000199: information;
p.000199: (c) limits on the use, disclosure and retention of the information;
p.000199: (d) risks to participants should the security of the data be breached, including risks of re-identification of
p.000199: individuals;
p.000199: (e) appropriate security safeguards for the full life cycle of information;
p.000199: (f) any recording of observations (e.g., photographs, videos, sound recordings) in the research that may allow
p.000199: identification of particular participants;
p.000199:
p.000199:
p.000199: 60 TCPS 2
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: (g) any anticipated uses of personal information from the research; and
p.000199: (h) any anticipated linkage of data gathered in the research with other data about participants, whether those data
p.000199: are contained in public or personal records (see also Section E of this chapter).
p.000199: In considering the adequacy of proposed measures for safeguarding information during its full life cycle, REBs should
p.000199: not automatically impose a requirement that researchers destroy the research data. Stored information may be useful for
p.000199: a variety of future purposes. Appropriate data retention periods vary depending on the re- search discipline,
p.000199: research purpose and the kind of data involved. In some situations, formal data sharing with participants may
p.000199: occur, for example, by giving individual participants copies of a recording or transcript as a gift for personal,
p.000199: family or other archival use. Similarly, some funding bodies, such as the Social Sciences and Humanities Research
p.000199: Council and the Canadian Institutes of Health Research, have specific policies on data archiving and sharing.2
p.000199: Researchers should address how participants’ information will be handled if participants choose to withdraw from the
p.000199: research.
p.000199: In disseminating findings, researchers shall not disclose identifiable information without the consent of participants.
p.000199: In the case of critical inquiry research, identi- fiable information may be revealed about any objects of the inquiry
p.000199: as they are usually not regarded as participants (see Article 3.6). Researchers shall take rea- sonable measures to
p.000199: avoid inadvertent identification of individuals or groups in publications or other means of dissemination – and they
p.000199: must address this issue to the satisfaction of the REB.
p.000199: Consideration of future uses of personal information refers not just to research, but also to other purposes, such as
p.000199: the future use of research materials for educational purposes.
p.000199: Research data sent over the Internet may require encryption or use of special de- nominalization software to prevent
p.000199: interception by unauthorized individuals, or other risks to data security. In general, identifiable data obtained
p.000199: through research that is kept on a computer and connected to the Internet should be encrypted.
p.000199: Article 5.4 Institutions or organizations where research data are held have a responsibility to establish
p.000199: appropriate institutional security safeguards.
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p.000199: inherent tensions and pressures that may impact deliberative decision making. Taking all of this into consideration,
p.000199: REBs and researchers should ensure that the risks and potential ben- efits posed by any proposed research are
p.000199: appropriately evaluated, including provisions for greater-than-normal attention to risk, where applicable.
p.000199:
p.000199:
p.000199: 1 Memorandum of Understanding on the Roles and Responsibilities in the Management of Federal Grants and Awards.
p.000199: www.nserc-crsng.gc.ca/NSERC-CRSNG/Policies-Politiques/MOURoles-Protocol- Roles/index_eng.asp
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p.000199: 88 TCPS 2
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p.000199:
p.000199:
p.000199:
p.000199:
p.000199: Introduction
p.000199: Chapter 7
p.000199: CONFLICTS OF INTEREST
p.000199: This chapter addresses ethical issues that can arise when research activities and other activities conflict. A conflict
p.000199: of interest may arise when activities or situations place an individual or insti- tution in a real, potential or
p.000199: perceived conflict between the duties or responsibilities related to research, and personal, institutional or other
p.000199: interests.1 These interests include, but are not limited to, business, commercial or financial interests pertaining to
p.000199: the institution and/or the individual, their family members, friends, or their former, current or prospective
p.000199: professional associates.
p.000199: Conflicts of interest must be assessed when conducting research as they may jeopardize the in- tegrity of the research
p.000199: and the protection offered to participants. Conflicts that create divided loyalties may distract researchers, research
p.000199: ethics boards (REBs), and institutions from concern for the welfare of participants and are contrary to the core
p.000199: principles on which this Policy is based. Failure to disclose and manage conflicts may impede the informed and
p.000199: autonomous choices of in- dividuals to participate in research. Prospective participants need to know about real,
p.000199: potential or perceived conflicts of interest in order to make an informed decision about whether or not to par-
p.000199: ticipate (see Article 3.2[e]). Conflicts of interest may also undermine the respect for participants that is
p.000199: fundamental to the principle of Justice.
p.000199: It is preferable to avoid or prevent being in a position of conflict of interest, if possible. When it is not possible
p.000199: to avoid a conflict of interest, then it shall be disclosed to the appropriate people and steps taken to minimize or
p.000199: manage the conflict. Researchers, their institutions and REBs should identify and address conflicts of interest – real,
p.000199: potential or perceived – to discharge professional and institutional obligations, maintain public confidence and trust,
p.000199: and ensure accountability. In some cases, the conflict cannot be managed and the institutions, the researcher or the
...
p.000199: applicant. REB members may also be in a conflict of interest situation when they have interpersonal or financial
p.000199: relationships with the researchers, or personal or financial interests in a company, labour union or not-for-profit
p.000199: organization that may be the sponsor of the research project, or that may be substantially affected by the research.
p.000199: Conflicts of interest based on collaborations or disputes with colleagues, students or others may be ongoing or of
p.000199: limited duration. REBs have an obligation to ensure that the fairness and trans- parency of research ethics review is
p.000199: not compromised by real, potential or perceived conflicts of interest.
p.000199:
p.000199:
p.000199:
p.000199: 90 TCPS 2
p.000199:
p.000199: Chapter 7 – Conflicts of Interest
p.000199:
p.000199: Researcher Conflict of Interest
p.000199: Researchers and research students hold trust relationships, either directly or indirectly, with par- ticipants,
p.000199: research sponsors, institutions, their professional bodies and society. These trust relationships can be put
p.000199: at risk by conflicts of interest that may compromise independence, objec- tivity or ethical duties of loyalty. Although
p.000199: the potential for such conflicts has always existed, pressures on researchers (e.g., to delay or withhold dissemination
p.000199: of research outcomes or to use inappropriate recruitment strategies) heighten concerns that conflicts of interest may
p.000199: affect ethical behaviour.
p.000199: Researchers’ conflicts of interest may arise from interpersonal relationships (e.g., family or com- munity
p.000199: relationships), financial partnerships, other economic interests (e.g., spin-off companies in which researchers have
p.000199: stakes or private contract research outside of the academic realm), ac- ademic interests or any other incentives that
p.000199: may compromise integrity or respect for the core principles of this Policy. Conflicts may arise from an individual’s
p.000199: involvement in dual and multiple roles within or outside an institution. While it may not be possible to eliminate all
p.000199: conflicts of in- terest, researchers are expected to identify, minimize or otherwise manage their individual conflicts
p.000199: in a manner that is satisfactory to the REB.
p.000199:
p.000199: B. Institutions and Conflicts of Interest
p.000199: Article 7.1 Institutions shall develop and implement conflict of interest policies including procedures to
p.000199: identify, eliminate, minimize or otherwise manage conflicts of interest that may affect research. All parties
p.000199: (e.g., researchers, administrators, REB members) should act in a transparent manner in identifying and addressing
p.000199: conflicts of interest. Institutions should make their written conflict of interest policies and procedures publicly
p.000199: available to all members of the research enterprise, including participants, REBs, researchers, administrators and
p.000199: research sponsors.
p.000199: Application To meet obligations to protect participants, institutional policies should address the roles,
p.000199: responsibilities and process for identifying, eliminating, minimizing or oth- erwise managing institutional conflicts
p.000199: of interest relevant to research, including disclosure to REBs. Management of conflicts of interest includes, but is
...
p.000117: addresses issues of privacy, intellectual property, data custody and secondary use of data, which are also covered
p.000117: later in this chapter.
p.000117: Inuit communities and organizations are considering addressing similar concerns, including adoption or adaptation of
p.000117: OCAP. For example, possession agreements, which are distinct from research agreements, are set out in a
p.000117: memorandum of understanding between the institution of the researcher and the community (usually represented by the
p.000117: land claim organization). The possession agreement covers the control and use of data and human biological materials
p.000117: collected over the course of the research. The agreement may continue to exist long after the research is
p.000117: completed, to allow control and use of data and human biological materials for Inuit- initiated research.
p.000117: Researchers should consult their own institutions to ensure that the application of OCAP or other community-based
p.000117: ethics codes is consistent with institutional
p.000117:
p.000117:
p.000117: 118 TCPS 2
p.000117:
p.000117: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000117:
p.000117: policies. Where divergences exist, they should be addressed and resolved prior to the commencement of the research, or
p.000117: as they arise over the course of the research.
p.000117: First Nations, Inuit and Métis scholars attached to academic institutions as faculty members, students or research
p.000117: associates are increasingly engaged in research involving their own communities, and sometimes their own family
p.000117: members. They are generally exempt from restrictions on physical access to territory or personal access to community
p.000117: members. However, as members of institutions that adhere to this Policy, they are subject to the ethical duty to
p.000117: respect community customs and codes of research practice when conducting research in their own local or cultural
p.000117: communities, and to engage the relevant community as required by this Policy. In these cases, institutional REBs may be
p.000117: concerned about researchers being in a conflict of interest and should manage the conflict of interest in accordance
p.000117: with Articles 7.2 and 7.4.
p.000117: Life history and language research are examples of research areas where insider relationships and cultural competencies
p.000117: provide unique opportunities to extend the boundaries of knowledge. Although it can be argued that recording the life
p.000117: history of an elderly relative is a family matter rather than a community matter, when undertaken as research,
p.000117: community engagement is important to ensure that the following considerations are reviewed: the potential impact of
p.000117: such research on the wider community; conflicts between the individualist norms of the academic environment
p.000117: and the norms of the community; and the possibility of unclear or mistaken assumptions on the part of participant and
p.000117: researcher. During the consent process, researchers should give the participant the opportunity to identify the
p.000117: relevant form of community engagement, and at what stage such engagement should occur. This may include engaging with
p.000117: extended family members, peers of the participant with whom the researcher’s interpretations can be validated, or
p.000117: Elders knowledgeable about cultural rules governing disclosure of privileged information.
p.000117: Institutional Research Ethics Review Required
p.000117: Article 9.9 Research ethics review by community REBs or other responsible bodies at the research site will not be
p.000117: a substitute for research ethics review by institutional REBs, and will not exempt researchers affiliated with an
p.000117: institution from seeking REB approval at their institution, subject to Article 8.1. Prospective research and secondary
p.000117: use of data and human biological materials for research purposes is subject to research ethics review.
p.000117:
p.000117: Application Applying this Policy in a way that accommodates the diversity of First Nations, Inuit and Métis
p.000117: cultures, and mixed Aboriginal communities in urban centres is complex. For example, the fit between
p.000117: institutional policies and community customs and codes of research practice may be unclear, requiring researchers to
p.000117: adapt conventional practice or negotiate a resolution.
p.000117:
p.000117:
p.000117:
p.000117:
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p.000119:
p.000119: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000119:
p.000119: Consistent with Article 8.3(b), research conducted outside the jurisdiction of the researcher’s institution shall
...
p.000181: or Chapter 11 on clinical trials. This chapter does not reiterate guidance set out in earlier chapters. Rather, it
p.000181: focuses on issues that arise specifically in the context of human genetic research and provides guidance for managing
p.000181: information revealed through genetic research, provision of genetic counselling, participation of families, communities
p.000181: and groups in genetic research, banking of human biological materials, and research involving gene transfer.
p.000181:
p.000181: B. Plans for Managing Information Revealed through Genetic Research
p.000181: Article 13.2 Researchers conducting genetic research shall:
p.000181: (a) in their research proposal, develop a plan for managing information that may be revealed through their genetic
p.000181: research;
p.000181: (b) submit their plan to the REB; and
p.000181: (c) advise prospective participants of the plan for managing information revealed through the research.
p.000181: Application The types of information that may be revealed through genetic research – and the implications of this
p.000181: information for participants and their biological relatives – require that researchers and REBs ensure that an
p.000181: appropriate plan is in place for managing information. In some cases, genetic research may reveal known gene- disease
p.000181: associations or other information, including incidental findings, that may be clinically relevant for individuals (or
p.000181: their biological relatives) in treating or alleviating health conditions or risks. In other cases, research
p.000181: may reveal information that is inconclusive in its scientific, clinical or other implications. Genetic research may
p.000181: also reveal information about family relationships, including adoption and non-paternity.
p.000181: This range of information varies in its possible implications for individuals. In some cases, follow-up clinical
p.000181: testing and counselling may be recommended. Information may also have implications for biological relatives and may
p.000181: raise disclosure con- siderations, as discussed in Article 13.3(b). Genetic information may also affect el- igibility
p.000181: for employment or insurance if, for example, an individual who acquires genetic information is required to disclose
p.000181: disease predisposition risks to employers or insurers.
p.000181:
p.000181:
p.000181: 182 TCPS 2
p.000181:
p.000181: Chapter 13 – Human Genetic Research
p.000181:
p.000181: The plan for managing information shall take into account factors such as clinical relevance, risks and potential
p.000181: benefits for participants and others who may be af- fected. Plans may include sharing individual findings with
p.000181: participants, or notifi- cation of general, non-identifiable research results through newsletters, websites or other
p.000181: means. In regard to release or publication of research findings, the provi- sions of Chapter 5 apply.
p.000181: Article 13.3 Where researchers plan to share findings with individuals, researchers shall provide participants with
p.000181: an opportunity to:
p.000181: (a) make informed choices about whether they wish to receive information about themselves; and
p.000181: (b) express preferences about whether information will be shared with biological relatives, or others with whom the
p.000181: participants have a family, community or group relationship.
p.000181: Application The core principles on which this Policy is based emphasize autonomous choices regarding research
p.000181: participation. Researchers shall explain to participants the types of findings that may be revealed (as discussed in
p.000181: the Application of Article 13.2), and the potential implications of these findings, to permit participants to make in-
p.000181: formed choices about whether or not to receive information. Since the right to pri- vacy includes a right not to know,
p.000181: researchers shall give participants options for receiving or refusing different types of information.
p.000181: Where individual findings will be shared with participants, researchers must de- velop appropriate procedures for
p.000181: communicating findings in accordance with the participant’s preferences or instructions. These procedures shall be
p.000181: clearly described in the researcher’s plan. This may include direct communication of findings to the participant, or
p.000181: communication to a specified health care provider or other party au- thorized to receive the information. As discussed
p.000181: below, sharing research findings with individuals may give rise to a need for genetic counselling.
p.000181: Participants in genetic research shall have an opportunity to express their prefer- ences about the sharing of
p.000181: information with relatives or others. These preferences may be subject to overriding considerations that may warrant
p.000181: disclosure of infor- mation to relatives in exceptional circumstances (e.g., if genetic research reveals information
p.000181: about a serious or life-threatening condition that can be prevented or treated through intervention). Articles 5.1 and
...
p.000181:
p.000181:
p.000181:
p.000181: TCPS 2
p.000183: 183
p.000183:
p.000183: Chapter 13 – Human Genetic Research
p.000183:
p.000183: quence data publicly accessible. Where such policies apply, researchers must advise the REB and participants of
p.000183: data-sharing requirements, and measures for protection of personal information (see Articles 5.2 and 5.3 for further
p.000183: guidance). Publication of aggregated data from genome-wide association studies has raised concerns about individual
p.000183: re-identification.1 This underscores the need for researchers and REBs to ensure that measures for safeguarding
p.000183: information are responsive to risks that arise from continuing advances in genetic research and data linkage.
p.000183: C. Genetic Counselling
p.000183: Article 13.4 Where researchers plan to share results of genetic research with participants, the research proposal
p.000183: should make genetic counselling available at that time, where appropriate.
p.000183: Application Where the plan for managing information revealed in genetic research involves sharing individual
p.000183: findings with participants, genetic counselling may be required to explain the meaning and implications of the
p.000183: information. For example, genetic counselling can help explain the clinical significance of the information, whether
p.000183: health care interventions or lifestyle changes are recommended, and any implica- tions of the information for
p.000183: biological relatives. Researchers should explain differ- ences between genetic testing in a research context and
p.000183: testing in a clinical context. Clinical genetic testing may be needed to clarify or confirm findings obtained in
p.000183: research. Where researchers share information with biological relatives or other family, community or group members,
p.000183: genetic counselling should be made avail- able to them as well as the participants. The counselling service provider
p.000183: must have the appropriate experience or training to provide genetic counselling, but need not necessarily hold a
p.000183: diploma, degree or professional designation in genetic coun- selling.
p.000183: D. Genetic Research Involving Families
p.000183: Article 13.5 Researchers who seek to recruit members of a family to participate in genetic re- search shall:
p.000183: (a) ensure recruitment processes respect privacy and other personal interests of family members; and
p.000183: (b) seek consent from individual family members.
p.000183: Application Recruitment of members of a family may take place in various ways: through (a) the researcher, (b) an
p.000183: individual participant, or (c) a third party on behalf of an individual participant. A family group, such as parents
p.000183: and a child, or several adult siblings, may all receive an invitation at the same time from the researcher to
p.000183: participate in genetic research. Alternatively, researchers may seek permission from an individual participant to
p.000183: contact family members to invite participation. It may be preferable for the participant to make initial contact with
p.000183: the family member, in
p.000183:
p.000183:
p.000183: 184 TCPS 2
p.000183:
p.000183: Chapter 13 – Human Genetic Research
p.000183:
p.000183: order to respect privacy interests or known sensitivities. The participant may prefer to identify a third party to
p.000183: inform family members about the opportunity to participate in genetic research. However, an approach by someone
p.000183: in a position of authority over family members may raise concerns about undue influence or manipulation.
p.000183: Refer to Chapter 3 for further guidance in regard to the voluntariness of consent.
p.000183: Family members may have conflicting views about participation in research, and some may have specific sensitivities or
p.000183: objections. Researchers should recognize the potential for conflict within families and be respectful of any known
p.000183: sensitivi- ties. Where researchers seek participation from children or other members of a fam- ily who may lack
p.000183: capacity to consent, the applicable provisions in Chapter 3 shall be followed.
p.000183: E. Genetic Research Involving Communities and Groups
p.000183: Article 13.6 Where researchers intend to recruit participants for genetic research based on their membership in
p.000183: specific communities or groups, it may be appropriate for re- searchers to discuss the research with community
p.000183: or group members, and/or their leaders, in addition to seeking consent from individual participants. In these cases,
p.000183: researchers shall provide details to the REB about their proposed methods for en- gaging in discussion.
p.000183: Application Some genetic research seeks to explore genetic variations within specific commu- nities or groups. Such
p.000183: research may raise ethical concerns regarding stigmatization, unfair or inequitable treatment, and social disruption in
p.000183: communities or groups – especially if individual members disagree about participation in research. Discus- sion with
p.000183: formal or informal leaders or other members of the community or group may be appropriate. This determination will
p.000183: depend on factors such as: the objec- tives of the proposed research (in particular, the extent to which membership in,
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p.000199: meaningful, the choice must be informed. An informed choice is one that is based on as complete an understanding as is
p.000199: reasonably possible of the purpose of the research, what it entails, and its foreseeable risks and potential benefits,
p.000199: both to the partic- ipant and to others. Respect for Persons also includes a commitment to accountability
p.000199: and transparency in the ethical conduct of research.
p.000199: Certain factors may diminish a person’s ability to exercise their autonomy, such as inadequate information or
p.000199: understanding for deliberation, or a lack of freedom to act due to controlling influences or coercion. Such constraints
p.000199: may include the fear of alienating those in positions of authority, such as professional or personal caregivers,
p.000199: researchers, leaders, larger groups, or a community to which one belongs. Other constraints may consist of barriers to
p.000199: accessing resources or knowledge outside the research context. These factors and constraints should be addressed prior
p.000199: to any research being carried out, so as to ensure participants are sufficiently protected.
p.000199: Some people may be incapable of exercising autonomy because of youth, cognitive impairment, other mental health issues
p.000199: or illness. While autonomy may be considered a necessary condition for participation in research, involving those who
p.000199: lack capacity to make their own decisions to participate can be valuable, just and even necessary. For those
p.000199: prospective participants, additional measures are needed to protect their interests and to ensure that their wishes (to
p.000199: the extent that these are known) are respected. These measures will generally include seeking consent from an
p.000199: authorized third party who is entrusted to make decisions on behalf of the prospective participant, based on knowledge
p.000199: of that person and that person’s wishes or, if such wishes are unknown, on consideration of that person’s welfare. Even
p.000199: when the requirements of free, informed and ongoing consent cannot be met, Respect for Persons requires involving
p.000199: individuals in circumstances of vulnerability in decision making where possible. This may include asking about their
p.000199: feelings re- garding participation and/or for their assent.
p.000199: Where it is foreseeable that a participant may lose capacity during a research project, for example in studies of
p.000199: cognitive impairment, it may be appropriate to ask participants to express their pref- erences and ensure that they
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p.000199: separate issue for institutions to handle through mechanisms other than the REB.
p.000199: Community Member
p.000199: The community member shall not be affiliated with the institution. The community member requirement (Article 6.4[d]) is
p.000199: essential to help broaden the perspective and value base of the REB, and thus advances dialogue with, and
p.000199: accountability to, relevant communities. In addition to a broad-based representation from the com- munity, it is highly
p.000199: desirable that institutions seek to appoint former participants on REBs. Their experience as participants provides the
p.000199: REB with a vital perspective and an important contribution to the research ethics review process. It is advisable that
p.000199: members are not currently engaged in research or legal work as their principal activities.
p.000199: The role of community members on REBs during the ethics review process is unique and at arm’s length from the
p.000199: institution. Their primary role is to reflect the perspective of the participant. This is particularly important when
p.000199: participants are vulnerable and/or risks to participants are high.
p.000199: To maintain effective community representation, the number of community mem- bers should be commensurate with the size
p.000199: of an REB and should increase as the size of an REB increases. Institutions should provide training opportunities to
p.000199: com- munity members (see Article 6.7).
p.000199: Substitute Members
p.000199: Institutions should consider the nomination of substitute REB members so that REBs can continue to function when
p.000199: regular members are unable to attend due to illness or other unforeseen eventualities. The appointment of substitute
p.000199: members
p.000199:
p.000199:
p.000199: 72 TCPS 2
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: should not, however, alter the REB membership composition as set out in this article. Substitute members should have
p.000199: the appropriate knowledge, expertise and training to contribute to the research ethics review process.
p.000199: Ad Hoc Advisors
p.000199: Article 6.5 The REB should have provisions for consulting ad hoc advisors in the event that it lacks the specific
p.000199: expertise or knowledge to review the ethical acceptability of a research proposal competently.
p.000199: Application In the event that the REB is reviewing a project that requires particular community or participant
p.000199: representation or specific disciplinary or methodological expertise not available from its members, it should have
p.000199: provisions for consulting ad hoc ad- visors. Consultation with an ad hoc advisor shall not alter the composition and
p.000199: representation of the REB as outlined in Article 6.4.
p.000199: Ad hoc advisors are consulted for a specific research ethics review and for the du- ration of that review. Should this
p.000199: occur regularly, the membership of the REB should be modified to ensure appropriate expertise on the REB. For example,
p.000199: in cases where ethics review of research on topics related to Aboriginal peoples is regularly required, the REB
...
p.000199: • continuing ethics review of research undertaken prior to the occurrence of the emergency; and
p.000199: • the ethics review process for changes to approved research, because new information may become
p.000199: available and require action very rapidly during emergencies (see Articles 6.15 and 6.16).
p.000199: REB procedures may warrant reasonable adjustments to address the timing, locale, expertise, form and scope of research
p.000199: ethics review, and the holding of REB meet- ings during emergency situations (see Article 6.10). Special attention
p.000199: could be given to REB procedures to review and approve research (e.g., full or delegated research ethics reviews,
p.000199: quorum rules, or special agreements with other institutions), while considering the impact of the emergency on
p.000199: participants, researchers, REB mem- bers, institutional staff, and others. It is also important to coordinate research
p.000199: efforts
p.000199:
p.000199:
p.000199: 86 TCPS 2
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: and research ethics review processes within and across institutions. REB members may become unavailable (e.g., due to
p.000199: illness, relocation, or quarantine by public authorities). Institutions and REBs should explore the nomination of
p.000199: substitute REB members and consultation with ad hoc advisors with relevant expertise (see Articles
p.000199: 6.4 and 6.5), negotiate reciprocity agreements with other institutions for REB re- views (see Article 8.1), and revisit
p.000199: how scholarly review (see Article 2.7) would be applied in emergency situations.
p.000199: Research ethics review should be commensurate with the necessities occasioned by the emergency because of the
p.000199: critical interplay between public urgencies, essential research and a continuing commitment to the core principles
p.000199: even in the face of acute public necessity. Indeed, research ethics review during publicly declared
p.000199: emergencies is even more important than under normal circumstances, and may require even greater care, since everyone
p.000199: (participants, researchers and REB members themselves) may be rendered more vulnerable by the nature of the emergency.
p.000199: Research Ethics Review Policy and Procedures during Publicly Declared Emergencies Article 6.22 Research ethics
p.000199: policies and procedures for emergencies take effect once an emer-
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p.000151:
p.000151: Medical Device Trials
p.000151: Medical devices may take many forms (e.g., a magnetic resonance imaging machine, a cardiac pacemaker, a hip
p.000151: implant). The term “medical device” covers a wide range of instruments used in the prevention, diagnosis,
p.000151: mitigation, or treatment of a disease or abnormal physical condition or the restoration, correction or modification
p.000151: of body function or structure. The conduct of clinical trials involving medical devices is subject to
p.000151: regulations under the Medical Devices Bureau of Health Canada. Researchers and REB members are responsible for knowing
p.000151: how these regulations affect the design and conduct of medical device clinical trials.
p.000151: Researchers are responsible for providing up–to-date information about the device, for example, any feasibility studies
p.000151: it has been subject to in Canada or in other countries, and its risk classification. If an REB does not have
p.000151: enough safety information about the device to consider in its review of the trial, the researcher should be advised
p.000151: to work with the manufacturer of the device to provide appropriate risk information in the research proposal.
p.000151: In any case, REBs should satisfy themselves (with the assistance of external expertise, if necessary) that
p.000151: the use of the device in the trial is appropriate and that the foreseeable risks to participants are justified by the
p.000151: potential benefits.
p.000151: Psychotherapy Trials
p.000151: A clinical trial testing a psychotherapeutic approach to behavioural disorders or other mental illness may compare the
p.000151: outcomes of two or more patient populations with the same diagnosis but receiving different therapies; or a trial may
p.000151: compare the outcome of those who have received a therapy with those who are on the waiting list for treatment. Often a
p.000151: trial will compare a behavioural therapy approach with a pharmaceutical treatment approach or some combination of both.
p.000151: REBs should have a member knowledgeable in the relevant area to assess the ethical issues specific to the type of
p.000151: therapy involved.
p.000151: REBs should be aware that trials involving psychotherapy may be more focused on effectiveness in real world conditions
p.000151: than on efficacy under tightly controlled conditions. For example, the research question may be how participants
p.000151: undergoing a particular therapy are functioning in their daily lives. The duration of these trials may be longer as a
p.000151: function of the therapeutic approach and the characteristics of the condition to which it is applied. Particular areas
p.000151: of concern are whether the principal investigator or others on the research team are sufficiently trained to provide
p.000151: the investigational therapy and whether there is any risk of a negative impact on participants’ mental health.
p.000151:
p.000151:
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p.000153: Chapter 11 – Clinical Trials
p.000153:
p.000153: Issues of participant privacy and confidentiality may receive closer scrutiny in cases where people with specific
p.000153: psychological profiles are being recruited from the same institution as the researchers. Researchers shall indicate how
p.000153: recruitment, data collection and management, and compensation procedures have been designed to protect participant
...
p.000175: follow applicable guidance expressed in other chapters of this Policy. This section provides further guidance for
p.000175: research involving embryos, fetuses, fetal tissue, and reproductive materials. For the purposes of this Policy
p.000175: the following definitions apply:3
p.000175: • Embryo means a human organism during the first 56 days of its development following fertilization or creation,
p.000175: excluding any time during which its development has been suspended, and includes any cell derived from such an
p.000175: organism that is used for the purpose of creating a human being.
p.000175:
p.000175:
p.000175:
p.000175:
p.000175: 176 TCPS 2
p.000175:
p.000175: Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction
p.000175:
p.000175: • Fetus means a human organism during the period of its development beginning on the 57th day following fertilization
p.000175: or creation, excluding any time during which its development has been suspended, and ending at birth.
p.000175: • Fetal tissue includes membranes, placenta, umbilical cord, amniotic fluid and other tissue that contains genetic
p.000175: information about the fetus.
p.000175: • Human reproductive materials means a sperm, ovum or other human cell, or a human gene, and includes a part of any
p.000175: of them.
p.000175: While research involving materials related to human reproduction has great promise for assisting the development of
p.000175: healthy pregnancies, curing illness, and repairing or rebuilding tissue, it raises special ethical considerations.
p.000175: Accordingly, this research has provoked vigorous debate. Discussion and reflection should continue as our scientific
p.000175: understanding develops.
p.000175: Significant ethical issues include consent to research involving materials related to human reproduction,
p.000175: privacy concerns, the risk of harm to those who provide reproductive materials, an embryo or fetus, and potential
p.000175: commodification of reproductive capabilities and materials related to reproduction. Researchers and REBs have a
p.000175: continuing duty to remain mindful of the public interest in these issues, and to respect policy, legal and regulatory
p.000175: requirements. In particular, researchers and REBs shall be aware of the detailed requirements and prohibitions set out
p.000175: in the Assisted Human Reproduction Act.
p.000175: Article 12.6 In addition to requirements in this chapter that apply to all research involving human biological
p.000175: materials, the following guidelines apply to research involving materials related to human reproduction:
p.000175: (a) Research using materials related to human reproduction in the context of an anticipated or ongoing pregnancy shall
p.000175: not be undertaken if the knowledge sought can reasonably be obtained by alternative methods.
p.000175: (b) Materials related to human reproduction for research use shall not be obtained through commercial transaction,
p.000175: including exchange for services.
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p.000193: in epidemiological research.
p.000193:
p.000193: Ongoing research – Research that has received REB approval and has not yet been completed.
p.000193:
p.000193: Participant – An individual whose data, or responses to interventions, stimuli, or questions by a researcher are
p.000193: relevant to answering a research question; also referred to as “human participant,” and in other
p.000193: policies/guidance as “subject” or “research subject.”
p.000193:
p.000193: Participatory research – Research that includes the active involvement of those who are the subject of the research.
p.000193: Participatory research is usually action-oriented, where those involved in the research process collaborate to define
p.000193: the research project, collect and analyze the data, produce a final product and act on the results. See
p.000193: “Community-based research” and “Collaborative research.”
p.000193:
p.000193: Principal investigator – The leader of a research team who is responsible for the conduct of the research, and for the
p.000193: actions of any member of the research team.
p.000193:
p.000193:
p.000193:
p.000193:
p.000193: 194 TCPS 2
p.000193:
p.000193: Glossary
p.000193:
p.000193: Personal information – Identifiable information about an individual. See “Identifiable information.”
p.000193: Pharmaceutical trial – A clinical trial designed to test the safety and/or efficacy of a pharmaceutical product.
p.000193: A pharmaceutical product is any chemical substance intended for use in the medical diagnosis, cure, treatment, or
p.000193: prevention of disease, disorders, or other illness.
p.000193: Placebo-controlled trials – A clinical trial in which the safety or efficacy of one or more interventions are compared
p.000193: with a placebo control group.
p.000193: A placebo is an inactive substance or intervention that resembles the comparable active substance or intervention.
p.000193:
p.000193: Privacy – An individual’s right to be free from intrusion or interference by others.
p.000193:
p.000193: Privacy risks – The potential harms that participants, or the groups to which they belong, may experience from the
p.000193: collection, use, and disclosure of personal information for research purposes.
p.000193:
p.000193: Proportionate approach to research ethics review – The assessment of foreseeable risk to determine the level of
p.000193: scrutiny a research proposal will receive (i.e. delegated review for minimal risk research or full REB review for
p.000193: research above minimal risk), as well as the consideration of foreseeable risks, potential benefits, and ethical
p.000193: implications of the research in the context of initial and continuing review.
p.000193:
p.000193: Psychotherapy trials – A clinical trial testing the safety and/or efficacy of one or more psychotherapeutic approaches
p.000193: to behavioural disorders or other mental illness.
p.000193:
p.000193: Publicly declared emergency – An emergency situation which, due to the extraordinary risks it presents, has been
p.000193: proclaimed as such by an authorized public office (in accordance with legislation and/or public policy). Publicly
p.000193: declared emergencies are extraordinary events that arise suddenly or unexpectedly, and require urgent or quick
p.000193: responses to minimize devastation. Examples include hurricanes and other natural disasters, large communicable disease
p.000193: outbreaks, catastrophic civil disorders, bio-hazardous releases, en- vironmental disasters, and humanitarian
p.000193: emergencies.
p.000193:
p.000193: Publicly available information – Any existing stored documentary material, records or publications, which may or may
p.000193: not include identifiable information, and that has no restrictions on its use or distribution, or that may be released
p.000193: under certain legal conditions.
p.000193:
p.000193: Qualitative research – An approach that aims to understand how people think about the world and how they act and behave
p.000193: in it. This approach requires researchers to understand phenomena based on discourse, actions, and documents, and how
p.000193: and why individuals interpret and ascribe meaning to what they say and do, and to other aspects of the world (including
p.000193: other people) they encounter.
p.000193:
p.000193: Reciprocal research ethics board (REB) review – An official agreement between two or more institutions, in which they
...
Searching for indicator physically:
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p.000199: article details several considerations relevant to the use of third party authorization. Beyond the legal and
p.000199: regulatory requirements for seeking consent from authorized third parties, family members and friends may also provide
p.000199: information to the authorized third party about the interests and previous wishes of prospective
p.000199: participants. An authorized third party should take into account any research directives given in accordance with
p.000199: Article 3.11.
p.000199: Article 3.10 Where an authorized third party has consented on behalf of an individual who lacks legal capacity, but
p.000199: that person has some ability to understand the significance of the research, the researcher shall ascertain the wishes
p.000199: of that individual with respect to participation. Prospective participants’ dissent will preclude their participation.
p.000199: Application Many individuals who lack legal capacity to make decisions may still be able to express their wishes in
p.000199: a meaningful way, even if such expression may not fulfil all of the requirements for consent. Prospective participants
p.000199: may be capable of verbally or physically assenting to, or dissenting from, participation in research. Those who may be
p.000199: capable of assent or dissent include:
p.000199: (a) those whose capacity is in the process of development, such as children whose capacity for judgment and
p.000199: self-direction is maturing;
p.000199: (b) those who once were capable of making an autonomous decision regarding consent but whose capacity is diminishing or
p.000199: fluctuating; and
p.000199: (c) those whose capacity remains only partially developed, such as those living with permanent cognitive impairment.
p.000199: While their assent would not be sufficient to permit them to participate in the absence of consent by an authorized
p.000199: third party, their expression of dissent or signs suggesting they do not wish to participate must be respected.
p.000199: Research Directives
p.000199: Although advance directives for treatment are recognized as a legitimate tool in health care, the use of directives in
p.000199: the context of research is not well developed and they have no legal status. For the purposes of this Policy, research
p.000199: directives should be understood to express an individual’s preferences for participation in future research in the
...
p.000199: Article 6.10 REBs shall have regular meetings to discharge their responsibilities, and shall nor- mally meet face to
p.000199: face to review proposed research that is not assigned to delegated review.
p.000199: Application Face-to-face meetings are essential for adequate discussion of, and effective REB decision making on,
p.000199: research proposals, and for the collective education of the REB. The face-to-face medium provides interactive dynamics
p.000199: that tend to heighten the quality and effectiveness of communications and decisions.
p.000199: Planning regular meetings is essential to fulfilling REB responsibilities. Where a member is frequently absent, the REB
p.000199: should have some mechanism for reviewing whether that member should continue to serve on the REB. Unexpected circum-
p.000199: stances such as emergencies may prevent individual member(s) from attending the REB meeting. In these exceptional
p.000199: cases, input from member(s) by the use of tech- nology (e.g., phone or video link) would be acceptable.
p.000199: Videoconferencing, teleconferencing or use of other technologies may be regarded as necessary for meetings when REB
p.000199: members are geographically dispersed and there is no other way of holding an effective REB meeting, or when exceptional
p.000199: or exigent circumstances significantly disrupt or limit the feasibility of face-to-face REB meetings (e.g., during a
p.000199: public emergency). All efforts should be made to en- sure that technical difficulties do not prevent the maintenance of
p.000199: quorum throughout the meeting. Use of such technologies requires the Chair to ensure active participa- tion of members
p.000199: not physically present. Institutions should consider developing written procedures for the occasional use of
p.000199: videoconferences or other technologies by an REB.
p.000199: In the design phase of their research prior to the formal ethics review process, re- searchers may consult informally
p.000199: with REBs. Such dialogue can establish the stage at which REB review and approval would be required, or facilitate the
p.000199: review. Such
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 75
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: informal meetings cannot, however, substitute for the formal review process. A schedule of REB meetings should be
p.000199: communicated to researchers for the planning of ethics review of their research.
p.000199: On occasion REBs may need to consult other resources within or outside the insti- tution for advice, and may invite
p.000199: experts to attend their meetings. REBs should consider whether the institutional functions of other individuals
p.000199: attending their meetings could exercise undue influence, or provide elements of power imbalances or coercion that would
p.000199: affect REB review, deliberations and decisions (see Articles
p.000199: 6.4 and 6.5 and Chapter 7).
p.000199: REBs should establish a process for the basis of arriving at decisions requiring full REB review. For example, they may
...
Health / Pregnant
Searching for indicator pregnant:
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p.000199: that women and men benefit equally from research.
p.000199:
p.000199:
p.000199: 48 TCPS 2
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: Article 4.2 Women shall not be inappropriately excluded from research solely on the basis of gender or sex.
p.000199: Application Researchers should not exclude women from research unless there is a valid reason for doing so. While
p.000199: some research is properly focused on particular research pop- ulations that do not include women, or include very few
p.000199: women, women should generally be represented where there is a reasonable expectation that the results of the research
p.000199: will be generalized to women.
p.000199: Article 4.2 rejects discriminatory and unethical use of inclusion or exclusion criteria that presumptively or
p.000199: inappropriately exclude women because of their gender or sex.
p.000199: Article 4.3 Women shall not be inappropriately excluded from research solely on the basis of their reproductive
p.000199: capacity, or because they are pregnant or breastfeeding.
p.000199: Application Researchers should not exclude women from research on the basis of their repro- ductive capacity, or
p.000199: their pregnancy, or because they are breastfeeding, unless there is a valid reason for doing so.
p.000199: Subjecting women of childbearing potential to inappropriate requirements pre- cludes their participation in research.
p.000199: Exclusions should be made on the basis of clear criteria that reflect balanced attention to the potential benefits as
p.000199: well as the foreseeable risks of the research that may affect the welfare of women. For exam- ple, researchers should
p.000199: not require participants to use oral contraception, unless there is a valid reason for doing so.
p.000199: In considering research on pregnant or breastfeeding women, researchers and REBs shall take into account foreseeable
p.000199: risks and potential benefits for the woman and her embryo, fetus or infant, as well as the foreseeable risks and
p.000199: potential benefits of excluding pregnant or breastfeeding women from the research.
p.000199: Research Involving Children
p.000199: Children have varying degrees of maturity – metabolically, immunologically and cognitively – that may present important
p.000199: challenges for research design and the consent process, depending on the nature and complexity of the research. In
p.000199: addition to the vulnerability that arises from their developmental stage, children may also lack capacity to consent to
p.000199: participate in research (see Ar- ticle 4.6). As well, physical or psychological harms a child may experience in a
p.000199: research setting may have long-lasting consequences. As a result, researchers have often avoided the inclusion of
p.000199: children in some research, especially in clinical trials testing new treatments, so as to eliminate any risks. Clinical
p.000199: trials conducted only with adults yield a generally poor understanding of the results that apply to children.
p.000199: As is the case with women, the inclusion of children in research advances the commitment to jus- tice in research by
...
p.000207: consent, 62-64, 130-132
p.000207: definition, 19, 62
p.000207: genetic material, 186
p.000207: privacy, 62-64
p.000207: Security of information, 56, 60-61, 64-65 StemXcells
p.000207: Guidelines for Human Pluripotent Stem Cell Research, 179 pluripotent, 179
p.000207: Students, 25, 67-68, 77-79 Subjects (see Participants)
p.000207: T
p.000207: Therapeutic misconception, 148, 149, 158-159
p.000207: Third party consent (see Consent: authorized third parties) Trials (see Clinical trials)
p.000207: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) application, 11-13
p.000207: compliance with, 5-6
p.000207: interpretation, 13
p.000207:
p.000207: U
p.000207: Unanticipated issues, 22, 34, 81, 161-163
p.000207: Undue influence, 28-29
p.000207:
p.000207: V
p.000207: Vulnerability, 9, 10, 23, 47, 52, 116, 137, 148
p.000207:
p.000207: W
p.000207: Welfare (see Concern for Welfare)
p.000207: Withdrawal
p.000207: of consent, 28-30, 31
p.000207: of data, 28-30, 31
p.000207: of human biological materials, 28-30, 31, 172
p.000207: from research, 28-30, 31, 61, 140, 186
p.000207: Women
p.000207: as research participants, 10, 47, 48-49, 116, 178-179 pregnant, inclusion in research, 49
p.000207:
p.000207:
p.000207:
p.000207:
p.000207:
p.000207:
p.000207: TCPS 2
p.000209: 209
p.000209:
...
Health / Unconscious People
Searching for indicator unconscious:
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p.000199: SARS crisis or a major flood) that disrupts the ordinary system for obtaining REB approval for research. For guidance
p.000199: on research ethics review during a publicly declared emergency, see Articles 6.21 and 6.22.
p.000199: Article 3.8 Subject to all applicable legal and regulatory requirements, research involving medical emergencies
p.000199: shall be conducted only if it addresses the emergency needs of the individuals involved, and then only in accordance
p.000199: with criteria established in advance of such research by the REB. The REB may allow research that involves medical
p.000199: emergencies to be carried out without the consent of participants, or of their authorized third party, if all of the
p.000199: following apply:
p.000199: (a) a serious threat to the prospective participant requires immediate intervention;
p.000199: (b) either no standard efficacious care exists or the research offers a realistic possibility of direct
p.000199: benefit to the participant in comparison with standard care;
p.000199: (c) either the risk is not greater than that involved in standard efficacious care, or it is clearly justified by the
p.000199: prospect for direct benefits to the participant;
p.000199: (d) the prospective participant is unconscious or lacks capacity to understand the risks, methods and purposes of the
p.000199: research project;
p.000199: (e) third party authorization cannot be secured in sufficient time, despite diligent and documented efforts to do so;
p.000199: and
p.000199: (f) no relevant prior directive by the participant is known to exist.
p.000199: When a previously incapacitated participant regains capacity, or when an authorized third party is found, consent
p.000199: shall be sought promptly for continuation in the project, and for subsequent examinations or tests related to
p.000199: the research project.
p.000199: Application For purposes of studying potential improvement in the treatment of life-threatening conditions, Article
p.000199: 3.8 outlines an exception (in addition to that in Article 3.7) to the general obligation of seeking consent from those
p.000199: participating in research.
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 39
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: It is the responsibility of researchers to justify to the REB the need for this exception. The underlying
p.000199: assumption of Article 3.8 is that participants could not receive any direct benefits of the research without setting
...
Health / breastfeeding
Searching for indicator breastfeeding:
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p.000199:
p.000199:
p.000199: 48 TCPS 2
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: Article 4.2 Women shall not be inappropriately excluded from research solely on the basis of gender or sex.
p.000199: Application Researchers should not exclude women from research unless there is a valid reason for doing so. While
p.000199: some research is properly focused on particular research pop- ulations that do not include women, or include very few
p.000199: women, women should generally be represented where there is a reasonable expectation that the results of the research
p.000199: will be generalized to women.
p.000199: Article 4.2 rejects discriminatory and unethical use of inclusion or exclusion criteria that presumptively or
p.000199: inappropriately exclude women because of their gender or sex.
p.000199: Article 4.3 Women shall not be inappropriately excluded from research solely on the basis of their reproductive
p.000199: capacity, or because they are pregnant or breastfeeding.
p.000199: Application Researchers should not exclude women from research on the basis of their repro- ductive capacity, or
p.000199: their pregnancy, or because they are breastfeeding, unless there is a valid reason for doing so.
p.000199: Subjecting women of childbearing potential to inappropriate requirements pre- cludes their participation in research.
p.000199: Exclusions should be made on the basis of clear criteria that reflect balanced attention to the potential benefits as
p.000199: well as the foreseeable risks of the research that may affect the welfare of women. For exam- ple, researchers should
p.000199: not require participants to use oral contraception, unless there is a valid reason for doing so.
p.000199: In considering research on pregnant or breastfeeding women, researchers and REBs shall take into account foreseeable
p.000199: risks and potential benefits for the woman and her embryo, fetus or infant, as well as the foreseeable risks and
p.000199: potential benefits of excluding pregnant or breastfeeding women from the research.
p.000199: Research Involving Children
p.000199: Children have varying degrees of maturity – metabolically, immunologically and cognitively – that may present important
p.000199: challenges for research design and the consent process, depending on the nature and complexity of the research. In
p.000199: addition to the vulnerability that arises from their developmental stage, children may also lack capacity to consent to
p.000199: participate in research (see Ar- ticle 4.6). As well, physical or psychological harms a child may experience in a
p.000199: research setting may have long-lasting consequences. As a result, researchers have often avoided the inclusion of
p.000199: children in some research, especially in clinical trials testing new treatments, so as to eliminate any risks. Clinical
p.000199: trials conducted only with adults yield a generally poor understanding of the results that apply to children.
p.000199: As is the case with women, the inclusion of children in research advances the commitment to jus- tice in research by
...
Health / degenerative conditions
Searching for indicator degenerative:
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p.000199: participation in research in the event that they lose capacity or upon death, researchers and authorized third parties
p.000199: should be guided by these directives during the consent process.
p.000199: Application Research directives allow individuals with capacity to express preferences about their future
p.000199: participation in research should they ever lose capacity. Researchers and authorized third parties should take these
p.000199: directives into account during the consent process, but only if the individual who provided the research directive
p.000199: lacks capacity at the time the research is initiated. Research directives may also be used for participants who have
p.000199: capacity when research is initiated but lose capacity during research.
p.000199: Research directives are useful to individuals who are already participating in research as well as those who
p.000199: are not participating but may wish to participate in research at a later date. They give individuals a range of options
p.000199: regarding future participation in research. The use of research directives is particularly relevant for research
p.000199: involving participants with diminishing capacity, fluctuating capacity or degenerative conditions, and research that
p.000199: collects information or human biological materials.
p.000199: The use of research directives does not alter the requirements for consent as articulated by the provisions
p.000199: of this Policy. In particular, in accordance with Article 3.9, researchers are required to seek the consent of
p.000199: authorized third parties before individuals who lack capacity can participate in research. If an individual regains
p.000199: capacity, the researcher should promptly seek the consent of the individual as a condition of continuing participation.
p.000199: Researchers, institutions and organizations may suggest the use of research direc- tives in order to give participants
p.000199: an opportunity to express preferences about the use of information or human biological material that has already been
p.000199: collected. Researchers who collect information or human biological materials for a specific research project may
p.000199: anticipate subsequent research uses. Some types of research initiatives (e.g., the creation of large databases
p.000199: sometimes known as research plat- forms) involve long-term retention and use of information or human biological
p.000199: materials for research purposes (e.g., longitudinal studies that involve biobanking).
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 43
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
...
Health / patients in emergency situations
Searching for indicator emergencies:
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p.000055: Introduction 55
p.000055: A. Key Concepts 55
p.000055: B. Ethical Duty of Confidentiality 58
p.000055: C. Safeguarding Information 60
p.000055: D. Consent and Secondary Use of Identifiable Information for
p.000055: Research Purposes 62
p.000055: E. Data Linkage. 64
p.000055: TCPS 2 i
p.000055:
p.000055: Chapter 6
p.000067: 67
p.000067: GOVERNANCE OF RESEARCH ETHICS REVIEW 67
p.000067: Introduction 67
p.000067: A. Establishment of Research Ethics Boards 67
p.000067: B. Procedures for Research Ethics Board Review 76
p.000067: C. Reconsideration and Appeals 83
p.000067: D. Research Ethics Review during Publicly Declared Emergencies 85
p.000067: Chapter 7
p.000089: 89
p.000089: CONFLICTS OF INTEREST
p.000089: 89
p.000089: Introduction 89
p.000089: A. Key Concepts 89
p.000089: B. Institutions and Conflicts of Interest 91
p.000089: C. Research Ethics Board Members and Conflicts of Interest 93
p.000089: D. Researchers and Conflicts of Interest 94
p.000089: Chapter 8
p.000097: 97
p.000097: MULTI-JURISDICTIONAL RESEARCH 97
p.000097: Introduction 97
p.000097: A. Review Mechanisms for Research Involving Multiple Institutions and/or Multiple Research Ethics Boards
p.000097: 97
p.000097: B. Review of Research Conducted outside the Institution 101
p.000097: Chapter 9
p.000105: 105
p.000105: RESEARCH INVOLVING THE FIRST NATIONS, INUIT AND
p.000105: MÉTIS PEOPLES OF CANADA
p.000105: 105
p.000105: Introduction 105
p.000105: A. Key Concepts and Definitions 107
p.000105: B. Interpreting the Ethics Framework in Aboriginal Contexts 109
p.000105: C. Applying Provisions of This Policy in Aboriginal Contexts 110
p.000105: Chapter 10
p.000135: 135
...
p.000199: feelings, reactions and concerns.
p.000199: In studies involving partial disclosure or deception in which an alteration to the requirement for prior consent has
p.000199: been allowed, participants must nevertheless be able to indicate their consent or their refusal at the
p.000199: conclusion of the project, following debriefing. In cases where participants express concerns about their
p.000199: participation in a project, the researcher may give participants the option of removing their data from the project.
p.000199: Where the terms of the research proposal do not permit the participants to withdraw their data, in the absence
p.000199: of the consent of the participant, the identity of the participants shall be protected at all times during and
p.000199: following completion of the project. Participants who express concern about the conduct of the project at the time of
p.000199: debriefing, or who contest the limits imposed
p.000199:
p.000199:
p.000199: 38 TCPS 2
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: on withdrawing their data, should be given the contact information for the REB that approved the research. Researchers
p.000199: must report to the REB concerns about the conduct of the project raised by participants at the time of debriefing.
p.000199: Consent for Research in Individual Medical Emergencies
p.000199: This section addresses the exception to consent in situations where an individual who requires urgent medical care is
p.000199: unable to provide consent for research due to loss of consciousness or capacity – and the delay to seek authorized
p.000199: third party consent could seriously compromise that individual’s health. Certain types of medical emergency practices
p.000199: can be evaluated only when they occur, hence the need for this exception.
p.000199: This section is to be distinguished, however, from situations where there is a publicly declared emergency (such as the
p.000199: SARS crisis or a major flood) that disrupts the ordinary system for obtaining REB approval for research. For guidance
p.000199: on research ethics review during a publicly declared emergency, see Articles 6.21 and 6.22.
p.000199: Article 3.8 Subject to all applicable legal and regulatory requirements, research involving medical emergencies
p.000199: shall be conducted only if it addresses the emergency needs of the individuals involved, and then only in accordance
p.000199: with criteria established in advance of such research by the REB. The REB may allow research that involves medical
p.000199: emergencies to be carried out without the consent of participants, or of their authorized third party, if all of the
p.000199: following apply:
p.000199: (a) a serious threat to the prospective participant requires immediate intervention;
p.000199: (b) either no standard efficacious care exists or the research offers a realistic possibility of direct
p.000199: benefit to the participant in comparison with standard care;
p.000199: (c) either the risk is not greater than that involved in standard efficacious care, or it is clearly justified by the
p.000199: prospect for direct benefits to the participant;
p.000199: (d) the prospective participant is unconscious or lacks capacity to understand the risks, methods and purposes of the
p.000199: research project;
p.000199: (e) third party authorization cannot be secured in sufficient time, despite diligent and documented efforts to do so;
p.000199: and
p.000199: (f) no relevant prior directive by the participant is known to exist.
p.000199: When a previously incapacitated participant regains capacity, or when an authorized third party is found, consent
p.000199: shall be sought promptly for continuation in the project, and for subsequent examinations or tests related to
p.000199: the research project.
...
p.000199: Guiding Principles. www.science.gc.ca/default.asp?Lang=En&n=9990CB6B-1
p.000199: 3 See also the Canadian Institutes of Health Research, CIHR Guidelines for Health Research Involving Aboriginal People
p.000199: (May 2007). www.cihr-irsc.gc.ca/e/29134.html
p.000199: 4 For discussion of factors relevant to assessing impracticability of consent, see, for example, the Canadian
p.000199: Institutes of Health Research, CIHR Best Practices for Protecting Privacy in Health Research, Section 3.3, Secondary
p.000199: Use (September 2005). www.cihr-irsc.gc.ca/e/29072.html#Element3
p.000199: 5 See, for example, Statistics Canada, “Policy on Record Linkage.” www.statcan.gc.ca/record-
p.000199: enregistrement/policy4-1-politique4-1-eng.htm
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 65
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: Introduction
p.000199: Chapter 6
p.000199: GOVERNANCE OF RESEARCH ETHICS REVIEW
p.000199: This chapter sets out the elements of research ethics review including the procedures necessary to establish a research
p.000199: ethics board (REB), and operational guidelines for the REBs and research ethics review, both initially and throughout
p.000199: the course of the research project. It also includes guidelines for the conduct of research ethics review during
p.000199: publicly declared emergencies.
p.000199: A key goal in establishing an appropriate governance structure for research ethics review is to en- sure that REBs
p.000199: operate with a clear mandate, authority and accountability; and that roles and responsibilities are clearly defined.
p.000199: REBs need independence in their decision-making process to carry out their role effectively, and to properly apply the
p.000199: core principles of this Policy – Respect for Persons, Concern for Welfare and Justice – to their ethics review of
p.000199: research projects. These operational guidelines are meant to be flexible enough to apply in various contexts, at
p.000199: institutions of various sizes, and to the full range of research disciplines, fields and methodologies.
p.000199:
p.000199: A. Establishment of Research Ethics Boards
p.000199:
p.000199: Authority, Mandate and Accountability
p.000199: Article 6.1 Institutions shall establish or appoint REB(s) to review the ethical acceptability of all research
p.000199: involving humans conducted within their jurisdiction or under their auspices, that is, by their faculty, staff or
p.000199: students, regardless of where the research is conducted, in accordance with this Policy.
p.000199: Application Each institution is accountable for the research carried out in its own jurisdiction or under its
p.000199: auspices. In fulfilling this responsibility, where research involving hu- mans takes place within the jurisdiction or
...
p.000199: review process, based on institutional policies and procedures and this Policy. The Chair should monitor the REB’s
p.000199: decisions for consistency and en- sure that these decisions are recorded accurately and communicated clearly to
p.000199: researchers in writing as soon as possible by the Chair or his or her designate. In- stitutions shall provide the
p.000199: necessary resources and adequate administrative support to enable the REB Chair to fulfill his or her responsibilities.
p.000199: REB Quorum
p.000199: Article 6.9 Institutions shall establish quorum rules for REBs that meet the minimum require- ments of membership
p.000199: representation outlined in Article 6.4. When there is less than full attendance, decisions requiring full review should
p.000199: be adopted only when the members in attendance at that meeting have the specific expertise, relevant com- petence and
p.000199: knowledge necessary to provide an adequate research ethics review of the proposals under consideration.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: 74 TCPS 2
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: Application Institutions shall establish REB quorum rules subject to the range of competence and knowledge required
p.000199: by this Policy to ensure the soundness and integrity of the research ethics review process. To maintain quorum when REB
p.000199: members are geo- graphically dispersed or in unexpected circumstances (e.g., emergencies), input from member(s) is
p.000199: allowed by other means, such as the use of technology (see Ar- ticle 6.10).
p.000199: Ad hoc advisors, observers, research ethics administration staff and others attending REB meetings should not be
p.000199: counted in the quorum for an REB. Nor should they be allowed to vote on REB decisions (see Article 6.5). Decisions
p.000199: without a quorum are not valid or binding.
p.000199: REB Meetings and Attendance
p.000199: Article 6.10 REBs shall have regular meetings to discharge their responsibilities, and shall nor- mally meet face to
p.000199: face to review proposed research that is not assigned to delegated review.
p.000199: Application Face-to-face meetings are essential for adequate discussion of, and effective REB decision making on,
p.000199: research proposals, and for the collective education of the REB. The face-to-face medium provides interactive dynamics
p.000199: that tend to heighten the quality and effectiveness of communications and decisions.
p.000199: Planning regular meetings is essential to fulfilling REB responsibilities. Where a member is frequently absent, the REB
p.000199: should have some mechanism for reviewing whether that member should continue to serve on the REB. Unexpected circum-
p.000199: stances such as emergencies may prevent individual member(s) from attending the REB meeting. In these exceptional
p.000199: cases, input from member(s) by the use of tech- nology (e.g., phone or video link) would be acceptable.
p.000199: Videoconferencing, teleconferencing or use of other technologies may be regarded as necessary for meetings when REB
p.000199: members are geographically dispersed and there is no other way of holding an effective REB meeting, or when exceptional
p.000199: or exigent circumstances significantly disrupt or limit the feasibility of face-to-face REB meetings (e.g., during a
p.000199: public emergency). All efforts should be made to en- sure that technical difficulties do not prevent the maintenance of
p.000199: quorum throughout the meeting. Use of such technologies requires the Chair to ensure active participa- tion of members
p.000199: not physically present. Institutions should consider developing written procedures for the occasional use of
p.000199: videoconferences or other technologies by an REB.
p.000199: In the design phase of their research prior to the formal ethics review process, re- searchers may consult informally
p.000199: with REBs. Such dialogue can establish the stage at which REB review and approval would be required, or facilitate the
p.000199: review. Such
p.000199:
p.000199:
p.000199:
p.000199:
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p.000199:
...
p.000199: it may approve, reject or request modifications to the re- search proposal. Its decision on behalf of the institution
p.000199: shall be final.
p.000199: Application Researchers have the right to request an appeal of an REB decision. An appeal can be launched for
p.000199: procedural or substantive reasons. The onus is on the researchers to justify the grounds on which they request an
p.000199: appeal and to indicate any breaches to the research ethics review process or any elements of the REB decision that are
p.000199: not supported by this Policy.
p.000199: The appeal committee shall function impartially, provide a fair hearing to those in- volved, and provide reasoned
p.000199: and appropriately documented opinions and decisions. Both the researcher and a representative of the REB shall be
p.000199: granted the opportunity to address the appeal committee, but neither shall be present when the
p.000199:
p.000199:
p.000199:
p.000199: 84 TCPS 2
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: appeal committee deliberates and makes a decision. Appeal committee decisions on behalf of the institution shall be
p.000199: final, and should be communicated in writing (in print or by electronic means) to researchers and to the REB whose
p.000199: decision was appealed. Recourse to judicial review may be available to the researcher.
p.000199:
p.000199: D. Research Ethics Review during Publicly Declared Emergencies
p.000199:
p.000199: This section addresses research ethics review within the context of the official declaration of public emergencies. For
p.000199: the purposes of this Policy, a publicly declared emergency is an emergency sit- uation that, due to the extraordinary
p.000199: risks it presents, has been proclaimed as such by an authorized public official (in accordance with legislation and/or
p.000199: public policy).
p.000199: Publicly declared emergencies are extraordinary events that arise suddenly or unexpectedly, and require urgent or quick
p.000199: responses to minimize devastation. Examples include hurricanes and other natural disasters, large communicable disease
p.000199: outbreaks, catastrophic civil disorders, bio-hazardous releases, environmental disasters, and humanitarian emergencies.
p.000199: They tend to be time-limited. They may severely disrupt or may destroy normal functioning of institutions and
p.000199: communities, as well as individual lives. Once an emergency has been designated a publicly declared emergency,
p.000199: authorities may exercise special responsibilities and powers to deal with the situation, and the ex- ercise of those
p.000199: responsibilities may temporarily modify normal procedures or practices. This section therefore applies to narrow,
p.000199: limited and exceptional circumstances.
p.000199: There is a growing awareness of the need for institutional planning to respond to publicly declared emergencies, and
p.000199: the associated potential challenges for research ethics review. Given the extraor- dinary circumstances that
p.000199: participants are potentially subjected to in publicly declared emergencies, special attention and effort should be
p.000199: given to upholding the core principles of Respect for Persons, Concern for Welfare, and Justice when reviewing the
p.000199: ethics of research to be conducted in emer- gencies. It should be noted that the following articles and the requirement
p.000199: for consent will not apply to public health activities undertaken by federal, provincial and territorial public health
p.000199: of- ficials operating under statutory powers during publicly declared health emergencies.
p.000199: Preparedness Plans for Research Ethics Review during Publicly Declared Emergencies Article 6.21 In collaboration
p.000199: with their researchers, institutions and their REBs should develop
p.000199: preparedness plans for emergency research ethics review. Research ethics review during publicly declared emergencies
p.000199: may follow modified procedures and prac- tices.
p.000199: Application Preparedness plans should outline policies and procedures for addressing research ethics review during
p.000199: public health outbreaks, natural disasters and other publicly declared emergencies. Research ethics policies and
p.000199: procedures, and their imple- mentation, should adhere rigorously to a rule of reasonable, fair, and principled design
p.000199: and use during publicly declared emergencies.
p.000199:
p.000199:
p.000199:
p.000199:
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p.000199: Through their emergency preparedness plans, institutions, researchers and their REBs need to anticipate the pressures,
p.000199: time constraints, priorities and logistical challenges that may arise to ensure quality, timely, proportionate and
p.000199: appropriate research ethics review. The plan and its policies should proactively address basic operational questions.
p.000199: Examples include, but are not limited to, how emergencies may affect research and research ethics review in
p.000199: institutions; how REBs conduct business or meetings; what research needs should be planned in advance of, or ad-
p.000199: dressed after, an emergency; what research, if any, needs to be done during an emergency; what qualifies as
p.000199: time-sensitive or “essential” research; what proce- dures govern the research ethics review process in emergency
p.000199: circumstances; and what evaluation methods need to be developed for post-response evaluations to in- form any revisions
p.000199: to the institution’s emergency procedures. It is important to pilot test the emergency procedures and plans in advance.
p.000199: Policies should try to anticipate the extraordinary circumstances or demands occa- sioned by emergencies and set
p.000199: priorities among them. For example, REBs should try to work collaboratively with researchers who would likely be
p.000199: involved in emer- gency research (e.g., relevant biomedical, environmental and social science researchers), and
p.000199: determine what special consent provisions may be made (see Chapter 3). Institutions might consider the use of an
p.000199: instrument to identify and triage the kinds of research that should be designed before, undertaken during or conducted
p.000199: after officially declared public emergencies. Likewise, a plan to help pri- oritize REB reviews during emergencies
p.000199: should take into account the following:
p.000199: • what research is “essential” research during the emergency;
p.000199: • the initial ethics review process of new research projects arising from the emergency (e.g., research
p.000199: involving interviews with first responders and victims to understand human response during a
p.000199: disaster, such as a tornado or earthquake);
p.000199: • continuing ethics review of research undertaken prior to the occurrence of the emergency; and
p.000199: • the ethics review process for changes to approved research, because new information may become
p.000199: available and require action very rapidly during emergencies (see Articles 6.15 and 6.16).
p.000199: REB procedures may warrant reasonable adjustments to address the timing, locale, expertise, form and scope of research
p.000199: ethics review, and the holding of REB meet- ings during emergency situations (see Article 6.10). Special attention
p.000199: could be given to REB procedures to review and approve research (e.g., full or delegated research ethics reviews,
p.000199: quorum rules, or special agreements with other institutions), while considering the impact of the emergency on
p.000199: participants, researchers, REB mem- bers, institutional staff, and others. It is also important to coordinate research
p.000199: efforts
p.000199:
p.000199:
p.000199: 86 TCPS 2
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: and research ethics review processes within and across institutions. REB members may become unavailable (e.g., due to
p.000199: illness, relocation, or quarantine by public authorities). Institutions and REBs should explore the nomination of
p.000199: substitute REB members and consultation with ad hoc advisors with relevant expertise (see Articles
p.000199: 6.4 and 6.5), negotiate reciprocity agreements with other institutions for REB re- views (see Article 8.1), and revisit
p.000199: how scholarly review (see Article 2.7) would be applied in emergency situations.
p.000199: Research ethics review should be commensurate with the necessities occasioned by the emergency because of the
p.000199: critical interplay between public urgencies, essential research and a continuing commitment to the core principles
p.000199: even in the face of acute public necessity. Indeed, research ethics review during publicly declared
p.000199: emergencies is even more important than under normal circumstances, and may require even greater care, since everyone
p.000199: (participants, researchers and REB members themselves) may be rendered more vulnerable by the nature of the emergency.
p.000199: Research Ethics Review Policy and Procedures during Publicly Declared Emergencies Article 6.22 Research ethics
p.000199: policies and procedures for emergencies take effect once an emer-
p.000199: gency has been publicly declared. They should cease to apply as soon as is feasible after the end of the publicly
p.000199: declared emergency.
p.000199: Application Because emergencies present extraordinary public risks that warrant special re- sponses, legislation
p.000199: or public policies usually require that they be officially proclaimed or declared. Research ethics review
p.000199: procedures that have been estab- lished for use during publicly declared emergencies should be applied only after an
p.000199: authorized public official declares a public emergency. These procedures there- fore apply to very narrow, limited and
p.000199: exceptional circumstances. Institutions and REBs must endeavour to return to normal operating procedures as soon as
p.000199: possible after public officials have declared that the emergency is over.
p.000199: Respecting Core Principles: Limiting Exceptions
p.000199: Article 6.23 REBs should give special care to requests for exceptions to the principles and pro- cedures outlined in
p.000199: this Policy during publicly declared emergencies.
p.000199: Application Especially during times of emergency, researchers, REBs and institutions need to be vigilant and
p.000199: exercise due diligence in respecting ethical principles, procedures and the law in effect during the emergency to
p.000199: preserve the values, purpose and pro- tection that the principles of this Policy advance.
p.000199: To guide fair and reasonable implementation of these principles in emergency cir- cumstances, any exception to, or
p.000199: infringement of, ethics principles and REB procedures must be demonstrably justified by those urging the exception
p.000199: or in- fringement.
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 87
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p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: Endnote
p.000199:
p.000199: Where exceptions to or infringements of ethics principles and REB procedures are justified, they should be narrowly
p.000199: tailored to address the necessities occasioned by the publicly declared emergency, such that they rely on the most
p.000199: restrictive or least intrusive means necessary to achieve the Policy goal: the promotion and guidance of ethical
p.000199: conduct in research. This approach – consistent with international bioethics and human rights norms – maximizes
p.000199: respect for ethical principles and helps to ensure that exceptions and the means to implement them are not unduly
p.000199: broad, overreaching or unjustifiably invasive.
p.000199: Recognizing and respecting the principle of Justice means that research ethics re- view policies and procedures for
p.000199: publicly declared emergencies shall be used in a manner that is not discriminatory or arbitrary. The commitment to
p.000199: justice advances a fair and balanced distribution of risks and potential benefits even in the face of public
p.000199: emergencies.
p.000199: REBs and researchers should be aware that individuals, prospective participants, researchers, and institutions may not
p.000199: normally be considered vulnerable, but may become so by the very nature of public emergencies. Those already vulnerable
p.000199: may become acutely so (see Article 4.7). The increased public risks and devastation that cause public emergencies to be
p.000199: declared can threaten autonomy and physical, emo- tional, institutional and social welfare or safety. They also bring
p.000199: inherent tensions and pressures that may impact deliberative decision making. Taking all of this into consideration,
p.000199: REBs and researchers should ensure that the risks and potential ben- efits posed by any proposed research are
p.000199: appropriately evaluated, including provisions for greater-than-normal attention to risk, where applicable.
p.000199:
p.000199:
p.000199: 1 Memorandum of Understanding on the Roles and Responsibilities in the Management of Federal Grants and Awards.
p.000199: www.nserc-crsng.gc.ca/NSERC-CRSNG/Policies-Politiques/MOURoles-Protocol- Roles/index_eng.asp
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: 88 TCPS 2
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: Introduction
p.000199: Chapter 7
p.000199: CONFLICTS OF INTEREST
p.000199: This chapter addresses ethical issues that can arise when research activities and other activities conflict. A conflict
p.000199: of interest may arise when activities or situations place an individual or insti- tution in a real, potential or
p.000199: perceived conflict between the duties or responsibilities related to research, and personal, institutional or other
p.000199: interests.1 These interests include, but are not limited to, business, commercial or financial interests pertaining to
...
p.000193:
p.000193: Privacy – An individual’s right to be free from intrusion or interference by others.
p.000193:
p.000193: Privacy risks – The potential harms that participants, or the groups to which they belong, may experience from the
p.000193: collection, use, and disclosure of personal information for research purposes.
p.000193:
p.000193: Proportionate approach to research ethics review – The assessment of foreseeable risk to determine the level of
p.000193: scrutiny a research proposal will receive (i.e. delegated review for minimal risk research or full REB review for
p.000193: research above minimal risk), as well as the consideration of foreseeable risks, potential benefits, and ethical
p.000193: implications of the research in the context of initial and continuing review.
p.000193:
p.000193: Psychotherapy trials – A clinical trial testing the safety and/or efficacy of one or more psychotherapeutic approaches
p.000193: to behavioural disorders or other mental illness.
p.000193:
p.000193: Publicly declared emergency – An emergency situation which, due to the extraordinary risks it presents, has been
p.000193: proclaimed as such by an authorized public office (in accordance with legislation and/or public policy). Publicly
p.000193: declared emergencies are extraordinary events that arise suddenly or unexpectedly, and require urgent or quick
p.000193: responses to minimize devastation. Examples include hurricanes and other natural disasters, large communicable disease
p.000193: outbreaks, catastrophic civil disorders, bio-hazardous releases, en- vironmental disasters, and humanitarian
p.000193: emergencies.
p.000193:
p.000193: Publicly available information – Any existing stored documentary material, records or publications, which may or may
p.000193: not include identifiable information, and that has no restrictions on its use or distribution, or that may be released
p.000193: under certain legal conditions.
p.000193:
p.000193: Qualitative research – An approach that aims to understand how people think about the world and how they act and behave
p.000193: in it. This approach requires researchers to understand phenomena based on discourse, actions, and documents, and how
p.000193: and why individuals interpret and ascribe meaning to what they say and do, and to other aspects of the world (including
p.000193: other people) they encounter.
p.000193:
p.000193: Reciprocal research ethics board (REB) review – An official agreement between two or more institutions, in which they
p.000193: accept, with an agreed level of oversight, the research ethics reviews of each other’s REBs.
p.000193:
p.000193: Reimbursement – Payment to participants to ensure that they are not put at a direct, or indirect, financial
p.000193: disadvantage for the time and inconvenience of participation in research. Direct expenses refer to the costs incurred,
p.000193: and indirect expenses refer to losses that arise, because of research participation.
p.000193:
p.000193:
p.000193:
p.000193: TCPS 2
p.000195: 195
p.000195:
p.000195: Glossary
p.000195:
p.000195: Research – An undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation.
p.000195:
p.000195: Research agreement – A document that serves as a primary means of clarifying and confirming mutual expectations and,
p.000195: where appropriate, commitments between researchers and communities.
p.000195:
...
p.000199: Aboriginal, 107-108, 109
p.000199: and genetic research, 181, 183-184, 185
p.000199: Compensation
p.000199: and consent, 29, 31, 33
p.000199: for research ethics board members, 94 Concern for Welfare, 8, 9-10, 109 Confidentiality (see Privacy and
p.000199: confidentiality)
p.000199: Conflicts of interest
p.000199: clinical trials, 163-164
p.000199: definition, 89
p.000199: dual roles, 95, 149, 158
p.000199: financial, 95-96, 163-164
p.000199: incentives, 29-30, 52, 151, 164
p.000199: institutional, 89-90, 91-93
p.000199: research ethics board members, 69, 70-71, 78, 90, 93-94
p.000199: researchers, 91, 94-96
p.000199: Consent
p.000199: Aboriginal peoples, 109, 119, 123, 131
p.000199: alteration, 37-39
p.000199: authorized third parties, 27, 41-44 capacity to (see Capacity)
p.000199: clinical trials, 155, 158-159, 161-163
p.000199: coercion, 29
p.000199: and compensation, 29, 31, 33
p.000199: definition, 27
p.000199: documentation, 44-45
p.000199: evidence, 44-45, 140
p.000199: exceptions to requirement to seek, 37-40, 62-64, 85, 141-143, 172-175 free (see Consent: voluntary)
p.000199: general principles, 28-36
p.000199: general principles, departures from, 37-40
p.000199: human biological materials, 9, 28-30, 31, 171-175 human reproduction, materials related to, 177-179 incentives, 29-30,
p.000199: 31, 151
p.000199: individual medical emergencies, 39-40 informed, 27, 30-33
p.000199: modalities of expression, 140 ongoing, 27, 33-34, 137-138
p.000199: oral, 44, 140
p.000199: qualitative research, 137-138, 140, 141-144
p.000199: research directives, 42-44
p.000199: secondary use of human biological materials, 62-64, 130-132, 172-175
p.000199: secondary use of identifiable information, 62-64, 130-132 undue influence, 28-29
p.000199: voluntary, 27, 28-30, 31, 32
p.000199: withdrawal, 28-30, 31
p.000199: written, 44-45
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2
p.000201: 201
p.000201:
p.000201: Index
p.000201:
p.000201: Continuing research ethics review, 21-22, 79-81
p.000201: Core principles, 8-11
p.000201: Concern for Welfare, 8, 9-10, 109
p.000201: Justice, 8, 10-11, 47, 109-110
p.000201: interpretation, 13, 109-110
p.000201: Respect for Persons, 8-9, 27, 109
p.000201: Creative practice, 20
p.000201: Critical inquiry, 35-36, 117
p.000201: Cultural heritage, 110-111
p.000201: Cyber-material, 18
p.000201:
p.000201: D
p.000201: Data
p.000201: anonymized, 57
p.000201: anonymous, 57, 131-132
p.000201: collection, 64, 76-77, 137, 144-145
p.000201: destruction, 61
p.000201: linkage, 18, 19, 64-65, 131-132
p.000201: security, 61, 64-65
p.000201: withdrawal, 28-30, 31 (see also Information)
p.000201: Data safety monitoring board (DSMB), 160-161 Debriefing, 37-39, 143
p.000201: Design
p.000201: clinical trials, 149-156
p.000201: emergent, 144-145 Duty of care, 148-149
p.000201: E
p.000201: Elderly, as research participants, 10, 47, 50
p.000201: Elders, in Aboriginal communities, 119, 126
p.000201: Embryos, 15-17, 49, 176, 177-178
p.000201: Emergencies
p.000201: individual medical, 39-40
p.000201: publicly declared (see Publicly declared emergencies) Emergent design, 144-145
p.000201: Ethics (see Research ethics)
p.000201:
p.000201: F
p.000201: Fetal tissue, 15-17, 177, 178-179
p.000201: Fetuses, 15-17, 49, 177, 178, 178-791
p.000201: Findings
p.000201: commercialization, 30-32, 186
p.000201: dissemination, 61, 128, 143-144, 164-167, 183-184
p.000201: incidental, 34, 171-172
p.000201: interpretation, 126, 128
p.000201:
p.000201:
p.000201:
p.000201: 202 TCPS 2
p.000201:
p.000201: Index
p.000201:
p.000201: First Nations, 105, 107, 108, 110, 114, 115, 117, 121, 127
p.000201: (see also Aboriginal peoples)
p.000201:
p.000201: G
p.000201: Genetic research (see Human genetic research)
p.000201:
p.000201: H
p.000201: Harm, definition, 10, 22-23
p.000201: Human biological materials
p.000201: Aboriginal peoples, 119, 129-132
p.000201: anonymized, 170
p.000201: anonymous, 19, 131-132, 170
p.000201: coded, 170
p.000201: collection, 76-77, 129-130, 170-172
p.000201: consent for use, 9, 28-30, 31, 171-175
p.000201: definition, 16-17, 169
p.000201: identified, 170
p.000201: secondary use, 62-64, 119-121, 130-132, 172-175, 186
p.000201: storage and banking, 175-176 types, 169-170
p.000201: withdrawal, 28-30, 31, 172
p.000201: (see also Human reproduction, materials related to) Human dignity, respect for, 8-11, 28
p.000201: Human genetic research
p.000201: application of core principles, 181-182 definition, 181
p.000201: gene alteration, 186-187
p.000201: gene transfer, 186-187
p.000201: genetic counselling, 184 genetic material banks, 186
...
p.000203: Institutions
p.000203: appointment of appeal boards, 84-85 compliance with Policy, 5-6 conflicts of interest, 89-90, 91-93
p.000203: multi-jurisdictional review, 97-99, 100-103
p.000203: senior administrators, 70-71, 93-94
p.000203: support of research ethics boards, 68-70, 74, 77, 80
p.000203: support of researchers, 5, 58-59
p.000203: Intellectual property, 128-129
p.000203: Intermediaries, 32, 48
p.000203: Inuit, 105, 107, 108, 110, 114, 115, 117, 118, 121
p.000203: (see also Aboriginal peoples)
p.000203:
p.000203: J
p.000203: Justice, 8, 10-11, 47, 109-110
p.000203:
p.000203: K
p.000203: Knowledge, traditional, 108-109, 110-111, 126
p.000203:
p.000203:
p.000203:
p.000203:
p.000203: 204 TCPS 2
p.000203:
p.000203: Index
p.000203:
p.000203:
p.000203: L
p.000203: Law
p.000203:
p.000203:
p.000203:
p.000203:
p.000203:
p.000203:
p.000203:
p.000203:
p.000203:
p.000203: M
p.000203:
p.000203:
p.000203: capacity, 41
p.000203: confidentiality, 58, 59, 60
p.000203: consent, 12, 27, 33-34
p.000203: gene transfer, 186
p.000203: human biological materials, 130, 171
p.000203: human reproduction, materials related to, 177 incidental findings, 34
p.000203: multi-jurisdictional review, 101, 103
p.000203: privacy, 12, 17-18, 55, 63, 64, 142, 143, 174
p.000203: research ethics, 12
p.000203: Medical emergencies (see Emergencies)
p.000203: Memorandum of Understanding on the Roles and Responsibilities in the Management of Federal Grants and Awards, 5, 67,
p.000106: 106
p.000106: Métis, 105, 107, 108, 110, 114, 115, 117, 121
p.000106: (see also Aboriginal peoples)
p.000106: Minimal risk research, 11, 23, 24-25, 37-39, 41, 51, 77-79 Multi-jurisdictional research
p.000106: official agreements, 98, 100
p.000106: research ethics review models, 99-101 review mechanisms, 97-101
p.000106:
p.000106: O
p.000106: Observational research, 18-19, 118, 141-143
p.000106:
p.000106: P
p.000106: Participants
p.000106: autonomy, 8-9, 27, 40 capacity (see Capacity)
p.000106: children, 10, 34, 41-42, 47, 49-50, 51, 185, 187
p.000106: confidentiality, 56, 58-60, 126-128, 143-144, 186
p.000106: definition, 16
p.000106: elderly, 10, 47, 50
p.000106: as members of research ethics boards, 72 perspective, 12, 23, 28, 72, 161
p.000106: privacy, 55-56, 58-60, 126-128, 143-144, 171-172, 186
p.000106: recruitment, 11, 28, 76-77, 110, 158-159, 164, 184-185
p.000106: removal from research, 31, 33, 160 as research partners, 138
p.000106: vulnerability, 9, 10, 23, 47, 52, 116, 137, 148
p.000106: withdrawal from research, 28-30, 31, 61, 140, 186
p.000106: women, 10, 47, 48-49, 116, 178-179
p.000106: Participatory research, 123-125
p.000106: Performance review, 20
p.000106:
p.000106:
p.000106: TCPS 2
p.000205: 205
p.000205:
p.000205: Index
p.000205:
p.000205: Pilot studies, 76-77, 139
p.000205: Pluripotent stem cells, 179
p.000205: Policy, the (see Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans) Principal investigators,
p.000205: 27, 99, 153-154, 159, 162, 165-166
p.000205: Principles (see Core principles) Privacy and confidentiality
p.000205: Aboriginal peoples, 126-128
p.000205: data linkage, 18, 19, 64-65, 131-132
p.000205: definition, 55-56
p.000205: ethical duty, 56, 58-60
p.000205: identifiability of information, 56-57
p.000205: participant, 55-56, 58-60, 126-128, 143-144, 171-172, 186
p.000205: qualitative research, 138, 143-144
p.000205: research involving Aboriginal peoples, 126-128 safeguarding information, 60-61
p.000205: security, 56, 60-61, 64-65
p.000205: (see also Secondary use of human biological materials; Secondary use of identifiable information)
p.000205: Program evaluation, 20
p.000205: Proportionate approach to research ethics review, 11, 22, 24-25, 77-79, 82, 148
p.000205: Publicly available information, 17-18, 64-65, 131 Publicly declared emergencies, 85-88
p.000205: exceptions during, 87-88
p.000205: preparedness plans, 85-86
p.000205: research ethics review during, 87-88
p.000205:
p.000205: Q
p.000205: Qualitative research
p.000205: confidentiality, 138, 143-144
p.000205: consent, 137-138, 140, 141-144
p.000205: data collection, 137, 144 dissemination of results, 143-144 emergent design, 144-145
p.000205: exploratory phase, 76-77, 139
p.000205: nature of, 135-138
p.000205: observational, 18-19, 118, 141-143
p.000205: privacy, 138, 143-144
p.000205: timing of research ethics review, 139 Quality assurance, 20
p.000205: Quality improvement, 20
p.000205:
p.000205: R
p.000205: Reimbursement, 29, 31, 33 Research
p.000205: benefits (see Benefits, research)
p.000205: changes to, 33-34, 82, 144-145, 150, 161-163
p.000205: clinical trials (see Clinical trials) collaborative, 123-124, 125-126, 128
p.000205:
p.000205: 206 TCPS 2
p.000205:
p.000205: Index
p.000205:
p.000205: community-based, 93, 124, 138, 139
p.000205: deception in, 37-39
p.000205: definition, 15
p.000205: dissemination of results, 18-19, 31, 61, 128, 143-144, 164-167, 182-184
p.000205: exclusion, 47, 48-52
p.000205: exploratory phase, 76-77, 139
p.000205: human genetic (see Human genetic research) importance, 7-8
p.000205: inclusion, 11, 48
p.000205: involving Aboriginal peoples (see Aboriginal peoples) involving children, 10, 34, 41-42, 47, 49-50, 51, 185, 187
p.000205: involving the elderly, 10, 47, 50
p.000205: involving human biological materials (see Human biological materials) involving human reproduction (see Human
...
p.000205: ad hoc advisors, 24, 72, 73, 75, 120, 150
p.000205: appointment, 67-76
p.000205: authority, 67-70
p.000205: chair’s responsibilities, 74, 77-79
p.000205: composition, 70-75
p.000205: decision making, 68-69, 70, 79
p.000205: establishment, 67-76
p.000205: financial and administrative resources, 68-69, 74
p.000205: independence, 67, 68-69, 70-73, 93-94
p.000205: mandate, 67-70
p.000205: meetings and attendance, 75-76, 82-83 members (see Research ethics board members) membership requirements, 70-73
p.000205: multiple boards, 97-104
p.000205:
p.000205:
p.000205: TCPS 2
p.000207: 207
p.000207:
p.000207: Index
p.000207:
p.000207: quorum, 73, 74-75
p.000207: size, 70-72
p.000207: Research ethics board members appointment terms, 73-74
p.000207: chairs, 74, 77-79
p.000207: community members, 70, 72
p.000207: compensation, 94
p.000207: conflicts of interest, 69, 70-71, 78, 90, 93-94
p.000207: education and training, 74, 75, 76, 125
p.000207: ethics, members knowledgeable in, 70, 71
p.000207: expertise, 12, 70-75, 150
p.000207: law, members knowledgeable in, 70, 71-72
p.000207: substitute members, 72-73, 93 Research ethics review
p.000207: activities not requiring, 19-20 appeals, 84-85
p.000207: changes to approved research, 33-34, 82, 144-145, 150, 161, 163
p.000207: continuing, 21-22, 79-81
p.000207: delegated, 23, 24, 77-79, 82
p.000207: determining the level, 24-25, 77-79
p.000207: during publicly declared emergencies (see Publicly declared emergencies) full, 24, 74-76, 77-79, 82
p.000207: governance, 67-88
p.000207: initial, 76-77
p.000207: models, 98-101
p.000207: procedures, 76-83
p.000207: proportionate approach, 11, 22, 24-25, 77-79, 82, 148
p.000207: reconsideration, 83-85
p.000207: record keeping, 82-83
p.000207: research conducted outside the institution, 101-104 research exempt from, 17-19
p.000207: research requiring, 15-17, 119-121 scholarly review and, 20-21 scope, 15-22
p.000207: timing, 15, 76, 139
p.000207: Research participants (see Participants)
p.000207: Researchers
p.000207: academic freedom, 7, 11
p.000207: conflicts of interest, 91, 94-96
p.000207: dual roles, 95, 149, 158
p.000207: multiple affiliations, 68, 97-101
p.000207: Respect for Persons, 8-9, 27, 109 Risk
p.000207: and benefits, 10, 11, 22-25, 41-42, 51, 157-158
p.000207: in clinical trials, 148, 157-159
p.000207: definition, 22-23
p.000207: minimal, 11, 23, 24-25, 37-39, 41, 51, 77-79
p.000207: to researchers, 25
p.000207:
p.000207:
p.000207: 208 TCPS 2
p.000207:
p.000207: Index
p.000207:
p.000207: S
p.000207: Scholarly review, 20-21
p.000207: Secondary use of human biological materials, 62-64, 119-121, 130-132, 172-175, 186 Secondary use of identifiable
p.000207: information
p.000207: Aboriginal peoples, 119-121, 130-132
p.000207: anonymous, 19
p.000207: consent, 62-64, 130-132
p.000207: definition, 19, 62
p.000207: genetic material, 186
p.000207: privacy, 62-64
p.000207: Security of information, 56, 60-61, 64-65 StemXcells
p.000207: Guidelines for Human Pluripotent Stem Cell Research, 179 pluripotent, 179
p.000207: Students, 25, 67-68, 77-79 Subjects (see Participants)
p.000207: T
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p.000199: To respect the autonomy of the participant, Article 3.8(e) requires researchers to undertake diligent efforts to
p.000199: contact authorized third parties, if reasonably feasible, and to document such efforts for the benefit of both
p.000199: the participant and the continuing ethics review functions of the REB. The article also requires that
p.000199: participants who regain capacity be promptly afforded the opportunity to consent to their continued participation.
p.000199: Concern for the patient’s welfare is paramount and should be informed by ethical and professional judgment.
p.000199: Because their incapacity to exercise consent makes them vulnerable, prospective participants for emergency research
p.000199: are owed special ethical obligations and protection commensurate with the risks involved. Their welfare should be
p.000199: protected by additional safeguards, where feasible and appropriate. These might include: additional scientific,
p.000199: medical or REB consultation; procedures to identify prospective participants in advance so that consent may be
p.000199: sought prior to the occurrence of the emergency situation; consultation with former and prospective participants; and
p.000199: special monitoring procedures to be followed by data safety and monitoring boards.
p.000199: C. Capacity
p.000199: Capacity refers to the ability of prospective or actual participants to understand relevant information
p.000199: presented about a research project, and to appreciate the potential consequences of their decision to participate or
p.000199: not participate. This ability may vary according to the complexity of the choice being made, the circumstances
p.000199: surrounding the decision, or the point in time at which consent is sought. The determination of capacity to participate
p.000199: in research, then, is not a static determination. It is a process that may change over time, depending on the nature of
p.000199: the decision the prospective participant needs to make, and on any changes in the participant’s condition. Assessing
p.000199: capacity is a question of determining, at a particular point in time, whether a participant (or prospective
p.000199: participant) sufficiently understands the nature of a particular research project, and the risks, consequences and
p.000199: potential benefits associated with it.
p.000199:
p.000199:
p.000199: 40 TCPS 2
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
...
p.000193: with a placebo control group.
p.000193: A placebo is an inactive substance or intervention that resembles the comparable active substance or intervention.
p.000193:
p.000193: Privacy – An individual’s right to be free from intrusion or interference by others.
p.000193:
p.000193: Privacy risks – The potential harms that participants, or the groups to which they belong, may experience from the
p.000193: collection, use, and disclosure of personal information for research purposes.
p.000193:
p.000193: Proportionate approach to research ethics review – The assessment of foreseeable risk to determine the level of
p.000193: scrutiny a research proposal will receive (i.e. delegated review for minimal risk research or full REB review for
p.000193: research above minimal risk), as well as the consideration of foreseeable risks, potential benefits, and ethical
p.000193: implications of the research in the context of initial and continuing review.
p.000193:
p.000193: Psychotherapy trials – A clinical trial testing the safety and/or efficacy of one or more psychotherapeutic approaches
p.000193: to behavioural disorders or other mental illness.
p.000193:
p.000193: Publicly declared emergency – An emergency situation which, due to the extraordinary risks it presents, has been
p.000193: proclaimed as such by an authorized public office (in accordance with legislation and/or public policy). Publicly
p.000193: declared emergencies are extraordinary events that arise suddenly or unexpectedly, and require urgent or quick
p.000193: responses to minimize devastation. Examples include hurricanes and other natural disasters, large communicable disease
p.000193: outbreaks, catastrophic civil disorders, bio-hazardous releases, en- vironmental disasters, and humanitarian
p.000193: emergencies.
p.000193:
p.000193: Publicly available information – Any existing stored documentary material, records or publications, which may or may
p.000193: not include identifiable information, and that has no restrictions on its use or distribution, or that may be released
p.000193: under certain legal conditions.
p.000193:
p.000193: Qualitative research – An approach that aims to understand how people think about the world and how they act and behave
p.000193: in it. This approach requires researchers to understand phenomena based on discourse, actions, and documents, and how
p.000193: and why individuals interpret and ascribe meaning to what they say and do, and to other aspects of the world (including
p.000193: other people) they encounter.
p.000193:
p.000193: Reciprocal research ethics board (REB) review – An official agreement between two or more institutions, in which they
p.000193: accept, with an agreed level of oversight, the research ethics reviews of each other’s REBs.
p.000193:
...
Health / sexually transmitted disases
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p.000177: Health Research, CIHR Best Practices for Protecting Privacy in Health Research, Section 3.3, Secondary Use (September
p.000177: 2005). www.cihr-irsc.gc.ca/e/29072.html#Element3
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177: TCPS 2
p.000179: 179
p.000179:
p.000179: Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction
p.000179:
p.000179: 3 The definitions of embryo, fetus and human reproductive materials are taken from the Assisted Human Reproduction Act
p.000179: (2004, c. 2). http://laws.justice.gc.ca/en/A-13.4
p.000179: 4 Assisted Human Reproduction (Section 8 Consent) Regulations (SOR/2007-137). http://laws.justice.gc.ca/en/SOR-2007-137
p.000179: 5Canadian Institutes of Health Research, Guidelines for Human Pluripotent Stem Cell Research. June 30, 2010.
p.000179: www.cihr-irsc.gc.ca/e/42071.html
p.000179:
p.000179:
p.000179: References
p.000179:
p.000179:
p.000179: • International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for
p.000179: Human Use (ICH) defines biological sample coding categories. Health Canada has adopted these definitions.
p.000179: www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e15-eng.php
p.000179: • Organisation for Economic Co-operation and Development. (OECD), Guidelines for Human Biobanks and Genetic
p.000179: Research Databases. 2009. www.oecd.org/sti/biotechnology/hbgrd
p.000179: • Québec. Fonds de la recherche en santé du Québec. Final Report: Advisory Group on a Governance Framework for Data
p.000179: Banks and Biobanks Used for Health Research. 2006.
p.000179: www.frsq.gouv.qc.ca/en/ethique/pdfs_ethique/Rapport_groupe_conseil_anglais.pdf
p.000179:
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p.000179:
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p.000179:
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p.000179:
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p.000179:
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p.000179:
p.000179:
p.000179:
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p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179: 180 TCPS 2
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179: Introduction
p.000179: Chapter 13
p.000179: HUMAN GENETIC RESEARCH
p.000179:
p.000179: Human genetic research involves the study of genetic factors responsible for human traits and the interaction of those
p.000179: factors with each other, and with the environment. Research in this area includes the identification of genes that
p.000179: comprise: the human genome; functions of genes; the characterization of normal and disease conditions in individuals,
p.000179: biological relatives, families, communities and groups; and studies involving gene therapy. Participants in clinical
p.000179: trials are increasingly being asked to participate in genetic studies in addition to the primary clinical trial. With
p.000179: the growth of genetic research, especially whole-genome research, researchers, research ethics boards (REBs) and
p.000179: participants should be aware of the ethical issues that this research raises.
p.000179:
...
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p.000147: Introduction 147
p.000147: A. Key Concepts 148
p.000147: B. Clinical Trial Design and Registration 149
p.000147:
p.000147:
p.000147:
p.000147:
p.000147: ii TCPS 2
p.000147:
p.000147: C. Assessing Safety and Minimizing Risk 157
p.000147: D. Financial Conflicts of Interest 163
p.000147: E. Analysis and Dissemination of Clinical Trial Outcomes 164
p.000147: Chapter 12
p.000169: 169
p.000169: HUMAN BIOLOGICAL MATERIALS INCLUDING MATERIALS
p.000169: RELATED TO HUMAN REPRODUCTION 169
p.000169: Introduction 169
p.000169: A. Types of Human Biological Materials 169
p.000169: B. Collection of Human Biological Materials 170
p.000169: C. Consent and Secondary Use of Identifiable Human Biological
p.000169: Materials for Research Purposes 172
p.000169: D. Storage and Banking of Human Biological Materials 175
p.000169: E. Research Involving Materials Related to Human Reproduction 176
p.000169: F. Research Involving Pluripotent Stem Cells 179
p.000169: Chapter 13
p.000181: 181
p.000181: HUMAN GENETIC RESEARCH
p.000181: 181
p.000181: Introduction 181
p.000181: A. Application of Core Principles to Genetic Research 181
p.000181: B. Plans for Managing Information Revealed through Genetic Research 182
p.000181: C. Genetic Counselling 184
p.000181: D. Genetic Research Involving Families 184
p.000181: E. Genetic Research Involving Communities and Groups 185
p.000181: F. Genetic Material Banks 186
p.000181: G. Gene Transfer 186
p.000181: Glossary
p.000189: 189
p.000189: Index
p.000199: 199
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: iii
p.000199:
p.000199:
p.000199:
p.000199: Acknowledgements
p.000199: In August 2010, in accordance with its mandate, the Interagency Advisory Panel on Research Ethics (the Panel) submitted
p.000199: its final version of the 2nd edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans
...
p.000199: board (REB) tailors the level of scrutiny by an REB to the level of risk presented by the research, and assesses the
p.000199: ethical acceptability of the research through consideration of the foreseeable risks, the potential benefits and the
p.000199: ethical implications of the research, both at the stage of the initial REB review and throughout the life of the
p.000199: project (continuing ethics review). The establishment, governance, jurisdiction and composition of REBs, and
p.000199: operational issues related to their functioning are addressed in Chapter 6.
p.000199:
p.000199: A. Scope of Research Ethics Review
p.000199:
p.000199: Research Requiring REB Review
p.000199: The following article defines the general categories of research that require REB review in accordance
p.000199: with this Policy, subject to the exceptions set out further on in this Policy. These exceptions are distinct from
p.000199: research that is exempt from REB review, as described in Articles 2.2 to 2.4.
p.000199:
p.000199: Article 2.1 The following requires ethics review and approval by an REB before the research commences:
p.000199: (a) research involving living human participants;
p.000199: (b) research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive
p.000199: materials and stem cells. This applies to materials derived from living and deceased individuals.
p.000199: Application The scope of this Policy is restricted to the review of the ethical conduct of research involving
p.000199: humans. The scope of REB review is limited to those activities defined in this Policy as “research” involving “human
p.000199: participants.”
p.000199: For the purposes of this Policy, “research” is defined as an undertaking intended to extend knowledge through a
p.000199: disciplined inquiry or systematic investigation.
p.000199: A determination that research is the intended purpose of the undertaking is key for differentiating activities that
p.000199: require ethics review by an REB and those that do not.
p.000199:
p.000199: TCPS 2 15
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
p.000199: For the purposes of this Policy, “human participants” (referred to as “participants”) are those individuals whose data,
p.000199: or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question.
p.000199: Human participants are unique among the many parties involved in research, because they bear the primary
p.000199: risks of the research. These individuals are often referred to as “research subjects.” This Policy prefers the term
p.000199: “participant” because it better reflects the spirit behind the core principles: that individuals who choose to
p.000199: participate in research play a more active role than the term “subject” conveys. As well, it reflects the range of
p.000199: research covered by this Policy, and the varied degree of involvement by participants – including the use of their data
...
p.000167: The sources of these materials can be from patients following diagnostic or therapeutic procedures, autopsy specimens,
p.000167: donations of organs or tissue from living or dead humans, body wastes (including urine, saliva, sweat) or abandoned
p.000167: tissue. Biological materials may also be sought from individuals for use in a specific research project. Once
p.000167: collected, biolog- ical materials may be held in biobanks to serve as a research resource for many years.
p.000167: Ethical considerations raised by research involving human biological materials centre on accept- able access to, and
p.000167: use of, the materials, potential privacy concerns arising from the handling of information derived from such materials,
p.000167: and the special status some individuals and groups accord to the human body and its parts. Because the significance of
p.000167: biological materials varies among in- dividuals and groups, it is important to assess the ethics of research involving
p.000167: such materials with an awareness of and sensitivity to the known values, beliefs and attitudes of those from whom the
p.000167: materials originated.
p.000167:
p.000167: Sections A to D of this chapter provide guidance on research involving human biological materials. For the purposes of
p.000167: this Policy, human biological materials include tissues, organs, blood, plasma, skin, serum, DNA, RNA, proteins, cells,
p.000167: hair, nail clippings, urine, saliva and other body fluids. Section E addresses research involving the subset of
p.000167: biological materials that are related to human reproduction. Section F addresses research involving the subset of human
p.000167: biological materials known as human pluripotent stem cells, animal-human hybrids and chimeras.
p.000167: As noted in Chapter 2, an individual whose data and/or biological materials are used in research becomes a participant.
p.000167: In regard to human biological materials, individuals may become partici- pants by agreeing to provide a biological
p.000167: sample for use in a particular project. Individuals may also choose to donate organs, tissue or their entire body for
p.000167: research that occurs after their death. In this way, they become participants through their donation. Researchers may
p.000167: seek access to human biological materials for secondary use in research and, in accordance with Section C of this
p.000167: chapter, a research ethics board (REB) may waive a requirement for individual consent.
p.000167:
p.000167: A. Types of Human Biological Materials
p.000167: Human biological materials that may reasonably be expected to identify an individual, alone or in combination with
p.000167: other available information, are considered identifiable biological materials (or biological materials that are
p.000167: identifiable) for the purposes of this Policy. The following categories,
p.000167:
p.000167:
p.000167:
p.000167: TCPS 2
p.000169: 169
p.000169:
p.000169: Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction
p.000169:
p.000169: similar to those found in Chapter 5 in regard to categories of information, provide guidance for assessing the extent
p.000169: to which human biological materials could be used to identify an individual:
p.000169: • Identified human biological materials – the materials are labelled with a direct identifier (e.g., name, personal
...
p.000177: (a) requires the consent of the woman; and
p.000177:
p.000177:
p.000177:
p.000177: 178 TCPS 2
p.000177:
p.000177: Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction
p.000177:
p.000177: (b) should not compromise the woman’s ability to decide whether to continue her pregnancy.
p.000177: Application Research may be undertaken on methods to treat, in utero, a fetus with genetic or congenital disorders.
p.000177: Because the fetus and the woman cannot be treated separately, any intervention to one involves an intervention to the
p.000177: other. Research involving a fetus or fetal tissue shall be guided by respect for the woman’s autonomy and physical
p.000177: integrity. Guidance provided in other chapters of this Policy (e.g., consent, privacy and confidentiality, inclusion
p.000177: and exclusion) will also apply. Researchers should ensure that a clear distinction is made between consent to research
p.000177: and consent for any clinical procedures or testing. In practice, this may mean separate consent information and
p.000177: documents, but regardless of the process employed, the differences between research and clinical procedures must be
p.000177: clearly explained.
p.000177:
p.000177: F. Research Involving Pluripotent Stem Cells
p.000177:
p.000177: Article 12.10 Researchers who intend to conduct research to derive or use pluripotent stem cells shall follow the
p.000177: Guidelines for Human Pluripotent Stem Cell Research,5 as amended from time to time and published by the
p.000177: Canadian Institutes of Health Research.
p.000177: Application The Guidelines for Human Pluripotent Stem Cell Research establish principles that guide the conduct of
p.000177: research with human pluripotent stem cells. The Guidelines explain their scope of application, provide examples of
p.000177: types of research to which they apply, and identify examples of research that conform and do not conform with the
p.000177: guidance. Consent, privacy and confidentiality are addressed, along with issues of commercial interests.
p.000177: Hybrids and Chimeras
p.000177: Research involving the creation of animal-human hybrids and chimeras may raise serious ethical concerns, and federal
p.000177: legislation prohibits certain activities relating to their creation. Researchers and REBs are referred to the Assisted
p.000177: Human Reproduction Act and The Updated Guidelines for Human Pluripotent Stem Cell Research for these prohibitions.
p.000177:
p.000177: Endnotes
p.000177:
p.000177:
p.000177: 1 See also Canadian Institutes of Health Research, CIHR Guidelines for Health Research Involving Aboriginal People.
p.000177: www.cihr-irsc.gc.ca/e/29134.html
p.000177: 2 For discussion of factors relevant to assessing impracticability of consent, see, for example, Canadian Institutes of
p.000177: Health Research, CIHR Best Practices for Protecting Privacy in Health Research, Section 3.3, Secondary Use (September
p.000177: 2005). www.cihr-irsc.gc.ca/e/29072.html#Element3
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177: TCPS 2
p.000179: 179
p.000179:
p.000179: Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction
p.000179:
p.000179: 3 The definitions of embryo, fetus and human reproductive materials are taken from the Assisted Human Reproduction Act
p.000179: (2004, c. 2). http://laws.justice.gc.ca/en/A-13.4
...
p.000201: First Nations, 105, 107, 108, 110, 114, 115, 117, 121, 127
p.000201: (see also Aboriginal peoples)
p.000201:
p.000201: G
p.000201: Genetic research (see Human genetic research)
p.000201:
p.000201: H
p.000201: Harm, definition, 10, 22-23
p.000201: Human biological materials
p.000201: Aboriginal peoples, 119, 129-132
p.000201: anonymized, 170
p.000201: anonymous, 19, 131-132, 170
p.000201: coded, 170
p.000201: collection, 76-77, 129-130, 170-172
p.000201: consent for use, 9, 28-30, 31, 171-175
p.000201: definition, 16-17, 169
p.000201: identified, 170
p.000201: secondary use, 62-64, 119-121, 130-132, 172-175, 186
p.000201: storage and banking, 175-176 types, 169-170
p.000201: withdrawal, 28-30, 31, 172
p.000201: (see also Human reproduction, materials related to) Human dignity, respect for, 8-11, 28
p.000201: Human genetic research
p.000201: application of core principles, 181-182 definition, 181
p.000201: gene alteration, 186-187
p.000201: gene transfer, 186-187
p.000201: genetic counselling, 184 genetic material banks, 186
p.000201: involving communities and groups, 181, 183-184, 185
p.000201: involving families, 181, 183-184, 184-185
p.000201: managing information concerning, 182-184 Human participants (see Participants)
p.000201: Human reproduction, materials related to
p.000201: Assisted Human Reproduction Act, 177, 178, 179, 186
p.000201: consent, 177-179
p.000201: definition, 16-17, 176-177
p.000201: embryos, 15-17, 49, 176, 177-178
p.000201: fetal tissue, 15-17, 177, 178-179
p.000201: fetuses, 15-17, 49, 177, 178, 178-179
p.000201: human reproductive materials, 15-17, 177
p.000201: pluripotent stem cells, 179
p.000201: (see also Human biological materials) Hybrids, 179
p.000201:
p.000201:
p.000201:
p.000201:
p.000201:
p.000201:
p.000201: TCPS 2
p.000201:
p.000203: 203
p.000203:
p.000203: Index
p.000203:
p.000203: I
p.000203: Incentives for participation in research
p.000203: conflicts of interest, 29-30, 52, 151, 164
p.000203: consent, 29-30, 31, 151
p.000203: Incidental findings, 34, 171-172
p.000203: Indigenous peoples, 107, 108, 110 (see also Aboriginal peoples)
p.000203: Information
p.000203: anonymized, 57
p.000203: anonymous, 19, 57, 131-132
p.000203: coded, 57
p.000203: data linkage, 18, 19, 64-65, 131-132
p.000203: directly identifying, 56
p.000203: disclosure, 30-33, 59-61, 126-128
p.000203: dissemination, 18-19, 31, 128, 143-144, 164-167
p.000203: identifiable, 19, 56
p.000203: indirectly identifying, 56
p.000203: personal (see Information: identifiable) publicly available, 17-18, 64-65, 131 reporting new, in clinical trials,
p.000203: 159-163 safeguarding, 60-61
p.000203: secondary use of identifiable (see Secondary use of identifiable information) security, 56, 60-61, 64-65
p.000203: sharing, 159-163, 182-184
p.000203: types, 56-57 (see also Data)
p.000203: Informed consent (see Consent)
p.000203: Institutions
p.000203: appointment of appeal boards, 84-85 compliance with Policy, 5-6 conflicts of interest, 89-90, 91-93
p.000203: multi-jurisdictional review, 97-99, 100-103
p.000203: senior administrators, 70-71, 93-94
p.000203: support of research ethics boards, 68-70, 74, 77, 80
p.000203: support of researchers, 5, 58-59
...
p.000106: (see also Aboriginal peoples)
p.000106: Minimal risk research, 11, 23, 24-25, 37-39, 41, 51, 77-79 Multi-jurisdictional research
p.000106: official agreements, 98, 100
p.000106: research ethics review models, 99-101 review mechanisms, 97-101
p.000106:
p.000106: O
p.000106: Observational research, 18-19, 118, 141-143
p.000106:
p.000106: P
p.000106: Participants
p.000106: autonomy, 8-9, 27, 40 capacity (see Capacity)
p.000106: children, 10, 34, 41-42, 47, 49-50, 51, 185, 187
p.000106: confidentiality, 56, 58-60, 126-128, 143-144, 186
p.000106: definition, 16
p.000106: elderly, 10, 47, 50
p.000106: as members of research ethics boards, 72 perspective, 12, 23, 28, 72, 161
p.000106: privacy, 55-56, 58-60, 126-128, 143-144, 171-172, 186
p.000106: recruitment, 11, 28, 76-77, 110, 158-159, 164, 184-185
p.000106: removal from research, 31, 33, 160 as research partners, 138
p.000106: vulnerability, 9, 10, 23, 47, 52, 116, 137, 148
p.000106: withdrawal from research, 28-30, 31, 61, 140, 186
p.000106: women, 10, 47, 48-49, 116, 178-179
p.000106: Participatory research, 123-125
p.000106: Performance review, 20
p.000106:
p.000106:
p.000106: TCPS 2
p.000205: 205
p.000205:
p.000205: Index
p.000205:
p.000205: Pilot studies, 76-77, 139
p.000205: Pluripotent stem cells, 179
p.000205: Policy, the (see Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans) Principal investigators,
p.000205: 27, 99, 153-154, 159, 162, 165-166
p.000205: Principles (see Core principles) Privacy and confidentiality
p.000205: Aboriginal peoples, 126-128
p.000205: data linkage, 18, 19, 64-65, 131-132
p.000205: definition, 55-56
p.000205: ethical duty, 56, 58-60
p.000205: identifiability of information, 56-57
p.000205: participant, 55-56, 58-60, 126-128, 143-144, 171-172, 186
p.000205: qualitative research, 138, 143-144
p.000205: research involving Aboriginal peoples, 126-128 safeguarding information, 60-61
p.000205: security, 56, 60-61, 64-65
p.000205: (see also Secondary use of human biological materials; Secondary use of identifiable information)
p.000205: Program evaluation, 20
p.000205: Proportionate approach to research ethics review, 11, 22, 24-25, 77-79, 82, 148
p.000205: Publicly available information, 17-18, 64-65, 131 Publicly declared emergencies, 85-88
p.000205: exceptions during, 87-88
p.000205: preparedness plans, 85-86
p.000205: research ethics review during, 87-88
p.000205:
p.000205: Q
p.000205: Qualitative research
p.000205: confidentiality, 138, 143-144
p.000205: consent, 137-138, 140, 141-144
p.000205: data collection, 137, 144 dissemination of results, 143-144 emergent design, 144-145
p.000205: exploratory phase, 76-77, 139
p.000205: nature of, 135-138
p.000205: observational, 18-19, 118, 141-143
p.000205: privacy, 138, 143-144
p.000205: timing of research ethics review, 139 Quality assurance, 20
...
p.000207: during publicly declared emergencies (see Publicly declared emergencies) full, 24, 74-76, 77-79, 82
p.000207: governance, 67-88
p.000207: initial, 76-77
p.000207: models, 98-101
p.000207: procedures, 76-83
p.000207: proportionate approach, 11, 22, 24-25, 77-79, 82, 148
p.000207: reconsideration, 83-85
p.000207: record keeping, 82-83
p.000207: research conducted outside the institution, 101-104 research exempt from, 17-19
p.000207: research requiring, 15-17, 119-121 scholarly review and, 20-21 scope, 15-22
p.000207: timing, 15, 76, 139
p.000207: Research participants (see Participants)
p.000207: Researchers
p.000207: academic freedom, 7, 11
p.000207: conflicts of interest, 91, 94-96
p.000207: dual roles, 95, 149, 158
p.000207: multiple affiliations, 68, 97-101
p.000207: Respect for Persons, 8-9, 27, 109 Risk
p.000207: and benefits, 10, 11, 22-25, 41-42, 51, 157-158
p.000207: in clinical trials, 148, 157-159
p.000207: definition, 22-23
p.000207: minimal, 11, 23, 24-25, 37-39, 41, 51, 77-79
p.000207: to researchers, 25
p.000207:
p.000207:
p.000207: 208 TCPS 2
p.000207:
p.000207: Index
p.000207:
p.000207: S
p.000207: Scholarly review, 20-21
p.000207: Secondary use of human biological materials, 62-64, 119-121, 130-132, 172-175, 186 Secondary use of identifiable
p.000207: information
p.000207: Aboriginal peoples, 119-121, 130-132
p.000207: anonymous, 19
p.000207: consent, 62-64, 130-132
p.000207: definition, 19, 62
p.000207: genetic material, 186
p.000207: privacy, 62-64
p.000207: Security of information, 56, 60-61, 64-65 StemXcells
p.000207: Guidelines for Human Pluripotent Stem Cell Research, 179 pluripotent, 179
p.000207: Students, 25, 67-68, 77-79 Subjects (see Participants)
p.000207: T
p.000207: Therapeutic misconception, 148, 149, 158-159
p.000207: Third party consent (see Consent: authorized third parties) Trials (see Clinical trials)
p.000207: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) application, 11-13
p.000207: compliance with, 5-6
p.000207: interpretation, 13
p.000207:
p.000207: U
p.000207: Unanticipated issues, 22, 34, 81, 161-163
p.000207: Undue influence, 28-29
p.000207:
p.000207: V
p.000207: Vulnerability, 9, 10, 23, 47, 52, 116, 137, 148
p.000207:
p.000207: W
p.000207: Welfare (see Concern for Welfare)
p.000207: Withdrawal
p.000207: of consent, 28-30, 31
p.000207: of data, 28-30, 31
p.000207: of human biological materials, 28-30, 31, 172
p.000207: from research, 28-30, 31, 61, 140, 186
p.000207: Women
p.000207: as research participants, 10, 47, 48-49, 116, 178-179 pregnant, inclusion in research, 49
p.000207:
p.000207:
p.000207:
p.000207:
p.000207:
p.000207:
p.000207: TCPS 2
p.000209: 209
p.000209:
...
Health / visual impairment
Searching for indicator blind:
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p.000199: be debriefed and provided with additional pertinent information in accordance with Articles 3.2 and 3.4, at which point
p.000199: they will have the opportunity to refuse consent in accordance with Article 3.1; and
p.000199: (e) the research does not involve a therapeutic intervention, or other clinical or diagnostic interventions.
p.000199: Application In the circumstances described under Article 3.7, the nature of the research may justify a limited or
p.000199: temporary departure from the general requirement for consent prior to participation in research. “Impracticable” refers
p.000199: to undue hardship or oner- ousness that jeopardizes the conduct of the research. It is the responsibility of
p.000199: researchers to justify the need for such a departure. It is the responsibility of REBs, however, to understand that
p.000199: certain research methods necessitate a different ap- proach to consent, and to exercise judgment on whether the need
p.000199: for the research justifies a limited or temporary exception to the general requirements in a particular case (Article
p.000199: 3.7 does not address the exception to the requirement of consent for secondary use of identifiable information; this
p.000199: topic is addressed in Article 5.5).
p.000199: It should be noted that in cases of randomization and blinding in clinical trials, nei- ther the participants nor the
p.000199: researchers know which treatment arm the participant will be receiving before the research commences. As long as
p.000199: participants are in- formed of the probability of their assignment to each arm of the trial, this random and blind
p.000199: assignment does not constitute a waiver or alteration of consent.
p.000199: Research Involving Partial Disclosure or Deception
p.000199: Some social science research, particularly in psychology, seeks to learn about human responses to situations that have
p.000199: been created experimentally. Some types of research can be carried out only if the participants do not know the true
p.000199: purpose
p.000199:
p.000199:
p.000199: TCPS 2 37
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: of the research in advance. For example, some social science research that critically probes the inner workings of
p.000199: publicly accountable institutions might never be con- ducted without the limited use of partial disclosure. In some
p.000199: research that uses partial disclosure or deception, participants may not know that they are part of a research project
p.000199: until it is over, or they may be asked to perform a task and told about only one of several elements the researchers
p.000199: are observing. Research em- ploying deception can involve a number of techniques, such as giving participants false
p.000199: information about themselves, events, social conditions and/or the purpose of the research. For such techniques to fall
p.000199: within the exception to the general re- quirement of full disclosure for consent, the research must meet the
p.000199: requirements of Article 3.7.
p.000199: Where partial disclosure or deception has been used, debriefing is an important mechanism in maintaining the
p.000199: participant’s trust in the research community. The debriefing referred to in Article 3.7(d) should be proportionate to
...
Social / Access to Social Goods
Searching for indicator necessities:
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p.000199: ethics review, and the holding of REB meet- ings during emergency situations (see Article 6.10). Special attention
p.000199: could be given to REB procedures to review and approve research (e.g., full or delegated research ethics reviews,
p.000199: quorum rules, or special agreements with other institutions), while considering the impact of the emergency on
p.000199: participants, researchers, REB mem- bers, institutional staff, and others. It is also important to coordinate research
p.000199: efforts
p.000199:
p.000199:
p.000199: 86 TCPS 2
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: and research ethics review processes within and across institutions. REB members may become unavailable (e.g., due to
p.000199: illness, relocation, or quarantine by public authorities). Institutions and REBs should explore the nomination of
p.000199: substitute REB members and consultation with ad hoc advisors with relevant expertise (see Articles
p.000199: 6.4 and 6.5), negotiate reciprocity agreements with other institutions for REB re- views (see Article 8.1), and revisit
p.000199: how scholarly review (see Article 2.7) would be applied in emergency situations.
p.000199: Research ethics review should be commensurate with the necessities occasioned by the emergency because of the
p.000199: critical interplay between public urgencies, essential research and a continuing commitment to the core principles
p.000199: even in the face of acute public necessity. Indeed, research ethics review during publicly declared
p.000199: emergencies is even more important than under normal circumstances, and may require even greater care, since everyone
p.000199: (participants, researchers and REB members themselves) may be rendered more vulnerable by the nature of the emergency.
p.000199: Research Ethics Review Policy and Procedures during Publicly Declared Emergencies Article 6.22 Research ethics
p.000199: policies and procedures for emergencies take effect once an emer-
p.000199: gency has been publicly declared. They should cease to apply as soon as is feasible after the end of the publicly
p.000199: declared emergency.
p.000199: Application Because emergencies present extraordinary public risks that warrant special re- sponses, legislation
p.000199: or public policies usually require that they be officially proclaimed or declared. Research ethics review
...
p.000199: this Policy during publicly declared emergencies.
p.000199: Application Especially during times of emergency, researchers, REBs and institutions need to be vigilant and
p.000199: exercise due diligence in respecting ethical principles, procedures and the law in effect during the emergency to
p.000199: preserve the values, purpose and pro- tection that the principles of this Policy advance.
p.000199: To guide fair and reasonable implementation of these principles in emergency cir- cumstances, any exception to, or
p.000199: infringement of, ethics principles and REB procedures must be demonstrably justified by those urging the exception
p.000199: or in- fringement.
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 87
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: Endnote
p.000199:
p.000199: Where exceptions to or infringements of ethics principles and REB procedures are justified, they should be narrowly
p.000199: tailored to address the necessities occasioned by the publicly declared emergency, such that they rely on the most
p.000199: restrictive or least intrusive means necessary to achieve the Policy goal: the promotion and guidance of ethical
p.000199: conduct in research. This approach – consistent with international bioethics and human rights norms – maximizes
p.000199: respect for ethical principles and helps to ensure that exceptions and the means to implement them are not unduly
p.000199: broad, overreaching or unjustifiably invasive.
p.000199: Recognizing and respecting the principle of Justice means that research ethics re- view policies and procedures for
p.000199: publicly declared emergencies shall be used in a manner that is not discriminatory or arbitrary. The commitment to
p.000199: justice advances a fair and balanced distribution of risks and potential benefits even in the face of public
p.000199: emergencies.
p.000199: REBs and researchers should be aware that individuals, prospective participants, researchers, and institutions may not
p.000199: normally be considered vulnerable, but may become so by the very nature of public emergencies. Those already vulnerable
p.000199: may become acutely so (see Article 4.7). The increased public risks and devastation that cause public emergencies to be
...
Searching for indicator social goods:
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p.000199: Where research on individuals may affect the welfare of a group(s), the weight given to the group’s welfare will depend
p.000199: on the nature of the research being undertaken, and the individuals or group in question. This consideration does not
p.000199: imply, however, that the welfare of a group should be given priority over the welfare of individuals.
p.000199: Justice
p.000199: Justice refers to the obligation to treat people fairly and equitably. Fairness entails treating all peo- ple with
p.000199: equal respect and concern. Equity requires distributing the benefits and burdens of research participation in such a
p.000199: way that no segment of the population is unduly burdened by the harms of research or denied the benefits of the
p.000199: knowledge generated from it.
p.000199: Treating people fairly and equitably does not always mean treating people in the same way. Dif- ferences in treatment
p.000199: or distribution are justified when failures to take differences into account may result in the creation or
p.000199: reinforcement of inequities. One important difference that must be considered for fairness and equity is vulnerability.
p.000199: Vulnerability is often caused by limited capacity, or limited access to social goods, such as rights, opportunities and
p.000199: power. Individuals or groups in vulnerable circumstances have historically included children, the elderly, women,
p.000199: prisoners, those with mental health issues and those with diminished capacity for self-determination. Ethno- cultural
p.000199: minorities and those who are institutionalized are other examples of groups who have, at times, been treated unfairly
p.000199: and inequitably in research, or have been excluded from research op- portunities. People or groups whose circumstances
p.000199: cause them to be vulnerable or marginalized may need to be afforded special attention in order to be treated justly in
p.000199: research.
p.000199:
p.000199:
p.000199:
p.000199: 10 TCPS 2
p.000199:
p.000199: Chapter 1 – Ethics Framework
p.000199:
p.000199: The recruitment process, both of participants who may become directly involved in research and those who participate as
p.000199: the source of information or biological materials to be used in research, is an important component of the fair and
p.000199: equitable conduct of research. Participation should be based on inclusion criteria that are justified by the research
...
p.000195: multiple generations. It is determined by an Aboriginal community’s land, environment, region, culture, and language.
p.000195: It may also include new knowledge transmitted to subsequent generations.
p.000195:
p.000195: Unanticipated issues – Issues that: occur during the conduct of research; may increase the level of risk to
p.000195: participants or have other ethical implications that may affect participants’ welfare; and were not anticipated by the
p.000195: researcher in the research proposal submitted for research ethics review.
p.000195:
p.000195: Undue influence – The impact of an unequal power relationship on the voluntariness of consent. This may occur when
p.000195: prospective participants are recruited by individuals in a position of authority over them (e.g. doctor/patient,
p.000195: teacher/student, employer/employee). See “Coercion.”
p.000195:
p.000195: Vulnerability – A diminished ability to fully safeguard one’s own interests in the context of a specific research
p.000195: project. This may be caused by limited capacity or limited access to social goods, such as rights, opportunities and
p.000195: power. Individuals or groups may experience vulnerability to different degrees and at different times, depending on
p.000195: their circumstances. See also “Autonomy.”
p.000195:
p.000195: Welfare – The quality of a person’s experience of life in all its aspects. Welfare consists of the impact on
p.000195: individuals and/or groups of factors such as their physical, mental and spiritual health, as well as their physical,
p.000195: economic and social circumstances.
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195: TCPS 2
p.000195:
p.000197: 197
p.000197:
p.000197:
p.000197:
p.000197: Index
p.000197: The Index seeks to direct the reader to meaningful references to key concepts in TCPS 2. Main references to a term are
p.000197: indicated with bold type.
p.000197:
p.000197: The Index is not a record of all occurrences of the listed topics. Readers who wish to check all occurrences of these
p.000197: topics or specific terms may do so through the Adobe search tool available online in the PDF version of the Policy
p.000197: found at www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2- eptc2/Default/.
p.000197:
p.000197: A
p.000197: Aboriginal peoples
p.000197: collaborative research, 123-124, 125-126, 128
p.000197: communities, 107-108, 109
p.000197: community customs, 108, 117-119
...
Searching for indicator social welfare:
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p.000199: restrictive or least intrusive means necessary to achieve the Policy goal: the promotion and guidance of ethical
p.000199: conduct in research. This approach – consistent with international bioethics and human rights norms – maximizes
p.000199: respect for ethical principles and helps to ensure that exceptions and the means to implement them are not unduly
p.000199: broad, overreaching or unjustifiably invasive.
p.000199: Recognizing and respecting the principle of Justice means that research ethics re- view policies and procedures for
p.000199: publicly declared emergencies shall be used in a manner that is not discriminatory or arbitrary. The commitment to
p.000199: justice advances a fair and balanced distribution of risks and potential benefits even in the face of public
p.000199: emergencies.
p.000199: REBs and researchers should be aware that individuals, prospective participants, researchers, and institutions may not
p.000199: normally be considered vulnerable, but may become so by the very nature of public emergencies. Those already vulnerable
p.000199: may become acutely so (see Article 4.7). The increased public risks and devastation that cause public emergencies to be
p.000199: declared can threaten autonomy and physical, emo- tional, institutional and social welfare or safety. They also bring
p.000199: inherent tensions and pressures that may impact deliberative decision making. Taking all of this into consideration,
p.000199: REBs and researchers should ensure that the risks and potential ben- efits posed by any proposed research are
p.000199: appropriately evaluated, including provisions for greater-than-normal attention to risk, where applicable.
p.000199:
p.000199:
p.000199: 1 Memorandum of Understanding on the Roles and Responsibilities in the Management of Federal Grants and Awards.
p.000199: www.nserc-crsng.gc.ca/NSERC-CRSNG/Policies-Politiques/MOURoles-Protocol- Roles/index_eng.asp
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: 88 TCPS 2
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: Introduction
p.000199: Chapter 7
p.000199: CONFLICTS OF INTEREST
p.000199: This chapter addresses ethical issues that can arise when research activities and other activities conflict. A conflict
p.000199: of interest may arise when activities or situations place an individual or insti- tution in a real, potential or
p.000199: perceived conflict between the duties or responsibilities related to research, and personal, institutional or other
p.000199: interests.1 These interests include, but are not limited to, business, commercial or financial interests pertaining to
p.000199: the institution and/or the individual, their family members, friends, or their former, current or prospective
p.000199: professional associates.
...
Searching for indicator access:
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p.000199: Where research on individuals may affect the welfare of a group(s), the weight given to the group’s welfare will depend
p.000199: on the nature of the research being undertaken, and the individuals or group in question. This consideration does not
p.000199: imply, however, that the welfare of a group should be given priority over the welfare of individuals.
p.000199: Justice
p.000199: Justice refers to the obligation to treat people fairly and equitably. Fairness entails treating all peo- ple with
p.000199: equal respect and concern. Equity requires distributing the benefits and burdens of research participation in such a
p.000199: way that no segment of the population is unduly burdened by the harms of research or denied the benefits of the
p.000199: knowledge generated from it.
p.000199: Treating people fairly and equitably does not always mean treating people in the same way. Dif- ferences in treatment
p.000199: or distribution are justified when failures to take differences into account may result in the creation or
p.000199: reinforcement of inequities. One important difference that must be considered for fairness and equity is vulnerability.
p.000199: Vulnerability is often caused by limited capacity, or limited access to social goods, such as rights, opportunities and
p.000199: power. Individuals or groups in vulnerable circumstances have historically included children, the elderly, women,
p.000199: prisoners, those with mental health issues and those with diminished capacity for self-determination. Ethno- cultural
p.000199: minorities and those who are institutionalized are other examples of groups who have, at times, been treated unfairly
p.000199: and inequitably in research, or have been excluded from research op- portunities. People or groups whose circumstances
p.000199: cause them to be vulnerable or marginalized may need to be afforded special attention in order to be treated justly in
p.000199: research.
p.000199:
p.000199:
p.000199:
p.000199: 10 TCPS 2
p.000199:
p.000199: Chapter 1 – Ethics Framework
p.000199:
p.000199: The recruitment process, both of participants who may become directly involved in research and those who participate as
p.000199: the source of information or biological materials to be used in research, is an important component of the fair and
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p.000199: disciplined inquiry or systematic investigation.
p.000199: A determination that research is the intended purpose of the undertaking is key for differentiating activities that
p.000199: require ethics review by an REB and those that do not.
p.000199:
p.000199: TCPS 2 15
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
p.000199: For the purposes of this Policy, “human participants” (referred to as “participants”) are those individuals whose data,
p.000199: or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question.
p.000199: Human participants are unique among the many parties involved in research, because they bear the primary
p.000199: risks of the research. These individuals are often referred to as “research subjects.” This Policy prefers the term
p.000199: “participant” because it better reflects the spirit behind the core principles: that individuals who choose to
p.000199: participate in research play a more active role than the term “subject” conveys. As well, it reflects the range of
p.000199: research covered by this Policy, and the varied degree of involvement by participants – including the use of their data
p.000199: or human biological materials – that different types of research offer. The core principles of this Policy – Respect
p.000199: for Persons, Concern for Welfare, and Justice – help to shape the relationship between researchers and participants.
p.000199: Where researchers seek to collect, use, share and access different types of information or data about
p.000199: participants, they are expected to determine whether the information or data proposed in research may reasonably be
p.000199: expected to identify an individual. For the purposes of this Policy, researchers and REBs shall consider whether
p.000199: information is identifiable or non-identifiable. Information is identifiable if it, alone or when combined with other
p.000199: available information, may reasonably be expected to identify an individual. The term “personal information” generally
p.000199: denotes identifiable information about an individual. Guidance on the assessment of the potential for information to
p.000199: identify an individual is addressed in this Policy in Chapter 5, Section A.
p.000199: In some cases, research may involve interaction with individuals who are not themselves the focus of the research in
p.000199: order to obtain information. For example, one may collect information from authorized personnel to release information
p.000199: or data in the ordinary course of their employment about organizations, policies, procedures, professional practices or
p.000199: statistical reports. Such individuals are not considered participants for the purposes of this Policy. This is
p.000199: distinct from situations where individuals are considered participants because they are themselves
p.000199: the focus of the research. For example, individuals who are asked for their personal opinions about organizations, or
p.000199: who are observed in their work setting for the purposes of research, are considered participants.
p.000199: For the purposes of this Policy, human biological materials include tissues, organs, blood, plasma, serum, DNA, RNA,
p.000199: proteins, cells, skin, hair, nail clippings, urine, saliva and other body fluids. Materials related to human
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p.000199: them. The term “human biological materials” may be considered, for the purposes of this Policy, to include materials
p.000199: related to human reproduction. The last section of Chapter 12 discusses ethical issues specific to these materials.1
p.000199: When in doubt about the applicability of this Policy to a particular research project, the researcher shall seek the
p.000199: opinion of the REB. The REB makes the final decision on exemption from research ethics review.
p.000199:
p.000199: Research Exempt from REB Review
p.000199: Some research is exempt from REB review where protections are available by other means. This Policy allows the
p.000199: following exemptions from the requirement for REB review, as outlined below.
p.000199: Article 2.2 Research that relies exclusively on publicly available information does not require REB review when:
p.000199: (a) the information is legally accessible to the public and appropriately protected by law; or
p.000199: (b) the information is publicly accessible and there is no reasonable expectation of privacy.
p.000199: Application For the purposes of this Policy, publicly available information is any existing stored documentary
p.000199: material, records or publications, which may or may not include identifiable information. Some types of information are
p.000199: legally accessible to the public in a certain form and for a certain purpose, as specified by law or regulations:
p.000199: registries of deaths, court judgments, or public archives and publicly available statistics (e.g., Statistics Canada
p.000199: public use files), for example. In Canada, all publicly available archives (national, provincial or municipal)
p.000199: have policies governing access to their records. An archival record or database that is subject to restrictions, such
p.000199: as those under access to information and privacy legislation or contractual restrictions imposed by the donor of the
p.000199: records, may also be considered publicly available for the purposes of this Policy.
p.000199: Research that relies exclusively on information that is publicly available, or made accessible through legislation
p.000199: or regulation, does not require REB review. Exemption from REB review for research involving information that is
p.000199: legally accessible to the public is based on the presence of a legally designated custodian/steward who
p.000199: protects its privacy and proprietary interests (e.g., an access to information and privacy coordinator or a guardian of
p.000199: Canadian census data).
p.000199: REB review is also not required where research uses exclusively publicly available information that may contain
p.000199: identifiable information, and for which there is no
p.000199:
p.000199:
p.000199: TCPS 2 17
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
p.000199: reasonable expectation of privacy. For example, identifiable information may be disseminated in the public domain
p.000199: through print or electronic publications; film, audio or digital recordings; press accounts; official publications of
p.000199: private or public institutions; artistic installations, exhibitions or literary events freely open to the public; or
p.000199: publications accessible in public libraries. Research that is non-intrusive, and does not involve direct interaction
p.000199: between the researcher and individuals through the Internet, also does not require REB review. Cyber-material such as
p.000199: documents, records, performances, online archival materials or published third party interviews to which the public is
p.000199: given uncontrolled access on the Internet for which there is no expectation of privacy is considered to be publicly
p.000199: available information.
p.000199: Exemption from REB review is based on the information being accessible in the public domain, and that the individuals
p.000199: to whom the information refers have no reasonable expectation of privacy. Information contained in publicly accessible
p.000199: material may, however, be subject to copyright and/or intellectual property rights protections or dissemination
p.000199: restrictions imposed by the legal entity controlling the information.
p.000199: However, there are situations where REB review is required.
p.000199: There are publicly accessible digital sites where there is a reasonable expectation of privacy. When accessing
p.000199: identifiable information in publicly accessible digital sites, such as Internet chat rooms, and self-help groups with
p.000199: restricted membership, the privacy expectation of contributors of these sites is much higher. Researchers shall submit
p.000199: their proposal for REB review (see Article 10.3).
p.000199: Where data linkage of different sources of publicly available information is involved, it could give rise to
p.000199: new forms of identifiable information that would raise issues of privacy and confidentiality when used in
p.000199: research, and would therefore require REB review (see Article 5.7).
p.000199: When in doubt about the applicability of this article to their research, researchers should consult their REBs.
p.000199: Article 2.3 REB review is not required for research involving the observation of people in public places where:
p.000199: (a) it does not involve any intervention staged by the researcher, or direct interaction with the individuals or
p.000199: groups;
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p.000199: participant.
p.000199: In some areas of research, such as medical and genetic research, there is a greater likelihood of material incidental
p.000199: findings. When material incidental findings are likely, researchers should develop a plan indicating how they will
p.000199: disclose such findings to participants, and submit this plan to the REB. If there is uncertainty as to whether a
p.000199: research project warrants such a plan, researchers and REBs can make this determination on a case-by-case basis.
p.000199: If researchers are unsure of how to interpret findings or uncertain whether findings are material, they should consult
p.000199: with colleagues or refer to standards in the disci- pline. If researchers are unsure of the most appropriate method for
p.000199: disclosing material incidental findings to participants, they should consult with their REB or with colleagues.
p.000199: Researchers should exercise caution in disclosing incidental find- ings that may cause needless concern to
p.000199: participants. When necessary, researchers should direct participants to a qualified professional to discuss the
p.000199: possible impli- cations of the incidental findings for their welfare. In some cases, incidental findings may
p.000199: trigger legal reporting obligations and researchers should be aware of these obligations (see Article 5.1).
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: 34 TCPS 2
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: Consent Shall Precede Collection of, or Access to, Research Data
p.000199:
p.000199: Article 3.5 Research shall begin only after the participants, or their authorized third parties, have provided
p.000199: their consent.
p.000199: Application In keeping with the principle of Respect for Persons, participants shall provide their consent prior to
p.000199: engaging in research. This is the clearest demonstration that their participation is based on consideration of the
p.000199: risks and potential benefits of the research project, and other principles in this Policy.
p.000199: There are exceptions to this general ethical requirement, however, set out in Articles
p.000199: 3.7 and 3.8.
p.000199: This article does not apply to conversations that researchers may have with prospective participants as part
p.000199: of the development of the design of their research. These preliminary conversations – which may include negotiations
p.000199: concerning the terms on which a researcher may engage with a particular community or group – do not in themselves
p.000199: constitute research, and therefore do not require consent (see Chapter 2, Article 6.11, Articles 9.3 to 9.6, and
p.000199: Article 10.1).
p.000199: Critical Inquiry
p.000199: Article 3.6 Permission is not required from an organization in order to conduct research on that organization.
p.000199: If a researcher engages the participation of members of an organization without the organization’s permission,
p.000199: the researcher shall inform participants of any foreseeable risk that may be posed by their participation.
p.000199: Application Research in the form of critical inquiry, that is, the analysis of social structures or activities,
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p.000199: regimes, gang leaders, employers) on account of their involvement in research, researchers should ensure that copies of
p.000199: field materials are kept in secure locations. When sharing research materials such as consent forms or transcripts of
p.000199: field notes with participants, researchers must honour their commitment to protect the anonymity and confidentiality of
p.000199: participants to ensure that their human rights, and the ethical principles set out in this Policy, are not compro-
p.000199: mised. In general, regardless of where the researchers conduct their research, researchers and REBs should
p.000199: concern themselves with safeguarding information while it is in transit (see Articles 5.1 to 5.4).
p.000199: REBs should also be aware that some research, involving critical assessments of public, political or corporate
p.000199: institutions and associated public figures, for example, may be legitimately critical and/or opposed to the welfare of
p.000199: those individuals in a position of power, and may cause them some harm. There may be a compelling public interest in
p.000199: this research. Therefore, it should not be blocked through the use of risk-benefit analysis. Such research should be
p.000199: carried out according to the pro- fessional standards of the relevant discipline(s) or field(s) of research. Where an
p.000199: individual in a position of power is invited to be interviewed or gives access to pri- vate papers and thus becomes a
p.000199: participant as defined by this Policy, Article 3.2 applies (see also Article 3.12, Article 9.7 and Article 10.2). In
p.000199: such cases, the bal- ance of risks to those who are the object of the research is mainly considered along with the
p.000199: potential benefit of new knowledge to society and the indirect benefits to the population affected by the public,
p.000199: political or corporate institutions to which the participant belongs.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: 36 TCPS 2
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: B. Departures from General Principles of Consent
p.000199: Alteration of Consent in Minimal Risk Research
p.000199: Article 3.7 The REB may approve research without requiring that the researcher obtain the participant’s consent in
p.000199: accordance with Articles 3.1 to 3.5 where the REB is sat- isfied, and documents, that all of the following apply:
p.000199:
p.000199: (a) the research involves no more than minimal risk to the participants;
p.000199: (b) the lack of the participant’s consent is unlikely to adversely affect the welfare of the participant;
...
p.000199: form of information sharing, training for local personnel, the establishment of health care or similar services.
p.000199: Benefits may be indirect, where the participation in research of an individual or group, or in a research project in-
p.000199: volving a community contributes to the advancement of knowledge that may lead to improved conditions for a group to
p.000199: which the participant belongs. Such knowledge may also inform other communities or society in general.
p.000199: Researchers should also be sensitive to the expectations and opinions of participants regarding potential benefits of
p.000199: the research. Prior to the commencement of the research, researchers should formally or informally discuss these
p.000199: expectations with individuals and/or groups, and outline the scope and nature of potential benefits that may accrue to
p.000199: participants during and after the research (see Article 9.13). REBs should be vigilant to ensure that the proposed
p.000199: distribution of benefits is fair, without imposing undue burdens on the researcher that would make it too difficult or
p.000199: costly to complete research.
p.000199: Researchers should normally provide copies of publications, or other research reports or products, arising from the
p.000199: research to the institution or organization – normally the host institution – that is best suited to act as a
p.000199: repository and disseminator of the results within the participating commu- nities. This may not be necessary in
p.000199: jurisdictions where the results are readily available in print or electronically. In general, researchers should ensure
p.000199: that participating individuals, groups and com- munities are informed of how to access the results of the research.
p.000199: Results of the research should be made available to them in a culturally appropriate and meaningful format, such as
p.000199: reports in plain language in addition to technical reports.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 53
p.000199:
p.000199:
p.000199:
p.000199: Chapter 5
p.000199: PRIVACY AND CONFIDENTIALITY
p.000199:
p.000199: Introduction
p.000199: There is widespread agreement about the interests of participants in protection of privacy, and the corresponding
p.000199: duties of researchers to treat personal information in a confidential manner. Indeed, the respect for privacy in
p.000199: research is an internationally recognized norm and ethical standard. Fun- damental rights and freedoms in the Canadian
p.000199: Constitution have been interpreted by the courts to include privacy protections. Privacy rights are protected in
p.000199: federal and provincial/territorial leg- islation. Model voluntary codes1 have also been adopted to govern access to,
p.000199: and the protection of, personal information. Some professional organizations have established codes that set out the
p.000199: conditions and obligations of their members regarding the collection, use and disclosure of personal information.
p.000199: Privacy risks in research relate to the identifiability of participants, and the potential harms they, or groups to
p.000199: which they belong, may experience from the collection, use and disclosure of personal information. Privacy risks arise
p.000199: at all stages of the research life cycle, including initial collection of information, use and analysis to address
p.000199: research questions, dissemination of findings, storage and retention of information, and disposal of records or devices
p.000199: on which information is stored.
p.000199: This Policy is based on a proportionate approach to the assessment of the ethical acceptability of research.
p.000199: Researchers and research ethics boards (REBs) are expected to identify and minimize privacy risks, keeping in mind that
p.000199: a matter that is not sensitive or embarrassing for the researcher may be so for the participant.
p.000199: In addition to following the guidance provided in this Policy, researchers are responsible for com- pliance with all
p.000199: applicable legal and regulatory requirements with respect to protection of privacy, and consent for the collection, use
p.000199: or disclosure of information about participants. These require- ments may vary by jurisdiction and, depending on who is
p.000199: funding or conducting the research, may include obligations under the Constitution (including the Canadian Charter of
p.000199: Rights and Free-
p.000199: doms), and federal or provincial privacy legislation, among other legal and regulatory requirements.
p.000199:
p.000199: A. Key Concepts
p.000199: Privacy
p.000199: Privacy refers to an individual’s right to be free from intrusion or interference by others. It is a fundamental right
p.000199: in a free and democratic society. Individuals have privacy interests in relation to their bodies, personal information,
p.000199: expressed thoughts and opinions, personal communications with others, and spaces they occupy. Research affects these
p.000199: various domains of privacy in different ways, depending on its objectives and methods. An important aspect of privacy
p.000199: is the right to con-
p.000199:
p.000199: TCPS 2 55
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: trol information about oneself. The concept of consent is related to the right to privacy. Privacy is respected if an
p.000199: individual has an opportunity to exercise control over personal information by con- senting to, or withholding consent
p.000199: for, the collection, use and/or disclosure of information (see Chapter 3 for further discussion of consent).
p.000199: Confidentiality
p.000199: The ethical duty of confidentiality refers to the obligation of an individual or organization to safe- guard entrusted
p.000199: information. The ethical duty of confidentiality includes obligations to protect information from unauthorized access,
p.000199: use, disclosure, modification, loss or theft. Fulfilling the ethical duty of confidentiality is essential to the trust
p.000199: relationship between researcher and partici- pant, and to the integrity of the research project.
p.000199: Security
p.000199: Security refers to measures used to protect information. It includes physical, administrative and technical safeguards.
p.000199: An individual or organization fulfils its confidentiality duties, in part, by adopting and enforcing appropriate
p.000199: security measures. Physical safeguards include the use of locked filing cabinets, and the location of computers
p.000199: containing research data away from public areas. Administrative safeguards include the development and enforcement of
p.000199: organizational rules about who has access to personal information about participants. Technical safeguards include use
p.000199: of computer passwords, firewalls, anti-virus software, encryption and other measures that protect data from
p.000199: unauthorized access, loss or modification.
p.000199: Identifiable Information
p.000199: Information that may reasonably be expected to identify an individual, alone or in combination with other available
p.000199: information, is considered identifiable information (or information that is identifiable) for the purposes of this
p.000199: Policy. Where the term “personal information” appears in this Policy, it refers to identifiable information.
p.000199: Types of Information
p.000199: Researchers may seek to collect, use, share and access different types of information about par- ticipants. Such
p.000199: information may include personal characteristics or other information about which an individual has a reasonable
p.000199: expectation of privacy (e.g., age, ethnicity, educational background, employment history, health history, life
p.000199: experience, religion, social status).
p.000199: For the purposes of this Policy, researchers and REBs shall consider whether information proposed for use in research
p.000199: is identifiable. The following categories provide guidance for assessing the ex- tent to which information could be
p.000199: used to identify an individual:
p.000199: • Directly identifying information – the information identifies a specific individual through direct identifiers
p.000199: (e.g., name, social insurance number, personal health number).
p.000199: • Indirectly identifying information – the information can reasonably be expected to iden- tify an individual
p.000199: through a combination of indirect identifiers (e.g., date of birth, place of residence or unique personal
p.000199: characteristic).
p.000199:
p.000199: 56 TCPS 2
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: • Coded information – direct identifiers are removed from the information and replaced with a code. Depending on
p.000199: access to the code, it may be possible to re-identify specific participants (e.g., the principal investigator retains a
p.000199: list that links the participants’ code names with their actual name so data can be re-linked if necessary).
p.000199: • Anonymized information – the information is irrevocably stripped of direct identifiers, a code is not kept to
p.000199: allow future re-linkage, and risk of re-identification of individuals from remaining indirect identifiers is low or
p.000199: very low.
p.000199: • Anonymous information – the information never had identifiers associated with it (e.g., anonymous surveys) and
p.000199: risk of identification of individuals is low or very low.
p.000199: Ethical concerns regarding privacy decrease as it becomes more difficult (or impossible) to asso- ciate information
p.000199: with a particular individual. These concerns also vary with the sensitivity of the information and the extent to which
p.000199: access, use or disclosure may harm an individual or group.
p.000199: The easiest way to protect participants is through the collection and use of anonymous or anonymized
p.000199: data, although this is not always possible or desirable. For example, after information is anonymized, it is not
p.000199: possible to link new information to individuals within a dataset, or to return results to participants. A “next best”
p.000199: alternative is to use de-identified data: the data are pro- vided to the researcher in de-identified form and the
p.000199: existing key code is accessible only to a custodian or trusted third party who is independent of the researcher. The
p.000199: last alternative is for re- searchers to collect data in identifiable form and take measures to de-identify the data as
p.000199: soon as possible. Although these measures are effective ways to protect participants from identification, the use of
p.000199: indirectly identifying, coded or anonymized information for research may still present risks of re-identification.
p.000199: Technological developments have increased the ability to access, store and analyze large volumes of data. These
p.000199: activities may heighten risks of re-identification, such as when researchers link datasets (see Section E, this
p.000199: chapter), or where a dataset contains information about a population in a small geographical area, or about individuals
p.000199: with unique characteristics (e.g., uncommon field of occupational specialization, diagnosis of a very rare disease).
p.000199: Various factors can affect the risks of re-identification, and researchers and REBs should be vigilant in their efforts
p.000199: to rec- ognize and reduce these risks. Data linkage of two or more datasets of anonymous information may present risks
p.000199: of identification (see Article 2.4 or Article 9.22).
p.000199: Where it is not feasible to use anonymous or anonymized data for research (and there are many reasons why data may need
p.000199: to be gathered and retained in an identifiable form), the ethical duty of confidentiality and the use of appropriate
p.000199: measures to safeguard information become para- mount. This Policy generally requires more stringent protections in
p.000199: research involving identifiable information. Researchers are expected to consult their REB if they are uncertain about
p.000199: whether information proposed for use in research is identifiable (e.g., when proposing to link anonymized or coded
p.000199: datasets).
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 57
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: B. Ethical Duty of Confidentiality
p.000199: Article 5.1 Researchers shall safeguard information entrusted to them and not misuse or wrongfully
p.000199: disclose it. Institutions shall support their researchers in maintaining promises of confidentiality.
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p.000199: and/or the reputation of the research community. Research that probes sensitive topics (e.g., illegal activities)
p.000199: generally depends on strong promises of confiden- tiality to establish trust with participants.
p.000199: The ethical duty of confidentiality applies to information obtained directly from participants, or from other
p.000199: researchers or organizations that have legal, professional or other obligations to maintain confidentiality.
p.000199: The ethical duty of confidentiality must, at times, be balanced against competing ethical considerations or legal or
p.000199: professional requirements that call for disclosure of information obtained or created in a research context. For
p.000199: example, in excep- tional and compelling circumstances, researchers may be subject to obligations to report information
p.000199: to authorities to protect the health, life or safety of a participant or a third party. Researchers are expected to be
p.000199: aware of ethical codes (such as pro- fessional codes of conduct) or laws (e.g., those requiring the reporting of
p.000199: children in need of protection) that may require disclosure of information they obtain in a research context. In other
p.000199: situations, a third party may seek access to information obtained and/or created in confidence in a research context.
p.000199: An access request may seek voluntary disclosure of information, or may seek to compel disclosure through force of law
p.000199: (e.g., by subpoena). Chapter 1, Section C, elaborates on the relationship between research ethics and law.
p.000199: Certain areas of research (such as research involving children at risk of abuse or studies of criminal behaviour) are
p.000199: more likely to put researchers in positions where they may experience tension between the ethical duty of
p.000199: confidentiality and dis- closure to third parties. Researchers shall maintain their promise of confidentiality to
p.000199: participants within the extent permitted by ethical principles and/or law. This may involve resisting requests for
p.000199: access, such as opposing court applications seek- ing disclosure. Researchers’ conduct in such situations should be
p.000199: assessed on a case-by-case basis and guided by consultation with colleagues, any relevant pro- fessional body, the REB
p.000199: and/or legal counsel.
p.000199: In some instances, participants may waive anonymity (e.g., if they wish to be iden- tified for their contributions to
p.000199: the research). Researchers should obtain the consent of these participants, and negotiate agreements with them that
p.000199: specify how they may be identified or recognized for their contribution. Where an individual partic-
p.000199:
p.000199: 58 TCPS 2
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: ipant waives anonymity but other members of the participant group object because identification may cause harm to the
p.000199: group, researchers shall maintain anonymity for all members of the participant group (see Article 3.2[f] and Article
p.000199: 10.4).
p.000199: Article 5.2 Researchers shall describe measures for meeting confidentiality obligations and explain any reasonably
p.000199: foreseeable disclosure requirements:
p.000199: (a) in application materials they submit to the REB; and
p.000199: (b) during the consent process with prospective participants.
p.000199: Application This article recognizes that some research projects are more likely to put researchers in a position
p.000199: where they may have a requirement to disclose information to third parties. The reasonable foreseeability of disclosure
...
p.000199: When planning a study, researchers should incorporate any applicable statute-based or other legal principles that may
p.000199: afford protection for the privacy of participants and the confidentiality of research information.
p.000199:
p.000199: C. Safeguarding Information
p.000199: Article 5.3 Researchers shall provide details to the REB regarding their proposed measures for safeguarding
p.000199: information, for the full life cycle of information: its collection, use, dissemination, retention and/or disposal.
p.000199: Application Researchers shall assess privacy risks and threats to the security of information for all stages of the
p.000199: research life cycle, and implement appropriate measures to protect information. Safeguarding information helps respect
p.000199: the privacy of participants and helps researchers fulfil their confidentiality obligations. In adopting measures to
p.000199: safeguard information, researchers should follow disciplinary standards and prac- tices for the collection and
p.000199: protection of information gathered for research purposes. Formal privacy impact assessments are required in some
p.000199: institutions and may also be required under legislation or policy in some jurisdictions. Security measures should take
p.000199: into account the nature, type and state of data: the data’s form (e.g., paper or electronic records); content (e.g.,
p.000199: presence of direct or indirect identifiers); mobility (e.g., kept in one location or subject to physical or electronic
p.000199: transport); and vulnerability to unauthorized access (e.g., use of encryption or password pro- tection). Measures for
p.000199: safeguarding information apply both to original documents and copies of information.
p.000199: Factors relevant to the REB’s assessment of the adequacy of the researchers’ pro- posed measures for safeguarding
p.000199: information include:
p.000199: (a) the type of information to be collected;
p.000199: (b) the purpose for which the information will be used, and the purpose of any secondary use of identifiable
p.000199: information;
p.000199: (c) limits on the use, disclosure and retention of the information;
p.000199: (d) risks to participants should the security of the data be breached, including risks of re-identification of
p.000199: individuals;
p.000199: (e) appropriate security safeguards for the full life cycle of information;
p.000199: (f) any recording of observations (e.g., photographs, videos, sound recordings) in the research that may allow
p.000199: identification of particular participants;
p.000199:
p.000199:
p.000199: 60 TCPS 2
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: (g) any anticipated uses of personal information from the research; and
p.000199: (h) any anticipated linkage of data gathered in the research with other data about participants, whether those data
p.000199: are contained in public or personal records (see also Section E of this chapter).
p.000199: In considering the adequacy of proposed measures for safeguarding information during its full life cycle, REBs should
p.000199: not automatically impose a requirement that researchers destroy the research data. Stored information may be useful for
p.000199: a variety of future purposes. Appropriate data retention periods vary depending on the re- search discipline,
...
p.000199: further guidance on consent and approaches to recruitment.
p.000199:
p.000199: E. Data Linkage
p.000199: Article 5.7 Researchers who propose to engage in data linkage shall obtain REB approval prior to carrying out the
p.000199: data linkage, unless the research relies exclusively on publicly available information as discussed in Article 2.2. The
p.000199: application for approval shall describe the data that will be linked and the likelihood that identifiable information
p.000199: will be created through the data linkage.
p.000199: Where data linkage involves or is likely to produce identifiable information, re- searchers shall satisfy the REB that:
p.000199:
p.000199:
p.000199: 64 TCPS 2
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: (a) the data linkage is essential to the research; and
p.000199: (b) appropriate security measures will be implemented to safeguard information.
p.000199: Application Growing numbers of databases and advancing technological capacity to link data- bases create new
p.000199: research opportunities, but also new privacy risks. In particular, linkage of de-identified or anonymized databases may
p.000199: permit re-identification of individuals. This article provides guidance for researchers who propose to carry out data
p.000199: linkage and requires that they assess and minimize risks of re-identification. Only a restricted number of individuals
p.000199: should perform the function of merging databases. Researchers should use enhanced security measures to store the merged
p.000199: file.
p.000199: Where researchers seek access to datasets held by another organization, it may be preferable for the data holder to
p.000199: carry out the data linkage and remove identifiers before disclosing the merged dataset.
p.000199: Legislation and organizational policies may regulate data linkage in specific cir- cumstances. For example, some
p.000199: personal information protection legislation requires data-sharing agreements that regulate conditions under which data
p.000199: linkage may be carried out. Data holders, such as statistics agencies, may also have policies on data linkage.5
p.000199: Where researchers propose to access and link datasets of identifiable information for the secondary purpose of
p.000199: research, the requirements of Section D apply.
p.000199:
p.000199: Endnotes
p.000199:
p.000199:
p.000199: 1 See, for example, Canadian Standards Association, Model Code for the Protection of Personal Information (1996).
p.000199: 2 See the Social Sciences and Humanities Research Council, “Research Data Archiving Policy”
p.000199: www.sshrc-crsh.gc.ca/site/apply-demande/policies-politiques/edata-donnees_electroniques-eng.aspx; and the Canadian
p.000199: Institutes of Health Research “Policy on Access to Research Outputs” (September 2007).
p.000199: www.cihr-irsc.gc.ca/e/34846.html; and the Canadian Institutes of Health Research, Natural Sciences and Engineering
p.000199: Research Council of Canada, Social Sciences and Humanities Research Council of Canada, Access to Research Results:
p.000199: Guiding Principles. www.science.gc.ca/default.asp?Lang=En&n=9990CB6B-1
p.000199: 3 See also the Canadian Institutes of Health Research, CIHR Guidelines for Health Research Involving Aboriginal People
p.000199: (May 2007). www.cihr-irsc.gc.ca/e/29134.html
p.000199: 4 For discussion of factors relevant to assessing impracticability of consent, see, for example, the Canadian
p.000199: Institutes of Health Research, CIHR Best Practices for Protecting Privacy in Health Research, Section 3.3, Secondary
p.000199: Use (September 2005). www.cihr-irsc.gc.ca/e/29072.html#Element3
p.000199: 5 See, for example, Statistics Canada, “Policy on Record Linkage.” www.statcan.gc.ca/record-
p.000199: enregistrement/policy4-1-politique4-1-eng.htm
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 65
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: Introduction
p.000199: Chapter 6
p.000199: GOVERNANCE OF RESEARCH ETHICS REVIEW
p.000199: This chapter sets out the elements of research ethics review including the procedures necessary to establish a research
p.000199: ethics board (REB), and operational guidelines for the REBs and research ethics review, both initially and throughout
p.000199: the course of the research project. It also includes guidelines for the conduct of research ethics review during
p.000199: publicly declared emergencies.
...
p.000199: capable of reviewing the ethical acceptability of that research. In fulfilling this responsibility, institutions may
p.000199: opt to appoint an external REB in accordance with the Memoran- dum of Understanding between the Agencies and
p.000199: institutions.1 Any such appointment should be based on an official agreement clarifying the ultimate re-
p.000199: sponsibility of the institution for the ethical acceptability of research undertaken within its jurisdiction or under
p.000199: its auspices. To demonstrate their accountability, institutions may wish to issue public reports summarizing the
p.000199: institution’s activities and initiatives relevant to the ethics review of research involving humans, its re- search
p.000199: ethics administration, and relevant research ethics education and training.
p.000199: The number of REBs and the expertise of their members will depend on the range and volume of research for which that
p.000199: institution is responsible, in accordance with
p.000199:
p.000199: TCPS 2 67
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: Articles 6.4 and 6.5 relating to REB composition. Large institutions may find it necessary to create more than one REB
p.000199: to cover different areas of research or to accommodate a large volume of research. Small institutions may wish to
p.000199: explore regional cooperation or alliances for access to an REB based on formal agreements between the institutions (see
p.000199: Article 8.1).
p.000199: Members of an institution (i.e., its faculty, staff and students) may be affiliated with other institutions, or may be
p.000199: engaged in consulting or other professional activities in a separate enterprise, or in student co-op work or field
p.000199: placements. If members of the institution make reference to their affiliation to the institution, or use any of its
p.000199: resources when engaging in research, they should submit their research proposal to their institutional REB for research
p.000199: ethics review in accordance with this Policy. Where student co-op work or field placements involve components of
p.000199: research that require research ethics review, institutions and organizations hosting co-op student researchers may
p.000199: consider specifying in advance (e.g., in policies, agreements or contracts for co-op student placements) the roles and
p.000199: responsibilities pertaining to the ethics review of research involving humans of the host organization versus those of
p.000199: the institution.
p.000199: Should the institution determine that some situations warrant an exception to the requirement for REB review, the basis
p.000199: and conditions for case-by-case exceptions shall be clearly documented in the institutional policies. Case-by-case
p.000199: exceptions may be determined by such factors as the degree to which the members’ affiliation with the institution is
...
p.000199:
p.000199: informal meetings cannot, however, substitute for the formal review process. A schedule of REB meetings should be
p.000199: communicated to researchers for the planning of ethics review of their research.
p.000199: On occasion REBs may need to consult other resources within or outside the insti- tution for advice, and may invite
p.000199: experts to attend their meetings. REBs should consider whether the institutional functions of other individuals
p.000199: attending their meetings could exercise undue influence, or provide elements of power imbalances or coercion that would
p.000199: affect REB review, deliberations and decisions (see Articles
p.000199: 6.4 and 6.5 and Chapter 7).
p.000199: REBs should establish a process for the basis of arriving at decisions requiring full REB review. For example, they may
p.000199: arrive at decisions by consensus, and where this is not possible resort to a vote. REBs should hold general meetings,
p.000199: retreats and workshops to enhance educational opportunities that may benefit the overall operation of the REB, discuss
p.000199: any general issues arising out of the REB’s activities or revise relevant policies.
p.000199:
p.000199: B. Procedures for REB Review
p.000199:
p.000199: Initial Research Ethics Review
p.000199: Article 6.11 Researchers shall submit their research proposals, including proposals for pilot studies, for REB
p.000199: review and approval of its ethical acceptability prior to the start of recruitment of participants, access to data, or
p.000199: collection of human biological ma- terials. REB review is not required for the initial exploratory phase, which may
p.000199: involve contact with individuals or communities intended to establish research part- nerships or to inform the design
p.000199: of a research proposal.
p.000199: Application REB review and approval of the ethical acceptability of research is required before recruitment, formal
p.000199: data collection involving participants, access to data, or col- lection of human biological materials. Similarly, as an
p.000199: integral component of their research design, researchers may undertake pilot studies involving participants. For the
p.000199: conduct of pilot studies, researchers shall seek consent from prospective par- ticipants and obtain REB approval before
p.000199: recruitment or the formal data collection involving participants, or access to data, or collection of human biological
p.000199: materials in accordance with the provisions in this Policy.
p.000199: Researchers shall submit sufficient details to enable the REB to make an informed review of the ethical acceptability
p.000199: of the research.
p.000199: Some types of research using quantitative, qualitative research, or a combination of these methods, as well as
p.000199: collaborative or community-based research (see Chapters 9 and 10) may entail prior contact and dialogue
p.000199: with individuals or
p.000199:
p.000199:
p.000199:
p.000199: 76 TCPS 2
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: communities as a normal and integral component to establish research collaborations or partnerships
p.000199: prior to the actual design of the research. Other research may, at their initial stages, not involve humans, but
p.000199: require engaging the research team, setting up equipment and other preparatory stages. These activities may precede REB
p.000199: review.
p.000199: Determining the Level of Research Ethics Review
p.000199: Article 6.12 In keeping with a proportionate approach to research ethics review, the selection of the level of REB
p.000199: review shall be determined by the level of foreseeable risks to participants: the lower the level of risk, the lower
p.000199: the level of scrutiny (delegated review); the higher the level of risk, the higher the level of scrutiny (full board
p.000199: re- view).
...
p.000199: procedures.
p.000199: Reconsideration of REB Decisions
p.000199: Article 6.18 Researchers have the right to request, and REBs have an obligation to provide, prompt reconsideration
p.000199: of decisions affecting a research project.
p.000199: Application Researchers and REBs should make every effort to resolve disagreements they may have through
p.000199: deliberation, consultation or advice. If a disagreement between the researcher and the REB cannot be resolved through
p.000199: reconsideration, the researcher shall have the option of appealing the REB decisions through the established appeal
p.000199: mechanism (see Article 6.19). REBs should establish timelines to promptly conduct reconsiderations and issue their
p.000199: decision.
p.000199: The onus is on researchers to justify the grounds on which they request reconsid- eration by the REB and to indicate
p.000199: any alleged breaches to the established research ethics review process, or any elements of the REB decision that are
p.000199: not supported by this Policy.
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 83
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: Appeal of REB Decisions
p.000199: Article 6.19 Institutions shall have an established mechanism and a procedure in place for promptly handling appeals
p.000199: from researchers when, after reconsideration, the REB has refused ethics approval of the research.
p.000199: Application In cases when researchers and REBs cannot reach agreement through reconsider- ation, the institution
p.000199: shall provide access to an established appeal process for the review of an REB decision. The researcher and the REB
p.000199: must have fully exhausted the reconsideration process, and the REB must have issued a final decision before the
p.000199: researcher initiates an appeal.
p.000199: Based on its written institutional policies, the same authority that established the REB shall establish or appoint an
p.000199: appeal committee that reflects a range of expertise and knowledge similar to that of the REB, and that meets the
p.000199: procedural require- ments of this Policy. An appeal committee may be an ad hoc or a permanent committee.
p.000199: Members of the REB whose decision is under appeal shall not serve on that appeal committee.
p.000199: It should be stressed that the appeal process is not a substitute for REBs and re- searchers working closely together
p.000199: to ensure high-quality ethical research, nor is it a forum to merely seek a second opinion.
p.000199: Institutions may wish to explore regional cooperation or alliances, including the sharing of appeal boards. If two
p.000199: institutions decide to use each other’s REB as an appeal board, a formal letter of agreement between institutions is
p.000199: required (see Chapter 8).
p.000199: It is not the role of the three federal research Agencies that are responsible for this Policy to consider any appeals
p.000199: of REB decisions.
p.000199: Article 6.20 The appeal committee shall have the authority to review negative decisions made by an REB. In so doing,
p.000199: it may approve, reject or request modifications to the re- search proposal. Its decision on behalf of the institution
p.000199: shall be final.
...
p.000199: risks, such as disclosure to the participants of the possible conflicts between multiple roles, may be sufficient to
p.000199: manage the conflict (see also Articles 9.6, 9.8 and 9.12).
p.000199:
p.000199: C. REB Members and Conflicts of Interest
p.000199: Article 7.3 When reviewing research proposals, REB members shall disclose real, potential or perceived conflicts
p.000199: of interest to the REB. When necessary, the REB may decide that some of its members must withdraw from REB
p.000199: deliberations and decisions.
p.000199: Application To maintain the independence and integrity of research ethics review, members of the REB must identify,
p.000199: eliminate, minimize or otherwise manage real, potential or perceived conflicts of interest. If an REB is reviewing a
p.000199: research project in which a member of the REB has a personal or financial conflict of interest (see Section A of this
p.000199: chapter), the member must disclose the nature of the conflict and absent themselves from any discussion or decision
p.000199: regarding that research project. In the event that a member’s conflict of interest and necessary withdrawal from the
p.000199: meet- ing will threaten the maintenance of quorum, the REB can ensure that a substitute member be in attendance to
p.000199: maintain quorum.
p.000199: Conflict of interest policies should determine a reasonable time period during which an REB member is not allowed to
p.000199: review a proposal involving a recent collaborator, supervisor, student or other colleague (as defined by the
p.000199: institution). The purpose of these policies on time limits is to ensure adequate and continued access to com- petent
p.000199: expertise. In some cases, the scientific expertise of the REB member may still be sought when no other individuals with
p.000199: the scientific expertise relevant to the proposal under review are available to the REB. In such instances, the REB
p.000199: will record this explicitly in the minutes. The member should not be present when the REB makes its decision.
p.000199: REBs and Senior Administrators
p.000199: Institutional senior administrators (e.g., a vice-president of research or business de- velopment) should not serve on
p.000199: an REB, or directly or indirectly influence the REB decision-making process. The mere presence of an institutional
p.000199: senior administrator at REB meetings may undermine the independence of the REB by unduly influ- encing REB
p.000199: deliberations and decisions.
p.000199:
p.000199:
p.000199: TCPS 2 93
p.000199:
p.000199: Chapter 7 – Conflicts of Interest
p.000199:
p.000199: REBs and senior administrators should consider other venues to discuss policy is- sues, general issues arising from the
p.000199: REB’s activities, or training and educational needs, to the benefit of the overall operation and mandate of the REB. In
p.000199: the dis- charge of their interdependent roles and duties to participants, effective communications
p.000199: processes should be established between REBs and the relevant officers of institutions. In cases where senior
p.000199: administrators interfere with the REB decision-making process, REBs should invoke the institution’s conflict of
p.000199: interest policies.
p.000199: Compensation for REB members
...
p.000199: the responsibility of the principal REB.
p.000199: When selecting from among research ethics review models authorized by their in- stitution, researchers and REBs should
p.000199: consider the following:
p.000199:
p.000199:
p.000199: 100 TCPS 2
p.000199:
p.000199: Chapter 8 – Multi-Jurisdictional Research
p.000199:
p.000199: • the discipline and content area of the research, and the availability of appropri- ate experience and expertise
p.000199: within, or available to, the reviewing REB;
p.000199: • the scope of the project to be reviewed and appropriateness of the proposed re- search ethics review model;
p.000199: • the vulnerability of the study population overall and/or the particular charac- teristics of the local population
p.000199: at individual sites, differences in values and cultural norms, and the level of risk associated with the research under
p.000199: review;
p.000199: • any relevant differences in laws and/or guidelines pertaining to the research in question if the institutions are
p.000199: in different provinces, territories and/or coun- tries;
p.000199: • relationships between institutions and REBs, and conflict resolution mecha- nisms related to REB decisions;
p.000199: • the potential for conflicts of interest and undue influence, including those that may arise from funding sources;
p.000199: • any differences in the standard of care normally followed, or access to services at the participating
p.000199: institutions that might be relevant to the conduct of the re- search; and
p.000199: • any operational issues that might affect the research.
p.000199:
p.000199: B. Ethics Review of Research Conducted outside the Institution
p.000199: Researchers affiliated with Canadian institutions are undertaking research at numerous sites within Canada and in
p.000199: countries around the world. Such research may be carried out with or without any collaboration with host institutions
p.000199: and local researchers. Most middle-income countries, and many low-income countries, have laws, policies or guidelines
p.000199: governing the ethical conduct of research involving humans, but some parts of the world do not have developed or
p.000199: widespread research ethics infrastructure.
p.000199: National and international standards for research involving humans are evolving continually, but methods for comparing
p.000199: the precise levels of protection afforded participants in different countries or jurisdictions, and by different
p.000199: institutions within those countries and jurisdictions, have not yet been developed. In exercising its responsibilities
p.000199: for the initial and continuing ethics review of re- search conducted under its auspices, the Canadian REB shall satisfy
p.000199: itself that the requirements of this Policy are met, both within the Canadian institution, and within the other country
p.000199: or research site. The Canadian REB shall take appropriate steps to ensure researchers are responsive to ethi- cally
...
p.000199:
p.000199:
p.000199: TCPS 2
p.000101: 101
p.000101:
p.000101: Chapter 8 – Multi-Jurisdictional Research
p.000101:
p.000101: (b) Subject to Article 8.3(a), research conducted under the auspices of a Canadian research institution and conducted
p.000101: outside its jurisdiction, whether elsewhere in Canada, or outside Canada, shall undergo prior research ethics review by
p.000101: both:
p.000101: i. the REB at the Canadian institution under the auspices of which the research is being conducted; and
p.000101: ii. the REB or other responsible review body or bodies, if any, at the research site.
p.000101: Application An institution is responsible for the ethical conduct and ethical acceptability of re- search
p.000101: undertaken by its faculty, staff or students regardless of where the research is conducted (see Article 6.1). Thus, for
p.000101: a Canadian research institution, review of the ethical acceptability of the research by the institution’s REB is
p.000101: required, in ad- dition to ethics review by an REB or other appropriately constituted review body with jurisdiction at
p.000101: the research site elsewhere in Canada, or outside Canada, if any. Approval of a research proposal by an REB at the
p.000101: research site does not con- stitute sufficient authorization to conduct the research without the approval of the
p.000101: relevant Canadian REB(s). Conversely, approval by the Canadian REB(s) is not sufficient authorization to begin the
p.000101: research without the approval of the REB or other appropriately constituted review body at the research site.
p.000101: Researchers shall obtain necessary approvals of the ethical acceptability of their research prior to the start of
p.000101: recruitment of participants, access to data, or collection of human biological materials, in accordance with Article
p.000101: 6.11.
p.000101: Researchers may undertake research in Canada or abroad without formal collabo- ration with other academic institutions.
p.000101: In these cases, in addition to the REB review at their own institution, researchers may need to obtain access to the
p.000101: site and prospective participants from a responsible agency, where one exists. They shall inform the REB whether, or
p.000101: how, they will seek permission to proceed with the research at that site and with the target participants. Some
p.000101: organizations or groups have established mechanisms or guidelines (e.g., school boards, Aboriginal communities [see
p.000101: Chapter 9], correctional services, service agencies and commu- nity groups) to review requests for research
p.000101: prior to allowing access to their members, or access to data about them that are under their authority. When
p.000101: design- ing their research, researchers should consider these provisions. This article does not apply to research
p.000101: involving critical inquiry about organizations or institutions (see Article 3.6).
p.000101: Researchers shall inform the REB of the absence of established ethics review mech- anisms at the research site, and
p.000101: report their efforts to identify any other suitable review mechanisms in the other country.1 When no appropriate
p.000101: mechanisms for research ethics review exist at the research site, researchers and REBs shall apply the core principles
p.000101: outlined in this Policy (see Chapter 1).
p.000101:
p.000101:
p.000101: 102 TCPS 2
p.000101:
p.000101: Chapter 8 – Multi-Jurisdictional Research
p.000101:
p.000101: REBs should not prevent research from proceeding solely because the research cannot be reviewed and approved through a
p.000101: formal REB review process in another country or other jurisdiction. Under these circumstances, researchers should be
p.000101: aware of relevant cultural practices, such as those normally followed to seek entry into the relevant communities, and
p.000101: be respectful of them. Researchers shall inform the REB of their strategies to familiarize themselves with the relevant
p.000101: norms and cultural practices, and to minimize risks to individuals and communities partici- pating in, or potentially
...
p.000111: of community engagement required. In some situations, if the REB is satisfied that participants are not identified with
p.000111: a community or that the welfare of relevant communities is not affected, the REB may waive the requirement of a
p.000111: community engagement plan (see Article 9.10). In these cases, consent of individuals is sufficient to
p.000111: participate.
p.000111: Communities lacking the infrastructure to support pre-research community engagement should not be deprived
p.000111: of opportunities to participate in guiding research affecting their welfare (see Article 9.14).
p.000111: The following list, which is not exhaustive, provides examples to illustrate the forms of community engagement that
p.000111: might be appropriate for various types of research.
p.000111: 1) Research directly involving a community on First Nations, Inuit or Métis lands with a formal governance structure.
p.000111: For example, a project that examines the incidence of diabetes in Pond Inlet, Nunavut, or the impact on Inuit health of
p.000111: contaminants in animals and plants used for country food.
p.000111: • Permission of the Nunavut Research Institute that carries authority to approve research in Nunavut is
p.000111: required. Agreement of the hamlet council in Pond Inlet will normally be a condition of approval. The local health
p.000111: committee may co-manage the project.
p.000111: 2) Research involving Aboriginal people who comprise a sizeable proportion of the study or community and where
p.000111: Aboriginal-specific conclusions are intended. For example, a comparative study of access to public housing in Prince
p.000111: Albert, Saskatchewan.
p.000111: • First Nations in the district, represented by their tribal council, the local Métis association, and urban
p.000111: Aboriginal and women’s organizations may partner with the Prince Albert city council to sponsor, implement and use the
p.000111: results of the housing study.
p.000111: 3) Research focusing on a larger community that is known to include Aboriginal people (regardless of their
p.000111: proportion), and where Aboriginal-specific conclusions are anticipated. For example, a study of student retention
p.000111: in high schools in the Sault Ste. Marie district of Ontario.
p.000111: • A committee representing First Nations, Métis organizations and urban Aboriginal people whose children may
p.000111: be affected by the study may be convened to advise the District Board of Education and the researchers involved.
p.000111: 4) Research involving Aboriginal people who comprise a sizeable proportion of the larger community that is the
p.000111: subject of research even if no Aboriginal- specific conclusions will be made. For example, research on
p.000111: employment
p.000111:
p.000111: 112 TCPS 2
p.000111:
p.000111: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000111:
p.000111: development programs serving residents of the inner city of Winnipeg in Manitoba.
p.000111: • Aboriginal service agencies or political organizations may be engaged to help recruit Aboriginal participants and
...
p.000113: or national organizations may facilitate research ethics review and make recommendations, but the decision to
p.000113: participate normally rests with the local communities.
p.000113: Engagement with formal leadership is not a substitute for seeking consent from individual participants, as required by
p.000113: Chapter 3.
p.000113:
p.000113:
p.000113: 114 TCPS 2
p.000113:
p.000113: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000113:
p.000113: Engagement with Organizations and Communities of Interest
p.000113: Article 9.4 For the purposes of community engagement and collaboration in research undertakings,
p.000113: researchers and REBs shall recognize Aboriginal organizations, including First Nations, Inuit and Métis
p.000113: representative bodies, and service organizations and communities of interest, as communities. They shall
p.000113: also recognize these groups through representation of their members on ethical review and oversight of projects, where
p.000113: appropriate.
p.000113: Application Organizational communities and communities of interest may exist within the boundaries of territorial
p.000113: communities. Overlapping interests in these cases are considered in Articles 9.5 and 9.6. A majority of persons who
p.000113: self-identify as Aboriginal live in rural and urban communities outside of discrete First Nations, Métis or Inuit
p.000113: communities. Political organizations, friendship centres, housing associations, health access centres and other groups
p.000113: operating in rural or urban centres have been created to enhance the welfare of their own members or the populations
p.000113: that they serve. Organizations and communities of interest are potential partners in research on issues relevant
p.000113: to their communities, and are to be recognized as communities for the purposes of community engagement under this
p.000113: Policy.
p.000113: An organization may participate in research focusing on its members (e.g., the board and staff of a friendship centre),
p.000113: or it may facilitate ethical engagement with the population that it serves (e.g., the clientele of a health
p.000113: access centre). A community of interest (e.g., Aboriginal youth who use an urban service program) may designate a
p.000113: local organization to provide advice and ethical protection for a project in which they participate.
p.000113: Prospective participants may not necessarily recognize organizational communities or communities of interest as
p.000113: representing their interests. Where researchers and organizational communities or communities of interest collaborate
p.000113: in research (e.g., through a research agreement), prospective participants shall be informed about the extent of such
p.000113: collaboration (including how data will be shared) as part of the initial and ongoing consent process (see Article
p.000113: 3.2[i]).
p.000113: Complex Authority Structures
p.000113: Article 9.5 Where alternatives to securing the agreement of formal leadership are proposed for research on First
p.000113: Nations, Inuit or Métis lands or in organizational communities, researchers should engage community processes and
p.000113: document measures taken, to enable the REB to review the proposal with due consideration of complex
p.000113: community authority structures.
p.000113: Application Researchers and REBs should not assume that approval of a project by formal leaders is the only avenue
p.000113: for endorsing a project. In some communities and some domains of knowledge, authority to permit and monitor
p.000113: research rests with knowledge keepers designated by custom rather than by election or appointment.
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p.000115: Inconsistencies between community custom and this Policy should be identified and addressed in advance of initiating
p.000115: the research, or as they arise.
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p.000117: Application First Nations, Inuit and Métis codes of research practice derive from procedures and customs of
p.000117: predominantly oral cultures. While some rules may be in written form, their interpretation is dependent on experiential
p.000117: knowledge acquired through interactions in the community. An example is the strict limitation on making
p.000117: publicly available sacred knowledge that might be revealed within a trusting relationship. In academic
p.000117: culture, rules regarding limits on disclosure of information would reasonably be incorporated into a research
p.000117: proposal, and should be integrated into research agreements between communities and researchers where such exists.
p.000117: The absence, or perceived absence, of a formal local research code or guidelines does not relieve the researcher of the
p.000117: obligation to seek community engagement in order to identify local customs and codes of research practice.
p.000117: First Nation, Inuit and Métis customs and codes of behaviour distinguish among knowledge that can be publicly
p.000117: disclosed, disclosed to a specific audience, or disclosed under certain conditions. Determination of what information
p.000117: may be shared, and with whom, will depend on the culture of the community involved. Any restrictions on access to, or
p.000117: use of, traditional or sacred knowledge shared in the course of the research project should be addressed in the
p.000117: research agreement.
p.000117: In Aboriginal communities, custom may restrict the observation, recording, or reporting of ceremonies or certain
p.000117: performances, and require approval of appropriate individuals. Article 10.3 addresses the requirement for ethics
p.000117: review of research involving observational studies, and associated ethical implications, which may include infringement
p.000117: on consent and privacy.
p.000117: Many First Nations communities across Canada have adopted an ethics code originally developed to govern
p.000117: practice in the First Nations Regional Longitudinal Health Survey. The code asserts ownership of, control of, access
p.000117: to, and possession (OCAP) of research processes affecting participant communities, and the resulting data. OCAP
p.000117: addresses issues of privacy, intellectual property, data custody and secondary use of data, which are also covered
p.000117: later in this chapter.
p.000117: Inuit communities and organizations are considering addressing similar concerns, including adoption or adaptation of
p.000117: OCAP. For example, possession agreements, which are distinct from research agreements, are set out in a
p.000117: memorandum of understanding between the institution of the researcher and the community (usually represented by the
p.000117: land claim organization). The possession agreement covers the control and use of data and human biological materials
p.000117: collected over the course of the research. The agreement may continue to exist long after the research is
p.000117: completed, to allow control and use of data and human biological materials for Inuit- initiated research.
p.000117: Researchers should consult their own institutions to ensure that the application of OCAP or other community-based
p.000117: ethics codes is consistent with institutional
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p.000117: policies. Where divergences exist, they should be addressed and resolved prior to the commencement of the research, or
p.000117: as they arise over the course of the research.
p.000117: First Nations, Inuit and Métis scholars attached to academic institutions as faculty members, students or research
p.000117: associates are increasingly engaged in research involving their own communities, and sometimes their own family
p.000117: members. They are generally exempt from restrictions on physical access to territory or personal access to community
p.000117: members. However, as members of institutions that adhere to this Policy, they are subject to the ethical duty to
p.000117: respect community customs and codes of research practice when conducting research in their own local or cultural
p.000117: communities, and to engage the relevant community as required by this Policy. In these cases, institutional REBs may be
p.000117: concerned about researchers being in a conflict of interest and should manage the conflict of interest in accordance
p.000117: with Articles 7.2 and 7.4.
p.000117: Life history and language research are examples of research areas where insider relationships and cultural competencies
p.000117: provide unique opportunities to extend the boundaries of knowledge. Although it can be argued that recording the life
p.000117: history of an elderly relative is a family matter rather than a community matter, when undertaken as research,
p.000117: community engagement is important to ensure that the following considerations are reviewed: the potential impact of
p.000117: such research on the wider community; conflicts between the individualist norms of the academic environment
p.000117: and the norms of the community; and the possibility of unclear or mistaken assumptions on the part of participant and
p.000117: researcher. During the consent process, researchers should give the participant the opportunity to identify the
p.000117: relevant form of community engagement, and at what stage such engagement should occur. This may include engaging with
...
p.000119: researchers, prior to REB review, that the research may proceed but that it does not want further community engagement,
p.000119: researchers shall document and present to the REB the steps they took to invite and facilitate engagement by the
p.000119: community. See Article 9.14 on how researchers may assist in capacity building.
p.000119: Although researchers shall offer the option of engagement, a community may choose to engage nominally or not at all,
p.000119: despite being willing to allow the research to proceed. A community may, for example, support a research project
p.000119: carried out
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p.000121: independent of community influence, or without any further collaboration of the community in the actual implementation
p.000121: of the research in order to use scientifically defensible results to validate a negotiating position.
p.000121: Research Agreements
p.000121: Article 9.11 Where a community has formally engaged with a researcher or research team through a designated
p.000121: representative, the terms and undertakings of both the researcher and the community should be set out in a
p.000121: research agreement before participants are recruited.
p.000121: Application Research agreements serve as a primary means of clarifying and confirming mutual expectations and,
p.000121: where appropriate, commitments between researchers and communities. Research agreements, where applicable, shall
p.000121: precede recruitment of individual participants and collection of, or access to, research data. The scope of the
p.000121: agreement will depend on the level of engagement which the community desires, and the availability of resources to
p.000121: support community participation.
p.000121: At a minimum, the agreement should address the ethical protections that would apply to securing individual consent for
p.000121: a comparable project, and should specify any commitments regarding collective community participation and
p.000121: decision making, sharing of benefits and review, and updating of the agreement. Expanding on information normally
p.000121: provided to an individual participant (see Article 3.2), agreements typically set out the purpose of the
p.000121: research and detail mutual responsibilities in project design, data collection and management (see Article 5.3);
p.000121: analysis and interpretation; credit due to knowledge holders; protection (and non- disclosure) of restricted knowledge;
p.000121: sharing of benefits or royalties flowing from intellectual property where applicable; production of reports;
p.000121: co-authorship; dissemination of results; and a conflict resolution process. Provisions for any anticipated
p.000121: secondary use of the information or human biological material, and associated data collected, should also be addressed
p.000121: at that time, and documented in the research agreement (see Article 9.20).
p.000121: Where a community has adopted or adheres to a code of research practice, the agreement may set out responsibilities in
p.000121: accordance with that code and the specific requirements of the research project. In less formal circumstances, the
p.000121: agreement may be relatively brief, and subject to clarification as the project unfolds. The CIHR Guidelines for
p.000121: Health Research Involving Aboriginal People (2007) provide examples of elements that may be included in research
p.000121: agreements (see References at the end of this chapter).
p.000121: Research agreements are increasingly being recognized by academic institutions (and the researchers associated with
p.000121: them) as providing reference points for research ethics review process and approval on such elements as consent,
p.000121: confidentiality, and access to and use of information. Agreements that specify procedures for community
p.000121: research ethics review, included as part of the institutional ethics
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p.000121: application, can provide contextual information and guidance for REBs conducting initial review of applications, and
p.000121: continuing research ethics review throughout the project. Researchers should check with their institutions regarding
p.000121: signing authority for research agreements (see Article 9.18).
p.000121: Building relationships, clarifying the goals of a project, and negotiating agreements requires substantial investment
p.000121: of time and resources on the part of the community and the researcher. Development and participation costs incurred by
p.000121: the community and the researcher should be factored into proposals to the extent possible within funding guidelines.
p.000121: Community agreement that a research project may proceed is not a substitute for securing the consent of individuals
p.000121: recruited to participate in that project, in accordance with Chapter 3. Consent of prospective
p.000121: participants shall precede collection of, or access to, data or human biological materials. Consistent with the
p.000121: provisions of Article 3.12, if signed written consent is not culturally appropriate, the researcher shall inform the
p.000121: REB of alternative processes employed for seeking and documenting consent.
p.000121: Consent shall be given in accordance with the research agreement where one exists. Where research agreements provide
p.000121: that community partners will have limited or full access to identifiable personal data, the consent of participants to
p.000121: this disclosure shall form part of the consent process. Access to confidential information provided by an individual is
p.000121: subject to privacy law.
p.000121: Researchers should be aware of the first language of Aboriginal participants and, if an Aboriginal language,
p.000121: researchers should make available translation by a knowledgeable person during the consent process, and
p.000121: during the conduct of research in accordance with the wishes of the participant (see Article 4.1).
p.000121: Researchers should be aware of the official status of Inuit languages in Inuit regions.
p.000121: Collaborative Research
p.000121: Article 9.12 As part of the community engagement process, researchers and communities should consider applying a
p.000121: collaborative and participatory approach as appropriate to the nature of the research, and the level of ongoing
p.000121: engagement desired by the community.
p.000121: Application While community engagement is appropriate in any research that affects Aboriginal communities, the
p.000121: nature and degree of collaboration between the researcher and the community will depend on the nature of the research,
p.000121: and the community context. Collaborative approaches in research with Aboriginal communities are a means of facilitating
p.000121: mutually respectful and productive relations (see Article 9.2).
p.000121: Collaborative research is generally understood to involve respectful relationships among colleagues, each bringing
p.000121: distinct expertise to a project. Collaboration often involves one or another of the partners taking primary
p.000121: responsibility for certain
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p.000123: methods and social science tools, the nature, extent and consequences of the local housing shortage are documented,
p.000123: enabling the community to effectively communicate its needs to non-Inuit (Qallunaat) authorities. Other benefits
p.000123: include training workshops that provide employment and transfer skills to Inuit youth involved in data collection,
p.000123: field experience in community-based research for university student assistants and materials useful to other Inuit
p.000123: communities in subsequent research.
p.000123: Collaborative research approaches provide the community with the opportunity to discuss risks and potential benefits,
p.000123: and to minimize risks. Where participatory
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p.000123: research is undertaken, the research report might also formulate recommendations on how to implement interventions
p.000123: resulting from the research for the benefit of the participating community.
p.000123: A possible outcome of collaborative research, and in particular participatory research, is increased
p.000123: capacity to carry out research that can more readily be conducted in Aboriginal languages and oral modes. The
p.000123: exploration, articulation and application of knowledge specific to a community or communities are thus advanced,
p.000123: potentially benefiting other First Nations, Inuit or Métis communities through knowledge transfer.
p.000123: Researchers should provide communities access to research data that will allow them to address pressing issues through
p.000123: community-generated policies, programs, and services (see Article 9.8 and the Application of Article 9.11). Territorial
p.000123: and organizational communities and communities of interest may also seek to share in the benefits of research
p.000123: activities, which may include direct research grants, release time for project personnel, overhead levies on shared
p.000123: projects and commercializa- tion of research discoveries.
p.000123: Strengthening Research Capacity
p.000123: Article 9.14 Research projects should support capacity building through enhancement of the skills of community
p.000123: personnel in research methods, project management, and ethical review and oversight.
p.000123: Application Collaborative research approaches provide for reciprocal learning and for transfer of skills and
p.000123: knowledge between the community and the researcher. Researchers should foster education and training of community
p.000123: members to enhance their participation in research projects. Employing Aboriginal research assistants and
p.000123: translators is already common practice in community-based projects. Extending skills transfer through a program of
p.000123: training will support collaboration with institutions, and advance the capacity of communities to initiate and
p.000123: implement their own research. Collaborative research can also support building capacity of the research community to
p.000123: conduct culturally relevant research.
p.000123: Lack of engagement by communities may be due to inadequate financial or human resources. Communities vary widely in the
p.000123: level of human and material resources they have available to collaborate with research initiatives. Structural barriers
p.000123: may prevent access to, and participation in, research. For example, small, remote communities and many urban
p.000123: communities of interest have limited organizational resources to advise or collaborate in research. The least
p.000123: organizationally developed communities are the most vulnerable to exploitation. Research undertaken in these
p.000123: circumstances should strive to enhance capacity for participation.
p.000123: Funding programs that target the development of Aboriginal research and capacity building seek to generate
p.000123: significant research training opportunities. Funding criteria allow researchers to include in their grant
p.000123: applications stipends for
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p.000125: undergraduate, master’s or doctoral students, or post-doctoral researchers, as appropriate, with priority given
p.000125: to Aboriginal candidates. The time required to establish collaborative relationships may be difficult to
p.000125: accommodate in the programs of students. Mentorship by experienced researchers who introduce students to
p.000125: communities and monitor their ethical practice can facilitate the trust- building process and advance student progress.
p.000125: Recognition of the Role of Elders and Other Knowledge Holders
p.000125: Article 9.15 Researchers should engage the community in identifying Elders or other recognized knowledge holders to
p.000125: participate in the design and execution of research, and the interpretation of findings in the context of cultural
p.000125: norms and traditional knowledge. Community advice should also be sought to determine appropriate recognition for the
p.000125: unique advisory role fulfilled by these persons.
p.000125: Application Within First Nations, Inuit and Métis communities, persons with special gifts carry varied roles and
p.000125: responsibilities in conserving and transmitting traditional knowledge and expressions of culture. They often are
p.000125: fluent in their traditional language. They model respectful relationships and may conduct ceremonies, pass on oral
p.000125: history, and offer guidance in community affairs. Their gifts are normally refined over a lifetime. Thus, Elders who
p.000125: have followed a rigorous path of learning over a long period are highly respected. Younger persons may also gain
p.000125: recognition as gifted knowledge holders.
p.000125: High regard by the community that knows the Elder or other knowledge holder is the most reliable indicator of an
p.000125: individual’s authority. Each community or nation has particular ways of approaching Elders or knowledge holders
p.000125: respectfully. In many First Nations this involves the presentation and acceptance of tobacco to symbolize entering into
p.000125: a relationship. In some communities, feasting or gift-giving is appropriate.
p.000125: Elders are now being recognized in research proposals and grant applications as providers of access to community
p.000125: networks, ethical guidance to researchers, and advice in interpreting findings in the context of traditional knowledge
p.000125: (see Article 9.17). Researchers should seek advice from the community and the Elders regarding the appropriate
p.000125: recognition of the contribution of Elders and knowledge holders, which may include providing honoraria, acknowledging
p.000125: contributions by name or, as directed, withholding the Elder’s identity in reports and publications.
p.000125: Privacy and Confidentiality
p.000125: Article 9.16 Researchers and community partners shall address privacy and confidentiality for communities and
p.000125: individuals early on in the community engagement process. The extent to which limited or full disclosure of personal
p.000125: information related to the research is to be disclosed to community partners shall be addressed in research
p.000125:
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p.000125: agreements where these exist. Researchers shall not disclose personal information to community partners without the
p.000125: participant’s consent, as set out in Article 3.2(i).
p.000125: Application Researchers and community partners should consider early in the design of the research how community
p.000125: codes of research practice fit with provisions for privacy and confidentiality as set out in Chapter 5. Where
p.000125: inconsistencies exist, they should be resolved in advance of starting the research. The research agreement should
p.000125: address how inconsistencies will be addressed if they arise over the course of the conduct of the research project.
p.000125: In First Nations communities, privacy and confidentiality of identifiable personal and community information may be
p.000125: affected by the application of the principles of ownership, control, access and possession (OCAP – see definition in
p.000125: Application of Article 9.8). The First Nations Regional Longitudinal Health Survey adminis- tered by regional
p.000125: First Nations organizations has addressed balancing confidentiality and access by having communities
p.000125: designate a regional organization to hold data, while local authorities make decisions on who can access the data, and
p.000125: under what conditions. In practice, the organization that serves as data steward evaluates requests for information,
p.000125: and its recommendations to community author- ities have considerable influence.
p.000125: Whatever the nature of the research, it shall be designed to include safeguards for participant privacy and measures to
p.000125: protect the confidentiality of any data collected. Small Aboriginal communities are characterized by dense
p.000125: networks of relationships. As a result, coding individual data is often not sufficient to mask identities, even
p.000125: when data are aggregated. Some Aboriginal participants are reluctant to speak to interviewers from their own
p.000125: community because of privacy concerns. Communities themselves have distinguishing characteristics, which in some cases
p.000125: have compromised efforts to disguise the research site, and has led to the stigmatization of entire communities.
p.000125: On the other hand, in some social sciences and humanities research, the significance of information is tied to the
p.000125: identity of the source. In these cases individual attribution, with consent, is appropriate. When
p.000125: individual participants waive anonymity, researchers should ensure that this is documented (see Application of
p.000125: Article 5.1 and Article 9.11). Communities partnering in research may wish to be acknowledged (e.g., in the research
p.000125: report) for their contribution to the research effort.
p.000125: Research undertaken with participants who have suffered traumatic experiences (e.g., former residential school
p.000125: students) poses a risk of re-traumatizing participants. Researchers should anticipate such risks in the research
p.000125: design, and adhere to cultural protocols for determining participant needs and access to trauma counselling.
p.000125:
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p.000127: Privacy protections in research are evolving. Respect for, and accommodation of, First Nations, Inuit and Métis
p.000127: priorities on joint ownership of the products of research and maintaining access to data for community use should guide
p.000127: research practices – with appropriate deference to applicable federal, provincial and territorial privacy
p.000127: legislation.
p.000127: Interpretation and Dissemination of Research Results
p.000127: Article 9.17 Researchers should afford community representatives engaged in collaborative research an opportunity to
p.000127: participate in the interpretation of the data and the review of research findings before the completion of the final
p.000127: report, and before finalizing all relevant publications resulting from the research.
p.000127: Application Where collaborative approaches are followed, researchers should ensure continuing communications with
p.000127: the participating community. Territorial or organizational communities or communities of interest engaged in
p.000127: collaborative research may consider that their review and approval of reports and academic publications is essential to
p.000127: validate findings, correct any cultural inaccuracies, and maintain respect for community knowledge (which may
p.000127: entail limitations on its disclosure). Researchers should integrate suggestions from the community representatives
p.000127: in the publication. If disagreement about interpretation arises between researchers and the community and it cannot be
p.000127: resolved, researchers should either (a) provide the community with an opportunity to make its views known, or (b)
p.000127: accurately report any disagreement about the interpretation of the data in their reports or publications. This should
p.000127: not be construed as giving the community the right to block the publication of findings. Rather, it
p.000127: gives the community the opportunity to contextualize the findings.
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p.000127: dissemination of results (e.g., acknowledgement of co-authorship in research reports or at conferences and
p.000127: seminars).
p.000127: Intellectual Property Related to Research
p.000127: Article 9.18 In collaborative research, intellectual property rights should be discussed by researchers,
p.000127: communities and institutions. The assignment of rights, or the grant of licences and interests in material that may
p.000127: flow from the research, should be specified in a research agreement (as appropriate) before the research is conducted.
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p.000127: Application Researchers, communities and institutions should be aware that all knowledge and information is not
p.000127: necessarily protected under the existing law. Existing intellectual property legislation generally protects works and
p.000127: inventions. Strict criteria are used to define intellectual property rights. Understanding and communicating what
p.000127: qualifies, or does not qualify, as intellectual property for the purposes of research under this Policy is a joint
p.000127: responsibility of communities, researchers and institutions.
p.000127: When undertaking research guided by community engagement, researchers, institutions and communities may need to
p.000127: first address issues regarding access to data, and the use of data for the purpose of the research or in the
p.000127: dissemination of research findings. Regarding access to and use of data, a research agreement may set out any limits on
p.000127: the disclosure of personal or privileged information (subject to applicable legal and regulatory requirements and the
p.000127: guidance in Chapter 5 of this Policy). It might include provisions to review reports and publications
p.000127: regarding the research prior to publication, or limits on the release of, or access to, research results (subject to
p.000127: applicable laws). Provisions for any anticipated secondary use of the information or human biological material,
p.000127: and associated data collected, should also be addressed and documented in this agreement. It may also set out any
p.000127: interests, licences or assignments in copyright flowing from publications about, or based on, the research (see
p.000127: Articles 9.8, 9.11 and 9.16).
p.000127: Some knowledge collected as a result of the research may have commercial applications, and lead to the
p.000127: development of marketable products. With respect to commercialization of results of collaborative research, researchers
p.000127: and communities should discuss and agree on the use, assignment or licensing of any intellectual property (e.g., any
p.000127: patents or copyright), resulting from the marketable product, and document mutual understandings in an agreement. If
p.000127: the proposed research has explicit commercial objectives, or direct or indirect links to the commercial sector,
p.000127: researchers and communities may want to include provisions related to anticipated commercial use in research
p.000127: agreements. These provisions should be clearly communicated to all parties in advance, consistent with the consent
p.000127: process.
p.000127: Researchers should consult the research office of their institution before entering into a research agreement that
p.000127: includes intellectual property provisions. Researchers should also consult the program literature or policies on
p.000127: intellectual property and copyright adopted by the federal research agencies CIHR, NSERC and SSHRC (available on their
p.000127: websites), and seek legal advice where appropriate.
p.000127: Collection of Human Biological Materials Involving Aboriginal Peoples
p.000127: Article 9.19 As part of community engagement, researchers shall address and specify in the research agreement the
p.000127: rights and proprietary interests of individuals and communities, to the extent such exist, in human biological
p.000127: materials and associated data to be collected, stored and used in the course of the research.
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p.000129: Application Canadian law does not provide clear recognition of property rights in human biological
p.000129: materials. Researchers should be aware, however, that Aboriginal people and communities may seek to maintain control
p.000129: over, and access to, data and human biological materials collected for research. This is in accordance with Aboriginal
p.000129: world views about “full embodiment,” in which every part and product of the human body is sacred and cannot be
p.000129: alienated. Consistent with Articles 9.8 and
p.000129: 9.11 and Chapter 12, researchers and communities should address and specify in the research agreement:
p.000129: • the objectives for collection, use and storage of human biological materials;
p.000129: • the roles and responsibilities regarding custodianship of the data and the human biological materials; and
p.000129: • any future use of these human biological materials and associated data, including material transfer
p.000129: agreements to third parties, and any subsequent requirements for community engagement.
p.000129: Researchers must seek consent, in accordance with Articles 12.1 and 12.2, from individuals who are invited to donate
p.000129: their biological materials.
p.000129: Secondary Use of Information or Human Biological Materials Identifiable as Originating from Aboriginal Communities or
p.000129: Peoples
p.000129: Ongoing sensitivity about secondary use of data collected for approved purposes arises from experiences with
p.000129: misrepresentation of Aboriginal peoples; use of data or human biological materials without appropriate
p.000129: engagement with the source community or consent of participants; and lack of reporting to communities on research
p.000129: outcomes. For example, members of Nuu-chah- nulth communities in British Columbia provided blood samples for research
p.000129: on rheumatic disease. They vigorously protested the use of their blood components for subsequent unauthorized genetic
p.000129: research. In addition, there are fears in First Nations communities that access to health data for purposes other than
p.000129: treatment will facilitate unauthorized government surveillance.
p.000129: When seeking to undertake research involving secondary use of data identifiable as originating from a specific
p.000129: Aboriginal community or segment of the Aboriginal community at large, researchers shall, through community
p.000129: engagement as appropriate, address any potential inadvertent identification of communities, or misuse of traditional
p.000129: knowledge. Requirements regarding the participant’s consent for secondary use of identifiable information are addressed
p.000129: in Articles 9.20 and 9.21.
p.000129: Article 9.20 Secondary use of data and human biological material identifiable as originating from an Aboriginal
p.000129: community or peoples is subject to REB review.
p.000129: Researchers shall engage the community from which the data or human biological materials and associated identifiable
p.000129: information originate, prior to initiating secondary use where:
p.000129:
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p.000129:
p.000129: (a) secondary use has not been addressed in a research agreement and has not been authorized by the participants in
p.000129: their original individual consent; or
p.000129: (b) there is no research agreement; and
p.000129: (c) the data are not publicly available or legally accessible.
p.000129: Individual consent for the secondary use of identifiable information is required unless the REB agrees that either
p.000129: Articles 5.5 or 5.6, or Articles 12.3 or 12.4 may apply.
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p.000129: New consent from individuals for secondary use is not required where the proposed secondary use is authorized by the
p.000129: REB in accordance with this Policy.
p.000129: Article 9.21 Where research relies only on publicly available information, or on legally accessible
p.000129: information as defined in Article 2.2, community engagement is not required. Where the information can be identified as
p.000129: originating from a specific community or a segment of the Aboriginal community at large, seeking culturally informed
p.000129: advice may assist in identifying risks and potential benefits for the source community.
p.000129: Application Research based only on publicly available information or legally accessible information as
p.000129: defined by this Policy, does not involve the collection of data from communities directly, or from living persons. As
p.000129: indicated in Chapter 2, REB review for this type of research is not required. Community engagement is not required.
p.000129: Examples are historical or genealogical research or statistical analysis.
p.000129: In these cases, researchers may not have any direct relationship with communities but their findings may, nevertheless,
p.000129: have an impact on the identity or heritage of persons or communities. In order to minimize any harm, researchers should
p.000129: seek culturally informed advice before the use of such data to determine if harms may result and if other
p.000129: considerations, such as sharing of the research results, should be explored with the original source community (see
p.000129: Article 9.15).
p.000129: Where access to publicly available information or legally accessible information leads to new research initiatives to
p.000129: collect additional information from identified communities or individuals, REB review is required. The provisions set
p.000129: out in Article 5.6 apply for new initiatives of this kind.
p.000129: Article 9.22 REB review is required where the researcher seeks data linkage of two or more anonymous datasets or
p.000129: data associated with human biological materials and there
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p.000131: is a reasonable prospect that this could generate information identifiable as originating from a specific
p.000131: Aboriginal community or a segment of the Aboriginal community at large.
p.000131: Application The REB may determine that community engagement is required to seek guidance on secondary use. Articles
p.000131: 5.5 and 5.6 or Articles 12.3 and 12.4 may apply.
p.000131: Consistent with Article 2.4, REB review is not required for research involving only anonymous datasets or anonymous
p.000131: human biological materials, and associated data, that cannot be identified as originating from a specific Aboriginal
p.000131: community or a segment of the Aboriginal community at large. Community engagement is not possible given that the data
p.000131: or human biological materials cannot be linked to a specific Aboriginal community or specific individuals. Where the
p.000131: researcher seeks data linkage of two or more anonymous sets of information or human biological materials and there is a
p.000131: reasonable prospect that this could generate identifiable information, then REB review is required.
p.000131:
p.000131: Endnotes
p.000131:
p.000131:
p.000131: 1 Indian peoples commonly identify themselves as “First Nations.” First Nation: A term that came into common usage in
p.000131: the 1970s to replace the word “Indian,” which some people found offensive. Although the term First Nation is widely
p.000131: used, no legal definition of it exists. Among its uses, the term “First Nations peoples” refers to the Indian peoples
p.000131: in Canada, both Status and non-Status. Some Indian peoples have also adopted the term “First Nation” to replace the
p.000131: word “band” in the name of their community. See Indian and Northern Affairs Canada, Terminology, available at www.ainc-
p.000131: inac.gc.ca/ap/tln-eng.asp.
p.000131: 2 www.nserc-crsng.gc.ca/NSERC-CRSNG/Policies-Politiques/MOURoles-ProtocolRoles/index_eng.asp
p.000131: 3 Constitution Act, 1982, s. 35. http://laws.justice.gc.ca/en/const/9.html#anchorsc:7-bo-ga:l_II
p.000131: 4 www.wipce2008.com/enews/pdf/wipce_fact_sheet_21-10-07.pdf
p.000131:
p.000131: References
p.000131:
p.000131:
p.000131: • Canadian Institutes of Health Research. CIHR Guidelines for Health Research Involving Aboriginal People. May
p.000131: 2007. www.cihr-irsc.gc.ca/e/29134.html
p.000131: • ———. CIHR Best Practices for Protecting Privacy in Health Research. September 2005.
p.000131: www.cihr-irsc.gc.ca/e/29072.html
p.000131: • First Nations Centre. OCAP: Ownership, Control, Access and Possession. Sanctioned by the First Nations
p.000131: Information Governance Committee, Assembly of First Nations. Ottawa: National Aboriginal Health Organization
p.000131: www.naho.ca/english/pub_research.php
p.000131: • First Nations Regional Longitudinal Health Survey (RHS). www.rhs-ers.ca/english
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: 132 TCPS 2
p.000131:
p.000131: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000131:
p.000131: • Interagency Advisory Panel on Research Ethics. Aboriginal Research Ethics Initiative. “Issues and Options for
p.000131: Revisions to the Tri-Council Policy Statement: Ethical Conduct of Research Involving Humans (TCPS): Section 6: Research
p.000131: Involving Aboriginal Peoples.” February 2008.
p.000131: www.pre.ethics.gc.ca/eng/archives/policy-politique/reports-rapports/riap-rapa/
p.000131: • Inuit Tapiriit Kanatami (ITK) and Nunavut Research Institute (NRI). Negotiating Research Relationships with Inuit
p.000131: Communities: A Guide for Researchers. Edited by Scot Nickels, Jamal Shirley and Gita Laidler. ITK and NRI: Ottawa and
p.000131: Iqaluit. www.itk.ca/publications/negotiating-research-relationships-inuit-communities-guide- researchers
p.000131: • Nipingit: National Inuit Committee on Ethics and Research, a joint program of the Inuit Tuttarvingat the National
p.000131: Aboriginal Health Organization and Inuit Tapiriit Kanatami, Research and Research Ethics Fact Sheets.
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p.000135: data and discuss the expectations of participants (see Articles 3.2 and 5.2).
p.000135: (f) Research Goals and Objectives: The aims of qualitative research are very diverse, both within and across
p.000135: disciplines. The intended goals of qualitative projects may include “giving voice” to a particular population, engaging
p.000135: in research that is critical of settings and systems, or the power of those being studied, affecting change in a
p.000135: particular social environment, or exploring previously understudied phenomena to develop new theoretical approaches to
p.000135: research.
p.000135: (g) Dynamic, Negotiated and Ongoing Consent Process: Entry into a particular setting for research purposes sometimes
p.000135: requires negotiation with the population of interest; sometimes the researcher cannot ascertain the process in
p.000135: advance of the research, in part because the relevant contexts within which the research occurs evolve over time.
p.000135:
p.000135:
p.000135:
p.000135:
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p.000137:
p.000137: In some cases, participants hold equal or greater power in the researcher-participant rela- tionship, such as in
p.000137: community-based and/or organizational research when a collaborative process is used to define and design the research
p.000137: project and questions, or where partici- pants are public figures or hold other positions of power (e.g., research
p.000137: involving economic, social, political or cultural elites). In other cases, researchers themselves may hold greater
p.000137: power when access to prospective participant populations is gained through gatekeepers with whom the researcher has
p.000137: established a relationship (e.g., when a researcher engages with the police to do research in relation to a problem
p.000137: population, or when researchers en- gage with prison authorities to do research with offenders).
p.000137: (h) Research Partnerships: Access to particular settings and populations is sometimes developed over time, and
p.000137: the relationships that are formed may well exist outside the research setting per se, which sometimes makes it
p.000137: difficult to determine exactly where the “research” relationship begins and ends. In many cases, despite
p.000137: in-depth, advance preparation, a researcher may not know until the actual data collecting starts just where the search
p.000137: will lead. Indeed, the emergent nature of many qualitative studies makes the achievement of rapport with participants
p.000137: and feelings of interpersonal trust crucial to the generation of questions considered important or interesting by both
p.000137: parties, and to the collection of dependable data. Research often becomes a collaborative process negotiated between
p.000137: the participant(s) and the researcher, requiring considerable time spent initially simply figuring out the focus of the
p.000137: research.
p.000137: In certain cases, contacts between researchers and participants can extend over a lifetime, and these individuals may
p.000137: engage in a variety of relationships over and above their specific “research” relationship.
p.000137: (i) Research Results: Generalizability of the results to other contexts and the representative- ness of the sample may
p.000137: or may not be a concern in qualitative research. Transferability of results from one setting to another is often viewed
p.000137: as more of a theoretical issue than a procedural or a sampling issue.
p.000137:
p.000137: B. Research Ethics Review of Qualitative Research
p.000137: This section provides guidance on issues particularly germane to REB review of research employing
p.000137: qualitative methods. Qualitative research is also subject to the general guidelines that are applicable to research
p.000137: involving humans. The requirement for consent and the protection of privacy and confidentiality do not change with the
p.000137: nature of the research.
p.000137: Qualitative research may pose special ethical issues around gaining access, building rapport, using data and
p.000137: publishing results. Researchers and REBs should consider issues of consent, confidentiality and privacy, and
p.000137: relationships between researchers and participants in the design, review and conduct of the research. Some of these may
p.000137: be identified in the design phase. Others will arise during the research itself, which will require the exercise of
p.000137: discretion, sound judgment and flexibility commensurate with the level of risk and potential benefit arising from the
p.000137: research, and considering the welfare of the participants, individually or collectively.
p.000137:
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p.000137:
p.000137: Timing of the REB Review
p.000137: Article 10.1 Researchers shall submit their research proposals, including proposals for pilot studies, for REB
p.000137: review and approval of its ethical acceptability prior to the start of recruitment of participants, or access to data.
p.000137: Subject to the exceptions in Article 10.5, REB review is not required for the initial exploratory phase (often
p.000137: involving contact with individuals or communities) intended to discuss the feasibility of the research, establish
p.000137: research partnerships, or the design of a research proposal (see Article 6.11).
p.000137: Application It is sometimes difficult to ascertain the beginning and end of a qualitative research project. Access
p.000137: to particular settings and populations often develops over time, and it is not unusual for researchers to be
p.000137: passive observers, or simply passively interested in a setting for some time, before any formal effort is made to
p.000137: establish a “research” relationship. Preliminary activities may include note taking, diary writing and observation long
p.000137: before the researcher formalizes a research project. These types of preliminary activities are not subject to REB
p.000137: review (see Article 6.11). However, if researchers later wish to use material from this phase, they shall say so in
p.000137: their research proposal, and include any plan to seek consent from those interviewed in the exploratory phase to use
p.000137: their remarks.
p.000137: Researchers need to have the opportunity to engage in preliminary visits and dialogue to explore possible
p.000137: research relationships, and to define research collaborations with particular settings or communities. Activities
p.000137: may include, but are not limited to, determining research questions, methods, targeted sample and sample size, and
p.000137: addressing community-based concerns in the project design and data collection. REBs should be aware that dialogue
p.000137: between researchers and communities at the outset, and prior to formal REB review, is an integral component of the
p.000137: research design. Researchers may need to consult the REB informally when ethics issues arise prior to the data
p.000137: collection, or inform the REB of such issues over the course of the research.
p.000137: Qualitative research approaches involving a community, group or population of interest (e.g., marginalized or
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p.000141: means by which those participants may give permission to be identified. REBs shall ensure that the proposal contains
p.000141: measures to protect the privacy of the individual in accordance with the law.
p.000141: Researchers and REBs should consult Chapters 3 and 5 for additional details and considerations regarding consent, and
p.000141: privacy and confidentiality.
p.000141: For observational research in which consent is not sought, researchers shall demonstrate to the REB that
p.000141: necessary precautions and measures have been taken to address privacy and confidentiality issues.
p.000141: Because the knowledge that one is being observed can be expected to influence behaviour, research involving
p.000141: non-participant or covert observation generally requires that the participants not know that they are being
p.000141: observed for research purposes. Typically the researcher has no direct interaction with the individuals being observed
p.000141: and therefore their consent is not sought. Covert observation of queuing behaviours in shopping malls is one example of
p.000141: a study where the research could not be completed if shoppers knew that they were being observed. Some forms of
p.000141: qualitative research seek to observe and study criminal behaviours, violent groups, or groups with restricted
p.000141: membership or access using covert participant observation. For example, some social science research that critically
p.000141: probes the inner workings of criminal organizations might never be conducted if the participants know in
p.000141: advance that they are being observed. Other observational studies may be anonymous but involve intervention by the
p.000141: researcher (e.g., studying the propensity of bystanders to help in an emergency normally requires a staged emergency).
p.000141: These methodological approaches may require the researcher seeking an exception to the general requirement for consent.
p.000141:
p.000141:
p.000141:
p.000141:
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p.000141:
p.000141: Where no personal information is collected, consent is not required. Where personal information will be collected,
p.000141: researchers should explain whether the need for such covert research justifies an exception to the general
p.000141: requirement for seeking consent, and REBs should exercise their judgment taking into consideration the methodological
p.000141: requirements (see Article 3.7). Researchers and REBs shall take the necessary steps to ensure that the privacy of the
p.000141: individual is protected in accordance with the law in the absence of consent. Where no consent is sought, researchers
...
p.000143: followed in data collection. Final versions should be submitted as soon as they become available. REBs should not
p.000143: require researchers to provide them with a full questionnaire schedule in
p.000143:
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p.000143: Chapter 10 – Qualitative Research
p.000143:
p.000143: advance of data collection. Rather, REBs should ensure that the data collection is conducted according to
p.000143: methodological requirements, and acknowledge that questionnaires or interview guides may change to adapt to emerging
p.000143: data or circumstances in the field.
p.000143: In emergent design, some resulting changes to the research design will not merit requiring additional REB review, as
p.000143: they are not necessarily significant changes to the approved research. Consistent with Article 6.15, where changes of
p.000143: data collection procedures would represent a change in the level of the risk that may affect the welfare of the
p.000143: participants, researchers shall seek approval from the REB prior to implementing such changes. Additional REB review
p.000143: and approval may be required (see Chapter 2 and Articles 6.14 and 6.15).
p.000143:
p.000143: References
p.000143:
p.000143:
p.000143: • Canadian Institutes for Health Research. CIHR Best Practices for Protecting Privacy in Health Research. September
p.000143: 2005. www.cihr-irsc.gc.ca/e/29072.html
p.000143: • Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social
p.000143: Sciences and Humanities Research Council of Canada, Access to Research Results: Guiding Principles.
p.000143: www.science.gc.ca/default.asp?Lang=En&n=9990CB6B-1
p.000143: • Canadian Institutes for Health Research, Natural Sciences and Engineering Research Council of Canada, and Social
p.000143: Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: Integrity in Research and
p.000143: Scholarship.
p.000143: www.nserc-crsng.gc.ca/NSERC-CRSNG/Policies-Politiques/tpsintegrity-picintegritie_eng.asp
p.000143: • National Health and Medical Research Council (Australia), Australian Research Council and Australian
p.000143: Vice-Chancellors’ Committee. National Statement on Ethical Conduct in Human Research. 2007.
p.000143: www.nhmrc.gov.au/PUBLICATIONS/synopses/e72syn.htm
p.000143: • Social Sciences and Humanities Research Council of Canada. SSHRC Research Data Archiving Policy.
p.000143: www.sshrc-crsh.gc.ca/site/apply-demande/policies-politiques/edata- donnees_electroniques-eng.aspx
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
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p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: Introduction
p.000145: Chapter 11
p.000145: CLINICAL TRIALS
p.000145:
p.000145: This chapter focuses on the ethical issues involved in the design, review and conduct of clinical trials (as defined
p.000145: below). In particular, it addresses clinical trial design, therapeutic misconception, research-attributable risk, and
p.000145: other issues that may be unique to clinical trials. As clinical trials are, perhaps, the most regulated type of
...
p.000149: drug is initially given to a small number of participants and that dosing is increased in clearly defined
p.000149: increments only after participants’ responses to the initial dose is known. Recruitment and consent
p.000149: procedures shall ensure that participants are aware of the untested nature of the therapy and that participants do not
p.000149: accept, because of the incentives being offered, risks they would otherwise refuse.
p.000149: Phase II
p.000149: Phase II or combined phase I/II clinical trials raise particular ethical concerns, because they are often conducted
p.000149: with populations whose therapeutic options have been exhausted. Examples include patients with cancer that is incurable
p.000149: by standard therapies and HIV/AIDS, or people with conditions that cause them acute or chronic pain. These
p.000149: circumstances may affect the perceptions of patients and their families as to the balance between the risks and
p.000149: potential benefits of the trial and thus may affect their decision whether to participate. Additionally,
p.000149: because participants in phase II trials may include patients who are unwell and frequently not working, the REB should
p.000149: ensure incentives for participation is not coercive, and patients do not accept risks they would otherwise
p.000149: refuse because of the incentives being offered. Researchers should be encouraged to consult with the REB at an early
p.000149: stage about any recruiting, consent or safety issues that arise.
p.000149: During the course of a phase II clinical trial, patients will have access to a new drug that may be efficacious
p.000149: (provide clinical benefit). Researchers shall: a) as part of the consent process, provide details on access to
p.000149: the new drug upon trial completion; and b) make reasonable efforts to secure continued access to the drug following
p.000149: the phase II trial, for those patients for whom the drugs appear to be efficacious.
p.000149: Phase III
p.000149: The REB should carefully examine phase III clinical trials to ensure that the care of patient-participants is not
p.000149: compromised in the random assignment to any arm of the trial (including the placebo arm – see Article 11.2).
p.000149: Researchers should also provide a plan for interim analysis of data, early unblinding of clinicians and/or patients,
p.000149: and/or ending the trial if the drug should prove effective or harmful. The REB should evaluate such plans with due
p.000149: consideration for the welfare of the participants and the group which is the focus of the research (see Article 3.2
p.000149: [l]).
p.000149: Researchers and the REB should also address the issue of continuing access to the experimental therapy after the trial
p.000149: closes. If the treatment benefits participants
p.000149:
p.000149:
p.000149:
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p.000151:
p.000151: and is safe, the proposal should state whether it will continue to be provided and under what conditions. REBs should
p.000151: be concerned about what provisions are possible to ensure that participants continue to receive adequate treatment.
p.000151: Phase IV
p.000151: Phase IV trials can be valuable for assessing the long-term safety and effectiveness of marketed drugs and devices.
p.000151: Earlier-stage trials are of limited duration, and subsequent research can identify side effects, toxicities, drug
p.000151: interactions and overall tolerance that may only emerge over time. However, in some cases, phase IV trials may be
p.000151: designed to serve primarily as marketing initiatives to encourage the prescription and continued use of an approved
p.000151: drug. For example, a clinician may be paid a per capita fee by a sponsor to collect data on the side effects and
p.000151: acceptance by patients of a drug being marketed by that drug’s sponsor. REBs should carefully consider the financial
p.000151: terms between sponsors and investigators associated with these trials as they may create problems such as inappropriate
p.000151: prescription practices, billing practices and/or inappropriate utilization of public resources (e.g., diagnostic
p.000151: services and medical imaging). Researchers and REBs must ensure that trials are undertaken for a bona fide scientific
...
p.000163: (see Article 7.4).
p.000163:
p.000163: E. Analysis and Dissemination of Clinical Trial Outcomes
p.000163: The rights of sponsors with respect to the analysis of data, interpretation of results and publication of findings, and
p.000163: ownership thereof, are typically described in sponsor-researcher contracts (often referred to as clinical trial
p.000163: agreements), which are reviewed by the institution. These contracts may seek to place restrictions on the publication
p.000163: of findings, either directly or through provisions that seek to protect, in favour of the sponsor, the intellectual
p.000163: property of research procedures, data or other information. It is the responsibility of the institution to ensure that
p.000163: these contracts are in compliance with the guidance of this Policy, and in particular Article 11.12.
p.000163: Article 11.12 With respect to research findings:
p.000163: (a) Institutions and REBs should take reasonable measures to ensure that sponsors, researchers and institutions
p.000163: publish or otherwise disseminate the analysis of
p.000163:
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p.000163:
p.000163: data and interpretation of clinical trial results in a timely manner without undue restriction.
p.000163: (b) Any prohibition or undue limitation on the publication or dissemination of scientific findings from clinical trials
p.000163: is ethically unacceptable.
p.000163: (c) Institutions should develop reasonable written policies regarding acceptable and unacceptable clauses in
p.000163: clinical trial research contracts relating to confidentiality, publication and access to data.
p.000163: Application To justify the involvement of participants, and the risks and other burdens they are asked to bear,
p.000163: research must be valuable. That is, it must have a reasonable likelihood of promoting social good. If
p.000163: research findings and the research materials and research data they are based upon, are not disseminated (e.g.,
p.000163: published in a peer-reviewed journal, added to a publicly available clinical trials database) within a reasonable
p.000163: time, their value may be diminished or lost, betraying the contributions and sacrifices of participants. For
p.000163: this reason, and based on respect for participant expectations and protection of the public good, researchers and
p.000163: institutions have an ethical responsibility to make reasonable efforts to publicly disseminate the findings of clinical
p.000163: trials in a timely manner by publications and by the inclusion of raw data and results in appropriate databases. In
p.000163: publications, they have the obligation to report trial details (for example, method, all planned outcomes, and harms
p.000163: as defined by the Consolidated Standards of Reporting Trials4).
p.000163: However, negative findings of research are not always published or otherwise disseminated. Clinical trial registries do
p.000163: not currently require dissemination of findings. Failing to publish negative findings could lead to publication bias
p.000163: and thus contribute to a series of risks, including misinformed clinical decision making based on incomplete or skewed
p.000163: data, inappropriate and potentially harmful clinical practices and injury to health, needless and wasteful duplication
p.000163: of research with associated risks to participants, fraud or deception in the clinical trials process, and erosion of
p.000163: public trust and accountability in research.
p.000163: Although it is beyond the scope of the Policy to provide guidance for journal editors and publishers, both have ethical
p.000163: obligations with regard to the publication of the findings of research. Both negative and positive findings
p.000163: should be published. Sources of funding, any restrictions regarding public disclosure of trial data, institutional
p.000163: affiliations and conflicts of interest should be declared in publications.
p.000163: Institutions and REBs should require the satisfactory amendment or removal of any confidentiality clauses or
p.000163: publication restrictions that unduly limit either the content of the scientific information that may be disseminated or
p.000163: the timing of dissemination. Contracts should also ensure that principal investigators have the
p.000163:
p.000163:
p.000163:
p.000163:
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p.000165:
p.000165: necessary access to original trial data, and the opportunity to analyze them, to ensure that they can report trial
p.000165: findings fairly and accurately, particularly with respect to both efficacy and safety.
p.000165: Institutional and REB policies should ensure that sponsors’ legitimate interests are reasonably balanced against the
p.000165: researcher’s ethical and legal obligations to participants, and to the scientific and public good to disseminate
p.000165: data and research findings (see Chapter 7 with respect to Conflicts of Interest). It shall be understood that the
p.000165: welfare of participants takes precedence over the interests of both researchers and sponsors.
p.000165: Such policies should require that clinical trial research contracts be examined to ensure that contractual provisions
p.000165: comply with institutional policy standards. They should do all of the following:
p.000165: 1) require that confidentiality and publication clauses be submitted to a respon- sible authority (e.g., the REB or
p.000165: research administration) for a determination of their consistency with the policy;
p.000165: 2) require that any ethical concerns arising in the review be referred to the REB as an integral part of the
p.000165: research ethics review process;
p.000165: 3) provide that any proposed restrictions on publication include an ethically acceptable justification;
p.000165: 4) provide that all confidentiality and publication clauses:
p.000165: (a) be consistent with the researcher’s duty to share new information from clinical trials with REBs and trial
p.000165: participants in a timely manner (Section D);
p.000165: (b) be reasonable in terms of any limitations or restrictions on the publication or other dissemination or
p.000165: communication of information; and
p.000165: (c) permit researchers to access all trial data.
p.000165:
p.000165: Review of ethical aspects of researcher-sponsor contracts should be undertaken by an REB, or by or under the auspices
p.000165: of another competent institutional authority as an integral part of the research ethics review process. If done under
p.000165: the latter process, the review of contracts should be conducted in a manner that: (1) conforms to the special ethical
p.000165: duties, mandate and purposes of REB review; and (2) consults with the REB when necessary.
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
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p.000165: 166 TCPS 2
p.000165:
p.000165: Chapter 11 – Clinical Trials
p.000165:
p.000165: In the review process, the onus to justify restrictions on dissemination or access to data should lie with the one
p.000165: seeking such restriction, usually the researcher or sponsor. The reasonableness of restrictions on either the content
p.000165: or timing of dissemination should be measured against the written institutional policies. For example, some existing
p.000165: institutional policies deem unacceptable any publication restrictions that exceed a time limit of three to six months
p.000165: after the close of the trial. Such policies should also address restrictions on the dissemination of
p.000165: particular kinds of information, such as information that may be considered proprietary or trade secrets.
p.000165: Restrictions on information that participants would reasonably consider relevant to their welfare (see Articles 11.7
p.000165: and 11.8), or that are required to give appropriate context to a manuscript or other publication, are seldom, if ever,
p.000165: justified.
p.000165:
p.000165:
p.000165: Endnotes
p.000165:
p.000165:
p.000165: 1 These conditions are drawn from the recommendations of the Final Report of the National Placebo Working Committee on
p.000165: the Appropriate Use of Placebos in Clinical Trials in Canada (July 2004), with minor amendments approved by the
p.000165: Canadian Institutes of Health Research (CIHR) Standing Committee on Ethics. www.cihr-irsc.gc.ca/e/25139.html
p.000165: 2 World Health Organizations standards, International Clinical Trials Registry Platform. www.who.int/ictrp/en
p.000165: 3 International Committee of Medical Journal Editors, Sponsorship, Authorship, and Accountability
p.000165: (August 2007). www.icmje.org/update_sponsor.html
p.000165: 4 CONSORT Statement: www.consort-statement.org/consort-statement (accessed April 19, 2010).
p.000165:
p.000165: References
p.000165:
p.000165:
p.000165: • Canada. Food and Drugs Act. Natural Health Products Regulations, Part 4: Clinical Trials Involving Human Subjects
p.000165: (SOR/2003-196) 5 June 2003. gazette.gc.ca/archives/p2/2003/2003-06-18/html/sor-dors196-eng.html
p.000165: • Canadian Institutes of Health Research. “Policy on Access to Research Outputs.” September 2007.
p.000165: www.cihr-irsc.gc.ca/e/34846.html
p.000165: • Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social
p.000165: Sciences and Humanities Research Council of Canada, Access to Research Results: Guiding Principles.
p.000165: www.science.gc.ca/default.asp?Lang=En&n=9990CB6B-1
p.000165: • Consolidated Standards of Reporting Trials: CONSORT Statement, and Explanation and Elaboration document.
p.000165: www.consort-statement.org
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165: TCPS 2
p.000165:
p.000167: 167
p.000167:
p.000167: Chapter 11 – Clinical Trials
p.000167:
p.000167: • Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to
p.000167: the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. 1997.
p.000167: http://conventions.coe.int/Treaty/EN/Treaties/Html/164.htm
p.000167: • Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for
p.000167: Biomedical Research Involving Human Subjects. Geneva: 2002. www.cioms.ch/publications/layout_guide2002.pdf
p.000167: • Health Canada. Therapeutic Products Directorate. Medical Devices Bureau. Guidance documents.
p.000167: www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/index-eng.php
p.000167: • International Conference on Harmonisation. Guidance for Industry: Good Clinical Practice – Consolidated
p.000167: Guidelines, ICH Topic E6: Technical Requirements for the Registration of Pharmaceuticals for Human Use. 1996. Adopted
p.000167: by Health Canada in 1997.
p.000167: www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-eng.php
p.000167: • Ottawa Hospital Research Institute. Ottawa Statement on Trial Registration. http://ottawagroup.ohri.ca
...
p.000167: www.grants.nih.gov/grants/guide/notice-files/not98-084.html
p.000167: • ———. Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials. Released 2000.
p.000167: www.grants.nih.gov/grants/guide/notice-files/not-od-00-038.html
p.000167: • World Medical Association. Declaration of Helsinki – Ethical Principles of Medical Research Involving Human
p.000167: Subjects. 2008. www.wma.net/en/30publications/10policies/b3/index.html
p.000167:
p.000167:
p.000167:
p.000167:
p.000167:
p.000167:
p.000167:
p.000167:
p.000167:
p.000167:
p.000167:
p.000167:
p.000167:
p.000167:
p.000167:
p.000167:
p.000167:
p.000167:
p.000167:
p.000167:
p.000167:
p.000167:
p.000167:
p.000167:
p.000167:
p.000167:
p.000167:
p.000167: 168 TCPS 2
p.000167:
p.000167: Chapter 12
p.000167: HUMAN BIOLOGICAL MATERIALS INCLUDING MATERIALS RELATED TO HUMAN REPRODUCTION
p.000167:
p.000167: Introduction
p.000167: The use of materials originating from human bodies for research contributes greatly to the ad- vancement of knowledge.
p.000167: The sources of these materials can be from patients following diagnostic or therapeutic procedures, autopsy specimens,
p.000167: donations of organs or tissue from living or dead humans, body wastes (including urine, saliva, sweat) or abandoned
p.000167: tissue. Biological materials may also be sought from individuals for use in a specific research project. Once
p.000167: collected, biolog- ical materials may be held in biobanks to serve as a research resource for many years.
p.000167: Ethical considerations raised by research involving human biological materials centre on accept- able access to, and
p.000167: use of, the materials, potential privacy concerns arising from the handling of information derived from such materials,
p.000167: and the special status some individuals and groups accord to the human body and its parts. Because the significance of
p.000167: biological materials varies among in- dividuals and groups, it is important to assess the ethics of research involving
p.000167: such materials with an awareness of and sensitivity to the known values, beliefs and attitudes of those from whom the
p.000167: materials originated.
p.000167:
p.000167: Sections A to D of this chapter provide guidance on research involving human biological materials. For the purposes of
p.000167: this Policy, human biological materials include tissues, organs, blood, plasma, skin, serum, DNA, RNA, proteins, cells,
p.000167: hair, nail clippings, urine, saliva and other body fluids. Section E addresses research involving the subset of
p.000167: biological materials that are related to human reproduction. Section F addresses research involving the subset of human
p.000167: biological materials known as human pluripotent stem cells, animal-human hybrids and chimeras.
p.000167: As noted in Chapter 2, an individual whose data and/or biological materials are used in research becomes a participant.
p.000167: In regard to human biological materials, individuals may become partici- pants by agreeing to provide a biological
p.000167: sample for use in a particular project. Individuals may also choose to donate organs, tissue or their entire body for
p.000167: research that occurs after their death. In this way, they become participants through their donation. Researchers may
p.000167: seek access to human biological materials for secondary use in research and, in accordance with Section C of this
p.000167: chapter, a research ethics board (REB) may waive a requirement for individual consent.
p.000167:
p.000167: A. Types of Human Biological Materials
p.000167: Human biological materials that may reasonably be expected to identify an individual, alone or in combination with
p.000167: other available information, are considered identifiable biological materials (or biological materials that are
p.000167: identifiable) for the purposes of this Policy. The following categories,
p.000167:
p.000167:
p.000167:
p.000167: TCPS 2
p.000169: 169
p.000169:
p.000169: Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction
p.000169:
p.000169: similar to those found in Chapter 5 in regard to categories of information, provide guidance for assessing the extent
p.000169: to which human biological materials could be used to identify an individual:
p.000169: • Identified human biological materials – the materials are labelled with a direct identifier (e.g., name, personal
p.000169: health number). Materials and any associated information are directly traceable back to a specific individual.
p.000169: • Coded human biological materials – direct identifiers are removed from the materials and replaced with a code.
p.000169: Depending on access to the code, it may be possible to re- identify specific individuals (e.g., a principal
p.000169: investigator retains a key that links the coded material with a specific individual if re-linkage is necessary).
p.000169: • Anonymized human biological materials – the materials are irrevocably stripped of direct identifiers, a code is
p.000169: not kept to allow future re-linkage, and risk of re-identification of individuals from remaining indirect identifiers
p.000169: is low or very low.
p.000169: • Anonymous human biological materials – the materials never had identifiers attached to them and risk of
p.000169: identification of individuals is low or very low.
p.000169: Due to continuing technological development in genetics, individuals with access to stored human biological materials
p.000169: are increasingly able to use genetic markers to link a non-identifiable sample with an identified sample. For this
p.000169: reason, genetic analysis has made it more difficult to categorize human biological materials as anonymous or
p.000169: anonymized. The definitions above relate to identification of individuals; however, some research involving
p.000169: human biological materials, especially genetic research, may involve identification of groups, even though the human
p.000169: biological materials are non-identifiable at an individual level. Researchers and REBs should be aware of, and guard
p.000169: against, threats to individual privacy and autonomy that arise from re-identification risks, as well as risks to
p.000169: groups, particularly where sensitive research findings will be linked to specific groups.
p.000169: To maintain confidentiality, it may seem desirable to use anonymized or anonymous human biological materials. However,
p.000169: the scientific requirements of many studies may necessitate use of identifiable human biological materials, to link
p.000169: materials with information about participants, and to avoid using different samples from the same individual. Use of
p.000169: anonymized or anonymous human biological materials has the disadvantage of making it impossible to offer the benefits
p.000169: of research findings to participants and their families, or to alert them to relevant clinical findings. This is
p.000169: particularly significant when research may disclose a previously undiagnosed condition, such as HIV infection or an
p.000169: inherited predisposition to breast cancer, for which potentially effective treatments are available. Use of
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p.000169: (a) consent of the participant who will donate biological materials; or
p.000169: (b) consent of an authorized third party on behalf of a participant who lacks capacity, taking into account any
p.000169: research directive that applies to the participant; or
p.000169: (c) consent of a deceased participant through a donation decision made prior to death, or by an authorized third
p.000169: party.
p.000169: Application Article 12.1 applies prospectively, that is, prior to the collection of human biological materials for
p.000169: research purposes. It applies the general elements of consent in Chapter 3 to the collection and use of human
p.000169: biological materials. During the consent process, a clear distinction should be made between consent to research
p.000169: participation and consent for any clinical procedure or test. In practice, this may mean separate consent information
p.000169: and forms, but in any event the different uses must be clearly explained. Individuals who do not wish to
p.000169: contribute human biological materials for research are free to withhold consent without penalty, and without
p.000169: prejudicing access to any treatment they would otherwise receive. For individuals who lack capacity to consent, the
p.000169: guidance developed in Chapter 3 regarding authorized third parties shall be observed.
p.000169: Where a participant has expressed preferences for future research participation in a research directive before losing
p.000169: capacity, researchers and authorized third parties shall take such directives into account during the consent
p.000169: process. Chapter 3 provides guidance on research directives. REBs and researchers should be aware that provincial
p.000169: human tissue gift laws may provide a legal framework for the donation of tissue upon death.
p.000169:
p.000169: Article 12.2 To seek consent for use of human biological materials in research, researchers shall provide to
p.000169: prospective participants or authorized third parties, applicable information as set out in Article 3.2 as well as
p.000169: the following details:
p.000169: (a) the type and amount of biological materials to be taken;
p.000169:
p.000169:
p.000169:
p.000169:
p.000169:
p.000169: TCPS 2
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p.000171: Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction
p.000171:
p.000171: (b) the manner in which biological materials will be taken, and the safety and invasiveness of the procedures for
p.000171: acquisition;
p.000171: (c) the intended uses of the biological materials, including any commercial use;
p.000171: (d) the measures employed to protect the privacy of and minimize risks to participants;
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p.000173: biological materials) and the nature of their relationship with those individuals. Researchers must also ensure that a
p.000173: plan for follow-up contact complies with applicable privacy legislation; for example, some privacy laws prohibit
p.000173: researchers from contacting individuals unless the custodian of the information has first obtained individuals’
p.000173: consent to be contacted. Whenever possible, it is preferable that re-contact with participants be carried out by the
p.000173: organization or the custodian holding the biological materials. Researchers will need to seek consent from individual
p.000173: participants for any new collection of data or biological materials. Article 3.1 provides further guidance on
p.000173: consent and approaches to recruitment.
p.000173:
p.000173: D. Storage and Banking of Human Biological Materials
p.000173: The collection and retention of human biological materials in biobanks creates an ongoing resource for research.
p.000173: Biobanks vary widely in their characteristics: some are very small, while others hold biological materials from
p.000173: thousands of individuals; they may be disease-specific or contain materials from a wide population base.
p.000173: Different types of human biological materials may be stored in biobanks, such as blood, tumour or tissue samples.
p.000173: Biobanks may include, or be linked with, databases of identifiable or non-identifiable information. Materials held in a
p.000173: biobank may be intended only for use in a specific project, or a biobank may be established to provide access to
p.000173: biological materials for numerous projects over many years. Researchers engaged in multi-site research may seek access
p.000173: to materials held in biobanks in different jurisdictions (see Chapter 8 for additional guidance).
p.000173: Biobanking facilitates research with human biological materials and offers potential benefits to society. Access to
p.000173: stored human biological materials – and associated information about individuals whose materials are banked – can be
p.000173: particularly useful in helping researchers understand diseases that result from complex interactions between our
p.000173: genetic makeup, environmental exposure and lifestyles. Banking of human biological materials may also present risks to
p.000173: individuals whose biological materials and other personal information are stored, accessed, used, retained
p.000173: and disclosed through a biobank. Research involving such materials may also implicate the interests of biological
p.000173: relatives and others with shared genetic characteristics.
p.000173:
p.000173:
p.000173:
p.000173:
p.000173:
p.000173: TCPS 2
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p.000175: Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction
p.000175:
p.000175: Article 12.5 Institutions and researchers that maintain biobanks:
p.000175: (a) shall ensure that they have or use appropriate facilities, equipment, policies and procedures to store human
p.000175: biological materials safely, and in accordance with applicable standards; and
p.000175: (b) shall establish appropriate physical, administrative and technical safeguards to protect human biological materials
p.000175: and any information about participants from unauthorized handling.
p.000175: Application Safe storage of human biological materials is important to maintain their scientific value, and to
p.000175: protect materials and associated information about participants. Procedures for storage and record keeping shall
p.000175: include effective measures to ensure that participants’ identities are protected. Such measures include the security of
p.000175: facilities and effective procedures for data handling, record keeping and regulating access to human
p.000175: biological materials and information. Appropriate governance of biobanks is also important for managing access to
p.000175: and use of stored biological materials. The appropriate governance structure and management of a biobank will vary
p.000175: depending on its size and usage.
p.000175: Organizations that maintain biobanks may have their own policies on privacy of, confidentiality of and access to
p.000175: materials. Researchers should be aware of requirements for compliance with such policies. For example, researchers
p.000175: may be required to apply to the organization for permission to access biological samples, and they may be required to
p.000175: enter into an agreement with the organization that sets out conditions for research access and use of materials in the
p.000175: biobank.
p.000175: Identifiable data derived from human biological materials may be linked to other research or public databases. Such
p.000175: data linking can be a powerful research tool and a valuable resource for monitoring the health of populations,
p.000175: understanding factors influencing disease, and evaluating health services and interventions. However, data linkage also
p.000175: raises separate privacy issues, discussed in Section E of Chapter 5.
p.000175:
p.000175: E. Research Involving Materials Related to Human Reproduction
p.000175: Researchers who conduct research involving human biological materials related to human reproduction shall
p.000175: follow applicable guidance expressed in other chapters of this Policy. This section provides further guidance for
p.000175: research involving embryos, fetuses, fetal tissue, and reproductive materials. For the purposes of this Policy
p.000175: the following definitions apply:3
p.000175: • Embryo means a human organism during the first 56 days of its development following fertilization or creation,
p.000175: excluding any time during which its development has been suspended, and includes any cell derived from such an
p.000175: organism that is used for the purpose of creating a human being.
p.000175:
p.000175:
p.000175:
p.000175:
p.000175: 176 TCPS 2
p.000175:
p.000175: Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction
p.000175:
p.000175: • Fetus means a human organism during the period of its development beginning on the 57th day following fertilization
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p.000183: individual members. Refer to Chapter 3 for further guidance in regard to voluntariness of consent.
p.000183: Researchers who propose to conduct genetic research involving Aboriginal participants or communities, or to
p.000183: use human biological materials that are identifiable as originating from Aboriginal peoples, should refer to
p.000183: Chapter 9 for further guidance.
p.000183:
p.000183:
p.000183:
p.000183: TCPS 2
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p.000185:
p.000185: Chapter 13 – Human Genetic Research
p.000185:
p.000185: F. Genetic Material Banks
p.000185: Article 13.7 (a) Researchers who propose research involving the collection and banking of genetic material shall
p.000185: indicate in their research proposal, and in the information they provide to prospective participants, how they plan to
p.000185: address the associated ethical issues, including confidentiality, privacy, storage, use of the data and results,
p.000185: possibility of commercialization of research findings and withdrawal by participants as well as future contact of
p.000185: participants, families, communities and groups.
p.000185: (b) Researchers who propose research involving the secondary use of previously collected and banked genetic material
p.000185: shall, likewise, indicate in their research proposal how they plan to address associated ethical issues.
p.000185: Application Collection of human biological materials including genetic materials, and their re- tention in biobanks
p.000185: provides an increasingly important research resource. Guidance for research involving human biological materials (see
p.000185: Chapter 12) applies to bank- ing of genetic material. Chapter 12, Section D, provides guidance for the creation of
p.000185: biobanks of genetic material, and Section C addresses access to, and use of, pre- viously collected genetic material.
p.000185: Researchers who intend to bank genetic material shall inform participants of the potential for secondary use. See
p.000185: Chapter 5 for guid- ance regarding secondary use.
p.000185: G. Gene Transfer
p.000185: Guidance set out in Chapter 11 applies to clinical trial research involving gene transfer, and Article
p.000185: 12.9 is applicable to gene transfer in utero. In the context of gene transfer research, researchers and REBs shall pay
p.000185: careful attention to the need to assess safety, minimize risk, and minimize therapeutic misconception (see Chapter 11,
p.000185: Section C). Researchers have obligations to share with participants new information that may be relevant to ongoing
p.000185: consent, and to follow up with former participants to inform them of issues that may affect their welfare.
p.000185:
p.000185: Gene alteration involves the transfer of genes into cells to induce an altered capacity of the cell. Viruses are
p.000185: commonly used vectors (carriers) to introduce the gene into the host genome. Gene alteration is irreversible – the cell
p.000185: and its descendants are forever altered and introduced changes cannot be removed. The possible use of germ line
p.000185: alteration implies changes that could be transmitted to future generations.
p.000185:
p.000185: Gene transfer research that involves alteration of human germ line cells is governed in Canada by the Assisted Human
p.000185: Reproduction Act2 and its regulations. Researchers should be aware of how this law applies to their work, such as the
p.000185: Act’s prohibition on knowingly altering the genome of a cell of a human being, or in vitro embryo, such that the
p.000185: alteration is capable of being transmitted to descendants.
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185: 186 TCPS 2
p.000185:
p.000185: Chapter 13 – Human Genetic Research
p.000185:
p.000185: The special circumstances of gene transfer must be explained to prospective participants (or authorized third parties)
p.000185: during the consent process. This includes providing information about uncertain and potentially latent risks of gene
p.000185: transfer, and any processes for long-term follow-up of participants. Guidance regarding inclusion in research (see
p.000185: Chapter 4) should be followed where gene transfer research involves children, or others who lack capacity to consent
p.000185: for themselves.
p.000185:
p.000185:
p.000185: Endnotes
p.000185:
p.000185:
p.000185: 1 In 2008, the U.S. National Institutes of Health amended its policy on publication of and access to data from
p.000185: genome-wide association studies. See National Institutes of Health, Modifications to Genome-Wide Association Studies
p.000185: (GWAS) Data Access, August 28, 2008, http://grants.nih.gov/grants/gwas/data_sharing_policy_modifications_20080828.pdf
p.000185: 2 Assisted Human Reproduction Act (2004, c. 2). http://laws.justice.gc.ca/eng/A-13.4
p.000185:
p.000185:
p.000185:
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p.000185: TCPS 2
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p.000187:
p.000187:
p.000187:
p.000187: Glossary
p.000187:
p.000187: This glossary is intended to assist readers in their understanding of the Tri-Council Policy Statement: Ethical Conduct
p.000187: for Research Involving Humans (TCPS), also referred to as “the Policy.” Definitions that have been provided in the main
p.000187: text of the Policy are also repeated here. Additional terms are defined in accordance with the purposes of the Policy.
p.000187: For more detailed descriptions of many terms it is best to read them in the context of the chapters in which they
p.000187: appear – consult the Index for the appropriate reference.
p.000187:
p.000187: Aboriginal peoples – Persons of Indian (First Nations), Inuit, or Métis descent, regardless of where they reside and
p.000187: whether or not their names appear on an official register. In the international context, the term comparable to
p.000187: Aboriginal peoples is Indigenous peoples.
p.000187:
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p.000189: collective. A community may be territorial, organizational, or a community of interest.
p.000189:
p.000189: Community-based research – Research conducted at a community site that focuses not only on individuals but on the
p.000189: community itself. Community-based research may be initiated by the community independently or in collaboration with a
p.000189: researcher. See “Collaborative research” and “Participatory research.”
p.000189:
p.000189: Community engagement – A process that establishes an interaction between a researcher (or a research team) and a
p.000189: community with regard to a research project. It signifies the intent of forming a collaborative relationship between
p.000189: researchers and communities, although the degree of collaboration may vary depend- ing on the community context and the
p.000189: nature of the research.
p.000189:
p.000189: Concern for Welfare – A core principle of this Policy that requires researchers and research ethics boards to aim to
p.000189: protect the welfare of participants, and, in some circumstances, to promote that welfare in view of any foreseeable
p.000189: risks associated with the research. See “Risk” and “Welfare.”
p.000189:
p.000189: Confidentiality – An ethical and/or legal responsibility of individuals or organizations to safeguard informa- tion
p.000189: entrusted to them, from unauthorized access, use, disclosure, modification, loss or theft.
p.000189:
p.000189: Conflict of interest – The incompatibility of two or more duties, responsibilities, or interests (personal or
p.000189: professional) of an individual or institution as they relate to the ethical conduct of research, such that one cannot
p.000189: be fulfilled without compromising another.
p.000189:
p.000189: Consent – An indication of agreement by an individual to become a participant in a research project. Throughout this
p.000189: Policy, the term “consent” means “free (also referred to as voluntary), informed and on- going consent.”
p.000189:
p.000189:
p.000189: 190 TCPS 2
p.000189:
p.000189: Glossary
p.000189:
p.000189: Continuing research ethics review (also referred to as “Continuing ethics review”) – Any review of ongoing research
p.000189: conducted by a research ethics board (REB) occurring after the date of initial REB approval and continuing throughout
p.000189: the life of the project to ensure that all stages of a research project are ethically acceptable in accordance with the
p.000189: principles in the Policy.
p.000189:
p.000189: Core principles – The three core principles of the Policy that together express the overarching value of re- spect for
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p.000191: research involving humans.
p.000191:
p.000191: Gene alteration – The transfer of genes into cells to induce an altered capacity of the cell.
p.000191:
p.000191: Genetic counselling – The explanation of the meaning and implication of information revealed in genetic research to a
p.000191: participant by someone with the experience or training to provide the appropriate context and support .
p.000191:
p.000191: Harm – Anything that has a negative effect on participants’ welfare, broadly construed. The nature of the harm may be
p.000191: social, behavioural, psychological, physical or economic. See “Welfare.”
p.000191:
p.000191: Human biological materials – Tissues, organs, blood, plasma, skin, serum, DNA, RNA, proteins, cells, hair, nail
p.000191: clippings, urine, saliva, and other body fluids. The term also includes materials related to human reproduction,
p.000191: including embryos, fetuses, fetal tissues and human reproductive materials.
p.000191: Identified human biological materials – The materials are labelled with a direct identifier (e.g. name, personal health
p.000191: number). Materials and any associated information are directly traceable back to a specific individual.
p.000191: Coded human biological materials – Direct identifiers are removed from the materials and replaced with a code.
p.000191: Depending on access to the code, it may be possible to re-identify specific individuals (e.g. a principal investigator
p.000191: retains a key that links the coded material with a specific individual if re-linkage is necessary).
p.000191: Anonymized human biological materials – The materials are irrevocably stripped of direct iden- tifiers, a code is not
p.000191: kept to allow future re-linkage, and risk of re-identification of individuals from remaining indirect identifiers is
p.000191: low or very low.
p.000191: Anonymous human biological materials – The materials never had identifiers attached to them and risk of identification
p.000191: of individuals is low or very low.
p.000191: Human genetic research – The study of genetic factors responsible for human traits and the interaction of those factors
p.000191: with each other, and with the environment.
p.000191:
p.000191:
p.000191:
p.000191: 192 TCPS 2
p.000191:
p.000191: Glossary
p.000191:
p.000191: Human participant – See “Participant.”
p.000191: Human reproductive materials – A sperm, ovum, or other human cell, or a human gene, including a part of any of them.
p.000191:
p.000191: Identifiable information – Information that may reasonably be expected to identify an individual, alone or in
p.000191: combination with other available information. Also referred to as “personal information.”
p.000191:
p.000191: Directly identifying information – The information identifies a specific individual through direct identifiers (e.g.
p.000191: name, social insurance number, personal health number).
p.000191: Indirectly identifying information – The information can reasonably be expected to identify an individual through a
p.000191: combination of indirect identifiers (e.g. date of birth, place of residence, or unique personal characteristic).
p.000191: Coded information – Direct identifiers are removed from the information and replaced with a code. Depending on access
p.000191: to the code, it may be possible to re-identify specific participants (e.g. the principal investigator retains a list
p.000191: that links the participants’ code names with their actual name so data can be re-linked if necessary).
p.000191: Anonymized information – The information is irrevocably stripped of direct identifiers, a code is not kept to allow
p.000191: future re-linkage, and risk of re-identification of individuals from remaining in- direct identifiers is low or very
p.000191: low.
p.000191: Anonymous information – The information never had identifiers associated with it (e.g. anony- mous surveys) and risk of
p.000191: identification of individuals is low or very low.
p.000191: Impracticable – Incapable of being put into practice due to a degree of hardship or onerousness that jeop- ardizes the
p.000191: conduct of the research; it does not mean mere inconvenience.
p.000191:
p.000191: Incentive – Anything offered to participants, monetary or otherwise, to encourage participation in research.
p.000191:
p.000191: Incidental findings – Unanticipated discoveries made in the course of research that are outside the scope of the
p.000191: research.
p.000191:
p.000191: Indigenous knowledge – See “Traditional knowledge.”
p.000191:
p.000191: Indigenous peoples – See “Aboriginal peoples.”
p.000191:
p.000191: Institutions – The universities, hospitals, colleges, research institutes, centres and other organizations eligible to
p.000191: receive and manage Agency grant funds on behalf of the grant holders and the Agencies.
p.000191:
...
p.000195: Canada. Traditional knowledge is specific to place, usually transmitted orally, and rooted in the experience of
p.000195: multiple generations. It is determined by an Aboriginal community’s land, environment, region, culture, and language.
p.000195: It may also include new knowledge transmitted to subsequent generations.
p.000195:
p.000195: Unanticipated issues – Issues that: occur during the conduct of research; may increase the level of risk to
p.000195: participants or have other ethical implications that may affect participants’ welfare; and were not anticipated by the
p.000195: researcher in the research proposal submitted for research ethics review.
p.000195:
p.000195: Undue influence – The impact of an unequal power relationship on the voluntariness of consent. This may occur when
p.000195: prospective participants are recruited by individuals in a position of authority over them (e.g. doctor/patient,
p.000195: teacher/student, employer/employee). See “Coercion.”
p.000195:
p.000195: Vulnerability – A diminished ability to fully safeguard one’s own interests in the context of a specific research
p.000195: project. This may be caused by limited capacity or limited access to social goods, such as rights, opportunities and
p.000195: power. Individuals or groups may experience vulnerability to different degrees and at different times, depending on
p.000195: their circumstances. See also “Autonomy.”
p.000195:
p.000195: Welfare – The quality of a person’s experience of life in all its aspects. Welfare consists of the impact on
p.000195: individuals and/or groups of factors such as their physical, mental and spiritual health, as well as their physical,
p.000195: economic and social circumstances.
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195: TCPS 2
p.000195:
p.000197: 197
p.000197:
p.000197:
p.000197:
p.000197: Index
p.000197: The Index seeks to direct the reader to meaningful references to key concepts in TCPS 2. Main references to a term are
p.000197: indicated with bold type.
p.000197:
p.000197: The Index is not a record of all occurrences of the listed topics. Readers who wish to check all occurrences of these
p.000197: topics or specific terms may do so through the Adobe search tool available online in the PDF version of the Policy
p.000197: found at www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2- eptc2/Default/.
p.000197:
p.000197: A
p.000197: Aboriginal peoples
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p.000199: When in doubt about the applicability of this Policy to a particular research project, the researcher shall seek the
p.000199: opinion of the REB. The REB makes the final decision on exemption from research ethics review.
p.000199:
p.000199: Research Exempt from REB Review
p.000199: Some research is exempt from REB review where protections are available by other means. This Policy allows the
p.000199: following exemptions from the requirement for REB review, as outlined below.
p.000199: Article 2.2 Research that relies exclusively on publicly available information does not require REB review when:
p.000199: (a) the information is legally accessible to the public and appropriately protected by law; or
p.000199: (b) the information is publicly accessible and there is no reasonable expectation of privacy.
p.000199: Application For the purposes of this Policy, publicly available information is any existing stored documentary
p.000199: material, records or publications, which may or may not include identifiable information. Some types of information are
p.000199: legally accessible to the public in a certain form and for a certain purpose, as specified by law or regulations:
p.000199: registries of deaths, court judgments, or public archives and publicly available statistics (e.g., Statistics Canada
p.000199: public use files), for example. In Canada, all publicly available archives (national, provincial or municipal)
p.000199: have policies governing access to their records. An archival record or database that is subject to restrictions, such
p.000199: as those under access to information and privacy legislation or contractual restrictions imposed by the donor of the
p.000199: records, may also be considered publicly available for the purposes of this Policy.
p.000199: Research that relies exclusively on information that is publicly available, or made accessible through legislation
p.000199: or regulation, does not require REB review. Exemption from REB review for research involving information that is
p.000199: legally accessible to the public is based on the presence of a legally designated custodian/steward who
p.000199: protects its privacy and proprietary interests (e.g., an access to information and privacy coordinator or a guardian of
p.000199: Canadian census data).
p.000199: REB review is also not required where research uses exclusively publicly available information that may contain
p.000199: identifiable information, and for which there is no
p.000199:
p.000199:
p.000199: TCPS 2 17
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
p.000199: reasonable expectation of privacy. For example, identifiable information may be disseminated in the public domain
p.000199: through print or electronic publications; film, audio or digital recordings; press accounts; official publications of
p.000199: private or public institutions; artistic installations, exhibitions or literary events freely open to the public; or
p.000199: publications accessible in public libraries. Research that is non-intrusive, and does not involve direct interaction
p.000199: between the researcher and individuals through the Internet, also does not require REB review. Cyber-material such as
p.000199: documents, records, performances, online archival materials or published third party interviews to which the public is
p.000199: given uncontrolled access on the Internet for which there is no expectation of privacy is considered to be publicly
p.000199: available information.
p.000199: Exemption from REB review is based on the information being accessible in the public domain, and that the individuals
p.000199: to whom the information refers have no reasonable expectation of privacy. Information contained in publicly accessible
p.000199: material may, however, be subject to copyright and/or intellectual property rights protections or dissemination
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p.000199:
p.000199:
p.000199: 30 TCPS 2
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: (d) an assurance that prospective participants:
p.000199: • are under no obligation to participate; are free to withdraw at any time without prejudice to pre-existing
p.000199: entitlements;
p.000199: • will be given, in a timely manner throughout the course of the research project, information that is relevant to
p.000199: their decision to continue or withdraw from participation; and
p.000199: • will be given information on the participant’s right to request the withdrawal of data or human biological
p.000199: materials, including any limitations on the feasibility of that withdrawal;
p.000199: (e) information concerning the possibility of commercialization of research findings, and the presence of any
p.000199: real, potential or perceived conflicts of interest on the part of the researchers, their institutions or the research
p.000199: sponsors;
p.000199: (f) the measures to be undertaken for dissemination of research results and whether participants will be identified
p.000199: directly or indirectly;
p.000199: (g) the identity and contact information of a qualified designated representative who can explain scientific or
p.000199: scholarly aspects of the research to participants;
p.000199: (h) the identity and contact information of the appropriate individual(s) outside the research team whom participants
p.000199: may contact regarding possible ethical issues in the research;
p.000199: (i) an indication of what information will be collected about participants and for what purposes; an indication of who
p.000199: will have access to information collected about the identity of participants, a description of how confidentiality will
p.000199: be protected (see Article 5.2), a description of the anticipated uses of data; and in- formation indicating who may
p.000199: have a duty to disclose information collected, and to whom such disclosures could be made;
p.000199: (j) information about any payments, including incentives for participants, reimbursement for
p.000199: participation-related expenses and compensation for injury;
p.000199: (k) a statement to the effect that, by consenting, participants have not waived any rights to legal recourse in the
p.000199: event of research-related harm; and
p.000199: (l) in clinical trials, information on stopping rules and when researchers may remove participants from trial.
p.000199: For consent to be informed, prospective participants shall be given adequate time and opportunity to assimilate the
p.000199: information provided, pose any questions they may have, and discuss and consider whether they will participate. The
p.000199: time required for this initial phase of the consent process will depend on such factors as the
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 31
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: magnitude and probability of harms, the complexity of the information conveyed, and the setting where the information
p.000199: is given.
p.000199: The key to informed consent is that prospective participants understand the information being conveyed to
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p.000199: harm the participant, the trust relationship between the researcher and the participant, other individuals or groups,
p.000199: and/or the reputation of the research community. Research that probes sensitive topics (e.g., illegal activities)
p.000199: generally depends on strong promises of confiden- tiality to establish trust with participants.
p.000199: The ethical duty of confidentiality applies to information obtained directly from participants, or from other
p.000199: researchers or organizations that have legal, professional or other obligations to maintain confidentiality.
p.000199: The ethical duty of confidentiality must, at times, be balanced against competing ethical considerations or legal or
p.000199: professional requirements that call for disclosure of information obtained or created in a research context. For
p.000199: example, in excep- tional and compelling circumstances, researchers may be subject to obligations to report information
p.000199: to authorities to protect the health, life or safety of a participant or a third party. Researchers are expected to be
p.000199: aware of ethical codes (such as pro- fessional codes of conduct) or laws (e.g., those requiring the reporting of
p.000199: children in need of protection) that may require disclosure of information they obtain in a research context. In other
p.000199: situations, a third party may seek access to information obtained and/or created in confidence in a research context.
p.000199: An access request may seek voluntary disclosure of information, or may seek to compel disclosure through force of law
p.000199: (e.g., by subpoena). Chapter 1, Section C, elaborates on the relationship between research ethics and law.
p.000199: Certain areas of research (such as research involving children at risk of abuse or studies of criminal behaviour) are
p.000199: more likely to put researchers in positions where they may experience tension between the ethical duty of
p.000199: confidentiality and dis- closure to third parties. Researchers shall maintain their promise of confidentiality to
p.000199: participants within the extent permitted by ethical principles and/or law. This may involve resisting requests for
p.000199: access, such as opposing court applications seek- ing disclosure. Researchers’ conduct in such situations should be
p.000199: assessed on a case-by-case basis and guided by consultation with colleagues, any relevant pro- fessional body, the REB
p.000199: and/or legal counsel.
p.000199: In some instances, participants may waive anonymity (e.g., if they wish to be iden- tified for their contributions to
p.000199: the research). Researchers should obtain the consent of these participants, and negotiate agreements with them that
p.000199: specify how they may be identified or recognized for their contribution. Where an individual partic-
p.000199:
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p.000171: require to make an informed decision to donate biological materials for use in research. While all the basic guidelines
p.000171: of Chapter 3 regarding consent apply to research involving human biological materials, some deserve special attention.
p.000171: For example, explaining the potential for commercialization or financial conflict of interest is important, as some
p.000171: research with human biological materials may involve the possibility of significant commercial gain for researchers or
p.000171: sponsors. The process for requesting withdrawal of human biological materials from research shall also be
p.000171: clearly explained, along with an explanation of the conditions under which researchers would not be able to remove a
p.000171: participant’s data from the project. For instance, where participants request the withdrawal of their biological
p.000171: materials, information already derived from the materials and aggregated into findings cannot be withdrawn.
p.000171: Anonymization of human biological materials may also preclude subsequent withdrawal. Chapter 3 provides further
p.000171: guidance on handling incidental findings.
p.000171:
p.000171: C. Consent and Secondary Use of Identifiable Human Biological Materials for Research Purposes
p.000171: Chapter 5 provides detailed guidance on secondary use of information for research purposes (in particular, see Articles
p.000171: 5.5 and 5.6). The following section adapts the provisions in Chapter 5 to the specific context of research
p.000171: involving secondary use of human biological materials. As researchers who seek to use human biological materials
p.000171: for research will often also seek access to information about individuals from whom the materials originate, this
p.000171: section and Chapter 5 should be read together.
p.000171: Secondary use refers to the use in research of human biological materials originally collected for a purpose other than
p.000171: the current research purpose. A researcher may seek to use human biological
p.000171:
p.000171: 172 TCPS 2
p.000171:
p.000171: Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction
p.000171:
p.000171: materials left over from a diagnostic examination or surgical procedure, or materials that were collected for an
p.000171: earlier project. Reasons to conduct secondary analyses include: avoidance of duplication in primary collection and
p.000171: the associated reduction of burdens on participants; corroboration or criticism of the conclusions of the
p.000171: original research; comparison of change in a research sample over time; application of new tests of hypotheses that
p.000171: were not available at the time of original collection; and confirmation that the data or materials are authentic.
p.000171: Privacy concerns and questions about the need to seek consent arise, however, when human biological materials provided
p.000171: for secondary use in research can be linked to individuals, and when the possibility exists that individuals can be
p.000171: identified in published reports, or through linkage of human biological materials with other data.
p.000171: Article 12.3 Researchers who have not obtained consent from participants for secondary use of identifiable human
p.000171: biological materials shall only use such material for these purposes if the REB is satisfied that:
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p.000199: participate. Coercion would negate the voluntariness of a decision to participate, or to remain, in a research project.
p.000199: Incentives
p.000199: Incentives are anything offered to participants, monetary or otherwise, for par- ticipation in research (incentives
p.000199: differ from reimbursements and compensation for injury, which are discussed in Article 3.2[j]). Because incentives are
p.000199: used to encourage participation in a research project, they are an important consid- eration in assessing
p.000199: voluntariness. Where incentives are offered to participants, they should not be so large or attractive as to encourage
p.000199: reckless disregard of risks. This is a particular consideration in the case of healthy volunteers for the early phases
p.000199: of clinical trials, as discussed in Article 11.1. The offer of incen- tives in some contexts may be perceived by
p.000199: prospective participants as a way for them to gain favour or improve their situation. This may amount to undue
p.000199: inducement and thus negate the voluntariness of participants’ consent.
p.000199: This Policy neither recommends nor discourages the use of incentives. The onus is on the researcher to justify to the
p.000199: REB the use of a particular model and the level of incentives. In considering the possibility of undue influence in re-
p.000199: search involving financial or other incentives, researchers and REBs should be sensitive to issues such as the economic
p.000199: circumstances of those in the pool of prospective participants, the age and capacity of participants, the customs and
p.000199: practices of the community, and the magnitude and probability of harms (see Chapter 4, Section B). Guardians and
p.000199: authorized third parties should not receive incentives for arranging the involvement in research of the individual they
p.000199: rep- resent. However, they may accept reasonable incentives or compensation on behalf of that individual, as long as
p.000199: these are suitable to the circumstances.
p.000199: (b) To maintain the element of voluntariness, participants shall be free to withdraw their consent to participate in
p.000199: the research at any time, and need not offer any reason for doing so. In some cases, however, the physical
p.000199: practicalities of the project may prevent the actual withdrawal of the participant partway through, for example, if
p.000199: the project involves only a single intervention, or if the termination of a medical research procedure may
p.000199: compromise the safety of the participant.
p.000199:
p.000199: TCPS 2 29
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: The participant should not suffer any disadvantage or reprisal for withdrawing nor should any payment due prior to the
p.000199: point of withdrawal be withheld. If the research project used a lump-sum incentive for participation, the participant
p.000199: is entitled to the entire amount. If a payment schedule is used, participants shall be paid in proportion to their
p.000199: participation.
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p.000199: Application Consent encompasses a process that begins with the initial contact (e.g., recruit- ment) and carries
p.000199: through to the end of participants’ involvement in the project. Throughout the process, researchers have an ongoing
p.000199: duty to provide participants and REBs with all information relevant to participants’ ongoing consent to partic- ipate
p.000199: in the research. The researcher has an ongoing ethical and legal obligation to
p.000199:
p.000199:
p.000199: TCPS 2 33
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: bring to participants’ attention any changes to the research project that may affect them. These changes may have
p.000199: ethical implications, or may be germane to their decision to continue research participation, or may be relevant to the
p.000199: particular cir- cumstances of individual participants. In particular, researchers shall disclose changes to the
p.000199: risks or potential benefits of the research. This gives participants the opportunity to reconsider the basis for their
p.000199: consent in light of the new infor- mation.
p.000199: In the case of children who begin participation in a project on the basis of consent from an authorized third party,
p.000199: the researcher must seek their autonomous consent if they reach the age of majority during the research, in order for
p.000199: their participation to continue.
p.000199: Incidental Findings
p.000199:
p.000199: Article 3.4 Researchers have an obligation to disclose to the participant any material incidental findings
p.000199: discovered in the course of research.
p.000199: Application “Incidental findings” is a term that describes unanticipated discoveries made in the course of research
p.000199: but that are outside the scope of the research. Material incidental findings are findings that have been interpreted as
p.000199: having significant welfare im- plications for the participant, whether health-related, psychological or social. If, in
p.000199: the course of research, material incidental findings are discovered, researchers have an obligation to inform the
p.000199: participant.
p.000199: In some areas of research, such as medical and genetic research, there is a greater likelihood of material incidental
p.000199: findings. When material incidental findings are likely, researchers should develop a plan indicating how they will
p.000199: disclose such findings to participants, and submit this plan to the REB. If there is uncertainty as to whether a
p.000199: research project warrants such a plan, researchers and REBs can make this determination on a case-by-case basis.
p.000199: If researchers are unsure of how to interpret findings or uncertain whether findings are material, they should consult
p.000199: with colleagues or refer to standards in the disci- pline. If researchers are unsure of the most appropriate method for
p.000199: disclosing material incidental findings to participants, they should consult with their REB or with colleagues.
p.000199: Researchers should exercise caution in disclosing incidental find- ings that may cause needless concern to
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p.000199:
p.000199:
p.000199:
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p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
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p.000199:
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p.000199: TCPS 2 45
p.000199:
p.000199:
p.000199:
p.000199: Chapter 4
p.000199: FAIRNESS AND EQUITY IN RESEARCH PARTICIPATION
p.000199:
p.000199: Introduction
p.000199: The principle of Justice holds that particular individuals, groups or communities should neither bear an unfair share
p.000199: of the direct burdens of participating in research, nor should they be unfairly excluded from the potential benefits of
p.000199: research participation. Inclusiveness in research and fair distribution of benefits and burdens should be important
p.000199: considerations for researchers, research ethics boards (REBs), research institutions and sponsors. Issues of fair and
p.000199: equitable treatment arise in deciding whether and how to include individuals, groups or communities in research, and
p.000199: the basis for the exclusion of some.
p.000199: This chapter addresses inclusion in research of individuals and groups that might be inappropriately excluded on the
p.000199: basis of attributes such as culture, language, gender, race, ethnicity, age and dis- ability. It provides guidance
p.000199: relevant to inclusion in research of specific groups such as women, children, the elderly and those who lack capacity
p.000199: to consent to participate in research. Historically, these groups have often been inappropriately excluded from
p.000199: research.
p.000199: This chapter also addresses the fair inclusion and equitable treatment of individuals, groups and communities whose
p.000199: situation or circumstances make them vulnerable in the context of a specific research project. These individuals run
p.000199: the risk of being included in research in ways that may be unfair and inequitable. This chapter provides guidance
p.000199: relevant to the equitable distribution of the risks and benefits of research.
p.000199: Over-protectionist attitudes or practices of researchers or REBs, whether intentional or inadvertent, can exclude some
p.000199: members of society from participating in research. The exclusion of individuals, groups or communities may constitute a
p.000199: failure to treat them justly. For example, age has been used to exclude individuals from participation in research,
p.000199: particularly health research (e.g., studies that only accept participants between the ages of 18 to 35). As a result,
p.000199: sufficient research may not be done on groups that fall outside of narrow age criteria. The inclusion of the young and
p.000199: the elderly in research, for example, ensures that treatments frequently given to these populations are effective and
p.000199: safe.
p.000199: Researchers, institutions and REBs all have important roles to play in advancing that societal com- mitment, and
p.000199: ensuring a fair distribution of the benefits and burdens of research. Researchers and REBs must navigate between the
p.000199: dangers of imposing unfair burdens on particular participants, groups and communities, and overprotecting them. In
p.000199: assessing fairness and equity issues in the research ethics process, REBs should not intervene in the choice of
p.000199: research topics.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 47
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: A. Appropriate Inclusion
p.000199: Article 4.1 Taking into account the scope and objectives of their research, researchers should be inclusive in
p.000199: selecting participants. Researchers shall not exclude individuals from the opportunity to participate in research on
p.000199: the basis of attributes such as culture, language, religion, race, disability, sexual orientation, ethnicity,
p.000199: linguistic proficiency, gender or age, unless there is a valid reason for the exclusion.
p.000199: Application Article 4.1 is based on the principle of Justice. It imposes a duty on researchers not to exclude
p.000199: individuals or groups from participation for reasons that are unrelated to the research. This duty is explicitly stated
p.000199: because groups have been inappropri- ately excluded from participation in research on the basis of attributes such as
p.000199: gender, race, ethnicity, age and disability.
p.000199: The focus, objective, nature of research and context in which the research is con- ducted inform the inclusion and
p.000199: exclusion criteria for a specific research project. Some research may be focused on a certain individual (such as in a
p.000199: biography), or a group of individuals who share a specific characteristic (e.g., an identifiable group of painters who
p.000199: happen to be all of one sex; a religious order that is restricted to one sex). Other examples include research that is
p.000199: focused on specific cultural tra- ditions or languages, or on one age group (e.g., a biomechanical modeling study of
p.000199: posture corrections in adolescents). Such research should not be precluded so long as the selection criteria for those
p.000199: to be included in the research are germane to answering the research question. Researchers who plan to actively exclude
p.000199: par- ticular groups should clarify to their REBs the grounds for the exclusion.
p.000199: Where a language barrier exists between the researcher and the prospective partic- ipant, various measures may be
p.000199: used to ensure effective communication in recruitment and consent discussions. For example, an intermediary who
p.000199: may not be part of the research project or team, but who is competent in the language used by the researchers, as well
p.000199: as that preferred by the participant, may assist with com- munication between prospective participants and researchers.
p.000199: The selection of an intermediary and their activities will depend on the nature, context and risks of the research.
p.000199:
p.000199: B. Inappropriate Exclusion
p.000199: Research Involving Women
p.000199: Women have historically been inappropriately excluded from participating in some research. This exclusion of women,
p.000199: where unwarranted, has delayed the advancement of knowledge, denied po- tential benefits to women, and exposed women to
...
p.000199: participate in research (see Ar- ticle 4.6). As well, physical or psychological harms a child may experience in a
p.000199: research setting may have long-lasting consequences. As a result, researchers have often avoided the inclusion of
p.000199: children in some research, especially in clinical trials testing new treatments, so as to eliminate any risks. Clinical
p.000199: trials conducted only with adults yield a generally poor understanding of the results that apply to children.
p.000199: As is the case with women, the inclusion of children in research advances the commitment to jus- tice in research by
p.000199: improving our knowledge of, and ability to respond to, the unique needs of children throughout their development.
p.000199:
p.000199:
p.000199: TCPS 2 49
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: Article 4.4 Children shall not be inappropriately excluded from research solely on the basis of their age or
p.000199: developmental stage. The inclusion of children in research is subject to Article 4.6.
p.000199: Application Researchers should not exclude children from research unless there is a valid reason for doing so.
p.000199: Participation of children in research is justifiable when the research objective cannot be achieved with adult
p.000199: participants only. When considering the inclusion of children in research, researchers and REBs shall consider a
p.000199: child’s stage of physical, physiological, psychological, and social development to ensure adequate protections for the
p.000199: child’s welfare. Where children have not yet attained the capacity to consent for themselves to participate in
p.000199: research, researchers shall seek consent from an authorized third party while ascertaining the child’s assent or
p.000199: dissent, as outlined in Chapter 3. Note that Article 4.6 equally applies to children.
p.000199: Research Involving the Elderly
p.000199: As the population ages, the proportion of elderly people is increasing, and so is their life ex- pectancy. Research
p.000199: designed to improve our understanding of a wide range of aspects of aging and the lives of elderly people is important
p.000199: for ensuring that they stay fully integrated into society and maintain a continuing high quality of life. Medically,
p.000199: elderly patients are the highest consumers of drugs, yet many of these treatments have not been tested adequately on
p.000199: elderly patients. Re- search that takes into account the differential effects on the elderly and how best to
p.000199: accommodate their needs provides scientific evidence that can inform changes to policies and standards of care for the
p.000199: elderly.
p.000199: Article 4.5 Elderly people shall not be inappropriately excluded from research solely on the basis of their age.
p.000199: Application Researchers should not exclude elderly people from research unless there is a valid reason for doing
p.000199: so. When considering the inclusion of elderly people in research, researchers and REBs shall consider their physical
p.000199: and social needs to ensure ad- equate protections. Depending on their social circumstances, elderly people may require
p.000199: some reasonable accommodation for mobility, transportation support and other types of assistance to facilitate their
p.000199: participation in research. The principle of Justice requires that such accommodations for the natural processes of
p.000199: aging be considered by REBs and researchers. Exclusion of the elderly shall not be based on easily remediable issues
p.000199: that are not germane to the research question.
p.000199: Research Involving Participants Who Lack the Capacity to Consent for Themselves
p.000199: The core principles of Justice and Concern for Welfare entail special ethical obligations toward individuals who lack
p.000199: capacity to consent to participate in research. This section sets out conditions that apply to research involving those
p.000199: who cannot consent for themselves. It should be read in conjunction with Section C of Chapter 3.
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p.000199: Security
p.000199: Security refers to measures used to protect information. It includes physical, administrative and technical safeguards.
p.000199: An individual or organization fulfils its confidentiality duties, in part, by adopting and enforcing appropriate
p.000199: security measures. Physical safeguards include the use of locked filing cabinets, and the location of computers
p.000199: containing research data away from public areas. Administrative safeguards include the development and enforcement of
p.000199: organizational rules about who has access to personal information about participants. Technical safeguards include use
p.000199: of computer passwords, firewalls, anti-virus software, encryption and other measures that protect data from
p.000199: unauthorized access, loss or modification.
p.000199: Identifiable Information
p.000199: Information that may reasonably be expected to identify an individual, alone or in combination with other available
p.000199: information, is considered identifiable information (or information that is identifiable) for the purposes of this
p.000199: Policy. Where the term “personal information” appears in this Policy, it refers to identifiable information.
p.000199: Types of Information
p.000199: Researchers may seek to collect, use, share and access different types of information about par- ticipants. Such
p.000199: information may include personal characteristics or other information about which an individual has a reasonable
p.000199: expectation of privacy (e.g., age, ethnicity, educational background, employment history, health history, life
p.000199: experience, religion, social status).
p.000199: For the purposes of this Policy, researchers and REBs shall consider whether information proposed for use in research
p.000199: is identifiable. The following categories provide guidance for assessing the ex- tent to which information could be
p.000199: used to identify an individual:
p.000199: • Directly identifying information – the information identifies a specific individual through direct identifiers
p.000199: (e.g., name, social insurance number, personal health number).
p.000199: • Indirectly identifying information – the information can reasonably be expected to iden- tify an individual
p.000199: through a combination of indirect identifiers (e.g., date of birth, place of residence or unique personal
p.000199: characteristic).
p.000199:
p.000199: 56 TCPS 2
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: • Coded information – direct identifiers are removed from the information and replaced with a code. Depending on
p.000199: access to the code, it may be possible to re-identify specific participants (e.g., the principal investigator retains a
p.000199: list that links the participants’ code names with their actual name so data can be re-linked if necessary).
p.000199: • Anonymized information – the information is irrevocably stripped of direct identifiers, a code is not kept to
...
p.000199: Participants should also be informed during the consent process of the conflict and the extent of the
p.000199:
p.000199:
p.000199: 94 TCPS 2
p.000199:
p.000199: Chapter 7 – Conflicts of Interest
p.000199:
p.000199: researcher’s involvement. In line with the proportionate approach to REB review, and through the continued research
p.000199: ethics review process, REBs may impose ad- ditional control mechanisms if necessary.
p.000199: Dual Roles
p.000199: Dual roles of researchers and their associated obligations (e.g., acting as both a re- searcher and a therapist, health
p.000199: care provider, caregiver, teacher, advisor, consultant, supervisor, student or employer) may create conflicts, undue
p.000199: influences, power im- balances or coercion that could affect relationships with others and affect
p.000199: decision-making procedures (e.g., consent of participants). Article 3.2(e) reminds researchers of relevant ethical
p.000199: duties that govern real, potential or perceived con- flicts of interest as they relate to the consent of participants.
p.000199: To preserve and not abuse the trust on which many professional relationships rest, researchers should be fully
p.000199: cognizant of conflicts of interest that may arise from their dual or multiple roles, their rights and responsibilities,
p.000199: and how they can man- age the conflict. When acting in dual or multiple roles, the researcher shall disclose the nature
p.000199: of the conflict to the participant in the consent process.
p.000199: Financial Conflicts of Interest
p.000199: Real, potential or perceived financial conflicts of interest may affect any type of research. Researchers and REBs
p.000199: should be aware of, and consider, the possibility of financial conflicts of interest. They should seek to ensure that
p.000199: financial consid- erations do not serve to diminish respect for the principles of this Policy or the scientific
p.000199: validity and transparency of research procedures.
p.000199: Financial incentives have the potential to distort researchers’ judgment in ensuring the design and conduct of research
p.000199: is ethical. When researchers partner with or- ganizations whose primary motive is profit, they must be aware of the
p.000199: potential for conflicts of interest. Consideration for the profitability of the research may threaten the ethical
p.000199: integrity of research design and conduct. Not all research spon- sored by for-profit organizations gives rise to
p.000199: financial conflicts of interest. However, REBs shall consider the potential for this type of conflict because its
p.000199: ability to undermine the ethical conduct of research has been empirically estab- lished.
p.000199: As part of a research project submitted for REB review, researchers shall disclose all kinds and amounts of payment
p.000199: (financial or in-kind) to the researchers by spon- sors, commercial interests, and consultative or other relationships,
p.000199: as well as any other relevant information that may affect the project (e.g., donation to an institu- tion by a
p.000199: research sponsor). Researchers shall also supply all relevant documentation and identify strategies to
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Social / Child
Searching for indicator child:
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p.000199: risks and potential benefits for the woman and her embryo, fetus or infant, as well as the foreseeable risks and
p.000199: potential benefits of excluding pregnant or breastfeeding women from the research.
p.000199: Research Involving Children
p.000199: Children have varying degrees of maturity – metabolically, immunologically and cognitively – that may present important
p.000199: challenges for research design and the consent process, depending on the nature and complexity of the research. In
p.000199: addition to the vulnerability that arises from their developmental stage, children may also lack capacity to consent to
p.000199: participate in research (see Ar- ticle 4.6). As well, physical or psychological harms a child may experience in a
p.000199: research setting may have long-lasting consequences. As a result, researchers have often avoided the inclusion of
p.000199: children in some research, especially in clinical trials testing new treatments, so as to eliminate any risks. Clinical
p.000199: trials conducted only with adults yield a generally poor understanding of the results that apply to children.
p.000199: As is the case with women, the inclusion of children in research advances the commitment to jus- tice in research by
p.000199: improving our knowledge of, and ability to respond to, the unique needs of children throughout their development.
p.000199:
p.000199:
p.000199: TCPS 2 49
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: Article 4.4 Children shall not be inappropriately excluded from research solely on the basis of their age or
p.000199: developmental stage. The inclusion of children in research is subject to Article 4.6.
p.000199: Application Researchers should not exclude children from research unless there is a valid reason for doing so.
p.000199: Participation of children in research is justifiable when the research objective cannot be achieved with adult
p.000199: participants only. When considering the inclusion of children in research, researchers and REBs shall consider a
p.000199: child’s stage of physical, physiological, psychological, and social development to ensure adequate protections for the
p.000199: child’s welfare. Where children have not yet attained the capacity to consent for themselves to participate in
p.000199: research, researchers shall seek consent from an authorized third party while ascertaining the child’s assent or
p.000199: dissent, as outlined in Chapter 3. Note that Article 4.6 equally applies to children.
p.000199: Research Involving the Elderly
p.000199: As the population ages, the proportion of elderly people is increasing, and so is their life ex- pectancy. Research
p.000199: designed to improve our understanding of a wide range of aspects of aging and the lives of elderly people is important
p.000199: for ensuring that they stay fully integrated into society and maintain a continuing high quality of life. Medically,
p.000199: elderly patients are the highest consumers of drugs, yet many of these treatments have not been tested adequately on
p.000199: elderly patients. Re- search that takes into account the differential effects on the elderly and how best to
p.000199: accommodate their needs provides scientific evidence that can inform changes to policies and standards of care for the
p.000199: elderly.
p.000199: Article 4.5 Elderly people shall not be inappropriately excluded from research solely on the basis of their age.
p.000199: Application Researchers should not exclude elderly people from research unless there is a valid reason for doing
...
p.000199: the research). Researchers should obtain the consent of these participants, and negotiate agreements with them that
p.000199: specify how they may be identified or recognized for their contribution. Where an individual partic-
p.000199:
p.000199: 58 TCPS 2
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: ipant waives anonymity but other members of the participant group object because identification may cause harm to the
p.000199: group, researchers shall maintain anonymity for all members of the participant group (see Article 3.2[f] and Article
p.000199: 10.4).
p.000199: Article 5.2 Researchers shall describe measures for meeting confidentiality obligations and explain any reasonably
p.000199: foreseeable disclosure requirements:
p.000199: (a) in application materials they submit to the REB; and
p.000199: (b) during the consent process with prospective participants.
p.000199: Application This article recognizes that some research projects are more likely to put researchers in a position
p.000199: where they may have a requirement to disclose information to third parties. The reasonable foreseeability of disclosure
p.000199: requirements can be assessed by considering the nature and objectives of the research inquiry. For example, re- search
p.000199: that involves interviewing high-risk families about intergenerational violence raises a reasonably foreseeable
p.000199: prospect that researchers may acquire in- formation that a child is being abused. Researchers who reasonably foresee
p.000199: that their inquiries may give rise to an ethical or legal reason to disclose information obtained in the research
p.000199: context shall advise the REB and prospective participants about the possibility of compelled disclosure. Advising
p.000199: participants of reasonably foreseeable disclosure requirements is an important aspect of the consent process.
p.000199: Situations may arise where researchers unexpectedly acquire information that gives rise to a reason for disclosure to a
p.000199: third party, or researchers may receive a disclo- sure demand from a third party. In such cases, advising a participant
p.000199: about the disclosure may be important to respect the trust relationship with the participant, and to ensure the
p.000199: validity of the participant’s ongoing consent. Decisions about whether, how and when to advise a participant of
p.000199: disclosure should be guided by any applicable disciplinary standards and consultation with the REB, colleagues,
p.000199: relevant professional body and/or legal counsel.
p.000199: Researchers shall also inform participants and seek their consent if their personal information may be shared with
p.000199: government departments or agencies, community partners in the research, personnel from an agency that monitors the
p.000199: research, a re- search sponsor (such as a pharmaceutical company), the REB or a regulatory agency.
p.000199: Researchers shall avoid being put in a position of becoming informants for author- ities or leaders of
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p.000183: biological relatives. Researchers should explain differ- ences between genetic testing in a research context and
p.000183: testing in a clinical context. Clinical genetic testing may be needed to clarify or confirm findings obtained in
p.000183: research. Where researchers share information with biological relatives or other family, community or group members,
p.000183: genetic counselling should be made avail- able to them as well as the participants. The counselling service provider
p.000183: must have the appropriate experience or training to provide genetic counselling, but need not necessarily hold a
p.000183: diploma, degree or professional designation in genetic coun- selling.
p.000183: D. Genetic Research Involving Families
p.000183: Article 13.5 Researchers who seek to recruit members of a family to participate in genetic re- search shall:
p.000183: (a) ensure recruitment processes respect privacy and other personal interests of family members; and
p.000183: (b) seek consent from individual family members.
p.000183: Application Recruitment of members of a family may take place in various ways: through (a) the researcher, (b) an
p.000183: individual participant, or (c) a third party on behalf of an individual participant. A family group, such as parents
p.000183: and a child, or several adult siblings, may all receive an invitation at the same time from the researcher to
p.000183: participate in genetic research. Alternatively, researchers may seek permission from an individual participant to
p.000183: contact family members to invite participation. It may be preferable for the participant to make initial contact with
p.000183: the family member, in
p.000183:
p.000183:
p.000183: 184 TCPS 2
p.000183:
p.000183: Chapter 13 – Human Genetic Research
p.000183:
p.000183: order to respect privacy interests or known sensitivities. The participant may prefer to identify a third party to
p.000183: inform family members about the opportunity to participate in genetic research. However, an approach by someone
p.000183: in a position of authority over family members may raise concerns about undue influence or manipulation.
p.000183: Refer to Chapter 3 for further guidance in regard to the voluntariness of consent.
p.000183: Family members may have conflicting views about participation in research, and some may have specific sensitivities or
p.000183: objections. Researchers should recognize the potential for conflict within families and be respectful of any known
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p.000199: on the nature of the research being undertaken, and the individuals or group in question. This consideration does not
p.000199: imply, however, that the welfare of a group should be given priority over the welfare of individuals.
p.000199: Justice
p.000199: Justice refers to the obligation to treat people fairly and equitably. Fairness entails treating all peo- ple with
p.000199: equal respect and concern. Equity requires distributing the benefits and burdens of research participation in such a
p.000199: way that no segment of the population is unduly burdened by the harms of research or denied the benefits of the
p.000199: knowledge generated from it.
p.000199: Treating people fairly and equitably does not always mean treating people in the same way. Dif- ferences in treatment
p.000199: or distribution are justified when failures to take differences into account may result in the creation or
p.000199: reinforcement of inequities. One important difference that must be considered for fairness and equity is vulnerability.
p.000199: Vulnerability is often caused by limited capacity, or limited access to social goods, such as rights, opportunities and
p.000199: power. Individuals or groups in vulnerable circumstances have historically included children, the elderly, women,
p.000199: prisoners, those with mental health issues and those with diminished capacity for self-determination. Ethno- cultural
p.000199: minorities and those who are institutionalized are other examples of groups who have, at times, been treated unfairly
p.000199: and inequitably in research, or have been excluded from research op- portunities. People or groups whose circumstances
p.000199: cause them to be vulnerable or marginalized may need to be afforded special attention in order to be treated justly in
p.000199: research.
p.000199:
p.000199:
p.000199:
p.000199: 10 TCPS 2
p.000199:
p.000199: Chapter 1 – Ethics Framework
p.000199:
p.000199: The recruitment process, both of participants who may become directly involved in research and those who participate as
p.000199: the source of information or biological materials to be used in research, is an important component of the fair and
p.000199: equitable conduct of research. Participation should be based on inclusion criteria that are justified by the research
p.000199: question. Inequity is created when par- ticular groups fail to receive fair benefits of research or when
p.000199: groups, or their data or their biological materials, are excluded from research arbitrarily or for reasons
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p.000199:
p.000199: Article 3.3 Consent shall be maintained throughout the research project. Researchers have an ongoing duty to
p.000199: provide participants with all information relevant to their ongoing consent to participate in the research.
p.000199: Application Consent encompasses a process that begins with the initial contact (e.g., recruit- ment) and carries
p.000199: through to the end of participants’ involvement in the project. Throughout the process, researchers have an ongoing
p.000199: duty to provide participants and REBs with all information relevant to participants’ ongoing consent to partic- ipate
p.000199: in the research. The researcher has an ongoing ethical and legal obligation to
p.000199:
p.000199:
p.000199: TCPS 2 33
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: bring to participants’ attention any changes to the research project that may affect them. These changes may have
p.000199: ethical implications, or may be germane to their decision to continue research participation, or may be relevant to the
p.000199: particular cir- cumstances of individual participants. In particular, researchers shall disclose changes to the
p.000199: risks or potential benefits of the research. This gives participants the opportunity to reconsider the basis for their
p.000199: consent in light of the new infor- mation.
p.000199: In the case of children who begin participation in a project on the basis of consent from an authorized third party,
p.000199: the researcher must seek their autonomous consent if they reach the age of majority during the research, in order for
p.000199: their participation to continue.
p.000199: Incidental Findings
p.000199:
p.000199: Article 3.4 Researchers have an obligation to disclose to the participant any material incidental findings
p.000199: discovered in the course of research.
p.000199: Application “Incidental findings” is a term that describes unanticipated discoveries made in the course of research
p.000199: but that are outside the scope of the research. Material incidental findings are findings that have been interpreted as
p.000199: having significant welfare im- plications for the participant, whether health-related, psychological or social. If, in
p.000199: the course of research, material incidental findings are discovered, researchers have an obligation to inform the
p.000199: participant.
p.000199: In some areas of research, such as medical and genetic research, there is a greater likelihood of material incidental
p.000199: findings. When material incidental findings are likely, researchers should develop a plan indicating how they will
p.000199: disclose such findings to participants, and submit this plan to the REB. If there is uncertainty as to whether a
p.000199: research project warrants such a plan, researchers and REBs can make this determination on a case-by-case basis.
p.000199: If researchers are unsure of how to interpret findings or uncertain whether findings are material, they should consult
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p.000199: information about themselves, events, social conditions and/or the purpose of the research. For such techniques to fall
p.000199: within the exception to the general re- quirement of full disclosure for consent, the research must meet the
p.000199: requirements of Article 3.7.
p.000199: Where partial disclosure or deception has been used, debriefing is an important mechanism in maintaining the
p.000199: participant’s trust in the research community. The debriefing referred to in Article 3.7(d) should be proportionate to
p.000199: the sensitivity of the issue. Often, debriefing can be a simple and straightforward candid disclosure. In sensitive
p.000199: cases, researchers should also provide a full explanation of why participants were temporarily led to believe
p.000199: that the research, or some aspect of it, had a different purpose, or why participants received less than full
p.000199: disclosure. The researchers should give details about the importance of the research, the necessity of having to use
p.000199: partial disclosure or deception, and express their concern about the welfare of the participants. They should seek to
p.000199: remove any misconceptions that may have arisen and to re-establish any trust that might have been lost, by explaining
p.000199: why these research procedures were necessary to obtain scientifically valid findings.
p.000199: Immediate, full debriefing of all individuals who have contributed data may not be feasible in all cases. In studies
p.000199: with data collection over a longer term, debriefing may have to be deferred until the end of the project. In some cases
p.000199: – for example, in research involving children – it may be more appropriate to debrief the parents, guardians or
p.000199: authorized third parties rather than the participants themselves. In other cases, it may be more appropriate to debrief
p.000199: the entire family or community. When debriefing, researchers should be alert and sensitive to participants’ needs,
p.000199: feelings, reactions and concerns.
p.000199: In studies involving partial disclosure or deception in which an alteration to the requirement for prior consent has
p.000199: been allowed, participants must nevertheless be able to indicate their consent or their refusal at the
p.000199: conclusion of the project, following debriefing. In cases where participants express concerns about their
p.000199: participation in a project, the researcher may give participants the option of removing their data from the project.
p.000199: Where the terms of the research proposal do not permit the participants to withdraw their data, in the absence
p.000199: of the consent of the participant, the identity of the participants shall be protected at all times during and
p.000199: following completion of the project. Participants who express concern about the conduct of the project at the time of
p.000199: debriefing, or who contest the limits imposed
p.000199:
p.000199:
p.000199: 38 TCPS 2
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
...
p.000199: regulatory requirements for seeking consent from authorized third parties, family members and friends may also provide
p.000199: information to the authorized third party about the interests and previous wishes of prospective
p.000199: participants. An authorized third party should take into account any research directives given in accordance with
p.000199: Article 3.11.
p.000199: Article 3.10 Where an authorized third party has consented on behalf of an individual who lacks legal capacity, but
p.000199: that person has some ability to understand the significance of the research, the researcher shall ascertain the wishes
p.000199: of that individual with respect to participation. Prospective participants’ dissent will preclude their participation.
p.000199: Application Many individuals who lack legal capacity to make decisions may still be able to express their wishes in
p.000199: a meaningful way, even if such expression may not fulfil all of the requirements for consent. Prospective participants
p.000199: may be capable of verbally or physically assenting to, or dissenting from, participation in research. Those who may be
p.000199: capable of assent or dissent include:
p.000199: (a) those whose capacity is in the process of development, such as children whose capacity for judgment and
p.000199: self-direction is maturing;
p.000199: (b) those who once were capable of making an autonomous decision regarding consent but whose capacity is diminishing or
p.000199: fluctuating; and
p.000199: (c) those whose capacity remains only partially developed, such as those living with permanent cognitive impairment.
p.000199: While their assent would not be sufficient to permit them to participate in the absence of consent by an authorized
p.000199: third party, their expression of dissent or signs suggesting they do not wish to participate must be respected.
p.000199: Research Directives
p.000199: Although advance directives for treatment are recognized as a legitimate tool in health care, the use of directives in
p.000199: the context of research is not well developed and they have no legal status. For the purposes of this Policy, research
p.000199: directives should be understood to express an individual’s preferences for participation in future research in the
p.000199: event that the individual loses capacity. Research directives are written instructions to be used by the authorized
p.000199: third party as information about a prospective participant’s preferences when the third party is asked to provide
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p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 45
p.000199:
p.000199:
p.000199:
p.000199: Chapter 4
p.000199: FAIRNESS AND EQUITY IN RESEARCH PARTICIPATION
p.000199:
p.000199: Introduction
p.000199: The principle of Justice holds that particular individuals, groups or communities should neither bear an unfair share
p.000199: of the direct burdens of participating in research, nor should they be unfairly excluded from the potential benefits of
p.000199: research participation. Inclusiveness in research and fair distribution of benefits and burdens should be important
p.000199: considerations for researchers, research ethics boards (REBs), research institutions and sponsors. Issues of fair and
p.000199: equitable treatment arise in deciding whether and how to include individuals, groups or communities in research, and
p.000199: the basis for the exclusion of some.
p.000199: This chapter addresses inclusion in research of individuals and groups that might be inappropriately excluded on the
p.000199: basis of attributes such as culture, language, gender, race, ethnicity, age and dis- ability. It provides guidance
p.000199: relevant to inclusion in research of specific groups such as women, children, the elderly and those who lack capacity
p.000199: to consent to participate in research. Historically, these groups have often been inappropriately excluded from
p.000199: research.
p.000199: This chapter also addresses the fair inclusion and equitable treatment of individuals, groups and communities whose
p.000199: situation or circumstances make them vulnerable in the context of a specific research project. These individuals run
p.000199: the risk of being included in research in ways that may be unfair and inequitable. This chapter provides guidance
p.000199: relevant to the equitable distribution of the risks and benefits of research.
p.000199: Over-protectionist attitudes or practices of researchers or REBs, whether intentional or inadvertent, can exclude some
p.000199: members of society from participating in research. The exclusion of individuals, groups or communities may constitute a
p.000199: failure to treat them justly. For example, age has been used to exclude individuals from participation in research,
p.000199: particularly health research (e.g., studies that only accept participants between the ages of 18 to 35). As a result,
p.000199: sufficient research may not be done on groups that fall outside of narrow age criteria. The inclusion of the young and
p.000199: the elderly in research, for example, ensures that treatments frequently given to these populations are effective and
p.000199: safe.
...
p.000199: their pregnancy, or because they are breastfeeding, unless there is a valid reason for doing so.
p.000199: Subjecting women of childbearing potential to inappropriate requirements pre- cludes their participation in research.
p.000199: Exclusions should be made on the basis of clear criteria that reflect balanced attention to the potential benefits as
p.000199: well as the foreseeable risks of the research that may affect the welfare of women. For exam- ple, researchers should
p.000199: not require participants to use oral contraception, unless there is a valid reason for doing so.
p.000199: In considering research on pregnant or breastfeeding women, researchers and REBs shall take into account foreseeable
p.000199: risks and potential benefits for the woman and her embryo, fetus or infant, as well as the foreseeable risks and
p.000199: potential benefits of excluding pregnant or breastfeeding women from the research.
p.000199: Research Involving Children
p.000199: Children have varying degrees of maturity – metabolically, immunologically and cognitively – that may present important
p.000199: challenges for research design and the consent process, depending on the nature and complexity of the research. In
p.000199: addition to the vulnerability that arises from their developmental stage, children may also lack capacity to consent to
p.000199: participate in research (see Ar- ticle 4.6). As well, physical or psychological harms a child may experience in a
p.000199: research setting may have long-lasting consequences. As a result, researchers have often avoided the inclusion of
p.000199: children in some research, especially in clinical trials testing new treatments, so as to eliminate any risks. Clinical
p.000199: trials conducted only with adults yield a generally poor understanding of the results that apply to children.
p.000199: As is the case with women, the inclusion of children in research advances the commitment to jus- tice in research by
p.000199: improving our knowledge of, and ability to respond to, the unique needs of children throughout their development.
p.000199:
p.000199:
p.000199: TCPS 2 49
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: Article 4.4 Children shall not be inappropriately excluded from research solely on the basis of their age or
p.000199: developmental stage. The inclusion of children in research is subject to Article 4.6.
p.000199: Application Researchers should not exclude children from research unless there is a valid reason for doing so.
p.000199: Participation of children in research is justifiable when the research objective cannot be achieved with adult
p.000199: participants only. When considering the inclusion of children in research, researchers and REBs shall consider a
p.000199: child’s stage of physical, physiological, psychological, and social development to ensure adequate protections for the
p.000199: child’s welfare. Where children have not yet attained the capacity to consent for themselves to participate in
p.000199: research, researchers shall seek consent from an authorized third party while ascertaining the child’s assent or
p.000199: dissent, as outlined in Chapter 3. Note that Article 4.6 equally applies to children.
p.000199: Research Involving the Elderly
p.000199: As the population ages, the proportion of elderly people is increasing, and so is their life ex- pectancy. Research
p.000199: designed to improve our understanding of a wide range of aspects of aging and the lives of elderly people is important
p.000199: for ensuring that they stay fully integrated into society and maintain a continuing high quality of life. Medically,
p.000199: elderly patients are the highest consumers of drugs, yet many of these treatments have not been tested adequately on
p.000199: elderly patients. Re- search that takes into account the differential effects on the elderly and how best to
p.000199: accommodate their needs provides scientific evidence that can inform changes to policies and standards of care for the
p.000199: elderly.
p.000199: Article 4.5 Elderly people shall not be inappropriately excluded from research solely on the basis of their age.
p.000199: Application Researchers should not exclude elderly people from research unless there is a valid reason for doing
p.000199: so. When considering the inclusion of elderly people in research, researchers and REBs shall consider their physical
...
p.000199: capacity to consent to participate in research. This section sets out conditions that apply to research involving those
p.000199: who cannot consent for themselves. It should be read in conjunction with Section C of Chapter 3.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: 50 TCPS 2
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: Article 4.6 Subject to applicable legal requirements, individuals who lack capacity to consent to participate in
p.000199: research shall not be inappropriately excluded from research. Where a researcher seeks to involve individuals in
p.000199: research who do not have ca- pacity to consent for themselves, the researcher shall, in addition to fulfilling the
p.000199: conditions in Articles 3.9 and 3.10, satisfy the REB that:
p.000199: (a) the research question can be addressed only with participants within the iden- tified group; and
p.000199: (b) the research does not expose the participants to more than minimal risk without the prospect of direct benefits for
p.000199: them; or
p.000199: (c) where the research entails only minimal risk, it should at least have the prospect of providing benefits to
p.000199: participants or to a group that is the focus of the re- search and to which the participants belong.
p.000199: Application Children and individuals with cognitive impairments or intellectual disabilities may lack capacity to
p.000199: consent to participate in particular research initiatives. As a result, they have, historically, experienced both
p.000199: over-inclusion as populations of conven- ience for some research and unjustified exclusion from other research. Yet the
p.000199: advancement of knowledge about their social, psychological, and health experi- ences and needs may depend on their
p.000199: appropriate participation in research. Their inclusion in research requires special considerations as outlined in this
p.000199: article.
p.000199: To be ethically acceptable, the participation of those who lack capacity to consent for themselves shall be necessary
p.000199: and appropriate to address the research question. Researchers and REBs shall consider the level of risk to which
p.000199: participants who lack capacity to consent are exposed, and the prospect of direct benefits to accruing to the
p.000199: participants. Their participation should generally be limited to research of minimal risk as defined in this Policy
p.000199: (see Chapter 2 for the definition of minimal risk).
p.000199: Where the research presents more than minimal risk, it should have appropriate justification aimed at generating
...
p.000199: disclose it. Institutions shall support their researchers in maintaining promises of confidentiality.
p.000199: Application When researchers obtain information with a promise of confidentiality, they assume an ethical duty that
p.000199: is central to respect for participants and the integrity of the re- search project. Breaches of confidentiality may
p.000199: harm the participant, the trust relationship between the researcher and the participant, other individuals or groups,
p.000199: and/or the reputation of the research community. Research that probes sensitive topics (e.g., illegal activities)
p.000199: generally depends on strong promises of confiden- tiality to establish trust with participants.
p.000199: The ethical duty of confidentiality applies to information obtained directly from participants, or from other
p.000199: researchers or organizations that have legal, professional or other obligations to maintain confidentiality.
p.000199: The ethical duty of confidentiality must, at times, be balanced against competing ethical considerations or legal or
p.000199: professional requirements that call for disclosure of information obtained or created in a research context. For
p.000199: example, in excep- tional and compelling circumstances, researchers may be subject to obligations to report information
p.000199: to authorities to protect the health, life or safety of a participant or a third party. Researchers are expected to be
p.000199: aware of ethical codes (such as pro- fessional codes of conduct) or laws (e.g., those requiring the reporting of
p.000199: children in need of protection) that may require disclosure of information they obtain in a research context. In other
p.000199: situations, a third party may seek access to information obtained and/or created in confidence in a research context.
p.000199: An access request may seek voluntary disclosure of information, or may seek to compel disclosure through force of law
p.000199: (e.g., by subpoena). Chapter 1, Section C, elaborates on the relationship between research ethics and law.
p.000199: Certain areas of research (such as research involving children at risk of abuse or studies of criminal behaviour) are
p.000199: more likely to put researchers in positions where they may experience tension between the ethical duty of
p.000199: confidentiality and dis- closure to third parties. Researchers shall maintain their promise of confidentiality to
p.000199: participants within the extent permitted by ethical principles and/or law. This may involve resisting requests for
p.000199: access, such as opposing court applications seek- ing disclosure. Researchers’ conduct in such situations should be
p.000199: assessed on a case-by-case basis and guided by consultation with colleagues, any relevant pro- fessional body, the REB
p.000199: and/or legal counsel.
p.000199: In some instances, participants may waive anonymity (e.g., if they wish to be iden- tified for their contributions to
p.000199: the research). Researchers should obtain the consent of these participants, and negotiate agreements with them that
p.000199: specify how they may be identified or recognized for their contribution. Where an individual partic-
p.000199:
p.000199: 58 TCPS 2
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: ipant waives anonymity but other members of the participant group object because identification may cause harm to the
p.000199: group, researchers shall maintain anonymity for all members of the participant group (see Article 3.2[f] and Article
p.000199: 10.4).
...
p.000111: 1) Research directly involving a community on First Nations, Inuit or Métis lands with a formal governance structure.
p.000111: For example, a project that examines the incidence of diabetes in Pond Inlet, Nunavut, or the impact on Inuit health of
p.000111: contaminants in animals and plants used for country food.
p.000111: • Permission of the Nunavut Research Institute that carries authority to approve research in Nunavut is
p.000111: required. Agreement of the hamlet council in Pond Inlet will normally be a condition of approval. The local health
p.000111: committee may co-manage the project.
p.000111: 2) Research involving Aboriginal people who comprise a sizeable proportion of the study or community and where
p.000111: Aboriginal-specific conclusions are intended. For example, a comparative study of access to public housing in Prince
p.000111: Albert, Saskatchewan.
p.000111: • First Nations in the district, represented by their tribal council, the local Métis association, and urban
p.000111: Aboriginal and women’s organizations may partner with the Prince Albert city council to sponsor, implement and use the
p.000111: results of the housing study.
p.000111: 3) Research focusing on a larger community that is known to include Aboriginal people (regardless of their
p.000111: proportion), and where Aboriginal-specific conclusions are anticipated. For example, a study of student retention
p.000111: in high schools in the Sault Ste. Marie district of Ontario.
p.000111: • A committee representing First Nations, Métis organizations and urban Aboriginal people whose children may
p.000111: be affected by the study may be convened to advise the District Board of Education and the researchers involved.
p.000111: 4) Research involving Aboriginal people who comprise a sizeable proportion of the larger community that is the
p.000111: subject of research even if no Aboriginal- specific conclusions will be made. For example, research on
p.000111: employment
p.000111:
p.000111: 112 TCPS 2
p.000111:
p.000111: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000111:
p.000111: development programs serving residents of the inner city of Winnipeg in Manitoba.
p.000111: • Aboriginal service agencies or political organizations may be engaged to help recruit Aboriginal participants and
p.000111: secure community representation on an oversight committee, and to ensure cultural sensitivity in collecting and
p.000111: interpreting data on employment program impacts.
p.000111: 5) Interviewing a sample of individuals of Aboriginal ancestry across Canada on the impact of a policy on their
p.000111: lives, where the results are not attributable to, or likely to affect, the community or communities with which they may
p.000111: identify. For example, survey research on the implementation of Indian Act provisions requiring ministerial approval of
p.000111: an “Indian’s” will.
p.000111: • First Nations, Inuit and Métis persons, whether or not they identify as members of an Aboriginal
p.000111: community, enjoy freedom of expression as does any citizen. They are free to consent and to participate in research
...
p.000183: participate in genetic research. Alternatively, researchers may seek permission from an individual participant to
p.000183: contact family members to invite participation. It may be preferable for the participant to make initial contact with
p.000183: the family member, in
p.000183:
p.000183:
p.000183: 184 TCPS 2
p.000183:
p.000183: Chapter 13 – Human Genetic Research
p.000183:
p.000183: order to respect privacy interests or known sensitivities. The participant may prefer to identify a third party to
p.000183: inform family members about the opportunity to participate in genetic research. However, an approach by someone
p.000183: in a position of authority over family members may raise concerns about undue influence or manipulation.
p.000183: Refer to Chapter 3 for further guidance in regard to the voluntariness of consent.
p.000183: Family members may have conflicting views about participation in research, and some may have specific sensitivities or
p.000183: objections. Researchers should recognize the potential for conflict within families and be respectful of any known
p.000183: sensitivi- ties. Where researchers seek participation from children or other members of a fam- ily who may lack
p.000183: capacity to consent, the applicable provisions in Chapter 3 shall be followed.
p.000183: E. Genetic Research Involving Communities and Groups
p.000183: Article 13.6 Where researchers intend to recruit participants for genetic research based on their membership in
p.000183: specific communities or groups, it may be appropriate for re- searchers to discuss the research with community
p.000183: or group members, and/or their leaders, in addition to seeking consent from individual participants. In these cases,
p.000183: researchers shall provide details to the REB about their proposed methods for en- gaging in discussion.
p.000183: Application Some genetic research seeks to explore genetic variations within specific commu- nities or groups. Such
p.000183: research may raise ethical concerns regarding stigmatization, unfair or inequitable treatment, and social disruption in
p.000183: communities or groups – especially if individual members disagree about participation in research. Discus- sion with
p.000183: formal or informal leaders or other members of the community or group may be appropriate. This determination will
p.000183: depend on factors such as: the objec- tives of the proposed research (in particular, the extent to which membership in,
p.000183: or characteristics of, the community or group are a key aspect of the research); the risks and potential benefits of
p.000183: the research to the community or group; the nature of the community or group from which participants will be recruited;
p.000183: and the com- munity’s or group’s organizational structure.
...
p.000185:
p.000185: Gene alteration involves the transfer of genes into cells to induce an altered capacity of the cell. Viruses are
p.000185: commonly used vectors (carriers) to introduce the gene into the host genome. Gene alteration is irreversible – the cell
p.000185: and its descendants are forever altered and introduced changes cannot be removed. The possible use of germ line
p.000185: alteration implies changes that could be transmitted to future generations.
p.000185:
p.000185: Gene transfer research that involves alteration of human germ line cells is governed in Canada by the Assisted Human
p.000185: Reproduction Act2 and its regulations. Researchers should be aware of how this law applies to their work, such as the
p.000185: Act’s prohibition on knowingly altering the genome of a cell of a human being, or in vitro embryo, such that the
p.000185: alteration is capable of being transmitted to descendants.
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185: 186 TCPS 2
p.000185:
p.000185: Chapter 13 – Human Genetic Research
p.000185:
p.000185: The special circumstances of gene transfer must be explained to prospective participants (or authorized third parties)
p.000185: during the consent process. This includes providing information about uncertain and potentially latent risks of gene
p.000185: transfer, and any processes for long-term follow-up of participants. Guidance regarding inclusion in research (see
p.000185: Chapter 4) should be followed where gene transfer research involves children, or others who lack capacity to consent
p.000185: for themselves.
p.000185:
p.000185:
p.000185: Endnotes
p.000185:
p.000185:
p.000185: 1 In 2008, the U.S. National Institutes of Health amended its policy on publication of and access to data from
p.000185: genome-wide association studies. See National Institutes of Health, Modifications to Genome-Wide Association Studies
p.000185: (GWAS) Data Access, August 28, 2008, http://grants.nih.gov/grants/gwas/data_sharing_policy_modifications_20080828.pdf
p.000185: 2 Assisted Human Reproduction Act (2004, c. 2). http://laws.justice.gc.ca/eng/A-13.4
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185: TCPS 2
p.000187: 187
p.000187:
p.000187:
p.000187:
p.000187: Glossary
p.000187:
p.000187: This glossary is intended to assist readers in their understanding of the Tri-Council Policy Statement: Ethical Conduct
p.000187: for Research Involving Humans (TCPS), also referred to as “the Policy.” Definitions that have been provided in the main
p.000187: text of the Policy are also repeated here. Additional terms are defined in accordance with the purposes of the Policy.
...
p.000197: privacy, 126-128
p.000197: research agreements, 121, 122-123, 126-127, 128-130, 131
p.000197: research ethics review - research ethics boards and community, 115, 119-122 secondary use of information or human
p.000197: biological materials, 119-121, 130-132 strengthening research capacity, 125-126
p.000197: traditional knowledge, 108-109, 110-111, 126
p.000197: Academic freedom, 7, 11
p.000197: Ad hoc advisors, 24, 72, 73, 75, 120, 150
p.000197: Agencies, 5 Anonymity
p.000197: anonymized human biological materials, 170 anonymized information, 57
p.000197: anonymous human biological materials, 19, 131-132, 170
p.000197: anonymous information, 19, 57, 131-132
p.000197:
p.000197:
p.000197: TCPS 2
p.000199: 199
p.000199:
p.000199: Index
p.000199:
p.000199: Appeals, 83-85
p.000199: Assisted human reproduction (see Human reproduction, materials related to) Authorized third parties, 27, 41-44
p.000199: Autonomy, 8-9, 27, 40
p.000199:
p.000199: B
p.000199: Benefits, research
p.000199: equitable distribution, 10, 53
p.000199: mutual, 124-125
p.000199: and risk, 10, 11, 22-25, 41-42, 51, 157-158
p.000199: Biobanks, 175-176, 186
p.000199: Biological materials (see Human biological materials)
p.000199:
p.000199: C
p.000199: Canadian Charter of Rights and Freedoms, 12, 55 Capacity
p.000199: definition, 40-41
p.000199: diminished, 10, 41
p.000199: lack of, 9, 27, 39, 40-44, 47, 49-52, 171, 185, 187
p.000199: regaining, 39, 41, 43
p.000199: Children, 10, 34, 41-42, 47, 49-50, 51, 185, 187
p.000199: Chimeras, 179
p.000199: Clinical equipoise, 148 Clinical trials
p.000199: budgets, 164
p.000199: conflicts of interest, 163-164 consent, 155, 158-159, 161-163
p.000199: definition, 147
p.000199: design, 149-156
p.000199: dissemination of outcomes, 164-167 duty of care, 148-149
p.000199: medical device trials, 153 natural health product trials, 152 pharmaceutical trials, 150-152
p.000199: phases of pharmaceutical trials, 150-152 placebo-controlled trials, 154-156
p.000199: psychotherapy trials, 153
p.000199: registration, 149, 156-157
p.000199: reporting new information, 159-163 risk, 148, 157-159
p.000199: safety, 150, 157, 159-163
p.000199: surgical trials, 154
p.000199: therapeutic misconception, 148, 149, 158-159
p.000199: types, 149-156
p.000199: Coercion, 29
p.000199: Collaborative research, 123-124, 125-126, 128
p.000199:
p.000199:
p.000199:
p.000199: 200 TCPS 2
p.000199:
p.000199: Index
p.000199:
p.000199: Communities
p.000199: Aboriginal, 107-108, 109
p.000199: and genetic research, 181, 183-184, 185
p.000199: Compensation
p.000199: and consent, 29, 31, 33
p.000199: for research ethics board members, 94 Concern for Welfare, 8, 9-10, 109 Confidentiality (see Privacy and
p.000199: confidentiality)
p.000199: Conflicts of interest
p.000199: clinical trials, 163-164
p.000199: definition, 89
p.000199: dual roles, 95, 149, 158
p.000199: financial, 95-96, 163-164
...
p.000203:
p.000203: Index
p.000203:
p.000203:
p.000203: L
p.000203: Law
p.000203:
p.000203:
p.000203:
p.000203:
p.000203:
p.000203:
p.000203:
p.000203:
p.000203:
p.000203: M
p.000203:
p.000203:
p.000203: capacity, 41
p.000203: confidentiality, 58, 59, 60
p.000203: consent, 12, 27, 33-34
p.000203: gene transfer, 186
p.000203: human biological materials, 130, 171
p.000203: human reproduction, materials related to, 177 incidental findings, 34
p.000203: multi-jurisdictional review, 101, 103
p.000203: privacy, 12, 17-18, 55, 63, 64, 142, 143, 174
p.000203: research ethics, 12
p.000203: Medical emergencies (see Emergencies)
p.000203: Memorandum of Understanding on the Roles and Responsibilities in the Management of Federal Grants and Awards, 5, 67,
p.000106: 106
p.000106: Métis, 105, 107, 108, 110, 114, 115, 117, 121
p.000106: (see also Aboriginal peoples)
p.000106: Minimal risk research, 11, 23, 24-25, 37-39, 41, 51, 77-79 Multi-jurisdictional research
p.000106: official agreements, 98, 100
p.000106: research ethics review models, 99-101 review mechanisms, 97-101
p.000106:
p.000106: O
p.000106: Observational research, 18-19, 118, 141-143
p.000106:
p.000106: P
p.000106: Participants
p.000106: autonomy, 8-9, 27, 40 capacity (see Capacity)
p.000106: children, 10, 34, 41-42, 47, 49-50, 51, 185, 187
p.000106: confidentiality, 56, 58-60, 126-128, 143-144, 186
p.000106: definition, 16
p.000106: elderly, 10, 47, 50
p.000106: as members of research ethics boards, 72 perspective, 12, 23, 28, 72, 161
p.000106: privacy, 55-56, 58-60, 126-128, 143-144, 171-172, 186
p.000106: recruitment, 11, 28, 76-77, 110, 158-159, 164, 184-185
p.000106: removal from research, 31, 33, 160 as research partners, 138
p.000106: vulnerability, 9, 10, 23, 47, 52, 116, 137, 148
p.000106: withdrawal from research, 28-30, 31, 61, 140, 186
p.000106: women, 10, 47, 48-49, 116, 178-179
p.000106: Participatory research, 123-125
p.000106: Performance review, 20
p.000106:
p.000106:
p.000106: TCPS 2
p.000205: 205
p.000205:
p.000205: Index
p.000205:
p.000205: Pilot studies, 76-77, 139
p.000205: Pluripotent stem cells, 179
p.000205: Policy, the (see Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans) Principal investigators,
p.000205: 27, 99, 153-154, 159, 162, 165-166
p.000205: Principles (see Core principles) Privacy and confidentiality
p.000205: Aboriginal peoples, 126-128
p.000205: data linkage, 18, 19, 64-65, 131-132
p.000205: definition, 55-56
p.000205: ethical duty, 56, 58-60
p.000205: identifiability of information, 56-57
p.000205: participant, 55-56, 58-60, 126-128, 143-144, 171-172, 186
p.000205: qualitative research, 138, 143-144
p.000205: research involving Aboriginal peoples, 126-128 safeguarding information, 60-61
p.000205: security, 56, 60-61, 64-65
...
p.000205: Publicly available information, 17-18, 64-65, 131 Publicly declared emergencies, 85-88
p.000205: exceptions during, 87-88
p.000205: preparedness plans, 85-86
p.000205: research ethics review during, 87-88
p.000205:
p.000205: Q
p.000205: Qualitative research
p.000205: confidentiality, 138, 143-144
p.000205: consent, 137-138, 140, 141-144
p.000205: data collection, 137, 144 dissemination of results, 143-144 emergent design, 144-145
p.000205: exploratory phase, 76-77, 139
p.000205: nature of, 135-138
p.000205: observational, 18-19, 118, 141-143
p.000205: privacy, 138, 143-144
p.000205: timing of research ethics review, 139 Quality assurance, 20
p.000205: Quality improvement, 20
p.000205:
p.000205: R
p.000205: Reimbursement, 29, 31, 33 Research
p.000205: benefits (see Benefits, research)
p.000205: changes to, 33-34, 82, 144-145, 150, 161-163
p.000205: clinical trials (see Clinical trials) collaborative, 123-124, 125-126, 128
p.000205:
p.000205: 206 TCPS 2
p.000205:
p.000205: Index
p.000205:
p.000205: community-based, 93, 124, 138, 139
p.000205: deception in, 37-39
p.000205: definition, 15
p.000205: dissemination of results, 18-19, 31, 61, 128, 143-144, 164-167, 182-184
p.000205: exclusion, 47, 48-52
p.000205: exploratory phase, 76-77, 139
p.000205: human genetic (see Human genetic research) importance, 7-8
p.000205: inclusion, 11, 48
p.000205: involving Aboriginal peoples (see Aboriginal peoples) involving children, 10, 34, 41-42, 47, 49-50, 51, 185, 187
p.000205: involving the elderly, 10, 47, 50
p.000205: involving human biological materials (see Human biological materials) involving human reproduction (see Human
p.000205: reproduction, materials related to) involving participants lacking capacity (see Capacity)
p.000205: involving women, 10, 47, 48-49, 116, 178-179
p.000205: minimal risk, 11, 23, 24-25, 37-39, 41, 51, 77-79
p.000205: multi-jurisdictional (see Multi-jurisdictional research) observational, 18-19, 118, 141-143
p.000205: partial disclosure, 37-39
p.000205: participant withdrawal, 28-30, 31, 61, 140, 186
p.000205: participatory, 123-125
p.000205: qualitative (see Qualitative Research) research ethics review, exempt from, 17-19
p.000205: research ethics review, requiring, 15-17, 119-121
p.000205: sponsored, 163-164
p.000205: stopping rules, 30-33
p.000205: unanticipated issues, 22, 34, 81, 161-163
p.000205: Research agreements, 121, 122-123, 126-127, 128-130, 131
p.000205: Research directives, 42-44 Research ethics
p.000205: core principles (see Core principles) framework, 7-13, 109-110
p.000205: importance, 7-8 Research ethics boards (REBs)
p.000205: ad hoc advisors, 24, 72, 73, 75, 120, 150
p.000205: appointment, 67-76
p.000205: authority, 67-70
p.000205: chair’s responsibilities, 74, 77-79
p.000205: composition, 70-75
...
Social / Elderly
Searching for indicator elderly:
(return to top)
p.000199: imply, however, that the welfare of a group should be given priority over the welfare of individuals.
p.000199: Justice
p.000199: Justice refers to the obligation to treat people fairly and equitably. Fairness entails treating all peo- ple with
p.000199: equal respect and concern. Equity requires distributing the benefits and burdens of research participation in such a
p.000199: way that no segment of the population is unduly burdened by the harms of research or denied the benefits of the
p.000199: knowledge generated from it.
p.000199: Treating people fairly and equitably does not always mean treating people in the same way. Dif- ferences in treatment
p.000199: or distribution are justified when failures to take differences into account may result in the creation or
p.000199: reinforcement of inequities. One important difference that must be considered for fairness and equity is vulnerability.
p.000199: Vulnerability is often caused by limited capacity, or limited access to social goods, such as rights, opportunities and
p.000199: power. Individuals or groups in vulnerable circumstances have historically included children, the elderly, women,
p.000199: prisoners, those with mental health issues and those with diminished capacity for self-determination. Ethno- cultural
p.000199: minorities and those who are institutionalized are other examples of groups who have, at times, been treated unfairly
p.000199: and inequitably in research, or have been excluded from research op- portunities. People or groups whose circumstances
p.000199: cause them to be vulnerable or marginalized may need to be afforded special attention in order to be treated justly in
p.000199: research.
p.000199:
p.000199:
p.000199:
p.000199: 10 TCPS 2
p.000199:
p.000199: Chapter 1 – Ethics Framework
p.000199:
p.000199: The recruitment process, both of participants who may become directly involved in research and those who participate as
p.000199: the source of information or biological materials to be used in research, is an important component of the fair and
p.000199: equitable conduct of research. Participation should be based on inclusion criteria that are justified by the research
p.000199: question. Inequity is created when par- ticular groups fail to receive fair benefits of research or when
p.000199: groups, or their data or their biological materials, are excluded from research arbitrarily or for reasons
p.000199: unrelated to the research question.
...
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 45
p.000199:
p.000199:
p.000199:
p.000199: Chapter 4
p.000199: FAIRNESS AND EQUITY IN RESEARCH PARTICIPATION
p.000199:
p.000199: Introduction
p.000199: The principle of Justice holds that particular individuals, groups or communities should neither bear an unfair share
p.000199: of the direct burdens of participating in research, nor should they be unfairly excluded from the potential benefits of
p.000199: research participation. Inclusiveness in research and fair distribution of benefits and burdens should be important
p.000199: considerations for researchers, research ethics boards (REBs), research institutions and sponsors. Issues of fair and
p.000199: equitable treatment arise in deciding whether and how to include individuals, groups or communities in research, and
p.000199: the basis for the exclusion of some.
p.000199: This chapter addresses inclusion in research of individuals and groups that might be inappropriately excluded on the
p.000199: basis of attributes such as culture, language, gender, race, ethnicity, age and dis- ability. It provides guidance
p.000199: relevant to inclusion in research of specific groups such as women, children, the elderly and those who lack capacity
p.000199: to consent to participate in research. Historically, these groups have often been inappropriately excluded from
p.000199: research.
p.000199: This chapter also addresses the fair inclusion and equitable treatment of individuals, groups and communities whose
p.000199: situation or circumstances make them vulnerable in the context of a specific research project. These individuals run
p.000199: the risk of being included in research in ways that may be unfair and inequitable. This chapter provides guidance
p.000199: relevant to the equitable distribution of the risks and benefits of research.
p.000199: Over-protectionist attitudes or practices of researchers or REBs, whether intentional or inadvertent, can exclude some
p.000199: members of society from participating in research. The exclusion of individuals, groups or communities may constitute a
p.000199: failure to treat them justly. For example, age has been used to exclude individuals from participation in research,
p.000199: particularly health research (e.g., studies that only accept participants between the ages of 18 to 35). As a result,
p.000199: sufficient research may not be done on groups that fall outside of narrow age criteria. The inclusion of the young and
p.000199: the elderly in research, for example, ensures that treatments frequently given to these populations are effective and
p.000199: safe.
p.000199: Researchers, institutions and REBs all have important roles to play in advancing that societal com- mitment, and
p.000199: ensuring a fair distribution of the benefits and burdens of research. Researchers and REBs must navigate between the
p.000199: dangers of imposing unfair burdens on particular participants, groups and communities, and overprotecting them. In
p.000199: assessing fairness and equity issues in the research ethics process, REBs should not intervene in the choice of
p.000199: research topics.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 47
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: A. Appropriate Inclusion
p.000199: Article 4.1 Taking into account the scope and objectives of their research, researchers should be inclusive in
p.000199: selecting participants. Researchers shall not exclude individuals from the opportunity to participate in research on
p.000199: the basis of attributes such as culture, language, religion, race, disability, sexual orientation, ethnicity,
p.000199: linguistic proficiency, gender or age, unless there is a valid reason for the exclusion.
...
p.000199: developmental stage. The inclusion of children in research is subject to Article 4.6.
p.000199: Application Researchers should not exclude children from research unless there is a valid reason for doing so.
p.000199: Participation of children in research is justifiable when the research objective cannot be achieved with adult
p.000199: participants only. When considering the inclusion of children in research, researchers and REBs shall consider a
p.000199: child’s stage of physical, physiological, psychological, and social development to ensure adequate protections for the
p.000199: child’s welfare. Where children have not yet attained the capacity to consent for themselves to participate in
p.000199: research, researchers shall seek consent from an authorized third party while ascertaining the child’s assent or
p.000199: dissent, as outlined in Chapter 3. Note that Article 4.6 equally applies to children.
p.000199: Research Involving the Elderly
p.000199: As the population ages, the proportion of elderly people is increasing, and so is their life ex- pectancy. Research
p.000199: designed to improve our understanding of a wide range of aspects of aging and the lives of elderly people is important
p.000199: for ensuring that they stay fully integrated into society and maintain a continuing high quality of life. Medically,
p.000199: elderly patients are the highest consumers of drugs, yet many of these treatments have not been tested adequately on
p.000199: elderly patients. Re- search that takes into account the differential effects on the elderly and how best to
p.000199: accommodate their needs provides scientific evidence that can inform changes to policies and standards of care for the
p.000199: elderly.
p.000199: Article 4.5 Elderly people shall not be inappropriately excluded from research solely on the basis of their age.
p.000199: Application Researchers should not exclude elderly people from research unless there is a valid reason for doing
p.000199: so. When considering the inclusion of elderly people in research, researchers and REBs shall consider their physical
p.000199: and social needs to ensure ad- equate protections. Depending on their social circumstances, elderly people may require
p.000199: some reasonable accommodation for mobility, transportation support and other types of assistance to facilitate their
p.000199: participation in research. The principle of Justice requires that such accommodations for the natural processes of
p.000199: aging be considered by REBs and researchers. Exclusion of the elderly shall not be based on easily remediable issues
p.000199: that are not germane to the research question.
p.000199: Research Involving Participants Who Lack the Capacity to Consent for Themselves
p.000199: The core principles of Justice and Concern for Welfare entail special ethical obligations toward individuals who lack
p.000199: capacity to consent to participate in research. This section sets out conditions that apply to research involving those
p.000199: who cannot consent for themselves. It should be read in conjunction with Section C of Chapter 3.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: 50 TCPS 2
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: Article 4.6 Subject to applicable legal requirements, individuals who lack capacity to consent to participate in
p.000199: research shall not be inappropriately excluded from research. Where a researcher seeks to involve individuals in
p.000199: research who do not have ca- pacity to consent for themselves, the researcher shall, in addition to fulfilling the
p.000199: conditions in Articles 3.9 and 3.10, satisfy the REB that:
p.000199: (a) the research question can be addressed only with participants within the iden- tified group; and
...
p.000117:
p.000117: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000117:
p.000117: policies. Where divergences exist, they should be addressed and resolved prior to the commencement of the research, or
p.000117: as they arise over the course of the research.
p.000117: First Nations, Inuit and Métis scholars attached to academic institutions as faculty members, students or research
p.000117: associates are increasingly engaged in research involving their own communities, and sometimes their own family
p.000117: members. They are generally exempt from restrictions on physical access to territory or personal access to community
p.000117: members. However, as members of institutions that adhere to this Policy, they are subject to the ethical duty to
p.000117: respect community customs and codes of research practice when conducting research in their own local or cultural
p.000117: communities, and to engage the relevant community as required by this Policy. In these cases, institutional REBs may be
p.000117: concerned about researchers being in a conflict of interest and should manage the conflict of interest in accordance
p.000117: with Articles 7.2 and 7.4.
p.000117: Life history and language research are examples of research areas where insider relationships and cultural competencies
p.000117: provide unique opportunities to extend the boundaries of knowledge. Although it can be argued that recording the life
p.000117: history of an elderly relative is a family matter rather than a community matter, when undertaken as research,
p.000117: community engagement is important to ensure that the following considerations are reviewed: the potential impact of
p.000117: such research on the wider community; conflicts between the individualist norms of the academic environment
p.000117: and the norms of the community; and the possibility of unclear or mistaken assumptions on the part of participant and
p.000117: researcher. During the consent process, researchers should give the participant the opportunity to identify the
p.000117: relevant form of community engagement, and at what stage such engagement should occur. This may include engaging with
p.000117: extended family members, peers of the participant with whom the researcher’s interpretations can be validated, or
p.000117: Elders knowledgeable about cultural rules governing disclosure of privileged information.
p.000117: Institutional Research Ethics Review Required
p.000117: Article 9.9 Research ethics review by community REBs or other responsible bodies at the research site will not be
p.000117: a substitute for research ethics review by institutional REBs, and will not exempt researchers affiliated with an
p.000117: institution from seeking REB approval at their institution, subject to Article 8.1. Prospective research and secondary
p.000117: use of data and human biological materials for research purposes is subject to research ethics review.
...
p.000199: individual medical emergencies, 39-40 informed, 27, 30-33
p.000199: modalities of expression, 140 ongoing, 27, 33-34, 137-138
p.000199: oral, 44, 140
p.000199: qualitative research, 137-138, 140, 141-144
p.000199: research directives, 42-44
p.000199: secondary use of human biological materials, 62-64, 130-132, 172-175
p.000199: secondary use of identifiable information, 62-64, 130-132 undue influence, 28-29
p.000199: voluntary, 27, 28-30, 31, 32
p.000199: withdrawal, 28-30, 31
p.000199: written, 44-45
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2
p.000201: 201
p.000201:
p.000201: Index
p.000201:
p.000201: Continuing research ethics review, 21-22, 79-81
p.000201: Core principles, 8-11
p.000201: Concern for Welfare, 8, 9-10, 109
p.000201: Justice, 8, 10-11, 47, 109-110
p.000201: interpretation, 13, 109-110
p.000201: Respect for Persons, 8-9, 27, 109
p.000201: Creative practice, 20
p.000201: Critical inquiry, 35-36, 117
p.000201: Cultural heritage, 110-111
p.000201: Cyber-material, 18
p.000201:
p.000201: D
p.000201: Data
p.000201: anonymized, 57
p.000201: anonymous, 57, 131-132
p.000201: collection, 64, 76-77, 137, 144-145
p.000201: destruction, 61
p.000201: linkage, 18, 19, 64-65, 131-132
p.000201: security, 61, 64-65
p.000201: withdrawal, 28-30, 31 (see also Information)
p.000201: Data safety monitoring board (DSMB), 160-161 Debriefing, 37-39, 143
p.000201: Design
p.000201: clinical trials, 149-156
p.000201: emergent, 144-145 Duty of care, 148-149
p.000201: E
p.000201: Elderly, as research participants, 10, 47, 50
p.000201: Elders, in Aboriginal communities, 119, 126
p.000201: Embryos, 15-17, 49, 176, 177-178
p.000201: Emergencies
p.000201: individual medical, 39-40
p.000201: publicly declared (see Publicly declared emergencies) Emergent design, 144-145
p.000201: Ethics (see Research ethics)
p.000201:
p.000201: F
p.000201: Fetal tissue, 15-17, 177, 178-179
p.000201: Fetuses, 15-17, 49, 177, 178, 178-791
p.000201: Findings
p.000201: commercialization, 30-32, 186
p.000201: dissemination, 61, 128, 143-144, 164-167, 183-184
p.000201: incidental, 34, 171-172
p.000201: interpretation, 126, 128
p.000201:
p.000201:
p.000201:
p.000201: 202 TCPS 2
p.000201:
p.000201: Index
p.000201:
p.000201: First Nations, 105, 107, 108, 110, 114, 115, 117, 121, 127
p.000201: (see also Aboriginal peoples)
p.000201:
p.000201: G
p.000201: Genetic research (see Human genetic research)
p.000201:
p.000201: H
p.000201: Harm, definition, 10, 22-23
p.000201: Human biological materials
p.000201: Aboriginal peoples, 119, 129-132
p.000201: anonymized, 170
p.000201: anonymous, 19, 131-132, 170
p.000201: coded, 170
p.000201: collection, 76-77, 129-130, 170-172
p.000201: consent for use, 9, 28-30, 31, 171-175
p.000201: definition, 16-17, 169
p.000201: identified, 170
p.000201: secondary use, 62-64, 119-121, 130-132, 172-175, 186
p.000201: storage and banking, 175-176 types, 169-170
p.000201: withdrawal, 28-30, 31, 172
...
p.000203:
p.000203: M
p.000203:
p.000203:
p.000203: capacity, 41
p.000203: confidentiality, 58, 59, 60
p.000203: consent, 12, 27, 33-34
p.000203: gene transfer, 186
p.000203: human biological materials, 130, 171
p.000203: human reproduction, materials related to, 177 incidental findings, 34
p.000203: multi-jurisdictional review, 101, 103
p.000203: privacy, 12, 17-18, 55, 63, 64, 142, 143, 174
p.000203: research ethics, 12
p.000203: Medical emergencies (see Emergencies)
p.000203: Memorandum of Understanding on the Roles and Responsibilities in the Management of Federal Grants and Awards, 5, 67,
p.000106: 106
p.000106: Métis, 105, 107, 108, 110, 114, 115, 117, 121
p.000106: (see also Aboriginal peoples)
p.000106: Minimal risk research, 11, 23, 24-25, 37-39, 41, 51, 77-79 Multi-jurisdictional research
p.000106: official agreements, 98, 100
p.000106: research ethics review models, 99-101 review mechanisms, 97-101
p.000106:
p.000106: O
p.000106: Observational research, 18-19, 118, 141-143
p.000106:
p.000106: P
p.000106: Participants
p.000106: autonomy, 8-9, 27, 40 capacity (see Capacity)
p.000106: children, 10, 34, 41-42, 47, 49-50, 51, 185, 187
p.000106: confidentiality, 56, 58-60, 126-128, 143-144, 186
p.000106: definition, 16
p.000106: elderly, 10, 47, 50
p.000106: as members of research ethics boards, 72 perspective, 12, 23, 28, 72, 161
p.000106: privacy, 55-56, 58-60, 126-128, 143-144, 171-172, 186
p.000106: recruitment, 11, 28, 76-77, 110, 158-159, 164, 184-185
p.000106: removal from research, 31, 33, 160 as research partners, 138
p.000106: vulnerability, 9, 10, 23, 47, 52, 116, 137, 148
p.000106: withdrawal from research, 28-30, 31, 61, 140, 186
p.000106: women, 10, 47, 48-49, 116, 178-179
p.000106: Participatory research, 123-125
p.000106: Performance review, 20
p.000106:
p.000106:
p.000106: TCPS 2
p.000205: 205
p.000205:
p.000205: Index
p.000205:
p.000205: Pilot studies, 76-77, 139
p.000205: Pluripotent stem cells, 179
p.000205: Policy, the (see Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans) Principal investigators,
p.000205: 27, 99, 153-154, 159, 162, 165-166
p.000205: Principles (see Core principles) Privacy and confidentiality
p.000205: Aboriginal peoples, 126-128
p.000205: data linkage, 18, 19, 64-65, 131-132
p.000205: definition, 55-56
p.000205: ethical duty, 56, 58-60
p.000205: identifiability of information, 56-57
p.000205: participant, 55-56, 58-60, 126-128, 143-144, 171-172, 186
p.000205: qualitative research, 138, 143-144
p.000205: research involving Aboriginal peoples, 126-128 safeguarding information, 60-61
p.000205: security, 56, 60-61, 64-65
p.000205: (see also Secondary use of human biological materials; Secondary use of identifiable information)
p.000205: Program evaluation, 20
p.000205: Proportionate approach to research ethics review, 11, 22, 24-25, 77-79, 82, 148
p.000205: Publicly available information, 17-18, 64-65, 131 Publicly declared emergencies, 85-88
p.000205: exceptions during, 87-88
p.000205: preparedness plans, 85-86
p.000205: research ethics review during, 87-88
p.000205:
p.000205: Q
p.000205: Qualitative research
p.000205: confidentiality, 138, 143-144
p.000205: consent, 137-138, 140, 141-144
p.000205: data collection, 137, 144 dissemination of results, 143-144 emergent design, 144-145
p.000205: exploratory phase, 76-77, 139
p.000205: nature of, 135-138
p.000205: observational, 18-19, 118, 141-143
p.000205: privacy, 138, 143-144
p.000205: timing of research ethics review, 139 Quality assurance, 20
p.000205: Quality improvement, 20
p.000205:
p.000205: R
p.000205: Reimbursement, 29, 31, 33 Research
p.000205: benefits (see Benefits, research)
p.000205: changes to, 33-34, 82, 144-145, 150, 161-163
p.000205: clinical trials (see Clinical trials) collaborative, 123-124, 125-126, 128
p.000205:
p.000205: 206 TCPS 2
p.000205:
p.000205: Index
p.000205:
p.000205: community-based, 93, 124, 138, 139
p.000205: deception in, 37-39
p.000205: definition, 15
p.000205: dissemination of results, 18-19, 31, 61, 128, 143-144, 164-167, 182-184
p.000205: exclusion, 47, 48-52
p.000205: exploratory phase, 76-77, 139
p.000205: human genetic (see Human genetic research) importance, 7-8
p.000205: inclusion, 11, 48
p.000205: involving Aboriginal peoples (see Aboriginal peoples) involving children, 10, 34, 41-42, 47, 49-50, 51, 185, 187
p.000205: involving the elderly, 10, 47, 50
p.000205: involving human biological materials (see Human biological materials) involving human reproduction (see Human
p.000205: reproduction, materials related to) involving participants lacking capacity (see Capacity)
p.000205: involving women, 10, 47, 48-49, 116, 178-179
p.000205: minimal risk, 11, 23, 24-25, 37-39, 41, 51, 77-79
p.000205: multi-jurisdictional (see Multi-jurisdictional research) observational, 18-19, 118, 141-143
p.000205: partial disclosure, 37-39
p.000205: participant withdrawal, 28-30, 31, 61, 140, 186
p.000205: participatory, 123-125
p.000205: qualitative (see Qualitative Research) research ethics review, exempt from, 17-19
p.000205: research ethics review, requiring, 15-17, 119-121
p.000205: sponsored, 163-164
p.000205: stopping rules, 30-33
p.000205: unanticipated issues, 22, 34, 81, 161-163
p.000205: Research agreements, 121, 122-123, 126-127, 128-130, 131
p.000205: Research directives, 42-44 Research ethics
p.000205: core principles (see Core principles) framework, 7-13, 109-110
p.000205: importance, 7-8 Research ethics boards (REBs)
p.000205: ad hoc advisors, 24, 72, 73, 75, 120, 150
p.000205: appointment, 67-76
p.000205: authority, 67-70
p.000205: chair’s responsibilities, 74, 77-79
p.000205: composition, 70-75
p.000205: decision making, 68-69, 70, 79
p.000205: establishment, 67-76
p.000205: financial and administrative resources, 68-69, 74
...
Social / Ethnicity
Searching for indicator ethnicity:
(return to top)
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 45
p.000199:
p.000199:
p.000199:
p.000199: Chapter 4
p.000199: FAIRNESS AND EQUITY IN RESEARCH PARTICIPATION
p.000199:
p.000199: Introduction
p.000199: The principle of Justice holds that particular individuals, groups or communities should neither bear an unfair share
p.000199: of the direct burdens of participating in research, nor should they be unfairly excluded from the potential benefits of
p.000199: research participation. Inclusiveness in research and fair distribution of benefits and burdens should be important
p.000199: considerations for researchers, research ethics boards (REBs), research institutions and sponsors. Issues of fair and
p.000199: equitable treatment arise in deciding whether and how to include individuals, groups or communities in research, and
p.000199: the basis for the exclusion of some.
p.000199: This chapter addresses inclusion in research of individuals and groups that might be inappropriately excluded on the
p.000199: basis of attributes such as culture, language, gender, race, ethnicity, age and dis- ability. It provides guidance
p.000199: relevant to inclusion in research of specific groups such as women, children, the elderly and those who lack capacity
p.000199: to consent to participate in research. Historically, these groups have often been inappropriately excluded from
p.000199: research.
p.000199: This chapter also addresses the fair inclusion and equitable treatment of individuals, groups and communities whose
p.000199: situation or circumstances make them vulnerable in the context of a specific research project. These individuals run
p.000199: the risk of being included in research in ways that may be unfair and inequitable. This chapter provides guidance
p.000199: relevant to the equitable distribution of the risks and benefits of research.
p.000199: Over-protectionist attitudes or practices of researchers or REBs, whether intentional or inadvertent, can exclude some
p.000199: members of society from participating in research. The exclusion of individuals, groups or communities may constitute a
p.000199: failure to treat them justly. For example, age has been used to exclude individuals from participation in research,
p.000199: particularly health research (e.g., studies that only accept participants between the ages of 18 to 35). As a result,
p.000199: sufficient research may not be done on groups that fall outside of narrow age criteria. The inclusion of the young and
p.000199: the elderly in research, for example, ensures that treatments frequently given to these populations are effective and
p.000199: safe.
p.000199: Researchers, institutions and REBs all have important roles to play in advancing that societal com- mitment, and
p.000199: ensuring a fair distribution of the benefits and burdens of research. Researchers and REBs must navigate between the
p.000199: dangers of imposing unfair burdens on particular participants, groups and communities, and overprotecting them. In
p.000199: assessing fairness and equity issues in the research ethics process, REBs should not intervene in the choice of
p.000199: research topics.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 47
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: A. Appropriate Inclusion
p.000199: Article 4.1 Taking into account the scope and objectives of their research, researchers should be inclusive in
p.000199: selecting participants. Researchers shall not exclude individuals from the opportunity to participate in research on
p.000199: the basis of attributes such as culture, language, religion, race, disability, sexual orientation, ethnicity,
p.000199: linguistic proficiency, gender or age, unless there is a valid reason for the exclusion.
p.000199: Application Article 4.1 is based on the principle of Justice. It imposes a duty on researchers not to exclude
p.000199: individuals or groups from participation for reasons that are unrelated to the research. This duty is explicitly stated
p.000199: because groups have been inappropri- ately excluded from participation in research on the basis of attributes such as
p.000199: gender, race, ethnicity, age and disability.
p.000199: The focus, objective, nature of research and context in which the research is con- ducted inform the inclusion and
p.000199: exclusion criteria for a specific research project. Some research may be focused on a certain individual (such as in a
p.000199: biography), or a group of individuals who share a specific characteristic (e.g., an identifiable group of painters who
p.000199: happen to be all of one sex; a religious order that is restricted to one sex). Other examples include research that is
p.000199: focused on specific cultural tra- ditions or languages, or on one age group (e.g., a biomechanical modeling study of
p.000199: posture corrections in adolescents). Such research should not be precluded so long as the selection criteria for those
p.000199: to be included in the research are germane to answering the research question. Researchers who plan to actively exclude
p.000199: par- ticular groups should clarify to their REBs the grounds for the exclusion.
p.000199: Where a language barrier exists between the researcher and the prospective partic- ipant, various measures may be
p.000199: used to ensure effective communication in recruitment and consent discussions. For example, an intermediary who
p.000199: may not be part of the research project or team, but who is competent in the language used by the researchers, as well
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p.000199: Security
p.000199: Security refers to measures used to protect information. It includes physical, administrative and technical safeguards.
p.000199: An individual or organization fulfils its confidentiality duties, in part, by adopting and enforcing appropriate
p.000199: security measures. Physical safeguards include the use of locked filing cabinets, and the location of computers
p.000199: containing research data away from public areas. Administrative safeguards include the development and enforcement of
p.000199: organizational rules about who has access to personal information about participants. Technical safeguards include use
p.000199: of computer passwords, firewalls, anti-virus software, encryption and other measures that protect data from
p.000199: unauthorized access, loss or modification.
p.000199: Identifiable Information
p.000199: Information that may reasonably be expected to identify an individual, alone or in combination with other available
p.000199: information, is considered identifiable information (or information that is identifiable) for the purposes of this
p.000199: Policy. Where the term “personal information” appears in this Policy, it refers to identifiable information.
p.000199: Types of Information
p.000199: Researchers may seek to collect, use, share and access different types of information about par- ticipants. Such
p.000199: information may include personal characteristics or other information about which an individual has a reasonable
p.000199: expectation of privacy (e.g., age, ethnicity, educational background, employment history, health history, life
p.000199: experience, religion, social status).
p.000199: For the purposes of this Policy, researchers and REBs shall consider whether information proposed for use in research
p.000199: is identifiable. The following categories provide guidance for assessing the ex- tent to which information could be
p.000199: used to identify an individual:
p.000199: • Directly identifying information – the information identifies a specific individual through direct identifiers
p.000199: (e.g., name, social insurance number, personal health number).
p.000199: • Indirectly identifying information – the information can reasonably be expected to iden- tify an individual
p.000199: through a combination of indirect identifiers (e.g., date of birth, place of residence or unique personal
p.000199: characteristic).
p.000199:
p.000199: 56 TCPS 2
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: • Coded information – direct identifiers are removed from the information and replaced with a code. Depending on
p.000199: access to the code, it may be possible to re-identify specific participants (e.g., the principal investigator retains a
p.000199: list that links the participants’ code names with their actual name so data can be re-linked if necessary).
p.000199: • Anonymized information – the information is irrevocably stripped of direct identifiers, a code is not kept to
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p.000199: identify an individual is addressed in this Policy in Chapter 5, Section A.
p.000199: In some cases, research may involve interaction with individuals who are not themselves the focus of the research in
p.000199: order to obtain information. For example, one may collect information from authorized personnel to release information
p.000199: or data in the ordinary course of their employment about organizations, policies, procedures, professional practices or
p.000199: statistical reports. Such individuals are not considered participants for the purposes of this Policy. This is
p.000199: distinct from situations where individuals are considered participants because they are themselves
p.000199: the focus of the research. For example, individuals who are asked for their personal opinions about organizations, or
p.000199: who are observed in their work setting for the purposes of research, are considered participants.
p.000199: For the purposes of this Policy, human biological materials include tissues, organs, blood, plasma, serum, DNA, RNA,
p.000199: proteins, cells, skin, hair, nail clippings, urine, saliva and other body fluids. Materials related to human
p.000199: reproduction include embryos, fetuses, fetal tissues and human reproductive materials. Embryo means a human organism
p.000199: during the first 56 days of its development following fertilization or creation, excluding any time during which its
p.000199: development has been suspended, and includes any cell derived from such an organism that is used for the purpose of
p.000199: creating a human being. Fetus means a human organism during the period of its development beginning on the 57th day
p.000199: following fertilization or creation, excluding
p.000199:
p.000199: 16 TCPS 2
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
p.000199: any time during which its development has been suspended, and ending at birth. Fetal tissue includes membranes,
p.000199: placenta, umbilical cord, amniotic fluid and other tissue that contains genetic information about the fetus.
p.000199: Human reproductive materials mean a sperm, ovum or other human cell, or a human gene, as well as a part of any of
p.000199: them. The term “human biological materials” may be considered, for the purposes of this Policy, to include materials
p.000199: related to human reproduction. The last section of Chapter 12 discusses ethical issues specific to these materials.1
p.000199: When in doubt about the applicability of this Policy to a particular research project, the researcher shall seek the
p.000199: opinion of the REB. The REB makes the final decision on exemption from research ethics review.
p.000199:
p.000199: Research Exempt from REB Review
p.000199: Some research is exempt from REB review where protections are available by other means. This Policy allows the
p.000199: following exemptions from the requirement for REB review, as outlined below.
p.000199: Article 2.2 Research that relies exclusively on publicly available information does not require REB review when:
p.000199: (a) the information is legally accessible to the public and appropriately protected by law; or
p.000199: (b) the information is publicly accessible and there is no reasonable expectation of privacy.
p.000199: Application For the purposes of this Policy, publicly available information is any existing stored documentary
p.000199: material, records or publications, which may or may not include identifiable information. Some types of information are
p.000199: legally accessible to the public in a certain form and for a certain purpose, as specified by law or regulations:
p.000199: registries of deaths, court judgments, or public archives and publicly available statistics (e.g., Statistics Canada
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p.000199: otherwise have an impact on the ethics of research. Regardless of the level of review selected, the review should
p.000199: include the necessary expertise.
p.000199: Both risks and potential benefits may span the spectrum from minimal to substantial. The concept of minimal
p.000199: risk (described above) provides a foundation for the proportionate approach to REB review. The various applications of
p.000199: the proportionate approach to REB review are addressed in Article 6.12.
p.000199: Risks to Researchers
p.000199: Risks in research are not limited to participants. In their conduct of research, researchers themselves
p.000199: may be exposed to risks that may take many forms (e.g., injury, incarceration). Risks to researchers may become a
p.000199: safety concern, especially for student researchers who are at a learning stage regarding the conduct of research, and
p.000199: who may be subject to pressures from supervisors to conduct research in unsafe situations.
p.000199: While it is not a formal part of its responsibilities, an REB may raise concerns about the safety of student
p.000199: researchers as part of its communication to the student researchers, and to their supervisors. Based on the level of
p.000199: risk, the REB may consider referring these concerns for review by an appropriate body within the institution.
p.000199:
p.000199: Endnotes
p.000199:
p.000199:
p.000199: 1 The definitions of embryo, fetus and human reproductive materials are taken from the Assisted Human Reproduction Act
p.000199: (2004, c. 2) at http://laws.justice.gc.ca/en/A-13.4 and Guidelines for Human Pluripotent Stem Cell Research at
p.000199: www.cihr-irsc.gc.ca/e/34460.html.
p.000199: 2 See guidance 3.2.1 of the International Conference on Harmonisation (ICH), Guidance for Industry – Good Clinical
p.000199: Practice: Consolidated Guideline, ICH Topic E6: Technical Requirements for the Registration of Pharmaceuticals for
p.000199: Human Use (1996, adopted by Health Canada in 1997).
p.000199: www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-eng.php
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 25
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: Introduction
p.000199: Chapter 3
p.000199: THE CONSENT PROCESS
p.000199: This chapter sets out the ethical requirements for consent in research involving humans. Throughout this
p.000199: Policy, the term “consent” means “free, informed and ongoing consent.” For the purpose of this Policy, “free” and
p.000199: “voluntary” are used interchangeably.
p.000199: Respect for Persons implies that individuals who participate in research should do so voluntarily, understanding the
p.000199: purpose of the research, and its risks and potential benefits, as fully as reasonably possible. Where a person has the
...
p.000199: capacity, or because they are pregnant or breastfeeding.
p.000199: Application Researchers should not exclude women from research on the basis of their repro- ductive capacity, or
p.000199: their pregnancy, or because they are breastfeeding, unless there is a valid reason for doing so.
p.000199: Subjecting women of childbearing potential to inappropriate requirements pre- cludes their participation in research.
p.000199: Exclusions should be made on the basis of clear criteria that reflect balanced attention to the potential benefits as
p.000199: well as the foreseeable risks of the research that may affect the welfare of women. For exam- ple, researchers should
p.000199: not require participants to use oral contraception, unless there is a valid reason for doing so.
p.000199: In considering research on pregnant or breastfeeding women, researchers and REBs shall take into account foreseeable
p.000199: risks and potential benefits for the woman and her embryo, fetus or infant, as well as the foreseeable risks and
p.000199: potential benefits of excluding pregnant or breastfeeding women from the research.
p.000199: Research Involving Children
p.000199: Children have varying degrees of maturity – metabolically, immunologically and cognitively – that may present important
p.000199: challenges for research design and the consent process, depending on the nature and complexity of the research. In
p.000199: addition to the vulnerability that arises from their developmental stage, children may also lack capacity to consent to
p.000199: participate in research (see Ar- ticle 4.6). As well, physical or psychological harms a child may experience in a
p.000199: research setting may have long-lasting consequences. As a result, researchers have often avoided the inclusion of
p.000199: children in some research, especially in clinical trials testing new treatments, so as to eliminate any risks. Clinical
p.000199: trials conducted only with adults yield a generally poor understanding of the results that apply to children.
...
p.000175: biobank.
p.000175: Identifiable data derived from human biological materials may be linked to other research or public databases. Such
p.000175: data linking can be a powerful research tool and a valuable resource for monitoring the health of populations,
p.000175: understanding factors influencing disease, and evaluating health services and interventions. However, data linkage also
p.000175: raises separate privacy issues, discussed in Section E of Chapter 5.
p.000175:
p.000175: E. Research Involving Materials Related to Human Reproduction
p.000175: Researchers who conduct research involving human biological materials related to human reproduction shall
p.000175: follow applicable guidance expressed in other chapters of this Policy. This section provides further guidance for
p.000175: research involving embryos, fetuses, fetal tissue, and reproductive materials. For the purposes of this Policy
p.000175: the following definitions apply:3
p.000175: • Embryo means a human organism during the first 56 days of its development following fertilization or creation,
p.000175: excluding any time during which its development has been suspended, and includes any cell derived from such an
p.000175: organism that is used for the purpose of creating a human being.
p.000175:
p.000175:
p.000175:
p.000175:
p.000175: 176 TCPS 2
p.000175:
p.000175: Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction
p.000175:
p.000175: • Fetus means a human organism during the period of its development beginning on the 57th day following fertilization
p.000175: or creation, excluding any time during which its development has been suspended, and ending at birth.
p.000175: • Fetal tissue includes membranes, placenta, umbilical cord, amniotic fluid and other tissue that contains genetic
p.000175: information about the fetus.
p.000175: • Human reproductive materials means a sperm, ovum or other human cell, or a human gene, and includes a part of any
p.000175: of them.
p.000175: While research involving materials related to human reproduction has great promise for assisting the development of
p.000175: healthy pregnancies, curing illness, and repairing or rebuilding tissue, it raises special ethical considerations.
p.000175: Accordingly, this research has provoked vigorous debate. Discussion and reflection should continue as our scientific
p.000175: understanding develops.
p.000175: Significant ethical issues include consent to research involving materials related to human reproduction,
p.000175: privacy concerns, the risk of harm to those who provide reproductive materials, an embryo or fetus, and potential
p.000175: commodification of reproductive capabilities and materials related to reproduction. Researchers and REBs have a
p.000175: continuing duty to remain mindful of the public interest in these issues, and to respect policy, legal and regulatory
p.000175: requirements. In particular, researchers and REBs shall be aware of the detailed requirements and prohibitions set out
p.000175: in the Assisted Human Reproduction Act.
p.000175: Article 12.6 In addition to requirements in this chapter that apply to all research involving human biological
p.000175: materials, the following guidelines apply to research involving materials related to human reproduction:
p.000175: (a) Research using materials related to human reproduction in the context of an anticipated or ongoing pregnancy shall
p.000175: not be undertaken if the knowledge sought can reasonably be obtained by alternative methods.
p.000175: (b) Materials related to human reproduction for research use shall not be obtained through commercial transaction,
p.000175: including exchange for services.
p.000175: Application Because of the risk of harm to the woman or the fetus, Article 12.6(a) requires that the use of these
p.000175: materials be avoided where pregnancy is anticipated or ongoing, if research goals may be accomplished in some other
p.000175: way.
p.000175: Article 12.6(b) reflects concerns about the commercialization or commodification of human reproduction. Exchange for
p.000175: services refers, for instance, to trading a service, such as a medical treatment, for an in vitro embryo or gamete.
p.000175:
p.000175: Research Involving Human Embryos
p.000175: Article 12.7 Research on in vitro embryos already created and intended for implantation to achieve pregnancy is
p.000175: acceptable if:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175: TCPS 2
p.000175:
p.000177: 177
p.000177:
p.000177: Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction
p.000177:
p.000177: (a) the research is intended to benefit the embryo;
p.000177: (b) research interventions will not compromise the care of the woman, or the subsequent fetus;
p.000177: (c) researchers closely monitor the safety and comfort of the woman and the safety of the embryo; and
p.000177: (d) consent was provided by the gamete donors.
p.000177: Application Research potentially altering the embryo by chemical or physical manipulation shall be distinguished
p.000177: from research directed at ensuring normal fetal development. For example, the evaluation of potential teratogens and
p.000177: their effects on certain cell lineages may use early embryos, but those embryos must not be implanted for an ongoing
p.000177: pregnancy.
p.000177: The Assisted Human Reproduction Act prohibits the creation of a human embryo specifically for research purposes, with
p.000177: the limited exception of creating an embryo for the purpose of improving, or providing instruction in, assisted
p.000177: reproduction procedures.
p.000177: Article 12.8 Research involving embryos that have been created for reproductive or other purposes
p.000177: permitted under the Assisted Human Reproduction Act, but are no longer required for these purposes, may be ethically
p.000177: acceptable if:
p.000177: (a) the ova and sperm from which they are formed were obtained in accordance with Article 12.7;
p.000177: (b) consent was provided by the gamete donors;
p.000177: (c) embryos exposed to manipulations not directed specifically to their ongoing normal development will not be
p.000177: transferred for continuing pregnancy; and
p.000177: (d) research involving embryos will take place only during the first 14 days after their formation by combination of
p.000177: the gametes, excluding any time during which embryonic development has been suspended.
p.000177: Application Research on embryos requires the consent of the gamete donors. The REB may not waive the requirement
p.000177: for such consent. In particular, researchers and REBs should be aware of the Assisted Human Reproduction (Section 8
p.000177: Consent) Regulations under the Assisted Human Reproduction Act.4
p.000177:
p.000177: Research Involving Fetuses and Fetal Tissue
p.000177: Article 12.9 Research involving a fetus or fetal tissue:
p.000177: (a) requires the consent of the woman; and
p.000177:
p.000177:
p.000177:
p.000177: 178 TCPS 2
p.000177:
p.000177: Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction
p.000177:
p.000177: (b) should not compromise the woman’s ability to decide whether to continue her pregnancy.
p.000177: Application Research may be undertaken on methods to treat, in utero, a fetus with genetic or congenital disorders.
p.000177: Because the fetus and the woman cannot be treated separately, any intervention to one involves an intervention to the
p.000177: other. Research involving a fetus or fetal tissue shall be guided by respect for the woman’s autonomy and physical
p.000177: integrity. Guidance provided in other chapters of this Policy (e.g., consent, privacy and confidentiality, inclusion
p.000177: and exclusion) will also apply. Researchers should ensure that a clear distinction is made between consent to research
p.000177: and consent for any clinical procedures or testing. In practice, this may mean separate consent information and
p.000177: documents, but regardless of the process employed, the differences between research and clinical procedures must be
p.000177: clearly explained.
p.000177:
p.000177: F. Research Involving Pluripotent Stem Cells
p.000177:
p.000177: Article 12.10 Researchers who intend to conduct research to derive or use pluripotent stem cells shall follow the
p.000177: Guidelines for Human Pluripotent Stem Cell Research,5 as amended from time to time and published by the
p.000177: Canadian Institutes of Health Research.
p.000177: Application The Guidelines for Human Pluripotent Stem Cell Research establish principles that guide the conduct of
p.000177: research with human pluripotent stem cells. The Guidelines explain their scope of application, provide examples of
p.000177: types of research to which they apply, and identify examples of research that conform and do not conform with the
p.000177: guidance. Consent, privacy and confidentiality are addressed, along with issues of commercial interests.
p.000177: Hybrids and Chimeras
p.000177: Research involving the creation of animal-human hybrids and chimeras may raise serious ethical concerns, and federal
p.000177: legislation prohibits certain activities relating to their creation. Researchers and REBs are referred to the Assisted
p.000177: Human Reproduction Act and The Updated Guidelines for Human Pluripotent Stem Cell Research for these prohibitions.
p.000177:
p.000177: Endnotes
p.000177:
p.000177:
p.000177: 1 See also Canadian Institutes of Health Research, CIHR Guidelines for Health Research Involving Aboriginal People.
p.000177: www.cihr-irsc.gc.ca/e/29134.html
p.000177: 2 For discussion of factors relevant to assessing impracticability of consent, see, for example, Canadian Institutes of
p.000177: Health Research, CIHR Best Practices for Protecting Privacy in Health Research, Section 3.3, Secondary Use (September
p.000177: 2005). www.cihr-irsc.gc.ca/e/29072.html#Element3
p.000177:
p.000177:
p.000177:
p.000177:
p.000177:
p.000177: TCPS 2
p.000179: 179
p.000179:
p.000179: Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction
p.000179:
p.000179: 3 The definitions of embryo, fetus and human reproductive materials are taken from the Assisted Human Reproduction Act
p.000179: (2004, c. 2). http://laws.justice.gc.ca/en/A-13.4
p.000179: 4 Assisted Human Reproduction (Section 8 Consent) Regulations (SOR/2007-137). http://laws.justice.gc.ca/en/SOR-2007-137
p.000179: 5Canadian Institutes of Health Research, Guidelines for Human Pluripotent Stem Cell Research. June 30, 2010.
p.000179: www.cihr-irsc.gc.ca/e/42071.html
p.000179:
p.000179:
p.000179: References
p.000179:
p.000179:
p.000179: • International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for
p.000179: Human Use (ICH) defines biological sample coding categories. Health Canada has adopted these definitions.
p.000179: www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e15-eng.php
p.000179: • Organisation for Economic Co-operation and Development. (OECD), Guidelines for Human Biobanks and Genetic
p.000179: Research Databases. 2009. www.oecd.org/sti/biotechnology/hbgrd
p.000179: • Québec. Fonds de la recherche en santé du Québec. Final Report: Advisory Group on a Governance Framework for Data
p.000179: Banks and Biobanks Used for Health Research. 2006.
p.000179: www.frsq.gouv.qc.ca/en/ethique/pdfs_ethique/Rapport_groupe_conseil_anglais.pdf
p.000179:
p.000179:
p.000179:
p.000179:
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p.000179:
p.000179:
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p.000179:
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p.000189: Delegated reviewers are selected from among the REB membership, with the exception of the ethics review of student
p.000189: course-based research which can be reviewed by delegates from the student’s department, faculty, or an equivalent
p.000189: level.
p.000189: Embryo – A human organism during the first 56 days of its development following fertilization or creation, excluding
p.000189: any time during which its development has been suspended. It also includes any cell derived from such an organism that
p.000189: is used for the purpose of creating a human being.
p.000189:
p.000189:
p.000189:
p.000189:
p.000189:
p.000189:
p.000189: TCPS 2
p.000191: 191
p.000191:
p.000191: Glossary
p.000191:
p.000191: Emergency preparedness plans – Plans that detail an institution’s policies and procedures for addressing research
p.000191: ethics review during public health outbreaks, natural disasters, and other publicly declared emer- gencies. See
p.000191: “Publicly declared emergency.”
p.000191:
p.000191: Emergent design – A research method in which data collection and analyses can evolve over the course of a research
p.000191: project in response to what is learned in earlier parts of the study.
p.000191:
p.000191: Fetal tissue – Membranes, placenta, umbilical cord, amniotic fluid, and other tissue that contains genetic information
p.000191: about the fetus.
p.000191: Fetus – A human organism during the period of its development beginning on the 57th day following fertilization or
p.000191: creation, excluding any time during which its development has been suspended, and ending at birth.
p.000191:
p.000191: Full research ethics board (REB) review – The level of REB review assigned to above minimal risk re- search projects.
p.000191: Conducted by the full membership of the research ethics board, it is the default requirement for the ethics review of
p.000191: research involving humans.
p.000191:
p.000191: Gene alteration – The transfer of genes into cells to induce an altered capacity of the cell.
p.000191:
p.000191: Genetic counselling – The explanation of the meaning and implication of information revealed in genetic research to a
p.000191: participant by someone with the experience or training to provide the appropriate context and support .
p.000191:
p.000191: Harm – Anything that has a negative effect on participants’ welfare, broadly construed. The nature of the harm may be
p.000191: social, behavioural, psychological, physical or economic. See “Welfare.”
p.000191:
p.000191: Human biological materials – Tissues, organs, blood, plasma, skin, serum, DNA, RNA, proteins, cells, hair, nail
p.000191: clippings, urine, saliva, and other body fluids. The term also includes materials related to human reproduction,
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p.000199: Welfare, and Justice. The preferred approach to research ethics review is a proportionate approach. The research ethics
p.000199: board (REB) tailors the level of scrutiny by an REB to the level of risk presented by the research, and assesses the
p.000199: ethical acceptability of the research through consideration of the foreseeable risks, the potential benefits and the
p.000199: ethical implications of the research, both at the stage of the initial REB review and throughout the life of the
p.000199: project (continuing ethics review). The establishment, governance, jurisdiction and composition of REBs, and
p.000199: operational issues related to their functioning are addressed in Chapter 6.
p.000199:
p.000199: A. Scope of Research Ethics Review
p.000199:
p.000199: Research Requiring REB Review
p.000199: The following article defines the general categories of research that require REB review in accordance
p.000199: with this Policy, subject to the exceptions set out further on in this Policy. These exceptions are distinct from
p.000199: research that is exempt from REB review, as described in Articles 2.2 to 2.4.
p.000199:
p.000199: Article 2.1 The following requires ethics review and approval by an REB before the research commences:
p.000199: (a) research involving living human participants;
p.000199: (b) research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive
p.000199: materials and stem cells. This applies to materials derived from living and deceased individuals.
p.000199: Application The scope of this Policy is restricted to the review of the ethical conduct of research involving
p.000199: humans. The scope of REB review is limited to those activities defined in this Policy as “research” involving “human
p.000199: participants.”
p.000199: For the purposes of this Policy, “research” is defined as an undertaking intended to extend knowledge through a
p.000199: disciplined inquiry or systematic investigation.
p.000199: A determination that research is the intended purpose of the undertaking is key for differentiating activities that
p.000199: require ethics review by an REB and those that do not.
p.000199:
p.000199: TCPS 2 15
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
p.000199: For the purposes of this Policy, “human participants” (referred to as “participants”) are those individuals whose data,
p.000199: or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question.
p.000199: Human participants are unique among the many parties involved in research, because they bear the primary
p.000199: risks of the research. These individuals are often referred to as “research subjects.” This Policy prefers the term
p.000199: “participant” because it better reflects the spirit behind the core principles: that individuals who choose to
p.000199: participate in research play a more active role than the term “subject” conveys. As well, it reflects the range of
...
p.000199: participants, they are expected to determine whether the information or data proposed in research may reasonably be
p.000199: expected to identify an individual. For the purposes of this Policy, researchers and REBs shall consider whether
p.000199: information is identifiable or non-identifiable. Information is identifiable if it, alone or when combined with other
p.000199: available information, may reasonably be expected to identify an individual. The term “personal information” generally
p.000199: denotes identifiable information about an individual. Guidance on the assessment of the potential for information to
p.000199: identify an individual is addressed in this Policy in Chapter 5, Section A.
p.000199: In some cases, research may involve interaction with individuals who are not themselves the focus of the research in
p.000199: order to obtain information. For example, one may collect information from authorized personnel to release information
p.000199: or data in the ordinary course of their employment about organizations, policies, procedures, professional practices or
p.000199: statistical reports. Such individuals are not considered participants for the purposes of this Policy. This is
p.000199: distinct from situations where individuals are considered participants because they are themselves
p.000199: the focus of the research. For example, individuals who are asked for their personal opinions about organizations, or
p.000199: who are observed in their work setting for the purposes of research, are considered participants.
p.000199: For the purposes of this Policy, human biological materials include tissues, organs, blood, plasma, serum, DNA, RNA,
p.000199: proteins, cells, skin, hair, nail clippings, urine, saliva and other body fluids. Materials related to human
p.000199: reproduction include embryos, fetuses, fetal tissues and human reproductive materials. Embryo means a human organism
p.000199: during the first 56 days of its development following fertilization or creation, excluding any time during which its
p.000199: development has been suspended, and includes any cell derived from such an organism that is used for the purpose of
p.000199: creating a human being. Fetus means a human organism during the period of its development beginning on the 57th day
p.000199: following fertilization or creation, excluding
p.000199:
p.000199: 16 TCPS 2
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
p.000199: any time during which its development has been suspended, and ending at birth. Fetal tissue includes membranes,
p.000199: placenta, umbilical cord, amniotic fluid and other tissue that contains genetic information about the fetus.
p.000199: Human reproductive materials mean a sperm, ovum or other human cell, or a human gene, as well as a part of any of
p.000199: them. The term “human biological materials” may be considered, for the purposes of this Policy, to include materials
p.000199: related to human reproduction. The last section of Chapter 12 discusses ethical issues specific to these materials.1
p.000199: When in doubt about the applicability of this Policy to a particular research project, the researcher shall seek the
p.000199: opinion of the REB. The REB makes the final decision on exemption from research ethics review.
p.000199:
...
p.000175: and use of stored biological materials. The appropriate governance structure and management of a biobank will vary
p.000175: depending on its size and usage.
p.000175: Organizations that maintain biobanks may have their own policies on privacy of, confidentiality of and access to
p.000175: materials. Researchers should be aware of requirements for compliance with such policies. For example, researchers
p.000175: may be required to apply to the organization for permission to access biological samples, and they may be required to
p.000175: enter into an agreement with the organization that sets out conditions for research access and use of materials in the
p.000175: biobank.
p.000175: Identifiable data derived from human biological materials may be linked to other research or public databases. Such
p.000175: data linking can be a powerful research tool and a valuable resource for monitoring the health of populations,
p.000175: understanding factors influencing disease, and evaluating health services and interventions. However, data linkage also
p.000175: raises separate privacy issues, discussed in Section E of Chapter 5.
p.000175:
p.000175: E. Research Involving Materials Related to Human Reproduction
p.000175: Researchers who conduct research involving human biological materials related to human reproduction shall
p.000175: follow applicable guidance expressed in other chapters of this Policy. This section provides further guidance for
p.000175: research involving embryos, fetuses, fetal tissue, and reproductive materials. For the purposes of this Policy
p.000175: the following definitions apply:3
p.000175: • Embryo means a human organism during the first 56 days of its development following fertilization or creation,
p.000175: excluding any time during which its development has been suspended, and includes any cell derived from such an
p.000175: organism that is used for the purpose of creating a human being.
p.000175:
p.000175:
p.000175:
p.000175:
p.000175: 176 TCPS 2
p.000175:
p.000175: Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction
p.000175:
p.000175: • Fetus means a human organism during the period of its development beginning on the 57th day following fertilization
p.000175: or creation, excluding any time during which its development has been suspended, and ending at birth.
p.000175: • Fetal tissue includes membranes, placenta, umbilical cord, amniotic fluid and other tissue that contains genetic
p.000175: information about the fetus.
p.000175: • Human reproductive materials means a sperm, ovum or other human cell, or a human gene, and includes a part of any
p.000175: of them.
p.000175: While research involving materials related to human reproduction has great promise for assisting the development of
p.000175: healthy pregnancies, curing illness, and repairing or rebuilding tissue, it raises special ethical considerations.
...
p.000177: pregnancy.
p.000177: The Assisted Human Reproduction Act prohibits the creation of a human embryo specifically for research purposes, with
p.000177: the limited exception of creating an embryo for the purpose of improving, or providing instruction in, assisted
p.000177: reproduction procedures.
p.000177: Article 12.8 Research involving embryos that have been created for reproductive or other purposes
p.000177: permitted under the Assisted Human Reproduction Act, but are no longer required for these purposes, may be ethically
p.000177: acceptable if:
p.000177: (a) the ova and sperm from which they are formed were obtained in accordance with Article 12.7;
p.000177: (b) consent was provided by the gamete donors;
p.000177: (c) embryos exposed to manipulations not directed specifically to their ongoing normal development will not be
p.000177: transferred for continuing pregnancy; and
p.000177: (d) research involving embryos will take place only during the first 14 days after their formation by combination of
p.000177: the gametes, excluding any time during which embryonic development has been suspended.
p.000177: Application Research on embryos requires the consent of the gamete donors. The REB may not waive the requirement
p.000177: for such consent. In particular, researchers and REBs should be aware of the Assisted Human Reproduction (Section 8
p.000177: Consent) Regulations under the Assisted Human Reproduction Act.4
p.000177:
p.000177: Research Involving Fetuses and Fetal Tissue
p.000177: Article 12.9 Research involving a fetus or fetal tissue:
p.000177: (a) requires the consent of the woman; and
p.000177:
p.000177:
p.000177:
p.000177: 178 TCPS 2
p.000177:
p.000177: Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction
p.000177:
p.000177: (b) should not compromise the woman’s ability to decide whether to continue her pregnancy.
p.000177: Application Research may be undertaken on methods to treat, in utero, a fetus with genetic or congenital disorders.
p.000177: Because the fetus and the woman cannot be treated separately, any intervention to one involves an intervention to the
p.000177: other. Research involving a fetus or fetal tissue shall be guided by respect for the woman’s autonomy and physical
p.000177: integrity. Guidance provided in other chapters of this Policy (e.g., consent, privacy and confidentiality, inclusion
p.000177: and exclusion) will also apply. Researchers should ensure that a clear distinction is made between consent to research
...
p.000191: creation, excluding any time during which its development has been suspended, and ending at birth.
p.000191:
p.000191: Full research ethics board (REB) review – The level of REB review assigned to above minimal risk re- search projects.
p.000191: Conducted by the full membership of the research ethics board, it is the default requirement for the ethics review of
p.000191: research involving humans.
p.000191:
p.000191: Gene alteration – The transfer of genes into cells to induce an altered capacity of the cell.
p.000191:
p.000191: Genetic counselling – The explanation of the meaning and implication of information revealed in genetic research to a
p.000191: participant by someone with the experience or training to provide the appropriate context and support .
p.000191:
p.000191: Harm – Anything that has a negative effect on participants’ welfare, broadly construed. The nature of the harm may be
p.000191: social, behavioural, psychological, physical or economic. See “Welfare.”
p.000191:
p.000191: Human biological materials – Tissues, organs, blood, plasma, skin, serum, DNA, RNA, proteins, cells, hair, nail
p.000191: clippings, urine, saliva, and other body fluids. The term also includes materials related to human reproduction,
p.000191: including embryos, fetuses, fetal tissues and human reproductive materials.
p.000191: Identified human biological materials – The materials are labelled with a direct identifier (e.g. name, personal health
p.000191: number). Materials and any associated information are directly traceable back to a specific individual.
p.000191: Coded human biological materials – Direct identifiers are removed from the materials and replaced with a code.
p.000191: Depending on access to the code, it may be possible to re-identify specific individuals (e.g. a principal investigator
p.000191: retains a key that links the coded material with a specific individual if re-linkage is necessary).
p.000191: Anonymized human biological materials – The materials are irrevocably stripped of direct iden- tifiers, a code is not
p.000191: kept to allow future re-linkage, and risk of re-identification of individuals from remaining indirect identifiers is
p.000191: low or very low.
p.000191: Anonymous human biological materials – The materials never had identifiers attached to them and risk of identification
p.000191: of individuals is low or very low.
p.000191: Human genetic research – The study of genetic factors responsible for human traits and the interaction of those factors
p.000191: with each other, and with the environment.
p.000191:
p.000191:
p.000191:
p.000191: 192 TCPS 2
p.000191:
p.000191: Glossary
p.000191:
p.000191: Human participant – See “Participant.”
p.000191: Human reproductive materials – A sperm, ovum, or other human cell, or a human gene, including a part of any of them.
p.000191:
p.000191: Identifiable information – Information that may reasonably be expected to identify an individual, alone or in
...
p.000201: 201
p.000201:
p.000201: Index
p.000201:
p.000201: Continuing research ethics review, 21-22, 79-81
p.000201: Core principles, 8-11
p.000201: Concern for Welfare, 8, 9-10, 109
p.000201: Justice, 8, 10-11, 47, 109-110
p.000201: interpretation, 13, 109-110
p.000201: Respect for Persons, 8-9, 27, 109
p.000201: Creative practice, 20
p.000201: Critical inquiry, 35-36, 117
p.000201: Cultural heritage, 110-111
p.000201: Cyber-material, 18
p.000201:
p.000201: D
p.000201: Data
p.000201: anonymized, 57
p.000201: anonymous, 57, 131-132
p.000201: collection, 64, 76-77, 137, 144-145
p.000201: destruction, 61
p.000201: linkage, 18, 19, 64-65, 131-132
p.000201: security, 61, 64-65
p.000201: withdrawal, 28-30, 31 (see also Information)
p.000201: Data safety monitoring board (DSMB), 160-161 Debriefing, 37-39, 143
p.000201: Design
p.000201: clinical trials, 149-156
p.000201: emergent, 144-145 Duty of care, 148-149
p.000201: E
p.000201: Elderly, as research participants, 10, 47, 50
p.000201: Elders, in Aboriginal communities, 119, 126
p.000201: Embryos, 15-17, 49, 176, 177-178
p.000201: Emergencies
p.000201: individual medical, 39-40
p.000201: publicly declared (see Publicly declared emergencies) Emergent design, 144-145
p.000201: Ethics (see Research ethics)
p.000201:
p.000201: F
p.000201: Fetal tissue, 15-17, 177, 178-179
p.000201: Fetuses, 15-17, 49, 177, 178, 178-791
p.000201: Findings
p.000201: commercialization, 30-32, 186
p.000201: dissemination, 61, 128, 143-144, 164-167, 183-184
p.000201: incidental, 34, 171-172
p.000201: interpretation, 126, 128
p.000201:
p.000201:
p.000201:
p.000201: 202 TCPS 2
p.000201:
p.000201: Index
p.000201:
p.000201: First Nations, 105, 107, 108, 110, 114, 115, 117, 121, 127
p.000201: (see also Aboriginal peoples)
p.000201:
p.000201: G
p.000201: Genetic research (see Human genetic research)
p.000201:
p.000201: H
p.000201: Harm, definition, 10, 22-23
p.000201: Human biological materials
p.000201: Aboriginal peoples, 119, 129-132
p.000201: anonymized, 170
p.000201: anonymous, 19, 131-132, 170
p.000201: coded, 170
p.000201: collection, 76-77, 129-130, 170-172
p.000201: consent for use, 9, 28-30, 31, 171-175
p.000201: definition, 16-17, 169
p.000201: identified, 170
p.000201: secondary use, 62-64, 119-121, 130-132, 172-175, 186
p.000201: storage and banking, 175-176 types, 169-170
p.000201: withdrawal, 28-30, 31, 172
p.000201: (see also Human reproduction, materials related to) Human dignity, respect for, 8-11, 28
p.000201: Human genetic research
p.000201: application of core principles, 181-182 definition, 181
p.000201: gene alteration, 186-187
p.000201: gene transfer, 186-187
p.000201: genetic counselling, 184 genetic material banks, 186
p.000201: involving communities and groups, 181, 183-184, 185
p.000201: involving families, 181, 183-184, 184-185
p.000201: managing information concerning, 182-184 Human participants (see Participants)
p.000201: Human reproduction, materials related to
p.000201: Assisted Human Reproduction Act, 177, 178, 179, 186
p.000201: consent, 177-179
p.000201: definition, 16-17, 176-177
p.000201: embryos, 15-17, 49, 176, 177-178
p.000201: fetal tissue, 15-17, 177, 178-179
p.000201: fetuses, 15-17, 49, 177, 178, 178-179
p.000201: human reproductive materials, 15-17, 177
p.000201: pluripotent stem cells, 179
p.000201: (see also Human biological materials) Hybrids, 179
p.000201:
p.000201:
p.000201:
p.000201:
p.000201:
p.000201:
p.000201: TCPS 2
p.000201:
p.000203: 203
p.000203:
p.000203: Index
p.000203:
p.000203: I
p.000203: Incentives for participation in research
p.000203: conflicts of interest, 29-30, 52, 151, 164
p.000203: consent, 29-30, 31, 151
p.000203: Incidental findings, 34, 171-172
p.000203: Indigenous peoples, 107, 108, 110 (see also Aboriginal peoples)
p.000203: Information
p.000203: anonymized, 57
p.000203: anonymous, 19, 57, 131-132
p.000203: coded, 57
p.000203: data linkage, 18, 19, 64-65, 131-132
p.000203: directly identifying, 56
p.000203: disclosure, 30-33, 59-61, 126-128
p.000203: dissemination, 18-19, 31, 128, 143-144, 164-167
p.000203: identifiable, 19, 56
p.000203: indirectly identifying, 56
p.000203: personal (see Information: identifiable) publicly available, 17-18, 64-65, 131 reporting new, in clinical trials,
p.000203: 159-163 safeguarding, 60-61
p.000203: secondary use of identifiable (see Secondary use of identifiable information) security, 56, 60-61, 64-65
p.000203: sharing, 159-163, 182-184
p.000203: types, 56-57 (see also Data)
p.000203: Informed consent (see Consent)
p.000203: Institutions
p.000203: appointment of appeal boards, 84-85 compliance with Policy, 5-6 conflicts of interest, 89-90, 91-93
p.000203: multi-jurisdictional review, 97-99, 100-103
p.000203: senior administrators, 70-71, 93-94
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Social / Incarcerated
Searching for indicator liberty:
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p.000199: In addition to the principles and guidelines in this Policy, researchers are responsible for ascertaining
p.000199: and complying with all applicable legal and regulatory requirements with respect to consent and the protection of
p.000199: privacy of participants (see Chapter 5). These legal and regulatory requirements may vary depending on the jurisdiction
p.000199: in Canada in which the research is being conducted, and who is funding and/or conducting the research, and
p.000199: they may comprise constitutional, statutory, regulatory, common law, and/or international or legal requirements of
p.000199: jurisdictions outside of Canada. Where the research is considered to be a governmental activity, for example, standards
p.000199: for protecting privacy flowing from the Canadian Charter of Rights and Freedoms, federal privacy legislation and
p.000199: regulatory requirements would apply.
p.000199: The law affects and regulates the standards and conduct of research involving humans in a variety of areas, including,
p.000199: but not limited to privacy, confidentiality, intellectual property and the capacity of participants. In addition, human
p.000199: rights legislation and most documents on research ethics prohibit discrimination on a variety of grounds and recognize
p.000199: equal treatment as fundamental. REBs and researchers should also respect the spirit of the Canadian Charter
p.000199: of Rights and Freedoms, particularly the sections dealing with life, liberty and security of the person, as well as
p.000199: those involving equality and discrimination.
p.000199: Researchers may face situations where they experience a tension between the requirements of the law and the guidance of
p.000199: the ethical principles in this Policy. In such situations, researchers should strive to comply with the law in the
p.000199: application of ethical principles. Researchers should consult with colleagues, the REB or any relevant professional
p.000199: body, and if necessary, seek independent legal advice to help resolve any conflicts between law and ethics, and guide
p.000199: an appropriate course of action.
p.000199: This legal context for research involving humans is constantly evolving and varies from jurisdiction to jurisdiction.
p.000199: For this reason, REBs and researchers should be aware of applicable laws so they can identify legal issues that may
p.000199: occur in the conduct of research. REBs may satisfy this obligation through expertise among their members or through
p.000199: wider consultation. The researcher may seek independent legal advice when necessary.
p.000199: The Perspective of the Participant
p.000199: In designing and conducting research or reviewing the ethics of research, researchers and REBs must be mindful of the
p.000199: perspective of the participant. It may be necessary to consider the various contexts (e.g., social, economic, cultural)
p.000199: that shape the participant’s life, to properly evaluate the implications of the research in terms of the core
p.000199: principles.
p.000199: Appropriate Expertise for Review
...
Searching for indicator prison:
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p.000135: particular social environment, or exploring previously understudied phenomena to develop new theoretical approaches to
p.000135: research.
p.000135: (g) Dynamic, Negotiated and Ongoing Consent Process: Entry into a particular setting for research purposes sometimes
p.000135: requires negotiation with the population of interest; sometimes the researcher cannot ascertain the process in
p.000135: advance of the research, in part because the relevant contexts within which the research occurs evolve over time.
p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135: TCPS 2
p.000137: 137
p.000137:
p.000137: Chapter 10 – Qualitative Research
p.000137:
p.000137: In some cases, participants hold equal or greater power in the researcher-participant rela- tionship, such as in
p.000137: community-based and/or organizational research when a collaborative process is used to define and design the research
p.000137: project and questions, or where partici- pants are public figures or hold other positions of power (e.g., research
p.000137: involving economic, social, political or cultural elites). In other cases, researchers themselves may hold greater
p.000137: power when access to prospective participant populations is gained through gatekeepers with whom the researcher has
p.000137: established a relationship (e.g., when a researcher engages with the police to do research in relation to a problem
p.000137: population, or when researchers en- gage with prison authorities to do research with offenders).
p.000137: (h) Research Partnerships: Access to particular settings and populations is sometimes developed over time, and
p.000137: the relationships that are formed may well exist outside the research setting per se, which sometimes makes it
p.000137: difficult to determine exactly where the “research” relationship begins and ends. In many cases, despite
p.000137: in-depth, advance preparation, a researcher may not know until the actual data collecting starts just where the search
p.000137: will lead. Indeed, the emergent nature of many qualitative studies makes the achievement of rapport with participants
p.000137: and feelings of interpersonal trust crucial to the generation of questions considered important or interesting by both
p.000137: parties, and to the collection of dependable data. Research often becomes a collaborative process negotiated between
p.000137: the participant(s) and the researcher, requiring considerable time spent initially simply figuring out the focus of the
p.000137: research.
p.000137: In certain cases, contacts between researchers and participants can extend over a lifetime, and these individuals may
p.000137: engage in a variety of relationships over and above their specific “research” relationship.
p.000137: (i) Research Results: Generalizability of the results to other contexts and the representative- ness of the sample may
p.000137: or may not be a concern in qualitative research. Transferability of results from one setting to another is often viewed
p.000137: as more of a theoretical issue than a procedural or a sampling issue.
p.000137:
p.000137: B. Research Ethics Review of Qualitative Research
...
Searching for indicator restricted:
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p.000199: board (REB) tailors the level of scrutiny by an REB to the level of risk presented by the research, and assesses the
p.000199: ethical acceptability of the research through consideration of the foreseeable risks, the potential benefits and the
p.000199: ethical implications of the research, both at the stage of the initial REB review and throughout the life of the
p.000199: project (continuing ethics review). The establishment, governance, jurisdiction and composition of REBs, and
p.000199: operational issues related to their functioning are addressed in Chapter 6.
p.000199:
p.000199: A. Scope of Research Ethics Review
p.000199:
p.000199: Research Requiring REB Review
p.000199: The following article defines the general categories of research that require REB review in accordance
p.000199: with this Policy, subject to the exceptions set out further on in this Policy. These exceptions are distinct from
p.000199: research that is exempt from REB review, as described in Articles 2.2 to 2.4.
p.000199:
p.000199: Article 2.1 The following requires ethics review and approval by an REB before the research commences:
p.000199: (a) research involving living human participants;
p.000199: (b) research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive
p.000199: materials and stem cells. This applies to materials derived from living and deceased individuals.
p.000199: Application The scope of this Policy is restricted to the review of the ethical conduct of research involving
p.000199: humans. The scope of REB review is limited to those activities defined in this Policy as “research” involving “human
p.000199: participants.”
p.000199: For the purposes of this Policy, “research” is defined as an undertaking intended to extend knowledge through a
p.000199: disciplined inquiry or systematic investigation.
p.000199: A determination that research is the intended purpose of the undertaking is key for differentiating activities that
p.000199: require ethics review by an REB and those that do not.
p.000199:
p.000199: TCPS 2 15
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
p.000199: For the purposes of this Policy, “human participants” (referred to as “participants”) are those individuals whose data,
p.000199: or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question.
p.000199: Human participants are unique among the many parties involved in research, because they bear the primary
p.000199: risks of the research. These individuals are often referred to as “research subjects.” This Policy prefers the term
p.000199: “participant” because it better reflects the spirit behind the core principles: that individuals who choose to
p.000199: participate in research play a more active role than the term “subject” conveys. As well, it reflects the range of
p.000199: research covered by this Policy, and the varied degree of involvement by participants – including the use of their data
p.000199: or human biological materials – that different types of research offer. The core principles of this Policy – Respect
...
p.000199:
p.000199: reasonable expectation of privacy. For example, identifiable information may be disseminated in the public domain
p.000199: through print or electronic publications; film, audio or digital recordings; press accounts; official publications of
p.000199: private or public institutions; artistic installations, exhibitions or literary events freely open to the public; or
p.000199: publications accessible in public libraries. Research that is non-intrusive, and does not involve direct interaction
p.000199: between the researcher and individuals through the Internet, also does not require REB review. Cyber-material such as
p.000199: documents, records, performances, online archival materials or published third party interviews to which the public is
p.000199: given uncontrolled access on the Internet for which there is no expectation of privacy is considered to be publicly
p.000199: available information.
p.000199: Exemption from REB review is based on the information being accessible in the public domain, and that the individuals
p.000199: to whom the information refers have no reasonable expectation of privacy. Information contained in publicly accessible
p.000199: material may, however, be subject to copyright and/or intellectual property rights protections or dissemination
p.000199: restrictions imposed by the legal entity controlling the information.
p.000199: However, there are situations where REB review is required.
p.000199: There are publicly accessible digital sites where there is a reasonable expectation of privacy. When accessing
p.000199: identifiable information in publicly accessible digital sites, such as Internet chat rooms, and self-help groups with
p.000199: restricted membership, the privacy expectation of contributors of these sites is much higher. Researchers shall submit
p.000199: their proposal for REB review (see Article 10.3).
p.000199: Where data linkage of different sources of publicly available information is involved, it could give rise to
p.000199: new forms of identifiable information that would raise issues of privacy and confidentiality when used in
p.000199: research, and would therefore require REB review (see Article 5.7).
p.000199: When in doubt about the applicability of this article to their research, researchers should consult their REBs.
p.000199: Article 2.3 REB review is not required for research involving the observation of people in public places where:
p.000199: (a) it does not involve any intervention staged by the researcher, or direct interaction with the individuals or
p.000199: groups;
p.000199: (b) individuals or groups targeted for observation have no reasonable expectation of privacy; and
p.000199: (c) any dissemination of research results does not allow identification of specific individuals.
p.000199:
p.000199:
p.000199:
p.000199: 18 TCPS 2
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
p.000199: Application For the purposes of this article, observational research is used to study acts or behaviour in a
p.000199: natural environment. It does not refer to observational methods used in epidemiological studies.
p.000199: When designing their research, researchers shall pay attention to the environment in which observation takes place, the
p.000199: expectation of privacy that individuals in public places might have, and the means of recording observations.
p.000199: Researchers shall also determine whether the use of this information in the dissemination of research results (e.g.,
...
p.000199: and
p.000199: (f) no relevant prior directive by the participant is known to exist.
p.000199: When a previously incapacitated participant regains capacity, or when an authorized third party is found, consent
p.000199: shall be sought promptly for continuation in the project, and for subsequent examinations or tests related to
p.000199: the research project.
p.000199: Application For purposes of studying potential improvement in the treatment of life-threatening conditions, Article
p.000199: 3.8 outlines an exception (in addition to that in Article 3.7) to the general obligation of seeking consent from those
p.000199: participating in research.
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 39
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: It is the responsibility of researchers to justify to the REB the need for this exception. The underlying
p.000199: assumption of Article 3.8 is that participants could not receive any direct benefits of the research without setting
p.000199: aside the need for the researcher to seek the prior consent of participants, or of their authorized third party.
p.000199: Article 3.8 indicates that research in emergency medicine must be reviewed by the REB, be restricted to the emergency
p.000199: needs of the participants, and be conducted under criteria designated by the REB.
p.000199: It is unethical to expose participants to any additional risk without their consent if standard efficacious care
p.000199: exists, unless it can clearly be shown that there is a realistic possibility of meaningful improvement of the
p.000199: participant’s condition. Accordingly, paragraphs (b) and (c) of Article 3.8 indicate that researchers and REBs must
p.000199: assess the risks and potential benefits of proposed research against existing standard efficacious care.
p.000199: To respect the autonomy of the participant, Article 3.8(e) requires researchers to undertake diligent efforts to
p.000199: contact authorized third parties, if reasonably feasible, and to document such efforts for the benefit of both
p.000199: the participant and the continuing ethics review functions of the REB. The article also requires that
p.000199: participants who regain capacity be promptly afforded the opportunity to consent to their continued participation.
p.000199: Concern for the patient’s welfare is paramount and should be informed by ethical and professional judgment.
...
p.000199: linguistic proficiency, gender or age, unless there is a valid reason for the exclusion.
p.000199: Application Article 4.1 is based on the principle of Justice. It imposes a duty on researchers not to exclude
p.000199: individuals or groups from participation for reasons that are unrelated to the research. This duty is explicitly stated
p.000199: because groups have been inappropri- ately excluded from participation in research on the basis of attributes such as
p.000199: gender, race, ethnicity, age and disability.
p.000199: The focus, objective, nature of research and context in which the research is con- ducted inform the inclusion and
p.000199: exclusion criteria for a specific research project. Some research may be focused on a certain individual (such as in a
p.000199: biography), or a group of individuals who share a specific characteristic (e.g., an identifiable group of painters who
p.000199: happen to be all of one sex; a religious order that is restricted to one sex). Other examples include research that is
p.000199: focused on specific cultural tra- ditions or languages, or on one age group (e.g., a biomechanical modeling study of
p.000199: posture corrections in adolescents). Such research should not be precluded so long as the selection criteria for those
p.000199: to be included in the research are germane to answering the research question. Researchers who plan to actively exclude
p.000199: par- ticular groups should clarify to their REBs the grounds for the exclusion.
p.000199: Where a language barrier exists between the researcher and the prospective partic- ipant, various measures may be
p.000199: used to ensure effective communication in recruitment and consent discussions. For example, an intermediary who
p.000199: may not be part of the research project or team, but who is competent in the language used by the researchers, as well
p.000199: as that preferred by the participant, may assist with com- munication between prospective participants and researchers.
p.000199: The selection of an intermediary and their activities will depend on the nature, context and risks of the research.
p.000199:
p.000199: B. Inappropriate Exclusion
p.000199: Research Involving Women
p.000199: Women have historically been inappropriately excluded from participating in some research. This exclusion of women,
...
p.000199: Researchers will need to seek consent from individual participants for any new data collection. Article 3.1 provides
p.000199: further guidance on consent and approaches to recruitment.
p.000199:
p.000199: E. Data Linkage
p.000199: Article 5.7 Researchers who propose to engage in data linkage shall obtain REB approval prior to carrying out the
p.000199: data linkage, unless the research relies exclusively on publicly available information as discussed in Article 2.2. The
p.000199: application for approval shall describe the data that will be linked and the likelihood that identifiable information
p.000199: will be created through the data linkage.
p.000199: Where data linkage involves or is likely to produce identifiable information, re- searchers shall satisfy the REB that:
p.000199:
p.000199:
p.000199: 64 TCPS 2
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: (a) the data linkage is essential to the research; and
p.000199: (b) appropriate security measures will be implemented to safeguard information.
p.000199: Application Growing numbers of databases and advancing technological capacity to link data- bases create new
p.000199: research opportunities, but also new privacy risks. In particular, linkage of de-identified or anonymized databases may
p.000199: permit re-identification of individuals. This article provides guidance for researchers who propose to carry out data
p.000199: linkage and requires that they assess and minimize risks of re-identification. Only a restricted number of individuals
p.000199: should perform the function of merging databases. Researchers should use enhanced security measures to store the merged
p.000199: file.
p.000199: Where researchers seek access to datasets held by another organization, it may be preferable for the data holder to
p.000199: carry out the data linkage and remove identifiers before disclosing the merged dataset.
p.000199: Legislation and organizational policies may regulate data linkage in specific cir- cumstances. For example, some
p.000199: personal information protection legislation requires data-sharing agreements that regulate conditions under which data
p.000199: linkage may be carried out. Data holders, such as statistics agencies, may also have policies on data linkage.5
p.000199: Where researchers propose to access and link datasets of identifiable information for the secondary purpose of
p.000199: research, the requirements of Section D apply.
p.000199:
p.000199: Endnotes
p.000199:
p.000199:
p.000199: 1 See, for example, Canadian Standards Association, Model Code for the Protection of Personal Information (1996).
p.000199: 2 See the Social Sciences and Humanities Research Council, “Research Data Archiving Policy”
p.000199: www.sshrc-crsh.gc.ca/site/apply-demande/policies-politiques/edata-donnees_electroniques-eng.aspx; and the Canadian
p.000199: Institutes of Health Research “Policy on Access to Research Outputs” (September 2007).
p.000199: www.cihr-irsc.gc.ca/e/34846.html; and the Canadian Institutes of Health Research, Natural Sciences and Engineering
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p.000121: of the research in order to use scientifically defensible results to validate a negotiating position.
p.000121: Research Agreements
p.000121: Article 9.11 Where a community has formally engaged with a researcher or research team through a designated
p.000121: representative, the terms and undertakings of both the researcher and the community should be set out in a
p.000121: research agreement before participants are recruited.
p.000121: Application Research agreements serve as a primary means of clarifying and confirming mutual expectations and,
p.000121: where appropriate, commitments between researchers and communities. Research agreements, where applicable, shall
p.000121: precede recruitment of individual participants and collection of, or access to, research data. The scope of the
p.000121: agreement will depend on the level of engagement which the community desires, and the availability of resources to
p.000121: support community participation.
p.000121: At a minimum, the agreement should address the ethical protections that would apply to securing individual consent for
p.000121: a comparable project, and should specify any commitments regarding collective community participation and
p.000121: decision making, sharing of benefits and review, and updating of the agreement. Expanding on information normally
p.000121: provided to an individual participant (see Article 3.2), agreements typically set out the purpose of the
p.000121: research and detail mutual responsibilities in project design, data collection and management (see Article 5.3);
p.000121: analysis and interpretation; credit due to knowledge holders; protection (and non- disclosure) of restricted knowledge;
p.000121: sharing of benefits or royalties flowing from intellectual property where applicable; production of reports;
p.000121: co-authorship; dissemination of results; and a conflict resolution process. Provisions for any anticipated
p.000121: secondary use of the information or human biological material, and associated data collected, should also be addressed
p.000121: at that time, and documented in the research agreement (see Article 9.20).
p.000121: Where a community has adopted or adheres to a code of research practice, the agreement may set out responsibilities in
p.000121: accordance with that code and the specific requirements of the research project. In less formal circumstances, the
p.000121: agreement may be relatively brief, and subject to clarification as the project unfolds. The CIHR Guidelines for
p.000121: Health Research Involving Aboriginal People (2007) provide examples of elements that may be included in research
p.000121: agreements (see References at the end of this chapter).
p.000121: Research agreements are increasingly being recognized by academic institutions (and the researchers associated with
p.000121: them) as providing reference points for research ethics review process and approval on such elements as consent,
p.000121: confidentiality, and access to and use of information. Agreements that specify procedures for community
p.000121: research ethics review, included as part of the institutional ethics
p.000121:
p.000121: 122 TCPS 2
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p.000141: observations, whether the research records or published reports involve identification of the participants, and any
p.000141: means by which those participants may give permission to be identified. REBs shall ensure that the proposal contains
p.000141: measures to protect the privacy of the individual in accordance with the law.
p.000141: Researchers and REBs should consult Chapters 3 and 5 for additional details and considerations regarding consent, and
p.000141: privacy and confidentiality.
p.000141: For observational research in which consent is not sought, researchers shall demonstrate to the REB that
p.000141: necessary precautions and measures have been taken to address privacy and confidentiality issues.
p.000141: Because the knowledge that one is being observed can be expected to influence behaviour, research involving
p.000141: non-participant or covert observation generally requires that the participants not know that they are being
p.000141: observed for research purposes. Typically the researcher has no direct interaction with the individuals being observed
p.000141: and therefore their consent is not sought. Covert observation of queuing behaviours in shopping malls is one example of
p.000141: a study where the research could not be completed if shoppers knew that they were being observed. Some forms of
p.000141: qualitative research seek to observe and study criminal behaviours, violent groups, or groups with restricted
p.000141: membership or access using covert participant observation. For example, some social science research that critically
p.000141: probes the inner workings of criminal organizations might never be conducted if the participants know in
p.000141: advance that they are being observed. Other observational studies may be anonymous but involve intervention by the
p.000141: researcher (e.g., studying the propensity of bystanders to help in an emergency normally requires a staged emergency).
p.000141: These methodological approaches may require the researcher seeking an exception to the general requirement for consent.
p.000141:
p.000141:
p.000141:
p.000141:
p.000141: 142 TCPS 2
p.000141:
p.000141: Chapter 10 – Qualitative Research
p.000141:
p.000141: Where no personal information is collected, consent is not required. Where personal information will be collected,
p.000141: researchers should explain whether the need for such covert research justifies an exception to the general
p.000141: requirement for seeking consent, and REBs should exercise their judgment taking into consideration the methodological
p.000141: requirements (see Article 3.7). Researchers and REBs shall take the necessary steps to ensure that the privacy of the
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p.000143: TCPS 2
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p.000145:
p.000145:
p.000145:
p.000145:
p.000145: Introduction
p.000145: Chapter 11
p.000145: CLINICAL TRIALS
p.000145:
p.000145: This chapter focuses on the ethical issues involved in the design, review and conduct of clinical trials (as defined
p.000145: below). In particular, it addresses clinical trial design, therapeutic misconception, research-attributable risk, and
p.000145: other issues that may be unique to clinical trials. As clinical trials are, perhaps, the most regulated type of
p.000145: research – subject to provincial, national and international regulatory bodies – reference will be made to these
p.000145: regulations, where appropriate. However, the emphasis in this chapter is on ethical guidance, grounded in the core
p.000145: principles of this Policy: Respect for Persons, Concern for Welfare, and Justice. As is the case throughout this
p.000145: Policy, the welfare of participants takes precedence over the interests of researchers and sponsors.
p.000145: For the purposes of this Policy, a clinical trial, a form of clinical research (also known as patient- oriented
p.000145: research), is any investigation involving participants that evaluates the effects of one or more health-related
p.000145: interventions on health outcomes. Interventions include, but are not restricted to, drugs, radiopharmaceuticals, cells
p.000145: and other biological products, surgical procedures, radiologic procedures, devices, genetic therapies, natural health
p.000145: products, process-of-care changes, preventive care, manual therapies and psychotherapies. Clinical trials may also
p.000145: include questions that are not directly related to therapeutic goals – for example, drug metabolism – in addition to
p.000145: those that directly evaluate the treatment of participants.
p.000145: Clinical trials are most frequently undertaken in biomedical research, although research that evaluates interventions,
p.000145: usually by comparing two or more approaches, is also conducted in related disciplines, such as psychology. The
p.000145: researcher leading a clinical trial is often (but not always) a clinician, that is, a health care provider (e.g.,
p.000145: physician, dentist, naturopath, nurse, physiotherapist). Although various types and forms of clinical trials have
p.000145: methodological differences, the ethical principles and procedures articulated in this Policy are applicable, and can be
p.000145: adapted as needed. Researchers and research ethics boards (REBs) should consult the other chapters of the Policy for
p.000145: additional guidance on principles, norms and practices applicable to all research.
p.000145: This chapter will require periodic revision, particularly in light of the ongoing efforts to develop provincial,
p.000145: national and international guidance for new methods and emerging areas of clinical re- search, including, but not
p.000145: limited to, clinical trials. Though much clinical research is observational and evaluative such that previous chapters
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Social / Infant
Searching for indicator infant:
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p.000199: capacity, or because they are pregnant or breastfeeding.
p.000199: Application Researchers should not exclude women from research on the basis of their repro- ductive capacity, or
p.000199: their pregnancy, or because they are breastfeeding, unless there is a valid reason for doing so.
p.000199: Subjecting women of childbearing potential to inappropriate requirements pre- cludes their participation in research.
p.000199: Exclusions should be made on the basis of clear criteria that reflect balanced attention to the potential benefits as
p.000199: well as the foreseeable risks of the research that may affect the welfare of women. For exam- ple, researchers should
p.000199: not require participants to use oral contraception, unless there is a valid reason for doing so.
p.000199: In considering research on pregnant or breastfeeding women, researchers and REBs shall take into account foreseeable
p.000199: risks and potential benefits for the woman and her embryo, fetus or infant, as well as the foreseeable risks and
p.000199: potential benefits of excluding pregnant or breastfeeding women from the research.
p.000199: Research Involving Children
p.000199: Children have varying degrees of maturity – metabolically, immunologically and cognitively – that may present important
p.000199: challenges for research design and the consent process, depending on the nature and complexity of the research. In
p.000199: addition to the vulnerability that arises from their developmental stage, children may also lack capacity to consent to
p.000199: participate in research (see Ar- ticle 4.6). As well, physical or psychological harms a child may experience in a
p.000199: research setting may have long-lasting consequences. As a result, researchers have often avoided the inclusion of
p.000199: children in some research, especially in clinical trials testing new treatments, so as to eliminate any risks. Clinical
p.000199: trials conducted only with adults yield a generally poor understanding of the results that apply to children.
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Social / Institutionalized
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p.000199: equal respect and concern. Equity requires distributing the benefits and burdens of research participation in such a
p.000199: way that no segment of the population is unduly burdened by the harms of research or denied the benefits of the
p.000199: knowledge generated from it.
p.000199: Treating people fairly and equitably does not always mean treating people in the same way. Dif- ferences in treatment
p.000199: or distribution are justified when failures to take differences into account may result in the creation or
p.000199: reinforcement of inequities. One important difference that must be considered for fairness and equity is vulnerability.
p.000199: Vulnerability is often caused by limited capacity, or limited access to social goods, such as rights, opportunities and
p.000199: power. Individuals or groups in vulnerable circumstances have historically included children, the elderly, women,
p.000199: prisoners, those with mental health issues and those with diminished capacity for self-determination. Ethno- cultural
p.000199: minorities and those who are institutionalized are other examples of groups who have, at times, been treated unfairly
p.000199: and inequitably in research, or have been excluded from research op- portunities. People or groups whose circumstances
p.000199: cause them to be vulnerable or marginalized may need to be afforded special attention in order to be treated justly in
p.000199: research.
p.000199:
p.000199:
p.000199:
p.000199: 10 TCPS 2
p.000199:
p.000199: Chapter 1 – Ethics Framework
p.000199:
p.000199: The recruitment process, both of participants who may become directly involved in research and those who participate as
p.000199: the source of information or biological materials to be used in research, is an important component of the fair and
p.000199: equitable conduct of research. Participation should be based on inclusion criteria that are justified by the research
p.000199: question. Inequity is created when par- ticular groups fail to receive fair benefits of research or when
p.000199: groups, or their data or their biological materials, are excluded from research arbitrarily or for reasons
p.000199: unrelated to the research question.
p.000199: An important threat to Justice is the imbalance of power that may exist in the relationship between researcher and
p.000199: participant. Participants will generally not understand the research in the same way and in the same depth as does the
p.000199: researcher. Historically, there have been instances in which this power imbalance has been abused, with resulting harm
p.000199: to participants.
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p.000199:
p.000199: over time (e.g., the participant’s capacity to consent may fluctuate over time). Ar- ticles 3.9 and 3.10 in Chapter 3
p.000199: establish other conditions regarding research that involve individuals who lack capacity to consent. This includes the
p.000199: involvement of an authorized third party to consent on their behalf, and adequate provisions to ascertain the wishes of
p.000199: the individuals concerning their participation.
p.000199: Participants’ Vulnerability and Research
p.000199: Article 4.7 Individuals or groups whose circumstances may make them vulnerable in the con- text of research should
p.000199: not be inappropriately included or automatically excluded from participation in research on the basis of their
p.000199: circumstances.
p.000199: Application The core principles of Respect for Persons, Concern for Welfare, and Justice entail special ethical
p.000199: obligations toward individuals or groups whose circumstances may lead to their vulnerability in the context of a
p.000199: specific research project and limit their ability to fully safeguard their own interests. Those who are owed special
p.000199: ethical obligations may include individuals who are institutionalized, those in dependent situations, or those whose
p.000199: circumstances (e.g., poverty or poor health status) may render even modest participation incentives so attractive as to
p.000199: constitute an induce- ment to take risks they would otherwise not take. Their situation may also compromise
p.000199: the voluntariness of consent in other ways. However, individuals should not automatically be considered vulnerable
p.000199: simply because of assumptions made about the vulnerability of the group to which they belong. Their particular
p.000199: circumstances shall be considered in the context of the proposed research project.
p.000199: REBs and researchers shall carefully examine the relationship between the circum- stances of the individuals and groups
p.000199: they aim to recruit, and the proposed research question. They should not presume that these circumstances will
p.000199: automatically re- sult in the inclusion or exclusion of individuals or groups as prospective participants.
p.000199: Participation should be based on inclusion or exclusion criteria that are justified by the research question.
p.000199: Researchers and REBs should recognize and address changes in a participant’s circumstances that may create, heighten,
p.000199: or at- tenuate their vulnerability, and provide special protections or consideration.
p.000199: In general, researchers should be familiar with the cultural, social and economic circumstances of prospective
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Social / Linguistic Proficiency
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p.000199: when personal information has been anonymized and added to a data pool). Participants shall also be informed that it is
p.000199: difficult, if not impossible, to withdraw results once they have been published or otherwise disseminated.
p.000199: Consent Shall Be Informed
p.000199: Article 3.2 Researchers shall provide to prospective participants, or authorized third parties, full disclosure of
p.000199: all information necessary for making an informed decision to participate in a research project.
p.000199: Application At the commencement of any process of consent, researchers (or their qualified representatives) shall
p.000199: provide prospective participants with the information set out in the following list, as appropriate to the particular
p.000199: research project. Not all the listed elements are required for all research. However, additional information may be
p.000199: required in particular types of research or under particular circumstances.
p.000199: If a researcher does not include some of the listed disclosure requirements, they should explain to the REB why these
p.000199: requirements do not apply to that particular project. It is also up to the REB to consider whether all elements listed,
p.000199: or additional elements, are necessary to the consent process of the research project.
p.000199: The information generally required for informed consent includes:
p.000199: (a) information that the individual is being invited to participate in a research project;
p.000199: (b) a statement of the research purpose in plain language, the identity of the researcher, the identity of
p.000199: the funder or sponsor, the expected duration and nature of participation, a description of research procedures, and an
p.000199: explanation of the responsibilities of the participant;
p.000199: (c) a plain language description of all reasonably foreseeable risks and potential benefits, both to the participants
p.000199: and in general, that may arise from research participation;
p.000199:
p.000199:
p.000199: 30 TCPS 2
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: (d) an assurance that prospective participants:
p.000199: • are under no obligation to participate; are free to withdraw at any time without prejudice to pre-existing
p.000199: entitlements;
p.000199: • will be given, in a timely manner throughout the course of the research project, information that is relevant to
p.000199: their decision to continue or withdraw from participation; and
p.000199: • will be given information on the participant’s right to request the withdrawal of data or human biological
p.000199: materials, including any limitations on the feasibility of that withdrawal;
p.000199: (e) information concerning the possibility of commercialization of research findings, and the presence of any
p.000199: real, potential or perceived conflicts of interest on the part of the researchers, their institutions or the research
p.000199: sponsors;
p.000199: (f) the measures to be undertaken for dissemination of research results and whether participants will be identified
p.000199: directly or indirectly;
p.000199: (g) the identity and contact information of a qualified designated representative who can explain scientific or
p.000199: scholarly aspects of the research to participants;
p.000199: (h) the identity and contact information of the appropriate individual(s) outside the research team whom participants
p.000199: may contact regarding possible ethical issues in the research;
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p.000199: participation-related expenses and compensation for injury;
p.000199: (k) a statement to the effect that, by consenting, participants have not waived any rights to legal recourse in the
p.000199: event of research-related harm; and
p.000199: (l) in clinical trials, information on stopping rules and when researchers may remove participants from trial.
p.000199: For consent to be informed, prospective participants shall be given adequate time and opportunity to assimilate the
p.000199: information provided, pose any questions they may have, and discuss and consider whether they will participate. The
p.000199: time required for this initial phase of the consent process will depend on such factors as the
p.000199:
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p.000199: TCPS 2 31
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: magnitude and probability of harms, the complexity of the information conveyed, and the setting where the information
p.000199: is given.
p.000199: The key to informed consent is that prospective participants understand the information being conveyed to
p.000199: them by researchers. Researchers and REBs should consider how best to convey that information to facilitate
p.000199: understanding. For example, written documentation may be supplemented with audio and/or visual aids, or accompanied by
p.000199: video presentations.
p.000199: When language barriers necessitate the assistance of an intermediary for commu- nication between the research team and
p.000199: participants, the researcher should select an intermediary who has the necessary language skills to ensure effective
p.000199: commu- nication (see Article 4.1). The involvement of such intermediaries may raise confidentiality issues
p.000199: (see Article 5.2).
p.000199: Paragraphs (a) to (c) require researchers to clearly explain the nature and goals of the research, and other
p.000199: essential information, in a manner that best promotes understanding on the part of prospective participants.
p.000199: Paragraph (b) requires the disclosure of those who support a particular research project, through funding or
p.000199: sponsorship. It is unethical for researchers to engage in clandestine activities for intelligence, police or military
p.000199: purposes under the guise of research.
p.000199: Paragraph (c) requires researchers to consider all reasonably foreseeable risks that may result from participation.
p.000199: When research is conducted about an organization or a community, researchers should inform prospective participants
p.000199: within that organization or community of the extent to which the organization or community is collaborating with the
p.000199: research, as well as any risk this collaboration may pose to the participant.
p.000199: Paragraph (d) helps to ensure the effectiveness of Article 3.1 – that a prospective participant’s choice to participate
p.000199: is voluntary. Paragraph (d) also supports the requirement that the consent process continue throughout the research.
p.000199: Paragraph (e) aims at managing real, potential or perceived conflicts of interests. Researchers should separate, to the
p.000199: greatest extent possible, their role as researcher from their other roles as therapists, caregivers, teachers,
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p.000199:
p.000199:
p.000199: 1 For example, see Article 21 of the Civil Code of Québec, which sets conditions for the conduct of research involving
p.000199: minors or adults who lack the capacity to consent.
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p.000199:
p.000199:
p.000199: Chapter 4
p.000199: FAIRNESS AND EQUITY IN RESEARCH PARTICIPATION
p.000199:
p.000199: Introduction
p.000199: The principle of Justice holds that particular individuals, groups or communities should neither bear an unfair share
p.000199: of the direct burdens of participating in research, nor should they be unfairly excluded from the potential benefits of
p.000199: research participation. Inclusiveness in research and fair distribution of benefits and burdens should be important
p.000199: considerations for researchers, research ethics boards (REBs), research institutions and sponsors. Issues of fair and
p.000199: equitable treatment arise in deciding whether and how to include individuals, groups or communities in research, and
p.000199: the basis for the exclusion of some.
p.000199: This chapter addresses inclusion in research of individuals and groups that might be inappropriately excluded on the
p.000199: basis of attributes such as culture, language, gender, race, ethnicity, age and dis- ability. It provides guidance
p.000199: relevant to inclusion in research of specific groups such as women, children, the elderly and those who lack capacity
p.000199: to consent to participate in research. Historically, these groups have often been inappropriately excluded from
p.000199: research.
p.000199: This chapter also addresses the fair inclusion and equitable treatment of individuals, groups and communities whose
p.000199: situation or circumstances make them vulnerable in the context of a specific research project. These individuals run
p.000199: the risk of being included in research in ways that may be unfair and inequitable. This chapter provides guidance
p.000199: relevant to the equitable distribution of the risks and benefits of research.
p.000199: Over-protectionist attitudes or practices of researchers or REBs, whether intentional or inadvertent, can exclude some
p.000199: members of society from participating in research. The exclusion of individuals, groups or communities may constitute a
p.000199: failure to treat them justly. For example, age has been used to exclude individuals from participation in research,
p.000199: particularly health research (e.g., studies that only accept participants between the ages of 18 to 35). As a result,
p.000199: sufficient research may not be done on groups that fall outside of narrow age criteria. The inclusion of the young and
p.000199: the elderly in research, for example, ensures that treatments frequently given to these populations are effective and
p.000199: safe.
p.000199: Researchers, institutions and REBs all have important roles to play in advancing that societal com- mitment, and
p.000199: ensuring a fair distribution of the benefits and burdens of research. Researchers and REBs must navigate between the
p.000199: dangers of imposing unfair burdens on particular participants, groups and communities, and overprotecting them. In
p.000199: assessing fairness and equity issues in the research ethics process, REBs should not intervene in the choice of
p.000199: research topics.
p.000199:
p.000199:
p.000199:
p.000199:
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p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: A. Appropriate Inclusion
p.000199: Article 4.1 Taking into account the scope and objectives of their research, researchers should be inclusive in
p.000199: selecting participants. Researchers shall not exclude individuals from the opportunity to participate in research on
p.000199: the basis of attributes such as culture, language, religion, race, disability, sexual orientation, ethnicity,
p.000199: linguistic proficiency, gender or age, unless there is a valid reason for the exclusion.
p.000199: Application Article 4.1 is based on the principle of Justice. It imposes a duty on researchers not to exclude
p.000199: individuals or groups from participation for reasons that are unrelated to the research. This duty is explicitly stated
p.000199: because groups have been inappropri- ately excluded from participation in research on the basis of attributes such as
p.000199: gender, race, ethnicity, age and disability.
p.000199: The focus, objective, nature of research and context in which the research is con- ducted inform the inclusion and
p.000199: exclusion criteria for a specific research project. Some research may be focused on a certain individual (such as in a
p.000199: biography), or a group of individuals who share a specific characteristic (e.g., an identifiable group of painters who
p.000199: happen to be all of one sex; a religious order that is restricted to one sex). Other examples include research that is
p.000199: focused on specific cultural tra- ditions or languages, or on one age group (e.g., a biomechanical modeling study of
p.000199: posture corrections in adolescents). Such research should not be precluded so long as the selection criteria for those
p.000199: to be included in the research are germane to answering the research question. Researchers who plan to actively exclude
p.000199: par- ticular groups should clarify to their REBs the grounds for the exclusion.
p.000199: Where a language barrier exists between the researcher and the prospective partic- ipant, various measures may be
p.000199: used to ensure effective communication in recruitment and consent discussions. For example, an intermediary who
p.000199: may not be part of the research project or team, but who is competent in the language used by the researchers, as well
p.000199: as that preferred by the participant, may assist with com- munication between prospective participants and researchers.
p.000199: The selection of an intermediary and their activities will depend on the nature, context and risks of the research.
p.000199:
p.000199: B. Inappropriate Exclusion
p.000199: Research Involving Women
p.000199: Women have historically been inappropriately excluded from participating in some research. This exclusion of women,
p.000199: where unwarranted, has delayed the advancement of knowledge, denied po- tential benefits to women, and exposed women to
p.000199: harm when research findings from male-only research projects were generalized inappropriately to women, as has often
p.000199: been the case in clinical drug trials. The inclusion of women in research advances the commitment to Justice, improves
p.000199: the generalizability of research findings to women where that is a goal of the research, and is es- sential to ensure
p.000199: that women and men benefit equally from research.
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p.000199: volving a community contributes to the advancement of knowledge that may lead to improved conditions for a group to
p.000199: which the participant belongs. Such knowledge may also inform other communities or society in general.
p.000199: Researchers should also be sensitive to the expectations and opinions of participants regarding potential benefits of
p.000199: the research. Prior to the commencement of the research, researchers should formally or informally discuss these
p.000199: expectations with individuals and/or groups, and outline the scope and nature of potential benefits that may accrue to
p.000199: participants during and after the research (see Article 9.13). REBs should be vigilant to ensure that the proposed
p.000199: distribution of benefits is fair, without imposing undue burdens on the researcher that would make it too difficult or
p.000199: costly to complete research.
p.000199: Researchers should normally provide copies of publications, or other research reports or products, arising from the
p.000199: research to the institution or organization – normally the host institution – that is best suited to act as a
p.000199: repository and disseminator of the results within the participating commu- nities. This may not be necessary in
p.000199: jurisdictions where the results are readily available in print or electronically. In general, researchers should ensure
p.000199: that participating individuals, groups and com- munities are informed of how to access the results of the research.
p.000199: Results of the research should be made available to them in a culturally appropriate and meaningful format, such as
p.000199: reports in plain language in addition to technical reports.
p.000199:
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p.000199: Chapter 5
p.000199: PRIVACY AND CONFIDENTIALITY
p.000199:
p.000199: Introduction
p.000199: There is widespread agreement about the interests of participants in protection of privacy, and the corresponding
p.000199: duties of researchers to treat personal information in a confidential manner. Indeed, the respect for privacy in
p.000199: research is an internationally recognized norm and ethical standard. Fun- damental rights and freedoms in the Canadian
p.000199: Constitution have been interpreted by the courts to include privacy protections. Privacy rights are protected in
p.000199: federal and provincial/territorial leg- islation. Model voluntary codes1 have also been adopted to govern access to,
p.000199: and the protection of, personal information. Some professional organizations have established codes that set out the
p.000199: conditions and obligations of their members regarding the collection, use and disclosure of personal information.
p.000199: Privacy risks in research relate to the identifiability of participants, and the potential harms they, or groups to
p.000199: which they belong, may experience from the collection, use and disclosure of personal information. Privacy risks arise
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p.000105: whether or not their names appear on an official register. The term “Aboriginal” fails to reflect the
p.000105: distinctions among First Nations, Inuit and Métis peoples, who have their own histories, cultures and languages, so an
p.000105: attempt has been made to limit use of the term in this Policy to instances where a global term is appropriate. Indian
p.000105: peoples commonly identify themselves by distinct nation names such as Mi’kmaq, Dene or Haida, and as First Nations. In
p.000105: the international context, the term comparable to Aboriginal peoples is Indigenous peoples.
p.000105: • Community – describes a collectivity with shared identity or interests, that has the capacity to act or express
p.000105: itself as a collective. In this Policy, a community may include members from multiple cultural groups. A community may
p.000105: be territorial, organizational or a com- munity of interest. “Territorial communities” have governing bodies exercising
p.000105: local or regional jurisdiction (e.g., members of a First Nations resident on reserve lands). “Organi- zational
p.000105: communities” have explicit mandates and formal leadership (e.g., a regional Inuit association or a friendship centre
p.000105: serving an urban Aboriginal community). In both terri- torial and organizational communities, membership is defined and
p.000105: the community has designated leaders. “Communities of interest” may be formed by individuals or organiza- tions who
p.000105: come together for a common purpose or undertaking, such as a commitment to conserving a First Nations language.
p.000105: Communities of interest are informal communities
p.000105:
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p.000107: whose boundaries and leadership may be fluid and less well-defined. They may exist tem- porarily or over the long term,
p.000107: within or outside of territorial or organizational communities.
p.000107: An individual may belong to multiple communities, both Aboriginal and non-Aboriginal (e.g., as a member of a local
p.000107: Métis community, a graduate students’ society and a coalition in support of Aboriginal rights). An individual may
p.000107: acknowledge being of First Nations, Inuit or Métis descent but not identify with any particular community. How
p.000107: individuals define which of their community relationships are most relevant will likely depend on the nature of the
p.000107: research project being proposed.
p.000107: • Community customs and codes of research practice – may be expressed in written or oral form. Consistent with the
p.000107: world views of particular First Nations, Inuit and Métis peoples, community customs and codes of research practice may
p.000107: embody kinship networks and responsibilities that include multi-generational obligations to ancestors and
p.000107: future generations. Ethical obligations often extend to respectful relations with plant, animal and marine life.
p.000107: • Community engagement – is a process that establishes interaction between a researcher or research team, and the
p.000107: Aboriginal community relevant to the research project. It signifies a collaborative relationship between researchers
p.000107: and communities, although the degree of collaboration may vary depending on the community context and the nature of the
p.000107: research. The engagement may take many forms including review and approval from formal leadership to conduct
p.000107: research in the community, joint planning with a responsible agency, commitment to a partnership formalized in a
p.000107: research agreement, or dialogue with an advisory group expert in the customs governing the knowledge being
p.000107: sought. The engagement may range from information sharing to active participation and collaboration, to empowerment
p.000107: and shared leadership of the research project. Communities may also choose not to engage actively in a research
p.000107: project, but simply to acknowledge it and register no objection to it.
p.000107: • First Nations, Inuit and Métis lands – include Indian reserves, Métis settlements, and lands governed under a
p.000107: self-government agreement or an Inuit or First Nations land claim agreement.
p.000107: • Indigenous knowledge – see traditional knowledge, below.
p.000107: • Indigenous peoples – a term used in international or scholarly discourse; there is no consensus on
p.000107: the definition of the term “indigenous.” In some countries, other terms may be used. Self-identification is a
p.000107: fundamental criterion for defining Indigenous peoples.4
p.000107: • Traditional knowledge – the knowledge held by First Nations, Inuit and Métis peoples, the Aboriginal peoples of
p.000107: Canada. Traditional knowledge is specific to place, usually transmitted orally, and rooted in the experience of
p.000107: multiple generations. It is determined by an Aboriginal community’s land, environment, region, culture and language.
p.000107: Traditional knowledge is usually described by Aboriginal peoples as holistic, involving body, mind, feelings and
p.000107: spirit. Knowledge may be expressed in symbols, arts, ceremonial and everyday practices, narratives and, especially, in
p.000107: relationships. The word tradition is not necessarily
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p.000107: synonymous with old. Traditional knowledge is held collectively by all members of a community, although some
p.000107: members may have particular responsibility for its transmission. It includes preserved knowledge
p.000107: created by, and received from, past generations and innovations and new knowledge transmitted to subsequent
p.000107: generations. In international or scholarly discourse, the terms traditional knowledge and Indigenous knowledge are
p.000107: sometimes used interchangeably.
p.000107:
p.000107: B. Interpreting the Ethics Framework in Aboriginal Contexts
p.000107: Chapter 1 identifies three principles that express the core ethical value of respect for human dignity
p.000107: – Respect for Persons, Concern for Welfare, and Justice. The three core principles are interpreted in this chapter as
p.000107: follows:
p.000107: Respect for Persons is expressed principally through the securing of free, informed and ongoing consent of
p.000107: participants. The concerns of First Nations, Inuit and Métis for their continuity as peoples with distinctive cultures
...
p.000109: complement to individual consent. It is critically important, however, to seek local guidance in the
p.000109: application or adaptation of this Policy to Indigenous peoples outside of Canada.
p.000109: For considerations that apply to research conducted in another country, see Chapter 8, Section B.
p.000109:
p.000109: C. Applying Provisions of This Policy in Aboriginal Contexts
p.000109: Requirement of Community Engagement in Aboriginal Research
p.000109: Article 9.1 Where the research is likely to affect the welfare of an Aboriginal community, or communities, to
p.000109: which prospective participants belong, researchers shall seek engagement with the relevant community. The
p.000109: conditions under which engagement is required include, but are not limited to:
p.000109: (a) research conducted on First Nations, Inuit or Métis lands;
p.000109: (b) recruitment criteria that include Aboriginal identity as a factor for the entire study or for a subgroup in the
p.000109: study;
p.000109: (c) research that seeks input from participants regarding a community’s cultural heritage, artefacts, traditional
p.000109: knowledge or unique characteristics;
p.000109: (d) research in which Aboriginal identity or membership in an Aboriginal community is used as a variable for
p.000109: the purpose of analysis of the research data; and
p.000109: (e) interpretation of research results that will refer to Aboriginal communities, peoples, language, history or
p.000109: culture.
p.000109: Application Paragraph (a) refers to First Nations, Inuit and Métis lands that include Indian reserves, Métis
p.000109: settlements and lands governed under a self-government agreement or an Inuit or First Nations land claim agreement.
p.000109: Researchers should become informed about formal rules or oral customs that may apply in accordance with a particular
p.000109: First Nations, Inuit or Métis authority. In different jurisdictions, research activities may be regulated in various
p.000109: ways.
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p.000109: Paragraph (c) refers to cultural heritage, which includes, but is not limited to, First Nations, Inuit and Métis
p.000109: peoples’ relations with particular territories, material objects, traditional knowledge and skills, and intangibles
p.000109: that are transmitted from one generation to the next (e.g., sacred narratives, customs, representations or practices).
p.000109: Cultural heritage is a dynamic concept, in that materials, knowledge and practices are continuously adapted to the
p.000109: realities of current experience.
p.000109: Cultural heritage research such as archaeological research involving burial sites or sacred landscapes and handling of
p.000109: artefacts may raise ethical obligations important to the Aboriginal community that may not be addressed in academic
p.000109: research proposals. Researchers and communities should agree in advance on how to reconcile or address these
...
p.000113: collaboration (including how data will be shared) as part of the initial and ongoing consent process (see Article
p.000113: 3.2[i]).
p.000113: Complex Authority Structures
p.000113: Article 9.5 Where alternatives to securing the agreement of formal leadership are proposed for research on First
p.000113: Nations, Inuit or Métis lands or in organizational communities, researchers should engage community processes and
p.000113: document measures taken, to enable the REB to review the proposal with due consideration of complex
p.000113: community authority structures.
p.000113: Application Researchers and REBs should not assume that approval of a project by formal leaders is the only avenue
p.000113: for endorsing a project. In some communities and some domains of knowledge, authority to permit and monitor
p.000113: research rests with knowledge keepers designated by custom rather than by election or appointment.
p.000113:
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p.000115: In First Nations settings, a confederacy council spanning several communities may be recognized as having authority
p.000115: over its members’ traditional knowledge. In an Inuit community, the hamlet council, an Elders’ circle, and a hunters
p.000115: and trappers organization may have overlapping responsibility and expertise with respect to the knowledge being sought.
p.000115: Métis Elders dedicated to conserving Michif language may assert their autonomy from political leaders, but choose to
p.000115: collaborate with educational or cultural agencies (see also Article 9.15).
p.000115: The preferred course is to secure approval for research from both formal leaders of a community and customary
p.000115: authority. This is especially important for outsiders to communities, whose presence or intentions might be challenged
p.000115: as inappropriate. Researchers should engage community processes, including the guidance of moral authorities such as
p.000115: Elders, to avert potential conflict. These measures should be documented to assist the REB in considering the community
p.000115: engagement processes proposed (see Article 9.10). Where no agreement exists between formal community leadership and
p.000115: customary authority regarding the conduct of the proposed research, researchers should inform the REB. When alternative
p.000115: community engagement processes are followed to endorse a project, all other ethical safeguards set out in this chapter
p.000115: remain applicable.
p.000115: Recognizing Diverse Interests within Communities
p.000115: Article 9.6 In engaging territorial or organizational communities, researchers should ensure, to the extent
p.000115: possible, that they take into consideration the views of all relevant sectors – including individuals and subgroups who
p.000115: may not have a voice in the formal leadership. Groups or individuals whose circumstances make them vulnerable
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p.000117: Researchers should consult their own institutions to ensure that the application of OCAP or other community-based
p.000117: ethics codes is consistent with institutional
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p.000117: policies. Where divergences exist, they should be addressed and resolved prior to the commencement of the research, or
p.000117: as they arise over the course of the research.
p.000117: First Nations, Inuit and Métis scholars attached to academic institutions as faculty members, students or research
p.000117: associates are increasingly engaged in research involving their own communities, and sometimes their own family
p.000117: members. They are generally exempt from restrictions on physical access to territory or personal access to community
p.000117: members. However, as members of institutions that adhere to this Policy, they are subject to the ethical duty to
p.000117: respect community customs and codes of research practice when conducting research in their own local or cultural
p.000117: communities, and to engage the relevant community as required by this Policy. In these cases, institutional REBs may be
p.000117: concerned about researchers being in a conflict of interest and should manage the conflict of interest in accordance
p.000117: with Articles 7.2 and 7.4.
p.000117: Life history and language research are examples of research areas where insider relationships and cultural competencies
p.000117: provide unique opportunities to extend the boundaries of knowledge. Although it can be argued that recording the life
p.000117: history of an elderly relative is a family matter rather than a community matter, when undertaken as research,
p.000117: community engagement is important to ensure that the following considerations are reviewed: the potential impact of
p.000117: such research on the wider community; conflicts between the individualist norms of the academic environment
p.000117: and the norms of the community; and the possibility of unclear or mistaken assumptions on the part of participant and
p.000117: researcher. During the consent process, researchers should give the participant the opportunity to identify the
p.000117: relevant form of community engagement, and at what stage such engagement should occur. This may include engaging with
p.000117: extended family members, peers of the participant with whom the researcher’s interpretations can be validated, or
p.000117: Elders knowledgeable about cultural rules governing disclosure of privileged information.
p.000117: Institutional Research Ethics Review Required
p.000117: Article 9.9 Research ethics review by community REBs or other responsible bodies at the research site will not be
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p.000119: has constituted a local REB that is party to an agreement with the researcher’s institution, review by the
p.000119: institution’s REB may not be required.
p.000119: In accordance with Article 8.4, communication between the institutional REB and the responsible agency in the community
p.000119: may assist in resolving inconsistencies between institutional policy and community customs and codes of research
p.000119: practice. Where a community research ethics review is required in addition to the mandatory institutional REB review,
p.000119: reconciling differences may require resubmission to one or both review bodies.
p.000119: Researchers and REBs should recognize that research ethics review by community bodies will often pursue purposes and
p.000119: apply criteria that differ from the provisions of this Policy. The express purpose of most Aboriginal community
p.000119: codes of research practice is to ensure the relevance of research undertakings to community needs and priorities,
p.000119: and respect for First Nations, Inuit and Métis identities, cultures and knowledge systems. While community
p.000119: codes of practice and research agreements typically share many of the goals of institutional policies, the
p.000119: approaches to achieving those goals may differ significantly. It is therefore inappropriate to insist on
p.000119: uniformity between community practices and institutional policies. For example, when researchers seek to interview
p.000119: Elders willing to share their knowledge according to traditional customs of consent, REBs should not impose language
p.000119: and processes that may be experienced as culturally inappropriate or awkward (see Article 3.12).
p.000119: In cases where REB review of research on topics related to Aboriginal peoples or affecting Aboriginal communities is
p.000119: regularly required, the REB membership should be modified to ensure that relevant and competent knowledge and
p.000119: expertise in Aboriginal cultures are available within its regular complement. Aboriginal scholars or members drawn from
p.000119: First Nations, Inuit or Métis communities may fill this role (see Article 6.4). For occasional review of Aboriginal
p.000119: research that is likely to affect the welfare of a community or communities, consultation with ad hoc advisors or
p.000119: delegation to a specialized or multi-institutional REB may be appropriate (see Articles 6.5 and Article 8.1).
p.000119: The membership of community review bodies of First Nations, Inuit or Métis communities will not necessarily duplicate
p.000119: the membership criteria set out in this Policy. In the context of scarce resources in community organizations, the same
p.000119:
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p.000119: personnel may be involved in reviewing the ethics of a proposal and co-managing the research project. An expectation
p.000119: that conflicts of interest will be managed by separating research ethics review and project management functions may
p.000119: impose unsupportable demands on small communities. In these circumstances, researchers and participating Aboriginal
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p.000121: the community and the researcher should be factored into proposals to the extent possible within funding guidelines.
p.000121: Community agreement that a research project may proceed is not a substitute for securing the consent of individuals
p.000121: recruited to participate in that project, in accordance with Chapter 3. Consent of prospective
p.000121: participants shall precede collection of, or access to, data or human biological materials. Consistent with the
p.000121: provisions of Article 3.12, if signed written consent is not culturally appropriate, the researcher shall inform the
p.000121: REB of alternative processes employed for seeking and documenting consent.
p.000121: Consent shall be given in accordance with the research agreement where one exists. Where research agreements provide
p.000121: that community partners will have limited or full access to identifiable personal data, the consent of participants to
p.000121: this disclosure shall form part of the consent process. Access to confidential information provided by an individual is
p.000121: subject to privacy law.
p.000121: Researchers should be aware of the first language of Aboriginal participants and, if an Aboriginal language,
p.000121: researchers should make available translation by a knowledgeable person during the consent process, and
p.000121: during the conduct of research in accordance with the wishes of the participant (see Article 4.1).
p.000121: Researchers should be aware of the official status of Inuit languages in Inuit regions.
p.000121: Collaborative Research
p.000121: Article 9.12 As part of the community engagement process, researchers and communities should consider applying a
p.000121: collaborative and participatory approach as appropriate to the nature of the research, and the level of ongoing
p.000121: engagement desired by the community.
p.000121: Application While community engagement is appropriate in any research that affects Aboriginal communities, the
p.000121: nature and degree of collaboration between the researcher and the community will depend on the nature of the research,
p.000121: and the community context. Collaborative approaches in research with Aboriginal communities are a means of facilitating
p.000121: mutually respectful and productive relations (see Article 9.2).
p.000121: Collaborative research is generally understood to involve respectful relationships among colleagues, each bringing
p.000121: distinct expertise to a project. Collaboration often involves one or another of the partners taking primary
p.000121: responsibility for certain
p.000121:
p.000121:
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p.000123: aspects of the research, such as addressing sensitive issues in community relations, or scientific analysis and
p.000123: interpretation of data.
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p.000123: significant research training opportunities. Funding criteria allow researchers to include in their grant
p.000123: applications stipends for
p.000123:
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p.000125: undergraduate, master’s or doctoral students, or post-doctoral researchers, as appropriate, with priority given
p.000125: to Aboriginal candidates. The time required to establish collaborative relationships may be difficult to
p.000125: accommodate in the programs of students. Mentorship by experienced researchers who introduce students to
p.000125: communities and monitor their ethical practice can facilitate the trust- building process and advance student progress.
p.000125: Recognition of the Role of Elders and Other Knowledge Holders
p.000125: Article 9.15 Researchers should engage the community in identifying Elders or other recognized knowledge holders to
p.000125: participate in the design and execution of research, and the interpretation of findings in the context of cultural
p.000125: norms and traditional knowledge. Community advice should also be sought to determine appropriate recognition for the
p.000125: unique advisory role fulfilled by these persons.
p.000125: Application Within First Nations, Inuit and Métis communities, persons with special gifts carry varied roles and
p.000125: responsibilities in conserving and transmitting traditional knowledge and expressions of culture. They often are
p.000125: fluent in their traditional language. They model respectful relationships and may conduct ceremonies, pass on oral
p.000125: history, and offer guidance in community affairs. Their gifts are normally refined over a lifetime. Thus, Elders who
p.000125: have followed a rigorous path of learning over a long period are highly respected. Younger persons may also gain
p.000125: recognition as gifted knowledge holders.
p.000125: High regard by the community that knows the Elder or other knowledge holder is the most reliable indicator of an
p.000125: individual’s authority. Each community or nation has particular ways of approaching Elders or knowledge holders
p.000125: respectfully. In many First Nations this involves the presentation and acceptance of tobacco to symbolize entering into
p.000125: a relationship. In some communities, feasting or gift-giving is appropriate.
p.000125: Elders are now being recognized in research proposals and grant applications as providers of access to community
p.000125: networks, ethical guidance to researchers, and advice in interpreting findings in the context of traditional knowledge
p.000125: (see Article 9.17). Researchers should seek advice from the community and the Elders regarding the appropriate
p.000125: recognition of the contribution of Elders and knowledge holders, which may include providing honoraria, acknowledging
p.000125: contributions by name or, as directed, withholding the Elder’s identity in reports and publications.
p.000125: Privacy and Confidentiality
p.000125: Article 9.16 Researchers and community partners shall address privacy and confidentiality for communities and
p.000125: individuals early on in the community engagement process. The extent to which limited or full disclosure of personal
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p.000127: participate in the interpretation of the data and the review of research findings before the completion of the final
p.000127: report, and before finalizing all relevant publications resulting from the research.
p.000127: Application Where collaborative approaches are followed, researchers should ensure continuing communications with
p.000127: the participating community. Territorial or organizational communities or communities of interest engaged in
p.000127: collaborative research may consider that their review and approval of reports and academic publications is essential to
p.000127: validate findings, correct any cultural inaccuracies, and maintain respect for community knowledge (which may
p.000127: entail limitations on its disclosure). Researchers should integrate suggestions from the community representatives
p.000127: in the publication. If disagreement about interpretation arises between researchers and the community and it cannot be
p.000127: resolved, researchers should either (a) provide the community with an opportunity to make its views known, or (b)
p.000127: accurately report any disagreement about the interpretation of the data in their reports or publications. This should
p.000127: not be construed as giving the community the right to block the publication of findings. Rather, it
p.000127: gives the community the opportunity to contextualize the findings.
p.000127: Final reports shall be made available to the territorial or organizational community or community of interest
p.000127: participating in the research. Researchers and communities should clarify the extent to which research
p.000127: findings will require translation, plain language summaries or oral presentations to community members, in order to
p.000127: make the research findings accessible to the community.
p.000127: An Aboriginal community, and those who participated in the research, should have the option to participate in deciding
p.000127: how collective or individual contributions to the research project will be acknowledged and credited in the
p.000127: dissemination of results (e.g., acknowledgement of co-authorship in research reports or at conferences and
p.000127: seminars).
p.000127: Intellectual Property Related to Research
p.000127: Article 9.18 In collaborative research, intellectual property rights should be discussed by researchers,
p.000127: communities and institutions. The assignment of rights, or the grant of licences and interests in material that may
p.000127: flow from the research, should be specified in a research agreement (as appropriate) before the research is conducted.
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p.000127:
p.000127: 128 TCPS 2
p.000127:
p.000127: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000127:
p.000127: Application Researchers, communities and institutions should be aware that all knowledge and information is not
p.000127: necessarily protected under the existing law. Existing intellectual property legislation generally protects works and
p.000127: inventions. Strict criteria are used to define intellectual property rights. Understanding and communicating what
...
p.000191: that links the participants’ code names with their actual name so data can be re-linked if necessary).
p.000191: Anonymized information – The information is irrevocably stripped of direct identifiers, a code is not kept to allow
p.000191: future re-linkage, and risk of re-identification of individuals from remaining in- direct identifiers is low or very
p.000191: low.
p.000191: Anonymous information – The information never had identifiers associated with it (e.g. anony- mous surveys) and risk of
p.000191: identification of individuals is low or very low.
p.000191: Impracticable – Incapable of being put into practice due to a degree of hardship or onerousness that jeop- ardizes the
p.000191: conduct of the research; it does not mean mere inconvenience.
p.000191:
p.000191: Incentive – Anything offered to participants, monetary or otherwise, to encourage participation in research.
p.000191:
p.000191: Incidental findings – Unanticipated discoveries made in the course of research that are outside the scope of the
p.000191: research.
p.000191:
p.000191: Indigenous knowledge – See “Traditional knowledge.”
p.000191:
p.000191: Indigenous peoples – See “Aboriginal peoples.”
p.000191:
p.000191: Institutions – The universities, hospitals, colleges, research institutes, centres and other organizations eligible to
p.000191: receive and manage Agency grant funds on behalf of the grant holders and the Agencies.
p.000191:
p.000191: Intermediary – An individual with the necessary language skills to ensure effective communication between the research
p.000191: team and participants, should any language barriers exist.
p.000191:
p.000191: Institutional conflicts of interest – An incompatibility between two or more substantial institutional obligations
p.000191: that cannot be adequately fulfilled without compromising one or another of the obligations.
p.000191:
p.000191:
p.000191:
p.000191:
p.000191:
p.000191:
p.000191:
p.000191: TCPS 2
p.000191:
p.000193: 193
p.000193:
p.000193: Glossary
p.000193:
p.000193: Justice – A core principle of this Policy that refers to the obligation to treat people fairly and equitably. Fairness
p.000193: entails treating all people with equal respect and concern. Equity requires distributing the benefits and burdens of
p.000193: research participation in such a way that no segment of the population is unduly burdened by the harms of research or
p.000193: denied the benefits of the knowledge generated from it.
p.000193:
p.000193: Medical device trials – Clinical trials that test the safety and/or efficacy of one or more instruments used in the
p.000193: prevention, diagnosis, mitigation, or treatment of a disease or abnormal physical condition or the restoration,
p.000193: correction or modification of body function or structure.
p.000193:
p.000193: Medical emergency – A situation in which one or more individuals requires urgent medical care.
p.000193:
p.000193: Minimal risk research – Research in which the probability and magnitude of possible harms implied by participation in
p.000193: the research is no greater than those encountered by participants in the aspects of their everyday life that relate to
p.000193: the research.
p.000193:
p.000193: Memorandum of Understanding (MOU) – The agreement between the Agencies and institutions eligible to receive and manage
...
p.000195: will occur, whether to participants or to third parties.
p.000195:
p.000195: Secondary use – The use in research of information or human biological materials originally collected for a purpose
p.000195: other than the current research purpose.
p.000195:
p.000195: Security – Measures taken to protect information. It includes physical, administrative, and technical safe- guards.
p.000195:
p.000195: Shall – Indicates a mandatory provision.
p.000195:
p.000195: Should – Indicates guidance for the interpretation of the core principles.
p.000195:
p.000195: Stopping rules – Statistically significant end points and safety considerations for a clinical trial that are
p.000195: determined in advance, and, once reached, dictate that the trial must be terminated.
p.000195:
p.000195:
p.000195:
p.000195: 196 TCPS 2
p.000195:
p.000195: Glossary
p.000195:
p.000195: Surgical trials – A clinical trial which compares the safety and/or efficacy of different surgical techniques.
p.000195:
p.000195: Therapeutic misconception – A misunderstanding, on the part of participants, of the purpose, benefits, and/or risks
p.000195: of clinical trials. Often participants do not understand that research is aimed primarily at producing knowledge and
p.000195: may not provide any therapeutic benefit to them.
p.000195:
p.000195: Traditional knowledge – The knowledge held by First Nations, Inuit and Métis peoples, the Aboriginal peoples of
p.000195: Canada. Traditional knowledge is specific to place, usually transmitted orally, and rooted in the experience of
p.000195: multiple generations. It is determined by an Aboriginal community’s land, environment, region, culture, and language.
p.000195: It may also include new knowledge transmitted to subsequent generations.
p.000195:
p.000195: Unanticipated issues – Issues that: occur during the conduct of research; may increase the level of risk to
p.000195: participants or have other ethical implications that may affect participants’ welfare; and were not anticipated by the
p.000195: researcher in the research proposal submitted for research ethics review.
p.000195:
p.000195: Undue influence – The impact of an unequal power relationship on the voluntariness of consent. This may occur when
p.000195: prospective participants are recruited by individuals in a position of authority over them (e.g. doctor/patient,
p.000195: teacher/student, employer/employee). See “Coercion.”
p.000195:
p.000195: Vulnerability – A diminished ability to fully safeguard one’s own interests in the context of a specific research
p.000195: project. This may be caused by limited capacity or limited access to social goods, such as rights, opportunities and
p.000195: power. Individuals or groups may experience vulnerability to different degrees and at different times, depending on
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p.000199: the nature and context of the research being undertaken. Specific applica- tions are addressed in the following
p.000199: chapters.
p.000199: Respect for Persons
p.000199: Respect for Persons recognizes the intrinsic value of human beings and the respect and consider- ation that they are
p.000199: due. It encompasses the treatment of persons involved in research directly as participants and those who are
p.000199: participants because their data or human biological materials, which for the purposes of this Policy include materials
p.000199: related to human reproduction, are used in re- search. Respect for Persons incorporates the dual moral obligations to
p.000199: respect autonomy and to protect those with developing, impaired or diminished autonomy.
p.000199: Autonomy includes the ability to deliberate about a decision and to act based on that deliberation. Respecting autonomy
p.000199: means giving due deference to a person’s judgment and ensuring that the person is free to choose without
p.000199: interference. Autonomy is not exercised in isolation but is influenced by a person’s various connections to
p.000199: family, to community, and to cultural, social, linguistic, religious and other groups. Likewise, a person’s decisions
p.000199: can have an impact on any of these connections.
p.000199:
p.000199: 8 TCPS 2
p.000199:
p.000199: Chapter 1 – Ethics Framework
p.000199:
p.000199: An important mechanism for respecting participants’ autonomy in research is the requirement to seek their free,
p.000199: informed and ongoing consent. This requirement reflects the commitment that par- ticipation in research, including
p.000199: participation through the use of one’s data or biological materials, should be a matter of choice and that, to be
p.000199: meaningful, the choice must be informed. An informed choice is one that is based on as complete an understanding as is
p.000199: reasonably possible of the purpose of the research, what it entails, and its foreseeable risks and potential benefits,
p.000199: both to the partic- ipant and to others. Respect for Persons also includes a commitment to accountability
p.000199: and transparency in the ethical conduct of research.
p.000199: Certain factors may diminish a person’s ability to exercise their autonomy, such as inadequate information or
p.000199: understanding for deliberation, or a lack of freedom to act due to controlling influences or coercion. Such constraints
p.000199: may include the fear of alienating those in positions of authority, such as professional or personal caregivers,
...
p.000199: the elderly in research, for example, ensures that treatments frequently given to these populations are effective and
p.000199: safe.
p.000199: Researchers, institutions and REBs all have important roles to play in advancing that societal com- mitment, and
p.000199: ensuring a fair distribution of the benefits and burdens of research. Researchers and REBs must navigate between the
p.000199: dangers of imposing unfair burdens on particular participants, groups and communities, and overprotecting them. In
p.000199: assessing fairness and equity issues in the research ethics process, REBs should not intervene in the choice of
p.000199: research topics.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 47
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: A. Appropriate Inclusion
p.000199: Article 4.1 Taking into account the scope and objectives of their research, researchers should be inclusive in
p.000199: selecting participants. Researchers shall not exclude individuals from the opportunity to participate in research on
p.000199: the basis of attributes such as culture, language, religion, race, disability, sexual orientation, ethnicity,
p.000199: linguistic proficiency, gender or age, unless there is a valid reason for the exclusion.
p.000199: Application Article 4.1 is based on the principle of Justice. It imposes a duty on researchers not to exclude
p.000199: individuals or groups from participation for reasons that are unrelated to the research. This duty is explicitly stated
p.000199: because groups have been inappropri- ately excluded from participation in research on the basis of attributes such as
p.000199: gender, race, ethnicity, age and disability.
p.000199: The focus, objective, nature of research and context in which the research is con- ducted inform the inclusion and
p.000199: exclusion criteria for a specific research project. Some research may be focused on a certain individual (such as in a
p.000199: biography), or a group of individuals who share a specific characteristic (e.g., an identifiable group of painters who
p.000199: happen to be all of one sex; a religious order that is restricted to one sex). Other examples include research that is
p.000199: focused on specific cultural tra- ditions or languages, or on one age group (e.g., a biomechanical modeling study of
...
p.000107: well as concern for the community to which participants belong. This Policy acknowledges the important role of
p.000107: Aboriginal communities in promoting collective rights, interests and responsibilities that also serve the welfare of
p.000107: individuals.
p.000107: Aboriginal peoples are particularly concerned that research should enhance their capacity to maintain their cultures,
p.000107: languages and identities as First Nations, Inuit or Métis peoples, and to support their full participation in, and
p.000107: contributions to, Canadian society. The interpretation of Concern for Welfare in First Nations, Inuit and Métis
p.000107: contexts may therefore place strong emphasis on collective welfare as a complement to individual well-being.
p.000107: Justice may be compromised when a serious imbalance of power prevails between the researcher and participants.
p.000107: Resulting harms are seldom intentional, but nonetheless real for the participants. In the case of Aboriginal peoples,
p.000107: abuses stemming from research have included: misappropriation of sacred songs, stories and artefacts; devaluing of
p.000107: Aboriginal peoples’ knowledge as primitive or superstitious; violation of community norms regarding the use of human
p.000107: tissue and remains; failure to share data and resulting benefits; and dissemination of information that has
p.000107: misrepresented or stigmatized entire communities.
p.000107: Where the social, cultural or linguistic distance between the community and researchers from outside the community is
p.000107: significant, the potential for misunderstanding is likewise significant. Engagement between the community involved
p.000107: and researchers, initiated prior to recruiting
p.000107:
p.000107:
p.000107:
p.000107: TCPS 2
p.000109: 109
p.000109:
p.000109: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000109:
p.000109: participants and maintained over the course of the research, can enhance ethical practice and the quality of
p.000109: research. Taking time to establish a relationship can promote mutual trust and communication, identify
p.000109: mutually beneficial research goals, define appropriate research collaborations or partnerships, and ensure that
p.000109: the conduct of research adheres to the core principles of Respect for Persons, Concern for Welfare – which in this
p.000109: context includes welfare of the collective, as understood by all parties involved – and Justice.
p.000109: Research Involving Indigenous Peoples in Other Countries
p.000109: Although the present chapter addresses research involving Aboriginal peoples in Canada, researchers, REBs, participants
p.000109: and the research community at large may find the guidance articulated here useful when undertaking research or
p.000109: reviewing a proposal involving Indigenous peoples in other countries who endorse collective decision making as a
p.000109: complement to individual consent. It is critically important, however, to seek local guidance in the
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Social / Marital Status
Searching for indicator single:
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p.000199: professional standards. There is a corresponding responsibility on the part of institutions to de- fend researchers in
p.000199: their efforts to uphold academic freedom and high ethical, scientific and professional standards.
p.000199: Research is a step into the unknown. Because it seeks to understand something not yet revealed, research often entails
p.000199: risks to participants and others. These risks can be trivial or profound, phys- ical or psychological, individual or
p.000199: social. History offers unfortunate examples where research participants have been needlessly, and at times profoundly,
p.000199: harmed by research, sometimes even dying as a result. Ethical principles and guidelines play an important role in
p.000199: advancing the pursuit of knowledge while protecting and respecting research participants in order to try to prevent
p.000199: such occurrences.
p.000199: People have also been gratified and have had their lives enriched by their participation in research, either because
p.000199: they may have benefited directly or because their participation has contributed to
p.000199:
p.000199: TCPS 2 7
p.000199:
p.000199: Chapter 1 – Ethics Framework
p.000199:
p.000199: the expansion of knowledge. Given the fundamental importance of research and of human partic- ipation in research, we
p.000199: must do all that we can as a society to ensure that research is conducted in an ethical manner so as to build public
p.000199: confidence and trust. By promoting and guiding the ethical conduct of research involving humans, this Policy seeks to
p.000199: contribute tangibly to these goals.
p.000199: No single document can provide definitive answers to all ethical issues that may arise in an undertaking as complex as
p.000199: research involving humans. This Policy aims to assist those who use it
p.000199: – researchers, sponsors, members of research ethics boards (REBs), participants, and the public – to identify ethical
p.000199: issues in the design, conduct and oversight of research and to point the way to arriving at reasoned and ethical
p.000199: responses to these issues.
p.000199: B. Core Principles
p.000199: Respect for human dignity has been an underlying value of the Tri-Council Policy Statement: Eth- ical Conduct for
p.000199: Research Involving Humans (TCPS or the Policy) since its inception. Despite clear recognition of its centrality in
p.000199: research ethics, the term lends itself to a variety of definitions and interpretations that make it challenging to
p.000199: apply.
p.000199: Respect for human dignity requires that research involving humans be conducted in a manner that is sensitive to the
p.000199: inherent worth of all human beings and the respect and consideration that they are due. In this Policy, respect for
p.000199: human dignity is expressed through three core principles – Re- spect for Persons, Concern for Welfare, and Justice.
p.000199: These core principles transcend disciplinary boundaries and, therefore, are relevant to the full range of research
p.000199: covered by this Policy.1
p.000199: Article 1.1 The guidelines in this Policy are based on the following three core principles:
p.000199: • Respect for Persons
...
p.000199: inducement and thus negate the voluntariness of participants’ consent.
p.000199: This Policy neither recommends nor discourages the use of incentives. The onus is on the researcher to justify to the
p.000199: REB the use of a particular model and the level of incentives. In considering the possibility of undue influence in re-
p.000199: search involving financial or other incentives, researchers and REBs should be sensitive to issues such as the economic
p.000199: circumstances of those in the pool of prospective participants, the age and capacity of participants, the customs and
p.000199: practices of the community, and the magnitude and probability of harms (see Chapter 4, Section B). Guardians and
p.000199: authorized third parties should not receive incentives for arranging the involvement in research of the individual they
p.000199: rep- resent. However, they may accept reasonable incentives or compensation on behalf of that individual, as long as
p.000199: these are suitable to the circumstances.
p.000199: (b) To maintain the element of voluntariness, participants shall be free to withdraw their consent to participate in
p.000199: the research at any time, and need not offer any reason for doing so. In some cases, however, the physical
p.000199: practicalities of the project may prevent the actual withdrawal of the participant partway through, for example, if
p.000199: the project involves only a single intervention, or if the termination of a medical research procedure may
p.000199: compromise the safety of the participant.
p.000199:
p.000199: TCPS 2 29
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: The participant should not suffer any disadvantage or reprisal for withdrawing nor should any payment due prior to the
p.000199: point of withdrawal be withheld. If the research project used a lump-sum incentive for participation, the participant
p.000199: is entitled to the entire amount. If a payment schedule is used, participants shall be paid in proportion to their
p.000199: participation.
p.000199: (c) The consent form should set out any circumstances that do not allow withdrawal of data or human biological
p.000199: materials once collected. Where the terms of the research do not allow for withdrawal of their data or human
p.000199: biological materials, the identity of the participants shall be protected at all times during the project and after its
p.000199: completion. In some research projects, the withdrawal of data or human biological materials may not be feasible (e.g.,
p.000199: when personal information has been anonymized and added to a data pool). Participants shall also be informed that it is
p.000199: difficult, if not impossible, to withdraw results once they have been published or otherwise disseminated.
p.000199: Consent Shall Be Informed
p.000199: Article 3.2 Researchers shall provide to prospective participants, or authorized third parties, full disclosure of
p.000199: all information necessary for making an informed decision to participate in a research project.
...
p.000199: • REBs make the final decision about the nature and frequency of continuing ethics review;
p.000199: • Researchers’ responsibilities include monitoring their research to ensure that it is conducted in an
p.000199: ethical manner, reporting unanticipated issues
p.000199:
p.000199:
p.000199: 80 TCPS 2
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: (see Article 6.15) or changes to the research (see Article 6.16), supervising all team members in the
p.000199: application of the research procedures, and ensuring that they are properly qualified and versed in
p.000199: the conduct of ethical research.
p.000199: Reports of Unanticipated Issues
p.000199: Article 6.15 Researchers shall report to the REB any unanticipated issue or event that may in- crease the level of
p.000199: risk to participants, or has other ethical implications that may affect participants’ welfare.
p.000199: Application Over the course of the implementation of the approved research project, issues may arise that the
p.000199: researcher did not anticipate when originally submitting the research for ethics review. Unanticipated issues include
p.000199: unexpected reactions by participants to a research intervention (e.g., unintended stimulation of traumatic memories,
p.000199: un- foreseen side-effects of a medication or natural health product), as well as unavoidable single
p.000199: incidents (e.g., a translator not available for a day, or a failure to follow correct research procedure for one
p.000199: participant on one occasion). They may be minor or serious in magnitude, with short- or long-term implications.
p.000199: Any unanticipated issue that increases the level of risk to participants or has other ethical implications should be
p.000199: reported to the REB without delay. Changes that are necessary to eliminate an immediate risk(s) to the participants may
p.000199: be implemented as needed, but must be reported to the REB at the earliest opportunity. For clinical trials, reporting
p.000199: requirements for safety data or unanticipated issues are also ad- dressed in Chapter 11 (Articles 11.7 and 11.8). If
p.000199: the incident or issue has immediate implications for the safety of participants, the REB may withdraw ethics approval,
p.000199: which would require that the research be halted or modified until the matter can be addressed (see Article 6.3 and
p.000199: Articles 11.8 and 11.9). It may require submission of a revised research proposal for REB review.
p.000199: Minor deviations from the research (e.g., a slight increase or decrease of testing time, a wording adjustment on a
p.000199: question) should not require immediate reporting to the REB, but may be summarized in annual status reports (see
p.000199: Article 6.14). In some types of qualitative research, for example, emergent design (see Article 10.5), the research
p.000199: design evolves over time, so adjustments to the research are to be ex- pected and need not be reported to the REB,
...
p.000199: Contemporary research often involves collaborative partnerships among researchers from multiple institutions or
p.000199: countries. It may call upon the participation of a number of local populations and involve multiple institutions and/or
p.000199: multiple research ethics boards (REBs).
p.000199: Collaborations in research may require institutions to adopt policies and procedures that permit arrangements for REB
p.000199: review by REBs at other institutions or external or independent REBs. To be effective, these review arrangements should
p.000199: ensure that research involving humans is designed, reviewed, and conducted in a way that is informed by the core
p.000199: principles of this Policy: Respect for Persons, Concern for Welfare, and Justice. These core principles should be
p.000199: balanced with a proportionate approach to the research ethics review process (described in Article 2.9) for research
p.000199: being undertaken in Canada or abroad. Multi-jurisdictional research should take into account other relevant policies,
p.000199: and applicable laws and regulations.
p.000199:
p.000199: A. Review Mechanisms for Research Involving Multiple Institutions and/or Multiple REBs
p.000199: This section primarily addresses the ethics review mechanisms for research involving multiple in- stitutions and/or
p.000199: multiple REBs. It is not intended to apply to ethics review mechanisms for research involving multiple REBs within the
p.000199: jurisdiction or under the auspices of a single institu- tion (addressed in Article 6.3).
p.000199: Research involving humans that may require the involvement of multiple institutions and/or mul- tiple REBs includes,
p.000199: but is not limited to, the following situations:
p.000199: (a) a research project conducted by a team of researchers affiliated with different institutions;
p.000199: (b) several research projects independently conducted by researchers affiliated with different institutions, with data
p.000199: combined at some point to form one overall research project;
p.000199: (c) a research project conducted by a researcher affiliated with one institution, but that involves collecting data or
p.000199: recruiting participants at different institutions;
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 97
p.000199:
p.000199: Chapter 8 – Multi-Jurisdictional Research
p.000199:
p.000199: (d) a research project conducted by a researcher who has multiple institutional affiliations (e.g., two universities, a
p.000199: university and a college, or a university and a hospital. See Application of Article 6.1);
p.000199: (e) a research project conducted by a researcher at one institution that requires the limited col- laboration of
p.000199: individuals affiliated with different institutions or organizations (e.g., statisticians, lab or X-ray
p.000199: technicians, social workers and school teachers); or
p.000199: (f) a research project that researcher(s) working under the auspices of a Canadian research in- stitution conduct in
p.000199: another province, territory or country.
p.000199:
p.000199: Adoption of Alternative Review Models – An Institutional Responsibility
p.000199: Article 8.1 An institution that has established an REB may approve alternative review models for research
...
p.000199: re- search ethics review.
p.000199:
p.000199: 98 TCPS 2
p.000199:
p.000199: Chapter 8 – Multi-Jurisdictional Research
p.000199:
p.000199: Researchers and REBs should use the research ethics review models defined by their institution (see Article 8.2) and
p.000199: facilitate coordination of the research ethics review process. Whatever model is chosen, roles and responsibilities of
p.000199: all involved in the process should be defined and agreed to at the outset. Continuing ethics re- view of research
p.000199: involving multiple institutions and/or multiple REBs should follow the same process outlined in Article 6.14.
p.000199:
p.000199: Research Ethics Review Models
p.000199: The following models for the ethics review of research involving multiple REBs and/or multiple institutions are
p.000199: intended to provide flexibility and efficiency, and avoid unnecessary duplication of review without compromising the
p.000199: protection of participants. All other provisions of this Policy remain applicable.
p.000199: 1) Independent Ethics Review by Several REBs
p.000199: This model follows the same research ethics review process as when the research only involves a single REB review. The
p.000199: REBs involved at each participating institution conduct an independent research ethics review and provide their
p.000199: separate decisions, either concurrently or sequentially. The level of ethics review for research that involves multiple
p.000199: REBs and/or institutions shall be proportionate to the risk involved in the research (see Article 6.12).
p.000199: Ethics review of the proposed research at each collaborating institution helps to ensure that local issues and values
p.000199: are taken into consideration. This approach may be particularly important, though often more challenging, when there
p.000199: are relevant social or cultural differences between the partic- ipating institutions. When several REBs consider the
p.000199: same proposal from their own institutional perspectives, they may reach different conclusions on one or more aspects of
p.000199: the proposed research, that reflect local issues and values. REBs may therefore wish to coordinate their ethics review
p.000199: of research projects requiring multiple REB involvement, including conducting their research ethics reviews in a timely
p.000199: manner, and communicating any concerns that they may have with other REBs reviewing the same project. When multiple
p.000199: REBs are involved, the principal investigators should work with their REBs to formulate a strategy to address
p.000199: procedural inconsistencies or substantive disagreements that may arise among the participating REBs.
p.000199: Where possible, researchers should provide their REB with the name and contact information of the other REBs that will
p.000199: also review the project to facilitate direct communication between the REBs, and help resolve disagreements that may
p.000199: arise.
p.000199: 2) Research Ethics Review Delegated to an External, Specialized or Multi-Institutional REB
p.000199: Institutions may allow research on specialized content or research methods to be reviewed by an external, specialized
p.000199: or multi-institutional REB, where such a body exists. External, specialized or multi-institutional REBs may be
p.000199: established regionally, provincially/territorially or nationally, as necessary. Two or more institutions may choose to
p.000199: create a single joint REB, or to appoint an external REB, to which they delegate research ethics review. This
p.000199: delegation of review may be based on geographical proximity or other considerations such as resources, volume of
p.000199: reviews or shared expertise.
p.000199:
p.000199: TCPS 2 99
p.000199:
p.000199: Chapter 8 – Multi-Jurisdictional Research
p.000199:
p.000199: Some provinces have introduced legislation or policies that designate one or more REBs for the review of certain types
p.000199: of research within the province (see References at the end of this chapter).
p.000199: In the official agreement between the selected REB and the institutions submitting research for ethics review, the
p.000199: external, specialized, or multi-institutional REB shall agree to adhere to this Policy. Roles and responsibilities
p.000199: should be clearly defined in the official agreement between the institution(s) delegating the review, and the
p.000199: institution or equivalent organization of the REB that will review the ethical acceptability of the research, or in the
p.000199: relevant legislation or policies. The external, specialized or multi-institutional REB may act as the responsible REB
p.000199: for any given re- view, if formally mandated as such by the institutions in question. Where relevant, agreements should
p.000199: specify how the external, specialized or multi-institutional REB will assure familiarity with particular populations
p.000199: that may be involved in the research. Review by an external, specialized or multi-institutional REB need not be
p.000199: preceded or followed by local REB review unless warranted to help ensure that local issues and values are taken into
p.000199: account.
...
p.000111: community, enjoy freedom of expression as does any citizen. They are free to consent and to participate in research
p.000111: projects that they consider to be of personal or social benefit. If the project is unlikely to affect the welfare
p.000111: of the individuals’ communities, local community engagement is not required under this Policy. The necessity or
p.000111: desirability of engaging regional or national representatives of Aboriginal communities in policy research may,
p.000111: however, be determined by other considerations.
p.000111: 6) Natural sciences research on First Nations, Inuit or Métis lands where Aboriginal people may act as
p.000111: co-investigators, or benefit from findings. For example, research focusing exclusively on contaminants in animals or
p.000111: plants in Nunavik that does not make inferences regarding food intake.
p.000111: • Research that involves the collection and analysis of tissue samples from animals or plants, and not involving
p.000111: human research participants, is not covered within the scope of this Policy and does not require institutional REB
p.000111: review. However, funding program guidelines and licensing requirements in the North may impose obligations
p.000111: to engage communities. Community customs or codes of research practice may require securing regional and local
p.000111: permission, and reporting findings to communities (see NSERC literature on the Northern Research Program for professors
p.000111: and students/fellows, and Article 9.8).
p.000111: 7) Research that incidentally involves a small proportion of Aboriginal individuals but is not intended to single
p.000111: out, or describe, characteristics of Aboriginal people, for example, a study of the effectiveness of therapies to
p.000111: control high blood pressure in a sample of hospital outpatients, which is not designed to collect Aboriginal-specific
p.000111: data.
p.000111: • Since Aboriginal participation is incidental rather than scheduled, community engagement is not
p.000111: required. If Aboriginal individuals self- identify during the collection of primary data, researchers should inquire
p.000111:
p.000111:
p.000111:
p.000111: TCPS 2
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p.000113:
p.000113: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000113:
p.000113: whether culturally appropriate assistance is desired to interpret, or support compliance with, the research project.
p.000113: However, it should be noted that including markers of Aboriginal identity in data collection may reveal
p.000113: anomalies that warrant further, more targeted research, which, if followed up, would require community engagement.
p.000113: 8) Research based on publicly available information as defined by this Policy, for example, historical, genealogical
p.000113: or analytic research based on public records, or data available or accessible in accordance with legislation.
p.000113: • Such research does not involve the collection of data from communities directly or from living persons and is not
p.000113: subject to REB review (see Article 2.2). Community engagement is not required. Findings of such research nevertheless
p.000113: may have an impact on the identity or heritage of persons or communities. In order to minimize any harm,
...
p.000135:
p.000135: Some qualitative studies extend beyond individuals’ personal experiences to explore interactions and processes within
p.000135: organizations or other environments. Knowledge at both an individual and a cultural level is treated as socially
p.000135: constructed. This implies that all knowledge is, at least to some degree, interpretive, and hence, dependent on social
p.000135: context. It is also shaped by the personal perspective of the researcher as an observer and analyst. As a result,
p.000135: qualitative researchers devote a great deal of attention to demonstrating the trustworthiness of their findings using a
p.000135: range of methodological strategies.
p.000135: The section below provides a summary description of the general approach, as well as method- ological requirements and
p.000135: practices, of qualitative research, some of which may also apply to quantitative or other types of research involving
p.000135: humans.
p.000135: General Approach and Methodological Requirements and Practices
p.000135: (a) Inductive Understanding: Many forms of qualitative research entail gaining an inductive understanding of the world
p.000135: of participants to acquire an analytic understanding of how they view their actions and the world around them. In some
p.000135: projects, this approach also applies to the study of particular social settings, processes and experiences.
p.000135: To the extent that the methods involve direct interaction with participants, there is often an emphasis on gaining
p.000135: insights into participants’ perceptions of themselves and others, and of the meanings that participants attach to their
p.000135: thoughts and behaviours.
p.000135: (b) Diversity of Approaches: There is no single approach in qualitative research. Different fields or disciplines,
p.000135: and even individual scholars within a discipline, have different perspectives on, and approaches to, the use of
p.000135: qualitative methods. Qualitative research uses a variety of theoretical approaches, questions that guide the research,
p.000135: methodologies, epistemological approaches, and techniques that allow researchers to enter the participants’ world or
p.000135: to engage with particular social environments. Methodological approaches include, but are not limited to,
p.000135: ethnography, participatory action research, oral history, phenomenology, narrative inquiry, grounded theory and
p.000135: discourse analysis. The term “qualitative research” covers a wide range of overlapping paradigms or perspectives.
p.000135: (c) Dynamic, Reflective and Continuous Research Process: The emergence during the course of the research itself of
p.000135: questions, concepts, strategies, theories and ways to gather and engage with the data (e.g., emergent design research,
p.000135: see Article 10.5) requires a constant reflective approach and questioning by the researcher. Such flexibility,
p.000135: reflexivity and responsiveness contribute to the overall strength and rigour of data collection and analysis.
p.000135: (d) Diverse, Multiple and Often Evolving Contexts: Qualitative research takes place in a variety of contexts, each
p.000135: of which presents unique ethical issues. As knowledge is considered to be context-contingent in qualitative
p.000135: research, these studies tend to focus on particular individuals, sites or concepts that are empirically derived from
p.000135: other social settings. The researcher’s priority is to answer the research question stemming from the study of those
p.000135: individuals in a specific social setting at a specific time.
p.000135:
p.000135:
p.000135:
...
p.000157:
p.000157: Monitoring Safety and Reporting New Information
p.000157: In accordance with the core principle of Concern for Welfare, it is a key responsibility of researchers
p.000157: and REBs to ensure that, as clinical trials proceed, the risks to participants remain in the acceptable range, and the
p.000157: safety of participants is monitored. Articles 11.7 and 11.8 address researchers’ responsibility to include a safety
p.000157: monitoring plan in their proposal submitted for REB review, and their responsibility to ensure that any new information
p.000157: that may affect participant welfare or consent is shared with the REB and participants (see also Articles 6.15 and
p.000157: 6.16). Article 11.9 addresses the REB’s responsibility to have procedures in place to receive and respond to reports of
p.000157: new information, including, but not limited to, safety data, unanticipated issues and newly discovered risks (see the
p.000157: Application of Article 11.8 for an expanded definition).
p.000157: In the case of clinical trials, there are provincial, national and international guidelines that govern safety
p.000157: monitoring and reporting of new information. It is the responsibility of researchers to be aware of the guidelines that
p.000157: apply to their research (see References) and to adhere to them for the safety and benefit of participants.
p.000157: Roles and Responsibilities in the Sharing of New Information
p.000157: Typically, researchers in charge of a trial at a particular site are responsible for communicating new information to
p.000157: their REB, to participants and, in the case of multi-site research, to the principal investigator. In single-site
p.000157: clinical trials, such researchers will likely be the principal investigator (the leader of the trial who is
p.000157: responsible for its ethical conduct). In this chapter, the term “researcher” is used in the context of
p.000157: communication with REBs and participants, and the term “principal investigator” is used in the context of communication
p.000157: among researchers involved in a multi-site trial.
p.000157: Trials may also have sponsors who can be a source of new information. Sponsors may be the principal investigator
p.000157: (investigator-initiated trials), a research institution or another type of
p.000157:
p.000157:
p.000157: TCPS 2
p.000159: 159
p.000159:
p.000159: Chapter 11 – Clinical Trials
p.000159:
p.000159: organization (e.g., private company, not-for-profit association). When principal investigators receive new information,
p.000159: from the sponsor or any other source related to the trial, they are responsible for communicating this new information
p.000159: to their own REB, as well as to local site researchers, who must then inform their local REBs.
p.000159: The extent to which new information is shared with participants depends upon the nature of the information, and the
p.000159: REB’s evaluation of whether it affects the welfare or consent of some or all participants. In the case of multi-site
p.000159: trials (also known as multi-jurisdictional trials), the roles and responsibilities of the principal investigator,
p.000159: researchers and sponsor may vary depending on the model of research ethics review in use (see Chapter 8).
p.000159: Article 11.7 Researchers shall provide the REB with an acceptable plan for monitoring the safety of participants,
...
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179: 180 TCPS 2
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179: Introduction
p.000179: Chapter 13
p.000179: HUMAN GENETIC RESEARCH
p.000179:
p.000179: Human genetic research involves the study of genetic factors responsible for human traits and the interaction of those
p.000179: factors with each other, and with the environment. Research in this area includes the identification of genes that
p.000179: comprise: the human genome; functions of genes; the characterization of normal and disease conditions in individuals,
p.000179: biological relatives, families, communities and groups; and studies involving gene therapy. Participants in clinical
p.000179: trials are increasingly being asked to participate in genetic studies in addition to the primary clinical trial. With
p.000179: the growth of genetic research, especially whole-genome research, researchers, research ethics boards (REBs) and
p.000179: participants should be aware of the ethical issues that this research raises.
p.000179:
p.000179: Genetic research may have profound social impacts, both positive and negative. As genetic research advances,
p.000179: genes and their alleles (versions) are being identified, but the function of each gene and its relationship to disease
p.000179: conditions, or other characteristics may not be clear. In single- gene disorders, for example, an allele of a single
p.000179: gene is directly related to a hereditary disease. More commonly, diseases or personal characteristics are influenced by
p.000179: multiple genes, as well as environmental factors.
p.000179:
p.000179: Research may help us better understand the human genome, and genetic contributions to health and disease. It may lead
p.000179: to new approaches to preventing and treating disease. Individuals may benefit from learning about their genetic
p.000179: predispositions, if intervention strategies are available to prevent or minimize disease onset and mitigate symptoms,
p.000179: or to otherwise promote health. Genetic research also has the potential, however, to stigmatize individuals,
p.000179: communities or groups, who may experience discrimination or other harms because of their genetic status, or may be
p.000179: treated unfairly or inequitably.
p.000179:
p.000179: A. Application of Core Principles to Genetic Research
p.000179: Genetic information has implications beyond the individual because it may reveal information about biological relatives
p.000179: and others with whom the individual shares genetic ancestry. The participation of an individual in genetic research may
p.000179: therefore have ramifications for these other persons, communities or groups. In some cases, researchers specifically
p.000179: seek to conduct genetic research with members of families, communities or groups that requires particular attention to
p.000179: the social and cultural contexts in which participants live. Research with families, communities or groups may raise
p.000179: special considerations regarding recruitment of participants, consent processes, privacy and confidentiality.
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179: TCPS 2
p.000181: 181
p.000181:
...
p.000193: entails treating all people with equal respect and concern. Equity requires distributing the benefits and burdens of
p.000193: research participation in such a way that no segment of the population is unduly burdened by the harms of research or
p.000193: denied the benefits of the knowledge generated from it.
p.000193:
p.000193: Medical device trials – Clinical trials that test the safety and/or efficacy of one or more instruments used in the
p.000193: prevention, diagnosis, mitigation, or treatment of a disease or abnormal physical condition or the restoration,
p.000193: correction or modification of body function or structure.
p.000193:
p.000193: Medical emergency – A situation in which one or more individuals requires urgent medical care.
p.000193:
p.000193: Minimal risk research – Research in which the probability and magnitude of possible harms implied by participation in
p.000193: the research is no greater than those encountered by participants in the aspects of their everyday life that relate to
p.000193: the research.
p.000193:
p.000193: Memorandum of Understanding (MOU) – The agreement between the Agencies and institutions eligible to receive and manage
p.000193: research funding from the Agencies. A commitment to adhere to the TCPS is a part of the MOU.
p.000193:
p.000193: Multi-jurisdictional research – research involving multiple institutions and/or multiple REBs. It is not intended to
p.000193: apply to ethics review mechanisms for research involving multiple REBs within the jurisdiction or under the auspices of
p.000193: a single institution.
p.000193:
p.000193: Natural Health Product (NHP) Trial – A clinical trial testing the safety and/or efficacy of one or more natural
p.000193: health products. The term natural health product is used to describe substances such as vitamins and minerals, herbal
p.000193: medicines, homeopathic preparations, energy drinks, probiotics, and many alternative and traditional medicines.
p.000193:
p.000193: Observational research – The study of behaviour in a natural environment in which people involved in their normal
p.000193: activities are observed whether with or without their knowledge. This term does not include observational methods used
p.000193: in epidemiological research.
p.000193:
p.000193: Ongoing research – Research that has received REB approval and has not yet been completed.
p.000193:
p.000193: Participant – An individual whose data, or responses to interventions, stimuli, or questions by a researcher are
p.000193: relevant to answering a research question; also referred to as “human participant,” and in other
p.000193: policies/guidance as “subject” or “research subject.”
p.000193:
p.000193: Participatory research – Research that includes the active involvement of those who are the subject of the research.
p.000193: Participatory research is usually action-oriented, where those involved in the research process collaborate to define
p.000193: the research project, collect and analyze the data, produce a final product and act on the results. See
p.000193: “Community-based research” and “Collaborative research.”
p.000193:
p.000193: Principal investigator – The leader of a research team who is responsible for the conduct of the research, and for the
p.000193: actions of any member of the research team.
p.000193:
p.000193:
p.000193:
p.000193:
p.000193: 194 TCPS 2
p.000193:
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Social / Police Officer
Searching for indicator officer:
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p.000199: the institution.
p.000199: Should the institution determine that some situations warrant an exception to the requirement for REB review, the basis
p.000199: and conditions for case-by-case exceptions shall be clearly documented in the institutional policies. Case-by-case
p.000199: exceptions may be determined by such factors as the degree to which the members’ affiliation with the institution is
p.000199: their primary affiliation, or by how practical it is to distinguish the capacity in which the member is conducting the
p.000199: research, and the participants’ reasonable perceptions of this capacity. Other factors include the availability of
p.000199: other avenues through which the member may address the guidance in this Policy outside the institution, including the
p.000199: possibility of sharing responsibility for re- search ethics review, and the methods in place to address real, potential
p.000199: or perceived conflict of interest issues.
p.000199: Article 6.2 The highest body within an institution shall: establish the REB or REBs, define an appropriate
p.000199: reporting relationship with the REBs, and ensure the REBs are provided with necessary and sufficient ongoing financial
p.000199: and administrative resources to ful- fil their duties. REBs are independent in their decision making and are
p.000199: accountable to the highest body that established them for the process of research ethics review.
p.000199: Application The highest body of the institution that establishes the REB or REBs could be an individual, such as
p.000199: the president, rector or chief executive officer, or an equivalent body, such as a governing council, board of
p.000199: directors, or council of administration. Institutions shall have in place written procedures for the appointment,
p.000199: renewal and removal of REB members.
p.000199: For the integrity of the research ethics review process, and to safeguard public trust in that process, institutions
p.000199: shall ensure that REBs are able to operate effectively and independently in their decision making. Disagreement between
p.000199: the researcher
p.000199:
p.000199: 68 TCPS 2
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: and the REB over a decision that cannot be resolved through discussion and reconsideration can be resolved
p.000199: through the normal appeal process (see Articles 6.18 to 6.20).
p.000199: Institutional policies and procedures shall also support and promote the independ- ence of REBs in their decision
p.000199: making so that REBs may be free of inappropriate influence, including situations of real, potential or perceived
p.000199: conflicts of interest (see Chapter 7).
p.000199: It is critical that institutions provide appropriate administrative resources to REBs (e.g., research ethics
p.000199: administration staff, a research ethics office) for the effective and efficient operation of the REB. The means by
p.000199: which this support may be pro- vided will vary by institution, but may include REB coordination, support in policy
...
p.000139: there are valid reasons for not recording consent through a signed written consent form, the procedures used to seek
p.000139: and confirm consent must be documented.
p.000139: The consent process should be based on mutual understanding of the project goals and objectives between the
p.000139: participants and the researcher. The participant may perceive attempts to legalize or formalize the process as a
p.000139: violation of that trust. Qualitative researchers use a range of procedures to seek and document consent, including oral
p.000139: consent documented in field notes, and other forms of recording (a consent log, audio or video recordings, or other
p.000139: electronic means) Evidence of consent may also be documented via completed questionnaires (in person, by mail, or by
p.000139: email or other electronic means).
p.000139: REBs may need to consider the power relationship that might exist between researchers and participants, and
p.000139: whether a waiver of the requirement for signed written consent may affect the welfare of the participants. In cases
p.000139: where the participant holds a position of power, or routinely engages in communicative interactions similar
p.000139: to those involved in the research by virtue of their position or profession (e.g., a communications officer or
p.000139: spokesperson for an organization), consent can be inferred by the participant’s agreeing to interact with the
p.000139: researcher for the purpose of the research. For example, some political science research focuses on power
p.000139: structures and individuals in positions of power (e.g., a senior partner in a law firm, a cabinet minister or a senior
p.000139: corporate officer). In this type of research, where a prospective participant agrees to be interviewed on the basis of
p.000139: sufficient information provided by the researcher, it may be sufficient for the participant to signify consent to
p.000139: participate in the research. The researcher should record this in an appropriate way. Researchers shall demonstrate to
p.000139: the REB that the participant will be informed about the research including the option not to participate, or to
p.000139: withdraw from the study at any time. Nothing in this article should be interpreted to mean that prospective
p.000139: participants need not be informed about the study prior to their participation.
p.000139: Researchers and REBs should consult Chapter 3, and Articles 3.1, 3.2, 3.3 and 3.12 in particular, for additional
p.000139: details and considerations on consent, and how to document consent.
p.000139:
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p.000139:
p.000139: Chapter 10 – Qualitative Research
p.000139:
p.000139: Observational Studies
p.000139: In qualitative research, observation is used to study behaviour in a natural environment. It often takes
p.000139: place in living, natural and complex communities or settings, in physical environments, or in virtual settings.
p.000139: Observational studies may be undertaken in publicly accessible spaces (e.g., classrooms, hospital emergency wards,
p.000139: locations where religious services or practices are held), in virtual settings (e.g., Internet chat rooms), or in
...
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p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 31
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: magnitude and probability of harms, the complexity of the information conveyed, and the setting where the information
p.000199: is given.
p.000199: The key to informed consent is that prospective participants understand the information being conveyed to
p.000199: them by researchers. Researchers and REBs should consider how best to convey that information to facilitate
p.000199: understanding. For example, written documentation may be supplemented with audio and/or visual aids, or accompanied by
p.000199: video presentations.
p.000199: When language barriers necessitate the assistance of an intermediary for commu- nication between the research team and
p.000199: participants, the researcher should select an intermediary who has the necessary language skills to ensure effective
p.000199: commu- nication (see Article 4.1). The involvement of such intermediaries may raise confidentiality issues
p.000199: (see Article 5.2).
p.000199: Paragraphs (a) to (c) require researchers to clearly explain the nature and goals of the research, and other
p.000199: essential information, in a manner that best promotes understanding on the part of prospective participants.
p.000199: Paragraph (b) requires the disclosure of those who support a particular research project, through funding or
p.000199: sponsorship. It is unethical for researchers to engage in clandestine activities for intelligence, police or military
p.000199: purposes under the guise of research.
p.000199: Paragraph (c) requires researchers to consider all reasonably foreseeable risks that may result from participation.
p.000199: When research is conducted about an organization or a community, researchers should inform prospective participants
p.000199: within that organization or community of the extent to which the organization or community is collaborating with the
p.000199: research, as well as any risk this collaboration may pose to the participant.
p.000199: Paragraph (d) helps to ensure the effectiveness of Article 3.1 – that a prospective participant’s choice to participate
p.000199: is voluntary. Paragraph (d) also supports the requirement that the consent process continue throughout the research.
p.000199: Paragraph (e) aims at managing real, potential or perceived conflicts of interests. Researchers should separate, to the
p.000199: greatest extent possible, their role as researcher from their other roles as therapists, caregivers, teachers,
p.000199: advisors, consultants, supervisors, employers or the like. If a researcher is acting in dual roles, this fact must
p.000199: always be disclosed to the participant. Conflict of interest matters are further elaborated in Chapter 7.
p.000199: Paragraph (f) requires that researchers provide a reasonable explanation of the meas- ures they will undertake to
p.000199: publish and otherwise disseminate the results of the research – to the extent that it is feasible, and in a manner that
p.000199: is appropriate. Beyond
p.000199:
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p.000199:
p.000199: 32 TCPS 2
p.000199:
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p.000135: disciplines. The intended goals of qualitative projects may include “giving voice” to a particular population, engaging
p.000135: in research that is critical of settings and systems, or the power of those being studied, affecting change in a
p.000135: particular social environment, or exploring previously understudied phenomena to develop new theoretical approaches to
p.000135: research.
p.000135: (g) Dynamic, Negotiated and Ongoing Consent Process: Entry into a particular setting for research purposes sometimes
p.000135: requires negotiation with the population of interest; sometimes the researcher cannot ascertain the process in
p.000135: advance of the research, in part because the relevant contexts within which the research occurs evolve over time.
p.000135:
p.000135:
p.000135:
p.000135:
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p.000135: TCPS 2
p.000137: 137
p.000137:
p.000137: Chapter 10 – Qualitative Research
p.000137:
p.000137: In some cases, participants hold equal or greater power in the researcher-participant rela- tionship, such as in
p.000137: community-based and/or organizational research when a collaborative process is used to define and design the research
p.000137: project and questions, or where partici- pants are public figures or hold other positions of power (e.g., research
p.000137: involving economic, social, political or cultural elites). In other cases, researchers themselves may hold greater
p.000137: power when access to prospective participant populations is gained through gatekeepers with whom the researcher has
p.000137: established a relationship (e.g., when a researcher engages with the police to do research in relation to a problem
p.000137: population, or when researchers en- gage with prison authorities to do research with offenders).
p.000137: (h) Research Partnerships: Access to particular settings and populations is sometimes developed over time, and
p.000137: the relationships that are formed may well exist outside the research setting per se, which sometimes makes it
p.000137: difficult to determine exactly where the “research” relationship begins and ends. In many cases, despite
p.000137: in-depth, advance preparation, a researcher may not know until the actual data collecting starts just where the search
p.000137: will lead. Indeed, the emergent nature of many qualitative studies makes the achievement of rapport with participants
p.000137: and feelings of interpersonal trust crucial to the generation of questions considered important or interesting by both
p.000137: parties, and to the collection of dependable data. Research often becomes a collaborative process negotiated between
p.000137: the participant(s) and the researcher, requiring considerable time spent initially simply figuring out the focus of the
p.000137: research.
p.000137: In certain cases, contacts between researchers and participants can extend over a lifetime, and these individuals may
p.000137: engage in a variety of relationships over and above their specific “research” relationship.
p.000137: (i) Research Results: Generalizability of the results to other contexts and the representative- ness of the sample may
p.000137: or may not be a concern in qualitative research. Transferability of results from one setting to another is often viewed
p.000137: as more of a theoretical issue than a procedural or a sampling issue.
p.000137:
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Social / Presence of Coercion
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p.000183: Article 13.6 Where researchers intend to recruit participants for genetic research based on their membership in
p.000183: specific communities or groups, it may be appropriate for re- searchers to discuss the research with community
p.000183: or group members, and/or their leaders, in addition to seeking consent from individual participants. In these cases,
p.000183: researchers shall provide details to the REB about their proposed methods for en- gaging in discussion.
p.000183: Application Some genetic research seeks to explore genetic variations within specific commu- nities or groups. Such
p.000183: research may raise ethical concerns regarding stigmatization, unfair or inequitable treatment, and social disruption in
p.000183: communities or groups – especially if individual members disagree about participation in research. Discus- sion with
p.000183: formal or informal leaders or other members of the community or group may be appropriate. This determination will
p.000183: depend on factors such as: the objec- tives of the proposed research (in particular, the extent to which membership in,
p.000183: or characteristics of, the community or group are a key aspect of the research); the risks and potential benefits of
p.000183: the research to the community or group; the nature of the community or group from which participants will be recruited;
p.000183: and the com- munity’s or group’s organizational structure.
p.000183: Individuals within a community or group may have conflicting views about par- ticipation in research, including
p.000183: disagreements between leaders and members. Such conflicts may involve attempts by some to influence or coerce choices
p.000183: of others about whether to participate in research. Researchers should recognize the potential for conflict within
p.000183: communities or groups, and ensure that consent and discussion processes facilitate free and informed decisions by
p.000183: individual members. Refer to Chapter 3 for further guidance in regard to voluntariness of consent.
p.000183: Researchers who propose to conduct genetic research involving Aboriginal participants or communities, or to
p.000183: use human biological materials that are identifiable as originating from Aboriginal peoples, should refer to
p.000183: Chapter 9 for further guidance.
p.000183:
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p.000185: Chapter 13 – Human Genetic Research
p.000185:
p.000185: F. Genetic Material Banks
p.000185: Article 13.7 (a) Researchers who propose research involving the collection and banking of genetic material shall
p.000185: indicate in their research proposal, and in the information they provide to prospective participants, how they plan to
p.000185: address the associated ethical issues, including confidentiality, privacy, storage, use of the data and results,
p.000185: possibility of commercialization of research findings and withdrawal by participants as well as future contact of
p.000185: participants, families, communities and groups.
p.000185: (b) Researchers who propose research involving the secondary use of previously collected and banked genetic material
p.000185: shall, likewise, indicate in their research proposal how they plan to address associated ethical issues.
p.000185: Application Collection of human biological materials including genetic materials, and their re- tention in biobanks
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Social / Property Ownership
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p.000101: outlined in this Policy (see Chapter 1).
p.000101:
p.000101:
p.000101: 102 TCPS 2
p.000101:
p.000101: Chapter 8 – Multi-Jurisdictional Research
p.000101:
p.000101: REBs should not prevent research from proceeding solely because the research cannot be reviewed and approved through a
p.000101: formal REB review process in another country or other jurisdiction. Under these circumstances, researchers should be
p.000101: aware of relevant cultural practices, such as those normally followed to seek entry into the relevant communities, and
p.000101: be respectful of them. Researchers shall inform the REB of their strategies to familiarize themselves with the relevant
p.000101: norms and cultural practices, and to minimize risks to individuals and communities partici- pating in, or potentially
p.000101: affected by, the research.
p.000101: Researchers and REBs should afford prospective participants in other countries no less protection and respect than what
p.000101: this Policy requires. Respect for Persons, Concern for Welfare, and Justice considered in the context of the particular
p.000101: research project and setting should guide researchers in the design of their research, and REBs in their research
p.000101: ethics review.
p.000101: Article 8.4 (a) The information to be provided to the researcher’s home REB will be deter- mined by the provisions
p.000101: of the research ethics review model.
p.000101: (b) When conducting research outside the jurisdiction of their home institution, whether at a site abroad, or in
p.000101: Canada, researchers shall provide their home REBs with:
p.000101: • the relevant information about the rules governing research involving hu- mans and the ethics review requirements
p.000101: at the research site, where any exist;
p.000101: • the names and contact information for the relevant REBs or comparable ethics bodies, if known, that will review the
p.000101: proposal at the research site; and
p.000101: • relevant information about the target populations and circumstances that might have a bearing on the research
p.000101: ethics review by the researchers’ home REB.
p.000101: Application Researchers and REBs should be aware of the research ethics requirements and the types of protections
p.000101: for research involving humans, including legal protection, af- forded to participants at proposed research locations.
p.000101: Researchers and REBs should consult relevant reliable resources for details about governing laws or policies, and for
p.000101: information regarding appropriate REBs at the proposed research site in Canada or another country (see References at
p.000101: the end of this chapter). Applicable policies at the proposed site may differ considerably from this Policy, and
p.000101: therefore it is the responsibility of the researchers and REB(s) to ensure that, at a minimum, the pro- visions of this
p.000101: Policy, are followed.
p.000101: Disagreements may arise when one of the REBs or equivalent review body (Cana- dian or foreign) grants ethics approval
p.000101: while the other does not. Such disagreements require open communication among the researchers and the REBs, or
p.000101: equivalent review bodies involved (see also Section A of this chapter). In keeping with the
p.000101:
p.000101:
p.000101:
p.000101: TCPS 2
p.000103: 103
p.000103:
p.000103: Chapter 8 – Multi-Jurisdictional Research
p.000103:
p.000103: context-sensitive approach to research ethics review embodied in this Policy, the Canadian REB should ensure that it
p.000103: has a clear understanding of the differing ra- tionales that might underlie divergent REB positions or
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p.000199: the project (see Article 2.9). These two steps constitute the proportionate approach to REB review that is recommended
p.000199: throughout the Policy.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 11
p.000199:
p.000199: Chapter 1 – Ethics Framework
p.000199:
p.000199: Research Ethics and Law
p.000199: In addition to the principles and guidelines in this Policy, researchers are responsible for ascertaining
p.000199: and complying with all applicable legal and regulatory requirements with respect to consent and the protection of
p.000199: privacy of participants (see Chapter 5). These legal and regulatory requirements may vary depending on the jurisdiction
p.000199: in Canada in which the research is being conducted, and who is funding and/or conducting the research, and
p.000199: they may comprise constitutional, statutory, regulatory, common law, and/or international or legal requirements of
p.000199: jurisdictions outside of Canada. Where the research is considered to be a governmental activity, for example, standards
p.000199: for protecting privacy flowing from the Canadian Charter of Rights and Freedoms, federal privacy legislation and
p.000199: regulatory requirements would apply.
p.000199: The law affects and regulates the standards and conduct of research involving humans in a variety of areas, including,
p.000199: but not limited to privacy, confidentiality, intellectual property and the capacity of participants. In addition, human
p.000199: rights legislation and most documents on research ethics prohibit discrimination on a variety of grounds and recognize
p.000199: equal treatment as fundamental. REBs and researchers should also respect the spirit of the Canadian Charter
p.000199: of Rights and Freedoms, particularly the sections dealing with life, liberty and security of the person, as well as
p.000199: those involving equality and discrimination.
p.000199: Researchers may face situations where they experience a tension between the requirements of the law and the guidance of
p.000199: the ethical principles in this Policy. In such situations, researchers should strive to comply with the law in the
p.000199: application of ethical principles. Researchers should consult with colleagues, the REB or any relevant professional
p.000199: body, and if necessary, seek independent legal advice to help resolve any conflicts between law and ethics, and guide
p.000199: an appropriate course of action.
p.000199: This legal context for research involving humans is constantly evolving and varies from jurisdiction to jurisdiction.
p.000199: For this reason, REBs and researchers should be aware of applicable laws so they can identify legal issues that may
p.000199: occur in the conduct of research. REBs may satisfy this obligation through expertise among their members or through
p.000199: wider consultation. The researcher may seek independent legal advice when necessary.
p.000199: The Perspective of the Participant
...
p.000199: Canadian census data).
p.000199: REB review is also not required where research uses exclusively publicly available information that may contain
p.000199: identifiable information, and for which there is no
p.000199:
p.000199:
p.000199: TCPS 2 17
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
p.000199: reasonable expectation of privacy. For example, identifiable information may be disseminated in the public domain
p.000199: through print or electronic publications; film, audio or digital recordings; press accounts; official publications of
p.000199: private or public institutions; artistic installations, exhibitions or literary events freely open to the public; or
p.000199: publications accessible in public libraries. Research that is non-intrusive, and does not involve direct interaction
p.000199: between the researcher and individuals through the Internet, also does not require REB review. Cyber-material such as
p.000199: documents, records, performances, online archival materials or published third party interviews to which the public is
p.000199: given uncontrolled access on the Internet for which there is no expectation of privacy is considered to be publicly
p.000199: available information.
p.000199: Exemption from REB review is based on the information being accessible in the public domain, and that the individuals
p.000199: to whom the information refers have no reasonable expectation of privacy. Information contained in publicly accessible
p.000199: material may, however, be subject to copyright and/or intellectual property rights protections or dissemination
p.000199: restrictions imposed by the legal entity controlling the information.
p.000199: However, there are situations where REB review is required.
p.000199: There are publicly accessible digital sites where there is a reasonable expectation of privacy. When accessing
p.000199: identifiable information in publicly accessible digital sites, such as Internet chat rooms, and self-help groups with
p.000199: restricted membership, the privacy expectation of contributors of these sites is much higher. Researchers shall submit
p.000199: their proposal for REB review (see Article 10.3).
p.000199: Where data linkage of different sources of publicly available information is involved, it could give rise to
p.000199: new forms of identifiable information that would raise issues of privacy and confidentiality when used in
p.000199: research, and would therefore require REB review (see Article 5.7).
p.000199: When in doubt about the applicability of this article to their research, researchers should consult their REBs.
p.000199: Article 2.3 REB review is not required for research involving the observation of people in public places where:
p.000199: (a) it does not involve any intervention staged by the researcher, or direct interaction with the individuals or
p.000199: groups;
p.000199: (b) individuals or groups targeted for observation have no reasonable expectation of privacy; and
p.000199: (c) any dissemination of research results does not allow identification of specific individuals.
p.000199:
p.000199:
p.000199:
p.000199: 18 TCPS 2
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
p.000199: Application For the purposes of this article, observational research is used to study acts or behaviour in a
...
p.000199: human dignity as characterized by the core principles of this Policy. For example, institutions may experience
p.000199: pressures to attract particular research
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 89
p.000199:
p.000199: Chapter 7 – Conflicts of Interest
p.000199:
p.000199: funding or certain types of research activities that are self-sustaining, which may compromise their independence and
p.000199: public trust. Institutions have an obligation to ensure that the ethical conduct of research is not compromised by
p.000199: real, potential or perceived conflicts of interest.
p.000199: An institutional conflict of interest involves a conflict between at least two substantial institutional obligations
p.000199: that cannot be adequately fulfilled without compromising one or both obligations. Conflicts may occur when pursuing
p.000199: particular goals, for instance, the pursuit of two different “goods,” such as an effort to obtain general
p.000199: infrastructure funding from a donor that conflicts with an effort to promote research that the donor does not wish to
p.000199: support.
p.000199: Institutional conflicts of interest may compromise duties of loyalty and lead to biased judgments. Conflicts may also
p.000199: undermine public trust in the ability of the institution to carry out its missions, operations and ethical
p.000199: responsibilities in research.
p.000199: Institutions may be in conflict of interest, for example, when they (a) sponsor a research project;
p.000199: (b) manage the intellectual property that forms the basis of a research project or stand to benefit from intellectual
p.000199: property resulting from the research; (c) hold equity in companies and/or receive major donations; or (d) have
p.000199: conflicting roles carried out by one institutional official (e.g., a vice- president who is responsible for the
p.000199: promotion of research activity and funding and also for oversight of research).
p.000199: Acting in a professional role within the institution, individuals (e.g., institution president, vice- president, dean
p.000199: of a faculty or department head) are in a conflict of interest when they are subject to competing incentives or
p.000199: functions. These may significantly interfere with the impartial exercise of duties, including legal and ethical
p.000199: obligations within the institutional structure. The conflict may be chronic, relating to recurring situations resulting
p.000199: from the institutional structure, or it may be triggered by a unique situation that is not likely to recur.
p.000199: REB Member Conflict of Interest
p.000199: The REB, as an entity, or in the persons of the members who make up the board, also hold trust relationships with
p.000199: participants, research sponsors, researchers and society. REB members must also be aware of their own potential for
p.000199: real or perceived conflicts of interest.
p.000199: For example, REB members are in a conflict of interest when their own research projects are under review by their REB,
p.000199: when they are a co-investigator, or when they are in a supervisory or men- toring relationship with a graduate student
p.000199: applicant. REB members may also be in a conflict of interest situation when they have interpersonal or financial
p.000199: relationships with the researchers, or personal or financial interests in a company, labour union or not-for-profit
...
p.000117: obligation to seek community engagement in order to identify local customs and codes of research practice.
p.000117: First Nation, Inuit and Métis customs and codes of behaviour distinguish among knowledge that can be publicly
p.000117: disclosed, disclosed to a specific audience, or disclosed under certain conditions. Determination of what information
p.000117: may be shared, and with whom, will depend on the culture of the community involved. Any restrictions on access to, or
p.000117: use of, traditional or sacred knowledge shared in the course of the research project should be addressed in the
p.000117: research agreement.
p.000117: In Aboriginal communities, custom may restrict the observation, recording, or reporting of ceremonies or certain
p.000117: performances, and require approval of appropriate individuals. Article 10.3 addresses the requirement for ethics
p.000117: review of research involving observational studies, and associated ethical implications, which may include infringement
p.000117: on consent and privacy.
p.000117: Many First Nations communities across Canada have adopted an ethics code originally developed to govern
p.000117: practice in the First Nations Regional Longitudinal Health Survey. The code asserts ownership of, control of, access
p.000117: to, and possession (OCAP) of research processes affecting participant communities, and the resulting data. OCAP
p.000117: addresses issues of privacy, intellectual property, data custody and secondary use of data, which are also covered
p.000117: later in this chapter.
p.000117: Inuit communities and organizations are considering addressing similar concerns, including adoption or adaptation of
p.000117: OCAP. For example, possession agreements, which are distinct from research agreements, are set out in a
p.000117: memorandum of understanding between the institution of the researcher and the community (usually represented by the
p.000117: land claim organization). The possession agreement covers the control and use of data and human biological materials
p.000117: collected over the course of the research. The agreement may continue to exist long after the research is
p.000117: completed, to allow control and use of data and human biological materials for Inuit- initiated research.
p.000117: Researchers should consult their own institutions to ensure that the application of OCAP or other community-based
p.000117: ethics codes is consistent with institutional
p.000117:
p.000117:
p.000117: 118 TCPS 2
p.000117:
p.000117: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000117:
p.000117: policies. Where divergences exist, they should be addressed and resolved prior to the commencement of the research, or
p.000117: as they arise over the course of the research.
p.000117: First Nations, Inuit and Métis scholars attached to academic institutions as faculty members, students or research
p.000117: associates are increasingly engaged in research involving their own communities, and sometimes their own family
...
p.000121: representative, the terms and undertakings of both the researcher and the community should be set out in a
p.000121: research agreement before participants are recruited.
p.000121: Application Research agreements serve as a primary means of clarifying and confirming mutual expectations and,
p.000121: where appropriate, commitments between researchers and communities. Research agreements, where applicable, shall
p.000121: precede recruitment of individual participants and collection of, or access to, research data. The scope of the
p.000121: agreement will depend on the level of engagement which the community desires, and the availability of resources to
p.000121: support community participation.
p.000121: At a minimum, the agreement should address the ethical protections that would apply to securing individual consent for
p.000121: a comparable project, and should specify any commitments regarding collective community participation and
p.000121: decision making, sharing of benefits and review, and updating of the agreement. Expanding on information normally
p.000121: provided to an individual participant (see Article 3.2), agreements typically set out the purpose of the
p.000121: research and detail mutual responsibilities in project design, data collection and management (see Article 5.3);
p.000121: analysis and interpretation; credit due to knowledge holders; protection (and non- disclosure) of restricted knowledge;
p.000121: sharing of benefits or royalties flowing from intellectual property where applicable; production of reports;
p.000121: co-authorship; dissemination of results; and a conflict resolution process. Provisions for any anticipated
p.000121: secondary use of the information or human biological material, and associated data collected, should also be addressed
p.000121: at that time, and documented in the research agreement (see Article 9.20).
p.000121: Where a community has adopted or adheres to a code of research practice, the agreement may set out responsibilities in
p.000121: accordance with that code and the specific requirements of the research project. In less formal circumstances, the
p.000121: agreement may be relatively brief, and subject to clarification as the project unfolds. The CIHR Guidelines for
p.000121: Health Research Involving Aboriginal People (2007) provide examples of elements that may be included in research
p.000121: agreements (see References at the end of this chapter).
p.000121: Research agreements are increasingly being recognized by academic institutions (and the researchers associated with
p.000121: them) as providing reference points for research ethics review process and approval on such elements as consent,
p.000121: confidentiality, and access to and use of information. Agreements that specify procedures for community
p.000121: research ethics review, included as part of the institutional ethics
p.000121:
p.000121: 122 TCPS 2
p.000121:
p.000121: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000121:
...
p.000127: validate findings, correct any cultural inaccuracies, and maintain respect for community knowledge (which may
p.000127: entail limitations on its disclosure). Researchers should integrate suggestions from the community representatives
p.000127: in the publication. If disagreement about interpretation arises between researchers and the community and it cannot be
p.000127: resolved, researchers should either (a) provide the community with an opportunity to make its views known, or (b)
p.000127: accurately report any disagreement about the interpretation of the data in their reports or publications. This should
p.000127: not be construed as giving the community the right to block the publication of findings. Rather, it
p.000127: gives the community the opportunity to contextualize the findings.
p.000127: Final reports shall be made available to the territorial or organizational community or community of interest
p.000127: participating in the research. Researchers and communities should clarify the extent to which research
p.000127: findings will require translation, plain language summaries or oral presentations to community members, in order to
p.000127: make the research findings accessible to the community.
p.000127: An Aboriginal community, and those who participated in the research, should have the option to participate in deciding
p.000127: how collective or individual contributions to the research project will be acknowledged and credited in the
p.000127: dissemination of results (e.g., acknowledgement of co-authorship in research reports or at conferences and
p.000127: seminars).
p.000127: Intellectual Property Related to Research
p.000127: Article 9.18 In collaborative research, intellectual property rights should be discussed by researchers,
p.000127: communities and institutions. The assignment of rights, or the grant of licences and interests in material that may
p.000127: flow from the research, should be specified in a research agreement (as appropriate) before the research is conducted.
p.000127:
p.000127:
p.000127: 128 TCPS 2
p.000127:
p.000127: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000127:
p.000127: Application Researchers, communities and institutions should be aware that all knowledge and information is not
p.000127: necessarily protected under the existing law. Existing intellectual property legislation generally protects works and
p.000127: inventions. Strict criteria are used to define intellectual property rights. Understanding and communicating what
p.000127: qualifies, or does not qualify, as intellectual property for the purposes of research under this Policy is a joint
p.000127: responsibility of communities, researchers and institutions.
p.000127: When undertaking research guided by community engagement, researchers, institutions and communities may need to
p.000127: first address issues regarding access to data, and the use of data for the purpose of the research or in the
p.000127: dissemination of research findings. Regarding access to and use of data, a research agreement may set out any limits on
p.000127: the disclosure of personal or privileged information (subject to applicable legal and regulatory requirements and the
p.000127: guidance in Chapter 5 of this Policy). It might include provisions to review reports and publications
p.000127: regarding the research prior to publication, or limits on the release of, or access to, research results (subject to
p.000127: applicable laws). Provisions for any anticipated secondary use of the information or human biological material,
p.000127: and associated data collected, should also be addressed and documented in this agreement. It may also set out any
p.000127: interests, licences or assignments in copyright flowing from publications about, or based on, the research (see
p.000127: Articles 9.8, 9.11 and 9.16).
p.000127: Some knowledge collected as a result of the research may have commercial applications, and lead to the
p.000127: development of marketable products. With respect to commercialization of results of collaborative research, researchers
p.000127: and communities should discuss and agree on the use, assignment or licensing of any intellectual property (e.g., any
p.000127: patents or copyright), resulting from the marketable product, and document mutual understandings in an agreement. If
p.000127: the proposed research has explicit commercial objectives, or direct or indirect links to the commercial sector,
p.000127: researchers and communities may want to include provisions related to anticipated commercial use in research
p.000127: agreements. These provisions should be clearly communicated to all parties in advance, consistent with the consent
p.000127: process.
p.000127: Researchers should consult the research office of their institution before entering into a research agreement that
p.000127: includes intellectual property provisions. Researchers should also consult the program literature or policies on
p.000127: intellectual property and copyright adopted by the federal research agencies CIHR, NSERC and SSHRC (available on their
p.000127: websites), and seek legal advice where appropriate.
p.000127: Collection of Human Biological Materials Involving Aboriginal Peoples
p.000127: Article 9.19 As part of community engagement, researchers shall address and specify in the research agreement the
p.000127: rights and proprietary interests of individuals and communities, to the extent such exist, in human biological
p.000127: materials and associated data to be collected, stored and used in the course of the research.
p.000127:
p.000127:
p.000127:
p.000127:
p.000127: TCPS 2
p.000129: 129
p.000129:
p.000129: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000129:
p.000129: Application Canadian law does not provide clear recognition of property rights in human biological
p.000129: materials. Researchers should be aware, however, that Aboriginal people and communities may seek to maintain control
p.000129: over, and access to, data and human biological materials collected for research. This is in accordance with Aboriginal
p.000129: world views about “full embodiment,” in which every part and product of the human body is sacred and cannot be
p.000129: alienated. Consistent with Articles 9.8 and
p.000129: 9.11 and Chapter 12, researchers and communities should address and specify in the research agreement:
p.000129: • the objectives for collection, use and storage of human biological materials;
p.000129: • the roles and responsibilities regarding custodianship of the data and the human biological materials; and
p.000129: • any future use of these human biological materials and associated data, including material transfer
p.000129: agreements to third parties, and any subsequent requirements for community engagement.
p.000129: Researchers must seek consent, in accordance with Articles 12.1 and 12.2, from individuals who are invited to donate
p.000129: their biological materials.
p.000129: Secondary Use of Information or Human Biological Materials Identifiable as Originating from Aboriginal Communities or
p.000129: Peoples
p.000129: Ongoing sensitivity about secondary use of data collected for approved purposes arises from experiences with
p.000129: misrepresentation of Aboriginal peoples; use of data or human biological materials without appropriate
p.000129: engagement with the source community or consent of participants; and lack of reporting to communities on research
...
p.000163: body. The body should ensure financial conflicts of interest are reported to the REB. When no such
p.000163: institutional body exists, the REBs shall review clinical trial budgets for financial conflicts of interest. As a
p.000163: general guide, payments for clinical trial procedures should be no greater than the usual amounts charged by health
p.000163: care providers for the provision of comparable services. Researchers should disclose all kinds and amounts of payment
p.000163: to the REB (see Article 7.4).
p.000163: A particular concern in the context of clinical trials is the use of inappropriate incentives by the sponsor to
p.000163: encourage researchers to recruit participants quickly and without regard to their suitability for the trial.
p.000163: Differential incentives paid for different levels of recruitment, such as higher per-participant payments for those
p.000163: recruited above a set target, may also encourage inappropriate recruitment practices and should be prohibited. The REB
p.000163: can assist the researcher in identifying these and other types of financial conflicts and managing them appropriately
p.000163: (see Article 7.4).
p.000163:
p.000163: E. Analysis and Dissemination of Clinical Trial Outcomes
p.000163: The rights of sponsors with respect to the analysis of data, interpretation of results and publication of findings, and
p.000163: ownership thereof, are typically described in sponsor-researcher contracts (often referred to as clinical trial
p.000163: agreements), which are reviewed by the institution. These contracts may seek to place restrictions on the publication
p.000163: of findings, either directly or through provisions that seek to protect, in favour of the sponsor, the intellectual
p.000163: property of research procedures, data or other information. It is the responsibility of the institution to ensure that
p.000163: these contracts are in compliance with the guidance of this Policy, and in particular Article 11.12.
p.000163: Article 11.12 With respect to research findings:
p.000163: (a) Institutions and REBs should take reasonable measures to ensure that sponsors, researchers and institutions
p.000163: publish or otherwise disseminate the analysis of
p.000163:
p.000163:
p.000163: 164 TCPS 2
p.000163:
p.000163: Chapter 11 – Clinical Trials
p.000163:
p.000163: data and interpretation of clinical trial results in a timely manner without undue restriction.
p.000163: (b) Any prohibition or undue limitation on the publication or dissemination of scientific findings from clinical trials
p.000163: is ethically unacceptable.
p.000163: (c) Institutions should develop reasonable written policies regarding acceptable and unacceptable clauses in
p.000163: clinical trial research contracts relating to confidentiality, publication and access to data.
p.000163: Application To justify the involvement of participants, and the risks and other burdens they are asked to bear,
p.000163: research must be valuable. That is, it must have a reasonable likelihood of promoting social good. If
p.000163: research findings and the research materials and research data they are based upon, are not disseminated (e.g.,
p.000163: published in a peer-reviewed journal, added to a publicly available clinical trials database) within a reasonable
p.000163: time, their value may be diminished or lost, betraying the contributions and sacrifices of participants. For
...
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195: TCPS 2
p.000195:
p.000197: 197
p.000197:
p.000197:
p.000197:
p.000197: Index
p.000197: The Index seeks to direct the reader to meaningful references to key concepts in TCPS 2. Main references to a term are
p.000197: indicated with bold type.
p.000197:
p.000197: The Index is not a record of all occurrences of the listed topics. Readers who wish to check all occurrences of these
p.000197: topics or specific terms may do so through the Adobe search tool available online in the PDF version of the Policy
p.000197: found at www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2- eptc2/Default/.
p.000197:
p.000197: A
p.000197: Aboriginal peoples
p.000197: collaborative research, 123-124, 125-126, 128
p.000197: communities, 107-108, 109
p.000197: community customs, 108, 117-119
p.000197: community engagement, 108, 110-117, 121-125
p.000197: confidentiality, 126-128
p.000197: consent, 109, 119, 123, 131
p.000197: cultural heritage, 110-111
p.000197: definition, 107
p.000197: Elders, 119, 126
p.000197: First Nations, 105, 107, 108, 110, 114, 115, 117, 121, 127
p.000197: governing authorities, 114
p.000197: human biological materials, 119, 129-132
p.000197: Indigenous knowledge (see Aboriginal peoples: traditional knowledge)
p.000197: Indigenous peoples, 107, 108, 110
p.000197: intellectual property, 128-129
p.000197: interpretation and dissemination of research results, 128 interpretation of ethics framework, 109-110
p.000197: Inuit, 105, 107, 108, 110, 114, 115, 117, 118, 121
p.000197: Métis, 105, 107, 108, 110, 114, 115, 117, 121
p.000197: mutual benefits, 124-125
p.000197: privacy, 126-128
p.000197: research agreements, 121, 122-123, 126-127, 128-130, 131
p.000197: research ethics review - research ethics boards and community, 115, 119-122 secondary use of information or human
p.000197: biological materials, 119-121, 130-132 strengthening research capacity, 125-126
p.000197: traditional knowledge, 108-109, 110-111, 126
p.000197: Academic freedom, 7, 11
p.000197: Ad hoc advisors, 24, 72, 73, 75, 120, 150
p.000197: Agencies, 5 Anonymity
p.000197: anonymized human biological materials, 170 anonymized information, 57
p.000197: anonymous human biological materials, 19, 131-132, 170
p.000197: anonymous information, 19, 57, 131-132
p.000197:
p.000197:
p.000197: TCPS 2
p.000199: 199
p.000199:
p.000199: Index
p.000199:
p.000199: Appeals, 83-85
p.000199: Assisted human reproduction (see Human reproduction, materials related to) Authorized third parties, 27, 41-44
p.000199: Autonomy, 8-9, 27, 40
p.000199:
p.000199: B
p.000199: Benefits, research
p.000199: equitable distribution, 10, 53
p.000199: mutual, 124-125
p.000199: and risk, 10, 11, 22-25, 41-42, 51, 157-158
p.000199: Biobanks, 175-176, 186
p.000199: Biological materials (see Human biological materials)
p.000199:
p.000199: C
...
p.000201: (see also Human biological materials) Hybrids, 179
p.000201:
p.000201:
p.000201:
p.000201:
p.000201:
p.000201:
p.000201: TCPS 2
p.000201:
p.000203: 203
p.000203:
p.000203: Index
p.000203:
p.000203: I
p.000203: Incentives for participation in research
p.000203: conflicts of interest, 29-30, 52, 151, 164
p.000203: consent, 29-30, 31, 151
p.000203: Incidental findings, 34, 171-172
p.000203: Indigenous peoples, 107, 108, 110 (see also Aboriginal peoples)
p.000203: Information
p.000203: anonymized, 57
p.000203: anonymous, 19, 57, 131-132
p.000203: coded, 57
p.000203: data linkage, 18, 19, 64-65, 131-132
p.000203: directly identifying, 56
p.000203: disclosure, 30-33, 59-61, 126-128
p.000203: dissemination, 18-19, 31, 128, 143-144, 164-167
p.000203: identifiable, 19, 56
p.000203: indirectly identifying, 56
p.000203: personal (see Information: identifiable) publicly available, 17-18, 64-65, 131 reporting new, in clinical trials,
p.000203: 159-163 safeguarding, 60-61
p.000203: secondary use of identifiable (see Secondary use of identifiable information) security, 56, 60-61, 64-65
p.000203: sharing, 159-163, 182-184
p.000203: types, 56-57 (see also Data)
p.000203: Informed consent (see Consent)
p.000203: Institutions
p.000203: appointment of appeal boards, 84-85 compliance with Policy, 5-6 conflicts of interest, 89-90, 91-93
p.000203: multi-jurisdictional review, 97-99, 100-103
p.000203: senior administrators, 70-71, 93-94
p.000203: support of research ethics boards, 68-70, 74, 77, 80
p.000203: support of researchers, 5, 58-59
p.000203: Intellectual property, 128-129
p.000203: Intermediaries, 32, 48
p.000203: Inuit, 105, 107, 108, 110, 114, 115, 117, 118, 121
p.000203: (see also Aboriginal peoples)
p.000203:
p.000203: J
p.000203: Justice, 8, 10-11, 47, 109-110
p.000203:
p.000203: K
p.000203: Knowledge, traditional, 108-109, 110-111, 126
p.000203:
p.000203:
p.000203:
p.000203:
p.000203: 204 TCPS 2
p.000203:
p.000203: Index
p.000203:
p.000203:
p.000203: L
p.000203: Law
p.000203:
p.000203:
p.000203:
p.000203:
p.000203:
p.000203:
p.000203:
p.000203:
p.000203:
p.000203: M
p.000203:
p.000203:
p.000203: capacity, 41
p.000203: confidentiality, 58, 59, 60
p.000203: consent, 12, 27, 33-34
p.000203: gene transfer, 186
p.000203: human biological materials, 130, 171
p.000203: human reproduction, materials related to, 177 incidental findings, 34
p.000203: multi-jurisdictional review, 101, 103
p.000203: privacy, 12, 17-18, 55, 63, 64, 142, 143, 174
p.000203: research ethics, 12
p.000203: Medical emergencies (see Emergencies)
p.000203: Memorandum of Understanding on the Roles and Responsibilities in the Management of Federal Grants and Awards, 5, 67,
p.000106: 106
p.000106: Métis, 105, 107, 108, 110, 114, 115, 117, 121
p.000106: (see also Aboriginal peoples)
p.000106: Minimal risk research, 11, 23, 24-25, 37-39, 41, 51, 77-79 Multi-jurisdictional research
p.000106: official agreements, 98, 100
...
Social / Racial Minority
Searching for indicator minority:
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p.000199: reviewer(s) be well documented and formally re- ported to the full REB, in a timely and appropriate manner. Where the
p.000199: delegated review is conducted by non-voting members or non-members of the REB, this for- mal report shall be made
p.000199: through the Chair. This will permit the REB to maintain oversight over the decisions made on its behalf so as to
p.000199: protect the interests of par- ticipants. Accountability requires that, regardless of the review strategy, the REB
p.000199: continues to be responsible for the ethics of all research involving humans within its jurisdiction.
p.000199: Decision Making
p.000199: Article 6.13 REBs shall function impartially, provide a fair hearing to the researchers involved, and provide
p.000199: reasoned and appropriately documented opinions and decisions. REBs should make their decisions on the ethical
p.000199: acceptability of research in an efficient and timely manner, and shall communicate all approvals and refusals to
p.000199: researchers in writing, in print or by electronic means, in accordance with their procedures.
p.000199: Application The REB shall accommodate reasonable requests from researchers to participate in discussions about
p.000199: their proposals. The REB may also invite researchers to attend an REB meeting to provide further information about
p.000199: their proposal. In either case, the researchers shall not be present when the REB is making its decision. When an REB
p.000199: is considering a negative decision, it shall provide the researcher with all the reasons for doing so and give the
p.000199: researcher an opportunity to reply before making a final decision (see Article 6.18).
p.000199: In the event that a minority within the REB membership considers a research proj- ect unethical, even though it is
p.000199: acceptable to a majority of members, an effort should be made to reach consensus. Consultation with the researcher,
p.000199: external ad- vice or further reflection by the REB may be helpful. If disagreement persists, a decision should be made
p.000199: in accordance with the process agreed upon, and docu- mented by the REB. In such instances, the minority position may
p.000199: be communicated to the researcher.
p.000199: Participation by the researcher in REB discussions is often very helpful to both REBs and researchers. It may result in
p.000199: a deferral of the REB’s decision until the researcher has considered the discussions and possibly modified the
p.000199: proposal. Such discussions are an essential part of the educational role of the REB.
p.000199: Continuing Research Ethics Review
p.000199: Article 6.14 The REB shall make the final determination as to the nature and frequency of con- tinuing research
p.000199: ethics review in accordance with a proportionate approach to research ethics review. At minimum, continuing research
p.000199: ethics review shall consist of an annual status report (for multi-year research projects), and an end-of-study report
p.000199: (projects lasting less than one year).
p.000199:
p.000199:
p.000199: TCPS 2 79
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: Application Research is subject to continuing research ethics review from the date of initial REB approval
p.000199: throughout the life of the project (see Article 2.8). At the time of the initial review, the REB has the authority to
...
Searching for indicator race:
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p.000199: minors or adults who lack the capacity to consent.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 45
p.000199:
p.000199:
p.000199:
p.000199: Chapter 4
p.000199: FAIRNESS AND EQUITY IN RESEARCH PARTICIPATION
p.000199:
p.000199: Introduction
p.000199: The principle of Justice holds that particular individuals, groups or communities should neither bear an unfair share
p.000199: of the direct burdens of participating in research, nor should they be unfairly excluded from the potential benefits of
p.000199: research participation. Inclusiveness in research and fair distribution of benefits and burdens should be important
p.000199: considerations for researchers, research ethics boards (REBs), research institutions and sponsors. Issues of fair and
p.000199: equitable treatment arise in deciding whether and how to include individuals, groups or communities in research, and
p.000199: the basis for the exclusion of some.
p.000199: This chapter addresses inclusion in research of individuals and groups that might be inappropriately excluded on the
p.000199: basis of attributes such as culture, language, gender, race, ethnicity, age and dis- ability. It provides guidance
p.000199: relevant to inclusion in research of specific groups such as women, children, the elderly and those who lack capacity
p.000199: to consent to participate in research. Historically, these groups have often been inappropriately excluded from
p.000199: research.
p.000199: This chapter also addresses the fair inclusion and equitable treatment of individuals, groups and communities whose
p.000199: situation or circumstances make them vulnerable in the context of a specific research project. These individuals run
p.000199: the risk of being included in research in ways that may be unfair and inequitable. This chapter provides guidance
p.000199: relevant to the equitable distribution of the risks and benefits of research.
p.000199: Over-protectionist attitudes or practices of researchers or REBs, whether intentional or inadvertent, can exclude some
p.000199: members of society from participating in research. The exclusion of individuals, groups or communities may constitute a
p.000199: failure to treat them justly. For example, age has been used to exclude individuals from participation in research,
p.000199: particularly health research (e.g., studies that only accept participants between the ages of 18 to 35). As a result,
p.000199: sufficient research may not be done on groups that fall outside of narrow age criteria. The inclusion of the young and
p.000199: the elderly in research, for example, ensures that treatments frequently given to these populations are effective and
p.000199: safe.
p.000199: Researchers, institutions and REBs all have important roles to play in advancing that societal com- mitment, and
p.000199: ensuring a fair distribution of the benefits and burdens of research. Researchers and REBs must navigate between the
p.000199: dangers of imposing unfair burdens on particular participants, groups and communities, and overprotecting them. In
p.000199: assessing fairness and equity issues in the research ethics process, REBs should not intervene in the choice of
p.000199: research topics.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 47
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: A. Appropriate Inclusion
p.000199: Article 4.1 Taking into account the scope and objectives of their research, researchers should be inclusive in
p.000199: selecting participants. Researchers shall not exclude individuals from the opportunity to participate in research on
p.000199: the basis of attributes such as culture, language, religion, race, disability, sexual orientation, ethnicity,
p.000199: linguistic proficiency, gender or age, unless there is a valid reason for the exclusion.
p.000199: Application Article 4.1 is based on the principle of Justice. It imposes a duty on researchers not to exclude
p.000199: individuals or groups from participation for reasons that are unrelated to the research. This duty is explicitly stated
p.000199: because groups have been inappropri- ately excluded from participation in research on the basis of attributes such as
p.000199: gender, race, ethnicity, age and disability.
p.000199: The focus, objective, nature of research and context in which the research is con- ducted inform the inclusion and
p.000199: exclusion criteria for a specific research project. Some research may be focused on a certain individual (such as in a
p.000199: biography), or a group of individuals who share a specific characteristic (e.g., an identifiable group of painters who
p.000199: happen to be all of one sex; a religious order that is restricted to one sex). Other examples include research that is
p.000199: focused on specific cultural tra- ditions or languages, or on one age group (e.g., a biomechanical modeling study of
p.000199: posture corrections in adolescents). Such research should not be precluded so long as the selection criteria for those
p.000199: to be included in the research are germane to answering the research question. Researchers who plan to actively exclude
p.000199: par- ticular groups should clarify to their REBs the grounds for the exclusion.
p.000199: Where a language barrier exists between the researcher and the prospective partic- ipant, various measures may be
p.000199: used to ensure effective communication in recruitment and consent discussions. For example, an intermediary who
...
Social / Religion
Searching for indicator belief:
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p.000199: beyond.
p.000199: The conception and refinement of the TCPS was carried out by the current and recent members of the Panel and
p.000199: Secretariat, led by Susan Zimmerman, Executive Director of the Secretariat. The enormity of the task they faced was
p.000199: matched by their dedication and tireless commitment to the vigorous collegial process. They warrant special
p.000199: acknowledgement for their efforts.
p.000199: The development of this document has been a long process. The groundwork was laid by the first generation of Panel and
p.000199: Secretariat members led by Derek Jones, former Executive Director of the Secretariat, and the numerous working
p.000199: committee members who began the debate and framing of the issues that are addressed in the new edition.
p.000199: Thanks are also due to the members of the research community who took part in the consultations in 2009 and provided
p.000199: comments on the 2008 and 2009 drafts. This national outreach involved meetings with roughly 2,000 members of the
p.000199: research community and yielded 370 submissions. The Panel found this feedback to be thoughtful, clear and critical to
p.000199: the revision process. As might be expected from such a wide array of independent-minded academics, administrators,
p.000199: practition- ers and members of the general public – their views were not always compatible. Nevertheless, they
p.000199: furnished the grist for what we believe to be substantial improvements to the sequential drafts. Their efforts are
p.000199: deeply appreciated.
p.000199: No document designed to cover the ethical conduct of all types of research involving humans can hope to be definitive.
p.000199: As with the 1st edition of the TCPS, the 2nd is a work in progress and is de- signed to be a living document. It is our
p.000199: hope and belief that the process we have employed, and the efforts of all those involved, will facilitate the ethical
p.000199: conduct of research.
p.000199: Respectfully submitted by:
p.000199: Norman Frohlich Samuel K. Ludwin
p.000199: Chair, Panel on Research Ethics Chair, Panel on Research Ethics
p.000199: (2007–2010) (2010– )
p.000199:
p.000199:
p.000199: TCPS 2 1
p.000199:
p.000199: Panel Members
p.000199: Samuel K. Ludwin, Chair (2010– ); Norman Frohlich, Chair (2007–2010); Michel Bergeron; Marlene Brant Castellano;
p.000199: Timothy Caulfield; Laurie Chan; Anne Dooley; Pierrette Fortin; Jim Frideres; James Lavery; Patrick O’Neill
p.000199:
p.000199: Secretariat
p.000199: Susan Zimmerman, Executive Director; Hanan Abdel-Akher; Laura-Lee Balkwill; Wendy Burgess; Thérèse De Groote; Guylaine
p.000199: Ménard; Heather Dana Munroe
p.000199:
p.000199: Former Panel Members
p.000199: Howard Brunt, Chair (2002–2005); Bruce Clayman , Chair (2005–2007); Pierre Deschamps; Hubert Doucet; Paul Johnston;
p.000199: Ian Mitchell; Florence Piron; Carol Sawka; Janice Singer; Maureen Smith; Susan Sykes;
p.000199: Will van den Hoonaard; Peter Venner
p.000199:
p.000199: Former Secretariat Members
p.000199: Natasha Bendin; Michele Bourgeois-Doyle; Lucie Essiembre; Mary Fraser Valiquette; Derek Jones; Jacqueline Jorge
p.000199:
p.000199: Clinical Trials Information (CTI) Working Committee
p.000199: Albert Clark; Pierre Deschamps; Anne Dooley; Margo Farren; Barry Hoffmaster; Peter Venner
p.000199:
p.000199: Conflict of Interest Working Group
...
p.000131: • Royal Commission on Aboriginal Peoples. Report of the Royal Commission on Aboriginal Peoples. “Ethical Guidelines
p.000131: for Research.” In Volume 5, Renewal: A Twenty-Year Commitment, Ottawa: Canada Communications Group. 1996. It can also
p.000131: be accessed at www.ainc-inac.gc.ca/ap/rrc-eng.asp
p.000131: • United Nations Educational, Scientific and Cultural Organization. Universal Declaration on Bioethics and Human
p.000131: Rights. Adopted October 19, 2005, by the 33rd session of the General Conference of UNESCO. 2005.
p.000131: http://unesdoc.unesco.org/images/0014/001461/146180e.pdf
p.000131: • United Nations. Convention on Biological Diversity. 1992. www.cbd.int/convention/convention.shtml
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: TCPS 2
p.000133: 133
p.000133:
p.000133:
p.000133:
p.000133: Chapter 10
p.000133: QUALITATIVE RESEARCH
p.000133:
p.000133: Introduction
p.000133: Researchers in social sciences and humanities – such as anthropology, sociology, philosophy, psychology, criminology,
p.000133: business administration, political science, communications, education and history – have a common belief in the
p.000133: desirability of trying to understand human action through systematic study and analysis. Some researchers use
p.000133: quantitative research approaches, others opt for qualitative research methods, and some use a combination of both.
p.000133: Qualitative research has a long history in many established disciplines in the social sciences and humanities, as well
p.000133: as many areas in the health sciences (e.g., nursing, occupational therapy). The use of qualitative approaches is
p.000133: increasing, whether in health research or in social sciences and humanities disciplines. Within specific disciplines,
p.000133: ethics guidelines have been created to address the issues inherent in the use of, for example, particular methods,
p.000133: technologies and settings. Qualitative research approaches are inherently dynamic and may be grounded in
p.000133: different assumptions than those that shape quantitative research approaches. Many of the research practices and
p.000133: methodological requirements that characterize qualitative research approaches parallel those that characterize
p.000133: quantitative approaches such as concerns regarding research quality. However, as is the case with all research
p.000133: involving humans, the criteria are adapted to the specific subject matter, context and epistemological assumptions
p.000133: about the nature of knowledge in the specific area of research of the specific project.
p.000133: This chapter seeks to provide specific guidance on some issues that are particularly germane to qualitative research,
p.000133: although such guidance may also be applicable to research using quantitative or mixed methods. In particular, it
...
Searching for indicator religion:
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p.000199: particularly health research (e.g., studies that only accept participants between the ages of 18 to 35). As a result,
p.000199: sufficient research may not be done on groups that fall outside of narrow age criteria. The inclusion of the young and
p.000199: the elderly in research, for example, ensures that treatments frequently given to these populations are effective and
p.000199: safe.
p.000199: Researchers, institutions and REBs all have important roles to play in advancing that societal com- mitment, and
p.000199: ensuring a fair distribution of the benefits and burdens of research. Researchers and REBs must navigate between the
p.000199: dangers of imposing unfair burdens on particular participants, groups and communities, and overprotecting them. In
p.000199: assessing fairness and equity issues in the research ethics process, REBs should not intervene in the choice of
p.000199: research topics.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 47
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: A. Appropriate Inclusion
p.000199: Article 4.1 Taking into account the scope and objectives of their research, researchers should be inclusive in
p.000199: selecting participants. Researchers shall not exclude individuals from the opportunity to participate in research on
p.000199: the basis of attributes such as culture, language, religion, race, disability, sexual orientation, ethnicity,
p.000199: linguistic proficiency, gender or age, unless there is a valid reason for the exclusion.
p.000199: Application Article 4.1 is based on the principle of Justice. It imposes a duty on researchers not to exclude
p.000199: individuals or groups from participation for reasons that are unrelated to the research. This duty is explicitly stated
p.000199: because groups have been inappropri- ately excluded from participation in research on the basis of attributes such as
p.000199: gender, race, ethnicity, age and disability.
p.000199: The focus, objective, nature of research and context in which the research is con- ducted inform the inclusion and
p.000199: exclusion criteria for a specific research project. Some research may be focused on a certain individual (such as in a
p.000199: biography), or a group of individuals who share a specific characteristic (e.g., an identifiable group of painters who
p.000199: happen to be all of one sex; a religious order that is restricted to one sex). Other examples include research that is
...
p.000199: An individual or organization fulfils its confidentiality duties, in part, by adopting and enforcing appropriate
p.000199: security measures. Physical safeguards include the use of locked filing cabinets, and the location of computers
p.000199: containing research data away from public areas. Administrative safeguards include the development and enforcement of
p.000199: organizational rules about who has access to personal information about participants. Technical safeguards include use
p.000199: of computer passwords, firewalls, anti-virus software, encryption and other measures that protect data from
p.000199: unauthorized access, loss or modification.
p.000199: Identifiable Information
p.000199: Information that may reasonably be expected to identify an individual, alone or in combination with other available
p.000199: information, is considered identifiable information (or information that is identifiable) for the purposes of this
p.000199: Policy. Where the term “personal information” appears in this Policy, it refers to identifiable information.
p.000199: Types of Information
p.000199: Researchers may seek to collect, use, share and access different types of information about par- ticipants. Such
p.000199: information may include personal characteristics or other information about which an individual has a reasonable
p.000199: expectation of privacy (e.g., age, ethnicity, educational background, employment history, health history, life
p.000199: experience, religion, social status).
p.000199: For the purposes of this Policy, researchers and REBs shall consider whether information proposed for use in research
p.000199: is identifiable. The following categories provide guidance for assessing the ex- tent to which information could be
p.000199: used to identify an individual:
p.000199: • Directly identifying information – the information identifies a specific individual through direct identifiers
p.000199: (e.g., name, social insurance number, personal health number).
p.000199: • Indirectly identifying information – the information can reasonably be expected to iden- tify an individual
p.000199: through a combination of indirect identifiers (e.g., date of birth, place of residence or unique personal
p.000199: characteristic).
p.000199:
p.000199: 56 TCPS 2
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: • Coded information – direct identifiers are removed from the information and replaced with a code. Depending on
p.000199: access to the code, it may be possible to re-identify specific participants (e.g., the principal investigator retains a
p.000199: list that links the participants’ code names with their actual name so data can be re-linked if necessary).
p.000199: • Anonymized information – the information is irrevocably stripped of direct identifiers, a code is not kept to
p.000199: allow future re-linkage, and risk of re-identification of individuals from remaining indirect identifiers is low or
p.000199: very low.
p.000199: • Anonymous information – the information never had identifiers associated with it (e.g., anonymous surveys) and
...
Searching for indicator religious:
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p.000199: the nature and context of the research being undertaken. Specific applica- tions are addressed in the following
p.000199: chapters.
p.000199: Respect for Persons
p.000199: Respect for Persons recognizes the intrinsic value of human beings and the respect and consider- ation that they are
p.000199: due. It encompasses the treatment of persons involved in research directly as participants and those who are
p.000199: participants because their data or human biological materials, which for the purposes of this Policy include materials
p.000199: related to human reproduction, are used in re- search. Respect for Persons incorporates the dual moral obligations to
p.000199: respect autonomy and to protect those with developing, impaired or diminished autonomy.
p.000199: Autonomy includes the ability to deliberate about a decision and to act based on that deliberation. Respecting autonomy
p.000199: means giving due deference to a person’s judgment and ensuring that the person is free to choose without
p.000199: interference. Autonomy is not exercised in isolation but is influenced by a person’s various connections to
p.000199: family, to community, and to cultural, social, linguistic, religious and other groups. Likewise, a person’s decisions
p.000199: can have an impact on any of these connections.
p.000199:
p.000199: 8 TCPS 2
p.000199:
p.000199: Chapter 1 – Ethics Framework
p.000199:
p.000199: An important mechanism for respecting participants’ autonomy in research is the requirement to seek their free,
p.000199: informed and ongoing consent. This requirement reflects the commitment that par- ticipation in research, including
p.000199: participation through the use of one’s data or biological materials, should be a matter of choice and that, to be
p.000199: meaningful, the choice must be informed. An informed choice is one that is based on as complete an understanding as is
p.000199: reasonably possible of the purpose of the research, what it entails, and its foreseeable risks and potential benefits,
p.000199: both to the partic- ipant and to others. Respect for Persons also includes a commitment to accountability
p.000199: and transparency in the ethical conduct of research.
p.000199: Certain factors may diminish a person’s ability to exercise their autonomy, such as inadequate information or
p.000199: understanding for deliberation, or a lack of freedom to act due to controlling influences or coercion. Such constraints
p.000199: may include the fear of alienating those in positions of authority, such as professional or personal caregivers,
p.000199: researchers, leaders, larger groups, or a community to which one belongs. Other constraints may consist of barriers to
...
p.000199: linguistic proficiency, gender or age, unless there is a valid reason for the exclusion.
p.000199: Application Article 4.1 is based on the principle of Justice. It imposes a duty on researchers not to exclude
p.000199: individuals or groups from participation for reasons that are unrelated to the research. This duty is explicitly stated
p.000199: because groups have been inappropri- ately excluded from participation in research on the basis of attributes such as
p.000199: gender, race, ethnicity, age and disability.
p.000199: The focus, objective, nature of research and context in which the research is con- ducted inform the inclusion and
p.000199: exclusion criteria for a specific research project. Some research may be focused on a certain individual (such as in a
p.000199: biography), or a group of individuals who share a specific characteristic (e.g., an identifiable group of painters who
p.000199: happen to be all of one sex; a religious order that is restricted to one sex). Other examples include research that is
p.000199: focused on specific cultural tra- ditions or languages, or on one age group (e.g., a biomechanical modeling study of
p.000199: posture corrections in adolescents). Such research should not be precluded so long as the selection criteria for those
p.000199: to be included in the research are germane to answering the research question. Researchers who plan to actively exclude
p.000199: par- ticular groups should clarify to their REBs the grounds for the exclusion.
p.000199: Where a language barrier exists between the researcher and the prospective partic- ipant, various measures may be
p.000199: used to ensure effective communication in recruitment and consent discussions. For example, an intermediary who
p.000199: may not be part of the research project or team, but who is competent in the language used by the researchers, as well
p.000199: as that preferred by the participant, may assist with com- munication between prospective participants and researchers.
p.000199: The selection of an intermediary and their activities will depend on the nature, context and risks of the research.
p.000199:
p.000199: B. Inappropriate Exclusion
p.000199: Research Involving Women
p.000199: Women have historically been inappropriately excluded from participating in some research. This exclusion of women,
...
p.000139: corporate officer). In this type of research, where a prospective participant agrees to be interviewed on the basis of
p.000139: sufficient information provided by the researcher, it may be sufficient for the participant to signify consent to
p.000139: participate in the research. The researcher should record this in an appropriate way. Researchers shall demonstrate to
p.000139: the REB that the participant will be informed about the research including the option not to participate, or to
p.000139: withdraw from the study at any time. Nothing in this article should be interpreted to mean that prospective
p.000139: participants need not be informed about the study prior to their participation.
p.000139: Researchers and REBs should consult Chapter 3, and Articles 3.1, 3.2, 3.3 and 3.12 in particular, for additional
p.000139: details and considerations on consent, and how to document consent.
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139: 140 TCPS 2
p.000139:
p.000139: Chapter 10 – Qualitative Research
p.000139:
p.000139: Observational Studies
p.000139: In qualitative research, observation is used to study behaviour in a natural environment. It often takes
p.000139: place in living, natural and complex communities or settings, in physical environments, or in virtual settings.
p.000139: Observational studies may be undertaken in publicly accessible spaces (e.g., classrooms, hospital emergency wards,
p.000139: locations where religious services or practices are held), in virtual settings (e.g., Internet chat rooms), or in
p.000139: private or controlled spaces (e.g., private clubs or organizations.)
p.000139: Observational research is of two kinds: “non-participant” where the researcher observes, but is not a participant
p.000139: in, the action (also known as “naturalistic observation”); and “participant” where the researcher engages in, and
p.000139: observes, the action.
p.000139: Participant observation is often identified with ethnographic research, in which the researcher’s role is to gain a
p.000139: holistic overview of the studied context through engagement in, and observation of, the setting to describe its social
p.000139: environments, processes and relationships. Participant observation may or may not require permission to
p.000139: observe and participate in activities of the setting studied. In some situations, researchers will identify themselves
p.000139: and seek consent from individuals in that setting; in others, researchers will engage in covert
p.000139: non-participant or participant observation and not seek consent.
p.000139: A matter that is publicly accessible may, nevertheless, be considered private in a prospective participant’s culture.
p.000139: There may be a reasonable expectation of privacy by some groups, or for some activities. For example,
p.000139: individuals involved in religious services or practices, or chat rooms on the Internet, may assume that participants
p.000139: and observers will accord the proceedings some degree of privacy. Observing sacred ceremonies without approval from the
p.000139: appropriate individuals or groups (e.g., Elders or traditional knowledge holders in Aboriginal research) and without
p.000139: engaging them about the subsequent use or interpretation of the data may have unintended negative implications
p.000139: (see Articles 9.5, 9.6 and 9.8). Considerations of the nature of the research, its aims and its potential to
p.000139: invade sensitive interests may help researchers improve the design and conduct of such research.
p.000139: Observational studies in public places where there is no expectation of privacy are exempt from REB review (see Article
p.000139: 2.3).
p.000139:
p.000139: Article 10.3 In research involving observation in natural environments or virtual settings where people have a
p.000139: reasonable or limited expectation of privacy, the researcher shall explain the need for an exception to the general
p.000139: requirement for consent. The REB may approve research without requiring that the researcher obtain consent from
p.000139: individuals being observed on the basis of the justification provided by the researcher and appropriate
p.000139: privacy protection.
p.000139:
p.000139:
p.000139:
p.000139: TCPS 2
p.000139:
p.000141: 141
p.000141:
p.000141: Chapter 10 – Qualitative Research
p.000141:
p.000141: Application Observational studies raise concerns for the privacy of those being observed. In observational
...
p.000185: 2 Assisted Human Reproduction Act (2004, c. 2). http://laws.justice.gc.ca/eng/A-13.4
p.000185:
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p.000185: TCPS 2
p.000187: 187
p.000187:
p.000187:
p.000187:
p.000187: Glossary
p.000187:
p.000187: This glossary is intended to assist readers in their understanding of the Tri-Council Policy Statement: Ethical Conduct
p.000187: for Research Involving Humans (TCPS), also referred to as “the Policy.” Definitions that have been provided in the main
p.000187: text of the Policy are also repeated here. Additional terms are defined in accordance with the purposes of the Policy.
p.000187: For more detailed descriptions of many terms it is best to read them in the context of the chapters in which they
p.000187: appear – consult the Index for the appropriate reference.
p.000187:
p.000187: Aboriginal peoples – Persons of Indian (First Nations), Inuit, or Métis descent, regardless of where they reside and
p.000187: whether or not their names appear on an official register. In the international context, the term comparable to
p.000187: Aboriginal peoples is Indigenous peoples.
p.000187:
p.000187: Academic freedom – The collective freedom of faculty and students to conduct research, and to disseminate ideas or
p.000187: facts without religious, political, or institutional restrictions. It includes freedom of inquiry, freedom to challenge
p.000187: conventional thought, freedom to express one’s opinion about the institution, its administration, or the system in
p.000187: which one works, and freedom from institutional censorship.
p.000187:
p.000187: Ad hoc advisor – A person with relevant and competent knowledge and expertise consulted by a research ethics board for
p.000187: a specific research ethics review, and for the duration of that review. The ad hoc advisor is not a member of the
p.000187: research ethics board.
p.000187:
p.000187: Agencies, the – Canada’s three federal research agencies: the Canadian Institutes of Health Research (CIHR); the
p.000187: Natural Sciences and Engineering Research Council of Canada (NSERC); and the Social Sci- ences and Humanities Research
p.000187: Council of Canada (SSHRC).
p.000187:
p.000187: Appeal – A process that allows a researcher to request a review of a research ethics board (REB) decision when, after
p.000187: reconsideration, the REB has refused ethics approval of the research.
p.000187:
p.000187: Appeal mechanism – A procedure established by an institution to promptly handle a researcher’s appeal of a research
p.000187: ethics board (REB) decision. An ad hoc or permanent appeal committee, which reflects a range of expertise and knowledge
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p.000199: (c) If a participant withdraws consent, the participant can also request the with- drawal of their data or human
p.000199: biological materials.
p.000199: Application (a) The voluntariness of consent is important because it respects human dignity and means that
p.000199: individuals have chosen to participate in research according to their own values, preferences and wishes.
p.000199: The approach to recruitment is an important element in assuring voluntariness. In particular, how, when and where
p.000199: participants are approached, and who re- cruits them are important elements in assuring (or undermining) voluntariness.
p.000199: In considering the voluntariness of consent, REBs and researchers should be cognizant of situations where undue
p.000199: influence, coercion or the offer of incen- tives may undermine the voluntariness of a participant’s consent to
p.000199: participate in research.
p.000199: UndueXInfluence
p.000199: Undue influence and manipulation may arise when prospective participants are recruited by individuals in a position of
p.000199: authority. The influence of power re- lationships (e.g., employers and employees, teachers and students, commanding
p.000199: officers and members of the military or correctional officers and prisoners) on the voluntariness of consent should be
p.000199: judged from the perspective of prospec- tive participants, since the individuals being recruited may feel constrained
p.000199: to follow the wishes of those who have some form of control over them. This con- trol may be physical, psychological,
p.000199: financial or professional, for example, and may involve offering some form of inducement or threatening some form of
p.000199: deprivation. In such situations, the control exerted in a power relationship may place undue pressure on the
p.000199: prospective participants. At the extreme, there can be no voluntariness if consent is secured by the order of
p.000199: authorities.
p.000199: REBs and researchers should also pay particular attention to elements of trust and dependency in relationships (e.g.,
p.000199: between physician and patient or between professor and student). These relationships can impose undue influence on the
p.000199: individual in the position of dependence to participate in research projects. Any relationship of dependency, even a
p.000199: nurturing one, may give rise to undue in- fluence even if it is not applied overtly. There may be a greater risk of
p.000199: undue influence in situations of ongoing or significant dependency.
p.000199:
...
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: magnitude and probability of harms, the complexity of the information conveyed, and the setting where the information
p.000199: is given.
p.000199: The key to informed consent is that prospective participants understand the information being conveyed to
p.000199: them by researchers. Researchers and REBs should consider how best to convey that information to facilitate
p.000199: understanding. For example, written documentation may be supplemented with audio and/or visual aids, or accompanied by
p.000199: video presentations.
p.000199: When language barriers necessitate the assistance of an intermediary for commu- nication between the research team and
p.000199: participants, the researcher should select an intermediary who has the necessary language skills to ensure effective
p.000199: commu- nication (see Article 4.1). The involvement of such intermediaries may raise confidentiality issues
p.000199: (see Article 5.2).
p.000199: Paragraphs (a) to (c) require researchers to clearly explain the nature and goals of the research, and other
p.000199: essential information, in a manner that best promotes understanding on the part of prospective participants.
p.000199: Paragraph (b) requires the disclosure of those who support a particular research project, through funding or
p.000199: sponsorship. It is unethical for researchers to engage in clandestine activities for intelligence, police or military
p.000199: purposes under the guise of research.
p.000199: Paragraph (c) requires researchers to consider all reasonably foreseeable risks that may result from participation.
p.000199: When research is conducted about an organization or a community, researchers should inform prospective participants
p.000199: within that organization or community of the extent to which the organization or community is collaborating with the
p.000199: research, as well as any risk this collaboration may pose to the participant.
p.000199: Paragraph (d) helps to ensure the effectiveness of Article 3.1 – that a prospective participant’s choice to participate
p.000199: is voluntary. Paragraph (d) also supports the requirement that the consent process continue throughout the research.
p.000199: Paragraph (e) aims at managing real, potential or perceived conflicts of interests. Researchers should separate, to the
p.000199: greatest extent possible, their role as researcher from their other roles as therapists, caregivers, teachers,
p.000199: advisors, consultants, supervisors, employers or the like. If a researcher is acting in dual roles, this fact must
p.000199: always be disclosed to the participant. Conflict of interest matters are further elaborated in Chapter 7.
p.000199: Paragraph (f) requires that researchers provide a reasonable explanation of the meas- ures they will undertake to
p.000199: publish and otherwise disseminate the results of the research – to the extent that it is feasible, and in a manner that
p.000199: is appropriate. Beyond
p.000199:
p.000199:
p.000199:
p.000199: 32 TCPS 2
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
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p.000199: Articles 2.5 and 2.6), as defined in this Policy, may still raise ethical issues that would benefit from careful
p.000199: consideration by an individual or a body capable of providing some independent guidance, other than an REB. These
p.000199:
p.000199: TCPS 2 19
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
p.000199: ethics resources may be based in professional or disciplinary associations, particularly where those associations have
p.000199: established best practices guidelines for such activities in their discipline.
p.000199: Article 2.5 Quality assurance and quality improvement studies, program evaluation activities, and performance
p.000199: reviews, or testing within normal educational requirements when used exclusively for assessment, management or
p.000199: improvement purposes, do not constitute research for the purposes of this Policy, and do not fall within the scope of
p.000199: REB review.
p.000199: Application Article 2.5 refers to assessments of the performance of an organization or its employees or
p.000199: students, within the mandate of the organization, or according to the terms and conditions of employment or training.
p.000199: Those activities are normally administered in the ordinary course of the operation of an organization where
p.000199: participation is required, for example, as a condition of employment in the case of staff performance reviews, or
p.000199: an evaluation in the course of academic or professional training. Other examples include student course
p.000199: evaluations, or data collection for internal or external organizational reports. Such activities do not normally follow
p.000199: the consent procedures outlined in this Policy.
p.000199: If data are collected for the purposes of such activities but later proposed for research purposes, it would be
p.000199: considered secondary use of information not originally intended for research, and at that time may
p.000199: require REB review in accordance with this Policy. Refer to Section D of Chapter 5 for guidance
p.000199: concerning secondary use of identifiable information for research purposes.
p.000199: Article 2.6 Creative practice activities, in and of themselves, do not require REB review. However, research
p.000199: that employs creative practice to obtain responses from participants that will be analyzed to answer a research
p.000199: question is subject to REB review.
p.000199: Application Creative practice is a process through which an artist makes or interprets a work or works of art. It
p.000199: may also include a study of the process of how a work of art is generated. Creative practice activities do not require
p.000199: REB review, but they may be governed by ethical practices established within the cultural sector.
p.000199: Relationship between Research Ethics Review and Scholarly Review
p.000199: Article 2.7 As part of research ethics review, the REB shall review the ethical implications of the methods and
p.000199: design of the research.
p.000199: Application The primary test to be used by REBs in evaluating a research project should be ethical acceptability
p.000199: and, where appropriate, relevant disciplinary scholarly standards.
p.000199: Traditions for scholarly review vary among disciplines or fields of research, including the stage at which
p.000199: scholarly review occurs, and this needs to be taken into account by REBs. The extent of the scholarly review that is
p.000199: required for biomedical research that does not involve more than minimal risk will vary
p.000199:
p.000199: 20 TCPS 2
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
p.000199: according to the research being carried out. Research in the humanities and the social sciences that poses, at most,
p.000199: minimal risk shall not normally be required by the REB to be peer reviewed.
p.000199: REBs should normally avoid duplicating previous professional peer-review assessments unless there is a good and
p.000199: defined reason to do so. It is to be noted that for specific types of research (e.g., clinical trials) REBs should
p.000199: respect the relevant guidelines2 that require REBs to evaluate the scientific aspects of the research as part of their
p.000199: research ethics review.
p.000199: Researchers have a role to play in demonstrating to their REB whether, when and how appropriate scholarly review has
p.000199: been or will be undertaken for their research. REBs may request that the researcher provide them with the full
p.000199: documentation of scholarly reviews already completed.
p.000199: Where scholarly review is required,
p.000199: • an REB should consider what scholarly review has been applied to a particular research project (e.g., by a funder
p.000199: or sponsor, or for student research by the research supervisor or thesis committee, or by a permanent peer
p.000199: review committee where it exists);
p.000199: • if scholarly review as indicated by the relevant disciplinary tradition has not yet been done, and there is no body
p.000199: available to do it, the REB should consider the following mechanisms in satisfying itself that scholarly review of the
p.000199: research is completed:
p.000199: - establish an ad hoc independent peer review committee;
p.000199: - if the REB has the necessary scholarly expertise, assume complete responsibility for the scholarly review.
p.000199: In assuming this responsibility, the REB should not be driven by factors such as personal biases or preferences, and
p.000199: should not reject proposals because they are controversial, challenge mainstream thought, or offend powerful or vocal
p.000199: interest groups.
p.000199: REB Review Shall Be Continuing
p.000199: Article 2.8 Following initial REB review and approval, research ethics review shall continue throughout the life
p.000199: of the project in accordance with Article 6.14.
p.000199: Application The primary goal of REB review is to ensure the ethical acceptability of research involving humans that
p.000199: falls within the scope of this Policy. Following the initial REB review and approval, the ethics review shall continue
p.000199: to ensure that all stages of a research project are ethically acceptable in accordance with the principles of this
p.000199: Policy.
p.000199: Continuing ethics review by an REB provides those involved in the research process (in particular,
p.000199: researchers and REBs) with multiple opportunities to reflect
p.000199:
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p.000199: review. Whether the review is delegated, full-board, initial or continuing, foreseeable risks and potential benefits
p.000199: should be considered as well as the ethical implications of the research. The proportionate approach to REB review
p.000199: requires that a project
p.000199:
p.000199:
p.000199:
p.000199: 24 TCPS 2
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
p.000199: have a favourable balance of risks and benefits in order to receive REB approval. The REB should make this assessment
p.000199: in light of the context of the research – that is, elements of the research that may produce benefits or harms, or
p.000199: otherwise have an impact on the ethics of research. Regardless of the level of review selected, the review should
p.000199: include the necessary expertise.
p.000199: Both risks and potential benefits may span the spectrum from minimal to substantial. The concept of minimal
p.000199: risk (described above) provides a foundation for the proportionate approach to REB review. The various applications of
p.000199: the proportionate approach to REB review are addressed in Article 6.12.
p.000199: Risks to Researchers
p.000199: Risks in research are not limited to participants. In their conduct of research, researchers themselves
p.000199: may be exposed to risks that may take many forms (e.g., injury, incarceration). Risks to researchers may become a
p.000199: safety concern, especially for student researchers who are at a learning stage regarding the conduct of research, and
p.000199: who may be subject to pressures from supervisors to conduct research in unsafe situations.
p.000199: While it is not a formal part of its responsibilities, an REB may raise concerns about the safety of student
p.000199: researchers as part of its communication to the student researchers, and to their supervisors. Based on the level of
p.000199: risk, the REB may consider referring these concerns for review by an appropriate body within the institution.
p.000199:
p.000199: Endnotes
p.000199:
p.000199:
p.000199: 1 The definitions of embryo, fetus and human reproductive materials are taken from the Assisted Human Reproduction Act
p.000199: (2004, c. 2) at http://laws.justice.gc.ca/en/A-13.4 and Guidelines for Human Pluripotent Stem Cell Research at
p.000199: www.cihr-irsc.gc.ca/e/34460.html.
p.000199: 2 See guidance 3.2.1 of the International Conference on Harmonisation (ICH), Guidance for Industry – Good Clinical
p.000199: Practice: Consolidated Guideline, ICH Topic E6: Technical Requirements for the Registration of Pharmaceuticals for
p.000199: Human Use (1996, adopted by Health Canada in 1997).
p.000199: www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-eng.php
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 25
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: Introduction
p.000199: Chapter 3
p.000199: THE CONSENT PROCESS
p.000199: This chapter sets out the ethical requirements for consent in research involving humans. Throughout this
...
p.000199: participate in research.
p.000199: UndueXInfluence
p.000199: Undue influence and manipulation may arise when prospective participants are recruited by individuals in a position of
p.000199: authority. The influence of power re- lationships (e.g., employers and employees, teachers and students, commanding
p.000199: officers and members of the military or correctional officers and prisoners) on the voluntariness of consent should be
p.000199: judged from the perspective of prospec- tive participants, since the individuals being recruited may feel constrained
p.000199: to follow the wishes of those who have some form of control over them. This con- trol may be physical, psychological,
p.000199: financial or professional, for example, and may involve offering some form of inducement or threatening some form of
p.000199: deprivation. In such situations, the control exerted in a power relationship may place undue pressure on the
p.000199: prospective participants. At the extreme, there can be no voluntariness if consent is secured by the order of
p.000199: authorities.
p.000199: REBs and researchers should also pay particular attention to elements of trust and dependency in relationships (e.g.,
p.000199: between physician and patient or between professor and student). These relationships can impose undue influence on the
p.000199: individual in the position of dependence to participate in research projects. Any relationship of dependency, even a
p.000199: nurturing one, may give rise to undue in- fluence even if it is not applied overtly. There may be a greater risk of
p.000199: undue influence in situations of ongoing or significant dependency.
p.000199:
p.000199:
p.000199:
p.000199: 28 TCPS 2
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: Pre-existing entitlements to care, education and other services should not be prejudiced by the decision of whether or
p.000199: not to participate in, or to withdraw from, a research project. Accordingly, for example, a physician should ensure
p.000199: that continued clinical care is not linked to research participation. Similarly, where students do not wish to
p.000199: participate in research studies for course credits, they should be offered a comparable alternative.
p.000199: Coercion
p.000199: Coercion is a more extreme form of undue influence, involving a threat of harm or punishment for failure to
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p.000199: sponsibility of the institution for the ethical acceptability of research undertaken within its jurisdiction or under
p.000199: its auspices. To demonstrate their accountability, institutions may wish to issue public reports summarizing the
p.000199: institution’s activities and initiatives relevant to the ethics review of research involving humans, its re- search
p.000199: ethics administration, and relevant research ethics education and training.
p.000199: The number of REBs and the expertise of their members will depend on the range and volume of research for which that
p.000199: institution is responsible, in accordance with
p.000199:
p.000199: TCPS 2 67
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: Articles 6.4 and 6.5 relating to REB composition. Large institutions may find it necessary to create more than one REB
p.000199: to cover different areas of research or to accommodate a large volume of research. Small institutions may wish to
p.000199: explore regional cooperation or alliances for access to an REB based on formal agreements between the institutions (see
p.000199: Article 8.1).
p.000199: Members of an institution (i.e., its faculty, staff and students) may be affiliated with other institutions, or may be
p.000199: engaged in consulting or other professional activities in a separate enterprise, or in student co-op work or field
p.000199: placements. If members of the institution make reference to their affiliation to the institution, or use any of its
p.000199: resources when engaging in research, they should submit their research proposal to their institutional REB for research
p.000199: ethics review in accordance with this Policy. Where student co-op work or field placements involve components of
p.000199: research that require research ethics review, institutions and organizations hosting co-op student researchers may
p.000199: consider specifying in advance (e.g., in policies, agreements or contracts for co-op student placements) the roles and
p.000199: responsibilities pertaining to the ethics review of research involving humans of the host organization versus those of
p.000199: the institution.
p.000199: Should the institution determine that some situations warrant an exception to the requirement for REB review, the basis
p.000199: and conditions for case-by-case exceptions shall be clearly documented in the institutional policies. Case-by-case
p.000199: exceptions may be determined by such factors as the degree to which the members’ affiliation with the institution is
p.000199: their primary affiliation, or by how practical it is to distinguish the capacity in which the member is conducting the
p.000199: research, and the participants’ reasonable perceptions of this capacity. Other factors include the availability of
p.000199: other avenues through which the member may address the guidance in this Policy outside the institution, including the
p.000199: possibility of sharing responsibility for re- search ethics review, and the methods in place to address real, potential
p.000199: or perceived conflict of interest issues.
p.000199: Article 6.2 The highest body within an institution shall: establish the REB or REBs, define an appropriate
p.000199: reporting relationship with the REBs, and ensure the REBs are provided with necessary and sufficient ongoing financial
p.000199: and administrative resources to ful- fil their duties. REBs are independent in their decision making and are
p.000199: accountable to the highest body that established them for the process of research ethics review.
...
p.000199: However, an institutional senior administrator (e.g., vice-president of research, director general or director of
p.000199: business development) should not serve on an REB, or directly or indirectly influence the REB decision-making process
p.000199: (see Articles 6.2 and 6.10). The mere presence of a non-voting institutional senior administrator at REB meetings may
p.000199: be a source of real, potential or perceived con-
p.000199:
p.000199: 70 TCPS 2
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: flict of interest, and may therefore undermine the independence of the REB by un- duly influencing REB deliberations
p.000199: and decisions (see Article 7.2).
p.000199: The size of an REB may vary based on the diversity of disciplines, fields of research and methodologies to be covered
p.000199: by the REB, as well as on the needs of the insti- tution. In appointing REB members, institutions should strive
p.000199: for appropriate diversity. Institutions may need to exceed the minimum REB membership require- ments in order to
p.000199: ensure adequate and thorough reviews, reasonable workload for REB members, or to respond to other local,
p.000199: provincial/territorial, or federal legal or regulatory requirements. For example, in the case of REB review of clinical
p.000199: tri- als, provincial/territorial or federal regulations may outline specific membership requirements in addition to the
p.000199: requirements set out in this Policy. Where REBs mainly review student research, they may consider adding a student REB
p.000199: member. Additional community representation should be commensurate with the size of the REB. Institutions are
p.000199: encouraged to establish a pool of substitute members (see below). Where research ethics administration staff have the
p.000199: requisite experience, expertise and knowledge comparable to what is expected of REB members, insti- tutions may appoint
p.000199: them (based on the written policies and procedures of the institution) to serve as non-voting members on the REB.
p.000199: Relevant Expertise in Research Content and Methodology
p.000199: At least two members should have the relevant knowledge and expertise to under- stand the content area and methodology
p.000199: of the proposed or ongoing research, and to assess the risks and potential benefits that may be associated with the
p.000199: research (Article 6.4[a]). For example, REBs reviewing oncology research, education or topics involving Aboriginal
p.000199: peoples, or research using qualitative methodologies, should have members that are knowledgeable and competent to
p.000199: address those fields of research, disciplines and methodologies.
p.000199: Knowledgeable in Ethics
p.000199: Knowledge of ethics of research involving humans is key within the REB mem- bership as a whole. A member knowledgeable
p.000199: in ethics (Article 6.4[b]) needs to have sufficient knowledge to guide an REB in identifying and addressing ethics
...
p.000199: the appropriate level of research ethics review (delegated or full REB review). (For a full discussion of the
p.000199: proportionate approach to research ethics review, see Chapter 1, Section C, and Article 2.9). This applies to both
p.000199: initial re- search ethics review (see Article 6.11) and continuing research ethics review (see Article 6.14).
p.000199: With the support of their institutions, REBs may develop their own mechanisms under which delegation of the conduct of
p.000199: research ethics review, decision making and the associated reporting processes will occur. Those mechanisms and proce-
p.000199: dures should be made public. It is the REB, based on its established procedures and through its Chair, that decides on
p.000199: the level of review for each research pro- posal.
p.000199: Two levels of research ethics review may apply:
p.000199: 1) Full REB review
p.000199: Research ethics review by the full REB should be the default requirement for research involving humans.
p.000199: 2) Delegated REB review of minimal risk research
p.000199: The REB delegates research ethics review to an individual or individuals. Del- egates shall be selected from among the
p.000199: REB membership with the exception of the ethics review of student course-based research. This can be delegated to the
p.000199: department, faculty or equivalent level as indicated below.
p.000199: Where it is determined that the research is of minimal risk (defined in Chapter 2 of this Policy), an REB may authorize
p.000199: a delegated research ethics review in accor- dance with its institutional policies and written procedures. Delegated
p.000199: reviewer(s) shall be selected from the REB membership: the REB Chair or another member
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 77
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: (see Article 6.4 on the appointment of research ethics administration staff to the REB as non-voting members). Research
p.000199: ethics review may also be undertaken by non-REB members for student course-based research as outlined below. Delegated
p.000199: reviewers who are non-members or non-voting members of the REB must have experience, expertise and knowledge comparable
p.000199: to what is expected of an REB member.
p.000199: The REB may decide that its Chair or other REB member(s) may review and ap- prove categories of research that are
p.000199: confidently expected to involve minimal risk. Delegated reviewers may call on other reviewers within the REB or refer
p.000199: projects back to the full REB if they determine that full board review is required. Where delegates consider a negative
p.000199: decision (i.e., one that would refuse ethics approval), this decision shall be referred to the full REB for review and
p.000199: endorsement before communicating the decision to the researcher.
p.000199: An institution may decide that ethics review of course-based research activities in- tended solely for pedagogical
p.000199: purposes can be delegated to non-REB members at the institution’s department, faculty or equivalent level. Such
p.000199: pedagogical activities are normally required of students (at all levels) with the objective of providing them with
p.000199: exposure to research methods in their field of study. If these activities are used for the purposes of research (e.g.,
p.000199: as part of a researcher’s own research program), they should be reviewed by the regular institutional REB procedures.
p.000199: The REB should establish written procedures and set out criteria for determining which cat- egories of research
p.000199: proposals may be eligible for this type of review, and specify who is responsible for implementing and overseeing the
p.000199: approval mechanisms.
...
p.000199: (b) manage the intellectual property that forms the basis of a research project or stand to benefit from intellectual
p.000199: property resulting from the research; (c) hold equity in companies and/or receive major donations; or (d) have
p.000199: conflicting roles carried out by one institutional official (e.g., a vice- president who is responsible for the
p.000199: promotion of research activity and funding and also for oversight of research).
p.000199: Acting in a professional role within the institution, individuals (e.g., institution president, vice- president, dean
p.000199: of a faculty or department head) are in a conflict of interest when they are subject to competing incentives or
p.000199: functions. These may significantly interfere with the impartial exercise of duties, including legal and ethical
p.000199: obligations within the institutional structure. The conflict may be chronic, relating to recurring situations resulting
p.000199: from the institutional structure, or it may be triggered by a unique situation that is not likely to recur.
p.000199: REB Member Conflict of Interest
p.000199: The REB, as an entity, or in the persons of the members who make up the board, also hold trust relationships with
p.000199: participants, research sponsors, researchers and society. REB members must also be aware of their own potential for
p.000199: real or perceived conflicts of interest.
p.000199: For example, REB members are in a conflict of interest when their own research projects are under review by their REB,
p.000199: when they are a co-investigator, or when they are in a supervisory or men- toring relationship with a graduate student
p.000199: applicant. REB members may also be in a conflict of interest situation when they have interpersonal or financial
p.000199: relationships with the researchers, or personal or financial interests in a company, labour union or not-for-profit
p.000199: organization that may be the sponsor of the research project, or that may be substantially affected by the research.
p.000199: Conflicts of interest based on collaborations or disputes with colleagues, students or others may be ongoing or of
p.000199: limited duration. REBs have an obligation to ensure that the fairness and trans- parency of research ethics review is
p.000199: not compromised by real, potential or perceived conflicts of interest.
p.000199:
p.000199:
p.000199:
p.000199: 90 TCPS 2
p.000199:
p.000199: Chapter 7 – Conflicts of Interest
p.000199:
p.000199: Researcher Conflict of Interest
p.000199: Researchers and research students hold trust relationships, either directly or indirectly, with par- ticipants,
p.000199: research sponsors, institutions, their professional bodies and society. These trust relationships can be put
p.000199: at risk by conflicts of interest that may compromise independence, objec- tivity or ethical duties of loyalty. Although
p.000199: the potential for such conflicts has always existed, pressures on researchers (e.g., to delay or withhold dissemination
p.000199: of research outcomes or to use inappropriate recruitment strategies) heighten concerns that conflicts of interest may
p.000199: affect ethical behaviour.
...
p.000199: and/or possibly co-managing the approved research. As outlined in Article 7.1, an approach relative to the level of
p.000199: risks, such as disclosure to the participants of the possible conflicts between multiple roles, may be sufficient to
p.000199: manage the conflict (see also Articles 9.6, 9.8 and 9.12).
p.000199:
p.000199: C. REB Members and Conflicts of Interest
p.000199: Article 7.3 When reviewing research proposals, REB members shall disclose real, potential or perceived conflicts
p.000199: of interest to the REB. When necessary, the REB may decide that some of its members must withdraw from REB
p.000199: deliberations and decisions.
p.000199: Application To maintain the independence and integrity of research ethics review, members of the REB must identify,
p.000199: eliminate, minimize or otherwise manage real, potential or perceived conflicts of interest. If an REB is reviewing a
p.000199: research project in which a member of the REB has a personal or financial conflict of interest (see Section A of this
p.000199: chapter), the member must disclose the nature of the conflict and absent themselves from any discussion or decision
p.000199: regarding that research project. In the event that a member’s conflict of interest and necessary withdrawal from the
p.000199: meet- ing will threaten the maintenance of quorum, the REB can ensure that a substitute member be in attendance to
p.000199: maintain quorum.
p.000199: Conflict of interest policies should determine a reasonable time period during which an REB member is not allowed to
p.000199: review a proposal involving a recent collaborator, supervisor, student or other colleague (as defined by the
p.000199: institution). The purpose of these policies on time limits is to ensure adequate and continued access to com- petent
p.000199: expertise. In some cases, the scientific expertise of the REB member may still be sought when no other individuals with
p.000199: the scientific expertise relevant to the proposal under review are available to the REB. In such instances, the REB
p.000199: will record this explicitly in the minutes. The member should not be present when the REB makes its decision.
p.000199: REBs and Senior Administrators
p.000199: Institutional senior administrators (e.g., a vice-president of research or business de- velopment) should not serve on
p.000199: an REB, or directly or indirectly influence the REB decision-making process. The mere presence of an institutional
p.000199: senior administrator at REB meetings may undermine the independence of the REB by unduly influ- encing REB
p.000199: deliberations and decisions.
p.000199:
p.000199:
p.000199: TCPS 2 93
p.000199:
p.000199: Chapter 7 – Conflicts of Interest
p.000199:
p.000199: REBs and senior administrators should consider other venues to discuss policy is- sues, general issues arising from the
p.000199: REB’s activities, or training and educational needs, to the benefit of the overall operation and mandate of the REB. In
p.000199: the dis- charge of their interdependent roles and duties to participants, effective communications
p.000199: processes should be established between REBs and the relevant officers of institutions. In cases where senior
...
p.000199: conflict of interest to the participant. When disclo- sure to the REB is not enough to manage the conflict of interest,
p.000199: the REB, guided by established institutional policies, may require that the researcher withdraw from the research, or
p.000199: that others on the research team, who are not in conflict of interest, make research-related decisions. Where
p.000199: appropriate, disclosure to the sponsor, the institution and any relevant professional body may also be necessary. In
p.000199: exceptional cases, the REB has the discretion to refuse approval of a research project where the REB decides that the
p.000199: conflict of interest has not been avoided or cannot be ap- propriately managed.
p.000199: If there is a need for a researcher with a conflict of interest in a research project to be involved in some aspect of
p.000199: the project, the extent of the involvement should be reviewed and explicitly endorsed by the REB in its minutes.
p.000199: Participants should also be informed during the consent process of the conflict and the extent of the
p.000199:
p.000199:
p.000199: 94 TCPS 2
p.000199:
p.000199: Chapter 7 – Conflicts of Interest
p.000199:
p.000199: researcher’s involvement. In line with the proportionate approach to REB review, and through the continued research
p.000199: ethics review process, REBs may impose ad- ditional control mechanisms if necessary.
p.000199: Dual Roles
p.000199: Dual roles of researchers and their associated obligations (e.g., acting as both a re- searcher and a therapist, health
p.000199: care provider, caregiver, teacher, advisor, consultant, supervisor, student or employer) may create conflicts, undue
p.000199: influences, power im- balances or coercion that could affect relationships with others and affect
p.000199: decision-making procedures (e.g., consent of participants). Article 3.2(e) reminds researchers of relevant ethical
p.000199: duties that govern real, potential or perceived con- flicts of interest as they relate to the consent of participants.
p.000199: To preserve and not abuse the trust on which many professional relationships rest, researchers should be fully
p.000199: cognizant of conflicts of interest that may arise from their dual or multiple roles, their rights and responsibilities,
p.000199: and how they can man- age the conflict. When acting in dual or multiple roles, the researcher shall disclose the nature
p.000199: of the conflict to the participant in the consent process.
p.000199: Financial Conflicts of Interest
p.000199: Real, potential or perceived financial conflicts of interest may affect any type of research. Researchers and REBs
p.000199: should be aware of, and consider, the possibility of financial conflicts of interest. They should seek to ensure that
p.000199: financial consid- erations do not serve to diminish respect for the principles of this Policy or the scientific
p.000199: validity and transparency of research procedures.
p.000199: Financial incentives have the potential to distort researchers’ judgment in ensuring the design and conduct of research
p.000199: is ethical. When researchers partner with or- ganizations whose primary motive is profit, they must be aware of the
...
p.000111: The following list, which is not exhaustive, provides examples to illustrate the forms of community engagement that
p.000111: might be appropriate for various types of research.
p.000111: 1) Research directly involving a community on First Nations, Inuit or Métis lands with a formal governance structure.
p.000111: For example, a project that examines the incidence of diabetes in Pond Inlet, Nunavut, or the impact on Inuit health of
p.000111: contaminants in animals and plants used for country food.
p.000111: • Permission of the Nunavut Research Institute that carries authority to approve research in Nunavut is
p.000111: required. Agreement of the hamlet council in Pond Inlet will normally be a condition of approval. The local health
p.000111: committee may co-manage the project.
p.000111: 2) Research involving Aboriginal people who comprise a sizeable proportion of the study or community and where
p.000111: Aboriginal-specific conclusions are intended. For example, a comparative study of access to public housing in Prince
p.000111: Albert, Saskatchewan.
p.000111: • First Nations in the district, represented by their tribal council, the local Métis association, and urban
p.000111: Aboriginal and women’s organizations may partner with the Prince Albert city council to sponsor, implement and use the
p.000111: results of the housing study.
p.000111: 3) Research focusing on a larger community that is known to include Aboriginal people (regardless of their
p.000111: proportion), and where Aboriginal-specific conclusions are anticipated. For example, a study of student retention
p.000111: in high schools in the Sault Ste. Marie district of Ontario.
p.000111: • A committee representing First Nations, Métis organizations and urban Aboriginal people whose children may
p.000111: be affected by the study may be convened to advise the District Board of Education and the researchers involved.
p.000111: 4) Research involving Aboriginal people who comprise a sizeable proportion of the larger community that is the
p.000111: subject of research even if no Aboriginal- specific conclusions will be made. For example, research on
p.000111: employment
p.000111:
p.000111: 112 TCPS 2
p.000111:
p.000111: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000111:
p.000111: development programs serving residents of the inner city of Winnipeg in Manitoba.
p.000111: • Aboriginal service agencies or political organizations may be engaged to help recruit Aboriginal participants and
p.000111: secure community representation on an oversight committee, and to ensure cultural sensitivity in collecting and
p.000111: interpreting data on employment program impacts.
p.000111: 5) Interviewing a sample of individuals of Aboriginal ancestry across Canada on the impact of a policy on their
p.000111: lives, where the results are not attributable to, or likely to affect, the community or communities with which they may
p.000111: identify. For example, survey research on the implementation of Indian Act provisions requiring ministerial approval of
p.000111: an “Indian’s” will.
...
p.000123: should be relevant to community needs and priorities. The research should benefit the participating community
p.000123: (e.g., training, local hiring, recognition of contributors, return of results), as well as extend the boundaries of
p.000123: knowledge.
p.000123: Application To benefit the participating community, a research project should be relevant to community priorities
p.000123: and have the potential to produce valued outcomes from the perspective of the community and its members.
p.000123: Relevance and community benefit can take a number of forms depending on the type of research being conducted, and the
p.000123: forms of community engagement. For example, genetic research on diabetes in a First Nations community is unlikely to
p.000123: benefit the community in the short term, but collaboration may facilitate increased knowledge of the condition, and
p.000123: what changes can be made to improve health outcomes. Collaborative research can thus accommodate basic, as well as
p.000123: applied, research, and include short-term and long-term benefits. In another example, a community invites a researcher
p.000123: to collaborate in a research project about housing and homelessness in an Inuit community. Using participatory research
p.000123: methods and social science tools, the nature, extent and consequences of the local housing shortage are documented,
p.000123: enabling the community to effectively communicate its needs to non-Inuit (Qallunaat) authorities. Other benefits
p.000123: include training workshops that provide employment and transfer skills to Inuit youth involved in data collection,
p.000123: field experience in community-based research for university student assistants and materials useful to other Inuit
p.000123: communities in subsequent research.
p.000123: Collaborative research approaches provide the community with the opportunity to discuss risks and potential benefits,
p.000123: and to minimize risks. Where participatory
p.000123:
p.000123: 124 TCPS 2
p.000123:
p.000123: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000123:
p.000123: research is undertaken, the research report might also formulate recommendations on how to implement interventions
p.000123: resulting from the research for the benefit of the participating community.
p.000123: A possible outcome of collaborative research, and in particular participatory research, is increased
p.000123: capacity to carry out research that can more readily be conducted in Aboriginal languages and oral modes. The
p.000123: exploration, articulation and application of knowledge specific to a community or communities are thus advanced,
p.000123: potentially benefiting other First Nations, Inuit or Métis communities through knowledge transfer.
p.000123: Researchers should provide communities access to research data that will allow them to address pressing issues through
p.000123: community-generated policies, programs, and services (see Article 9.8 and the Application of Article 9.11). Territorial
p.000123: and organizational communities and communities of interest may also seek to share in the benefits of research
p.000123: activities, which may include direct research grants, release time for project personnel, overhead levies on shared
p.000123: projects and commercializa- tion of research discoveries.
...
p.000123: Lack of engagement by communities may be due to inadequate financial or human resources. Communities vary widely in the
p.000123: level of human and material resources they have available to collaborate with research initiatives. Structural barriers
p.000123: may prevent access to, and participation in, research. For example, small, remote communities and many urban
p.000123: communities of interest have limited organizational resources to advise or collaborate in research. The least
p.000123: organizationally developed communities are the most vulnerable to exploitation. Research undertaken in these
p.000123: circumstances should strive to enhance capacity for participation.
p.000123: Funding programs that target the development of Aboriginal research and capacity building seek to generate
p.000123: significant research training opportunities. Funding criteria allow researchers to include in their grant
p.000123: applications stipends for
p.000123:
p.000123:
p.000123: TCPS 2
p.000125: 125
p.000125:
p.000125: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000125:
p.000125: undergraduate, master’s or doctoral students, or post-doctoral researchers, as appropriate, with priority given
p.000125: to Aboriginal candidates. The time required to establish collaborative relationships may be difficult to
p.000125: accommodate in the programs of students. Mentorship by experienced researchers who introduce students to
p.000125: communities and monitor their ethical practice can facilitate the trust- building process and advance student progress.
p.000125: Recognition of the Role of Elders and Other Knowledge Holders
p.000125: Article 9.15 Researchers should engage the community in identifying Elders or other recognized knowledge holders to
p.000125: participate in the design and execution of research, and the interpretation of findings in the context of cultural
p.000125: norms and traditional knowledge. Community advice should also be sought to determine appropriate recognition for the
p.000125: unique advisory role fulfilled by these persons.
p.000125: Application Within First Nations, Inuit and Métis communities, persons with special gifts carry varied roles and
p.000125: responsibilities in conserving and transmitting traditional knowledge and expressions of culture. They often are
p.000125: fluent in their traditional language. They model respectful relationships and may conduct ceremonies, pass on oral
p.000125: history, and offer guidance in community affairs. Their gifts are normally refined over a lifetime. Thus, Elders who
p.000125: have followed a rigorous path of learning over a long period are highly respected. Younger persons may also gain
p.000125: recognition as gifted knowledge holders.
p.000125: High regard by the community that knows the Elder or other knowledge holder is the most reliable indicator of an
p.000125: individual’s authority. Each community or nation has particular ways of approaching Elders or knowledge holders
p.000125: respectfully. In many First Nations this involves the presentation and acceptance of tobacco to symbolize entering into
p.000125: a relationship. In some communities, feasting or gift-giving is appropriate.
...
p.000189: transmitted from one generation to the next, such as sacred narratives, customs, representa- tions or practices.
p.000189:
p.000189: Cyber-material – Documents, images, audio or video recordings, records, performances, or on-line archival materials
p.000189: available in digital form on the Internet.
p.000189:
p.000189: Data linkage – The merging or analysis of two or more separate data sets (e.g. health information and education
p.000189: information about the same individuals) for research purposes. See also “Data set.”
p.000189:
p.000189: Data safety monitoring board – A multi-disciplinary, expert advisory group established by a research sponsor, that
p.000189: is responsible for safeguarding the interests of participants by reviewing emerging data, assessing the safety and
p.000189: efficacy of clinical trial procedures, and monitoring the overall conduct of a trial.
p.000189:
p.000189: Data set – A collection of information to be used for research purposes, including human biological materials.
p.000189:
p.000189: Debriefing – The full disclosure of the research purpose and other pertinent information to participants who have been
p.000189: involved in research employing partial disclosure or deception. Debriefing is typically done after participation has
p.000189: ended, but may be done at any time during the study.
p.000189:
p.000189: Delegated research ethics board (REB) review – The level of REB review assigned to minimal risk research projects.
p.000189: Delegated reviewers are selected from among the REB membership, with the exception of the ethics review of student
p.000189: course-based research which can be reviewed by delegates from the student’s department, faculty, or an equivalent
p.000189: level.
p.000189: Embryo – A human organism during the first 56 days of its development following fertilization or creation, excluding
p.000189: any time during which its development has been suspended. It also includes any cell derived from such an organism that
p.000189: is used for the purpose of creating a human being.
p.000189:
p.000189:
p.000189:
p.000189:
p.000189:
p.000189:
p.000189: TCPS 2
p.000191: 191
p.000191:
p.000191: Glossary
p.000191:
p.000191: Emergency preparedness plans – Plans that detail an institution’s policies and procedures for addressing research
p.000191: ethics review during public health outbreaks, natural disasters, and other publicly declared emer- gencies. See
p.000191: “Publicly declared emergency.”
p.000191:
p.000191: Emergent design – A research method in which data collection and analyses can evolve over the course of a research
p.000191: project in response to what is learned in earlier parts of the study.
p.000191:
p.000191: Fetal tissue – Membranes, placenta, umbilical cord, amniotic fluid, and other tissue that contains genetic information
p.000191: about the fetus.
p.000191: Fetus – A human organism during the period of its development beginning on the 57th day following fertilization or
p.000191: creation, excluding any time during which its development has been suspended, and ending at birth.
p.000191:
...
p.000195:
p.000195: Therapeutic misconception – A misunderstanding, on the part of participants, of the purpose, benefits, and/or risks
p.000195: of clinical trials. Often participants do not understand that research is aimed primarily at producing knowledge and
p.000195: may not provide any therapeutic benefit to them.
p.000195:
p.000195: Traditional knowledge – The knowledge held by First Nations, Inuit and Métis peoples, the Aboriginal peoples of
p.000195: Canada. Traditional knowledge is specific to place, usually transmitted orally, and rooted in the experience of
p.000195: multiple generations. It is determined by an Aboriginal community’s land, environment, region, culture, and language.
p.000195: It may also include new knowledge transmitted to subsequent generations.
p.000195:
p.000195: Unanticipated issues – Issues that: occur during the conduct of research; may increase the level of risk to
p.000195: participants or have other ethical implications that may affect participants’ welfare; and were not anticipated by the
p.000195: researcher in the research proposal submitted for research ethics review.
p.000195:
p.000195: Undue influence – The impact of an unequal power relationship on the voluntariness of consent. This may occur when
p.000195: prospective participants are recruited by individuals in a position of authority over them (e.g. doctor/patient,
p.000195: teacher/student, employer/employee). See “Coercion.”
p.000195:
p.000195: Vulnerability – A diminished ability to fully safeguard one’s own interests in the context of a specific research
p.000195: project. This may be caused by limited capacity or limited access to social goods, such as rights, opportunities and
p.000195: power. Individuals or groups may experience vulnerability to different degrees and at different times, depending on
p.000195: their circumstances. See also “Autonomy.”
p.000195:
p.000195: Welfare – The quality of a person’s experience of life in all its aspects. Welfare consists of the impact on
p.000195: individuals and/or groups of factors such as their physical, mental and spiritual health, as well as their physical,
p.000195: economic and social circumstances.
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195: TCPS 2
p.000195:
p.000197: 197
p.000197:
p.000197:
p.000197:
p.000197: Index
p.000197: The Index seeks to direct the reader to meaningful references to key concepts in TCPS 2. Main references to a term are
p.000197: indicated with bold type.
p.000197:
...
Social / Threat of Stigma
Searching for indicator threat:
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p.000199: prisoners, those with mental health issues and those with diminished capacity for self-determination. Ethno- cultural
p.000199: minorities and those who are institutionalized are other examples of groups who have, at times, been treated unfairly
p.000199: and inequitably in research, or have been excluded from research op- portunities. People or groups whose circumstances
p.000199: cause them to be vulnerable or marginalized may need to be afforded special attention in order to be treated justly in
p.000199: research.
p.000199:
p.000199:
p.000199:
p.000199: 10 TCPS 2
p.000199:
p.000199: Chapter 1 – Ethics Framework
p.000199:
p.000199: The recruitment process, both of participants who may become directly involved in research and those who participate as
p.000199: the source of information or biological materials to be used in research, is an important component of the fair and
p.000199: equitable conduct of research. Participation should be based on inclusion criteria that are justified by the research
p.000199: question. Inequity is created when par- ticular groups fail to receive fair benefits of research or when
p.000199: groups, or their data or their biological materials, are excluded from research arbitrarily or for reasons
p.000199: unrelated to the research question.
p.000199: An important threat to Justice is the imbalance of power that may exist in the relationship between researcher and
p.000199: participant. Participants will generally not understand the research in the same way and in the same depth as does the
p.000199: researcher. Historically, there have been instances in which this power imbalance has been abused, with resulting harm
p.000199: to participants.
p.000199: The Core Principles – Conclusion
p.000199: The importance of research and the need to ensure the ethical conduct of research requires both researchers and REB
p.000199: members to navigate a sometimes difficult course between the two main goals of providing the necessary protection of
p.000199: participants and serving the legitimate requirements of research. The three core principles that express the value of
p.000199: human dignity provide the compass for that journey. Their application will help ensure that a balance between these two
p.000199: goals is main- tained. Applying the core principles will also maintain free, informed and ongoing consent
p.000199: throughout the research process and lead to sharing the benefits of the research. These results will help to build and
p.000199: maintain the trust of participants and the public in the research process.
p.000199:
p.000199: C. How to Apply This Policy
p.000199: Proportionate Approach to REB Review
p.000199: This Policy aims to strike an appropriate balance between recognition of the potential benefits of research, and
p.000199: protection of participants from research-related harms, including injustices and breaches of Respect for Persons. Given
...
p.000199: individual in the position of dependence to participate in research projects. Any relationship of dependency, even a
p.000199: nurturing one, may give rise to undue in- fluence even if it is not applied overtly. There may be a greater risk of
p.000199: undue influence in situations of ongoing or significant dependency.
p.000199:
p.000199:
p.000199:
p.000199: 28 TCPS 2
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: Pre-existing entitlements to care, education and other services should not be prejudiced by the decision of whether or
p.000199: not to participate in, or to withdraw from, a research project. Accordingly, for example, a physician should ensure
p.000199: that continued clinical care is not linked to research participation. Similarly, where students do not wish to
p.000199: participate in research studies for course credits, they should be offered a comparable alternative.
p.000199: Coercion
p.000199: Coercion is a more extreme form of undue influence, involving a threat of harm or punishment for failure to
p.000199: participate. Coercion would negate the voluntariness of a decision to participate, or to remain, in a research project.
p.000199: Incentives
p.000199: Incentives are anything offered to participants, monetary or otherwise, for par- ticipation in research (incentives
p.000199: differ from reimbursements and compensation for injury, which are discussed in Article 3.2[j]). Because incentives are
p.000199: used to encourage participation in a research project, they are an important consid- eration in assessing
p.000199: voluntariness. Where incentives are offered to participants, they should not be so large or attractive as to encourage
p.000199: reckless disregard of risks. This is a particular consideration in the case of healthy volunteers for the early phases
p.000199: of clinical trials, as discussed in Article 11.1. The offer of incen- tives in some contexts may be perceived by
p.000199: prospective participants as a way for them to gain favour or improve their situation. This may amount to undue
p.000199: inducement and thus negate the voluntariness of participants’ consent.
p.000199: This Policy neither recommends nor discourages the use of incentives. The onus is on the researcher to justify to the
p.000199: REB the use of a particular model and the level of incentives. In considering the possibility of undue influence in re-
p.000199: search involving financial or other incentives, researchers and REBs should be sensitive to issues such as the economic
...
p.000199: third party consent could seriously compromise that individual’s health. Certain types of medical emergency practices
p.000199: can be evaluated only when they occur, hence the need for this exception.
p.000199: This section is to be distinguished, however, from situations where there is a publicly declared emergency (such as the
p.000199: SARS crisis or a major flood) that disrupts the ordinary system for obtaining REB approval for research. For guidance
p.000199: on research ethics review during a publicly declared emergency, see Articles 6.21 and 6.22.
p.000199: Article 3.8 Subject to all applicable legal and regulatory requirements, research involving medical emergencies
p.000199: shall be conducted only if it addresses the emergency needs of the individuals involved, and then only in accordance
p.000199: with criteria established in advance of such research by the REB. The REB may allow research that involves medical
p.000199: emergencies to be carried out without the consent of participants, or of their authorized third party, if all of the
p.000199: following apply:
p.000199: (a) a serious threat to the prospective participant requires immediate intervention;
p.000199: (b) either no standard efficacious care exists or the research offers a realistic possibility of direct
p.000199: benefit to the participant in comparison with standard care;
p.000199: (c) either the risk is not greater than that involved in standard efficacious care, or it is clearly justified by the
p.000199: prospect for direct benefits to the participant;
p.000199: (d) the prospective participant is unconscious or lacks capacity to understand the risks, methods and purposes of the
p.000199: research project;
p.000199: (e) third party authorization cannot be secured in sufficient time, despite diligent and documented efforts to do so;
p.000199: and
p.000199: (f) no relevant prior directive by the participant is known to exist.
p.000199: When a previously incapacitated participant regains capacity, or when an authorized third party is found, consent
p.000199: shall be sought promptly for continuation in the project, and for subsequent examinations or tests related to
p.000199: the research project.
p.000199: Application For purposes of studying potential improvement in the treatment of life-threatening conditions, Article
p.000199: 3.8 outlines an exception (in addition to that in Article 3.7) to the general obligation of seeking consent from those
p.000199: participating in research.
p.000199:
p.000199:
...
p.000199: identify, eliminate, minimize or otherwise manage conflicts of interest that may affect research. All parties
p.000199: (e.g., researchers, administrators, REB members) should act in a transparent manner in identifying and addressing
p.000199: conflicts of interest. Institutions should make their written conflict of interest policies and procedures publicly
p.000199: available to all members of the research enterprise, including participants, REBs, researchers, administrators and
p.000199: research sponsors.
p.000199: Application To meet obligations to protect participants, institutional policies should address the roles,
p.000199: responsibilities and process for identifying, eliminating, minimizing or oth- erwise managing institutional conflicts
p.000199: of interest relevant to research, including disclosure to REBs. Management of conflicts of interest includes, but is
p.000199: not limited to, prevention, evaluation, disclosure and the application of appropriate remedies as defined by the
p.000199: institution.
p.000199: When developing institutional policies and procedures on conflicts of interest, in- stitutions should clarify roles and
p.000199: the distribution of responsibilities, and clarify associated potential for conflicts. This clarity should reduce or
p.000199: eliminate the pos- sibility for confusion of roles that may ultimately lead to conflicting obligations. Ideally,
p.000199: institutional policies will organize roles, responsibilities, reporting lines and accountabilities to eliminate,
p.000199: minimize or otherwise manage conflicts of inter- est (see Articles 6.1, 6.2 and 7.2).
p.000199: Measures to manage conflicts of interest should reflect the inherent threat of con- flicts of interest to participants,
p.000199: as well as to the scientific and scholarly integrity
p.000199:
p.000199:
p.000199: TCPS 2 91
p.000199:
p.000199: Chapter 7 – Conflicts of Interest
p.000199:
p.000199: and credibility of research. These measures should also be commensurate with the risks. Institutions should consider
p.000199: the following measures to address conflicts of interest at the institutional level that are germane to research
p.000199: involving humans:
p.000199: • Create central institutional mechanisms, such as a competent institutional au- thority, a conflict of interest
p.000199: committee, or other delegated bodies within the institution to help identify, eliminate, minimize or otherwise manage
p.000199: conflicts of interest.
p.000199: • Refine or redesign roles, responsibilities, and reporting lines to eliminate, min- imize or manage the potential
p.000199: for conflict of interest.
p.000199: • Prevent or minimize conflict of interest in institutional design and structuring when creating new roles,
p.000199: responsibilities or relationships.
p.000199: • Apply barriers to insulate potentially conflicting roles and responsibilities.
p.000199: • Require that individuals involved in the conduct of research withdraw from, or not participate in, roles or
p.000199: functions unduly compromised or disabled by any real, potential or perceived conflict.
p.000199: Conflict of interest policies and procedures should be developed in a transparent manner. The goal of these policies is
p.000199: to eliminate conflict of interest where possible, or alternatively, to identify and disclose real, potential or
...
p.000187: project. In other policies/guidance they are also known as “authorized third party deci- sion makers.”
p.000187:
p.000187: Autonomy – The capacity to understand information and to be able to act on it voluntarily; the ability of individuals
p.000187: to use their own judgement to make decisions about their own actions, such as the decision to consent to participate in
p.000187: research.
p.000187:
p.000187:
p.000187:
p.000187: TCPS 2
p.000189: 189
p.000189:
p.000189: Glossary
p.000189:
p.000189: Biobank – A collection of human biological materials. It may also include associated information about individuals from
p.000189: whom biological materials were collected.
p.000189:
p.000189: Capacity – The ability of prospective or actual participants to understand relevant information presented (e.g. purpose
p.000189: of the research, foreseeable risks, and potential benefits), and to appreciate the potential con- sequences of any
p.000189: decision they make based upon this information.
p.000189:
p.000189: Clinical equipoise – The existence of a genuine uncertainty on the part of the relevant expert community about what
p.000189: therapy or therapies are most effective for a given condition.
p.000189:
p.000189: Clinical trial – Any investigation involving participants that evaluates the effects of one or more health- related
p.000189: interventions on health outcomes.
p.000189:
p.000189: Coercion – An extreme form of undue influence, involving a threat of harm or punishment for failure to participate in
p.000189: research. See “Undue influence.”
p.000189:
p.000189: Collaborative research – Research that involves the cooperation of researchers, institutions, organizations and/or
p.000189: communities, each bringing distinct expertise to a project, and that is characterized by respectful relationships. See
p.000189: “Community-based research” and “Participatory research.”
p.000189:
p.000189: Community – A group of people with a shared identity or interest that has the capacity to act or express itself as a
p.000189: collective. A community may be territorial, organizational, or a community of interest.
p.000189:
p.000189: Community-based research – Research conducted at a community site that focuses not only on individuals but on the
p.000189: community itself. Community-based research may be initiated by the community independently or in collaboration with a
p.000189: researcher. See “Collaborative research” and “Participatory research.”
p.000189:
p.000189: Community engagement – A process that establishes an interaction between a researcher (or a research team) and a
p.000189: community with regard to a research project. It signifies the intent of forming a collaborative relationship between
p.000189: researchers and communities, although the degree of collaboration may vary depend- ing on the community context and the
p.000189: nature of the research.
p.000189:
p.000189: Concern for Welfare – A core principle of this Policy that requires researchers and research ethics boards to aim to
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p.000199: between risk and harm, see Chapter 2, Section B). Note that, for the purposes of this Policy, “group” and “community”
p.000199: are used in their ordinary sense. More detailed types of community as defined in Chapter 9 are specific to Aboriginal
p.000199: contexts.
p.000199: Concern for Welfare means that researchers and REBs should aim to protect the welfare of par- ticipants, and, in some
p.000199: circumstances, to promote that welfare in view of any foreseeable risks associated with the research. They are to
p.000199: provide participants with enough information to be able to adequately assess risks and potential benefits associated
p.000199: with their participation in the research. To do so, researchers and REBs must ensure that participants are not exposed
p.000199: to unnecessary risks. Researchers and REBs must attempt to minimize the risks associated with answering any given
p.000199: research question. They should attempt to achieve the most favourable balance of risks and po- tential benefits in a
p.000199: research proposal. Then, in keeping with the principle of Respect for Persons, participants or authorized third
p.000199: parties, make the final judgment about the acceptability of this balance to them.
p.000199: The welfare of groups can also be affected by research. Groups may benefit from the knowledge gained from the research,
p.000199: but they may also suffer from stigmatization, discrimination or damage to reputation. Engagement during the design
p.000199: process with groups whose welfare may be affected by the research can help to clarify the potential impact of the
p.000199: research and indicate where any neg- ative impact on welfare can be minimized. Researchers must also consider the risks
p.000199: and potential benefits of their research and the knowledge it might generate for the welfare of society as a whole.
p.000199: Where research on individuals may affect the welfare of a group(s), the weight given to the group’s welfare will depend
p.000199: on the nature of the research being undertaken, and the individuals or group in question. This consideration does not
p.000199: imply, however, that the welfare of a group should be given priority over the welfare of individuals.
p.000199: Justice
p.000199: Justice refers to the obligation to treat people fairly and equitably. Fairness entails treating all peo- ple with
p.000199: equal respect and concern. Equity requires distributing the benefits and burdens of research participation in such a
p.000199: way that no segment of the population is unduly burdened by the harms of research or denied the benefits of the
p.000199: knowledge generated from it.
p.000199: Treating people fairly and equitably does not always mean treating people in the same way. Dif- ferences in treatment
...
p.000199: natural environment. It does not refer to observational methods used in epidemiological studies.
p.000199: When designing their research, researchers shall pay attention to the environment in which observation takes place, the
p.000199: expectation of privacy that individuals in public places might have, and the means of recording observations.
p.000199: Researchers shall also determine whether the use of this information in the dissemination of research results (e.g.,
p.000199: through publications, photographs, audio recordings, or video footage of groups or particular individuals) will
p.000199: allow the identification of individuals observed in public places. When in doubt, researchers should consult the REB
p.000199: prior to the conduct of such research. Article 10.3 addresses observational studies in qualitative research.
p.000199: Article 2.4 REB review is not required for research that relies exclusively on secondary use of anonymous
p.000199: information, or anonymous human biological materials, so long as the process of data linkage or recording or
p.000199: dissemination of results does not generate identifiable information.
p.000199: Application Secondary use refers to the use in research of information or human biological materials originally
p.000199: collected for a purpose other than the current research purpose. Anonymous information and human biological materials
p.000199: are distinct from those that have been coded, and also from those that have been anonymized (see Section A of Chapters
p.000199: 5 and 12).
p.000199: Rapid technological advances facilitate identification of information and make it harder to achieve anonymity. These
p.000199: activities may heighten risks of identification and possible stigmatization where a dataset contains information about
p.000199: or human biological materials from a population in a small geographical area, or information about individuals with
p.000199: unique characteristics (e.g., uncommon field of occupational specialization, diagnosis with a very rare disease). Where
p.000199: the researcher seeks data linkage of two or more anonymous sets of information or human biological materials
p.000199: and there is a reasonable prospect that this could generate identifiable information, then REB review is required.
p.000199: Guidance related to other categories of identifiable and non-identifiable information and human biological materials
p.000199: and their possible secondary use is provided in Chapters 5 and 12.
p.000199: Activities Not Requiring REB Review
p.000199: The following distinguishes research requiring REB review from non-research activities that have traditionally employed
p.000199: methods and techniques similar to those employed in research. Such activities are not considered “research” as defined
p.000199: in this Policy, and do not require REB review. Activities outside the scope of research subject to REB review (see
p.000199: Articles 2.5 and 2.6), as defined in this Policy, may still raise ethical issues that would benefit from careful
p.000199: consideration by an individual or a body capable of providing some independent guidance, other than an REB. These
p.000199:
p.000199: TCPS 2 19
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
p.000199: ethics resources may be based in professional or disciplinary associations, particularly where those associations have
p.000199: established best practices guidelines for such activities in their discipline.
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p.000199: policies and practices of institutions, governments, interest groups or corporations, researchers do not need to seek
p.000199: the organization’s permission to proceed with the proposed research. If institutional approval were required, it is
p.000199: unlikely that research could be conducted effectively on such matters as institutional sexual abuse or a government’s
p.000199: silencing of dissi- dent scientists. Important knowledge and insights from research would be forgone. Specific
p.000199: requirements pertain to Aboriginal organizations, which are discussed in detail in Articles 9.4 to 9.8.
p.000199: REBs should not prohibit research simply because the research is unpopular or looked upon with disfavour by a community
p.000199: or organization, in Canada or abroad.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 35
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: Similarly, REBs should not veto research on the grounds that the government in place or its agents have not given
p.000199: approval for the research project, or have ex- pressed a dislike for the researchers.
p.000199: However, individuals who are approached to participate in a research project about their organization should be fully
p.000199: informed about the views of the organization re- garding the research, if these are known. Researchers shall inform
p.000199: participants when the permission of the organization has not been obtained. Researchers engaging in critical inquiry
p.000199: need to be attentive to risks, both of stigmatization or breach of pri- vacy, to those who participate in research
p.000199: about their organization. In particular, prospective participants should be fully informed of the possible consequences
p.000199: of participation.
p.000199: REBs should, however, legitimately concern themselves with the welfare of participants and the security of research
p.000199: materials in such circumstances. When participants are vul- nerable to risks from third parties (e.g., authoritarian
p.000199: regimes, gang leaders, employers) on account of their involvement in research, researchers should ensure that copies of
p.000199: field materials are kept in secure locations. When sharing research materials such as consent forms or transcripts of
p.000199: field notes with participants, researchers must honour their commitment to protect the anonymity and confidentiality of
p.000199: participants to ensure that their human rights, and the ethical principles set out in this Policy, are not compro-
p.000199: mised. In general, regardless of where the researchers conduct their research, researchers and REBs should
p.000199: concern themselves with safeguarding information while it is in transit (see Articles 5.1 to 5.4).
p.000199: REBs should also be aware that some research, involving critical assessments of public, political or corporate
p.000199: institutions and associated public figures, for example, may be legitimately critical and/or opposed to the welfare of
p.000199: those individuals in a position of power, and may cause them some harm. There may be a compelling public interest in
...
p.000125: In First Nations communities, privacy and confidentiality of identifiable personal and community information may be
p.000125: affected by the application of the principles of ownership, control, access and possession (OCAP – see definition in
p.000125: Application of Article 9.8). The First Nations Regional Longitudinal Health Survey adminis- tered by regional
p.000125: First Nations organizations has addressed balancing confidentiality and access by having communities
p.000125: designate a regional organization to hold data, while local authorities make decisions on who can access the data, and
p.000125: under what conditions. In practice, the organization that serves as data steward evaluates requests for information,
p.000125: and its recommendations to community author- ities have considerable influence.
p.000125: Whatever the nature of the research, it shall be designed to include safeguards for participant privacy and measures to
p.000125: protect the confidentiality of any data collected. Small Aboriginal communities are characterized by dense
p.000125: networks of relationships. As a result, coding individual data is often not sufficient to mask identities, even
p.000125: when data are aggregated. Some Aboriginal participants are reluctant to speak to interviewers from their own
p.000125: community because of privacy concerns. Communities themselves have distinguishing characteristics, which in some cases
p.000125: have compromised efforts to disguise the research site, and has led to the stigmatization of entire communities.
p.000125: On the other hand, in some social sciences and humanities research, the significance of information is tied to the
p.000125: identity of the source. In these cases individual attribution, with consent, is appropriate. When
p.000125: individual participants waive anonymity, researchers should ensure that this is documented (see Application of
p.000125: Article 5.1 and Article 9.11). Communities partnering in research may wish to be acknowledged (e.g., in the research
p.000125: report) for their contribution to the research effort.
p.000125: Research undertaken with participants who have suffered traumatic experiences (e.g., former residential school
p.000125: students) poses a risk of re-traumatizing participants. Researchers should anticipate such risks in the research
p.000125: design, and adhere to cultural protocols for determining participant needs and access to trauma counselling.
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125: TCPS 2
p.000127: 127
p.000127:
p.000127: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000127:
p.000127: Privacy protections in research are evolving. Respect for, and accommodation of, First Nations, Inuit and Métis
p.000127: priorities on joint ownership of the products of research and maintaining access to data for community use should guide
p.000127: research practices – with appropriate deference to applicable federal, provincial and territorial privacy
p.000127: legislation.
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p.000135: ethnography, participatory action research, oral history, phenomenology, narrative inquiry, grounded theory and
p.000135: discourse analysis. The term “qualitative research” covers a wide range of overlapping paradigms or perspectives.
p.000135: (c) Dynamic, Reflective and Continuous Research Process: The emergence during the course of the research itself of
p.000135: questions, concepts, strategies, theories and ways to gather and engage with the data (e.g., emergent design research,
p.000135: see Article 10.5) requires a constant reflective approach and questioning by the researcher. Such flexibility,
p.000135: reflexivity and responsiveness contribute to the overall strength and rigour of data collection and analysis.
p.000135: (d) Diverse, Multiple and Often Evolving Contexts: Qualitative research takes place in a variety of contexts, each
p.000135: of which presents unique ethical issues. As knowledge is considered to be context-contingent in qualitative
p.000135: research, these studies tend to focus on particular individuals, sites or concepts that are empirically derived from
p.000135: other social settings. The researcher’s priority is to answer the research question stemming from the study of those
p.000135: individuals in a specific social setting at a specific time.
p.000135:
p.000135:
p.000135:
p.000135: 136 TCPS 2
p.000135:
p.000135: Chapter 10 – Qualitative Research
p.000135:
p.000135: Researchers sometimes engage in research that questions social structures and activities that create, or result in,
p.000135: inequality and injustice. Studies may involve participants who are in highly vulnerable circumstances because of the
p.000135: social and/or legal stigmatization that is associated with their activity or identity, and who may have little trust in
p.000135: the law, social agencies or institutional authorities. Regardless of the methodological approach, researchers
p.000135: who question social structures, or deal with the disempowered, may face pressures from authority figures. Research may
p.000135: also involve participants, such as business executives or government officials, who may be more powerful than the
p.000135: researchers.
p.000135: (e) Data Collection and Sample Size: There is generally a greater emphasis placed on depth of research than on
p.000135: breadth. Most qualitative researchers would emphasize gathering diverse but overlapping data on a limited number of
p.000135: cases or situations to the point of data saturation or thematic redundancy. Samples and research sites in these studies
p.000135: are chosen because they are viewed as particularly useful or rich sources of information for furthering one’s
p.000135: understanding of phenomena of interest, and not because the results may prove statistically significant. Participants
p.000135: are selected for their potential to inform theory development, and often selection of participants is guided by
p.000135: emerging patterns over the course of the data collection.
p.000135: A researcher may rely on multiple sources of information and data gathering strategies to enhance data quality.
p.000135: Researchers use a variety of methods for data gathering, including interviews, participant observation, focus groups
p.000135: and other techniques. In some cases, gathering of trustworthy data is best achieved by closeness and extended contact
p.000135: with participants. In other cases, researchers and participants may continue research exchanges through electronic or
...
p.000183: Refer to Chapter 3 for further guidance in regard to the voluntariness of consent.
p.000183: Family members may have conflicting views about participation in research, and some may have specific sensitivities or
p.000183: objections. Researchers should recognize the potential for conflict within families and be respectful of any known
p.000183: sensitivi- ties. Where researchers seek participation from children or other members of a fam- ily who may lack
p.000183: capacity to consent, the applicable provisions in Chapter 3 shall be followed.
p.000183: E. Genetic Research Involving Communities and Groups
p.000183: Article 13.6 Where researchers intend to recruit participants for genetic research based on their membership in
p.000183: specific communities or groups, it may be appropriate for re- searchers to discuss the research with community
p.000183: or group members, and/or their leaders, in addition to seeking consent from individual participants. In these cases,
p.000183: researchers shall provide details to the REB about their proposed methods for en- gaging in discussion.
p.000183: Application Some genetic research seeks to explore genetic variations within specific commu- nities or groups. Such
p.000183: research may raise ethical concerns regarding stigmatization, unfair or inequitable treatment, and social disruption in
p.000183: communities or groups – especially if individual members disagree about participation in research. Discus- sion with
p.000183: formal or informal leaders or other members of the community or group may be appropriate. This determination will
p.000183: depend on factors such as: the objec- tives of the proposed research (in particular, the extent to which membership in,
p.000183: or characteristics of, the community or group are a key aspect of the research); the risks and potential benefits of
p.000183: the research to the community or group; the nature of the community or group from which participants will be recruited;
p.000183: and the com- munity’s or group’s organizational structure.
p.000183: Individuals within a community or group may have conflicting views about par- ticipation in research, including
p.000183: disagreements between leaders and members. Such conflicts may involve attempts by some to influence or coerce choices
p.000183: of others about whether to participate in research. Researchers should recognize the potential for conflict within
p.000183: communities or groups, and ensure that consent and discussion processes facilitate free and informed decisions by
p.000183: individual members. Refer to Chapter 3 for further guidance in regard to voluntariness of consent.
p.000183: Researchers who propose to conduct genetic research involving Aboriginal participants or communities, or to
p.000183: use human biological materials that are identifiable as originating from Aboriginal peoples, should refer to
p.000183: Chapter 9 for further guidance.
p.000183:
p.000183:
p.000183:
p.000183: TCPS 2
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p.000107: prospective participants in their physical, social, economic and cultural environments, where applicable, as
p.000107: well as concern for the community to which participants belong. This Policy acknowledges the important role of
p.000107: Aboriginal communities in promoting collective rights, interests and responsibilities that also serve the welfare of
p.000107: individuals.
p.000107: Aboriginal peoples are particularly concerned that research should enhance their capacity to maintain their cultures,
p.000107: languages and identities as First Nations, Inuit or Métis peoples, and to support their full participation in, and
p.000107: contributions to, Canadian society. The interpretation of Concern for Welfare in First Nations, Inuit and Métis
p.000107: contexts may therefore place strong emphasis on collective welfare as a complement to individual well-being.
p.000107: Justice may be compromised when a serious imbalance of power prevails between the researcher and participants.
p.000107: Resulting harms are seldom intentional, but nonetheless real for the participants. In the case of Aboriginal peoples,
p.000107: abuses stemming from research have included: misappropriation of sacred songs, stories and artefacts; devaluing of
p.000107: Aboriginal peoples’ knowledge as primitive or superstitious; violation of community norms regarding the use of human
p.000107: tissue and remains; failure to share data and resulting benefits; and dissemination of information that has
p.000107: misrepresented or stigmatized entire communities.
p.000107: Where the social, cultural or linguistic distance between the community and researchers from outside the community is
p.000107: significant, the potential for misunderstanding is likewise significant. Engagement between the community involved
p.000107: and researchers, initiated prior to recruiting
p.000107:
p.000107:
p.000107:
p.000107: TCPS 2
p.000109: 109
p.000109:
p.000109: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000109:
p.000109: participants and maintained over the course of the research, can enhance ethical practice and the quality of
p.000109: research. Taking time to establish a relationship can promote mutual trust and communication, identify
p.000109: mutually beneficial research goals, define appropriate research collaborations or partnerships, and ensure that
p.000109: the conduct of research adheres to the core principles of Respect for Persons, Concern for Welfare – which in this
p.000109: context includes welfare of the collective, as understood by all parties involved – and Justice.
p.000109: Research Involving Indigenous Peoples in Other Countries
p.000109: Although the present chapter addresses research involving Aboriginal peoples in Canada, researchers, REBs, participants
p.000109: and the research community at large may find the guidance articulated here useful when undertaking research or
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Social / Threat of Violence
Searching for indicator violence:
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p.000199: and/or legal counsel.
p.000199: In some instances, participants may waive anonymity (e.g., if they wish to be iden- tified for their contributions to
p.000199: the research). Researchers should obtain the consent of these participants, and negotiate agreements with them that
p.000199: specify how they may be identified or recognized for their contribution. Where an individual partic-
p.000199:
p.000199: 58 TCPS 2
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: ipant waives anonymity but other members of the participant group object because identification may cause harm to the
p.000199: group, researchers shall maintain anonymity for all members of the participant group (see Article 3.2[f] and Article
p.000199: 10.4).
p.000199: Article 5.2 Researchers shall describe measures for meeting confidentiality obligations and explain any reasonably
p.000199: foreseeable disclosure requirements:
p.000199: (a) in application materials they submit to the REB; and
p.000199: (b) during the consent process with prospective participants.
p.000199: Application This article recognizes that some research projects are more likely to put researchers in a position
p.000199: where they may have a requirement to disclose information to third parties. The reasonable foreseeability of disclosure
p.000199: requirements can be assessed by considering the nature and objectives of the research inquiry. For example, re- search
p.000199: that involves interviewing high-risk families about intergenerational violence raises a reasonably foreseeable
p.000199: prospect that researchers may acquire in- formation that a child is being abused. Researchers who reasonably foresee
p.000199: that their inquiries may give rise to an ethical or legal reason to disclose information obtained in the research
p.000199: context shall advise the REB and prospective participants about the possibility of compelled disclosure. Advising
p.000199: participants of reasonably foreseeable disclosure requirements is an important aspect of the consent process.
p.000199: Situations may arise where researchers unexpectedly acquire information that gives rise to a reason for disclosure to a
p.000199: third party, or researchers may receive a disclo- sure demand from a third party. In such cases, advising a participant
p.000199: about the disclosure may be important to respect the trust relationship with the participant, and to ensure the
p.000199: validity of the participant’s ongoing consent. Decisions about whether, how and when to advise a participant of
p.000199: disclosure should be guided by any applicable disciplinary standards and consultation with the REB, colleagues,
p.000199: relevant professional body and/or legal counsel.
p.000199: Researchers shall also inform participants and seek their consent if their personal information may be shared with
p.000199: government departments or agencies, community partners in the research, personnel from an agency that monitors the
p.000199: research, a re- search sponsor (such as a pharmaceutical company), the REB or a regulatory agency.
...
p.000199: individuals and seek consent may impose undue hardship on the researcher. In some jurisdictions, privacy laws may
p.000199: preclude researchers from using personal information to contact individuals to seek their consent for secondary use of
p.000199: information.4
p.000199: Privacy laws may also impose specific rules regarding disclosure of information for secondary use in research. These
p.000199: laws may require the individual or organization that has custody or control of requested personal information to obtain
p.000199: approval from a privacy commissioner or other body before disclosing information to researchers. They may
p.000199: also impose additional requirements such as information- sharing agreements that describe disclosure conditions. These
p.000199: requirements may include the stipulation that the researcher not publish identifiable information or contact
p.000199: individuals to whom the information relates.
p.000199: At the time of initial collection, individuals may have had an opportunity to express preferences about future uses of
p.000199: information, including research uses (see paragraph
p.000199: [d] in the Application of Article 3.2). Data custodians have an obligation to respect the individual’s expressed
p.000199: preferences. For example, where an individual does not want information used for future research, data custodians shall
p.000199: remove this infor- mation from any datasets used or made available for research.
p.000199: In cases where the proposed research involves information of greater sensitivity (e.g., genetic information,
p.000199: information about individuals who seek help through do- mestic violence shelters, information about sexual practices),
p.000199: the REB may require that researchers engage in discussion with people whose perspectives can help iden- tify the
p.000199: ethical implications of the research, and suggest ways to minimize any associated risks. Discussion is not intended to
p.000199: serve as proxy consent. Rather, a goal of discussion is to seek input regarding the proposed research, such as the de-
p.000199: sign of the research, measures for privacy protection, and potential uses of findings.
p.000199:
p.000199: TCPS 2 63
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: Discussion may also be useful to determine whether or not the research will ad- versely affect the welfare of
p.000199: individuals to whom the information relates. Researchers shall advise the REB of the outcome of such discussions.
p.000199: The REB may require modifications to the research proposal based on these discussions.
p.000199: Article 5.6 When secondary use of identifiable information without the requirement to seek consent has been
p.000199: approved under Article 5.5, researchers who propose to contact individuals for additional information shall, prior to
p.000199: contact, seek REB approval of the plan for making contact.
p.000199: Application In certain cases, a research goal may be achieved only through follow up contact with individuals to
p.000199: collect additional information. Under Article 5.5, the REB may have approved secondary use without the requirement to
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Social / Trade Union Membership
Searching for indicator union:
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p.000199: property resulting from the research; (c) hold equity in companies and/or receive major donations; or (d) have
p.000199: conflicting roles carried out by one institutional official (e.g., a vice- president who is responsible for the
p.000199: promotion of research activity and funding and also for oversight of research).
p.000199: Acting in a professional role within the institution, individuals (e.g., institution president, vice- president, dean
p.000199: of a faculty or department head) are in a conflict of interest when they are subject to competing incentives or
p.000199: functions. These may significantly interfere with the impartial exercise of duties, including legal and ethical
p.000199: obligations within the institutional structure. The conflict may be chronic, relating to recurring situations resulting
p.000199: from the institutional structure, or it may be triggered by a unique situation that is not likely to recur.
p.000199: REB Member Conflict of Interest
p.000199: The REB, as an entity, or in the persons of the members who make up the board, also hold trust relationships with
p.000199: participants, research sponsors, researchers and society. REB members must also be aware of their own potential for
p.000199: real or perceived conflicts of interest.
p.000199: For example, REB members are in a conflict of interest when their own research projects are under review by their REB,
p.000199: when they are a co-investigator, or when they are in a supervisory or men- toring relationship with a graduate student
p.000199: applicant. REB members may also be in a conflict of interest situation when they have interpersonal or financial
p.000199: relationships with the researchers, or personal or financial interests in a company, labour union or not-for-profit
p.000199: organization that may be the sponsor of the research project, or that may be substantially affected by the research.
p.000199: Conflicts of interest based on collaborations or disputes with colleagues, students or others may be ongoing or of
p.000199: limited duration. REBs have an obligation to ensure that the fairness and trans- parency of research ethics review is
p.000199: not compromised by real, potential or perceived conflicts of interest.
p.000199:
p.000199:
p.000199:
p.000199: 90 TCPS 2
p.000199:
p.000199: Chapter 7 – Conflicts of Interest
p.000199:
p.000199: Researcher Conflict of Interest
p.000199: Researchers and research students hold trust relationships, either directly or indirectly, with par- ticipants,
p.000199: research sponsors, institutions, their professional bodies and society. These trust relationships can be put
p.000199: at risk by conflicts of interest that may compromise independence, objec- tivity or ethical duties of loyalty. Although
p.000199: the potential for such conflicts has always existed, pressures on researchers (e.g., to delay or withhold dissemination
p.000199: of research outcomes or to use inappropriate recruitment strategies) heighten concerns that conflicts of interest may
p.000199: affect ethical behaviour.
p.000199: Researchers’ conflicts of interest may arise from interpersonal relationships (e.g., family or com- munity
p.000199: relationships), financial partnerships, other economic interests (e.g., spin-off companies in which researchers have
p.000199: stakes or private contract research outside of the academic realm), ac- ademic interests or any other incentives that
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Social / Unemployment
Searching for indicator unemployment:
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p.000199: Article 5.4 Institutions or organizations where research data are held have a responsibility to establish
p.000199: appropriate institutional security safeguards.
p.000199: Application In addition to the security measures researchers implement to protect data, safeguards put in
p.000199: place at the institutional or organizational level also provide important protection. These data security
p.000199: safeguards should include adequate physical, administrative and technical measures, and should address the full life
p.000199: cycle of information. This includes institutional or organizational safeguards for information while it is
p.000199: currently in use by researchers, and for any long-term retention of information.
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 61
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199: D. Consent and Secondary Use of Identifiable Information for Research Purposes
p.000199: Secondary use refers to the use in research of information originally collected for a purpose other than the current
p.000199: research purpose. Common examples are social science or health survey datasets that are collected for specific research
p.000199: or statistical purposes, but then re-used to answer other re-
p.000199: search questions. Information initially collected for program evaluation may be useful for subsequent
p.000199: research. Other examples include health care records, school records, biological spec- imens, vital statistics
p.000199: registries or unemployment records, all of which are originally created or collected for therapeutic, educational or
p.000199: administrative purposes, but which may be sought later for use in research. Chapter 12 provides further guidance on
p.000199: research involving secondary use of previously collected biological materials.
p.000199: Reasons to conduct secondary analyses of data include: avoidance of duplication in primary col- lection and the
p.000199: associated reduction of burdens on participants; corroboration or criticism of the conclusions of the original project;
p.000199: comparison of change in a research sample over time; appli- cation of new tests of hypotheses that were not available
p.000199: at the time of original data collection; and confirmation that the data are authentic. Privacy concerns and questions
p.000199: about the need to seek consent arise, however, when information provided for secondary use in research can be linked to
p.000199: individuals, and when the possibility exists that individuals can be identified in published reports, or through data
p.000199: linkage. Privacy legislation recognizes these concerns and permits sec- ondary use of identifiable information under
p.000199: certain circumstances.
p.000199: Article 5.5 Researchers who have not obtained consent from participants for secondary use of identifiable
p.000199: information shall only use such information for these purposes if the REB is satisfied that:
p.000199: (a) identifiable information is essential to the research;
p.000199: (b) the use of identifiable information without the participants’ consent is unlikely to adversely affect the
...
Social / Victim of Abuse
Searching for indicator trauma:
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p.000199: advancement of knowledge for future generations, for participants themselves or for other individuals. However, much
p.000199: research offers little or no direct benefit to participants. In most research, the primary benefits produced are for
p.000199: society and for the advancement of knowledge.
p.000199: Risks
p.000199: Because research is a step into the unknown, its undertaking can involve harms to participants and to others. Harm is
p.000199: anything that has a negative effect on the welfare of participants, and the nature of the harm may be social,
p.000199: behavioural, psychological, physical or economic.
p.000199: Risk is a function of the magnitude or seriousness of the harm, and the probability that it will occur, whether to
p.000199: participants or to third parties (as outlined below). A proper ethical analysis of research should consider both the
p.000199: foreseeable risk and the available methods of eliminating or mitigating the risk.
p.000199:
p.000199:
p.000199:
p.000199: 22 TCPS 2
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
p.000199: • The magnitude or seriousness of the harm
p.000199: Potential harms in research may span the spectrum from minimal (e.g., inconvenience of participation in research) to
p.000199: substantial (e.g., a major physical injury or an emotional trauma). Harms may be transient, such as a temporary
p.000199: emotional reaction to a survey question, while other types of harm may be longer lasting, such as the loss of
p.000199: reputation following a breach of confidentiality, or a traumatic experience. The perspective of the participants
p.000199: regarding harm may vary from that of researchers. Participants themselves may vary in their reaction to the research.
p.000199: Researchers and REBs should attempt to assess the harm from the perspective of the participants to the extent
p.000199: possible. Research in certain disciplines, such as epidemiology, genetics, sociology or cultural anthropology,
p.000199: may present risks that go beyond the individual and may involve the interests of communities, societies or other
p.000199: defined groups.
p.000199: • The probability of occurrence of the harm
p.000199: This refers to the likelihood of participants actually suffering the relevant harms. An assessment of such
p.000199: probability may be based on the researcher’s past experience conducting such studies, the review of existing
p.000199: publications that provide rates of the relevant harms in similar issues, or on other empirical evidence. And while
p.000199: researchers should attempt to estimate the occurrence of the relevant harms, this may be more difficult, or not
p.000199: possible, for new or emerging areas of research where no prior experience, comparable research or publications exist.
...
p.000125: protect the confidentiality of any data collected. Small Aboriginal communities are characterized by dense
p.000125: networks of relationships. As a result, coding individual data is often not sufficient to mask identities, even
p.000125: when data are aggregated. Some Aboriginal participants are reluctant to speak to interviewers from their own
p.000125: community because of privacy concerns. Communities themselves have distinguishing characteristics, which in some cases
p.000125: have compromised efforts to disguise the research site, and has led to the stigmatization of entire communities.
p.000125: On the other hand, in some social sciences and humanities research, the significance of information is tied to the
p.000125: identity of the source. In these cases individual attribution, with consent, is appropriate. When
p.000125: individual participants waive anonymity, researchers should ensure that this is documented (see Application of
p.000125: Article 5.1 and Article 9.11). Communities partnering in research may wish to be acknowledged (e.g., in the research
p.000125: report) for their contribution to the research effort.
p.000125: Research undertaken with participants who have suffered traumatic experiences (e.g., former residential school
p.000125: students) poses a risk of re-traumatizing participants. Researchers should anticipate such risks in the research
p.000125: design, and adhere to cultural protocols for determining participant needs and access to trauma counselling.
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125:
p.000125: TCPS 2
p.000127: 127
p.000127:
p.000127: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000127:
p.000127: Privacy protections in research are evolving. Respect for, and accommodation of, First Nations, Inuit and Métis
p.000127: priorities on joint ownership of the products of research and maintaining access to data for community use should guide
p.000127: research practices – with appropriate deference to applicable federal, provincial and territorial privacy
p.000127: legislation.
p.000127: Interpretation and Dissemination of Research Results
p.000127: Article 9.17 Researchers should afford community representatives engaged in collaborative research an opportunity to
p.000127: participate in the interpretation of the data and the review of research findings before the completion of the final
p.000127: report, and before finalizing all relevant publications resulting from the research.
p.000127: Application Where collaborative approaches are followed, researchers should ensure continuing communications with
p.000127: the participating community. Territorial or organizational communities or communities of interest engaged in
p.000127: collaborative research may consider that their review and approval of reports and academic publications is essential to
p.000127: validate findings, correct any cultural inaccuracies, and maintain respect for community knowledge (which may
p.000127: entail limitations on its disclosure). Researchers should integrate suggestions from the community representatives
p.000127: in the publication. If disagreement about interpretation arises between researchers and the community and it cannot be
...
Searching for indicator abuse:
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p.000199: concerning the terms on which a researcher may engage with a particular community or group – do not in themselves
p.000199: constitute research, and therefore do not require consent (see Chapter 2, Article 6.11, Articles 9.3 to 9.6, and
p.000199: Article 10.1).
p.000199: Critical Inquiry
p.000199: Article 3.6 Permission is not required from an organization in order to conduct research on that organization.
p.000199: If a researcher engages the participation of members of an organization without the organization’s permission,
p.000199: the researcher shall inform participants of any foreseeable risk that may be posed by their participation.
p.000199: Application Research in the form of critical inquiry, that is, the analysis of social structures or activities,
p.000199: public policies, or other social phenomena, requires an adjustment in the assessment of consent. Where the goal of the
p.000199: research is to adopt a critical perspec- tive with respect to an institution, organization or other entity, the fact
p.000199: that the object of the research may not endorse the research project should not be a bar to the re- search receiving
p.000199: ethics approval. Where social sciences or humanities researchers seek knowledge that critiques or challenges the
p.000199: policies and practices of institutions, governments, interest groups or corporations, researchers do not need to seek
p.000199: the organization’s permission to proceed with the proposed research. If institutional approval were required, it is
p.000199: unlikely that research could be conducted effectively on such matters as institutional sexual abuse or a government’s
p.000199: silencing of dissi- dent scientists. Important knowledge and insights from research would be forgone. Specific
p.000199: requirements pertain to Aboriginal organizations, which are discussed in detail in Articles 9.4 to 9.8.
p.000199: REBs should not prohibit research simply because the research is unpopular or looked upon with disfavour by a community
p.000199: or organization, in Canada or abroad.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 35
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: Similarly, REBs should not veto research on the grounds that the government in place or its agents have not given
p.000199: approval for the research project, or have ex- pressed a dislike for the researchers.
p.000199: However, individuals who are approached to participate in a research project about their organization should be fully
p.000199: informed about the views of the organization re- garding the research, if these are known. Researchers shall inform
p.000199: participants when the permission of the organization has not been obtained. Researchers engaging in critical inquiry
p.000199: need to be attentive to risks, both of stigmatization or breach of pri- vacy, to those who participate in research
p.000199: about their organization. In particular, prospective participants should be fully informed of the possible consequences
p.000199: of participation.
p.000199: REBs should, however, legitimately concern themselves with the welfare of participants and the security of research
...
p.000199: The ethical duty of confidentiality must, at times, be balanced against competing ethical considerations or legal or
p.000199: professional requirements that call for disclosure of information obtained or created in a research context. For
p.000199: example, in excep- tional and compelling circumstances, researchers may be subject to obligations to report information
p.000199: to authorities to protect the health, life or safety of a participant or a third party. Researchers are expected to be
p.000199: aware of ethical codes (such as pro- fessional codes of conduct) or laws (e.g., those requiring the reporting of
p.000199: children in need of protection) that may require disclosure of information they obtain in a research context. In other
p.000199: situations, a third party may seek access to information obtained and/or created in confidence in a research context.
p.000199: An access request may seek voluntary disclosure of information, or may seek to compel disclosure through force of law
p.000199: (e.g., by subpoena). Chapter 1, Section C, elaborates on the relationship between research ethics and law.
p.000199: Certain areas of research (such as research involving children at risk of abuse or studies of criminal behaviour) are
p.000199: more likely to put researchers in positions where they may experience tension between the ethical duty of
p.000199: confidentiality and dis- closure to third parties. Researchers shall maintain their promise of confidentiality to
p.000199: participants within the extent permitted by ethical principles and/or law. This may involve resisting requests for
p.000199: access, such as opposing court applications seek- ing disclosure. Researchers’ conduct in such situations should be
p.000199: assessed on a case-by-case basis and guided by consultation with colleagues, any relevant pro- fessional body, the REB
p.000199: and/or legal counsel.
p.000199: In some instances, participants may waive anonymity (e.g., if they wish to be iden- tified for their contributions to
p.000199: the research). Researchers should obtain the consent of these participants, and negotiate agreements with them that
p.000199: specify how they may be identified or recognized for their contribution. Where an individual partic-
p.000199:
p.000199: 58 TCPS 2
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: ipant waives anonymity but other members of the participant group object because identification may cause harm to the
p.000199: group, researchers shall maintain anonymity for all members of the participant group (see Article 3.2[f] and Article
p.000199: 10.4).
p.000199: Article 5.2 Researchers shall describe measures for meeting confidentiality obligations and explain any reasonably
p.000199: foreseeable disclosure requirements:
...
p.000199: conflict of interest has not been avoided or cannot be ap- propriately managed.
p.000199: If there is a need for a researcher with a conflict of interest in a research project to be involved in some aspect of
p.000199: the project, the extent of the involvement should be reviewed and explicitly endorsed by the REB in its minutes.
p.000199: Participants should also be informed during the consent process of the conflict and the extent of the
p.000199:
p.000199:
p.000199: 94 TCPS 2
p.000199:
p.000199: Chapter 7 – Conflicts of Interest
p.000199:
p.000199: researcher’s involvement. In line with the proportionate approach to REB review, and through the continued research
p.000199: ethics review process, REBs may impose ad- ditional control mechanisms if necessary.
p.000199: Dual Roles
p.000199: Dual roles of researchers and their associated obligations (e.g., acting as both a re- searcher and a therapist, health
p.000199: care provider, caregiver, teacher, advisor, consultant, supervisor, student or employer) may create conflicts, undue
p.000199: influences, power im- balances or coercion that could affect relationships with others and affect
p.000199: decision-making procedures (e.g., consent of participants). Article 3.2(e) reminds researchers of relevant ethical
p.000199: duties that govern real, potential or perceived con- flicts of interest as they relate to the consent of participants.
p.000199: To preserve and not abuse the trust on which many professional relationships rest, researchers should be fully
p.000199: cognizant of conflicts of interest that may arise from their dual or multiple roles, their rights and responsibilities,
p.000199: and how they can man- age the conflict. When acting in dual or multiple roles, the researcher shall disclose the nature
p.000199: of the conflict to the participant in the consent process.
p.000199: Financial Conflicts of Interest
p.000199: Real, potential or perceived financial conflicts of interest may affect any type of research. Researchers and REBs
p.000199: should be aware of, and consider, the possibility of financial conflicts of interest. They should seek to ensure that
p.000199: financial consid- erations do not serve to diminish respect for the principles of this Policy or the scientific
p.000199: validity and transparency of research procedures.
p.000199: Financial incentives have the potential to distort researchers’ judgment in ensuring the design and conduct of research
p.000199: is ethical. When researchers partner with or- ganizations whose primary motive is profit, they must be aware of the
p.000199: potential for conflicts of interest. Consideration for the profitability of the research may threaten the ethical
p.000199: integrity of research design and conduct. Not all research spon- sored by for-profit organizations gives rise to
p.000199: financial conflicts of interest. However, REBs shall consider the potential for this type of conflict because its
p.000199: ability to undermine the ethical conduct of research has been empirically estab- lished.
p.000199: As part of a research project submitted for REB review, researchers shall disclose all kinds and amounts of payment
...
p.000115: customary authority regarding the conduct of the proposed research, researchers should inform the REB. When alternative
p.000115: community engagement processes are followed to endorse a project, all other ethical safeguards set out in this chapter
p.000115: remain applicable.
p.000115: Recognizing Diverse Interests within Communities
p.000115: Article 9.6 In engaging territorial or organizational communities, researchers should ensure, to the extent
p.000115: possible, that they take into consideration the views of all relevant sectors – including individuals and subgroups who
p.000115: may not have a voice in the formal leadership. Groups or individuals whose circumstances make them vulnerable
p.000115: may need or desire special measures to ensure their safety in the context of a specific research project. Those who
p.000115: have been excluded from participation in the past may need special measures to ensure their inclusion in research.
p.000115: Application Groups or individuals whose circumstances may make them vulnerable or marginalized within
p.000115: territorial or organizational communities should not be deprived of opportunities to participate in, and
p.000115: influence, research affecting their welfare. For example, people living with HIV/AIDS, impoverished youth or
p.000115: women who have suffered abuse may experience barriers to participation.
p.000115: Gender-based analysis is being applied in First Nations, Inuit and Métis organizations and communities to
p.000115: promote or restore recognition of women’s responsibilities in the conduct of community life – including decision
p.000115: making that directly affects their welfare. The legacy of patriarchal governance structures continues to pose
p.000115: challenges to women’s full participation. Approaches that are attentive to cultural considerations help to ensure the
p.000115: equitable participation and benefit of women throughout the life cycle of a research project (see Article 4.2).
p.000115: Research undertaken secretly or as a direct challenge to legitimate authority may increase risks to participants whose
p.000115: circumstances make them vulnerable, may deepen rifts within the community, and actually impede the advancement of
p.000115: social
p.000115:
p.000115: 116 TCPS 2
p.000115:
p.000115: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000115:
p.000115: justice. Strategies that have proven effective to secure the inclusion and promote the safety of diverse sectors within
...
p.000153: According to Article 11.2, researchers should consider a proven effective therapy as control if one is available. The
p.000153: implications of various choices of trial design directly affect the interpretability of trial results, and a trial that
p.000153: cannot return useful information is by definition not ethical. Good science is a necessary albeit
p.000153: insufficient condition for good ethics. To properly assess the ethics of placebo- controlled superiority design vs.
p.000153: active controlled non-inferiority design, an appreciation of the interplay of ethics and science is required (see
p.000153: Article 2.7). Conditions that work against carrying out a non-inferiority trial successfully include low
p.000153: and/or variable response to treatment, and high placebo response. The researcher must provide adequate justification
p.000153: for the use of a non-inferiority design.
p.000153: Participants in the test arm of a trial of a new therapy are not receiving proven effective therapy. Risks to the
p.000153: safety of participants can come from lack of efficacy or from undesirable side effects. These risks should be assessed
p.000153: for each treatment arm, including the experimental and control arm(s).
p.000153: The use of an active treatment comparator in a clinical trial of a new therapy is generally the appropriate trial
p.000153: design when an established effective therapy exists for the population and clinical indication under study.
p.000153: Great care should be taken to avoid abuse of placebo comparators. However, they are acceptable in any of the following
p.000153: situations:
p.000153:
p.000153:
p.000153:
p.000153:
p.000153: TCPS 2
p.000155: 155
p.000155:
p.000155: Chapter 11 – Clinical Trials
p.000155:
p.000155: 1) there are no established effective therapies for the population or for the indication under study;
p.000155: 2) existing evidence raises substantial doubt within the relevant expert community regarding the net therapeutic
p.000155: benefit of available therapies;
p.000155: 3) patients are resistant to the available therapies by virtue of their past treatment history or known medical
p.000155: history;
p.000155: 4) the trial involves adding a new investigational therapy to established effective therapies: established
p.000155: effective therapy plus new therapy vs. established effective therapy plus placebo;
p.000155: 5) patients have provided an informed refusal of established effective therapy, and withholding such therapy will not
p.000155: cause serious or irreversible harm.
p.000155: The determination of response satisfaction and refusal of treatment must take place outside the context of recruitment
p.000155: for the clinical trial and prior to offering trial participation to the prospective participant, and both must be
p.000155: documented.1
p.000155: The use of a placebo comparator in situation (5) is permitted because prospective trial participants are not using
p.000155: established therapies and therefore are not benefiting from therapy. For that reason, such participants would not be
...
Social / Women
Searching for indicator women:
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p.000199: imply, however, that the welfare of a group should be given priority over the welfare of individuals.
p.000199: Justice
p.000199: Justice refers to the obligation to treat people fairly and equitably. Fairness entails treating all peo- ple with
p.000199: equal respect and concern. Equity requires distributing the benefits and burdens of research participation in such a
p.000199: way that no segment of the population is unduly burdened by the harms of research or denied the benefits of the
p.000199: knowledge generated from it.
p.000199: Treating people fairly and equitably does not always mean treating people in the same way. Dif- ferences in treatment
p.000199: or distribution are justified when failures to take differences into account may result in the creation or
p.000199: reinforcement of inequities. One important difference that must be considered for fairness and equity is vulnerability.
p.000199: Vulnerability is often caused by limited capacity, or limited access to social goods, such as rights, opportunities and
p.000199: power. Individuals or groups in vulnerable circumstances have historically included children, the elderly, women,
p.000199: prisoners, those with mental health issues and those with diminished capacity for self-determination. Ethno- cultural
p.000199: minorities and those who are institutionalized are other examples of groups who have, at times, been treated unfairly
p.000199: and inequitably in research, or have been excluded from research op- portunities. People or groups whose circumstances
p.000199: cause them to be vulnerable or marginalized may need to be afforded special attention in order to be treated justly in
p.000199: research.
p.000199:
p.000199:
p.000199:
p.000199: 10 TCPS 2
p.000199:
p.000199: Chapter 1 – Ethics Framework
p.000199:
p.000199: The recruitment process, both of participants who may become directly involved in research and those who participate as
p.000199: the source of information or biological materials to be used in research, is an important component of the fair and
p.000199: equitable conduct of research. Participation should be based on inclusion criteria that are justified by the research
p.000199: question. Inequity is created when par- ticular groups fail to receive fair benefits of research or when
p.000199: groups, or their data or their biological materials, are excluded from research arbitrarily or for reasons
p.000199: unrelated to the research question.
...
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 45
p.000199:
p.000199:
p.000199:
p.000199: Chapter 4
p.000199: FAIRNESS AND EQUITY IN RESEARCH PARTICIPATION
p.000199:
p.000199: Introduction
p.000199: The principle of Justice holds that particular individuals, groups or communities should neither bear an unfair share
p.000199: of the direct burdens of participating in research, nor should they be unfairly excluded from the potential benefits of
p.000199: research participation. Inclusiveness in research and fair distribution of benefits and burdens should be important
p.000199: considerations for researchers, research ethics boards (REBs), research institutions and sponsors. Issues of fair and
p.000199: equitable treatment arise in deciding whether and how to include individuals, groups or communities in research, and
p.000199: the basis for the exclusion of some.
p.000199: This chapter addresses inclusion in research of individuals and groups that might be inappropriately excluded on the
p.000199: basis of attributes such as culture, language, gender, race, ethnicity, age and dis- ability. It provides guidance
p.000199: relevant to inclusion in research of specific groups such as women, children, the elderly and those who lack capacity
p.000199: to consent to participate in research. Historically, these groups have often been inappropriately excluded from
p.000199: research.
p.000199: This chapter also addresses the fair inclusion and equitable treatment of individuals, groups and communities whose
p.000199: situation or circumstances make them vulnerable in the context of a specific research project. These individuals run
p.000199: the risk of being included in research in ways that may be unfair and inequitable. This chapter provides guidance
p.000199: relevant to the equitable distribution of the risks and benefits of research.
p.000199: Over-protectionist attitudes or practices of researchers or REBs, whether intentional or inadvertent, can exclude some
p.000199: members of society from participating in research. The exclusion of individuals, groups or communities may constitute a
p.000199: failure to treat them justly. For example, age has been used to exclude individuals from participation in research,
p.000199: particularly health research (e.g., studies that only accept participants between the ages of 18 to 35). As a result,
p.000199: sufficient research may not be done on groups that fall outside of narrow age criteria. The inclusion of the young and
p.000199: the elderly in research, for example, ensures that treatments frequently given to these populations are effective and
p.000199: safe.
...
p.000199: biography), or a group of individuals who share a specific characteristic (e.g., an identifiable group of painters who
p.000199: happen to be all of one sex; a religious order that is restricted to one sex). Other examples include research that is
p.000199: focused on specific cultural tra- ditions or languages, or on one age group (e.g., a biomechanical modeling study of
p.000199: posture corrections in adolescents). Such research should not be precluded so long as the selection criteria for those
p.000199: to be included in the research are germane to answering the research question. Researchers who plan to actively exclude
p.000199: par- ticular groups should clarify to their REBs the grounds for the exclusion.
p.000199: Where a language barrier exists between the researcher and the prospective partic- ipant, various measures may be
p.000199: used to ensure effective communication in recruitment and consent discussions. For example, an intermediary who
p.000199: may not be part of the research project or team, but who is competent in the language used by the researchers, as well
p.000199: as that preferred by the participant, may assist with com- munication between prospective participants and researchers.
p.000199: The selection of an intermediary and their activities will depend on the nature, context and risks of the research.
p.000199:
p.000199: B. Inappropriate Exclusion
p.000199: Research Involving Women
p.000199: Women have historically been inappropriately excluded from participating in some research. This exclusion of women,
p.000199: where unwarranted, has delayed the advancement of knowledge, denied po- tential benefits to women, and exposed women to
p.000199: harm when research findings from male-only research projects were generalized inappropriately to women, as has often
p.000199: been the case in clinical drug trials. The inclusion of women in research advances the commitment to Justice, improves
p.000199: the generalizability of research findings to women where that is a goal of the research, and is es- sential to ensure
p.000199: that women and men benefit equally from research.
p.000199:
p.000199:
p.000199: 48 TCPS 2
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: Article 4.2 Women shall not be inappropriately excluded from research solely on the basis of gender or sex.
p.000199: Application Researchers should not exclude women from research unless there is a valid reason for doing so. While
p.000199: some research is properly focused on particular research pop- ulations that do not include women, or include very few
p.000199: women, women should generally be represented where there is a reasonable expectation that the results of the research
p.000199: will be generalized to women.
p.000199: Article 4.2 rejects discriminatory and unethical use of inclusion or exclusion criteria that presumptively or
p.000199: inappropriately exclude women because of their gender or sex.
p.000199: Article 4.3 Women shall not be inappropriately excluded from research solely on the basis of their reproductive
p.000199: capacity, or because they are pregnant or breastfeeding.
p.000199: Application Researchers should not exclude women from research on the basis of their repro- ductive capacity, or
p.000199: their pregnancy, or because they are breastfeeding, unless there is a valid reason for doing so.
p.000199: Subjecting women of childbearing potential to inappropriate requirements pre- cludes their participation in research.
p.000199: Exclusions should be made on the basis of clear criteria that reflect balanced attention to the potential benefits as
p.000199: well as the foreseeable risks of the research that may affect the welfare of women. For exam- ple, researchers should
p.000199: not require participants to use oral contraception, unless there is a valid reason for doing so.
p.000199: In considering research on pregnant or breastfeeding women, researchers and REBs shall take into account foreseeable
p.000199: risks and potential benefits for the woman and her embryo, fetus or infant, as well as the foreseeable risks and
p.000199: potential benefits of excluding pregnant or breastfeeding women from the research.
p.000199: Research Involving Children
p.000199: Children have varying degrees of maturity – metabolically, immunologically and cognitively – that may present important
p.000199: challenges for research design and the consent process, depending on the nature and complexity of the research. In
p.000199: addition to the vulnerability that arises from their developmental stage, children may also lack capacity to consent to
p.000199: participate in research (see Ar- ticle 4.6). As well, physical or psychological harms a child may experience in a
p.000199: research setting may have long-lasting consequences. As a result, researchers have often avoided the inclusion of
p.000199: children in some research, especially in clinical trials testing new treatments, so as to eliminate any risks. Clinical
p.000199: trials conducted only with adults yield a generally poor understanding of the results that apply to children.
p.000199: As is the case with women, the inclusion of children in research advances the commitment to jus- tice in research by
p.000199: improving our knowledge of, and ability to respond to, the unique needs of children throughout their development.
p.000199:
p.000199:
p.000199: TCPS 2 49
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: Article 4.4 Children shall not be inappropriately excluded from research solely on the basis of their age or
p.000199: developmental stage. The inclusion of children in research is subject to Article 4.6.
p.000199: Application Researchers should not exclude children from research unless there is a valid reason for doing so.
p.000199: Participation of children in research is justifiable when the research objective cannot be achieved with adult
p.000199: participants only. When considering the inclusion of children in research, researchers and REBs shall consider a
p.000199: child’s stage of physical, physiological, psychological, and social development to ensure adequate protections for the
...
p.000199: competence and a manageable workload. Where the institution requires more than one REB, it should establish a mechanism
p.000199: to coordinate the operations of all its REBs, and clar- ify their relationship with each other, and with other relevant
p.000199: bodies or authorities. Institutions shall have clear written policies describing the mandate of each REB. An
p.000199: institution may wish to use different models for the ethics review of research conducted under its auspices (see
p.000199: Chapter 8).
p.000199: Institutions shall respect the authority delegated to the REB. An institution may not override an REB decision to
p.000199: reject a research proposal. An appeal of the REB decision to reject a research proposal can only be brought in
p.000199: accordance with Section C of this chapter.
p.000199:
p.000199: TCPS 2 69
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: An REB approval applies to the ethical acceptability of the research, and does not, in itself, constitute authorization
p.000199: for the research to proceed.
p.000199: REB Composition
p.000199: Basic REB Membership Requirements
p.000199: The membership of the REB is designed to ensure competent independent research ethics review. Provisions respecting its
p.000199: size, composition, terms of appointment and quorum are set out below.
p.000199: Article 6.4 The REB shall consist of at least five members, including both men and women, of whom:
p.000199: (a) at least two members have expertise in relevant research disciplines, fields and methodologies covered by the REB;
p.000199: (b) at least one member is knowledgeable in ethics;
p.000199: (c) at least one member is knowledgeable in the relevant law (but that member should not be the institution’s legal
p.000199: counsel or risk manager). This is mandatory for biomedical research and is advisable, but not mandatory, for other
p.000199: areas of research; and
p.000199: (d) at least one community member who has no affiliation with the institution.
p.000199: It is advisable that each member be appointed to formally fulfil the requirements of only one of the above categories.
p.000199: To ensure the independence of REB decision making, institutional senior adminis- trators shall not serve on the REB.
p.000199: Application This minimum requirement for REB membership brings to bear the necessary basic background, expertise
p.000199: and perspectives to allow informed independent reflection and decision making on the ethics of research involving
p.000199: humans. At a minimum, the REB shall have members appointed in one capacity only for each of the mem- bership
p.000199: categories. Where the size of the REB exceeds the minimum requirements, additional members may fulfil more than one
p.000199: capacity. In any case, REB members can contribute to the review based on their experience, expertise or knowledge in
p.000199: more than one of the categories above (Article 6.4[a] to [d]).
p.000199: As an entity created and supported by the institution, an REB is encouraged to build strong relationships with its host
...
p.000111: community engagement plan (see Article 9.10). In these cases, consent of individuals is sufficient to
p.000111: participate.
p.000111: Communities lacking the infrastructure to support pre-research community engagement should not be deprived
p.000111: of opportunities to participate in guiding research affecting their welfare (see Article 9.14).
p.000111: The following list, which is not exhaustive, provides examples to illustrate the forms of community engagement that
p.000111: might be appropriate for various types of research.
p.000111: 1) Research directly involving a community on First Nations, Inuit or Métis lands with a formal governance structure.
p.000111: For example, a project that examines the incidence of diabetes in Pond Inlet, Nunavut, or the impact on Inuit health of
p.000111: contaminants in animals and plants used for country food.
p.000111: • Permission of the Nunavut Research Institute that carries authority to approve research in Nunavut is
p.000111: required. Agreement of the hamlet council in Pond Inlet will normally be a condition of approval. The local health
p.000111: committee may co-manage the project.
p.000111: 2) Research involving Aboriginal people who comprise a sizeable proportion of the study or community and where
p.000111: Aboriginal-specific conclusions are intended. For example, a comparative study of access to public housing in Prince
p.000111: Albert, Saskatchewan.
p.000111: • First Nations in the district, represented by their tribal council, the local Métis association, and urban
p.000111: Aboriginal and women’s organizations may partner with the Prince Albert city council to sponsor, implement and use the
p.000111: results of the housing study.
p.000111: 3) Research focusing on a larger community that is known to include Aboriginal people (regardless of their
p.000111: proportion), and where Aboriginal-specific conclusions are anticipated. For example, a study of student retention
p.000111: in high schools in the Sault Ste. Marie district of Ontario.
p.000111: • A committee representing First Nations, Métis organizations and urban Aboriginal people whose children may
p.000111: be affected by the study may be convened to advise the District Board of Education and the researchers involved.
p.000111: 4) Research involving Aboriginal people who comprise a sizeable proportion of the larger community that is the
p.000111: subject of research even if no Aboriginal- specific conclusions will be made. For example, research on
p.000111: employment
p.000111:
p.000111: 112 TCPS 2
p.000111:
p.000111: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000111:
p.000111: development programs serving residents of the inner city of Winnipeg in Manitoba.
p.000111: • Aboriginal service agencies or political organizations may be engaged to help recruit Aboriginal participants and
p.000111: secure community representation on an oversight committee, and to ensure cultural sensitivity in collecting and
p.000111: interpreting data on employment program impacts.
...
p.000115: engagement processes proposed (see Article 9.10). Where no agreement exists between formal community leadership and
p.000115: customary authority regarding the conduct of the proposed research, researchers should inform the REB. When alternative
p.000115: community engagement processes are followed to endorse a project, all other ethical safeguards set out in this chapter
p.000115: remain applicable.
p.000115: Recognizing Diverse Interests within Communities
p.000115: Article 9.6 In engaging territorial or organizational communities, researchers should ensure, to the extent
p.000115: possible, that they take into consideration the views of all relevant sectors – including individuals and subgroups who
p.000115: may not have a voice in the formal leadership. Groups or individuals whose circumstances make them vulnerable
p.000115: may need or desire special measures to ensure their safety in the context of a specific research project. Those who
p.000115: have been excluded from participation in the past may need special measures to ensure their inclusion in research.
p.000115: Application Groups or individuals whose circumstances may make them vulnerable or marginalized within
p.000115: territorial or organizational communities should not be deprived of opportunities to participate in, and
p.000115: influence, research affecting their welfare. For example, people living with HIV/AIDS, impoverished youth or
p.000115: women who have suffered abuse may experience barriers to participation.
p.000115: Gender-based analysis is being applied in First Nations, Inuit and Métis organizations and communities to
p.000115: promote or restore recognition of women’s responsibilities in the conduct of community life – including decision
p.000115: making that directly affects their welfare. The legacy of patriarchal governance structures continues to pose
p.000115: challenges to women’s full participation. Approaches that are attentive to cultural considerations help to ensure the
p.000115: equitable participation and benefit of women throughout the life cycle of a research project (see Article 4.2).
p.000115: Research undertaken secretly or as a direct challenge to legitimate authority may increase risks to participants whose
p.000115: circumstances make them vulnerable, may deepen rifts within the community, and actually impede the advancement of
p.000115: social
p.000115:
p.000115: 116 TCPS 2
p.000115:
p.000115: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000115:
p.000115: justice. Strategies that have proven effective to secure the inclusion and promote the safety of diverse sectors within
p.000115: a community include: advocacy by moral authorities in the community; special measures to protect the identity of
p.000115: participants in small communities; identifying research questions that include rather than divide interest groups; or
p.000115: expanding the coverage of a project to multiple communities. In some cases, the risks to participants and communities
p.000115: involved with, or affected by, the proposed research outweigh the potential benefits likely to be gained, and the
p.000115: research should not be undertaken.
p.000115: Critical Inquiry
p.000115: Article 9.7 Research involving Aboriginal peoples that critically examines the conduct of public institutions,
p.000115: First Nations, Inuit and Métis governments, institutions or organizations or persons exercising authority over First
p.000115: Nations, Inuit or Métis individuals may be conducted ethically, notwithstanding the usual requirement of engaging
p.000115: community leaders.
p.000115: Application Considerations in conducting critical inquiry are discussed more fully in Article
p.000115: 3.6. As in the case of research involving groups whose circumstances make them vulnerable, or communities of interest
p.000115: within an Aboriginal community (see Article 9.6), researchers undertaking critical inquiry research will need to adopt
p.000115: appropriate approaches to ensure that cultural norms are respected, that the safety of participants is protected, and
p.000115: that potential harms to the welfare of the larger community are minimized to the extent possible. Researchers may
p.000115: need to consult culturally relevant regional or national Aboriginal organizations for guidance.
p.000115: For example, the Sisters in Spirit project of the Native Women’s Association of Canada (NWAC) that was launched in
p.000115: 2005 for a five-year period illustrates research of a national scope that incorporated a critical dimension. The
p.000115: project involved interviewing families of missing and murdered First Nations, Métis or Inuit women in urban and rural
p.000115: settings, and on First Nations territory. It examined, among other matters, the adequacy of public institutions and
p.000115: services, Aboriginal and non-Aboriginal, to protect the women’s well-being and support families in their efforts to
p.000115: deal with their losses. The objective was to effect policy change and improve the safety and well-being of Aboriginal
p.000115: women in Canada. NWAC has published its commitment to participatory research and the principles and practices that
p.000115: protect the privacy and well-being of participants. The project built on NWAC’s ongoing efforts to develop meaningful
p.000115: research relationships reflecting Aboriginal ways of knowing.
p.000115: Respect for Community Customs and Codes of Practice
p.000115: Article 9.8 Researchers have an obligation to become informed about, and to respect, the relevant customs and
p.000115: codes of research practice that apply in the particular community or communities affected by their research.
p.000115: Inconsistencies between community custom and this Policy should be identified and addressed in advance of initiating
p.000115: the research, or as they arise.
p.000115:
p.000115:
p.000115: TCPS 2
p.000117: 117
p.000117:
p.000117: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000117:
p.000117: Application First Nations, Inuit and Métis codes of research practice derive from procedures and customs of
p.000117: predominantly oral cultures. While some rules may be in written form, their interpretation is dependent on experiential
p.000117: knowledge acquired through interactions in the community. An example is the strict limitation on making
p.000117: publicly available sacred knowledge that might be revealed within a trusting relationship. In academic
p.000117: culture, rules regarding limits on disclosure of information would reasonably be incorporated into a research
p.000117: proposal, and should be integrated into research agreements between communities and researchers where such exists.
...
p.000203: Medical emergencies (see Emergencies)
p.000203: Memorandum of Understanding on the Roles and Responsibilities in the Management of Federal Grants and Awards, 5, 67,
p.000106: 106
p.000106: Métis, 105, 107, 108, 110, 114, 115, 117, 121
p.000106: (see also Aboriginal peoples)
p.000106: Minimal risk research, 11, 23, 24-25, 37-39, 41, 51, 77-79 Multi-jurisdictional research
p.000106: official agreements, 98, 100
p.000106: research ethics review models, 99-101 review mechanisms, 97-101
p.000106:
p.000106: O
p.000106: Observational research, 18-19, 118, 141-143
p.000106:
p.000106: P
p.000106: Participants
p.000106: autonomy, 8-9, 27, 40 capacity (see Capacity)
p.000106: children, 10, 34, 41-42, 47, 49-50, 51, 185, 187
p.000106: confidentiality, 56, 58-60, 126-128, 143-144, 186
p.000106: definition, 16
p.000106: elderly, 10, 47, 50
p.000106: as members of research ethics boards, 72 perspective, 12, 23, 28, 72, 161
p.000106: privacy, 55-56, 58-60, 126-128, 143-144, 171-172, 186
p.000106: recruitment, 11, 28, 76-77, 110, 158-159, 164, 184-185
p.000106: removal from research, 31, 33, 160 as research partners, 138
p.000106: vulnerability, 9, 10, 23, 47, 52, 116, 137, 148
p.000106: withdrawal from research, 28-30, 31, 61, 140, 186
p.000106: women, 10, 47, 48-49, 116, 178-179
p.000106: Participatory research, 123-125
p.000106: Performance review, 20
p.000106:
p.000106:
p.000106: TCPS 2
p.000205: 205
p.000205:
p.000205: Index
p.000205:
p.000205: Pilot studies, 76-77, 139
p.000205: Pluripotent stem cells, 179
p.000205: Policy, the (see Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans) Principal investigators,
p.000205: 27, 99, 153-154, 159, 162, 165-166
p.000205: Principles (see Core principles) Privacy and confidentiality
p.000205: Aboriginal peoples, 126-128
p.000205: data linkage, 18, 19, 64-65, 131-132
p.000205: definition, 55-56
p.000205: ethical duty, 56, 58-60
p.000205: identifiability of information, 56-57
p.000205: participant, 55-56, 58-60, 126-128, 143-144, 171-172, 186
p.000205: qualitative research, 138, 143-144
p.000205: research involving Aboriginal peoples, 126-128 safeguarding information, 60-61
p.000205: security, 56, 60-61, 64-65
p.000205: (see also Secondary use of human biological materials; Secondary use of identifiable information)
p.000205: Program evaluation, 20
p.000205: Proportionate approach to research ethics review, 11, 22, 24-25, 77-79, 82, 148
p.000205: Publicly available information, 17-18, 64-65, 131 Publicly declared emergencies, 85-88
p.000205: exceptions during, 87-88
p.000205: preparedness plans, 85-86
p.000205: research ethics review during, 87-88
p.000205:
p.000205: Q
p.000205: Qualitative research
p.000205: confidentiality, 138, 143-144
p.000205: consent, 137-138, 140, 141-144
p.000205: data collection, 137, 144 dissemination of results, 143-144 emergent design, 144-145
p.000205: exploratory phase, 76-77, 139
p.000205: nature of, 135-138
p.000205: observational, 18-19, 118, 141-143
p.000205: privacy, 138, 143-144
p.000205: timing of research ethics review, 139 Quality assurance, 20
p.000205: Quality improvement, 20
p.000205:
p.000205: R
p.000205: Reimbursement, 29, 31, 33 Research
p.000205: benefits (see Benefits, research)
p.000205: changes to, 33-34, 82, 144-145, 150, 161-163
p.000205: clinical trials (see Clinical trials) collaborative, 123-124, 125-126, 128
p.000205:
p.000205: 206 TCPS 2
p.000205:
p.000205: Index
p.000205:
p.000205: community-based, 93, 124, 138, 139
p.000205: deception in, 37-39
p.000205: definition, 15
p.000205: dissemination of results, 18-19, 31, 61, 128, 143-144, 164-167, 182-184
p.000205: exclusion, 47, 48-52
p.000205: exploratory phase, 76-77, 139
p.000205: human genetic (see Human genetic research) importance, 7-8
p.000205: inclusion, 11, 48
p.000205: involving Aboriginal peoples (see Aboriginal peoples) involving children, 10, 34, 41-42, 47, 49-50, 51, 185, 187
p.000205: involving the elderly, 10, 47, 50
p.000205: involving human biological materials (see Human biological materials) involving human reproduction (see Human
p.000205: reproduction, materials related to) involving participants lacking capacity (see Capacity)
p.000205: involving women, 10, 47, 48-49, 116, 178-179
p.000205: minimal risk, 11, 23, 24-25, 37-39, 41, 51, 77-79
p.000205: multi-jurisdictional (see Multi-jurisdictional research) observational, 18-19, 118, 141-143
p.000205: partial disclosure, 37-39
p.000205: participant withdrawal, 28-30, 31, 61, 140, 186
p.000205: participatory, 123-125
p.000205: qualitative (see Qualitative Research) research ethics review, exempt from, 17-19
p.000205: research ethics review, requiring, 15-17, 119-121
p.000205: sponsored, 163-164
p.000205: stopping rules, 30-33
p.000205: unanticipated issues, 22, 34, 81, 161-163
p.000205: Research agreements, 121, 122-123, 126-127, 128-130, 131
p.000205: Research directives, 42-44 Research ethics
p.000205: core principles (see Core principles) framework, 7-13, 109-110
p.000205: importance, 7-8 Research ethics boards (REBs)
p.000205: ad hoc advisors, 24, 72, 73, 75, 120, 150
p.000205: appointment, 67-76
p.000205: authority, 67-70
p.000205: chair’s responsibilities, 74, 77-79
p.000205: composition, 70-75
p.000205: decision making, 68-69, 70, 79
p.000205: establishment, 67-76
p.000205: financial and administrative resources, 68-69, 74
p.000205: independence, 67, 68-69, 70-73, 93-94
p.000205: mandate, 67-70
p.000205: meetings and attendance, 75-76, 82-83 members (see Research ethics board members) membership requirements, 70-73
p.000205: multiple boards, 97-104
p.000205:
p.000205:
p.000205: TCPS 2
p.000207: 207
p.000207:
p.000207: Index
p.000207:
p.000207: quorum, 73, 74-75
p.000207: size, 70-72
...
p.000207: information
p.000207: Aboriginal peoples, 119-121, 130-132
p.000207: anonymous, 19
p.000207: consent, 62-64, 130-132
p.000207: definition, 19, 62
p.000207: genetic material, 186
p.000207: privacy, 62-64
p.000207: Security of information, 56, 60-61, 64-65 StemXcells
p.000207: Guidelines for Human Pluripotent Stem Cell Research, 179 pluripotent, 179
p.000207: Students, 25, 67-68, 77-79 Subjects (see Participants)
p.000207: T
p.000207: Therapeutic misconception, 148, 149, 158-159
p.000207: Third party consent (see Consent: authorized third parties) Trials (see Clinical trials)
p.000207: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) application, 11-13
p.000207: compliance with, 5-6
p.000207: interpretation, 13
p.000207:
p.000207: U
p.000207: Unanticipated issues, 22, 34, 81, 161-163
p.000207: Undue influence, 28-29
p.000207:
p.000207: V
p.000207: Vulnerability, 9, 10, 23, 47, 52, 116, 137, 148
p.000207:
p.000207: W
p.000207: Welfare (see Concern for Welfare)
p.000207: Withdrawal
p.000207: of consent, 28-30, 31
p.000207: of data, 28-30, 31
p.000207: of human biological materials, 28-30, 31, 172
p.000207: from research, 28-30, 31, 61, 140, 186
p.000207: Women
p.000207: as research participants, 10, 47, 48-49, 116, 178-179 pregnant, inclusion in research, 49
p.000207:
p.000207:
p.000207:
p.000207:
p.000207:
p.000207:
p.000207: TCPS 2
p.000209: 209
p.000209:
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000199: ethical manner, reporting unanticipated issues
p.000199:
p.000199:
p.000199: 80 TCPS 2
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: (see Article 6.15) or changes to the research (see Article 6.16), supervising all team members in the
p.000199: application of the research procedures, and ensuring that they are properly qualified and versed in
p.000199: the conduct of ethical research.
p.000199: Reports of Unanticipated Issues
p.000199: Article 6.15 Researchers shall report to the REB any unanticipated issue or event that may in- crease the level of
p.000199: risk to participants, or has other ethical implications that may affect participants’ welfare.
p.000199: Application Over the course of the implementation of the approved research project, issues may arise that the
p.000199: researcher did not anticipate when originally submitting the research for ethics review. Unanticipated issues include
p.000199: unexpected reactions by participants to a research intervention (e.g., unintended stimulation of traumatic memories,
p.000199: un- foreseen side-effects of a medication or natural health product), as well as unavoidable single
p.000199: incidents (e.g., a translator not available for a day, or a failure to follow correct research procedure for one
p.000199: participant on one occasion). They may be minor or serious in magnitude, with short- or long-term implications.
p.000199: Any unanticipated issue that increases the level of risk to participants or has other ethical implications should be
p.000199: reported to the REB without delay. Changes that are necessary to eliminate an immediate risk(s) to the participants may
p.000199: be implemented as needed, but must be reported to the REB at the earliest opportunity. For clinical trials, reporting
p.000199: requirements for safety data or unanticipated issues are also ad- dressed in Chapter 11 (Articles 11.7 and 11.8). If
p.000199: the incident or issue has immediate implications for the safety of participants, the REB may withdraw ethics approval,
p.000199: which would require that the research be halted or modified until the matter can be addressed (see Article 6.3 and
p.000199: Articles 11.8 and 11.9). It may require submission of a revised research proposal for REB review.
p.000199: Minor deviations from the research (e.g., a slight increase or decrease of testing time, a wording adjustment on a
p.000199: question) should not require immediate reporting to the REB, but may be summarized in annual status reports (see
p.000199: Article 6.14). In some types of qualitative research, for example, emergent design (see Article 10.5), the research
p.000199: design evolves over time, so adjustments to the research are to be ex- pected and need not be reported to the REB,
p.000199: unless they alter the level of risk or have other ethical implications for participants (see Article 6.16).
p.000199: The report to the REB should include a description of the unanticipated issue or incident, including details of how the
p.000199: researcher(s) dealt with the situation. Reports may be submitted by researchers, or in some cases by data safety
p.000199: monitoring boards (see Article 11.7 and 11.8). The point in reporting is to enable the REB and the re- searcher to
p.000199: better protect participants. Depending on the nature of the issue, and in consultation with researchers, REBs may
p.000199: require that researchers adjust their pro- cedures to prevent its recurrence during the research project.
p.000199:
p.000199:
p.000199: TCPS 2 81
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: Requests for Changes to Approved Research
p.000199: Article 6.16 Researchers shall submit to their REBs in a timely manner requests for substantive changes to their
p.000199: originally approved research. REBs shall decide on the ethical ac- ceptability of those changes to the research in
...
p.000165: duties, mandate and purposes of REB review; and (2) consults with the REB when necessary.
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165: 166 TCPS 2
p.000165:
p.000165: Chapter 11 – Clinical Trials
p.000165:
p.000165: In the review process, the onus to justify restrictions on dissemination or access to data should lie with the one
p.000165: seeking such restriction, usually the researcher or sponsor. The reasonableness of restrictions on either the content
p.000165: or timing of dissemination should be measured against the written institutional policies. For example, some existing
p.000165: institutional policies deem unacceptable any publication restrictions that exceed a time limit of three to six months
p.000165: after the close of the trial. Such policies should also address restrictions on the dissemination of
p.000165: particular kinds of information, such as information that may be considered proprietary or trade secrets.
p.000165: Restrictions on information that participants would reasonably consider relevant to their welfare (see Articles 11.7
p.000165: and 11.8), or that are required to give appropriate context to a manuscript or other publication, are seldom, if ever,
p.000165: justified.
p.000165:
p.000165:
p.000165: Endnotes
p.000165:
p.000165:
p.000165: 1 These conditions are drawn from the recommendations of the Final Report of the National Placebo Working Committee on
p.000165: the Appropriate Use of Placebos in Clinical Trials in Canada (July 2004), with minor amendments approved by the
p.000165: Canadian Institutes of Health Research (CIHR) Standing Committee on Ethics. www.cihr-irsc.gc.ca/e/25139.html
p.000165: 2 World Health Organizations standards, International Clinical Trials Registry Platform. www.who.int/ictrp/en
p.000165: 3 International Committee of Medical Journal Editors, Sponsorship, Authorship, and Accountability
p.000165: (August 2007). www.icmje.org/update_sponsor.html
p.000165: 4 CONSORT Statement: www.consort-statement.org/consort-statement (accessed April 19, 2010).
p.000165:
p.000165: References
p.000165:
p.000165:
p.000165: • Canada. Food and Drugs Act. Natural Health Products Regulations, Part 4: Clinical Trials Involving Human Subjects
p.000165: (SOR/2003-196) 5 June 2003. gazette.gc.ca/archives/p2/2003/2003-06-18/html/sor-dors196-eng.html
p.000165: • Canadian Institutes of Health Research. “Policy on Access to Research Outputs.” September 2007.
p.000165: www.cihr-irsc.gc.ca/e/34846.html
p.000165: • Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social
p.000165: Sciences and Humanities Research Council of Canada, Access to Research Results: Guiding Principles.
p.000165: www.science.gc.ca/default.asp?Lang=En&n=9990CB6B-1
p.000165: • Consolidated Standards of Reporting Trials: CONSORT Statement, and Explanation and Elaboration document.
p.000165: www.consort-statement.org
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165: TCPS 2
p.000165:
p.000167: 167
p.000167:
p.000167: Chapter 11 – Clinical Trials
p.000167:
...
Searching for indicator youth:
(return to top)
p.000199: informed and ongoing consent. This requirement reflects the commitment that par- ticipation in research, including
p.000199: participation through the use of one’s data or biological materials, should be a matter of choice and that, to be
p.000199: meaningful, the choice must be informed. An informed choice is one that is based on as complete an understanding as is
p.000199: reasonably possible of the purpose of the research, what it entails, and its foreseeable risks and potential benefits,
p.000199: both to the partic- ipant and to others. Respect for Persons also includes a commitment to accountability
p.000199: and transparency in the ethical conduct of research.
p.000199: Certain factors may diminish a person’s ability to exercise their autonomy, such as inadequate information or
p.000199: understanding for deliberation, or a lack of freedom to act due to controlling influences or coercion. Such constraints
p.000199: may include the fear of alienating those in positions of authority, such as professional or personal caregivers,
p.000199: researchers, leaders, larger groups, or a community to which one belongs. Other constraints may consist of barriers to
p.000199: accessing resources or knowledge outside the research context. These factors and constraints should be addressed prior
p.000199: to any research being carried out, so as to ensure participants are sufficiently protected.
p.000199: Some people may be incapable of exercising autonomy because of youth, cognitive impairment, other mental health issues
p.000199: or illness. While autonomy may be considered a necessary condition for participation in research, involving those who
p.000199: lack capacity to make their own decisions to participate can be valuable, just and even necessary. For those
p.000199: prospective participants, additional measures are needed to protect their interests and to ensure that their wishes (to
p.000199: the extent that these are known) are respected. These measures will generally include seeking consent from an
p.000199: authorized third party who is entrusted to make decisions on behalf of the prospective participant, based on knowledge
p.000199: of that person and that person’s wishes or, if such wishes are unknown, on consideration of that person’s welfare. Even
p.000199: when the requirements of free, informed and ongoing consent cannot be met, Respect for Persons requires involving
p.000199: individuals in circumstances of vulnerability in decision making where possible. This may include asking about their
p.000199: feelings re- garding participation and/or for their assent.
p.000199: Where it is foreseeable that a participant may lose capacity during a research project, for example in studies of
...
p.000113: researchers and REBs shall recognize Aboriginal organizations, including First Nations, Inuit and Métis
p.000113: representative bodies, and service organizations and communities of interest, as communities. They shall
p.000113: also recognize these groups through representation of their members on ethical review and oversight of projects, where
p.000113: appropriate.
p.000113: Application Organizational communities and communities of interest may exist within the boundaries of territorial
p.000113: communities. Overlapping interests in these cases are considered in Articles 9.5 and 9.6. A majority of persons who
p.000113: self-identify as Aboriginal live in rural and urban communities outside of discrete First Nations, Métis or Inuit
p.000113: communities. Political organizations, friendship centres, housing associations, health access centres and other groups
p.000113: operating in rural or urban centres have been created to enhance the welfare of their own members or the populations
p.000113: that they serve. Organizations and communities of interest are potential partners in research on issues relevant
p.000113: to their communities, and are to be recognized as communities for the purposes of community engagement under this
p.000113: Policy.
p.000113: An organization may participate in research focusing on its members (e.g., the board and staff of a friendship centre),
p.000113: or it may facilitate ethical engagement with the population that it serves (e.g., the clientele of a health
p.000113: access centre). A community of interest (e.g., Aboriginal youth who use an urban service program) may designate a
p.000113: local organization to provide advice and ethical protection for a project in which they participate.
p.000113: Prospective participants may not necessarily recognize organizational communities or communities of interest as
p.000113: representing their interests. Where researchers and organizational communities or communities of interest collaborate
p.000113: in research (e.g., through a research agreement), prospective participants shall be informed about the extent of such
p.000113: collaboration (including how data will be shared) as part of the initial and ongoing consent process (see Article
p.000113: 3.2[i]).
p.000113: Complex Authority Structures
p.000113: Article 9.5 Where alternatives to securing the agreement of formal leadership are proposed for research on First
p.000113: Nations, Inuit or Métis lands or in organizational communities, researchers should engage community processes and
p.000113: document measures taken, to enable the REB to review the proposal with due consideration of complex
p.000113: community authority structures.
p.000113: Application Researchers and REBs should not assume that approval of a project by formal leaders is the only avenue
p.000113: for endorsing a project. In some communities and some domains of knowledge, authority to permit and monitor
p.000113: research rests with knowledge keepers designated by custom rather than by election or appointment.
p.000113:
p.000113:
p.000113:
p.000113: TCPS 2
p.000115: 115
p.000115:
...
p.000115: engagement processes proposed (see Article 9.10). Where no agreement exists between formal community leadership and
p.000115: customary authority regarding the conduct of the proposed research, researchers should inform the REB. When alternative
p.000115: community engagement processes are followed to endorse a project, all other ethical safeguards set out in this chapter
p.000115: remain applicable.
p.000115: Recognizing Diverse Interests within Communities
p.000115: Article 9.6 In engaging territorial or organizational communities, researchers should ensure, to the extent
p.000115: possible, that they take into consideration the views of all relevant sectors – including individuals and subgroups who
p.000115: may not have a voice in the formal leadership. Groups or individuals whose circumstances make them vulnerable
p.000115: may need or desire special measures to ensure their safety in the context of a specific research project. Those who
p.000115: have been excluded from participation in the past may need special measures to ensure their inclusion in research.
p.000115: Application Groups or individuals whose circumstances may make them vulnerable or marginalized within
p.000115: territorial or organizational communities should not be deprived of opportunities to participate in, and
p.000115: influence, research affecting their welfare. For example, people living with HIV/AIDS, impoverished youth or
p.000115: women who have suffered abuse may experience barriers to participation.
p.000115: Gender-based analysis is being applied in First Nations, Inuit and Métis organizations and communities to
p.000115: promote or restore recognition of women’s responsibilities in the conduct of community life – including decision
p.000115: making that directly affects their welfare. The legacy of patriarchal governance structures continues to pose
p.000115: challenges to women’s full participation. Approaches that are attentive to cultural considerations help to ensure the
p.000115: equitable participation and benefit of women throughout the life cycle of a research project (see Article 4.2).
p.000115: Research undertaken secretly or as a direct challenge to legitimate authority may increase risks to participants whose
p.000115: circumstances make them vulnerable, may deepen rifts within the community, and actually impede the advancement of
p.000115: social
p.000115:
p.000115: 116 TCPS 2
p.000115:
p.000115: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000115:
...
p.000123: Article 9.11).
p.000123: Mutual Benefits in Research
p.000123: Article 9.13 Where the form of community engagement and the nature of the research make it possible, research
p.000123: should be relevant to community needs and priorities. The research should benefit the participating community
p.000123: (e.g., training, local hiring, recognition of contributors, return of results), as well as extend the boundaries of
p.000123: knowledge.
p.000123: Application To benefit the participating community, a research project should be relevant to community priorities
p.000123: and have the potential to produce valued outcomes from the perspective of the community and its members.
p.000123: Relevance and community benefit can take a number of forms depending on the type of research being conducted, and the
p.000123: forms of community engagement. For example, genetic research on diabetes in a First Nations community is unlikely to
p.000123: benefit the community in the short term, but collaboration may facilitate increased knowledge of the condition, and
p.000123: what changes can be made to improve health outcomes. Collaborative research can thus accommodate basic, as well as
p.000123: applied, research, and include short-term and long-term benefits. In another example, a community invites a researcher
p.000123: to collaborate in a research project about housing and homelessness in an Inuit community. Using participatory research
p.000123: methods and social science tools, the nature, extent and consequences of the local housing shortage are documented,
p.000123: enabling the community to effectively communicate its needs to non-Inuit (Qallunaat) authorities. Other benefits
p.000123: include training workshops that provide employment and transfer skills to Inuit youth involved in data collection,
p.000123: field experience in community-based research for university student assistants and materials useful to other Inuit
p.000123: communities in subsequent research.
p.000123: Collaborative research approaches provide the community with the opportunity to discuss risks and potential benefits,
p.000123: and to minimize risks. Where participatory
p.000123:
p.000123: 124 TCPS 2
p.000123:
p.000123: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000123:
p.000123: research is undertaken, the research report might also formulate recommendations on how to implement interventions
p.000123: resulting from the research for the benefit of the participating community.
p.000123: A possible outcome of collaborative research, and in particular participatory research, is increased
p.000123: capacity to carry out research that can more readily be conducted in Aboriginal languages and oral modes. The
p.000123: exploration, articulation and application of knowledge specific to a community or communities are thus advanced,
p.000123: potentially benefiting other First Nations, Inuit or Métis communities through knowledge transfer.
p.000123: Researchers should provide communities access to research data that will allow them to address pressing issues through
p.000123: community-generated policies, programs, and services (see Article 9.8 and the Application of Article 9.11). Territorial
p.000123: and organizational communities and communities of interest may also seek to share in the benefits of research
...
Social / education
Searching for indicator education:
(return to top)
p.000199: financial or professional, for example, and may involve offering some form of inducement or threatening some form of
p.000199: deprivation. In such situations, the control exerted in a power relationship may place undue pressure on the
p.000199: prospective participants. At the extreme, there can be no voluntariness if consent is secured by the order of
p.000199: authorities.
p.000199: REBs and researchers should also pay particular attention to elements of trust and dependency in relationships (e.g.,
p.000199: between physician and patient or between professor and student). These relationships can impose undue influence on the
p.000199: individual in the position of dependence to participate in research projects. Any relationship of dependency, even a
p.000199: nurturing one, may give rise to undue in- fluence even if it is not applied overtly. There may be a greater risk of
p.000199: undue influence in situations of ongoing or significant dependency.
p.000199:
p.000199:
p.000199:
p.000199: 28 TCPS 2
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: Pre-existing entitlements to care, education and other services should not be prejudiced by the decision of whether or
p.000199: not to participate in, or to withdraw from, a research project. Accordingly, for example, a physician should ensure
p.000199: that continued clinical care is not linked to research participation. Similarly, where students do not wish to
p.000199: participate in research studies for course credits, they should be offered a comparable alternative.
p.000199: Coercion
p.000199: Coercion is a more extreme form of undue influence, involving a threat of harm or punishment for failure to
p.000199: participate. Coercion would negate the voluntariness of a decision to participate, or to remain, in a research project.
p.000199: Incentives
p.000199: Incentives are anything offered to participants, monetary or otherwise, for par- ticipation in research (incentives
p.000199: differ from reimbursements and compensation for injury, which are discussed in Article 3.2[j]). Because incentives are
p.000199: used to encourage participation in a research project, they are an important consid- eration in assessing
p.000199: voluntariness. Where incentives are offered to participants, they should not be so large or attractive as to encourage
p.000199: reckless disregard of risks. This is a particular consideration in the case of healthy volunteers for the early phases
p.000199: of clinical trials, as discussed in Article 11.1. The offer of incen- tives in some contexts may be perceived by
...
p.000199:
p.000199: Authority, Mandate and Accountability
p.000199: Article 6.1 Institutions shall establish or appoint REB(s) to review the ethical acceptability of all research
p.000199: involving humans conducted within their jurisdiction or under their auspices, that is, by their faculty, staff or
p.000199: students, regardless of where the research is conducted, in accordance with this Policy.
p.000199: Application Each institution is accountable for the research carried out in its own jurisdiction or under its
p.000199: auspices. In fulfilling this responsibility, where research involving hu- mans takes place within the jurisdiction or
p.000199: under the auspices of an institution, that institution shall establish the necessary structure of an REB (or REBs)
p.000199: capable of reviewing the ethical acceptability of that research. In fulfilling this responsibility, institutions may
p.000199: opt to appoint an external REB in accordance with the Memoran- dum of Understanding between the Agencies and
p.000199: institutions.1 Any such appointment should be based on an official agreement clarifying the ultimate re-
p.000199: sponsibility of the institution for the ethical acceptability of research undertaken within its jurisdiction or under
p.000199: its auspices. To demonstrate their accountability, institutions may wish to issue public reports summarizing the
p.000199: institution’s activities and initiatives relevant to the ethics review of research involving humans, its re- search
p.000199: ethics administration, and relevant research ethics education and training.
p.000199: The number of REBs and the expertise of their members will depend on the range and volume of research for which that
p.000199: institution is responsible, in accordance with
p.000199:
p.000199: TCPS 2 67
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: Articles 6.4 and 6.5 relating to REB composition. Large institutions may find it necessary to create more than one REB
p.000199: to cover different areas of research or to accommodate a large volume of research. Small institutions may wish to
p.000199: explore regional cooperation or alliances for access to an REB based on formal agreements between the institutions (see
p.000199: Article 8.1).
p.000199: Members of an institution (i.e., its faculty, staff and students) may be affiliated with other institutions, or may be
p.000199: engaged in consulting or other professional activities in a separate enterprise, or in student co-op work or field
p.000199: placements. If members of the institution make reference to their affiliation to the institution, or use any of its
p.000199: resources when engaging in research, they should submit their research proposal to their institutional REB for research
p.000199: ethics review in accordance with this Policy. Where student co-op work or field placements involve components of
...
p.000199: by the REB, as well as on the needs of the insti- tution. In appointing REB members, institutions should strive
p.000199: for appropriate diversity. Institutions may need to exceed the minimum REB membership require- ments in order to
p.000199: ensure adequate and thorough reviews, reasonable workload for REB members, or to respond to other local,
p.000199: provincial/territorial, or federal legal or regulatory requirements. For example, in the case of REB review of clinical
p.000199: tri- als, provincial/territorial or federal regulations may outline specific membership requirements in addition to the
p.000199: requirements set out in this Policy. Where REBs mainly review student research, they may consider adding a student REB
p.000199: member. Additional community representation should be commensurate with the size of the REB. Institutions are
p.000199: encouraged to establish a pool of substitute members (see below). Where research ethics administration staff have the
p.000199: requisite experience, expertise and knowledge comparable to what is expected of REB members, insti- tutions may appoint
p.000199: them (based on the written policies and procedures of the institution) to serve as non-voting members on the REB.
p.000199: Relevant Expertise in Research Content and Methodology
p.000199: At least two members should have the relevant knowledge and expertise to under- stand the content area and methodology
p.000199: of the proposed or ongoing research, and to assess the risks and potential benefits that may be associated with the
p.000199: research (Article 6.4[a]). For example, REBs reviewing oncology research, education or topics involving Aboriginal
p.000199: peoples, or research using qualitative methodologies, should have members that are knowledgeable and competent to
p.000199: address those fields of research, disciplines and methodologies.
p.000199: Knowledgeable in Ethics
p.000199: Knowledge of ethics of research involving humans is key within the REB mem- bership as a whole. A member knowledgeable
p.000199: in ethics (Article 6.4[b]) needs to have sufficient knowledge to guide an REB in identifying and addressing ethics
p.000199: issues. A balance of ethics theory, practice and experience offers the most effective path to knowledge in ethics for
p.000199: REB membership. The kind and level of knowledge or expertise needed on the REB will be commensurate with the types and
p.000199: com- plexities of research the REB reviews. For example, a member knowledgeable in ethics serving on a social sciences
p.000199: and humanities REB may need to have different contextual and disciplinary knowledge in ethics than a member
p.000199: knowledgeable in ethics serving on a biomedical REB.
p.000199: Knowledgeable in the Law
p.000199: The role of the member knowledgeable in the law (Article 6.4[c]) is to alert REBs to legal issues and their
p.000199: implications (e.g., privacy issues), not to provide formal
p.000199:
p.000199: TCPS 2 71
p.000199:
...
p.000199: Application In appointing REB members, institutions should arrange the terms of members and their rotation to
p.000199: balance the need to maintain continuity with the need to ensure di- versity of opinion, and the opportunity to spread
p.000199: knowledge and experience gained from REB membership throughout the institution and community. The REB mem- bership
p.000199: selection process should be fair and impartial. Institutions should have written policies that define the process of
p.000199: appointing REB members.
p.000199: Article 6.7 In appointing and renewing REB members, institutions should consider the quali- fications and
p.000199: expertise their REBs need. Institutions should provide REB members with necessary training opportunities to effectively
p.000199: review the ethical issues raised by research proposals that fall within the mandate of their REB.
p.000199:
p.000199:
p.000199: TCPS 2 73
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: Application An REB should have adequate expertise, experience and training to understand the research disciplines,
p.000199: methodologies and approaches of the research that it considers for research ethics review. Although an REB possesses
p.000199: the necessary expertise globally, each REB member brings specialized and complementary expertise and knowledge, or
p.000199: relevant experience to the ethics review of research involving hu- mans.
p.000199: Institutions should ensure that all REB members receive appropriate education and training in ethics review of research
p.000199: involving humans, to enable them to fulfil their duties. This includes providing training opportunities for all members
p.000199: in core prin- ciples and understanding of this Policy, basic ethics standards, applicable institutional
p.000199: policies, and legal or regulatory requirements. It includes an under- standing of the role and mandate of REBs and
p.000199: responsibilities of REB members. Training should be tailored to the types and complexities of the research the REB
p.000199: reviews. This training should be offered both upon the appointment of new mem- bers, and periodically throughout a
p.000199: member’s tenure.
p.000199: Institutions should promote and recognize the contribution of REB members to the research ethics review process, as a
p.000199: valued and essential component of the research enterprise.
p.000199: REB Chair
p.000199: Article 6.8 The REB Chair is responsible for ensuring that the REB review process conforms to the requirements of
p.000199: this Policy.
p.000199: Application The role of the REB Chair is to provide overall leadership for the REB and to fa- cilitate the REB
p.000199: review process, based on institutional policies and procedures and this Policy. The Chair should monitor the REB’s
p.000199: decisions for consistency and en- sure that these decisions are recorded accurately and communicated clearly to
p.000199: researchers in writing as soon as possible by the Chair or his or her designate. In- stitutions shall provide the
p.000199: necessary resources and adequate administrative support to enable the REB Chair to fulfill his or her responsibilities.
p.000199: REB Quorum
...
p.000199: knowledge necessary to provide an adequate research ethics review of the proposals under consideration.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: 74 TCPS 2
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: Application Institutions shall establish REB quorum rules subject to the range of competence and knowledge required
p.000199: by this Policy to ensure the soundness and integrity of the research ethics review process. To maintain quorum when REB
p.000199: members are geo- graphically dispersed or in unexpected circumstances (e.g., emergencies), input from member(s) is
p.000199: allowed by other means, such as the use of technology (see Ar- ticle 6.10).
p.000199: Ad hoc advisors, observers, research ethics administration staff and others attending REB meetings should not be
p.000199: counted in the quorum for an REB. Nor should they be allowed to vote on REB decisions (see Article 6.5). Decisions
p.000199: without a quorum are not valid or binding.
p.000199: REB Meetings and Attendance
p.000199: Article 6.10 REBs shall have regular meetings to discharge their responsibilities, and shall nor- mally meet face to
p.000199: face to review proposed research that is not assigned to delegated review.
p.000199: Application Face-to-face meetings are essential for adequate discussion of, and effective REB decision making on,
p.000199: research proposals, and for the collective education of the REB. The face-to-face medium provides interactive dynamics
p.000199: that tend to heighten the quality and effectiveness of communications and decisions.
p.000199: Planning regular meetings is essential to fulfilling REB responsibilities. Where a member is frequently absent, the REB
p.000199: should have some mechanism for reviewing whether that member should continue to serve on the REB. Unexpected circum-
p.000199: stances such as emergencies may prevent individual member(s) from attending the REB meeting. In these exceptional
p.000199: cases, input from member(s) by the use of tech- nology (e.g., phone or video link) would be acceptable.
p.000199: Videoconferencing, teleconferencing or use of other technologies may be regarded as necessary for meetings when REB
p.000199: members are geographically dispersed and there is no other way of holding an effective REB meeting, or when exceptional
p.000199: or exigent circumstances significantly disrupt or limit the feasibility of face-to-face REB meetings (e.g., during a
p.000199: public emergency). All efforts should be made to en- sure that technical difficulties do not prevent the maintenance of
p.000199: quorum throughout the meeting. Use of such technologies requires the Chair to ensure active participa- tion of members
p.000199: not physically present. Institutions should consider developing written procedures for the occasional use of
p.000199: videoconferences or other technologies by an REB.
p.000199: In the design phase of their research prior to the formal ethics review process, re- searchers may consult informally
...
p.000199: principles on which this Policy is based. Failure to disclose and manage conflicts may impede the informed and
p.000199: autonomous choices of in- dividuals to participate in research. Prospective participants need to know about real,
p.000199: potential or perceived conflicts of interest in order to make an informed decision about whether or not to par-
p.000199: ticipate (see Article 3.2[e]). Conflicts of interest may also undermine the respect for participants that is
p.000199: fundamental to the principle of Justice.
p.000199: It is preferable to avoid or prevent being in a position of conflict of interest, if possible. When it is not possible
p.000199: to avoid a conflict of interest, then it shall be disclosed to the appropriate people and steps taken to minimize or
p.000199: manage the conflict. Researchers, their institutions and REBs should identify and address conflicts of interest – real,
p.000199: potential or perceived – to discharge professional and institutional obligations, maintain public confidence and trust,
p.000199: and ensure accountability. In some cases, the conflict cannot be managed and the institutions, the researcher or the
p.000199: REB member may need to abandon one of the interests in conflict. When necessary, researchers may have to manage a
p.000199: conflict of interest either by disclosing it to participants or by removing themselves from the research.
p.000199:
p.000199: A. Key Concepts
p.000199: Institutional Conflict of Interest
p.000199: Institutions involved in research hold trust relationships with participants, research sponsors, re- searchers and
p.000199: society. These institutions may have financial or reputational interests including, but not limited to, the provision
p.000199: of education and the promotion of research that conflict with the institution’s obligations to protect and respect
p.000199: human dignity as characterized by the core principles of this Policy. For example, institutions may experience
p.000199: pressures to attract particular research
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 89
p.000199:
p.000199: Chapter 7 – Conflicts of Interest
p.000199:
p.000199: funding or certain types of research activities that are self-sustaining, which may compromise their independence and
p.000199: public trust. Institutions have an obligation to ensure that the ethical conduct of research is not compromised by
p.000199: real, potential or perceived conflicts of interest.
p.000199: An institutional conflict of interest involves a conflict between at least two substantial institutional obligations
p.000199: that cannot be adequately fulfilled without compromising one or both obligations. Conflicts may occur when pursuing
p.000199: particular goals, for instance, the pursuit of two different “goods,” such as an effort to obtain general
p.000199: infrastructure funding from a donor that conflicts with an effort to promote research that the donor does not wish to
p.000199: support.
p.000199: Institutional conflicts of interest may compromise duties of loyalty and lead to biased judgments. Conflicts may also
p.000199: undermine public trust in the ability of the institution to carry out its missions, operations and ethical
p.000199: responsibilities in research.
p.000199: Institutions may be in conflict of interest, for example, when they (a) sponsor a research project;
...
p.000109: research proposals. Researchers and communities should agree in advance on how to reconcile or address these
p.000109: divergent perspectives (see Articles 9.8 and 9.12).
p.000109: Appropriation of collective knowledge, treatment of such knowledge as a commodity to be traded, or making
p.000109: unauthorized adaptations for commercial purposes, may cause offence or harm to communities from which the knowledge
p.000109: originates. Such conduct has prompted initiatives in various countries and international agencies to address
p.000109: unethical, unfair, and inequitable treatment of traditional knowledge and knowledge holders (see Article 9.18).
p.000109: Paragraph (e) refers to both primary collection of research data and secondary use of information collected originally
p.000109: for a purpose other than the current research purpose (see Article 2.4 and Chapter 5, Section D). Articles 9.20 to 9.22
p.000109: address community engagement and individual consent for secondary use of identifiable information and human biological
p.000109: material for research purposes.
p.000109: Nature and Extent of Community Engagement
p.000109: Article 9.2 The nature and extent of community engagement in a project shall be determined jointly by the
p.000109: researcher and the relevant community, and shall be appropriate to community characteristics and the nature of the
p.000109: research.
p.000109:
p.000109: Application Diversity among and within communities makes generalizations about the form of community engagement
p.000109: inappropriate. Diversity within Aboriginal communities may encompass differences in levels of formal education
p.000109: and employment, mobility, generational differences and intermarriage with non-Aboriginal persons. This diversity
p.000109: increases the importance of clarifying mutual expectations and obligations with the community, and incorporating
p.000109: them into a research agreement.
p.000109: Community engagement as defined in this Policy can take varied forms. In geographic and organizational
p.000109: communities that have local governments or formal leadership, engagement prior to the recruitment of participants would
p.000109: normally take the form of review and approval of a research proposal by a designated body. In less structured
p.000109: situations (e.g., a community of interest), a key consideration for researchers, prospective participants and REBs is
p.000109: determining the nature and extent
p.000109:
p.000109:
p.000109:
p.000109:
p.000109: TCPS 2
p.000111: 111
p.000111:
p.000111: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000111:
p.000111: of community engagement required. In some situations, if the REB is satisfied that participants are not identified with
p.000111: a community or that the welfare of relevant communities is not affected, the REB may waive the requirement of a
p.000111: community engagement plan (see Article 9.10). In these cases, consent of individuals is sufficient to
p.000111: participate.
p.000111: Communities lacking the infrastructure to support pre-research community engagement should not be deprived
p.000111: of opportunities to participate in guiding research affecting their welfare (see Article 9.14).
...
p.000111: For example, a project that examines the incidence of diabetes in Pond Inlet, Nunavut, or the impact on Inuit health of
p.000111: contaminants in animals and plants used for country food.
p.000111: • Permission of the Nunavut Research Institute that carries authority to approve research in Nunavut is
p.000111: required. Agreement of the hamlet council in Pond Inlet will normally be a condition of approval. The local health
p.000111: committee may co-manage the project.
p.000111: 2) Research involving Aboriginal people who comprise a sizeable proportion of the study or community and where
p.000111: Aboriginal-specific conclusions are intended. For example, a comparative study of access to public housing in Prince
p.000111: Albert, Saskatchewan.
p.000111: • First Nations in the district, represented by their tribal council, the local Métis association, and urban
p.000111: Aboriginal and women’s organizations may partner with the Prince Albert city council to sponsor, implement and use the
p.000111: results of the housing study.
p.000111: 3) Research focusing on a larger community that is known to include Aboriginal people (regardless of their
p.000111: proportion), and where Aboriginal-specific conclusions are anticipated. For example, a study of student retention
p.000111: in high schools in the Sault Ste. Marie district of Ontario.
p.000111: • A committee representing First Nations, Métis organizations and urban Aboriginal people whose children may
p.000111: be affected by the study may be convened to advise the District Board of Education and the researchers involved.
p.000111: 4) Research involving Aboriginal people who comprise a sizeable proportion of the larger community that is the
p.000111: subject of research even if no Aboriginal- specific conclusions will be made. For example, research on
p.000111: employment
p.000111:
p.000111: 112 TCPS 2
p.000111:
p.000111: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000111:
p.000111: development programs serving residents of the inner city of Winnipeg in Manitoba.
p.000111: • Aboriginal service agencies or political organizations may be engaged to help recruit Aboriginal participants and
p.000111: secure community representation on an oversight committee, and to ensure cultural sensitivity in collecting and
p.000111: interpreting data on employment program impacts.
p.000111: 5) Interviewing a sample of individuals of Aboriginal ancestry across Canada on the impact of a policy on their
p.000111: lives, where the results are not attributable to, or likely to affect, the community or communities with which they may
p.000111: identify. For example, survey research on the implementation of Indian Act provisions requiring ministerial approval of
p.000111: an “Indian’s” will.
p.000111: • First Nations, Inuit and Métis persons, whether or not they identify as members of an Aboriginal
p.000111: community, enjoy freedom of expression as does any citizen. They are free to consent and to participate in research
p.000111: projects that they consider to be of personal or social benefit. If the project is unlikely to affect the welfare
...
p.000123: resulting from the research for the benefit of the participating community.
p.000123: A possible outcome of collaborative research, and in particular participatory research, is increased
p.000123: capacity to carry out research that can more readily be conducted in Aboriginal languages and oral modes. The
p.000123: exploration, articulation and application of knowledge specific to a community or communities are thus advanced,
p.000123: potentially benefiting other First Nations, Inuit or Métis communities through knowledge transfer.
p.000123: Researchers should provide communities access to research data that will allow them to address pressing issues through
p.000123: community-generated policies, programs, and services (see Article 9.8 and the Application of Article 9.11). Territorial
p.000123: and organizational communities and communities of interest may also seek to share in the benefits of research
p.000123: activities, which may include direct research grants, release time for project personnel, overhead levies on shared
p.000123: projects and commercializa- tion of research discoveries.
p.000123: Strengthening Research Capacity
p.000123: Article 9.14 Research projects should support capacity building through enhancement of the skills of community
p.000123: personnel in research methods, project management, and ethical review and oversight.
p.000123: Application Collaborative research approaches provide for reciprocal learning and for transfer of skills and
p.000123: knowledge between the community and the researcher. Researchers should foster education and training of community
p.000123: members to enhance their participation in research projects. Employing Aboriginal research assistants and
p.000123: translators is already common practice in community-based projects. Extending skills transfer through a program of
p.000123: training will support collaboration with institutions, and advance the capacity of communities to initiate and
p.000123: implement their own research. Collaborative research can also support building capacity of the research community to
p.000123: conduct culturally relevant research.
p.000123: Lack of engagement by communities may be due to inadequate financial or human resources. Communities vary widely in the
p.000123: level of human and material resources they have available to collaborate with research initiatives. Structural barriers
p.000123: may prevent access to, and participation in, research. For example, small, remote communities and many urban
p.000123: communities of interest have limited organizational resources to advise or collaborate in research. The least
p.000123: organizationally developed communities are the most vulnerable to exploitation. Research undertaken in these
p.000123: circumstances should strive to enhance capacity for participation.
p.000123: Funding programs that target the development of Aboriginal research and capacity building seek to generate
p.000123: significant research training opportunities. Funding criteria allow researchers to include in their grant
...
p.000131: www.naho.ca/inuit/e/ethics/factsheets.php
p.000131: • Royal Commission on Aboriginal Peoples. Report of the Royal Commission on Aboriginal Peoples. “Ethical Guidelines
p.000131: for Research.” In Volume 5, Renewal: A Twenty-Year Commitment, Ottawa: Canada Communications Group. 1996. It can also
p.000131: be accessed at www.ainc-inac.gc.ca/ap/rrc-eng.asp
p.000131: • United Nations Educational, Scientific and Cultural Organization. Universal Declaration on Bioethics and Human
p.000131: Rights. Adopted October 19, 2005, by the 33rd session of the General Conference of UNESCO. 2005.
p.000131: http://unesdoc.unesco.org/images/0014/001461/146180e.pdf
p.000131: • United Nations. Convention on Biological Diversity. 1992. www.cbd.int/convention/convention.shtml
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: TCPS 2
p.000133: 133
p.000133:
p.000133:
p.000133:
p.000133: Chapter 10
p.000133: QUALITATIVE RESEARCH
p.000133:
p.000133: Introduction
p.000133: Researchers in social sciences and humanities – such as anthropology, sociology, philosophy, psychology, criminology,
p.000133: business administration, political science, communications, education and history – have a common belief in the
p.000133: desirability of trying to understand human action through systematic study and analysis. Some researchers use
p.000133: quantitative research approaches, others opt for qualitative research methods, and some use a combination of both.
p.000133: Qualitative research has a long history in many established disciplines in the social sciences and humanities, as well
p.000133: as many areas in the health sciences (e.g., nursing, occupational therapy). The use of qualitative approaches is
p.000133: increasing, whether in health research or in social sciences and humanities disciplines. Within specific disciplines,
p.000133: ethics guidelines have been created to address the issues inherent in the use of, for example, particular methods,
p.000133: technologies and settings. Qualitative research approaches are inherently dynamic and may be grounded in
p.000133: different assumptions than those that shape quantitative research approaches. Many of the research practices and
p.000133: methodological requirements that characterize qualitative research approaches parallel those that characterize
p.000133: quantitative approaches such as concerns regarding research quality. However, as is the case with all research
p.000133: involving humans, the criteria are adapted to the specific subject matter, context and epistemological assumptions
p.000133: about the nature of knowledge in the specific area of research of the specific project.
p.000133: This chapter seeks to provide specific guidance on some issues that are particularly germane to qualitative research,
p.000133: although such guidance may also be applicable to research using quantitative or mixed methods. In particular, it
...
p.000189: the life of the project to ensure that all stages of a research project are ethically acceptable in accordance with the
p.000189: principles in the Policy.
p.000189:
p.000189: Core principles – The three core principles of the Policy that together express the overarching value of re- spect for
p.000189: human dignity: Respect for Persons, Concern for Welfare and Justice. See “Respect for Persons,” “Concern for Welfare”
p.000189: and “Justice.”
p.000189:
p.000189: Creative practice – A process through which an artist makes or interprets a work, or works, of art. It may also include
p.000189: a study of the process of how a work of art is generated.
p.000189:
p.000189: Critical inquiry – The analysis of social structures or activities, public policies, or other social phenomena for
p.000189: research purposes.
p.000189:
p.000189: Cultural heritage – A dynamic concept which includes, but is not limited to, First Nations, Inuit and Métis peoples’
p.000189: relations with particular territories, material objects, traditional knowledge and skills, and intan- gibles that are
p.000189: transmitted from one generation to the next, such as sacred narratives, customs, representa- tions or practices.
p.000189:
p.000189: Cyber-material – Documents, images, audio or video recordings, records, performances, or on-line archival materials
p.000189: available in digital form on the Internet.
p.000189:
p.000189: Data linkage – The merging or analysis of two or more separate data sets (e.g. health information and education
p.000189: information about the same individuals) for research purposes. See also “Data set.”
p.000189:
p.000189: Data safety monitoring board – A multi-disciplinary, expert advisory group established by a research sponsor, that
p.000189: is responsible for safeguarding the interests of participants by reviewing emerging data, assessing the safety and
p.000189: efficacy of clinical trial procedures, and monitoring the overall conduct of a trial.
p.000189:
p.000189: Data set – A collection of information to be used for research purposes, including human biological materials.
p.000189:
p.000189: Debriefing – The full disclosure of the research purpose and other pertinent information to participants who have been
p.000189: involved in research employing partial disclosure or deception. Debriefing is typically done after participation has
p.000189: ended, but may be done at any time during the study.
p.000189:
p.000189: Delegated research ethics board (REB) review – The level of REB review assigned to minimal risk research projects.
p.000189: Delegated reviewers are selected from among the REB membership, with the exception of the ethics review of student
p.000189: course-based research which can be reviewed by delegates from the student’s department, faculty, or an equivalent
p.000189: level.
p.000189: Embryo – A human organism during the first 56 days of its development following fertilization or creation, excluding
p.000189: any time during which its development has been suspended. It also includes any cell derived from such an organism that
...
p.000193: disadvantage for the time and inconvenience of participation in research. Direct expenses refer to the costs incurred,
p.000193: and indirect expenses refer to losses that arise, because of research participation.
p.000193:
p.000193:
p.000193:
p.000193: TCPS 2
p.000195: 195
p.000195:
p.000195: Glossary
p.000195:
p.000195: Research – An undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation.
p.000195:
p.000195: Research agreement – A document that serves as a primary means of clarifying and confirming mutual expectations and,
p.000195: where appropriate, commitments between researchers and communities.
p.000195:
p.000195: Research directive – Written instructions used to express an individual’s preferences for participation in future
p.000195: research, in the event that the individual loses capacity. It is intended to guide the individual’s authorized third
p.000195: party in deciding whether or not to give substitute consent for the individual to participate in research.
p.000195:
p.000195: Research ethics board (REB) – A body of researchers, community members, and others with specific ex- pertise (e.g. in
p.000195: ethics, in relevant research disciplines) established by an institution to review the ethical acceptability of all
p.000195: research involving humans conducted within the institution’s jurisdiction or under its auspices.
p.000195:
p.000195: Research ethics education and training – The provision of materials and corresponding instruction by an institution to
p.000195: research ethics board (REB) members or researchers with regard to the core principles and understanding of this Policy,
p.000195: basic ethics standards, applicable institutional policies, and legal or regulatory requirements. This term also
p.000195: includes an understanding of the role and mandate of REBs and responsibilities of REB members.
p.000195:
p.000195: Research involving partial disclosure or deception – A type of research, in which the participant may not know that
p.000195: they are part of a project until it is over or is not informed of the true purpose of the research in advance. See
p.000195: “Debriefing.”
p.000195:
p.000195: Respect for Persons – A core principle of this Policy that recognizes the intrinsic value of human beings and the
p.000195: respect and consideration that they are due. It incorporates the dual moral obligations to respect autonomy and to
p.000195: protect those with developing, impaired, or diminished autonomy.
p.000195:
p.000195: Risk – The possibility of the occurrence of harm. The level of foreseeable risk posed to participants by their
...
p.000205: participatory, 123-125
p.000205: qualitative (see Qualitative Research) research ethics review, exempt from, 17-19
p.000205: research ethics review, requiring, 15-17, 119-121
p.000205: sponsored, 163-164
p.000205: stopping rules, 30-33
p.000205: unanticipated issues, 22, 34, 81, 161-163
p.000205: Research agreements, 121, 122-123, 126-127, 128-130, 131
p.000205: Research directives, 42-44 Research ethics
p.000205: core principles (see Core principles) framework, 7-13, 109-110
p.000205: importance, 7-8 Research ethics boards (REBs)
p.000205: ad hoc advisors, 24, 72, 73, 75, 120, 150
p.000205: appointment, 67-76
p.000205: authority, 67-70
p.000205: chair’s responsibilities, 74, 77-79
p.000205: composition, 70-75
p.000205: decision making, 68-69, 70, 79
p.000205: establishment, 67-76
p.000205: financial and administrative resources, 68-69, 74
p.000205: independence, 67, 68-69, 70-73, 93-94
p.000205: mandate, 67-70
p.000205: meetings and attendance, 75-76, 82-83 members (see Research ethics board members) membership requirements, 70-73
p.000205: multiple boards, 97-104
p.000205:
p.000205:
p.000205: TCPS 2
p.000207: 207
p.000207:
p.000207: Index
p.000207:
p.000207: quorum, 73, 74-75
p.000207: size, 70-72
p.000207: Research ethics board members appointment terms, 73-74
p.000207: chairs, 74, 77-79
p.000207: community members, 70, 72
p.000207: compensation, 94
p.000207: conflicts of interest, 69, 70-71, 78, 90, 93-94
p.000207: education and training, 74, 75, 76, 125
p.000207: ethics, members knowledgeable in, 70, 71
p.000207: expertise, 12, 70-75, 150
p.000207: law, members knowledgeable in, 70, 71-72
p.000207: substitute members, 72-73, 93 Research ethics review
p.000207: activities not requiring, 19-20 appeals, 84-85
p.000207: changes to approved research, 33-34, 82, 144-145, 150, 161, 163
p.000207: continuing, 21-22, 79-81
p.000207: delegated, 23, 24, 77-79, 82
p.000207: determining the level, 24-25, 77-79
p.000207: during publicly declared emergencies (see Publicly declared emergencies) full, 24, 74-76, 77-79, 82
p.000207: governance, 67-88
p.000207: initial, 76-77
p.000207: models, 98-101
p.000207: procedures, 76-83
p.000207: proportionate approach, 11, 22, 24-25, 77-79, 82, 148
p.000207: reconsideration, 83-85
p.000207: record keeping, 82-83
p.000207: research conducted outside the institution, 101-104 research exempt from, 17-19
p.000207: research requiring, 15-17, 119-121 scholarly review and, 20-21 scope, 15-22
p.000207: timing, 15, 76, 139
p.000207: Research participants (see Participants)
p.000207: Researchers
p.000207: academic freedom, 7, 11
p.000207: conflicts of interest, 91, 94-96
p.000207: dual roles, 95, 149, 158
p.000207: multiple affiliations, 68, 97-101
p.000207: Respect for Persons, 8-9, 27, 109 Risk
p.000207: and benefits, 10, 11, 22-25, 41-42, 51, 157-158
p.000207: in clinical trials, 148, 157-159
p.000207: definition, 22-23
p.000207: minimal, 11, 23, 24-25, 37-39, 41, 51, 77-79
p.000207: to researchers, 25
p.000207:
p.000207:
p.000207: 208 TCPS 2
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p.000199: the researcher seeks data linkage of two or more anonymous sets of information or human biological materials
p.000199: and there is a reasonable prospect that this could generate identifiable information, then REB review is required.
p.000199: Guidance related to other categories of identifiable and non-identifiable information and human biological materials
p.000199: and their possible secondary use is provided in Chapters 5 and 12.
p.000199: Activities Not Requiring REB Review
p.000199: The following distinguishes research requiring REB review from non-research activities that have traditionally employed
p.000199: methods and techniques similar to those employed in research. Such activities are not considered “research” as defined
p.000199: in this Policy, and do not require REB review. Activities outside the scope of research subject to REB review (see
p.000199: Articles 2.5 and 2.6), as defined in this Policy, may still raise ethical issues that would benefit from careful
p.000199: consideration by an individual or a body capable of providing some independent guidance, other than an REB. These
p.000199:
p.000199: TCPS 2 19
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
p.000199: ethics resources may be based in professional or disciplinary associations, particularly where those associations have
p.000199: established best practices guidelines for such activities in their discipline.
p.000199: Article 2.5 Quality assurance and quality improvement studies, program evaluation activities, and performance
p.000199: reviews, or testing within normal educational requirements when used exclusively for assessment, management or
p.000199: improvement purposes, do not constitute research for the purposes of this Policy, and do not fall within the scope of
p.000199: REB review.
p.000199: Application Article 2.5 refers to assessments of the performance of an organization or its employees or
p.000199: students, within the mandate of the organization, or according to the terms and conditions of employment or training.
p.000199: Those activities are normally administered in the ordinary course of the operation of an organization where
p.000199: participation is required, for example, as a condition of employment in the case of staff performance reviews, or
p.000199: an evaluation in the course of academic or professional training. Other examples include student course
p.000199: evaluations, or data collection for internal or external organizational reports. Such activities do not normally follow
p.000199: the consent procedures outlined in this Policy.
p.000199: If data are collected for the purposes of such activities but later proposed for research purposes, it would be
p.000199: considered secondary use of information not originally intended for research, and at that time may
p.000199: require REB review in accordance with this Policy. Refer to Section D of Chapter 5 for guidance
p.000199: concerning secondary use of identifiable information for research purposes.
p.000199: Article 2.6 Creative practice activities, in and of themselves, do not require REB review. However, research
p.000199: that employs creative practice to obtain responses from participants that will be analyzed to answer a research
p.000199: question is subject to REB review.
...
p.000199: conduct of research.
p.000199: Equally, Respect for Persons implies that those who lack the capacity to decide for themselves should nevertheless have
p.000199: the opportunity to participate in research that may be of benefit to themselves or others. Authorized third parties
p.000199: acting on behalf of these individuals decide whether participation would be appropriate. For the purposes of this
p.000199: Policy, the term “authorized third party” (also known as “authorized third party decision makers”) refers to any person
p.000199: with the necessary legal authority to make decisions on behalf of an individual who lacks the capacity to consent to
p.000199: participate or to continue to participate in a particular research project. These decisions involve considerations of
p.000199: Concern for Welfare and Justice.
p.000199: Certain types of research require alternate processes for seeking consent. These are also described in this chapter.
p.000199: Where elements of the consent process may need to be adapted to the requirements of a particular research project, the
p.000199: research ethics board (REB) can play an educational and consultative role in determining the appropriate process for
p.000199: seeking and maintaining consent.
p.000199: The head of the research team, also known as the principal investigator, is responsible for ensuring that the consent
p.000199: process is followed. This person is also responsible for the actions of any member of the research team involved in the
p.000199: consent process.
p.000199: In addition to this Policy, researchers are responsible for ensuring that all applicable legal and regulatory
p.000199: requirements with respect to consent are met. In some circumstances, researchers may have further legal obligations
p.000199: that may be determined in part by the nature of the research and the jurisdiction in which the research is being
p.000199: conducted.1
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 27
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: A. General Principles
p.000199: Consent Shall Be Given Voluntarily
p.000199: Article 3.1 (a) Consent shall be given voluntarily.
p.000199: (b) Consent can be withdrawn at any time.
p.000199: (c) If a participant withdraws consent, the participant can also request the with- drawal of their data or human
p.000199: biological materials.
...
p.000199: An individual or organization fulfils its confidentiality duties, in part, by adopting and enforcing appropriate
p.000199: security measures. Physical safeguards include the use of locked filing cabinets, and the location of computers
p.000199: containing research data away from public areas. Administrative safeguards include the development and enforcement of
p.000199: organizational rules about who has access to personal information about participants. Technical safeguards include use
p.000199: of computer passwords, firewalls, anti-virus software, encryption and other measures that protect data from
p.000199: unauthorized access, loss or modification.
p.000199: Identifiable Information
p.000199: Information that may reasonably be expected to identify an individual, alone or in combination with other available
p.000199: information, is considered identifiable information (or information that is identifiable) for the purposes of this
p.000199: Policy. Where the term “personal information” appears in this Policy, it refers to identifiable information.
p.000199: Types of Information
p.000199: Researchers may seek to collect, use, share and access different types of information about par- ticipants. Such
p.000199: information may include personal characteristics or other information about which an individual has a reasonable
p.000199: expectation of privacy (e.g., age, ethnicity, educational background, employment history, health history, life
p.000199: experience, religion, social status).
p.000199: For the purposes of this Policy, researchers and REBs shall consider whether information proposed for use in research
p.000199: is identifiable. The following categories provide guidance for assessing the ex- tent to which information could be
p.000199: used to identify an individual:
p.000199: • Directly identifying information – the information identifies a specific individual through direct identifiers
p.000199: (e.g., name, social insurance number, personal health number).
p.000199: • Indirectly identifying information – the information can reasonably be expected to iden- tify an individual
p.000199: through a combination of indirect identifiers (e.g., date of birth, place of residence or unique personal
p.000199: characteristic).
p.000199:
p.000199: 56 TCPS 2
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: • Coded information – direct identifiers are removed from the information and replaced with a code. Depending on
p.000199: access to the code, it may be possible to re-identify specific participants (e.g., the principal investigator retains a
p.000199: list that links the participants’ code names with their actual name so data can be re-linked if necessary).
p.000199: • Anonymized information – the information is irrevocably stripped of direct identifiers, a code is not kept to
p.000199: allow future re-linkage, and risk of re-identification of individuals from remaining indirect identifiers is low or
p.000199: very low.
...
p.000199: In considering the adequacy of proposed measures for safeguarding information during its full life cycle, REBs should
p.000199: not automatically impose a requirement that researchers destroy the research data. Stored information may be useful for
p.000199: a variety of future purposes. Appropriate data retention periods vary depending on the re- search discipline,
p.000199: research purpose and the kind of data involved. In some situations, formal data sharing with participants may
p.000199: occur, for example, by giving individual participants copies of a recording or transcript as a gift for personal,
p.000199: family or other archival use. Similarly, some funding bodies, such as the Social Sciences and Humanities Research
p.000199: Council and the Canadian Institutes of Health Research, have specific policies on data archiving and sharing.2
p.000199: Researchers should address how participants’ information will be handled if participants choose to withdraw from the
p.000199: research.
p.000199: In disseminating findings, researchers shall not disclose identifiable information without the consent of participants.
p.000199: In the case of critical inquiry research, identi- fiable information may be revealed about any objects of the inquiry
p.000199: as they are usually not regarded as participants (see Article 3.6). Researchers shall take rea- sonable measures to
p.000199: avoid inadvertent identification of individuals or groups in publications or other means of dissemination – and they
p.000199: must address this issue to the satisfaction of the REB.
p.000199: Consideration of future uses of personal information refers not just to research, but also to other purposes, such as
p.000199: the future use of research materials for educational purposes.
p.000199: Research data sent over the Internet may require encryption or use of special de- nominalization software to prevent
p.000199: interception by unauthorized individuals, or other risks to data security. In general, identifiable data obtained
p.000199: through research that is kept on a computer and connected to the Internet should be encrypted.
p.000199: Article 5.4 Institutions or organizations where research data are held have a responsibility to establish
p.000199: appropriate institutional security safeguards.
p.000199: Application In addition to the security measures researchers implement to protect data, safeguards put in
p.000199: place at the institutional or organizational level also provide important protection. These data security
p.000199: safeguards should include adequate physical, administrative and technical measures, and should address the full life
p.000199: cycle of information. This includes institutional or organizational safeguards for information while it is
p.000199: currently in use by researchers, and for any long-term retention of information.
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 61
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199: D. Consent and Secondary Use of Identifiable Information for Research Purposes
p.000199: Secondary use refers to the use in research of information originally collected for a purpose other than the current
p.000199: research purpose. Common examples are social science or health survey datasets that are collected for specific research
p.000199: or statistical purposes, but then re-used to answer other re-
p.000199: search questions. Information initially collected for program evaluation may be useful for subsequent
p.000199: research. Other examples include health care records, school records, biological spec- imens, vital statistics
p.000199: registries or unemployment records, all of which are originally created or collected for therapeutic, educational or
p.000199: administrative purposes, but which may be sought later for use in research. Chapter 12 provides further guidance on
p.000199: research involving secondary use of previously collected biological materials.
p.000199: Reasons to conduct secondary analyses of data include: avoidance of duplication in primary col- lection and the
p.000199: associated reduction of burdens on participants; corroboration or criticism of the conclusions of the original project;
p.000199: comparison of change in a research sample over time; appli- cation of new tests of hypotheses that were not available
p.000199: at the time of original data collection; and confirmation that the data are authentic. Privacy concerns and questions
p.000199: about the need to seek consent arise, however, when information provided for secondary use in research can be linked to
p.000199: individuals, and when the possibility exists that individuals can be identified in published reports, or through data
p.000199: linkage. Privacy legislation recognizes these concerns and permits sec- ondary use of identifiable information under
p.000199: certain circumstances.
p.000199: Article 5.5 Researchers who have not obtained consent from participants for secondary use of identifiable
p.000199: information shall only use such information for these purposes if the REB is satisfied that:
p.000199: (a) identifiable information is essential to the research;
p.000199: (b) the use of identifiable information without the participants’ consent is unlikely to adversely affect the
p.000199: welfare of individuals to whom the information relates;
...
p.000199: videoconferences or other technologies by an REB.
p.000199: In the design phase of their research prior to the formal ethics review process, re- searchers may consult informally
p.000199: with REBs. Such dialogue can establish the stage at which REB review and approval would be required, or facilitate the
p.000199: review. Such
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 75
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: informal meetings cannot, however, substitute for the formal review process. A schedule of REB meetings should be
p.000199: communicated to researchers for the planning of ethics review of their research.
p.000199: On occasion REBs may need to consult other resources within or outside the insti- tution for advice, and may invite
p.000199: experts to attend their meetings. REBs should consider whether the institutional functions of other individuals
p.000199: attending their meetings could exercise undue influence, or provide elements of power imbalances or coercion that would
p.000199: affect REB review, deliberations and decisions (see Articles
p.000199: 6.4 and 6.5 and Chapter 7).
p.000199: REBs should establish a process for the basis of arriving at decisions requiring full REB review. For example, they may
p.000199: arrive at decisions by consensus, and where this is not possible resort to a vote. REBs should hold general meetings,
p.000199: retreats and workshops to enhance educational opportunities that may benefit the overall operation of the REB, discuss
p.000199: any general issues arising out of the REB’s activities or revise relevant policies.
p.000199:
p.000199: B. Procedures for REB Review
p.000199:
p.000199: Initial Research Ethics Review
p.000199: Article 6.11 Researchers shall submit their research proposals, including proposals for pilot studies, for REB
p.000199: review and approval of its ethical acceptability prior to the start of recruitment of participants, access to data, or
p.000199: collection of human biological ma- terials. REB review is not required for the initial exploratory phase, which may
p.000199: involve contact with individuals or communities intended to establish research part- nerships or to inform the design
p.000199: of a research proposal.
p.000199: Application REB review and approval of the ethical acceptability of research is required before recruitment, formal
p.000199: data collection involving participants, access to data, or col- lection of human biological materials. Similarly, as an
p.000199: integral component of their research design, researchers may undertake pilot studies involving participants. For the
p.000199: conduct of pilot studies, researchers shall seek consent from prospective par- ticipants and obtain REB approval before
p.000199: recruitment or the formal data collection involving participants, or access to data, or collection of human biological
p.000199: materials in accordance with the provisions in this Policy.
p.000199: Researchers shall submit sufficient details to enable the REB to make an informed review of the ethical acceptability
...
p.000199: acceptability of research in an efficient and timely manner, and shall communicate all approvals and refusals to
p.000199: researchers in writing, in print or by electronic means, in accordance with their procedures.
p.000199: Application The REB shall accommodate reasonable requests from researchers to participate in discussions about
p.000199: their proposals. The REB may also invite researchers to attend an REB meeting to provide further information about
p.000199: their proposal. In either case, the researchers shall not be present when the REB is making its decision. When an REB
p.000199: is considering a negative decision, it shall provide the researcher with all the reasons for doing so and give the
p.000199: researcher an opportunity to reply before making a final decision (see Article 6.18).
p.000199: In the event that a minority within the REB membership considers a research proj- ect unethical, even though it is
p.000199: acceptable to a majority of members, an effort should be made to reach consensus. Consultation with the researcher,
p.000199: external ad- vice or further reflection by the REB may be helpful. If disagreement persists, a decision should be made
p.000199: in accordance with the process agreed upon, and docu- mented by the REB. In such instances, the minority position may
p.000199: be communicated to the researcher.
p.000199: Participation by the researcher in REB discussions is often very helpful to both REBs and researchers. It may result in
p.000199: a deferral of the REB’s decision until the researcher has considered the discussions and possibly modified the
p.000199: proposal. Such discussions are an essential part of the educational role of the REB.
p.000199: Continuing Research Ethics Review
p.000199: Article 6.14 The REB shall make the final determination as to the nature and frequency of con- tinuing research
p.000199: ethics review in accordance with a proportionate approach to research ethics review. At minimum, continuing research
p.000199: ethics review shall consist of an annual status report (for multi-year research projects), and an end-of-study report
p.000199: (projects lasting less than one year).
p.000199:
p.000199:
p.000199: TCPS 2 79
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: Application Research is subject to continuing research ethics review from the date of initial REB approval
p.000199: throughout the life of the project (see Article 2.8). At the time of the initial review, the REB has the authority to
p.000199: determine the term of approval, and the level at which continuing ethics review occurs in accordance with a
p.000199: proportionate approach to research ethics review. As with initial review, continuing ethics review could be full board
p.000199: review or delegated review based on the level of risk of the re- search (see Article 6.12). The level of research
...
p.000199: maintain quorum.
p.000199: Conflict of interest policies should determine a reasonable time period during which an REB member is not allowed to
p.000199: review a proposal involving a recent collaborator, supervisor, student or other colleague (as defined by the
p.000199: institution). The purpose of these policies on time limits is to ensure adequate and continued access to com- petent
p.000199: expertise. In some cases, the scientific expertise of the REB member may still be sought when no other individuals with
p.000199: the scientific expertise relevant to the proposal under review are available to the REB. In such instances, the REB
p.000199: will record this explicitly in the minutes. The member should not be present when the REB makes its decision.
p.000199: REBs and Senior Administrators
p.000199: Institutional senior administrators (e.g., a vice-president of research or business de- velopment) should not serve on
p.000199: an REB, or directly or indirectly influence the REB decision-making process. The mere presence of an institutional
p.000199: senior administrator at REB meetings may undermine the independence of the REB by unduly influ- encing REB
p.000199: deliberations and decisions.
p.000199:
p.000199:
p.000199: TCPS 2 93
p.000199:
p.000199: Chapter 7 – Conflicts of Interest
p.000199:
p.000199: REBs and senior administrators should consider other venues to discuss policy is- sues, general issues arising from the
p.000199: REB’s activities, or training and educational needs, to the benefit of the overall operation and mandate of the REB. In
p.000199: the dis- charge of their interdependent roles and duties to participants, effective communications
p.000199: processes should be established between REBs and the relevant officers of institutions. In cases where senior
p.000199: administrators interfere with the REB decision-making process, REBs should invoke the institution’s conflict of
p.000199: interest policies.
p.000199: Compensation for REB members
p.000199: Reasonable compensation by institutions for work done by REB members is ap- propriate. However, in some instances,
p.000199: individual members of the REB may have a conflict of interest in accepting undue or excessive honoraria for their
p.000199: participa- tion in the REB. Institutions should define appropriate levels of compensation.
p.000199: D. Researchers and Conflicts of Interest
p.000199: Article 7.4 Researchers shall disclose in research proposals they submit to the REB any real, potential or
p.000199: perceived individual conflicts of interest, as well as any institutional conflicts of interest of which they are aware
p.000199: that may have an impact on their re- search. Upon discussion with the researcher, the REB shall determine the
p.000199: appropriate steps to manage the conflict of interest.
p.000199: Application Managing conflict of interest is a process that begins with identification and is fol- lowed by
p.000199: disclosure. Upon disclosure of a conflict by a researcher to the REB, the steps taken by the REB to manage the conflict
p.000199: should be context-based and com- mensurate with the risks. In some cases, the REB might conclude that the identified
p.000199: conflict of interest does not warrant further action.
p.000199: The REB should require, consistent with Article 3.2(e), that the researcher disclose any real, potential or perceived
...
p.000113: Article 9.5 Where alternatives to securing the agreement of formal leadership are proposed for research on First
p.000113: Nations, Inuit or Métis lands or in organizational communities, researchers should engage community processes and
p.000113: document measures taken, to enable the REB to review the proposal with due consideration of complex
p.000113: community authority structures.
p.000113: Application Researchers and REBs should not assume that approval of a project by formal leaders is the only avenue
p.000113: for endorsing a project. In some communities and some domains of knowledge, authority to permit and monitor
p.000113: research rests with knowledge keepers designated by custom rather than by election or appointment.
p.000113:
p.000113:
p.000113:
p.000113: TCPS 2
p.000115: 115
p.000115:
p.000115: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000115:
p.000115: In First Nations settings, a confederacy council spanning several communities may be recognized as having authority
p.000115: over its members’ traditional knowledge. In an Inuit community, the hamlet council, an Elders’ circle, and a hunters
p.000115: and trappers organization may have overlapping responsibility and expertise with respect to the knowledge being sought.
p.000115: Métis Elders dedicated to conserving Michif language may assert their autonomy from political leaders, but choose to
p.000115: collaborate with educational or cultural agencies (see also Article 9.15).
p.000115: The preferred course is to secure approval for research from both formal leaders of a community and customary
p.000115: authority. This is especially important for outsiders to communities, whose presence or intentions might be challenged
p.000115: as inappropriate. Researchers should engage community processes, including the guidance of moral authorities such as
p.000115: Elders, to avert potential conflict. These measures should be documented to assist the REB in considering the community
p.000115: engagement processes proposed (see Article 9.10). Where no agreement exists between formal community leadership and
p.000115: customary authority regarding the conduct of the proposed research, researchers should inform the REB. When alternative
p.000115: community engagement processes are followed to endorse a project, all other ethical safeguards set out in this chapter
p.000115: remain applicable.
p.000115: Recognizing Diverse Interests within Communities
p.000115: Article 9.6 In engaging territorial or organizational communities, researchers should ensure, to the extent
p.000115: possible, that they take into consideration the views of all relevant sectors – including individuals and subgroups who
p.000115: may not have a voice in the formal leadership. Groups or individuals whose circumstances make them vulnerable
p.000115: may need or desire special measures to ensure their safety in the context of a specific research project. Those who
p.000115: have been excluded from participation in the past may need special measures to ensure their inclusion in research.
...
p.000131:
p.000131: • Interagency Advisory Panel on Research Ethics. Aboriginal Research Ethics Initiative. “Issues and Options for
p.000131: Revisions to the Tri-Council Policy Statement: Ethical Conduct of Research Involving Humans (TCPS): Section 6: Research
p.000131: Involving Aboriginal Peoples.” February 2008.
p.000131: www.pre.ethics.gc.ca/eng/archives/policy-politique/reports-rapports/riap-rapa/
p.000131: • Inuit Tapiriit Kanatami (ITK) and Nunavut Research Institute (NRI). Negotiating Research Relationships with Inuit
p.000131: Communities: A Guide for Researchers. Edited by Scot Nickels, Jamal Shirley and Gita Laidler. ITK and NRI: Ottawa and
p.000131: Iqaluit. www.itk.ca/publications/negotiating-research-relationships-inuit-communities-guide- researchers
p.000131: • Nipingit: National Inuit Committee on Ethics and Research, a joint program of the Inuit Tuttarvingat the National
p.000131: Aboriginal Health Organization and Inuit Tapiriit Kanatami, Research and Research Ethics Fact Sheets.
p.000131: www.naho.ca/inuit/e/ethics/factsheets.php
p.000131: • Royal Commission on Aboriginal Peoples. Report of the Royal Commission on Aboriginal Peoples. “Ethical Guidelines
p.000131: for Research.” In Volume 5, Renewal: A Twenty-Year Commitment, Ottawa: Canada Communications Group. 1996. It can also
p.000131: be accessed at www.ainc-inac.gc.ca/ap/rrc-eng.asp
p.000131: • United Nations Educational, Scientific and Cultural Organization. Universal Declaration on Bioethics and Human
p.000131: Rights. Adopted October 19, 2005, by the 33rd session of the General Conference of UNESCO. 2005.
p.000131: http://unesdoc.unesco.org/images/0014/001461/146180e.pdf
p.000131: • United Nations. Convention on Biological Diversity. 1992. www.cbd.int/convention/convention.shtml
p.000131:
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p.000131:
p.000131:
p.000131:
p.000131:
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p.000131:
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p.000131:
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p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: TCPS 2
p.000133: 133
p.000133:
p.000133:
p.000133:
p.000133: Chapter 10
p.000133: QUALITATIVE RESEARCH
p.000133:
p.000133: Introduction
p.000133: Researchers in social sciences and humanities – such as anthropology, sociology, philosophy, psychology, criminology,
p.000133: business administration, political science, communications, education and history – have a common belief in the
p.000133: desirability of trying to understand human action through systematic study and analysis. Some researchers use
p.000133: quantitative research approaches, others opt for qualitative research methods, and some use a combination of both.
p.000133: Qualitative research has a long history in many established disciplines in the social sciences and humanities, as well
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p.000199: expected to identify an individual. For the purposes of this Policy, researchers and REBs shall consider whether
p.000199: information is identifiable or non-identifiable. Information is identifiable if it, alone or when combined with other
p.000199: available information, may reasonably be expected to identify an individual. The term “personal information” generally
p.000199: denotes identifiable information about an individual. Guidance on the assessment of the potential for information to
p.000199: identify an individual is addressed in this Policy in Chapter 5, Section A.
p.000199: In some cases, research may involve interaction with individuals who are not themselves the focus of the research in
p.000199: order to obtain information. For example, one may collect information from authorized personnel to release information
p.000199: or data in the ordinary course of their employment about organizations, policies, procedures, professional practices or
p.000199: statistical reports. Such individuals are not considered participants for the purposes of this Policy. This is
p.000199: distinct from situations where individuals are considered participants because they are themselves
p.000199: the focus of the research. For example, individuals who are asked for their personal opinions about organizations, or
p.000199: who are observed in their work setting for the purposes of research, are considered participants.
p.000199: For the purposes of this Policy, human biological materials include tissues, organs, blood, plasma, serum, DNA, RNA,
p.000199: proteins, cells, skin, hair, nail clippings, urine, saliva and other body fluids. Materials related to human
p.000199: reproduction include embryos, fetuses, fetal tissues and human reproductive materials. Embryo means a human organism
p.000199: during the first 56 days of its development following fertilization or creation, excluding any time during which its
p.000199: development has been suspended, and includes any cell derived from such an organism that is used for the purpose of
p.000199: creating a human being. Fetus means a human organism during the period of its development beginning on the 57th day
p.000199: following fertilization or creation, excluding
p.000199:
p.000199: 16 TCPS 2
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
p.000199: any time during which its development has been suspended, and ending at birth. Fetal tissue includes membranes,
p.000199: placenta, umbilical cord, amniotic fluid and other tissue that contains genetic information about the fetus.
p.000199: Human reproductive materials mean a sperm, ovum or other human cell, or a human gene, as well as a part of any of
p.000199: them. The term “human biological materials” may be considered, for the purposes of this Policy, to include materials
p.000199: related to human reproduction. The last section of Chapter 12 discusses ethical issues specific to these materials.1
p.000199: When in doubt about the applicability of this Policy to a particular research project, the researcher shall seek the
p.000199: opinion of the REB. The REB makes the final decision on exemption from research ethics review.
p.000199:
p.000199: Research Exempt from REB Review
p.000199: Some research is exempt from REB review where protections are available by other means. This Policy allows the
...
p.000199: otherwise have an impact on the ethics of research. Regardless of the level of review selected, the review should
p.000199: include the necessary expertise.
p.000199: Both risks and potential benefits may span the spectrum from minimal to substantial. The concept of minimal
p.000199: risk (described above) provides a foundation for the proportionate approach to REB review. The various applications of
p.000199: the proportionate approach to REB review are addressed in Article 6.12.
p.000199: Risks to Researchers
p.000199: Risks in research are not limited to participants. In their conduct of research, researchers themselves
p.000199: may be exposed to risks that may take many forms (e.g., injury, incarceration). Risks to researchers may become a
p.000199: safety concern, especially for student researchers who are at a learning stage regarding the conduct of research, and
p.000199: who may be subject to pressures from supervisors to conduct research in unsafe situations.
p.000199: While it is not a formal part of its responsibilities, an REB may raise concerns about the safety of student
p.000199: researchers as part of its communication to the student researchers, and to their supervisors. Based on the level of
p.000199: risk, the REB may consider referring these concerns for review by an appropriate body within the institution.
p.000199:
p.000199: Endnotes
p.000199:
p.000199:
p.000199: 1 The definitions of embryo, fetus and human reproductive materials are taken from the Assisted Human Reproduction Act
p.000199: (2004, c. 2) at http://laws.justice.gc.ca/en/A-13.4 and Guidelines for Human Pluripotent Stem Cell Research at
p.000199: www.cihr-irsc.gc.ca/e/34460.html.
p.000199: 2 See guidance 3.2.1 of the International Conference on Harmonisation (ICH), Guidance for Industry – Good Clinical
p.000199: Practice: Consolidated Guideline, ICH Topic E6: Technical Requirements for the Registration of Pharmaceuticals for
p.000199: Human Use (1996, adopted by Health Canada in 1997).
p.000199: www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-eng.php
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p.000199: TCPS 2 25
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p.000199:
p.000199:
p.000199:
p.000199: Introduction
p.000199: Chapter 3
p.000199: THE CONSENT PROCESS
p.000199: This chapter sets out the ethical requirements for consent in research involving humans. Throughout this
p.000199: Policy, the term “consent” means “free, informed and ongoing consent.” For the purpose of this Policy, “free” and
p.000199: “voluntary” are used interchangeably.
p.000199: Respect for Persons implies that individuals who participate in research should do so voluntarily, understanding the
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p.000199: Article 4.3 Women shall not be inappropriately excluded from research solely on the basis of their reproductive
p.000199: capacity, or because they are pregnant or breastfeeding.
p.000199: Application Researchers should not exclude women from research on the basis of their repro- ductive capacity, or
p.000199: their pregnancy, or because they are breastfeeding, unless there is a valid reason for doing so.
p.000199: Subjecting women of childbearing potential to inappropriate requirements pre- cludes their participation in research.
p.000199: Exclusions should be made on the basis of clear criteria that reflect balanced attention to the potential benefits as
p.000199: well as the foreseeable risks of the research that may affect the welfare of women. For exam- ple, researchers should
p.000199: not require participants to use oral contraception, unless there is a valid reason for doing so.
p.000199: In considering research on pregnant or breastfeeding women, researchers and REBs shall take into account foreseeable
p.000199: risks and potential benefits for the woman and her embryo, fetus or infant, as well as the foreseeable risks and
p.000199: potential benefits of excluding pregnant or breastfeeding women from the research.
p.000199: Research Involving Children
p.000199: Children have varying degrees of maturity – metabolically, immunologically and cognitively – that may present important
p.000199: challenges for research design and the consent process, depending on the nature and complexity of the research. In
p.000199: addition to the vulnerability that arises from their developmental stage, children may also lack capacity to consent to
p.000199: participate in research (see Ar- ticle 4.6). As well, physical or psychological harms a child may experience in a
p.000199: research setting may have long-lasting consequences. As a result, researchers have often avoided the inclusion of
p.000199: children in some research, especially in clinical trials testing new treatments, so as to eliminate any risks. Clinical
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p.000175: depending on its size and usage.
p.000175: Organizations that maintain biobanks may have their own policies on privacy of, confidentiality of and access to
p.000175: materials. Researchers should be aware of requirements for compliance with such policies. For example, researchers
p.000175: may be required to apply to the organization for permission to access biological samples, and they may be required to
p.000175: enter into an agreement with the organization that sets out conditions for research access and use of materials in the
p.000175: biobank.
p.000175: Identifiable data derived from human biological materials may be linked to other research or public databases. Such
p.000175: data linking can be a powerful research tool and a valuable resource for monitoring the health of populations,
p.000175: understanding factors influencing disease, and evaluating health services and interventions. However, data linkage also
p.000175: raises separate privacy issues, discussed in Section E of Chapter 5.
p.000175:
p.000175: E. Research Involving Materials Related to Human Reproduction
p.000175: Researchers who conduct research involving human biological materials related to human reproduction shall
p.000175: follow applicable guidance expressed in other chapters of this Policy. This section provides further guidance for
p.000175: research involving embryos, fetuses, fetal tissue, and reproductive materials. For the purposes of this Policy
p.000175: the following definitions apply:3
p.000175: • Embryo means a human organism during the first 56 days of its development following fertilization or creation,
p.000175: excluding any time during which its development has been suspended, and includes any cell derived from such an
p.000175: organism that is used for the purpose of creating a human being.
p.000175:
p.000175:
p.000175:
p.000175:
p.000175: 176 TCPS 2
p.000175:
p.000175: Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction
p.000175:
p.000175: • Fetus means a human organism during the period of its development beginning on the 57th day following fertilization
p.000175: or creation, excluding any time during which its development has been suspended, and ending at birth.
p.000175: • Fetal tissue includes membranes, placenta, umbilical cord, amniotic fluid and other tissue that contains genetic
p.000175: information about the fetus.
p.000175: • Human reproductive materials means a sperm, ovum or other human cell, or a human gene, and includes a part of any
p.000175: of them.
p.000175: While research involving materials related to human reproduction has great promise for assisting the development of
p.000175: healthy pregnancies, curing illness, and repairing or rebuilding tissue, it raises special ethical considerations.
p.000175: Accordingly, this research has provoked vigorous debate. Discussion and reflection should continue as our scientific
p.000175: understanding develops.
p.000175: Significant ethical issues include consent to research involving materials related to human reproduction,
p.000175: privacy concerns, the risk of harm to those who provide reproductive materials, an embryo or fetus, and potential
p.000175: commodification of reproductive capabilities and materials related to reproduction. Researchers and REBs have a
p.000175: continuing duty to remain mindful of the public interest in these issues, and to respect policy, legal and regulatory
p.000175: requirements. In particular, researchers and REBs shall be aware of the detailed requirements and prohibitions set out
p.000175: in the Assisted Human Reproduction Act.
p.000175: Article 12.6 In addition to requirements in this chapter that apply to all research involving human biological
p.000175: materials, the following guidelines apply to research involving materials related to human reproduction:
p.000175: (a) Research using materials related to human reproduction in the context of an anticipated or ongoing pregnancy shall
p.000175: not be undertaken if the knowledge sought can reasonably be obtained by alternative methods.
p.000175: (b) Materials related to human reproduction for research use shall not be obtained through commercial transaction,
p.000175: including exchange for services.
p.000175: Application Because of the risk of harm to the woman or the fetus, Article 12.6(a) requires that the use of these
p.000175: materials be avoided where pregnancy is anticipated or ongoing, if research goals may be accomplished in some other
p.000175: way.
p.000175: Article 12.6(b) reflects concerns about the commercialization or commodification of human reproduction. Exchange for
p.000175: services refers, for instance, to trading a service, such as a medical treatment, for an in vitro embryo or gamete.
p.000175:
p.000175: Research Involving Human Embryos
p.000175: Article 12.7 Research on in vitro embryos already created and intended for implantation to achieve pregnancy is
p.000175: acceptable if:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175: TCPS 2
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p.000177: 177
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p.000177: Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction
p.000177:
p.000177: (a) the research is intended to benefit the embryo;
p.000177: (b) research interventions will not compromise the care of the woman, or the subsequent fetus;
p.000177: (c) researchers closely monitor the safety and comfort of the woman and the safety of the embryo; and
p.000177: (d) consent was provided by the gamete donors.
p.000177: Application Research potentially altering the embryo by chemical or physical manipulation shall be distinguished
p.000177: from research directed at ensuring normal fetal development. For example, the evaluation of potential teratogens and
p.000177: their effects on certain cell lineages may use early embryos, but those embryos must not be implanted for an ongoing
p.000177: pregnancy.
p.000177: The Assisted Human Reproduction Act prohibits the creation of a human embryo specifically for research purposes, with
p.000177: the limited exception of creating an embryo for the purpose of improving, or providing instruction in, assisted
p.000177: reproduction procedures.
p.000177: Article 12.8 Research involving embryos that have been created for reproductive or other purposes
p.000177: permitted under the Assisted Human Reproduction Act, but are no longer required for these purposes, may be ethically
p.000177: acceptable if:
p.000177: (a) the ova and sperm from which they are formed were obtained in accordance with Article 12.7;
p.000177: (b) consent was provided by the gamete donors;
p.000177: (c) embryos exposed to manipulations not directed specifically to their ongoing normal development will not be
p.000177: transferred for continuing pregnancy; and
p.000177: (d) research involving embryos will take place only during the first 14 days after their formation by combination of
p.000177: the gametes, excluding any time during which embryonic development has been suspended.
p.000177: Application Research on embryos requires the consent of the gamete donors. The REB may not waive the requirement
p.000177: for such consent. In particular, researchers and REBs should be aware of the Assisted Human Reproduction (Section 8
p.000177: Consent) Regulations under the Assisted Human Reproduction Act.4
p.000177:
p.000177: Research Involving Fetuses and Fetal Tissue
p.000177: Article 12.9 Research involving a fetus or fetal tissue:
p.000177: (a) requires the consent of the woman; and
p.000177:
p.000177:
p.000177:
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p.000177: Application The Guidelines for Human Pluripotent Stem Cell Research establish principles that guide the conduct of
p.000177: research with human pluripotent stem cells. The Guidelines explain their scope of application, provide examples of
p.000177: types of research to which they apply, and identify examples of research that conform and do not conform with the
p.000177: guidance. Consent, privacy and confidentiality are addressed, along with issues of commercial interests.
p.000177: Hybrids and Chimeras
p.000177: Research involving the creation of animal-human hybrids and chimeras may raise serious ethical concerns, and federal
p.000177: legislation prohibits certain activities relating to their creation. Researchers and REBs are referred to the Assisted
p.000177: Human Reproduction Act and The Updated Guidelines for Human Pluripotent Stem Cell Research for these prohibitions.
p.000177:
p.000177: Endnotes
p.000177:
p.000177:
p.000177: 1 See also Canadian Institutes of Health Research, CIHR Guidelines for Health Research Involving Aboriginal People.
p.000177: www.cihr-irsc.gc.ca/e/29134.html
p.000177: 2 For discussion of factors relevant to assessing impracticability of consent, see, for example, Canadian Institutes of
p.000177: Health Research, CIHR Best Practices for Protecting Privacy in Health Research, Section 3.3, Secondary Use (September
p.000177: 2005). www.cihr-irsc.gc.ca/e/29072.html#Element3
p.000177:
p.000177:
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p.000177:
p.000177:
p.000177: TCPS 2
p.000179: 179
p.000179:
p.000179: Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction
p.000179:
p.000179: 3 The definitions of embryo, fetus and human reproductive materials are taken from the Assisted Human Reproduction Act
p.000179: (2004, c. 2). http://laws.justice.gc.ca/en/A-13.4
p.000179: 4 Assisted Human Reproduction (Section 8 Consent) Regulations (SOR/2007-137). http://laws.justice.gc.ca/en/SOR-2007-137
p.000179: 5Canadian Institutes of Health Research, Guidelines for Human Pluripotent Stem Cell Research. June 30, 2010.
p.000179: www.cihr-irsc.gc.ca/e/42071.html
p.000179:
p.000179:
p.000179: References
p.000179:
p.000179:
p.000179: • International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for
p.000179: Human Use (ICH) defines biological sample coding categories. Health Canada has adopted these definitions.
p.000179: www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e15-eng.php
p.000179: • Organisation for Economic Co-operation and Development. (OECD), Guidelines for Human Biobanks and Genetic
p.000179: Research Databases. 2009. www.oecd.org/sti/biotechnology/hbgrd
p.000179: • Québec. Fonds de la recherche en santé du Québec. Final Report: Advisory Group on a Governance Framework for Data
p.000179: Banks and Biobanks Used for Health Research. 2006.
p.000179: www.frsq.gouv.qc.ca/en/ethique/pdfs_ethique/Rapport_groupe_conseil_anglais.pdf
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p.000185: Chapter 5 for guid- ance regarding secondary use.
p.000185: G. Gene Transfer
p.000185: Guidance set out in Chapter 11 applies to clinical trial research involving gene transfer, and Article
p.000185: 12.9 is applicable to gene transfer in utero. In the context of gene transfer research, researchers and REBs shall pay
p.000185: careful attention to the need to assess safety, minimize risk, and minimize therapeutic misconception (see Chapter 11,
p.000185: Section C). Researchers have obligations to share with participants new information that may be relevant to ongoing
p.000185: consent, and to follow up with former participants to inform them of issues that may affect their welfare.
p.000185:
p.000185: Gene alteration involves the transfer of genes into cells to induce an altered capacity of the cell. Viruses are
p.000185: commonly used vectors (carriers) to introduce the gene into the host genome. Gene alteration is irreversible – the cell
p.000185: and its descendants are forever altered and introduced changes cannot be removed. The possible use of germ line
p.000185: alteration implies changes that could be transmitted to future generations.
p.000185:
p.000185: Gene transfer research that involves alteration of human germ line cells is governed in Canada by the Assisted Human
p.000185: Reproduction Act2 and its regulations. Researchers should be aware of how this law applies to their work, such as the
p.000185: Act’s prohibition on knowingly altering the genome of a cell of a human being, or in vitro embryo, such that the
p.000185: alteration is capable of being transmitted to descendants.
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185: 186 TCPS 2
p.000185:
p.000185: Chapter 13 – Human Genetic Research
p.000185:
p.000185: The special circumstances of gene transfer must be explained to prospective participants (or authorized third parties)
p.000185: during the consent process. This includes providing information about uncertain and potentially latent risks of gene
p.000185: transfer, and any processes for long-term follow-up of participants. Guidance regarding inclusion in research (see
p.000185: Chapter 4) should be followed where gene transfer research involves children, or others who lack capacity to consent
p.000185: for themselves.
p.000185:
p.000185:
p.000185: Endnotes
p.000185:
p.000185:
p.000185: 1 In 2008, the U.S. National Institutes of Health amended its policy on publication of and access to data from
p.000185: genome-wide association studies. See National Institutes of Health, Modifications to Genome-Wide Association Studies
p.000185: (GWAS) Data Access, August 28, 2008, http://grants.nih.gov/grants/gwas/data_sharing_policy_modifications_20080828.pdf
p.000185: 2 Assisted Human Reproduction Act (2004, c. 2). http://laws.justice.gc.ca/eng/A-13.4
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p.000189: available in digital form on the Internet.
p.000189:
p.000189: Data linkage – The merging or analysis of two or more separate data sets (e.g. health information and education
p.000189: information about the same individuals) for research purposes. See also “Data set.”
p.000189:
p.000189: Data safety monitoring board – A multi-disciplinary, expert advisory group established by a research sponsor, that
p.000189: is responsible for safeguarding the interests of participants by reviewing emerging data, assessing the safety and
p.000189: efficacy of clinical trial procedures, and monitoring the overall conduct of a trial.
p.000189:
p.000189: Data set – A collection of information to be used for research purposes, including human biological materials.
p.000189:
p.000189: Debriefing – The full disclosure of the research purpose and other pertinent information to participants who have been
p.000189: involved in research employing partial disclosure or deception. Debriefing is typically done after participation has
p.000189: ended, but may be done at any time during the study.
p.000189:
p.000189: Delegated research ethics board (REB) review – The level of REB review assigned to minimal risk research projects.
p.000189: Delegated reviewers are selected from among the REB membership, with the exception of the ethics review of student
p.000189: course-based research which can be reviewed by delegates from the student’s department, faculty, or an equivalent
p.000189: level.
p.000189: Embryo – A human organism during the first 56 days of its development following fertilization or creation, excluding
p.000189: any time during which its development has been suspended. It also includes any cell derived from such an organism that
p.000189: is used for the purpose of creating a human being.
p.000189:
p.000189:
p.000189:
p.000189:
p.000189:
p.000189:
p.000189: TCPS 2
p.000191: 191
p.000191:
p.000191: Glossary
p.000191:
p.000191: Emergency preparedness plans – Plans that detail an institution’s policies and procedures for addressing research
p.000191: ethics review during public health outbreaks, natural disasters, and other publicly declared emer- gencies. See
p.000191: “Publicly declared emergency.”
p.000191:
p.000191: Emergent design – A research method in which data collection and analyses can evolve over the course of a research
p.000191: project in response to what is learned in earlier parts of the study.
p.000191:
p.000191: Fetal tissue – Membranes, placenta, umbilical cord, amniotic fluid, and other tissue that contains genetic information
p.000191: about the fetus.
p.000191: Fetus – A human organism during the period of its development beginning on the 57th day following fertilization or
p.000191: creation, excluding any time during which its development has been suspended, and ending at birth.
p.000191:
p.000191: Full research ethics board (REB) review – The level of REB review assigned to above minimal risk re- search projects.
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Social / employees
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p.000199: and their possible secondary use is provided in Chapters 5 and 12.
p.000199: Activities Not Requiring REB Review
p.000199: The following distinguishes research requiring REB review from non-research activities that have traditionally employed
p.000199: methods and techniques similar to those employed in research. Such activities are not considered “research” as defined
p.000199: in this Policy, and do not require REB review. Activities outside the scope of research subject to REB review (see
p.000199: Articles 2.5 and 2.6), as defined in this Policy, may still raise ethical issues that would benefit from careful
p.000199: consideration by an individual or a body capable of providing some independent guidance, other than an REB. These
p.000199:
p.000199: TCPS 2 19
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
p.000199: ethics resources may be based in professional or disciplinary associations, particularly where those associations have
p.000199: established best practices guidelines for such activities in their discipline.
p.000199: Article 2.5 Quality assurance and quality improvement studies, program evaluation activities, and performance
p.000199: reviews, or testing within normal educational requirements when used exclusively for assessment, management or
p.000199: improvement purposes, do not constitute research for the purposes of this Policy, and do not fall within the scope of
p.000199: REB review.
p.000199: Application Article 2.5 refers to assessments of the performance of an organization or its employees or
p.000199: students, within the mandate of the organization, or according to the terms and conditions of employment or training.
p.000199: Those activities are normally administered in the ordinary course of the operation of an organization where
p.000199: participation is required, for example, as a condition of employment in the case of staff performance reviews, or
p.000199: an evaluation in the course of academic or professional training. Other examples include student course
p.000199: evaluations, or data collection for internal or external organizational reports. Such activities do not normally follow
p.000199: the consent procedures outlined in this Policy.
p.000199: If data are collected for the purposes of such activities but later proposed for research purposes, it would be
p.000199: considered secondary use of information not originally intended for research, and at that time may
p.000199: require REB review in accordance with this Policy. Refer to Section D of Chapter 5 for guidance
p.000199: concerning secondary use of identifiable information for research purposes.
p.000199: Article 2.6 Creative practice activities, in and of themselves, do not require REB review. However, research
p.000199: that employs creative practice to obtain responses from participants that will be analyzed to answer a research
p.000199: question is subject to REB review.
p.000199: Application Creative practice is a process through which an artist makes or interprets a work or works of art. It
p.000199: may also include a study of the process of how a work of art is generated. Creative practice activities do not require
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p.000199: (b) Consent can be withdrawn at any time.
p.000199: (c) If a participant withdraws consent, the participant can also request the with- drawal of their data or human
p.000199: biological materials.
p.000199: Application (a) The voluntariness of consent is important because it respects human dignity and means that
p.000199: individuals have chosen to participate in research according to their own values, preferences and wishes.
p.000199: The approach to recruitment is an important element in assuring voluntariness. In particular, how, when and where
p.000199: participants are approached, and who re- cruits them are important elements in assuring (or undermining) voluntariness.
p.000199: In considering the voluntariness of consent, REBs and researchers should be cognizant of situations where undue
p.000199: influence, coercion or the offer of incen- tives may undermine the voluntariness of a participant’s consent to
p.000199: participate in research.
p.000199: UndueXInfluence
p.000199: Undue influence and manipulation may arise when prospective participants are recruited by individuals in a position of
p.000199: authority. The influence of power re- lationships (e.g., employers and employees, teachers and students, commanding
p.000199: officers and members of the military or correctional officers and prisoners) on the voluntariness of consent should be
p.000199: judged from the perspective of prospec- tive participants, since the individuals being recruited may feel constrained
p.000199: to follow the wishes of those who have some form of control over them. This con- trol may be physical, psychological,
p.000199: financial or professional, for example, and may involve offering some form of inducement or threatening some form of
p.000199: deprivation. In such situations, the control exerted in a power relationship may place undue pressure on the
p.000199: prospective participants. At the extreme, there can be no voluntariness if consent is secured by the order of
p.000199: authorities.
p.000199: REBs and researchers should also pay particular attention to elements of trust and dependency in relationships (e.g.,
p.000199: between physician and patient or between professor and student). These relationships can impose undue influence on the
p.000199: individual in the position of dependence to participate in research projects. Any relationship of dependency, even a
p.000199: nurturing one, may give rise to undue in- fluence even if it is not applied overtly. There may be a greater risk of
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p.000199: context shall advise the REB and prospective participants about the possibility of compelled disclosure. Advising
p.000199: participants of reasonably foreseeable disclosure requirements is an important aspect of the consent process.
p.000199: Situations may arise where researchers unexpectedly acquire information that gives rise to a reason for disclosure to a
p.000199: third party, or researchers may receive a disclo- sure demand from a third party. In such cases, advising a participant
p.000199: about the disclosure may be important to respect the trust relationship with the participant, and to ensure the
p.000199: validity of the participant’s ongoing consent. Decisions about whether, how and when to advise a participant of
p.000199: disclosure should be guided by any applicable disciplinary standards and consultation with the REB, colleagues,
p.000199: relevant professional body and/or legal counsel.
p.000199: Researchers shall also inform participants and seek their consent if their personal information may be shared with
p.000199: government departments or agencies, community partners in the research, personnel from an agency that monitors the
p.000199: research, a re- search sponsor (such as a pharmaceutical company), the REB or a regulatory agency.
p.000199: Researchers shall avoid being put in a position of becoming informants for author- ities or leaders of
p.000199: organizations. For example, when records of prisoners, employees, students or others are used for research
p.000199: purposes, the researcher shall not provide authorities with results that could identify individuals unless the prior
p.000199: written consent of the participants has been given. Researchers may, however, pro- vide administrative bodies with
p.000199: aggregated data that cannot be linked to individuals for purposes such as policy-making or program evaluation. When
p.000199: seeking consent, researchers shall advise prospective participants if aggregated data from a project
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 59
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: may be disclosed, particularly where such disclosure may pose a risk to the partic- ipants. For example, aggregate data
p.000199: provided to authorities about research on illicit drug use in a penitentiary may pose risks of reprisal to the
p.000199: prisoners, even though they are not identified individually.
p.000199: When planning a study, researchers should incorporate any applicable statute-based or other legal principles that may
p.000199: afford protection for the privacy of participants and the confidentiality of research information.
p.000199:
p.000199: C. Safeguarding Information
p.000199: Article 5.3 Researchers shall provide details to the REB regarding their proposed measures for safeguarding
p.000199: information, for the full life cycle of information: its collection, use, dissemination, retention and/or disposal.
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p.000199: TCPS 2 45
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p.000199: Chapter 4
p.000199: FAIRNESS AND EQUITY IN RESEARCH PARTICIPATION
p.000199:
p.000199: Introduction
p.000199: The principle of Justice holds that particular individuals, groups or communities should neither bear an unfair share
p.000199: of the direct burdens of participating in research, nor should they be unfairly excluded from the potential benefits of
p.000199: research participation. Inclusiveness in research and fair distribution of benefits and burdens should be important
p.000199: considerations for researchers, research ethics boards (REBs), research institutions and sponsors. Issues of fair and
p.000199: equitable treatment arise in deciding whether and how to include individuals, groups or communities in research, and
p.000199: the basis for the exclusion of some.
p.000199: This chapter addresses inclusion in research of individuals and groups that might be inappropriately excluded on the
p.000199: basis of attributes such as culture, language, gender, race, ethnicity, age and dis- ability. It provides guidance
p.000199: relevant to inclusion in research of specific groups such as women, children, the elderly and those who lack capacity
p.000199: to consent to participate in research. Historically, these groups have often been inappropriately excluded from
p.000199: research.
p.000199: This chapter also addresses the fair inclusion and equitable treatment of individuals, groups and communities whose
p.000199: situation or circumstances make them vulnerable in the context of a specific research project. These individuals run
p.000199: the risk of being included in research in ways that may be unfair and inequitable. This chapter provides guidance
p.000199: relevant to the equitable distribution of the risks and benefits of research.
p.000199: Over-protectionist attitudes or practices of researchers or REBs, whether intentional or inadvertent, can exclude some
p.000199: members of society from participating in research. The exclusion of individuals, groups or communities may constitute a
p.000199: failure to treat them justly. For example, age has been used to exclude individuals from participation in research,
p.000199: particularly health research (e.g., studies that only accept participants between the ages of 18 to 35). As a result,
...
p.000199: the elderly in research, for example, ensures that treatments frequently given to these populations are effective and
p.000199: safe.
p.000199: Researchers, institutions and REBs all have important roles to play in advancing that societal com- mitment, and
p.000199: ensuring a fair distribution of the benefits and burdens of research. Researchers and REBs must navigate between the
p.000199: dangers of imposing unfair burdens on particular participants, groups and communities, and overprotecting them. In
p.000199: assessing fairness and equity issues in the research ethics process, REBs should not intervene in the choice of
p.000199: research topics.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 47
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: A. Appropriate Inclusion
p.000199: Article 4.1 Taking into account the scope and objectives of their research, researchers should be inclusive in
p.000199: selecting participants. Researchers shall not exclude individuals from the opportunity to participate in research on
p.000199: the basis of attributes such as culture, language, religion, race, disability, sexual orientation, ethnicity,
p.000199: linguistic proficiency, gender or age, unless there is a valid reason for the exclusion.
p.000199: Application Article 4.1 is based on the principle of Justice. It imposes a duty on researchers not to exclude
p.000199: individuals or groups from participation for reasons that are unrelated to the research. This duty is explicitly stated
p.000199: because groups have been inappropri- ately excluded from participation in research on the basis of attributes such as
p.000199: gender, race, ethnicity, age and disability.
p.000199: The focus, objective, nature of research and context in which the research is con- ducted inform the inclusion and
p.000199: exclusion criteria for a specific research project. Some research may be focused on a certain individual (such as in a
p.000199: biography), or a group of individuals who share a specific characteristic (e.g., an identifiable group of painters who
p.000199: happen to be all of one sex; a religious order that is restricted to one sex). Other examples include research that is
p.000199: focused on specific cultural tra- ditions or languages, or on one age group (e.g., a biomechanical modeling study of
p.000199: posture corrections in adolescents). Such research should not be precluded so long as the selection criteria for those
p.000199: to be included in the research are germane to answering the research question. Researchers who plan to actively exclude
p.000199: par- ticular groups should clarify to their REBs the grounds for the exclusion.
p.000199: Where a language barrier exists between the researcher and the prospective partic- ipant, various measures may be
p.000199: used to ensure effective communication in recruitment and consent discussions. For example, an intermediary who
...
p.000199:
p.000199: B. Inappropriate Exclusion
p.000199: Research Involving Women
p.000199: Women have historically been inappropriately excluded from participating in some research. This exclusion of women,
p.000199: where unwarranted, has delayed the advancement of knowledge, denied po- tential benefits to women, and exposed women to
p.000199: harm when research findings from male-only research projects were generalized inappropriately to women, as has often
p.000199: been the case in clinical drug trials. The inclusion of women in research advances the commitment to Justice, improves
p.000199: the generalizability of research findings to women where that is a goal of the research, and is es- sential to ensure
p.000199: that women and men benefit equally from research.
p.000199:
p.000199:
p.000199: 48 TCPS 2
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: Article 4.2 Women shall not be inappropriately excluded from research solely on the basis of gender or sex.
p.000199: Application Researchers should not exclude women from research unless there is a valid reason for doing so. While
p.000199: some research is properly focused on particular research pop- ulations that do not include women, or include very few
p.000199: women, women should generally be represented where there is a reasonable expectation that the results of the research
p.000199: will be generalized to women.
p.000199: Article 4.2 rejects discriminatory and unethical use of inclusion or exclusion criteria that presumptively or
p.000199: inappropriately exclude women because of their gender or sex.
p.000199: Article 4.3 Women shall not be inappropriately excluded from research solely on the basis of their reproductive
p.000199: capacity, or because they are pregnant or breastfeeding.
p.000199: Application Researchers should not exclude women from research on the basis of their repro- ductive capacity, or
p.000199: their pregnancy, or because they are breastfeeding, unless there is a valid reason for doing so.
p.000199: Subjecting women of childbearing potential to inappropriate requirements pre- cludes their participation in research.
p.000199: Exclusions should be made on the basis of clear criteria that reflect balanced attention to the potential benefits as
p.000199: well as the foreseeable risks of the research that may affect the welfare of women. For exam- ple, researchers should
p.000199: not require participants to use oral contraception, unless there is a valid reason for doing so.
p.000199: In considering research on pregnant or breastfeeding women, researchers and REBs shall take into account foreseeable
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p.000115: community engagement processes are followed to endorse a project, all other ethical safeguards set out in this chapter
p.000115: remain applicable.
p.000115: Recognizing Diverse Interests within Communities
p.000115: Article 9.6 In engaging territorial or organizational communities, researchers should ensure, to the extent
p.000115: possible, that they take into consideration the views of all relevant sectors – including individuals and subgroups who
p.000115: may not have a voice in the formal leadership. Groups or individuals whose circumstances make them vulnerable
p.000115: may need or desire special measures to ensure their safety in the context of a specific research project. Those who
p.000115: have been excluded from participation in the past may need special measures to ensure their inclusion in research.
p.000115: Application Groups or individuals whose circumstances may make them vulnerable or marginalized within
p.000115: territorial or organizational communities should not be deprived of opportunities to participate in, and
p.000115: influence, research affecting their welfare. For example, people living with HIV/AIDS, impoverished youth or
p.000115: women who have suffered abuse may experience barriers to participation.
p.000115: Gender-based analysis is being applied in First Nations, Inuit and Métis organizations and communities to
p.000115: promote or restore recognition of women’s responsibilities in the conduct of community life – including decision
p.000115: making that directly affects their welfare. The legacy of patriarchal governance structures continues to pose
p.000115: challenges to women’s full participation. Approaches that are attentive to cultural considerations help to ensure the
p.000115: equitable participation and benefit of women throughout the life cycle of a research project (see Article 4.2).
p.000115: Research undertaken secretly or as a direct challenge to legitimate authority may increase risks to participants whose
p.000115: circumstances make them vulnerable, may deepen rifts within the community, and actually impede the advancement of
p.000115: social
p.000115:
p.000115: 116 TCPS 2
p.000115:
p.000115: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000115:
p.000115: justice. Strategies that have proven effective to secure the inclusion and promote the safety of diverse sectors within
p.000115: a community include: advocacy by moral authorities in the community; special measures to protect the identity of
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Social / parents
Searching for indicator parents:
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p.000199: within the exception to the general re- quirement of full disclosure for consent, the research must meet the
p.000199: requirements of Article 3.7.
p.000199: Where partial disclosure or deception has been used, debriefing is an important mechanism in maintaining the
p.000199: participant’s trust in the research community. The debriefing referred to in Article 3.7(d) should be proportionate to
p.000199: the sensitivity of the issue. Often, debriefing can be a simple and straightforward candid disclosure. In sensitive
p.000199: cases, researchers should also provide a full explanation of why participants were temporarily led to believe
p.000199: that the research, or some aspect of it, had a different purpose, or why participants received less than full
p.000199: disclosure. The researchers should give details about the importance of the research, the necessity of having to use
p.000199: partial disclosure or deception, and express their concern about the welfare of the participants. They should seek to
p.000199: remove any misconceptions that may have arisen and to re-establish any trust that might have been lost, by explaining
p.000199: why these research procedures were necessary to obtain scientifically valid findings.
p.000199: Immediate, full debriefing of all individuals who have contributed data may not be feasible in all cases. In studies
p.000199: with data collection over a longer term, debriefing may have to be deferred until the end of the project. In some cases
p.000199: – for example, in research involving children – it may be more appropriate to debrief the parents, guardians or
p.000199: authorized third parties rather than the participants themselves. In other cases, it may be more appropriate to debrief
p.000199: the entire family or community. When debriefing, researchers should be alert and sensitive to participants’ needs,
p.000199: feelings, reactions and concerns.
p.000199: In studies involving partial disclosure or deception in which an alteration to the requirement for prior consent has
p.000199: been allowed, participants must nevertheless be able to indicate their consent or their refusal at the
p.000199: conclusion of the project, following debriefing. In cases where participants express concerns about their
p.000199: participation in a project, the researcher may give participants the option of removing their data from the project.
p.000199: Where the terms of the research proposal do not permit the participants to withdraw their data, in the absence
p.000199: of the consent of the participant, the identity of the participants shall be protected at all times during and
p.000199: following completion of the project. Participants who express concern about the conduct of the project at the time of
p.000199: debriefing, or who contest the limits imposed
p.000199:
p.000199:
p.000199: 38 TCPS 2
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: on withdrawing their data, should be given the contact information for the REB that approved the research. Researchers
...
p.000183: health care interventions or lifestyle changes are recommended, and any implica- tions of the information for
p.000183: biological relatives. Researchers should explain differ- ences between genetic testing in a research context and
p.000183: testing in a clinical context. Clinical genetic testing may be needed to clarify or confirm findings obtained in
p.000183: research. Where researchers share information with biological relatives or other family, community or group members,
p.000183: genetic counselling should be made avail- able to them as well as the participants. The counselling service provider
p.000183: must have the appropriate experience or training to provide genetic counselling, but need not necessarily hold a
p.000183: diploma, degree or professional designation in genetic coun- selling.
p.000183: D. Genetic Research Involving Families
p.000183: Article 13.5 Researchers who seek to recruit members of a family to participate in genetic re- search shall:
p.000183: (a) ensure recruitment processes respect privacy and other personal interests of family members; and
p.000183: (b) seek consent from individual family members.
p.000183: Application Recruitment of members of a family may take place in various ways: through (a) the researcher, (b) an
p.000183: individual participant, or (c) a third party on behalf of an individual participant. A family group, such as parents
p.000183: and a child, or several adult siblings, may all receive an invitation at the same time from the researcher to
p.000183: participate in genetic research. Alternatively, researchers may seek permission from an individual participant to
p.000183: contact family members to invite participation. It may be preferable for the participant to make initial contact with
p.000183: the family member, in
p.000183:
p.000183:
p.000183: 184 TCPS 2
p.000183:
p.000183: Chapter 13 – Human Genetic Research
p.000183:
p.000183: order to respect privacy interests or known sensitivities. The participant may prefer to identify a third party to
p.000183: inform family members about the opportunity to participate in genetic research. However, an approach by someone
p.000183: in a position of authority over family members may raise concerns about undue influence or manipulation.
p.000183: Refer to Chapter 3 for further guidance in regard to the voluntariness of consent.
p.000183: Family members may have conflicting views about participation in research, and some may have specific sensitivities or
p.000183: objections. Researchers should recognize the potential for conflict within families and be respectful of any known
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Social / philosophical differences/differences of opinion
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p.000199:
p.000199: Chapter 1
p.000199: ETHICS FRAMEWORK
p.000199:
p.000199: A. Importance of Research and Research Ethics
p.000199: The search for knowledge about ourselves and the world around us is a fundamental human endeavour. Research is a
p.000199: natural extension of this desire to understand and to improve the world in which we live.
p.000199: The scope of research is vast. On the purely physical side, it ranges from seeking to understand the origins of the
p.000199: universe down to the fundamental nature of matter. At the analytic level, it covers mathematics, logic and metaphysics.
p.000199: Research involving humans ranges widely, including attempts to understand the broad sweep of history, the workings of
p.000199: the human body and the body politic, the nature of human interactions and the impact of nature on humans – the list is
p.000199: as boundless as the human imagination. For the purposes of this Policy, research is defined as an undertaking in-
p.000199: tended to extend knowledge through a disciplined inquiry or systematic investigation.
p.000199: There can be no doubt that research has greatly enriched and improved our lives. Significant ad- vances in human
p.000199: understanding in the social sciences, humanities, natural sciences, engineering and health sciences have been made as a
p.000199: result of research involving humans. A fundamental prem- ise of this Policy is that research can benefit human society.
p.000199: In order to maximize the benefits of research, researchers must have academic freedom. Academic freedom includes
p.000199: freedom of in- quiry, the right to disseminate the results of that inquiry, freedom to challenge conventional thought,
p.000199: freedom to express one’s opinion about the institution, its administration or the system in which one works, and
p.000199: freedom from institutional censorship. With academic freedom comes responsibility, including the responsibility to
p.000199: ensure that research involving humans meets high scientific and ethical standards that respect and protect the
p.000199: participants. Thus, researchers’ com- mitment to the advancement of knowledge also implies duties of honest and
p.000199: thoughtful inquiry, rigorous analysis, commitment to the dissemination of research results, and adherence to the use of
p.000199: professional standards. There is a corresponding responsibility on the part of institutions to de- fend researchers in
p.000199: their efforts to uphold academic freedom and high ethical, scientific and professional standards.
p.000199: Research is a step into the unknown. Because it seeks to understand something not yet revealed, research often entails
p.000199: risks to participants and others. These risks can be trivial or profound, phys- ical or psychological, individual or
p.000199: social. History offers unfortunate examples where research participants have been needlessly, and at times profoundly,
p.000199: harmed by research, sometimes even dying as a result. Ethical principles and guidelines play an important role in
p.000199: advancing the pursuit of knowledge while protecting and respecting research participants in order to try to prevent
p.000199: such occurrences.
p.000199: People have also been gratified and have had their lives enriched by their participation in research, either because
p.000199: they may have benefited directly or because their participation has contributed to
p.000199:
p.000199: TCPS 2 7
p.000199:
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p.000199: proteins, cells, skin, hair, nail clippings, urine, saliva and other body fluids. Materials related to human
p.000199: reproduction include embryos, fetuses, fetal tissues and human reproductive materials. Embryo means a human organism
p.000199: during the first 56 days of its development following fertilization or creation, excluding any time during which its
p.000199: development has been suspended, and includes any cell derived from such an organism that is used for the purpose of
p.000199: creating a human being. Fetus means a human organism during the period of its development beginning on the 57th day
p.000199: following fertilization or creation, excluding
p.000199:
p.000199: 16 TCPS 2
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
p.000199: any time during which its development has been suspended, and ending at birth. Fetal tissue includes membranes,
p.000199: placenta, umbilical cord, amniotic fluid and other tissue that contains genetic information about the fetus.
p.000199: Human reproductive materials mean a sperm, ovum or other human cell, or a human gene, as well as a part of any of
p.000199: them. The term “human biological materials” may be considered, for the purposes of this Policy, to include materials
p.000199: related to human reproduction. The last section of Chapter 12 discusses ethical issues specific to these materials.1
p.000199: When in doubt about the applicability of this Policy to a particular research project, the researcher shall seek the
p.000199: opinion of the REB. The REB makes the final decision on exemption from research ethics review.
p.000199:
p.000199: Research Exempt from REB Review
p.000199: Some research is exempt from REB review where protections are available by other means. This Policy allows the
p.000199: following exemptions from the requirement for REB review, as outlined below.
p.000199: Article 2.2 Research that relies exclusively on publicly available information does not require REB review when:
p.000199: (a) the information is legally accessible to the public and appropriately protected by law; or
p.000199: (b) the information is publicly accessible and there is no reasonable expectation of privacy.
p.000199: Application For the purposes of this Policy, publicly available information is any existing stored documentary
p.000199: material, records or publications, which may or may not include identifiable information. Some types of information are
p.000199: legally accessible to the public in a certain form and for a certain purpose, as specified by law or regulations:
p.000199: registries of deaths, court judgments, or public archives and publicly available statistics (e.g., Statistics Canada
p.000199: public use files), for example. In Canada, all publicly available archives (national, provincial or municipal)
p.000199: have policies governing access to their records. An archival record or database that is subject to restrictions, such
p.000199: as those under access to information and privacy legislation or contractual restrictions imposed by the donor of the
p.000199: records, may also be considered publicly available for the purposes of this Policy.
...
p.000199: provisions for consulting ad hoc ad- visors. Consultation with an ad hoc advisor shall not alter the composition and
p.000199: representation of the REB as outlined in Article 6.4.
p.000199: Ad hoc advisors are consulted for a specific research ethics review and for the du- ration of that review. Should this
p.000199: occur regularly, the membership of the REB should be modified to ensure appropriate expertise on the REB. For example,
p.000199: in cases where ethics review of research on topics related to Aboriginal peoples is regularly required, the REB
p.000199: membership should be modified to ensure that relevant and competent knowledge and expertise of Aboriginal cultures are
p.000199: captured within its regular membership.
p.000199: While ad hoc advisors may complement the REB through their experience, knowl- edge or expertise, their input is a form
p.000199: of consultation that may or may not be considered in the final decision of an REB. They are not REB members and, as
p.000199: such, do not necessarily have the knowledge and experience gained from reviewing research proposals as members. Ad hoc
p.000199: advisors should not be counted in the quo- rum for an REB, nor be allowed to vote on REB decisions.
p.000199: Terms of Appointment of REB Members
p.000199: Article 6.6 In appointing REB members, institutions shall establish their terms to allow for continuity of the
p.000199: research ethics review process.
p.000199: Application In appointing REB members, institutions should arrange the terms of members and their rotation to
p.000199: balance the need to maintain continuity with the need to ensure di- versity of opinion, and the opportunity to spread
p.000199: knowledge and experience gained from REB membership throughout the institution and community. The REB mem- bership
p.000199: selection process should be fair and impartial. Institutions should have written policies that define the process of
p.000199: appointing REB members.
p.000199: Article 6.7 In appointing and renewing REB members, institutions should consider the quali- fications and
p.000199: expertise their REBs need. Institutions should provide REB members with necessary training opportunities to effectively
p.000199: review the ethical issues raised by research proposals that fall within the mandate of their REB.
p.000199:
p.000199:
p.000199: TCPS 2 73
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: Application An REB should have adequate expertise, experience and training to understand the research disciplines,
p.000199: methodologies and approaches of the research that it considers for research ethics review. Although an REB possesses
p.000199: the necessary expertise globally, each REB member brings specialized and complementary expertise and knowledge, or
p.000199: relevant experience to the ethics review of research involving hu- mans.
p.000199: Institutions should ensure that all REB members receive appropriate education and training in ethics review of research
p.000199: involving humans, to enable them to fulfil their duties. This includes providing training opportunities for all members
...
p.000199: not supported by this Policy.
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 83
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: Appeal of REB Decisions
p.000199: Article 6.19 Institutions shall have an established mechanism and a procedure in place for promptly handling appeals
p.000199: from researchers when, after reconsideration, the REB has refused ethics approval of the research.
p.000199: Application In cases when researchers and REBs cannot reach agreement through reconsider- ation, the institution
p.000199: shall provide access to an established appeal process for the review of an REB decision. The researcher and the REB
p.000199: must have fully exhausted the reconsideration process, and the REB must have issued a final decision before the
p.000199: researcher initiates an appeal.
p.000199: Based on its written institutional policies, the same authority that established the REB shall establish or appoint an
p.000199: appeal committee that reflects a range of expertise and knowledge similar to that of the REB, and that meets the
p.000199: procedural require- ments of this Policy. An appeal committee may be an ad hoc or a permanent committee.
p.000199: Members of the REB whose decision is under appeal shall not serve on that appeal committee.
p.000199: It should be stressed that the appeal process is not a substitute for REBs and re- searchers working closely together
p.000199: to ensure high-quality ethical research, nor is it a forum to merely seek a second opinion.
p.000199: Institutions may wish to explore regional cooperation or alliances, including the sharing of appeal boards. If two
p.000199: institutions decide to use each other’s REB as an appeal board, a formal letter of agreement between institutions is
p.000199: required (see Chapter 8).
p.000199: It is not the role of the three federal research Agencies that are responsible for this Policy to consider any appeals
p.000199: of REB decisions.
p.000199: Article 6.20 The appeal committee shall have the authority to review negative decisions made by an REB. In so doing,
p.000199: it may approve, reject or request modifications to the re- search proposal. Its decision on behalf of the institution
p.000199: shall be final.
p.000199: Application Researchers have the right to request an appeal of an REB decision. An appeal can be launched for
p.000199: procedural or substantive reasons. The onus is on the researchers to justify the grounds on which they request an
p.000199: appeal and to indicate any breaches to the research ethics review process or any elements of the REB decision that are
p.000199: not supported by this Policy.
p.000199: The appeal committee shall function impartially, provide a fair hearing to those in- volved, and provide reasoned
p.000199: and appropriately documented opinions and decisions. Both the researcher and a representative of the REB shall be
p.000199: granted the opportunity to address the appeal committee, but neither shall be present when the
p.000199:
p.000199:
p.000199:
p.000199: 84 TCPS 2
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
...
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p.000185:
p.000185:
p.000185:
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p.000185:
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p.000185:
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p.000185:
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p.000185:
p.000185:
p.000185:
p.000185:
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p.000185:
p.000185:
p.000185:
p.000185:
p.000185: TCPS 2
p.000187: 187
p.000187:
p.000187:
p.000187:
p.000187: Glossary
p.000187:
p.000187: This glossary is intended to assist readers in their understanding of the Tri-Council Policy Statement: Ethical Conduct
p.000187: for Research Involving Humans (TCPS), also referred to as “the Policy.” Definitions that have been provided in the main
p.000187: text of the Policy are also repeated here. Additional terms are defined in accordance with the purposes of the Policy.
p.000187: For more detailed descriptions of many terms it is best to read them in the context of the chapters in which they
p.000187: appear – consult the Index for the appropriate reference.
p.000187:
p.000187: Aboriginal peoples – Persons of Indian (First Nations), Inuit, or Métis descent, regardless of where they reside and
p.000187: whether or not their names appear on an official register. In the international context, the term comparable to
p.000187: Aboriginal peoples is Indigenous peoples.
p.000187:
p.000187: Academic freedom – The collective freedom of faculty and students to conduct research, and to disseminate ideas or
p.000187: facts without religious, political, or institutional restrictions. It includes freedom of inquiry, freedom to challenge
p.000187: conventional thought, freedom to express one’s opinion about the institution, its administration, or the system in
p.000187: which one works, and freedom from institutional censorship.
p.000187:
p.000187: Ad hoc advisor – A person with relevant and competent knowledge and expertise consulted by a research ethics board for
p.000187: a specific research ethics review, and for the duration of that review. The ad hoc advisor is not a member of the
p.000187: research ethics board.
p.000187:
p.000187: Agencies, the – Canada’s three federal research agencies: the Canadian Institutes of Health Research (CIHR); the
p.000187: Natural Sciences and Engineering Research Council of Canada (NSERC); and the Social Sci- ences and Humanities Research
p.000187: Council of Canada (SSHRC).
p.000187:
p.000187: Appeal – A process that allows a researcher to request a review of a research ethics board (REB) decision when, after
p.000187: reconsideration, the REB has refused ethics approval of the research.
p.000187:
p.000187: Appeal mechanism – A procedure established by an institution to promptly handle a researcher’s appeal of a research
p.000187: ethics board (REB) decision. An ad hoc or permanent appeal committee, which reflects a range of expertise and knowledge
p.000187: similar to that of the REB, is established or appointed by the same authority that established the REB.
p.000187:
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Searching for indicator philosophy:
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p.000131: Aboriginal Health Organization and Inuit Tapiriit Kanatami, Research and Research Ethics Fact Sheets.
p.000131: www.naho.ca/inuit/e/ethics/factsheets.php
p.000131: • Royal Commission on Aboriginal Peoples. Report of the Royal Commission on Aboriginal Peoples. “Ethical Guidelines
p.000131: for Research.” In Volume 5, Renewal: A Twenty-Year Commitment, Ottawa: Canada Communications Group. 1996. It can also
p.000131: be accessed at www.ainc-inac.gc.ca/ap/rrc-eng.asp
p.000131: • United Nations Educational, Scientific and Cultural Organization. Universal Declaration on Bioethics and Human
p.000131: Rights. Adopted October 19, 2005, by the 33rd session of the General Conference of UNESCO. 2005.
p.000131: http://unesdoc.unesco.org/images/0014/001461/146180e.pdf
p.000131: • United Nations. Convention on Biological Diversity. 1992. www.cbd.int/convention/convention.shtml
p.000131:
p.000131:
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p.000131: TCPS 2
p.000133: 133
p.000133:
p.000133:
p.000133:
p.000133: Chapter 10
p.000133: QUALITATIVE RESEARCH
p.000133:
p.000133: Introduction
p.000133: Researchers in social sciences and humanities – such as anthropology, sociology, philosophy, psychology, criminology,
p.000133: business administration, political science, communications, education and history – have a common belief in the
p.000133: desirability of trying to understand human action through systematic study and analysis. Some researchers use
p.000133: quantitative research approaches, others opt for qualitative research methods, and some use a combination of both.
p.000133: Qualitative research has a long history in many established disciplines in the social sciences and humanities, as well
p.000133: as many areas in the health sciences (e.g., nursing, occupational therapy). The use of qualitative approaches is
p.000133: increasing, whether in health research or in social sciences and humanities disciplines. Within specific disciplines,
p.000133: ethics guidelines have been created to address the issues inherent in the use of, for example, particular methods,
p.000133: technologies and settings. Qualitative research approaches are inherently dynamic and may be grounded in
p.000133: different assumptions than those that shape quantitative research approaches. Many of the research practices and
p.000133: methodological requirements that characterize qualitative research approaches parallel those that characterize
p.000133: quantitative approaches such as concerns regarding research quality. However, as is the case with all research
p.000133: involving humans, the criteria are adapted to the specific subject matter, context and epistemological assumptions
p.000133: about the nature of knowledge in the specific area of research of the specific project.
...
Social / public official
Searching for indicator public official:
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p.000199: not supported by this Policy.
p.000199: The appeal committee shall function impartially, provide a fair hearing to those in- volved, and provide reasoned
p.000199: and appropriately documented opinions and decisions. Both the researcher and a representative of the REB shall be
p.000199: granted the opportunity to address the appeal committee, but neither shall be present when the
p.000199:
p.000199:
p.000199:
p.000199: 84 TCPS 2
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: appeal committee deliberates and makes a decision. Appeal committee decisions on behalf of the institution shall be
p.000199: final, and should be communicated in writing (in print or by electronic means) to researchers and to the REB whose
p.000199: decision was appealed. Recourse to judicial review may be available to the researcher.
p.000199:
p.000199: D. Research Ethics Review during Publicly Declared Emergencies
p.000199:
p.000199: This section addresses research ethics review within the context of the official declaration of public emergencies. For
p.000199: the purposes of this Policy, a publicly declared emergency is an emergency sit- uation that, due to the extraordinary
p.000199: risks it presents, has been proclaimed as such by an authorized public official (in accordance with legislation and/or
p.000199: public policy).
p.000199: Publicly declared emergencies are extraordinary events that arise suddenly or unexpectedly, and require urgent or quick
p.000199: responses to minimize devastation. Examples include hurricanes and other natural disasters, large communicable disease
p.000199: outbreaks, catastrophic civil disorders, bio-hazardous releases, environmental disasters, and humanitarian emergencies.
p.000199: They tend to be time-limited. They may severely disrupt or may destroy normal functioning of institutions and
p.000199: communities, as well as individual lives. Once an emergency has been designated a publicly declared emergency,
p.000199: authorities may exercise special responsibilities and powers to deal with the situation, and the ex- ercise of those
p.000199: responsibilities may temporarily modify normal procedures or practices. This section therefore applies to narrow,
p.000199: limited and exceptional circumstances.
p.000199: There is a growing awareness of the need for institutional planning to respond to publicly declared emergencies, and
p.000199: the associated potential challenges for research ethics review. Given the extraor- dinary circumstances that
p.000199: participants are potentially subjected to in publicly declared emergencies, special attention and effort should be
...
p.000199: even in the face of acute public necessity. Indeed, research ethics review during publicly declared
p.000199: emergencies is even more important than under normal circumstances, and may require even greater care, since everyone
p.000199: (participants, researchers and REB members themselves) may be rendered more vulnerable by the nature of the emergency.
p.000199: Research Ethics Review Policy and Procedures during Publicly Declared Emergencies Article 6.22 Research ethics
p.000199: policies and procedures for emergencies take effect once an emer-
p.000199: gency has been publicly declared. They should cease to apply as soon as is feasible after the end of the publicly
p.000199: declared emergency.
p.000199: Application Because emergencies present extraordinary public risks that warrant special re- sponses, legislation
p.000199: or public policies usually require that they be officially proclaimed or declared. Research ethics review
p.000199: procedures that have been estab- lished for use during publicly declared emergencies should be applied only after an
p.000199: authorized public official declares a public emergency. These procedures there- fore apply to very narrow, limited and
p.000199: exceptional circumstances. Institutions and REBs must endeavour to return to normal operating procedures as soon as
p.000199: possible after public officials have declared that the emergency is over.
p.000199: Respecting Core Principles: Limiting Exceptions
p.000199: Article 6.23 REBs should give special care to requests for exceptions to the principles and pro- cedures outlined in
p.000199: this Policy during publicly declared emergencies.
p.000199: Application Especially during times of emergency, researchers, REBs and institutions need to be vigilant and
p.000199: exercise due diligence in respecting ethical principles, procedures and the law in effect during the emergency to
p.000199: preserve the values, purpose and pro- tection that the principles of this Policy advance.
p.000199: To guide fair and reasonable implementation of these principles in emergency cir- cumstances, any exception to, or
p.000199: infringement of, ethics principles and REB procedures must be demonstrably justified by those urging the exception
p.000199: or in- fringement.
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 87
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
...
Economic / Economic/Poverty
Searching for indicator poor:
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p.000199: potential benefits of excluding pregnant or breastfeeding women from the research.
p.000199: Research Involving Children
p.000199: Children have varying degrees of maturity – metabolically, immunologically and cognitively – that may present important
p.000199: challenges for research design and the consent process, depending on the nature and complexity of the research. In
p.000199: addition to the vulnerability that arises from their developmental stage, children may also lack capacity to consent to
p.000199: participate in research (see Ar- ticle 4.6). As well, physical or psychological harms a child may experience in a
p.000199: research setting may have long-lasting consequences. As a result, researchers have often avoided the inclusion of
p.000199: children in some research, especially in clinical trials testing new treatments, so as to eliminate any risks. Clinical
p.000199: trials conducted only with adults yield a generally poor understanding of the results that apply to children.
p.000199: As is the case with women, the inclusion of children in research advances the commitment to jus- tice in research by
p.000199: improving our knowledge of, and ability to respond to, the unique needs of children throughout their development.
p.000199:
p.000199:
p.000199: TCPS 2 49
p.000199:
p.000199: Chapter 4 – Fairness and Equity in Research Participation
p.000199:
p.000199: Article 4.4 Children shall not be inappropriately excluded from research solely on the basis of their age or
p.000199: developmental stage. The inclusion of children in research is subject to Article 4.6.
p.000199: Application Researchers should not exclude children from research unless there is a valid reason for doing so.
p.000199: Participation of children in research is justifiable when the research objective cannot be achieved with adult
p.000199: participants only. When considering the inclusion of children in research, researchers and REBs shall consider a
p.000199: child’s stage of physical, physiological, psychological, and social development to ensure adequate protections for the
...
p.000199: involvement of an authorized third party to consent on their behalf, and adequate provisions to ascertain the wishes of
p.000199: the individuals concerning their participation.
p.000199: Participants’ Vulnerability and Research
p.000199: Article 4.7 Individuals or groups whose circumstances may make them vulnerable in the con- text of research should
p.000199: not be inappropriately included or automatically excluded from participation in research on the basis of their
p.000199: circumstances.
p.000199: Application The core principles of Respect for Persons, Concern for Welfare, and Justice entail special ethical
p.000199: obligations toward individuals or groups whose circumstances may lead to their vulnerability in the context of a
p.000199: specific research project and limit their ability to fully safeguard their own interests. Those who are owed special
p.000199: ethical obligations may include individuals who are institutionalized, those in dependent situations, or those whose
p.000199: circumstances (e.g., poverty or poor health status) may render even modest participation incentives so attractive as to
p.000199: constitute an induce- ment to take risks they would otherwise not take. Their situation may also compromise
p.000199: the voluntariness of consent in other ways. However, individuals should not automatically be considered vulnerable
p.000199: simply because of assumptions made about the vulnerability of the group to which they belong. Their particular
p.000199: circumstances shall be considered in the context of the proposed research project.
p.000199: REBs and researchers shall carefully examine the relationship between the circum- stances of the individuals and groups
p.000199: they aim to recruit, and the proposed research question. They should not presume that these circumstances will
p.000199: automatically re- sult in the inclusion or exclusion of individuals or groups as prospective participants.
p.000199: Participation should be based on inclusion or exclusion criteria that are justified by the research question.
p.000199: Researchers and REBs should recognize and address changes in a participant’s circumstances that may create, heighten,
p.000199: or at- tenuate their vulnerability, and provide special protections or consideration.
p.000199: In general, researchers should be familiar with the cultural, social and economic circumstances of prospective
p.000199: participants, groups or communities. Researchers should anticipate, to the best of their ability, needs of
p.000199: participants, groups and their communities that might arise in any given research project. Especially when groups, and
...
Searching for indicator poverty:
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p.000199: establish other conditions regarding research that involve individuals who lack capacity to consent. This includes the
p.000199: involvement of an authorized third party to consent on their behalf, and adequate provisions to ascertain the wishes of
p.000199: the individuals concerning their participation.
p.000199: Participants’ Vulnerability and Research
p.000199: Article 4.7 Individuals or groups whose circumstances may make them vulnerable in the con- text of research should
p.000199: not be inappropriately included or automatically excluded from participation in research on the basis of their
p.000199: circumstances.
p.000199: Application The core principles of Respect for Persons, Concern for Welfare, and Justice entail special ethical
p.000199: obligations toward individuals or groups whose circumstances may lead to their vulnerability in the context of a
p.000199: specific research project and limit their ability to fully safeguard their own interests. Those who are owed special
p.000199: ethical obligations may include individuals who are institutionalized, those in dependent situations, or those whose
p.000199: circumstances (e.g., poverty or poor health status) may render even modest participation incentives so attractive as to
p.000199: constitute an induce- ment to take risks they would otherwise not take. Their situation may also compromise
p.000199: the voluntariness of consent in other ways. However, individuals should not automatically be considered vulnerable
p.000199: simply because of assumptions made about the vulnerability of the group to which they belong. Their particular
p.000199: circumstances shall be considered in the context of the proposed research project.
p.000199: REBs and researchers shall carefully examine the relationship between the circum- stances of the individuals and groups
p.000199: they aim to recruit, and the proposed research question. They should not presume that these circumstances will
p.000199: automatically re- sult in the inclusion or exclusion of individuals or groups as prospective participants.
p.000199: Participation should be based on inclusion or exclusion criteria that are justified by the research question.
p.000199: Researchers and REBs should recognize and address changes in a participant’s circumstances that may create, heighten,
p.000199: or at- tenuate their vulnerability, and provide special protections or consideration.
p.000199: In general, researchers should be familiar with the cultural, social and economic circumstances of prospective
p.000199: participants, groups or communities. Researchers should anticipate, to the best of their ability, needs of
...
Searching for indicator low-income:
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p.000199: • the vulnerability of the study population overall and/or the particular charac- teristics of the local population
p.000199: at individual sites, differences in values and cultural norms, and the level of risk associated with the research under
p.000199: review;
p.000199: • any relevant differences in laws and/or guidelines pertaining to the research in question if the institutions are
p.000199: in different provinces, territories and/or coun- tries;
p.000199: • relationships between institutions and REBs, and conflict resolution mecha- nisms related to REB decisions;
p.000199: • the potential for conflicts of interest and undue influence, including those that may arise from funding sources;
p.000199: • any differences in the standard of care normally followed, or access to services at the participating
p.000199: institutions that might be relevant to the conduct of the re- search; and
p.000199: • any operational issues that might affect the research.
p.000199:
p.000199: B. Ethics Review of Research Conducted outside the Institution
p.000199: Researchers affiliated with Canadian institutions are undertaking research at numerous sites within Canada and in
p.000199: countries around the world. Such research may be carried out with or without any collaboration with host institutions
p.000199: and local researchers. Most middle-income countries, and many low-income countries, have laws, policies or guidelines
p.000199: governing the ethical conduct of research involving humans, but some parts of the world do not have developed or
p.000199: widespread research ethics infrastructure.
p.000199: National and international standards for research involving humans are evolving continually, but methods for comparing
p.000199: the precise levels of protection afforded participants in different countries or jurisdictions, and by different
p.000199: institutions within those countries and jurisdictions, have not yet been developed. In exercising its responsibilities
p.000199: for the initial and continuing ethics review of re- search conducted under its auspices, the Canadian REB shall satisfy
p.000199: itself that the requirements of this Policy are met, both within the Canadian institution, and within the other country
p.000199: or research site. The Canadian REB shall take appropriate steps to ensure researchers are responsive to ethi- cally
p.000199: relevant aspects of the research context.
p.000199: Article 8.3 (a) Where research conducted under the auspices of a Canadian research institution and performed in
p.000199: whole or in part outside of Canada has been approved under a research ethics review model involving multiple
p.000199: institutions and/or REBs consistent with this Policy, the terms of that model apply.
p.000199:
p.000199:
p.000199: TCPS 2
p.000101: 101
p.000101:
p.000101: Chapter 8 – Multi-Jurisdictional Research
p.000101:
p.000101: (b) Subject to Article 8.3(a), research conducted under the auspices of a Canadian research institution and conducted
...
Searching for indicator social status:
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p.000199: security measures. Physical safeguards include the use of locked filing cabinets, and the location of computers
p.000199: containing research data away from public areas. Administrative safeguards include the development and enforcement of
p.000199: organizational rules about who has access to personal information about participants. Technical safeguards include use
p.000199: of computer passwords, firewalls, anti-virus software, encryption and other measures that protect data from
p.000199: unauthorized access, loss or modification.
p.000199: Identifiable Information
p.000199: Information that may reasonably be expected to identify an individual, alone or in combination with other available
p.000199: information, is considered identifiable information (or information that is identifiable) for the purposes of this
p.000199: Policy. Where the term “personal information” appears in this Policy, it refers to identifiable information.
p.000199: Types of Information
p.000199: Researchers may seek to collect, use, share and access different types of information about par- ticipants. Such
p.000199: information may include personal characteristics or other information about which an individual has a reasonable
p.000199: expectation of privacy (e.g., age, ethnicity, educational background, employment history, health history, life
p.000199: experience, religion, social status).
p.000199: For the purposes of this Policy, researchers and REBs shall consider whether information proposed for use in research
p.000199: is identifiable. The following categories provide guidance for assessing the ex- tent to which information could be
p.000199: used to identify an individual:
p.000199: • Directly identifying information – the information identifies a specific individual through direct identifiers
p.000199: (e.g., name, social insurance number, personal health number).
p.000199: • Indirectly identifying information – the information can reasonably be expected to iden- tify an individual
p.000199: through a combination of indirect identifiers (e.g., date of birth, place of residence or unique personal
p.000199: characteristic).
p.000199:
p.000199: 56 TCPS 2
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: • Coded information – direct identifiers are removed from the information and replaced with a code. Depending on
p.000199: access to the code, it may be possible to re-identify specific participants (e.g., the principal investigator retains a
p.000199: list that links the participants’ code names with their actual name so data can be re-linked if necessary).
p.000199: • Anonymized information – the information is irrevocably stripped of direct identifiers, a code is not kept to
p.000199: allow future re-linkage, and risk of re-identification of individuals from remaining indirect identifiers is low or
p.000199: very low.
p.000199: • Anonymous information – the information never had identifiers associated with it (e.g., anonymous surveys) and
...
General/Other / Dependent
Searching for indicator dependent:
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p.000199: establish other conditions regarding research that involve individuals who lack capacity to consent. This includes the
p.000199: involvement of an authorized third party to consent on their behalf, and adequate provisions to ascertain the wishes of
p.000199: the individuals concerning their participation.
p.000199: Participants’ Vulnerability and Research
p.000199: Article 4.7 Individuals or groups whose circumstances may make them vulnerable in the con- text of research should
p.000199: not be inappropriately included or automatically excluded from participation in research on the basis of their
p.000199: circumstances.
p.000199: Application The core principles of Respect for Persons, Concern for Welfare, and Justice entail special ethical
p.000199: obligations toward individuals or groups whose circumstances may lead to their vulnerability in the context of a
p.000199: specific research project and limit their ability to fully safeguard their own interests. Those who are owed special
p.000199: ethical obligations may include individuals who are institutionalized, those in dependent situations, or those whose
p.000199: circumstances (e.g., poverty or poor health status) may render even modest participation incentives so attractive as to
p.000199: constitute an induce- ment to take risks they would otherwise not take. Their situation may also compromise
p.000199: the voluntariness of consent in other ways. However, individuals should not automatically be considered vulnerable
p.000199: simply because of assumptions made about the vulnerability of the group to which they belong. Their particular
p.000199: circumstances shall be considered in the context of the proposed research project.
p.000199: REBs and researchers shall carefully examine the relationship between the circum- stances of the individuals and groups
p.000199: they aim to recruit, and the proposed research question. They should not presume that these circumstances will
p.000199: automatically re- sult in the inclusion or exclusion of individuals or groups as prospective participants.
p.000199: Participation should be based on inclusion or exclusion criteria that are justified by the research question.
p.000199: Researchers and REBs should recognize and address changes in a participant’s circumstances that may create, heighten,
p.000199: or at- tenuate their vulnerability, and provide special protections or consideration.
p.000199: In general, researchers should be familiar with the cultural, social and economic circumstances of prospective
...
p.000199: throughout the life of the project (see Article 2.8). At the time of the initial review, the REB has the authority to
p.000199: determine the term of approval, and the level at which continuing ethics review occurs in accordance with a
p.000199: proportionate approach to research ethics review. As with initial review, continuing ethics review could be full board
p.000199: review or delegated review based on the level of risk of the re- search (see Article 6.12). The level of research
p.000199: ethics review may be adjusted over the life of the project based on the level of risk.
p.000199: For research projects lasting longer than one year, researchers shall submit, at min- imum, an annual report with
p.000199: sufficient details to enable the REB to make an informed judgment about the continued ethical acceptability of
p.000199: the research. For research lasting less than one year, an end-of-study report may suffice.
p.000199: For some types of research (e.g., qualitative research or longitudinal research), there may be some difficulty in
p.000199: establishing start or end dates. In these cases, the REB should work with researchers to determine a reasonable
p.000199: timeline for contin- uing ethics review, and for determining the completion date dependent on the discipline and method
p.000199: of research. The reporting schedule for continuing ethics re- view may be adjusted throughout the life of the project.
p.000199: This would be necessary, for example, if the risk level of the research increases as a result of the addition of new
p.000199: procedures, or is re-assessed in light of changes to the approved research (see Articles 6.15 and 6.16).
p.000199: Research that involves minimal or no risk to participants should be held to the min- imum requirements for
p.000199: continuing ethics review, that is, an annual report. Consistent with a proportionate approach, an REB has the
p.000199: option of requesting more frequent and/or more substantive reports if necessary. Research that poses
p.000199: greater-than-minimal risk may require more extensive continuing ethics review. This may include more frequent reporting
p.000199: to the REB, monitoring and review of the consent process, review of participant records, and site visits. Other
p.000199: reporting mechanisms for continuing ethics review may be required by funders, sponsors or regulators.
p.000199: Continuing research ethics review should be understood as a collective responsi- bility, to be carried out with a
p.000199: common interest in maintaining the highest ethical standards:
p.000199: • Institutions have a responsibility to provide necessary resources to REBs to assist them in fulfilling
...
p.000115: settings, and on First Nations territory. It examined, among other matters, the adequacy of public institutions and
p.000115: services, Aboriginal and non-Aboriginal, to protect the women’s well-being and support families in their efforts to
p.000115: deal with their losses. The objective was to effect policy change and improve the safety and well-being of Aboriginal
p.000115: women in Canada. NWAC has published its commitment to participatory research and the principles and practices that
p.000115: protect the privacy and well-being of participants. The project built on NWAC’s ongoing efforts to develop meaningful
p.000115: research relationships reflecting Aboriginal ways of knowing.
p.000115: Respect for Community Customs and Codes of Practice
p.000115: Article 9.8 Researchers have an obligation to become informed about, and to respect, the relevant customs and
p.000115: codes of research practice that apply in the particular community or communities affected by their research.
p.000115: Inconsistencies between community custom and this Policy should be identified and addressed in advance of initiating
p.000115: the research, or as they arise.
p.000115:
p.000115:
p.000115: TCPS 2
p.000117: 117
p.000117:
p.000117: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000117:
p.000117: Application First Nations, Inuit and Métis codes of research practice derive from procedures and customs of
p.000117: predominantly oral cultures. While some rules may be in written form, their interpretation is dependent on experiential
p.000117: knowledge acquired through interactions in the community. An example is the strict limitation on making
p.000117: publicly available sacred knowledge that might be revealed within a trusting relationship. In academic
p.000117: culture, rules regarding limits on disclosure of information would reasonably be incorporated into a research
p.000117: proposal, and should be integrated into research agreements between communities and researchers where such exists.
p.000117: The absence, or perceived absence, of a formal local research code or guidelines does not relieve the researcher of the
p.000117: obligation to seek community engagement in order to identify local customs and codes of research practice.
p.000117: First Nation, Inuit and Métis customs and codes of behaviour distinguish among knowledge that can be publicly
p.000117: disclosed, disclosed to a specific audience, or disclosed under certain conditions. Determination of what information
p.000117: may be shared, and with whom, will depend on the culture of the community involved. Any restrictions on access to, or
p.000117: use of, traditional or sacred knowledge shared in the course of the research project should be addressed in the
p.000117: research agreement.
p.000117: In Aboriginal communities, custom may restrict the observation, recording, or reporting of ceremonies or certain
p.000117: performances, and require approval of appropriate individuals. Article 10.3 addresses the requirement for ethics
p.000117: review of research involving observational studies, and associated ethical implications, which may include infringement
p.000117: on consent and privacy.
...
p.000133: Some procedural issues related to the dynamics and characteristics of qualitative research that affect the timing and
p.000133: scope of the research ethics review process are detailed below. Note that subject to applicable laws, the articles in
p.000133: this Policy relating to consent, privacy and confidentiality equally apply in the context of qualitative research.
p.000133: Researchers and research ethics boards (REBs) should also consult other relevant chapters of the Policy for additional
p.000133: guidance on principles, norms, and practices applicable to qualitative research.
p.000133:
p.000133: A. Nature of Qualitative Research
p.000133: Qualitative research aims to understand how people think about the world and how they act and behave in it. This
p.000133: approach requires researchers to understand phenomena based on discourse, actions and documents, and how and why
p.000133: individuals interpret and ascribe meaning to what they say and do, and to other aspects of the world (including other
p.000133: people) they encounter.
p.000133:
p.000133:
p.000133:
p.000133:
p.000133: TCPS 2
p.000135: 135
p.000135:
p.000135: Chapter 10 – Qualitative Research
p.000135:
p.000135: Some qualitative studies extend beyond individuals’ personal experiences to explore interactions and processes within
p.000135: organizations or other environments. Knowledge at both an individual and a cultural level is treated as socially
p.000135: constructed. This implies that all knowledge is, at least to some degree, interpretive, and hence, dependent on social
p.000135: context. It is also shaped by the personal perspective of the researcher as an observer and analyst. As a result,
p.000135: qualitative researchers devote a great deal of attention to demonstrating the trustworthiness of their findings using a
p.000135: range of methodological strategies.
p.000135: The section below provides a summary description of the general approach, as well as method- ological requirements and
p.000135: practices, of qualitative research, some of which may also apply to quantitative or other types of research involving
p.000135: humans.
p.000135: General Approach and Methodological Requirements and Practices
p.000135: (a) Inductive Understanding: Many forms of qualitative research entail gaining an inductive understanding of the world
p.000135: of participants to acquire an analytic understanding of how they view their actions and the world around them. In some
p.000135: projects, this approach also applies to the study of particular social settings, processes and experiences.
p.000135: To the extent that the methods involve direct interaction with participants, there is often an emphasis on gaining
p.000135: insights into participants’ perceptions of themselves and others, and of the meanings that participants attach to their
p.000135: thoughts and behaviours.
p.000135: (b) Diversity of Approaches: There is no single approach in qualitative research. Different fields or disciplines,
p.000135: and even individual scholars within a discipline, have different perspectives on, and approaches to, the use of
p.000135: qualitative methods. Qualitative research uses a variety of theoretical approaches, questions that guide the research,
p.000135: methodologies, epistemological approaches, and techniques that allow researchers to enter the participants’ world or
...
General/Other / Diminished Autonomy
Searching for indicator diminished:
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p.000199: human dignity is expressed through three core principles – Re- spect for Persons, Concern for Welfare, and Justice.
p.000199: These core principles transcend disciplinary boundaries and, therefore, are relevant to the full range of research
p.000199: covered by this Policy.1
p.000199: Article 1.1 The guidelines in this Policy are based on the following three core principles:
p.000199: • Respect for Persons
p.000199: • Concern for Welfare
p.000199: • Justice
p.000199: These principles are complementary and interdependent. How they apply and the weight accorded to each will depend on
p.000199: the nature and context of the research being undertaken. Specific applica- tions are addressed in the following
p.000199: chapters.
p.000199: Respect for Persons
p.000199: Respect for Persons recognizes the intrinsic value of human beings and the respect and consider- ation that they are
p.000199: due. It encompasses the treatment of persons involved in research directly as participants and those who are
p.000199: participants because their data or human biological materials, which for the purposes of this Policy include materials
p.000199: related to human reproduction, are used in re- search. Respect for Persons incorporates the dual moral obligations to
p.000199: respect autonomy and to protect those with developing, impaired or diminished autonomy.
p.000199: Autonomy includes the ability to deliberate about a decision and to act based on that deliberation. Respecting autonomy
p.000199: means giving due deference to a person’s judgment and ensuring that the person is free to choose without
p.000199: interference. Autonomy is not exercised in isolation but is influenced by a person’s various connections to
p.000199: family, to community, and to cultural, social, linguistic, religious and other groups. Likewise, a person’s decisions
p.000199: can have an impact on any of these connections.
p.000199:
p.000199: 8 TCPS 2
p.000199:
p.000199: Chapter 1 – Ethics Framework
p.000199:
p.000199: An important mechanism for respecting participants’ autonomy in research is the requirement to seek their free,
p.000199: informed and ongoing consent. This requirement reflects the commitment that par- ticipation in research, including
p.000199: participation through the use of one’s data or biological materials, should be a matter of choice and that, to be
p.000199: meaningful, the choice must be informed. An informed choice is one that is based on as complete an understanding as is
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p.000199: Justice
p.000199: Justice refers to the obligation to treat people fairly and equitably. Fairness entails treating all peo- ple with
p.000199: equal respect and concern. Equity requires distributing the benefits and burdens of research participation in such a
p.000199: way that no segment of the population is unduly burdened by the harms of research or denied the benefits of the
p.000199: knowledge generated from it.
p.000199: Treating people fairly and equitably does not always mean treating people in the same way. Dif- ferences in treatment
p.000199: or distribution are justified when failures to take differences into account may result in the creation or
p.000199: reinforcement of inequities. One important difference that must be considered for fairness and equity is vulnerability.
p.000199: Vulnerability is often caused by limited capacity, or limited access to social goods, such as rights, opportunities and
p.000199: power. Individuals or groups in vulnerable circumstances have historically included children, the elderly, women,
p.000199: prisoners, those with mental health issues and those with diminished capacity for self-determination. Ethno- cultural
p.000199: minorities and those who are institutionalized are other examples of groups who have, at times, been treated unfairly
p.000199: and inequitably in research, or have been excluded from research op- portunities. People or groups whose circumstances
p.000199: cause them to be vulnerable or marginalized may need to be afforded special attention in order to be treated justly in
p.000199: research.
p.000199:
p.000199:
p.000199:
p.000199: 10 TCPS 2
p.000199:
p.000199: Chapter 1 – Ethics Framework
p.000199:
p.000199: The recruitment process, both of participants who may become directly involved in research and those who participate as
p.000199: the source of information or biological materials to be used in research, is an important component of the fair and
p.000199: equitable conduct of research. Participation should be based on inclusion criteria that are justified by the research
p.000199: question. Inequity is created when par- ticular groups fail to receive fair benefits of research or when
p.000199: groups, or their data or their biological materials, are excluded from research arbitrarily or for reasons
p.000199: unrelated to the research question.
p.000199: An important threat to Justice is the imbalance of power that may exist in the relationship between researcher and
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p.000199: special monitoring procedures to be followed by data safety and monitoring boards.
p.000199: C. Capacity
p.000199: Capacity refers to the ability of prospective or actual participants to understand relevant information
p.000199: presented about a research project, and to appreciate the potential consequences of their decision to participate or
p.000199: not participate. This ability may vary according to the complexity of the choice being made, the circumstances
p.000199: surrounding the decision, or the point in time at which consent is sought. The determination of capacity to participate
p.000199: in research, then, is not a static determination. It is a process that may change over time, depending on the nature of
p.000199: the decision the prospective participant needs to make, and on any changes in the participant’s condition. Assessing
p.000199: capacity is a question of determining, at a particular point in time, whether a participant (or prospective
p.000199: participant) sufficiently understands the nature of a particular research project, and the risks, consequences and
p.000199: potential benefits associated with it.
p.000199:
p.000199:
p.000199: 40 TCPS 2
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: One may therefore have diminished capacity but still be able to decide whether to participate in certain types of
p.000199: research. Researchers should be aware of all applicable legal and regulatory requirements with respect to capacity.
p.000199: These may vary among jurisdictions. Authorized third parties who are asked to make a consent decision on behalf of a
p.000199: prospective participant should also be aware of their legal responsibilities.
p.000199: In keeping with the principle of Justice, those who lack the capacity to consent on their own behalf must neither be
p.000199: unfairly excluded from the potential benefits of research participation, nor may their lack of capacity to consent be
p.000199: used to inappropriately include them in research. REBs and researchers should be aware of these ethical considerations
p.000199: and seek to find a balance between them for the benefit of prospective participants who lack capacity to consent (see
p.000199: Chapter 4).
p.000199: As indicated in Chapter 1, Respect for Persons and Concern for Welfare entails particular ethical obligations to
p.000199: individuals in vulnerable circumstances. Such obligations often translate into special procedures to promote and
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p.000163: property of research procedures, data or other information. It is the responsibility of the institution to ensure that
p.000163: these contracts are in compliance with the guidance of this Policy, and in particular Article 11.12.
p.000163: Article 11.12 With respect to research findings:
p.000163: (a) Institutions and REBs should take reasonable measures to ensure that sponsors, researchers and institutions
p.000163: publish or otherwise disseminate the analysis of
p.000163:
p.000163:
p.000163: 164 TCPS 2
p.000163:
p.000163: Chapter 11 – Clinical Trials
p.000163:
p.000163: data and interpretation of clinical trial results in a timely manner without undue restriction.
p.000163: (b) Any prohibition or undue limitation on the publication or dissemination of scientific findings from clinical trials
p.000163: is ethically unacceptable.
p.000163: (c) Institutions should develop reasonable written policies regarding acceptable and unacceptable clauses in
p.000163: clinical trial research contracts relating to confidentiality, publication and access to data.
p.000163: Application To justify the involvement of participants, and the risks and other burdens they are asked to bear,
p.000163: research must be valuable. That is, it must have a reasonable likelihood of promoting social good. If
p.000163: research findings and the research materials and research data they are based upon, are not disseminated (e.g.,
p.000163: published in a peer-reviewed journal, added to a publicly available clinical trials database) within a reasonable
p.000163: time, their value may be diminished or lost, betraying the contributions and sacrifices of participants. For
p.000163: this reason, and based on respect for participant expectations and protection of the public good, researchers and
p.000163: institutions have an ethical responsibility to make reasonable efforts to publicly disseminate the findings of clinical
p.000163: trials in a timely manner by publications and by the inclusion of raw data and results in appropriate databases. In
p.000163: publications, they have the obligation to report trial details (for example, method, all planned outcomes, and harms
p.000163: as defined by the Consolidated Standards of Reporting Trials4).
p.000163: However, negative findings of research are not always published or otherwise disseminated. Clinical trial registries do
p.000163: not currently require dissemination of findings. Failing to publish negative findings could lead to publication bias
p.000163: and thus contribute to a series of risks, including misinformed clinical decision making based on incomplete or skewed
p.000163: data, inappropriate and potentially harmful clinical practices and injury to health, needless and wasteful duplication
p.000163: of research with associated risks to participants, fraud or deception in the clinical trials process, and erosion of
p.000163: public trust and accountability in research.
p.000163: Although it is beyond the scope of the Policy to provide guidance for journal editors and publishers, both have ethical
p.000163: obligations with regard to the publication of the findings of research. Both negative and positive findings
p.000163: should be published. Sources of funding, any restrictions regarding public disclosure of trial data, institutional
p.000163: affiliations and conflicts of interest should be declared in publications.
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p.000195: ethics, in relevant research disciplines) established by an institution to review the ethical acceptability of all
p.000195: research involving humans conducted within the institution’s jurisdiction or under its auspices.
p.000195:
p.000195: Research ethics education and training – The provision of materials and corresponding instruction by an institution to
p.000195: research ethics board (REB) members or researchers with regard to the core principles and understanding of this Policy,
p.000195: basic ethics standards, applicable institutional policies, and legal or regulatory requirements. This term also
p.000195: includes an understanding of the role and mandate of REBs and responsibilities of REB members.
p.000195:
p.000195: Research involving partial disclosure or deception – A type of research, in which the participant may not know that
p.000195: they are part of a project until it is over or is not informed of the true purpose of the research in advance. See
p.000195: “Debriefing.”
p.000195:
p.000195: Respect for Persons – A core principle of this Policy that recognizes the intrinsic value of human beings and the
p.000195: respect and consideration that they are due. It incorporates the dual moral obligations to respect autonomy and to
p.000195: protect those with developing, impaired, or diminished autonomy.
p.000195:
p.000195: Risk – The possibility of the occurrence of harm. The level of foreseeable risk posed to participants by their
p.000195: involvement in research is assessed by considering the magnitude or seriousness of the harm and the probability that it
p.000195: will occur, whether to participants or to third parties.
p.000195:
p.000195: Secondary use – The use in research of information or human biological materials originally collected for a purpose
p.000195: other than the current research purpose.
p.000195:
p.000195: Security – Measures taken to protect information. It includes physical, administrative, and technical safe- guards.
p.000195:
p.000195: Shall – Indicates a mandatory provision.
p.000195:
p.000195: Should – Indicates guidance for the interpretation of the core principles.
p.000195:
p.000195: Stopping rules – Statistically significant end points and safety considerations for a clinical trial that are
p.000195: determined in advance, and, once reached, dictate that the trial must be terminated.
p.000195:
p.000195:
p.000195:
p.000195: 196 TCPS 2
p.000195:
p.000195: Glossary
p.000195:
p.000195: Surgical trials – A clinical trial which compares the safety and/or efficacy of different surgical techniques.
p.000195:
p.000195: Therapeutic misconception – A misunderstanding, on the part of participants, of the purpose, benefits, and/or risks
p.000195: of clinical trials. Often participants do not understand that research is aimed primarily at producing knowledge and
p.000195: may not provide any therapeutic benefit to them.
p.000195:
p.000195: Traditional knowledge – The knowledge held by First Nations, Inuit and Métis peoples, the Aboriginal peoples of
p.000195: Canada. Traditional knowledge is specific to place, usually transmitted orally, and rooted in the experience of
p.000195: multiple generations. It is determined by an Aboriginal community’s land, environment, region, culture, and language.
p.000195: It may also include new knowledge transmitted to subsequent generations.
p.000195:
p.000195: Unanticipated issues – Issues that: occur during the conduct of research; may increase the level of risk to
p.000195: participants or have other ethical implications that may affect participants’ welfare; and were not anticipated by the
p.000195: researcher in the research proposal submitted for research ethics review.
p.000195:
p.000195: Undue influence – The impact of an unequal power relationship on the voluntariness of consent. This may occur when
p.000195: prospective participants are recruited by individuals in a position of authority over them (e.g. doctor/patient,
p.000195: teacher/student, employer/employee). See “Coercion.”
p.000195:
p.000195: Vulnerability – A diminished ability to fully safeguard one’s own interests in the context of a specific research
p.000195: project. This may be caused by limited capacity or limited access to social goods, such as rights, opportunities and
p.000195: power. Individuals or groups may experience vulnerability to different degrees and at different times, depending on
p.000195: their circumstances. See also “Autonomy.”
p.000195:
p.000195: Welfare – The quality of a person’s experience of life in all its aspects. Welfare consists of the impact on
p.000195: individuals and/or groups of factors such as their physical, mental and spiritual health, as well as their physical,
p.000195: economic and social circumstances.
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p.000195: TCPS 2
p.000195:
p.000197: 197
p.000197:
p.000197:
p.000197:
p.000197: Index
p.000197: The Index seeks to direct the reader to meaningful references to key concepts in TCPS 2. Main references to a term are
p.000197: indicated with bold type.
p.000197:
p.000197: The Index is not a record of all occurrences of the listed topics. Readers who wish to check all occurrences of these
p.000197: topics or specific terms may do so through the Adobe search tool available online in the PDF version of the Policy
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p.000197: Inuit, 105, 107, 108, 110, 114, 115, 117, 118, 121
p.000197: Métis, 105, 107, 108, 110, 114, 115, 117, 121
p.000197: mutual benefits, 124-125
p.000197: privacy, 126-128
p.000197: research agreements, 121, 122-123, 126-127, 128-130, 131
p.000197: research ethics review - research ethics boards and community, 115, 119-122 secondary use of information or human
p.000197: biological materials, 119-121, 130-132 strengthening research capacity, 125-126
p.000197: traditional knowledge, 108-109, 110-111, 126
p.000197: Academic freedom, 7, 11
p.000197: Ad hoc advisors, 24, 72, 73, 75, 120, 150
p.000197: Agencies, 5 Anonymity
p.000197: anonymized human biological materials, 170 anonymized information, 57
p.000197: anonymous human biological materials, 19, 131-132, 170
p.000197: anonymous information, 19, 57, 131-132
p.000197:
p.000197:
p.000197: TCPS 2
p.000199: 199
p.000199:
p.000199: Index
p.000199:
p.000199: Appeals, 83-85
p.000199: Assisted human reproduction (see Human reproduction, materials related to) Authorized third parties, 27, 41-44
p.000199: Autonomy, 8-9, 27, 40
p.000199:
p.000199: B
p.000199: Benefits, research
p.000199: equitable distribution, 10, 53
p.000199: mutual, 124-125
p.000199: and risk, 10, 11, 22-25, 41-42, 51, 157-158
p.000199: Biobanks, 175-176, 186
p.000199: Biological materials (see Human biological materials)
p.000199:
p.000199: C
p.000199: Canadian Charter of Rights and Freedoms, 12, 55 Capacity
p.000199: definition, 40-41
p.000199: diminished, 10, 41
p.000199: lack of, 9, 27, 39, 40-44, 47, 49-52, 171, 185, 187
p.000199: regaining, 39, 41, 43
p.000199: Children, 10, 34, 41-42, 47, 49-50, 51, 185, 187
p.000199: Chimeras, 179
p.000199: Clinical equipoise, 148 Clinical trials
p.000199: budgets, 164
p.000199: conflicts of interest, 163-164 consent, 155, 158-159, 161-163
p.000199: definition, 147
p.000199: design, 149-156
p.000199: dissemination of outcomes, 164-167 duty of care, 148-149
p.000199: medical device trials, 153 natural health product trials, 152 pharmaceutical trials, 150-152
p.000199: phases of pharmaceutical trials, 150-152 placebo-controlled trials, 154-156
p.000199: psychotherapy trials, 153
p.000199: registration, 149, 156-157
p.000199: reporting new information, 159-163 risk, 148, 157-159
p.000199: safety, 150, 157, 159-163
p.000199: surgical trials, 154
p.000199: therapeutic misconception, 148, 149, 158-159
p.000199: types, 149-156
p.000199: Coercion, 29
p.000199: Collaborative research, 123-124, 125-126, 128
p.000199:
p.000199:
p.000199:
p.000199: 200 TCPS 2
p.000199:
p.000199: Index
p.000199:
p.000199: Communities
p.000199: Aboriginal, 107-108, 109
p.000199: and genetic research, 181, 183-184, 185
p.000199: Compensation
p.000199: and consent, 29, 31, 33
p.000199: for research ethics board members, 94 Concern for Welfare, 8, 9-10, 109 Confidentiality (see Privacy and
p.000199: confidentiality)
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General/Other / Impaired Autonomy
Searching for indicator autonomy:
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p.000199: apply.
p.000199: Respect for human dignity requires that research involving humans be conducted in a manner that is sensitive to the
p.000199: inherent worth of all human beings and the respect and consideration that they are due. In this Policy, respect for
p.000199: human dignity is expressed through three core principles – Re- spect for Persons, Concern for Welfare, and Justice.
p.000199: These core principles transcend disciplinary boundaries and, therefore, are relevant to the full range of research
p.000199: covered by this Policy.1
p.000199: Article 1.1 The guidelines in this Policy are based on the following three core principles:
p.000199: • Respect for Persons
p.000199: • Concern for Welfare
p.000199: • Justice
p.000199: These principles are complementary and interdependent. How they apply and the weight accorded to each will depend on
p.000199: the nature and context of the research being undertaken. Specific applica- tions are addressed in the following
p.000199: chapters.
p.000199: Respect for Persons
p.000199: Respect for Persons recognizes the intrinsic value of human beings and the respect and consider- ation that they are
p.000199: due. It encompasses the treatment of persons involved in research directly as participants and those who are
p.000199: participants because their data or human biological materials, which for the purposes of this Policy include materials
p.000199: related to human reproduction, are used in re- search. Respect for Persons incorporates the dual moral obligations to
p.000199: respect autonomy and to protect those with developing, impaired or diminished autonomy.
p.000199: Autonomy includes the ability to deliberate about a decision and to act based on that deliberation. Respecting autonomy
p.000199: means giving due deference to a person’s judgment and ensuring that the person is free to choose without
p.000199: interference. Autonomy is not exercised in isolation but is influenced by a person’s various connections to
p.000199: family, to community, and to cultural, social, linguistic, religious and other groups. Likewise, a person’s decisions
p.000199: can have an impact on any of these connections.
p.000199:
p.000199: 8 TCPS 2
p.000199:
p.000199: Chapter 1 – Ethics Framework
p.000199:
p.000199: An important mechanism for respecting participants’ autonomy in research is the requirement to seek their free,
p.000199: informed and ongoing consent. This requirement reflects the commitment that par- ticipation in research, including
p.000199: participation through the use of one’s data or biological materials, should be a matter of choice and that, to be
p.000199: meaningful, the choice must be informed. An informed choice is one that is based on as complete an understanding as is
p.000199: reasonably possible of the purpose of the research, what it entails, and its foreseeable risks and potential benefits,
p.000199: both to the partic- ipant and to others. Respect for Persons also includes a commitment to accountability
p.000199: and transparency in the ethical conduct of research.
p.000199: Certain factors may diminish a person’s ability to exercise their autonomy, such as inadequate information or
p.000199: understanding for deliberation, or a lack of freedom to act due to controlling influences or coercion. Such constraints
p.000199: may include the fear of alienating those in positions of authority, such as professional or personal caregivers,
p.000199: researchers, leaders, larger groups, or a community to which one belongs. Other constraints may consist of barriers to
p.000199: accessing resources or knowledge outside the research context. These factors and constraints should be addressed prior
p.000199: to any research being carried out, so as to ensure participants are sufficiently protected.
p.000199: Some people may be incapable of exercising autonomy because of youth, cognitive impairment, other mental health issues
p.000199: or illness. While autonomy may be considered a necessary condition for participation in research, involving those who
p.000199: lack capacity to make their own decisions to participate can be valuable, just and even necessary. For those
p.000199: prospective participants, additional measures are needed to protect their interests and to ensure that their wishes (to
p.000199: the extent that these are known) are respected. These measures will generally include seeking consent from an
p.000199: authorized third party who is entrusted to make decisions on behalf of the prospective participant, based on knowledge
p.000199: of that person and that person’s wishes or, if such wishes are unknown, on consideration of that person’s welfare. Even
p.000199: when the requirements of free, informed and ongoing consent cannot be met, Respect for Persons requires involving
p.000199: individuals in circumstances of vulnerability in decision making where possible. This may include asking about their
p.000199: feelings re- garding participation and/or for their assent.
p.000199: Where it is foreseeable that a participant may lose capacity during a research project, for example in studies of
p.000199: cognitive impairment, it may be appropriate to ask participants to express their pref- erences and ensure that they
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p.000199: 2 See guidance 3.2.1 of the International Conference on Harmonisation (ICH), Guidance for Industry – Good Clinical
p.000199: Practice: Consolidated Guideline, ICH Topic E6: Technical Requirements for the Registration of Pharmaceuticals for
p.000199: Human Use (1996, adopted by Health Canada in 1997).
p.000199: www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-eng.php
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p.000199: TCPS 2 25
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p.000199:
p.000199:
p.000199:
p.000199: Introduction
p.000199: Chapter 3
p.000199: THE CONSENT PROCESS
p.000199: This chapter sets out the ethical requirements for consent in research involving humans. Throughout this
p.000199: Policy, the term “consent” means “free, informed and ongoing consent.” For the purpose of this Policy, “free” and
p.000199: “voluntary” are used interchangeably.
p.000199: Respect for Persons implies that individuals who participate in research should do so voluntarily, understanding the
p.000199: purpose of the research, and its risks and potential benefits, as fully as reasonably possible. Where a person has the
p.000199: capacity to understand this information, and the ability to act on it voluntarily, the decision to participate is
p.000199: generally seen as an expression of autonomy. The Policy refers to the process of seeking consent from prospective
p.000199: participants, which may result in either agreement or refusal to participate. This process is meant to emphasize
p.000199: Respect for Persons. Under no circumstances may researchers proceed to conduct research with anyone who has refused to
p.000199: participate. Subject to exceptions set out in this Policy, consent must be obtained from participants prior to the
p.000199: conduct of research.
p.000199: Equally, Respect for Persons implies that those who lack the capacity to decide for themselves should nevertheless have
p.000199: the opportunity to participate in research that may be of benefit to themselves or others. Authorized third parties
p.000199: acting on behalf of these individuals decide whether participation would be appropriate. For the purposes of this
p.000199: Policy, the term “authorized third party” (also known as “authorized third party decision makers”) refers to any person
p.000199: with the necessary legal authority to make decisions on behalf of an individual who lacks the capacity to consent to
p.000199: participate or to continue to participate in a particular research project. These decisions involve considerations of
p.000199: Concern for Welfare and Justice.
...
p.000199: participating in research.
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 39
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: It is the responsibility of researchers to justify to the REB the need for this exception. The underlying
p.000199: assumption of Article 3.8 is that participants could not receive any direct benefits of the research without setting
p.000199: aside the need for the researcher to seek the prior consent of participants, or of their authorized third party.
p.000199: Article 3.8 indicates that research in emergency medicine must be reviewed by the REB, be restricted to the emergency
p.000199: needs of the participants, and be conducted under criteria designated by the REB.
p.000199: It is unethical to expose participants to any additional risk without their consent if standard efficacious care
p.000199: exists, unless it can clearly be shown that there is a realistic possibility of meaningful improvement of the
p.000199: participant’s condition. Accordingly, paragraphs (b) and (c) of Article 3.8 indicate that researchers and REBs must
p.000199: assess the risks and potential benefits of proposed research against existing standard efficacious care.
p.000199: To respect the autonomy of the participant, Article 3.8(e) requires researchers to undertake diligent efforts to
p.000199: contact authorized third parties, if reasonably feasible, and to document such efforts for the benefit of both
p.000199: the participant and the continuing ethics review functions of the REB. The article also requires that
p.000199: participants who regain capacity be promptly afforded the opportunity to consent to their continued participation.
p.000199: Concern for the patient’s welfare is paramount and should be informed by ethical and professional judgment.
p.000199: Because their incapacity to exercise consent makes them vulnerable, prospective participants for emergency research
p.000199: are owed special ethical obligations and protection commensurate with the risks involved. Their welfare should be
p.000199: protected by additional safeguards, where feasible and appropriate. These might include: additional scientific,
p.000199: medical or REB consultation; procedures to identify prospective participants in advance so that consent may be
p.000199: sought prior to the occurrence of the emergency situation; consultation with former and prospective participants; and
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p.000199: restrictive or least intrusive means necessary to achieve the Policy goal: the promotion and guidance of ethical
p.000199: conduct in research. This approach – consistent with international bioethics and human rights norms – maximizes
p.000199: respect for ethical principles and helps to ensure that exceptions and the means to implement them are not unduly
p.000199: broad, overreaching or unjustifiably invasive.
p.000199: Recognizing and respecting the principle of Justice means that research ethics re- view policies and procedures for
p.000199: publicly declared emergencies shall be used in a manner that is not discriminatory or arbitrary. The commitment to
p.000199: justice advances a fair and balanced distribution of risks and potential benefits even in the face of public
p.000199: emergencies.
p.000199: REBs and researchers should be aware that individuals, prospective participants, researchers, and institutions may not
p.000199: normally be considered vulnerable, but may become so by the very nature of public emergencies. Those already vulnerable
p.000199: may become acutely so (see Article 4.7). The increased public risks and devastation that cause public emergencies to be
p.000199: declared can threaten autonomy and physical, emo- tional, institutional and social welfare or safety. They also bring
p.000199: inherent tensions and pressures that may impact deliberative decision making. Taking all of this into consideration,
p.000199: REBs and researchers should ensure that the risks and potential ben- efits posed by any proposed research are
p.000199: appropriately evaluated, including provisions for greater-than-normal attention to risk, where applicable.
p.000199:
p.000199:
p.000199: 1 Memorandum of Understanding on the Roles and Responsibilities in the Management of Federal Grants and Awards.
p.000199: www.nserc-crsng.gc.ca/NSERC-CRSNG/Policies-Politiques/MOURoles-Protocol- Roles/index_eng.asp
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p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: 88 TCPS 2
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: Introduction
p.000199: Chapter 7
p.000199: CONFLICTS OF INTEREST
p.000199: This chapter addresses ethical issues that can arise when research activities and other activities conflict. A conflict
p.000199: of interest may arise when activities or situations place an individual or insti- tution in a real, potential or
p.000199: perceived conflict between the duties or responsibilities related to research, and personal, institutional or other
p.000199: interests.1 These interests include, but are not limited to, business, commercial or financial interests pertaining to
...
p.000105: Chapter 1) apply to research involving Aboriginal peoples. It accords respect to Aboriginal peoples’ knowledge systems
p.000105: by ensuring that the various and distinct world views of Indian, Inuit and Métis peoples are represented in planning
p.000105: and decision making, from the earliest stages of conception and design of projects through to the analysis and
p.000105: dissemination of results. It affirms respect for community customs and codes of research practice to better ensure
p.000105: balance in the relationship between researchers and participants, and mutual benefit in researcher-community relations.
p.000105: The purpose of this chapter specifically, and the Policy in general, is to provide guidance to researchers on the
p.000105: ethical conduct of research involving Aboriginal peoples.
p.000105:
p.000105:
p.000105: 106 TCPS 2
p.000105:
p.000105: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000105:
p.000105: The desire to conserve, reclaim and develop knowledge specific to First Nations, Inuit and Métis communities, and to
p.000105: benefit from contemporary applications of traditional knowledge, is a motivating force in community initiatives
p.000105: to assume a decisive role in research. The guidance provided in this chapter is based on the premise that engagement
p.000105: with community is an integral part of ethical research involving Aboriginal peoples.
p.000105: This Policy acknowledges the role of community in shaping the conduct of research that affects First Nations, Inuit and
p.000105: Métis communities. The Policy also respects the autonomy of individuals to decide whether they will participate in
p.000105: research in accordance with Articles 3.1 to 3.6. Articles in this chapter give guidance for balancing individual and
p.000105: collective interests. In light of the diversity within and among First Nations, Inuit and Métis communities,
p.000105: and the ongoing development of community codes of research practice by these communities at the local, regional and
p.000105: national level, ethical review of a proposed project shall be attentive to the specific context of the project and the
p.000105: community involved (see Articles 9.8 and 9.9).
p.000105:
p.000105: A. Key Concepts and Definitions
p.000105: Definitions of key concepts used in this chapter are provided to assist in applying the guidance in this Policy (see
p.000105: Chapter 1 regarding the scope of definitions used in this Policy) and to facilitate dialogue between researchers and
p.000105: Aboriginal communities. Since there is not universal agreement on the meaning of some terms, the definitions provided
p.000105: are intended for the purposes of this Policy only. This terminology will require periodic revision, particularly in
p.000105: light of the ongoing debate on the terms of art used in international and domestic contexts. This is in
p.000105: keeping with a commitment to the continued evolution of this Policy.
p.000105: • Aboriginal peoples – include persons of Indian, Inuit or Métis descent regardless of where they reside and
p.000105: whether or not their names appear on an official register. The term “Aboriginal” fails to reflect the
p.000105: distinctions among First Nations, Inuit and Métis peoples, who have their own histories, cultures and languages, so an
p.000105: attempt has been made to limit use of the term in this Policy to instances where a global term is appropriate. Indian
...
p.000113: 3.2[i]).
p.000113: Complex Authority Structures
p.000113: Article 9.5 Where alternatives to securing the agreement of formal leadership are proposed for research on First
p.000113: Nations, Inuit or Métis lands or in organizational communities, researchers should engage community processes and
p.000113: document measures taken, to enable the REB to review the proposal with due consideration of complex
p.000113: community authority structures.
p.000113: Application Researchers and REBs should not assume that approval of a project by formal leaders is the only avenue
p.000113: for endorsing a project. In some communities and some domains of knowledge, authority to permit and monitor
p.000113: research rests with knowledge keepers designated by custom rather than by election or appointment.
p.000113:
p.000113:
p.000113:
p.000113: TCPS 2
p.000115: 115
p.000115:
p.000115: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000115:
p.000115: In First Nations settings, a confederacy council spanning several communities may be recognized as having authority
p.000115: over its members’ traditional knowledge. In an Inuit community, the hamlet council, an Elders’ circle, and a hunters
p.000115: and trappers organization may have overlapping responsibility and expertise with respect to the knowledge being sought.
p.000115: Métis Elders dedicated to conserving Michif language may assert their autonomy from political leaders, but choose to
p.000115: collaborate with educational or cultural agencies (see also Article 9.15).
p.000115: The preferred course is to secure approval for research from both formal leaders of a community and customary
p.000115: authority. This is especially important for outsiders to communities, whose presence or intentions might be challenged
p.000115: as inappropriate. Researchers should engage community processes, including the guidance of moral authorities such as
p.000115: Elders, to avert potential conflict. These measures should be documented to assist the REB in considering the community
p.000115: engagement processes proposed (see Article 9.10). Where no agreement exists between formal community leadership and
p.000115: customary authority regarding the conduct of the proposed research, researchers should inform the REB. When alternative
p.000115: community engagement processes are followed to endorse a project, all other ethical safeguards set out in this chapter
p.000115: remain applicable.
p.000115: Recognizing Diverse Interests within Communities
p.000115: Article 9.6 In engaging territorial or organizational communities, researchers should ensure, to the extent
p.000115: possible, that they take into consideration the views of all relevant sectors – including individuals and subgroups who
p.000115: may not have a voice in the formal leadership. Groups or individuals whose circumstances make them vulnerable
p.000115: may need or desire special measures to ensure their safety in the context of a specific research project. Those who
...
p.000169: • Coded human biological materials – direct identifiers are removed from the materials and replaced with a code.
p.000169: Depending on access to the code, it may be possible to re- identify specific individuals (e.g., a principal
p.000169: investigator retains a key that links the coded material with a specific individual if re-linkage is necessary).
p.000169: • Anonymized human biological materials – the materials are irrevocably stripped of direct identifiers, a code is
p.000169: not kept to allow future re-linkage, and risk of re-identification of individuals from remaining indirect identifiers
p.000169: is low or very low.
p.000169: • Anonymous human biological materials – the materials never had identifiers attached to them and risk of
p.000169: identification of individuals is low or very low.
p.000169: Due to continuing technological development in genetics, individuals with access to stored human biological materials
p.000169: are increasingly able to use genetic markers to link a non-identifiable sample with an identified sample. For this
p.000169: reason, genetic analysis has made it more difficult to categorize human biological materials as anonymous or
p.000169: anonymized. The definitions above relate to identification of individuals; however, some research involving
p.000169: human biological materials, especially genetic research, may involve identification of groups, even though the human
p.000169: biological materials are non-identifiable at an individual level. Researchers and REBs should be aware of, and guard
p.000169: against, threats to individual privacy and autonomy that arise from re-identification risks, as well as risks to
p.000169: groups, particularly where sensitive research findings will be linked to specific groups.
p.000169: To maintain confidentiality, it may seem desirable to use anonymized or anonymous human biological materials. However,
p.000169: the scientific requirements of many studies may necessitate use of identifiable human biological materials, to link
p.000169: materials with information about participants, and to avoid using different samples from the same individual. Use of
p.000169: anonymized or anonymous human biological materials has the disadvantage of making it impossible to offer the benefits
p.000169: of research findings to participants and their families, or to alert them to relevant clinical findings. This is
p.000169: particularly significant when research may disclose a previously undiagnosed condition, such as HIV infection or an
p.000169: inherited predisposition to breast cancer, for which potentially effective treatments are available. Use of
p.000169: non-identifiable human biological materials also precludes withdrawal of a participant’s material from research
p.000169: use, even at the participant’s request.
p.000169:
p.000169: B. Collection of Human Biological Materials
p.000169: Human biological materials may be obtained in different ways:
p.000169: 1. they may be collected expressly for a specific research purpose;
p.000169: 2. they may be collected incidentally to medical or diagnostic procedures with no initial intent to be used in
p.000169: research; or
p.000169:
p.000169:
p.000169: 170 TCPS 2
p.000169:
p.000169: Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction
p.000169:
...
p.000177: the gametes, excluding any time during which embryonic development has been suspended.
p.000177: Application Research on embryos requires the consent of the gamete donors. The REB may not waive the requirement
p.000177: for such consent. In particular, researchers and REBs should be aware of the Assisted Human Reproduction (Section 8
p.000177: Consent) Regulations under the Assisted Human Reproduction Act.4
p.000177:
p.000177: Research Involving Fetuses and Fetal Tissue
p.000177: Article 12.9 Research involving a fetus or fetal tissue:
p.000177: (a) requires the consent of the woman; and
p.000177:
p.000177:
p.000177:
p.000177: 178 TCPS 2
p.000177:
p.000177: Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction
p.000177:
p.000177: (b) should not compromise the woman’s ability to decide whether to continue her pregnancy.
p.000177: Application Research may be undertaken on methods to treat, in utero, a fetus with genetic or congenital disorders.
p.000177: Because the fetus and the woman cannot be treated separately, any intervention to one involves an intervention to the
p.000177: other. Research involving a fetus or fetal tissue shall be guided by respect for the woman’s autonomy and physical
p.000177: integrity. Guidance provided in other chapters of this Policy (e.g., consent, privacy and confidentiality, inclusion
p.000177: and exclusion) will also apply. Researchers should ensure that a clear distinction is made between consent to research
p.000177: and consent for any clinical procedures or testing. In practice, this may mean separate consent information and
p.000177: documents, but regardless of the process employed, the differences between research and clinical procedures must be
p.000177: clearly explained.
p.000177:
p.000177: F. Research Involving Pluripotent Stem Cells
p.000177:
p.000177: Article 12.10 Researchers who intend to conduct research to derive or use pluripotent stem cells shall follow the
p.000177: Guidelines for Human Pluripotent Stem Cell Research,5 as amended from time to time and published by the
p.000177: Canadian Institutes of Health Research.
p.000177: Application The Guidelines for Human Pluripotent Stem Cell Research establish principles that guide the conduct of
p.000177: research with human pluripotent stem cells. The Guidelines explain their scope of application, provide examples of
p.000177: types of research to which they apply, and identify examples of research that conform and do not conform with the
p.000177: guidance. Consent, privacy and confidentiality are addressed, along with issues of commercial interests.
p.000177: Hybrids and Chimeras
...
p.000187:
p.000187: Agencies, the – Canada’s three federal research agencies: the Canadian Institutes of Health Research (CIHR); the
p.000187: Natural Sciences and Engineering Research Council of Canada (NSERC); and the Social Sci- ences and Humanities Research
p.000187: Council of Canada (SSHRC).
p.000187:
p.000187: Appeal – A process that allows a researcher to request a review of a research ethics board (REB) decision when, after
p.000187: reconsideration, the REB has refused ethics approval of the research.
p.000187:
p.000187: Appeal mechanism – A procedure established by an institution to promptly handle a researcher’s appeal of a research
p.000187: ethics board (REB) decision. An ad hoc or permanent appeal committee, which reflects a range of expertise and knowledge
p.000187: similar to that of the REB, is established or appointed by the same authority that established the REB.
p.000187:
p.000187: Authorized third party – Any person with the necessary legal authority to make decisions on behalf of a prospective
p.000187: participant who lacks the capacity to consent to participate, or to continue to participate, in a particular research
p.000187: project. In other policies/guidance they are also known as “authorized third party deci- sion makers.”
p.000187:
p.000187: Autonomy – The capacity to understand information and to be able to act on it voluntarily; the ability of individuals
p.000187: to use their own judgement to make decisions about their own actions, such as the decision to consent to participate in
p.000187: research.
p.000187:
p.000187:
p.000187:
p.000187: TCPS 2
p.000189: 189
p.000189:
p.000189: Glossary
p.000189:
p.000189: Biobank – A collection of human biological materials. It may also include associated information about individuals from
p.000189: whom biological materials were collected.
p.000189:
p.000189: Capacity – The ability of prospective or actual participants to understand relevant information presented (e.g. purpose
p.000189: of the research, foreseeable risks, and potential benefits), and to appreciate the potential con- sequences of any
p.000189: decision they make based upon this information.
p.000189:
p.000189: Clinical equipoise – The existence of a genuine uncertainty on the part of the relevant expert community about what
p.000189: therapy or therapies are most effective for a given condition.
p.000189:
p.000189: Clinical trial – Any investigation involving participants that evaluates the effects of one or more health- related
p.000189: interventions on health outcomes.
p.000189:
p.000189: Coercion – An extreme form of undue influence, involving a threat of harm or punishment for failure to participate in
p.000189: research. See “Undue influence.”
p.000189:
...
p.000195:
p.000195: Research ethics board (REB) – A body of researchers, community members, and others with specific ex- pertise (e.g. in
p.000195: ethics, in relevant research disciplines) established by an institution to review the ethical acceptability of all
p.000195: research involving humans conducted within the institution’s jurisdiction or under its auspices.
p.000195:
p.000195: Research ethics education and training – The provision of materials and corresponding instruction by an institution to
p.000195: research ethics board (REB) members or researchers with regard to the core principles and understanding of this Policy,
p.000195: basic ethics standards, applicable institutional policies, and legal or regulatory requirements. This term also
p.000195: includes an understanding of the role and mandate of REBs and responsibilities of REB members.
p.000195:
p.000195: Research involving partial disclosure or deception – A type of research, in which the participant may not know that
p.000195: they are part of a project until it is over or is not informed of the true purpose of the research in advance. See
p.000195: “Debriefing.”
p.000195:
p.000195: Respect for Persons – A core principle of this Policy that recognizes the intrinsic value of human beings and the
p.000195: respect and consideration that they are due. It incorporates the dual moral obligations to respect autonomy and to
p.000195: protect those with developing, impaired, or diminished autonomy.
p.000195:
p.000195: Risk – The possibility of the occurrence of harm. The level of foreseeable risk posed to participants by their
p.000195: involvement in research is assessed by considering the magnitude or seriousness of the harm and the probability that it
p.000195: will occur, whether to participants or to third parties.
p.000195:
p.000195: Secondary use – The use in research of information or human biological materials originally collected for a purpose
p.000195: other than the current research purpose.
p.000195:
p.000195: Security – Measures taken to protect information. It includes physical, administrative, and technical safe- guards.
p.000195:
p.000195: Shall – Indicates a mandatory provision.
p.000195:
p.000195: Should – Indicates guidance for the interpretation of the core principles.
p.000195:
p.000195: Stopping rules – Statistically significant end points and safety considerations for a clinical trial that are
p.000195: determined in advance, and, once reached, dictate that the trial must be terminated.
p.000195:
p.000195:
p.000195:
p.000195: 196 TCPS 2
p.000195:
p.000195: Glossary
p.000195:
p.000195: Surgical trials – A clinical trial which compares the safety and/or efficacy of different surgical techniques.
p.000195:
p.000195: Therapeutic misconception – A misunderstanding, on the part of participants, of the purpose, benefits, and/or risks
p.000195: of clinical trials. Often participants do not understand that research is aimed primarily at producing knowledge and
p.000195: may not provide any therapeutic benefit to them.
...
p.000195:
p.000195: Unanticipated issues – Issues that: occur during the conduct of research; may increase the level of risk to
p.000195: participants or have other ethical implications that may affect participants’ welfare; and were not anticipated by the
p.000195: researcher in the research proposal submitted for research ethics review.
p.000195:
p.000195: Undue influence – The impact of an unequal power relationship on the voluntariness of consent. This may occur when
p.000195: prospective participants are recruited by individuals in a position of authority over them (e.g. doctor/patient,
p.000195: teacher/student, employer/employee). See “Coercion.”
p.000195:
p.000195: Vulnerability – A diminished ability to fully safeguard one’s own interests in the context of a specific research
p.000195: project. This may be caused by limited capacity or limited access to social goods, such as rights, opportunities and
p.000195: power. Individuals or groups may experience vulnerability to different degrees and at different times, depending on
p.000195: their circumstances. See also “Autonomy.”
p.000195:
p.000195: Welfare – The quality of a person’s experience of life in all its aspects. Welfare consists of the impact on
p.000195: individuals and/or groups of factors such as their physical, mental and spiritual health, as well as their physical,
p.000195: economic and social circumstances.
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195: TCPS 2
p.000195:
p.000197: 197
p.000197:
p.000197:
p.000197:
p.000197: Index
p.000197: The Index seeks to direct the reader to meaningful references to key concepts in TCPS 2. Main references to a term are
p.000197: indicated with bold type.
p.000197:
p.000197: The Index is not a record of all occurrences of the listed topics. Readers who wish to check all occurrences of these
p.000197: topics or specific terms may do so through the Adobe search tool available online in the PDF version of the Policy
p.000197: found at www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2- eptc2/Default/.
p.000197:
p.000197: A
p.000197: Aboriginal peoples
p.000197: collaborative research, 123-124, 125-126, 128
p.000197: communities, 107-108, 109
p.000197: community customs, 108, 117-119
p.000197: community engagement, 108, 110-117, 121-125
p.000197: confidentiality, 126-128
p.000197: consent, 109, 119, 123, 131
p.000197: cultural heritage, 110-111
p.000197: definition, 107
p.000197: Elders, 119, 126
...
p.000197: governing authorities, 114
p.000197: human biological materials, 119, 129-132
p.000197: Indigenous knowledge (see Aboriginal peoples: traditional knowledge)
p.000197: Indigenous peoples, 107, 108, 110
p.000197: intellectual property, 128-129
p.000197: interpretation and dissemination of research results, 128 interpretation of ethics framework, 109-110
p.000197: Inuit, 105, 107, 108, 110, 114, 115, 117, 118, 121
p.000197: Métis, 105, 107, 108, 110, 114, 115, 117, 121
p.000197: mutual benefits, 124-125
p.000197: privacy, 126-128
p.000197: research agreements, 121, 122-123, 126-127, 128-130, 131
p.000197: research ethics review - research ethics boards and community, 115, 119-122 secondary use of information or human
p.000197: biological materials, 119-121, 130-132 strengthening research capacity, 125-126
p.000197: traditional knowledge, 108-109, 110-111, 126
p.000197: Academic freedom, 7, 11
p.000197: Ad hoc advisors, 24, 72, 73, 75, 120, 150
p.000197: Agencies, 5 Anonymity
p.000197: anonymized human biological materials, 170 anonymized information, 57
p.000197: anonymous human biological materials, 19, 131-132, 170
p.000197: anonymous information, 19, 57, 131-132
p.000197:
p.000197:
p.000197: TCPS 2
p.000199: 199
p.000199:
p.000199: Index
p.000199:
p.000199: Appeals, 83-85
p.000199: Assisted human reproduction (see Human reproduction, materials related to) Authorized third parties, 27, 41-44
p.000199: Autonomy, 8-9, 27, 40
p.000199:
p.000199: B
p.000199: Benefits, research
p.000199: equitable distribution, 10, 53
p.000199: mutual, 124-125
p.000199: and risk, 10, 11, 22-25, 41-42, 51, 157-158
p.000199: Biobanks, 175-176, 186
p.000199: Biological materials (see Human biological materials)
p.000199:
p.000199: C
p.000199: Canadian Charter of Rights and Freedoms, 12, 55 Capacity
p.000199: definition, 40-41
p.000199: diminished, 10, 41
p.000199: lack of, 9, 27, 39, 40-44, 47, 49-52, 171, 185, 187
p.000199: regaining, 39, 41, 43
p.000199: Children, 10, 34, 41-42, 47, 49-50, 51, 185, 187
p.000199: Chimeras, 179
p.000199: Clinical equipoise, 148 Clinical trials
p.000199: budgets, 164
p.000199: conflicts of interest, 163-164 consent, 155, 158-159, 161-163
p.000199: definition, 147
p.000199: design, 149-156
p.000199: dissemination of outcomes, 164-167 duty of care, 148-149
p.000199: medical device trials, 153 natural health product trials, 152 pharmaceutical trials, 150-152
p.000199: phases of pharmaceutical trials, 150-152 placebo-controlled trials, 154-156
p.000199: psychotherapy trials, 153
p.000199: registration, 149, 156-157
p.000199: reporting new information, 159-163 risk, 148, 157-159
p.000199: safety, 150, 157, 159-163
p.000199: surgical trials, 154
p.000199: therapeutic misconception, 148, 149, 158-159
p.000199: types, 149-156
p.000199: Coercion, 29
p.000199: Collaborative research, 123-124, 125-126, 128
p.000199:
p.000199:
p.000199:
...
p.000203:
p.000203: K
p.000203: Knowledge, traditional, 108-109, 110-111, 126
p.000203:
p.000203:
p.000203:
p.000203:
p.000203: 204 TCPS 2
p.000203:
p.000203: Index
p.000203:
p.000203:
p.000203: L
p.000203: Law
p.000203:
p.000203:
p.000203:
p.000203:
p.000203:
p.000203:
p.000203:
p.000203:
p.000203:
p.000203: M
p.000203:
p.000203:
p.000203: capacity, 41
p.000203: confidentiality, 58, 59, 60
p.000203: consent, 12, 27, 33-34
p.000203: gene transfer, 186
p.000203: human biological materials, 130, 171
p.000203: human reproduction, materials related to, 177 incidental findings, 34
p.000203: multi-jurisdictional review, 101, 103
p.000203: privacy, 12, 17-18, 55, 63, 64, 142, 143, 174
p.000203: research ethics, 12
p.000203: Medical emergencies (see Emergencies)
p.000203: Memorandum of Understanding on the Roles and Responsibilities in the Management of Federal Grants and Awards, 5, 67,
p.000106: 106
p.000106: Métis, 105, 107, 108, 110, 114, 115, 117, 121
p.000106: (see also Aboriginal peoples)
p.000106: Minimal risk research, 11, 23, 24-25, 37-39, 41, 51, 77-79 Multi-jurisdictional research
p.000106: official agreements, 98, 100
p.000106: research ethics review models, 99-101 review mechanisms, 97-101
p.000106:
p.000106: O
p.000106: Observational research, 18-19, 118, 141-143
p.000106:
p.000106: P
p.000106: Participants
p.000106: autonomy, 8-9, 27, 40 capacity (see Capacity)
p.000106: children, 10, 34, 41-42, 47, 49-50, 51, 185, 187
p.000106: confidentiality, 56, 58-60, 126-128, 143-144, 186
p.000106: definition, 16
p.000106: elderly, 10, 47, 50
p.000106: as members of research ethics boards, 72 perspective, 12, 23, 28, 72, 161
p.000106: privacy, 55-56, 58-60, 126-128, 143-144, 171-172, 186
p.000106: recruitment, 11, 28, 76-77, 110, 158-159, 164, 184-185
p.000106: removal from research, 31, 33, 160 as research partners, 138
p.000106: vulnerability, 9, 10, 23, 47, 52, 116, 137, 148
p.000106: withdrawal from research, 28-30, 31, 61, 140, 186
p.000106: women, 10, 47, 48-49, 116, 178-179
p.000106: Participatory research, 123-125
p.000106: Performance review, 20
p.000106:
p.000106:
p.000106: TCPS 2
p.000205: 205
p.000205:
p.000205: Index
p.000205:
p.000205: Pilot studies, 76-77, 139
p.000205: Pluripotent stem cells, 179
p.000205: Policy, the (see Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans) Principal investigators,
p.000205: 27, 99, 153-154, 159, 162, 165-166
p.000205: Principles (see Core principles) Privacy and confidentiality
p.000205: Aboriginal peoples, 126-128
p.000205: data linkage, 18, 19, 64-65, 131-132
p.000205: definition, 55-56
p.000205: ethical duty, 56, 58-60
p.000205: identifiability of information, 56-57
p.000205: participant, 55-56, 58-60, 126-128, 143-144, 171-172, 186
...
General/Other / Incapacitated
Searching for indicator incapacitated:
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p.000199: shall be conducted only if it addresses the emergency needs of the individuals involved, and then only in accordance
p.000199: with criteria established in advance of such research by the REB. The REB may allow research that involves medical
p.000199: emergencies to be carried out without the consent of participants, or of their authorized third party, if all of the
p.000199: following apply:
p.000199: (a) a serious threat to the prospective participant requires immediate intervention;
p.000199: (b) either no standard efficacious care exists or the research offers a realistic possibility of direct
p.000199: benefit to the participant in comparison with standard care;
p.000199: (c) either the risk is not greater than that involved in standard efficacious care, or it is clearly justified by the
p.000199: prospect for direct benefits to the participant;
p.000199: (d) the prospective participant is unconscious or lacks capacity to understand the risks, methods and purposes of the
p.000199: research project;
p.000199: (e) third party authorization cannot be secured in sufficient time, despite diligent and documented efforts to do so;
p.000199: and
p.000199: (f) no relevant prior directive by the participant is known to exist.
p.000199: When a previously incapacitated participant regains capacity, or when an authorized third party is found, consent
p.000199: shall be sought promptly for continuation in the project, and for subsequent examinations or tests related to
p.000199: the research project.
p.000199: Application For purposes of studying potential improvement in the treatment of life-threatening conditions, Article
p.000199: 3.8 outlines an exception (in addition to that in Article 3.7) to the general obligation of seeking consent from those
p.000199: participating in research.
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 39
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: It is the responsibility of researchers to justify to the REB the need for this exception. The underlying
p.000199: assumption of Article 3.8 is that participants could not receive any direct benefits of the research without setting
p.000199: aside the need for the researcher to seek the prior consent of participants, or of their authorized third party.
p.000199: Article 3.8 indicates that research in emergency medicine must be reviewed by the REB, be restricted to the emergency
p.000199: needs of the participants, and be conducted under criteria designated by the REB.
...
Searching for indicator incapacity:
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p.000199: needs of the participants, and be conducted under criteria designated by the REB.
p.000199: It is unethical to expose participants to any additional risk without their consent if standard efficacious care
p.000199: exists, unless it can clearly be shown that there is a realistic possibility of meaningful improvement of the
p.000199: participant’s condition. Accordingly, paragraphs (b) and (c) of Article 3.8 indicate that researchers and REBs must
p.000199: assess the risks and potential benefits of proposed research against existing standard efficacious care.
p.000199: To respect the autonomy of the participant, Article 3.8(e) requires researchers to undertake diligent efforts to
p.000199: contact authorized third parties, if reasonably feasible, and to document such efforts for the benefit of both
p.000199: the participant and the continuing ethics review functions of the REB. The article also requires that
p.000199: participants who regain capacity be promptly afforded the opportunity to consent to their continued participation.
p.000199: Concern for the patient’s welfare is paramount and should be informed by ethical and professional judgment.
p.000199: Because their incapacity to exercise consent makes them vulnerable, prospective participants for emergency research
p.000199: are owed special ethical obligations and protection commensurate with the risks involved. Their welfare should be
p.000199: protected by additional safeguards, where feasible and appropriate. These might include: additional scientific,
p.000199: medical or REB consultation; procedures to identify prospective participants in advance so that consent may be
p.000199: sought prior to the occurrence of the emergency situation; consultation with former and prospective participants; and
p.000199: special monitoring procedures to be followed by data safety and monitoring boards.
p.000199: C. Capacity
p.000199: Capacity refers to the ability of prospective or actual participants to understand relevant information
p.000199: presented about a research project, and to appreciate the potential consequences of their decision to participate or
p.000199: not participate. This ability may vary according to the complexity of the choice being made, the circumstances
p.000199: surrounding the decision, or the point in time at which consent is sought. The determination of capacity to participate
...
General/Other / Other Country
Searching for indicator another country:
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p.000101: how, they will seek permission to proceed with the research at that site and with the target participants. Some
p.000101: organizations or groups have established mechanisms or guidelines (e.g., school boards, Aboriginal communities [see
p.000101: Chapter 9], correctional services, service agencies and commu- nity groups) to review requests for research
p.000101: prior to allowing access to their members, or access to data about them that are under their authority. When
p.000101: design- ing their research, researchers should consider these provisions. This article does not apply to research
p.000101: involving critical inquiry about organizations or institutions (see Article 3.6).
p.000101: Researchers shall inform the REB of the absence of established ethics review mech- anisms at the research site, and
p.000101: report their efforts to identify any other suitable review mechanisms in the other country.1 When no appropriate
p.000101: mechanisms for research ethics review exist at the research site, researchers and REBs shall apply the core principles
p.000101: outlined in this Policy (see Chapter 1).
p.000101:
p.000101:
p.000101: 102 TCPS 2
p.000101:
p.000101: Chapter 8 – Multi-Jurisdictional Research
p.000101:
p.000101: REBs should not prevent research from proceeding solely because the research cannot be reviewed and approved through a
p.000101: formal REB review process in another country or other jurisdiction. Under these circumstances, researchers should be
p.000101: aware of relevant cultural practices, such as those normally followed to seek entry into the relevant communities, and
p.000101: be respectful of them. Researchers shall inform the REB of their strategies to familiarize themselves with the relevant
p.000101: norms and cultural practices, and to minimize risks to individuals and communities partici- pating in, or potentially
p.000101: affected by, the research.
p.000101: Researchers and REBs should afford prospective participants in other countries no less protection and respect than what
p.000101: this Policy requires. Respect for Persons, Concern for Welfare, and Justice considered in the context of the particular
p.000101: research project and setting should guide researchers in the design of their research, and REBs in their research
p.000101: ethics review.
p.000101: Article 8.4 (a) The information to be provided to the researcher’s home REB will be deter- mined by the provisions
p.000101: of the research ethics review model.
p.000101: (b) When conducting research outside the jurisdiction of their home institution, whether at a site abroad, or in
p.000101: Canada, researchers shall provide their home REBs with:
p.000101: • the relevant information about the rules governing research involving hu- mans and the ethics review requirements
p.000101: at the research site, where any exist;
p.000101: • the names and contact information for the relevant REBs or comparable ethics bodies, if known, that will review the
p.000101: proposal at the research site; and
p.000101: • relevant information about the target populations and circumstances that might have a bearing on the research
p.000101: ethics review by the researchers’ home REB.
p.000101: Application Researchers and REBs should be aware of the research ethics requirements and the types of protections
p.000101: for research involving humans, including legal protection, af- forded to participants at proposed research locations.
p.000101: Researchers and REBs should consult relevant reliable resources for details about governing laws or policies, and for
p.000101: information regarding appropriate REBs at the proposed research site in Canada or another country (see References at
p.000101: the end of this chapter). Applicable policies at the proposed site may differ considerably from this Policy, and
p.000101: therefore it is the responsibility of the researchers and REB(s) to ensure that, at a minimum, the pro- visions of this
p.000101: Policy, are followed.
p.000101: Disagreements may arise when one of the REBs or equivalent review body (Cana- dian or foreign) grants ethics approval
p.000101: while the other does not. Such disagreements require open communication among the researchers and the REBs, or
p.000101: equivalent review bodies involved (see also Section A of this chapter). In keeping with the
p.000101:
p.000101:
p.000101:
p.000101: TCPS 2
p.000103: 103
p.000103:
p.000103: Chapter 8 – Multi-Jurisdictional Research
p.000103:
p.000103: context-sensitive approach to research ethics review embodied in this Policy, the Canadian REB should ensure that it
p.000103: has a clear understanding of the differing ra- tionales that might underlie divergent REB positions or
p.000103: decisions on a given proposal. Where the REB is uncertain about the appropriate course of action in a given research
p.000103: proposal, it should make contact with its counterpart REB in the re- search site or country. In the absence of formal
p.000103: reciprocity agreements between countries or institutions with respect to initial and continuing research ethics review,
p.000103: the REBs should engage in dialogue and may establish a specific mechanism, such as a joint subcommittee of the two REBs
p.000103: (e.g., for situations in which institutions collaborate regularly), to facilitate appropriate deliberation in order to
...
p.000107:
p.000107:
p.000107: TCPS 2
p.000109: 109
p.000109:
p.000109: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000109:
p.000109: participants and maintained over the course of the research, can enhance ethical practice and the quality of
p.000109: research. Taking time to establish a relationship can promote mutual trust and communication, identify
p.000109: mutually beneficial research goals, define appropriate research collaborations or partnerships, and ensure that
p.000109: the conduct of research adheres to the core principles of Respect for Persons, Concern for Welfare – which in this
p.000109: context includes welfare of the collective, as understood by all parties involved – and Justice.
p.000109: Research Involving Indigenous Peoples in Other Countries
p.000109: Although the present chapter addresses research involving Aboriginal peoples in Canada, researchers, REBs, participants
p.000109: and the research community at large may find the guidance articulated here useful when undertaking research or
p.000109: reviewing a proposal involving Indigenous peoples in other countries who endorse collective decision making as a
p.000109: complement to individual consent. It is critically important, however, to seek local guidance in the
p.000109: application or adaptation of this Policy to Indigenous peoples outside of Canada.
p.000109: For considerations that apply to research conducted in another country, see Chapter 8, Section B.
p.000109:
p.000109: C. Applying Provisions of This Policy in Aboriginal Contexts
p.000109: Requirement of Community Engagement in Aboriginal Research
p.000109: Article 9.1 Where the research is likely to affect the welfare of an Aboriginal community, or communities, to
p.000109: which prospective participants belong, researchers shall seek engagement with the relevant community. The
p.000109: conditions under which engagement is required include, but are not limited to:
p.000109: (a) research conducted on First Nations, Inuit or Métis lands;
p.000109: (b) recruitment criteria that include Aboriginal identity as a factor for the entire study or for a subgroup in the
p.000109: study;
p.000109: (c) research that seeks input from participants regarding a community’s cultural heritage, artefacts, traditional
p.000109: knowledge or unique characteristics;
p.000109: (d) research in which Aboriginal identity or membership in an Aboriginal community is used as a variable for
p.000109: the purpose of analysis of the research data; and
p.000109: (e) interpretation of research results that will refer to Aboriginal communities, peoples, language, history or
p.000109: culture.
p.000109: Application Paragraph (a) refers to First Nations, Inuit and Métis lands that include Indian reserves, Métis
p.000109: settlements and lands governed under a self-government agreement or an Inuit or First Nations land claim agreement.
p.000109: Researchers should become informed about formal rules or oral customs that may apply in accordance with a particular
...
Searching for indicator other country:
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p.000199: • any differences in the standard of care normally followed, or access to services at the participating
p.000199: institutions that might be relevant to the conduct of the re- search; and
p.000199: • any operational issues that might affect the research.
p.000199:
p.000199: B. Ethics Review of Research Conducted outside the Institution
p.000199: Researchers affiliated with Canadian institutions are undertaking research at numerous sites within Canada and in
p.000199: countries around the world. Such research may be carried out with or without any collaboration with host institutions
p.000199: and local researchers. Most middle-income countries, and many low-income countries, have laws, policies or guidelines
p.000199: governing the ethical conduct of research involving humans, but some parts of the world do not have developed or
p.000199: widespread research ethics infrastructure.
p.000199: National and international standards for research involving humans are evolving continually, but methods for comparing
p.000199: the precise levels of protection afforded participants in different countries or jurisdictions, and by different
p.000199: institutions within those countries and jurisdictions, have not yet been developed. In exercising its responsibilities
p.000199: for the initial and continuing ethics review of re- search conducted under its auspices, the Canadian REB shall satisfy
p.000199: itself that the requirements of this Policy are met, both within the Canadian institution, and within the other country
p.000199: or research site. The Canadian REB shall take appropriate steps to ensure researchers are responsive to ethi- cally
p.000199: relevant aspects of the research context.
p.000199: Article 8.3 (a) Where research conducted under the auspices of a Canadian research institution and performed in
p.000199: whole or in part outside of Canada has been approved under a research ethics review model involving multiple
p.000199: institutions and/or REBs consistent with this Policy, the terms of that model apply.
p.000199:
p.000199:
p.000199: TCPS 2
p.000101: 101
p.000101:
p.000101: Chapter 8 – Multi-Jurisdictional Research
p.000101:
p.000101: (b) Subject to Article 8.3(a), research conducted under the auspices of a Canadian research institution and conducted
p.000101: outside its jurisdiction, whether elsewhere in Canada, or outside Canada, shall undergo prior research ethics review by
p.000101: both:
p.000101: i. the REB at the Canadian institution under the auspices of which the research is being conducted; and
p.000101: ii. the REB or other responsible review body or bodies, if any, at the research site.
p.000101: Application An institution is responsible for the ethical conduct and ethical acceptability of re- search
p.000101: undertaken by its faculty, staff or students regardless of where the research is conducted (see Article 6.1). Thus, for
p.000101: a Canadian research institution, review of the ethical acceptability of the research by the institution’s REB is
p.000101: required, in ad- dition to ethics review by an REB or other appropriately constituted review body with jurisdiction at
p.000101: the research site elsewhere in Canada, or outside Canada, if any. Approval of a research proposal by an REB at the
...
p.000101: recruitment of participants, access to data, or collection of human biological materials, in accordance with Article
p.000101: 6.11.
p.000101: Researchers may undertake research in Canada or abroad without formal collabo- ration with other academic institutions.
p.000101: In these cases, in addition to the REB review at their own institution, researchers may need to obtain access to the
p.000101: site and prospective participants from a responsible agency, where one exists. They shall inform the REB whether, or
p.000101: how, they will seek permission to proceed with the research at that site and with the target participants. Some
p.000101: organizations or groups have established mechanisms or guidelines (e.g., school boards, Aboriginal communities [see
p.000101: Chapter 9], correctional services, service agencies and commu- nity groups) to review requests for research
p.000101: prior to allowing access to their members, or access to data about them that are under their authority. When
p.000101: design- ing their research, researchers should consider these provisions. This article does not apply to research
p.000101: involving critical inquiry about organizations or institutions (see Article 3.6).
p.000101: Researchers shall inform the REB of the absence of established ethics review mech- anisms at the research site, and
p.000101: report their efforts to identify any other suitable review mechanisms in the other country.1 When no appropriate
p.000101: mechanisms for research ethics review exist at the research site, researchers and REBs shall apply the core principles
p.000101: outlined in this Policy (see Chapter 1).
p.000101:
p.000101:
p.000101: 102 TCPS 2
p.000101:
p.000101: Chapter 8 – Multi-Jurisdictional Research
p.000101:
p.000101: REBs should not prevent research from proceeding solely because the research cannot be reviewed and approved through a
p.000101: formal REB review process in another country or other jurisdiction. Under these circumstances, researchers should be
p.000101: aware of relevant cultural practices, such as those normally followed to seek entry into the relevant communities, and
p.000101: be respectful of them. Researchers shall inform the REB of their strategies to familiarize themselves with the relevant
p.000101: norms and cultural practices, and to minimize risks to individuals and communities partici- pating in, or potentially
p.000101: affected by, the research.
p.000101: Researchers and REBs should afford prospective participants in other countries no less protection and respect than what
p.000101: this Policy requires. Respect for Persons, Concern for Welfare, and Justice considered in the context of the particular
p.000101: research project and setting should guide researchers in the design of their research, and REBs in their research
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.000199: Where the terms of the research proposal do not permit the participants to withdraw their data, in the absence
p.000199: of the consent of the participant, the identity of the participants shall be protected at all times during and
p.000199: following completion of the project. Participants who express concern about the conduct of the project at the time of
p.000199: debriefing, or who contest the limits imposed
p.000199:
p.000199:
p.000199: 38 TCPS 2
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: on withdrawing their data, should be given the contact information for the REB that approved the research. Researchers
p.000199: must report to the REB concerns about the conduct of the project raised by participants at the time of debriefing.
p.000199: Consent for Research in Individual Medical Emergencies
p.000199: This section addresses the exception to consent in situations where an individual who requires urgent medical care is
p.000199: unable to provide consent for research due to loss of consciousness or capacity – and the delay to seek authorized
p.000199: third party consent could seriously compromise that individual’s health. Certain types of medical emergency practices
p.000199: can be evaluated only when they occur, hence the need for this exception.
p.000199: This section is to be distinguished, however, from situations where there is a publicly declared emergency (such as the
p.000199: SARS crisis or a major flood) that disrupts the ordinary system for obtaining REB approval for research. For guidance
p.000199: on research ethics review during a publicly declared emergency, see Articles 6.21 and 6.22.
p.000199: Article 3.8 Subject to all applicable legal and regulatory requirements, research involving medical emergencies
p.000199: shall be conducted only if it addresses the emergency needs of the individuals involved, and then only in accordance
p.000199: with criteria established in advance of such research by the REB. The REB may allow research that involves medical
p.000199: emergencies to be carried out without the consent of participants, or of their authorized third party, if all of the
p.000199: following apply:
p.000199: (a) a serious threat to the prospective participant requires immediate intervention;
p.000199: (b) either no standard efficacious care exists or the research offers a realistic possibility of direct
p.000199: benefit to the participant in comparison with standard care;
p.000199: (c) either the risk is not greater than that involved in standard efficacious care, or it is clearly justified by the
p.000199: prospect for direct benefits to the participant;
p.000199: (d) the prospective participant is unconscious or lacks capacity to understand the risks, methods and purposes of the
p.000199: research project;
p.000199: (e) third party authorization cannot be secured in sufficient time, despite diligent and documented efforts to do so;
p.000199: and
p.000199: (f) no relevant prior directive by the participant is known to exist.
p.000199: When a previously incapacitated participant regains capacity, or when an authorized third party is found, consent
p.000199: shall be sought promptly for continuation in the project, and for subsequent examinations or tests related to
p.000199: the research project.
p.000199: Application For purposes of studying potential improvement in the treatment of life-threatening conditions, Article
p.000199: 3.8 outlines an exception (in addition to that in Article 3.7) to the general obligation of seeking consent from those
p.000199: participating in research.
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 39
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: It is the responsibility of researchers to justify to the REB the need for this exception. The underlying
p.000199: assumption of Article 3.8 is that participants could not receive any direct benefits of the research without setting
p.000199: aside the need for the researcher to seek the prior consent of participants, or of their authorized third party.
p.000199: Article 3.8 indicates that research in emergency medicine must be reviewed by the REB, be restricted to the emergency
p.000199: needs of the participants, and be conducted under criteria designated by the REB.
p.000199: It is unethical to expose participants to any additional risk without their consent if standard efficacious care
p.000199: exists, unless it can clearly be shown that there is a realistic possibility of meaningful improvement of the
p.000199: participant’s condition. Accordingly, paragraphs (b) and (c) of Article 3.8 indicate that researchers and REBs must
p.000199: assess the risks and potential benefits of proposed research against existing standard efficacious care.
p.000199: To respect the autonomy of the participant, Article 3.8(e) requires researchers to undertake diligent efforts to
p.000199: contact authorized third parties, if reasonably feasible, and to document such efforts for the benefit of both
p.000199: the participant and the continuing ethics review functions of the REB. The article also requires that
p.000199: participants who regain capacity be promptly afforded the opportunity to consent to their continued participation.
p.000199: Concern for the patient’s welfare is paramount and should be informed by ethical and professional judgment.
p.000199: Because their incapacity to exercise consent makes them vulnerable, prospective participants for emergency research
p.000199: are owed special ethical obligations and protection commensurate with the risks involved. Their welfare should be
p.000199: protected by additional safeguards, where feasible and appropriate. These might include: additional scientific,
p.000199: medical or REB consultation; procedures to identify prospective participants in advance so that consent may be
p.000199: sought prior to the occurrence of the emergency situation; consultation with former and prospective participants; and
p.000199: special monitoring procedures to be followed by data safety and monitoring boards.
p.000199: C. Capacity
p.000199: Capacity refers to the ability of prospective or actual participants to understand relevant information
p.000199: presented about a research project, and to appreciate the potential consequences of their decision to participate or
p.000199: not participate. This ability may vary according to the complexity of the choice being made, the circumstances
p.000199: surrounding the decision, or the point in time at which consent is sought. The determination of capacity to participate
p.000199: in research, then, is not a static determination. It is a process that may change over time, depending on the nature of
p.000199: the decision the prospective participant needs to make, and on any changes in the participant’s condition. Assessing
...
p.000199: counted in the quorum for an REB. Nor should they be allowed to vote on REB decisions (see Article 6.5). Decisions
p.000199: without a quorum are not valid or binding.
p.000199: REB Meetings and Attendance
p.000199: Article 6.10 REBs shall have regular meetings to discharge their responsibilities, and shall nor- mally meet face to
p.000199: face to review proposed research that is not assigned to delegated review.
p.000199: Application Face-to-face meetings are essential for adequate discussion of, and effective REB decision making on,
p.000199: research proposals, and for the collective education of the REB. The face-to-face medium provides interactive dynamics
p.000199: that tend to heighten the quality and effectiveness of communications and decisions.
p.000199: Planning regular meetings is essential to fulfilling REB responsibilities. Where a member is frequently absent, the REB
p.000199: should have some mechanism for reviewing whether that member should continue to serve on the REB. Unexpected circum-
p.000199: stances such as emergencies may prevent individual member(s) from attending the REB meeting. In these exceptional
p.000199: cases, input from member(s) by the use of tech- nology (e.g., phone or video link) would be acceptable.
p.000199: Videoconferencing, teleconferencing or use of other technologies may be regarded as necessary for meetings when REB
p.000199: members are geographically dispersed and there is no other way of holding an effective REB meeting, or when exceptional
p.000199: or exigent circumstances significantly disrupt or limit the feasibility of face-to-face REB meetings (e.g., during a
p.000199: public emergency). All efforts should be made to en- sure that technical difficulties do not prevent the maintenance of
p.000199: quorum throughout the meeting. Use of such technologies requires the Chair to ensure active participa- tion of members
p.000199: not physically present. Institutions should consider developing written procedures for the occasional use of
p.000199: videoconferences or other technologies by an REB.
p.000199: In the design phase of their research prior to the formal ethics review process, re- searchers may consult informally
p.000199: with REBs. Such dialogue can establish the stage at which REB review and approval would be required, or facilitate the
p.000199: review. Such
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 75
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: informal meetings cannot, however, substitute for the formal review process. A schedule of REB meetings should be
p.000199: communicated to researchers for the planning of ethics review of their research.
p.000199: On occasion REBs may need to consult other resources within or outside the insti- tution for advice, and may invite
p.000199: experts to attend their meetings. REBs should consider whether the institutional functions of other individuals
p.000199: attending their meetings could exercise undue influence, or provide elements of power imbalances or coercion that would
...
p.000199: procedural or substantive reasons. The onus is on the researchers to justify the grounds on which they request an
p.000199: appeal and to indicate any breaches to the research ethics review process or any elements of the REB decision that are
p.000199: not supported by this Policy.
p.000199: The appeal committee shall function impartially, provide a fair hearing to those in- volved, and provide reasoned
p.000199: and appropriately documented opinions and decisions. Both the researcher and a representative of the REB shall be
p.000199: granted the opportunity to address the appeal committee, but neither shall be present when the
p.000199:
p.000199:
p.000199:
p.000199: 84 TCPS 2
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: appeal committee deliberates and makes a decision. Appeal committee decisions on behalf of the institution shall be
p.000199: final, and should be communicated in writing (in print or by electronic means) to researchers and to the REB whose
p.000199: decision was appealed. Recourse to judicial review may be available to the researcher.
p.000199:
p.000199: D. Research Ethics Review during Publicly Declared Emergencies
p.000199:
p.000199: This section addresses research ethics review within the context of the official declaration of public emergencies. For
p.000199: the purposes of this Policy, a publicly declared emergency is an emergency sit- uation that, due to the extraordinary
p.000199: risks it presents, has been proclaimed as such by an authorized public official (in accordance with legislation and/or
p.000199: public policy).
p.000199: Publicly declared emergencies are extraordinary events that arise suddenly or unexpectedly, and require urgent or quick
p.000199: responses to minimize devastation. Examples include hurricanes and other natural disasters, large communicable disease
p.000199: outbreaks, catastrophic civil disorders, bio-hazardous releases, environmental disasters, and humanitarian emergencies.
p.000199: They tend to be time-limited. They may severely disrupt or may destroy normal functioning of institutions and
p.000199: communities, as well as individual lives. Once an emergency has been designated a publicly declared emergency,
p.000199: authorities may exercise special responsibilities and powers to deal with the situation, and the ex- ercise of those
p.000199: responsibilities may temporarily modify normal procedures or practices. This section therefore applies to narrow,
p.000199: limited and exceptional circumstances.
p.000199: There is a growing awareness of the need for institutional planning to respond to publicly declared emergencies, and
p.000199: the associated potential challenges for research ethics review. Given the extraor- dinary circumstances that
p.000199: participants are potentially subjected to in publicly declared emergencies, special attention and effort should be
p.000199: given to upholding the core principles of Respect for Persons, Concern for Welfare, and Justice when reviewing the
p.000199: ethics of research to be conducted in emer- gencies. It should be noted that the following articles and the requirement
p.000199: for consent will not apply to public health activities undertaken by federal, provincial and territorial public health
p.000199: of- ficials operating under statutory powers during publicly declared health emergencies.
p.000199: Preparedness Plans for Research Ethics Review during Publicly Declared Emergencies Article 6.21 In collaboration
p.000199: with their researchers, institutions and their REBs should develop
p.000199: preparedness plans for emergency research ethics review. Research ethics review during publicly declared emergencies
p.000199: may follow modified procedures and prac- tices.
p.000199: Application Preparedness plans should outline policies and procedures for addressing research ethics review during
p.000199: public health outbreaks, natural disasters and other publicly declared emergencies. Research ethics policies and
p.000199: procedures, and their imple- mentation, should adhere rigorously to a rule of reasonable, fair, and principled design
p.000199: and use during publicly declared emergencies.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 85
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: Through their emergency preparedness plans, institutions, researchers and their REBs need to anticipate the pressures,
p.000199: time constraints, priorities and logistical challenges that may arise to ensure quality, timely, proportionate and
p.000199: appropriate research ethics review. The plan and its policies should proactively address basic operational questions.
p.000199: Examples include, but are not limited to, how emergencies may affect research and research ethics review in
p.000199: institutions; how REBs conduct business or meetings; what research needs should be planned in advance of, or ad-
p.000199: dressed after, an emergency; what research, if any, needs to be done during an emergency; what qualifies as
p.000199: time-sensitive or “essential” research; what proce- dures govern the research ethics review process in emergency
p.000199: circumstances; and what evaluation methods need to be developed for post-response evaluations to in- form any revisions
p.000199: to the institution’s emergency procedures. It is important to pilot test the emergency procedures and plans in advance.
p.000199: Policies should try to anticipate the extraordinary circumstances or demands occa- sioned by emergencies and set
p.000199: priorities among them. For example, REBs should try to work collaboratively with researchers who would likely be
p.000199: involved in emer- gency research (e.g., relevant biomedical, environmental and social science researchers), and
p.000199: determine what special consent provisions may be made (see Chapter 3). Institutions might consider the use of an
p.000199: instrument to identify and triage the kinds of research that should be designed before, undertaken during or conducted
p.000199: after officially declared public emergencies. Likewise, a plan to help pri- oritize REB reviews during emergencies
p.000199: should take into account the following:
p.000199: • what research is “essential” research during the emergency;
p.000199: • the initial ethics review process of new research projects arising from the emergency (e.g., research
p.000199: involving interviews with first responders and victims to understand human response during a
p.000199: disaster, such as a tornado or earthquake);
p.000199: • continuing ethics review of research undertaken prior to the occurrence of the emergency; and
p.000199: • the ethics review process for changes to approved research, because new information may become
p.000199: available and require action very rapidly during emergencies (see Articles 6.15 and 6.16).
p.000199: REB procedures may warrant reasonable adjustments to address the timing, locale, expertise, form and scope of research
p.000199: ethics review, and the holding of REB meet- ings during emergency situations (see Article 6.10). Special attention
p.000199: could be given to REB procedures to review and approve research (e.g., full or delegated research ethics reviews,
p.000199: quorum rules, or special agreements with other institutions), while considering the impact of the emergency on
p.000199: participants, researchers, REB mem- bers, institutional staff, and others. It is also important to coordinate research
p.000199: efforts
p.000199:
p.000199:
p.000199: 86 TCPS 2
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: and research ethics review processes within and across institutions. REB members may become unavailable (e.g., due to
p.000199: illness, relocation, or quarantine by public authorities). Institutions and REBs should explore the nomination of
p.000199: substitute REB members and consultation with ad hoc advisors with relevant expertise (see Articles
p.000199: 6.4 and 6.5), negotiate reciprocity agreements with other institutions for REB re- views (see Article 8.1), and revisit
p.000199: how scholarly review (see Article 2.7) would be applied in emergency situations.
p.000199: Research ethics review should be commensurate with the necessities occasioned by the emergency because of the
p.000199: critical interplay between public urgencies, essential research and a continuing commitment to the core principles
p.000199: even in the face of acute public necessity. Indeed, research ethics review during publicly declared
p.000199: emergencies is even more important than under normal circumstances, and may require even greater care, since everyone
p.000199: (participants, researchers and REB members themselves) may be rendered more vulnerable by the nature of the emergency.
p.000199: Research Ethics Review Policy and Procedures during Publicly Declared Emergencies Article 6.22 Research ethics
p.000199: policies and procedures for emergencies take effect once an emer-
p.000199: gency has been publicly declared. They should cease to apply as soon as is feasible after the end of the publicly
p.000199: declared emergency.
p.000199: Application Because emergencies present extraordinary public risks that warrant special re- sponses, legislation
p.000199: or public policies usually require that they be officially proclaimed or declared. Research ethics review
p.000199: procedures that have been estab- lished for use during publicly declared emergencies should be applied only after an
p.000199: authorized public official declares a public emergency. These procedures there- fore apply to very narrow, limited and
p.000199: exceptional circumstances. Institutions and REBs must endeavour to return to normal operating procedures as soon as
p.000199: possible after public officials have declared that the emergency is over.
p.000199: Respecting Core Principles: Limiting Exceptions
p.000199: Article 6.23 REBs should give special care to requests for exceptions to the principles and pro- cedures outlined in
p.000199: this Policy during publicly declared emergencies.
p.000199: Application Especially during times of emergency, researchers, REBs and institutions need to be vigilant and
p.000199: exercise due diligence in respecting ethical principles, procedures and the law in effect during the emergency to
p.000199: preserve the values, purpose and pro- tection that the principles of this Policy advance.
p.000199: To guide fair and reasonable implementation of these principles in emergency cir- cumstances, any exception to, or
p.000199: infringement of, ethics principles and REB procedures must be demonstrably justified by those urging the exception
p.000199: or in- fringement.
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 87
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: Endnote
p.000199:
p.000199: Where exceptions to or infringements of ethics principles and REB procedures are justified, they should be narrowly
p.000199: tailored to address the necessities occasioned by the publicly declared emergency, such that they rely on the most
p.000199: restrictive or least intrusive means necessary to achieve the Policy goal: the promotion and guidance of ethical
p.000199: conduct in research. This approach – consistent with international bioethics and human rights norms – maximizes
p.000199: respect for ethical principles and helps to ensure that exceptions and the means to implement them are not unduly
p.000199: broad, overreaching or unjustifiably invasive.
p.000199: Recognizing and respecting the principle of Justice means that research ethics re- view policies and procedures for
p.000199: publicly declared emergencies shall be used in a manner that is not discriminatory or arbitrary. The commitment to
p.000199: justice advances a fair and balanced distribution of risks and potential benefits even in the face of public
p.000199: emergencies.
p.000199: REBs and researchers should be aware that individuals, prospective participants, researchers, and institutions may not
p.000199: normally be considered vulnerable, but may become so by the very nature of public emergencies. Those already vulnerable
p.000199: may become acutely so (see Article 4.7). The increased public risks and devastation that cause public emergencies to be
...
p.000139: structures and individuals in positions of power (e.g., a senior partner in a law firm, a cabinet minister or a senior
p.000139: corporate officer). In this type of research, where a prospective participant agrees to be interviewed on the basis of
p.000139: sufficient information provided by the researcher, it may be sufficient for the participant to signify consent to
p.000139: participate in the research. The researcher should record this in an appropriate way. Researchers shall demonstrate to
p.000139: the REB that the participant will be informed about the research including the option not to participate, or to
p.000139: withdraw from the study at any time. Nothing in this article should be interpreted to mean that prospective
p.000139: participants need not be informed about the study prior to their participation.
p.000139: Researchers and REBs should consult Chapter 3, and Articles 3.1, 3.2, 3.3 and 3.12 in particular, for additional
p.000139: details and considerations on consent, and how to document consent.
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139: 140 TCPS 2
p.000139:
p.000139: Chapter 10 – Qualitative Research
p.000139:
p.000139: Observational Studies
p.000139: In qualitative research, observation is used to study behaviour in a natural environment. It often takes
p.000139: place in living, natural and complex communities or settings, in physical environments, or in virtual settings.
p.000139: Observational studies may be undertaken in publicly accessible spaces (e.g., classrooms, hospital emergency wards,
p.000139: locations where religious services or practices are held), in virtual settings (e.g., Internet chat rooms), or in
p.000139: private or controlled spaces (e.g., private clubs or organizations.)
p.000139: Observational research is of two kinds: “non-participant” where the researcher observes, but is not a participant
p.000139: in, the action (also known as “naturalistic observation”); and “participant” where the researcher engages in, and
p.000139: observes, the action.
p.000139: Participant observation is often identified with ethnographic research, in which the researcher’s role is to gain a
p.000139: holistic overview of the studied context through engagement in, and observation of, the setting to describe its social
p.000139: environments, processes and relationships. Participant observation may or may not require permission to
p.000139: observe and participate in activities of the setting studied. In some situations, researchers will identify themselves
p.000139: and seek consent from individuals in that setting; in others, researchers will engage in covert
p.000139: non-participant or participant observation and not seek consent.
p.000139: A matter that is publicly accessible may, nevertheless, be considered private in a prospective participant’s culture.
p.000139: There may be a reasonable expectation of privacy by some groups, or for some activities. For example,
p.000139: individuals involved in religious services or practices, or chat rooms on the Internet, may assume that participants
p.000139: and observers will accord the proceedings some degree of privacy. Observing sacred ceremonies without approval from the
...
p.000141: privacy and confidentiality.
p.000141: For observational research in which consent is not sought, researchers shall demonstrate to the REB that
p.000141: necessary precautions and measures have been taken to address privacy and confidentiality issues.
p.000141: Because the knowledge that one is being observed can be expected to influence behaviour, research involving
p.000141: non-participant or covert observation generally requires that the participants not know that they are being
p.000141: observed for research purposes. Typically the researcher has no direct interaction with the individuals being observed
p.000141: and therefore their consent is not sought. Covert observation of queuing behaviours in shopping malls is one example of
p.000141: a study where the research could not be completed if shoppers knew that they were being observed. Some forms of
p.000141: qualitative research seek to observe and study criminal behaviours, violent groups, or groups with restricted
p.000141: membership or access using covert participant observation. For example, some social science research that critically
p.000141: probes the inner workings of criminal organizations might never be conducted if the participants know in
p.000141: advance that they are being observed. Other observational studies may be anonymous but involve intervention by the
p.000141: researcher (e.g., studying the propensity of bystanders to help in an emergency normally requires a staged emergency).
p.000141: These methodological approaches may require the researcher seeking an exception to the general requirement for consent.
p.000141:
p.000141:
p.000141:
p.000141:
p.000141: 142 TCPS 2
p.000141:
p.000141: Chapter 10 – Qualitative Research
p.000141:
p.000141: Where no personal information is collected, consent is not required. Where personal information will be collected,
p.000141: researchers should explain whether the need for such covert research justifies an exception to the general
p.000141: requirement for seeking consent, and REBs should exercise their judgment taking into consideration the methodological
p.000141: requirements (see Article 3.7). Researchers and REBs shall take the necessary steps to ensure that the privacy of the
p.000141: individual is protected in accordance with the law in the absence of consent. Where no consent is sought, researchers
p.000141: and REBs may also consider whether debriefing is possible or necessary. Chapter 5 on privacy and
p.000141: confidentiality provides additional information.
p.000141: Researchers and REBs should also be aware that, in some jurisdictions, publication of identifying information – for
p.000141: example, a photograph taken in a public place, but focused on a private individual who was not expecting this
p.000141: action – may be interpreted in a civil suit as an invasion of privacy.
p.000141:
p.000141: Privacy and Confidentiality in the Dissemination of Research Results
...
p.000189: efficacy of clinical trial procedures, and monitoring the overall conduct of a trial.
p.000189:
p.000189: Data set – A collection of information to be used for research purposes, including human biological materials.
p.000189:
p.000189: Debriefing – The full disclosure of the research purpose and other pertinent information to participants who have been
p.000189: involved in research employing partial disclosure or deception. Debriefing is typically done after participation has
p.000189: ended, but may be done at any time during the study.
p.000189:
p.000189: Delegated research ethics board (REB) review – The level of REB review assigned to minimal risk research projects.
p.000189: Delegated reviewers are selected from among the REB membership, with the exception of the ethics review of student
p.000189: course-based research which can be reviewed by delegates from the student’s department, faculty, or an equivalent
p.000189: level.
p.000189: Embryo – A human organism during the first 56 days of its development following fertilization or creation, excluding
p.000189: any time during which its development has been suspended. It also includes any cell derived from such an organism that
p.000189: is used for the purpose of creating a human being.
p.000189:
p.000189:
p.000189:
p.000189:
p.000189:
p.000189:
p.000189: TCPS 2
p.000191: 191
p.000191:
p.000191: Glossary
p.000191:
p.000191: Emergency preparedness plans – Plans that detail an institution’s policies and procedures for addressing research
p.000191: ethics review during public health outbreaks, natural disasters, and other publicly declared emer- gencies. See
p.000191: “Publicly declared emergency.”
p.000191:
p.000191: Emergent design – A research method in which data collection and analyses can evolve over the course of a research
p.000191: project in response to what is learned in earlier parts of the study.
p.000191:
p.000191: Fetal tissue – Membranes, placenta, umbilical cord, amniotic fluid, and other tissue that contains genetic information
p.000191: about the fetus.
p.000191: Fetus – A human organism during the period of its development beginning on the 57th day following fertilization or
p.000191: creation, excluding any time during which its development has been suspended, and ending at birth.
p.000191:
p.000191: Full research ethics board (REB) review – The level of REB review assigned to above minimal risk re- search projects.
p.000191: Conducted by the full membership of the research ethics board, it is the default requirement for the ethics review of
p.000191: research involving humans.
p.000191:
p.000191: Gene alteration – The transfer of genes into cells to induce an altered capacity of the cell.
p.000191:
p.000191: Genetic counselling – The explanation of the meaning and implication of information revealed in genetic research to a
p.000191: participant by someone with the experience or training to provide the appropriate context and support .
p.000191:
...
p.000191:
p.000191: Institutions – The universities, hospitals, colleges, research institutes, centres and other organizations eligible to
p.000191: receive and manage Agency grant funds on behalf of the grant holders and the Agencies.
p.000191:
p.000191: Intermediary – An individual with the necessary language skills to ensure effective communication between the research
p.000191: team and participants, should any language barriers exist.
p.000191:
p.000191: Institutional conflicts of interest – An incompatibility between two or more substantial institutional obligations
p.000191: that cannot be adequately fulfilled without compromising one or another of the obligations.
p.000191:
p.000191:
p.000191:
p.000191:
p.000191:
p.000191:
p.000191:
p.000191: TCPS 2
p.000191:
p.000193: 193
p.000193:
p.000193: Glossary
p.000193:
p.000193: Justice – A core principle of this Policy that refers to the obligation to treat people fairly and equitably. Fairness
p.000193: entails treating all people with equal respect and concern. Equity requires distributing the benefits and burdens of
p.000193: research participation in such a way that no segment of the population is unduly burdened by the harms of research or
p.000193: denied the benefits of the knowledge generated from it.
p.000193:
p.000193: Medical device trials – Clinical trials that test the safety and/or efficacy of one or more instruments used in the
p.000193: prevention, diagnosis, mitigation, or treatment of a disease or abnormal physical condition or the restoration,
p.000193: correction or modification of body function or structure.
p.000193:
p.000193: Medical emergency – A situation in which one or more individuals requires urgent medical care.
p.000193:
p.000193: Minimal risk research – Research in which the probability and magnitude of possible harms implied by participation in
p.000193: the research is no greater than those encountered by participants in the aspects of their everyday life that relate to
p.000193: the research.
p.000193:
p.000193: Memorandum of Understanding (MOU) – The agreement between the Agencies and institutions eligible to receive and manage
p.000193: research funding from the Agencies. A commitment to adhere to the TCPS is a part of the MOU.
p.000193:
p.000193: Multi-jurisdictional research – research involving multiple institutions and/or multiple REBs. It is not intended to
p.000193: apply to ethics review mechanisms for research involving multiple REBs within the jurisdiction or under the auspices of
p.000193: a single institution.
p.000193:
p.000193: Natural Health Product (NHP) Trial – A clinical trial testing the safety and/or efficacy of one or more natural
p.000193: health products. The term natural health product is used to describe substances such as vitamins and minerals, herbal
p.000193: medicines, homeopathic preparations, energy drinks, probiotics, and many alternative and traditional medicines.
p.000193:
p.000193: Observational research – The study of behaviour in a natural environment in which people involved in their normal
p.000193: activities are observed whether with or without their knowledge. This term does not include observational methods used
p.000193: in epidemiological research.
p.000193:
p.000193: Ongoing research – Research that has received REB approval and has not yet been completed.
p.000193:
...
p.000193: with a placebo control group.
p.000193: A placebo is an inactive substance or intervention that resembles the comparable active substance or intervention.
p.000193:
p.000193: Privacy – An individual’s right to be free from intrusion or interference by others.
p.000193:
p.000193: Privacy risks – The potential harms that participants, or the groups to which they belong, may experience from the
p.000193: collection, use, and disclosure of personal information for research purposes.
p.000193:
p.000193: Proportionate approach to research ethics review – The assessment of foreseeable risk to determine the level of
p.000193: scrutiny a research proposal will receive (i.e. delegated review for minimal risk research or full REB review for
p.000193: research above minimal risk), as well as the consideration of foreseeable risks, potential benefits, and ethical
p.000193: implications of the research in the context of initial and continuing review.
p.000193:
p.000193: Psychotherapy trials – A clinical trial testing the safety and/or efficacy of one or more psychotherapeutic approaches
p.000193: to behavioural disorders or other mental illness.
p.000193:
p.000193: Publicly declared emergency – An emergency situation which, due to the extraordinary risks it presents, has been
p.000193: proclaimed as such by an authorized public office (in accordance with legislation and/or public policy). Publicly
p.000193: declared emergencies are extraordinary events that arise suddenly or unexpectedly, and require urgent or quick
p.000193: responses to minimize devastation. Examples include hurricanes and other natural disasters, large communicable disease
p.000193: outbreaks, catastrophic civil disorders, bio-hazardous releases, en- vironmental disasters, and humanitarian
p.000193: emergencies.
p.000193:
p.000193: Publicly available information – Any existing stored documentary material, records or publications, which may or may
p.000193: not include identifiable information, and that has no restrictions on its use or distribution, or that may be released
p.000193: under certain legal conditions.
p.000193:
p.000193: Qualitative research – An approach that aims to understand how people think about the world and how they act and behave
p.000193: in it. This approach requires researchers to understand phenomena based on discourse, actions, and documents, and how
p.000193: and why individuals interpret and ascribe meaning to what they say and do, and to other aspects of the world (including
p.000193: other people) they encounter.
p.000193:
p.000193: Reciprocal research ethics board (REB) review – An official agreement between two or more institutions, in which they
p.000193: accept, with an agreed level of oversight, the research ethics reviews of each other’s REBs.
p.000193:
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General/Other / Relationship to Authority
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p.000199: can have an impact on any of these connections.
p.000199:
p.000199: 8 TCPS 2
p.000199:
p.000199: Chapter 1 – Ethics Framework
p.000199:
p.000199: An important mechanism for respecting participants’ autonomy in research is the requirement to seek their free,
p.000199: informed and ongoing consent. This requirement reflects the commitment that par- ticipation in research, including
p.000199: participation through the use of one’s data or biological materials, should be a matter of choice and that, to be
p.000199: meaningful, the choice must be informed. An informed choice is one that is based on as complete an understanding as is
p.000199: reasonably possible of the purpose of the research, what it entails, and its foreseeable risks and potential benefits,
p.000199: both to the partic- ipant and to others. Respect for Persons also includes a commitment to accountability
p.000199: and transparency in the ethical conduct of research.
p.000199: Certain factors may diminish a person’s ability to exercise their autonomy, such as inadequate information or
p.000199: understanding for deliberation, or a lack of freedom to act due to controlling influences or coercion. Such constraints
p.000199: may include the fear of alienating those in positions of authority, such as professional or personal caregivers,
p.000199: researchers, leaders, larger groups, or a community to which one belongs. Other constraints may consist of barriers to
p.000199: accessing resources or knowledge outside the research context. These factors and constraints should be addressed prior
p.000199: to any research being carried out, so as to ensure participants are sufficiently protected.
p.000199: Some people may be incapable of exercising autonomy because of youth, cognitive impairment, other mental health issues
p.000199: or illness. While autonomy may be considered a necessary condition for participation in research, involving those who
p.000199: lack capacity to make their own decisions to participate can be valuable, just and even necessary. For those
p.000199: prospective participants, additional measures are needed to protect their interests and to ensure that their wishes (to
p.000199: the extent that these are known) are respected. These measures will generally include seeking consent from an
p.000199: authorized third party who is entrusted to make decisions on behalf of the prospective participant, based on knowledge
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p.000199: Respect for Persons implies that individuals who participate in research should do so voluntarily, understanding the
p.000199: purpose of the research, and its risks and potential benefits, as fully as reasonably possible. Where a person has the
p.000199: capacity to understand this information, and the ability to act on it voluntarily, the decision to participate is
p.000199: generally seen as an expression of autonomy. The Policy refers to the process of seeking consent from prospective
p.000199: participants, which may result in either agreement or refusal to participate. This process is meant to emphasize
p.000199: Respect for Persons. Under no circumstances may researchers proceed to conduct research with anyone who has refused to
p.000199: participate. Subject to exceptions set out in this Policy, consent must be obtained from participants prior to the
p.000199: conduct of research.
p.000199: Equally, Respect for Persons implies that those who lack the capacity to decide for themselves should nevertheless have
p.000199: the opportunity to participate in research that may be of benefit to themselves or others. Authorized third parties
p.000199: acting on behalf of these individuals decide whether participation would be appropriate. For the purposes of this
p.000199: Policy, the term “authorized third party” (also known as “authorized third party decision makers”) refers to any person
p.000199: with the necessary legal authority to make decisions on behalf of an individual who lacks the capacity to consent to
p.000199: participate or to continue to participate in a particular research project. These decisions involve considerations of
p.000199: Concern for Welfare and Justice.
p.000199: Certain types of research require alternate processes for seeking consent. These are also described in this chapter.
p.000199: Where elements of the consent process may need to be adapted to the requirements of a particular research project, the
p.000199: research ethics board (REB) can play an educational and consultative role in determining the appropriate process for
p.000199: seeking and maintaining consent.
p.000199: The head of the research team, also known as the principal investigator, is responsible for ensuring that the consent
p.000199: process is followed. This person is also responsible for the actions of any member of the research team involved in the
p.000199: consent process.
p.000199: In addition to this Policy, researchers are responsible for ensuring that all applicable legal and regulatory
p.000199: requirements with respect to consent are met. In some circumstances, researchers may have further legal obligations
...
p.000199: Consent Shall Be Given Voluntarily
p.000199: Article 3.1 (a) Consent shall be given voluntarily.
p.000199: (b) Consent can be withdrawn at any time.
p.000199: (c) If a participant withdraws consent, the participant can also request the with- drawal of their data or human
p.000199: biological materials.
p.000199: Application (a) The voluntariness of consent is important because it respects human dignity and means that
p.000199: individuals have chosen to participate in research according to their own values, preferences and wishes.
p.000199: The approach to recruitment is an important element in assuring voluntariness. In particular, how, when and where
p.000199: participants are approached, and who re- cruits them are important elements in assuring (or undermining) voluntariness.
p.000199: In considering the voluntariness of consent, REBs and researchers should be cognizant of situations where undue
p.000199: influence, coercion or the offer of incen- tives may undermine the voluntariness of a participant’s consent to
p.000199: participate in research.
p.000199: UndueXInfluence
p.000199: Undue influence and manipulation may arise when prospective participants are recruited by individuals in a position of
p.000199: authority. The influence of power re- lationships (e.g., employers and employees, teachers and students, commanding
p.000199: officers and members of the military or correctional officers and prisoners) on the voluntariness of consent should be
p.000199: judged from the perspective of prospec- tive participants, since the individuals being recruited may feel constrained
p.000199: to follow the wishes of those who have some form of control over them. This con- trol may be physical, psychological,
p.000199: financial or professional, for example, and may involve offering some form of inducement or threatening some form of
p.000199: deprivation. In such situations, the control exerted in a power relationship may place undue pressure on the
p.000199: prospective participants. At the extreme, there can be no voluntariness if consent is secured by the order of
p.000199: authorities.
p.000199: REBs and researchers should also pay particular attention to elements of trust and dependency in relationships (e.g.,
p.000199: between physician and patient or between professor and student). These relationships can impose undue influence on the
p.000199: individual in the position of dependence to participate in research projects. Any relationship of dependency, even a
...
p.000199: (May 2007). www.cihr-irsc.gc.ca/e/29134.html
p.000199: 4 For discussion of factors relevant to assessing impracticability of consent, see, for example, the Canadian
p.000199: Institutes of Health Research, CIHR Best Practices for Protecting Privacy in Health Research, Section 3.3, Secondary
p.000199: Use (September 2005). www.cihr-irsc.gc.ca/e/29072.html#Element3
p.000199: 5 See, for example, Statistics Canada, “Policy on Record Linkage.” www.statcan.gc.ca/record-
p.000199: enregistrement/policy4-1-politique4-1-eng.htm
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 65
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: Introduction
p.000199: Chapter 6
p.000199: GOVERNANCE OF RESEARCH ETHICS REVIEW
p.000199: This chapter sets out the elements of research ethics review including the procedures necessary to establish a research
p.000199: ethics board (REB), and operational guidelines for the REBs and research ethics review, both initially and throughout
p.000199: the course of the research project. It also includes guidelines for the conduct of research ethics review during
p.000199: publicly declared emergencies.
p.000199: A key goal in establishing an appropriate governance structure for research ethics review is to en- sure that REBs
p.000199: operate with a clear mandate, authority and accountability; and that roles and responsibilities are clearly defined.
p.000199: REBs need independence in their decision-making process to carry out their role effectively, and to properly apply the
p.000199: core principles of this Policy – Respect for Persons, Concern for Welfare and Justice – to their ethics review of
p.000199: research projects. These operational guidelines are meant to be flexible enough to apply in various contexts, at
p.000199: institutions of various sizes, and to the full range of research disciplines, fields and methodologies.
p.000199:
p.000199: A. Establishment of Research Ethics Boards
p.000199:
p.000199: Authority, Mandate and Accountability
p.000199: Article 6.1 Institutions shall establish or appoint REB(s) to review the ethical acceptability of all research
p.000199: involving humans conducted within their jurisdiction or under their auspices, that is, by their faculty, staff or
p.000199: students, regardless of where the research is conducted, in accordance with this Policy.
p.000199: Application Each institution is accountable for the research carried out in its own jurisdiction or under its
p.000199: auspices. In fulfilling this responsibility, where research involving hu- mans takes place within the jurisdiction or
p.000199: under the auspices of an institution, that institution shall establish the necessary structure of an REB (or REBs)
p.000199: capable of reviewing the ethical acceptability of that research. In fulfilling this responsibility, institutions may
p.000199: opt to appoint an external REB in accordance with the Memoran- dum of Understanding between the Agencies and
p.000199: institutions.1 Any such appointment should be based on an official agreement clarifying the ultimate re-
p.000199: sponsibility of the institution for the ethical acceptability of research undertaken within its jurisdiction or under
p.000199: its auspices. To demonstrate their accountability, institutions may wish to issue public reports summarizing the
p.000199: institution’s activities and initiatives relevant to the ethics review of research involving humans, its re- search
p.000199: ethics administration, and relevant research ethics education and training.
p.000199: The number of REBs and the expertise of their members will depend on the range and volume of research for which that
...
p.000199: making so that REBs may be free of inappropriate influence, including situations of real, potential or perceived
p.000199: conflicts of interest (see Chapter 7).
p.000199: It is critical that institutions provide appropriate administrative resources to REBs (e.g., research ethics
p.000199: administration staff, a research ethics office) for the effective and efficient operation of the REB. The means by
p.000199: which this support may be pro- vided will vary by institution, but may include REB coordination, support in policy
p.000199: development and interpretation, record keeping, and provision of research ethics training opportunities to REB members,
p.000199: researchers and students. The research ethics administration staff may provide important ethics expertise in support of
p.000199: the REB’s ethical analysis and discussion. Research ethics administration staff should also have the necessary
p.000199: qualifications, as well as initial and continuing training, to appropriately perform their roles and responsibilities.
p.000199: Institutions should recognize the integral role of research ethics administration staff and research ethics office(s),
p.000199: as applicable, in supporting the REB in fulfilling its mandate.
p.000199: As an entity that draws its authority and resources from the institution, the REB remains accountable to the highest
p.000199: body of the institution that established it for the integrity of its processes.
p.000199: Article 6.3 The institution shall grant the REB the mandate to review the ethical acceptability of research on
p.000199: behalf of the institution, including approving, rejecting, proposing modifications to, or terminating any proposed or
p.000199: ongoing research involving hu- mans. This mandate shall apply to research conducted under the auspices or within the
p.000199: jurisdiction of the institution, using the considerations set forth in this Policy.
p.000199: Application The institution shall delegate to the REB the authority to review the ethical accept- ability of
p.000199: research through its normal process of governance. In defining the scope of the REB’s mandate, the institution shall
p.000199: clearly define the jurisdiction of the REB to cover a range of research consistent with relevant disciplinary
p.000199: competence and a manageable workload. Where the institution requires more than one REB, it should establish a mechanism
p.000199: to coordinate the operations of all its REBs, and clar- ify their relationship with each other, and with other relevant
p.000199: bodies or authorities. Institutions shall have clear written policies describing the mandate of each REB. An
p.000199: institution may wish to use different models for the ethics review of research conducted under its auspices (see
p.000199: Chapter 8).
p.000199: Institutions shall respect the authority delegated to the REB. An institution may not override an REB decision to
p.000199: reject a research proposal. An appeal of the REB decision to reject a research proposal can only be brought in
p.000199: accordance with Section C of this chapter.
p.000199:
p.000199: TCPS 2 69
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: An REB approval applies to the ethical acceptability of the research, and does not, in itself, constitute authorization
p.000199: for the research to proceed.
p.000199: REB Composition
p.000199: Basic REB Membership Requirements
p.000199: The membership of the REB is designed to ensure competent independent research ethics review. Provisions respecting its
p.000199: size, composition, terms of appointment and quorum are set out below.
p.000199: Article 6.4 The REB shall consist of at least five members, including both men and women, of whom:
p.000199: (a) at least two members have expertise in relevant research disciplines, fields and methodologies covered by the REB;
p.000199: (b) at least one member is knowledgeable in ethics;
p.000199: (c) at least one member is knowledgeable in the relevant law (but that member should not be the institution’s legal
p.000199: counsel or risk manager). This is mandatory for biomedical research and is advisable, but not mandatory, for other
p.000199: areas of research; and
p.000199: (d) at least one community member who has no affiliation with the institution.
...
p.000199: in accordance with the process agreed upon, and docu- mented by the REB. In such instances, the minority position may
p.000199: be communicated to the researcher.
p.000199: Participation by the researcher in REB discussions is often very helpful to both REBs and researchers. It may result in
p.000199: a deferral of the REB’s decision until the researcher has considered the discussions and possibly modified the
p.000199: proposal. Such discussions are an essential part of the educational role of the REB.
p.000199: Continuing Research Ethics Review
p.000199: Article 6.14 The REB shall make the final determination as to the nature and frequency of con- tinuing research
p.000199: ethics review in accordance with a proportionate approach to research ethics review. At minimum, continuing research
p.000199: ethics review shall consist of an annual status report (for multi-year research projects), and an end-of-study report
p.000199: (projects lasting less than one year).
p.000199:
p.000199:
p.000199: TCPS 2 79
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: Application Research is subject to continuing research ethics review from the date of initial REB approval
p.000199: throughout the life of the project (see Article 2.8). At the time of the initial review, the REB has the authority to
p.000199: determine the term of approval, and the level at which continuing ethics review occurs in accordance with a
p.000199: proportionate approach to research ethics review. As with initial review, continuing ethics review could be full board
p.000199: review or delegated review based on the level of risk of the re- search (see Article 6.12). The level of research
p.000199: ethics review may be adjusted over the life of the project based on the level of risk.
p.000199: For research projects lasting longer than one year, researchers shall submit, at min- imum, an annual report with
p.000199: sufficient details to enable the REB to make an informed judgment about the continued ethical acceptability of
p.000199: the research. For research lasting less than one year, an end-of-study report may suffice.
p.000199: For some types of research (e.g., qualitative research or longitudinal research), there may be some difficulty in
p.000199: establishing start or end dates. In these cases, the REB should work with researchers to determine a reasonable
p.000199: timeline for contin- uing ethics review, and for determining the completion date dependent on the discipline and method
p.000199: of research. The reporting schedule for continuing ethics re- view may be adjusted throughout the life of the project.
...
p.000199: reconsideration, the researcher shall have the option of appealing the REB decisions through the established appeal
p.000199: mechanism (see Article 6.19). REBs should establish timelines to promptly conduct reconsiderations and issue their
p.000199: decision.
p.000199: The onus is on researchers to justify the grounds on which they request reconsid- eration by the REB and to indicate
p.000199: any alleged breaches to the established research ethics review process, or any elements of the REB decision that are
p.000199: not supported by this Policy.
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 83
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: Appeal of REB Decisions
p.000199: Article 6.19 Institutions shall have an established mechanism and a procedure in place for promptly handling appeals
p.000199: from researchers when, after reconsideration, the REB has refused ethics approval of the research.
p.000199: Application In cases when researchers and REBs cannot reach agreement through reconsider- ation, the institution
p.000199: shall provide access to an established appeal process for the review of an REB decision. The researcher and the REB
p.000199: must have fully exhausted the reconsideration process, and the REB must have issued a final decision before the
p.000199: researcher initiates an appeal.
p.000199: Based on its written institutional policies, the same authority that established the REB shall establish or appoint an
p.000199: appeal committee that reflects a range of expertise and knowledge similar to that of the REB, and that meets the
p.000199: procedural require- ments of this Policy. An appeal committee may be an ad hoc or a permanent committee.
p.000199: Members of the REB whose decision is under appeal shall not serve on that appeal committee.
p.000199: It should be stressed that the appeal process is not a substitute for REBs and re- searchers working closely together
p.000199: to ensure high-quality ethical research, nor is it a forum to merely seek a second opinion.
p.000199: Institutions may wish to explore regional cooperation or alliances, including the sharing of appeal boards. If two
p.000199: institutions decide to use each other’s REB as an appeal board, a formal letter of agreement between institutions is
p.000199: required (see Chapter 8).
p.000199: It is not the role of the three federal research Agencies that are responsible for this Policy to consider any appeals
p.000199: of REB decisions.
p.000199: Article 6.20 The appeal committee shall have the authority to review negative decisions made by an REB. In so doing,
p.000199: it may approve, reject or request modifications to the re- search proposal. Its decision on behalf of the institution
p.000199: shall be final.
p.000199: Application Researchers have the right to request an appeal of an REB decision. An appeal can be launched for
p.000199: procedural or substantive reasons. The onus is on the researchers to justify the grounds on which they request an
p.000199: appeal and to indicate any breaches to the research ethics review process or any elements of the REB decision that are
p.000199: not supported by this Policy.
p.000199: The appeal committee shall function impartially, provide a fair hearing to those in- volved, and provide reasoned
p.000199: and appropriately documented opinions and decisions. Both the researcher and a representative of the REB shall be
p.000199: granted the opportunity to address the appeal committee, but neither shall be present when the
p.000199:
p.000199:
p.000199:
p.000199: 84 TCPS 2
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: appeal committee deliberates and makes a decision. Appeal committee decisions on behalf of the institution shall be
p.000199: final, and should be communicated in writing (in print or by electronic means) to researchers and to the REB whose
p.000199: decision was appealed. Recourse to judicial review may be available to the researcher.
p.000199:
p.000199: D. Research Ethics Review during Publicly Declared Emergencies
p.000199:
...
p.000101: the research site elsewhere in Canada, or outside Canada, if any. Approval of a research proposal by an REB at the
p.000101: research site does not con- stitute sufficient authorization to conduct the research without the approval of the
p.000101: relevant Canadian REB(s). Conversely, approval by the Canadian REB(s) is not sufficient authorization to begin the
p.000101: research without the approval of the REB or other appropriately constituted review body at the research site.
p.000101: Researchers shall obtain necessary approvals of the ethical acceptability of their research prior to the start of
p.000101: recruitment of participants, access to data, or collection of human biological materials, in accordance with Article
p.000101: 6.11.
p.000101: Researchers may undertake research in Canada or abroad without formal collabo- ration with other academic institutions.
p.000101: In these cases, in addition to the REB review at their own institution, researchers may need to obtain access to the
p.000101: site and prospective participants from a responsible agency, where one exists. They shall inform the REB whether, or
p.000101: how, they will seek permission to proceed with the research at that site and with the target participants. Some
p.000101: organizations or groups have established mechanisms or guidelines (e.g., school boards, Aboriginal communities [see
p.000101: Chapter 9], correctional services, service agencies and commu- nity groups) to review requests for research
p.000101: prior to allowing access to their members, or access to data about them that are under their authority. When
p.000101: design- ing their research, researchers should consider these provisions. This article does not apply to research
p.000101: involving critical inquiry about organizations or institutions (see Article 3.6).
p.000101: Researchers shall inform the REB of the absence of established ethics review mech- anisms at the research site, and
p.000101: report their efforts to identify any other suitable review mechanisms in the other country.1 When no appropriate
p.000101: mechanisms for research ethics review exist at the research site, researchers and REBs shall apply the core principles
p.000101: outlined in this Policy (see Chapter 1).
p.000101:
p.000101:
p.000101: 102 TCPS 2
p.000101:
p.000101: Chapter 8 – Multi-Jurisdictional Research
p.000101:
p.000101: REBs should not prevent research from proceeding solely because the research cannot be reviewed and approved through a
p.000101: formal REB review process in another country or other jurisdiction. Under these circumstances, researchers should be
p.000101: aware of relevant cultural practices, such as those normally followed to seek entry into the relevant communities, and
p.000101: be respectful of them. Researchers shall inform the REB of their strategies to familiarize themselves with the relevant
p.000101: norms and cultural practices, and to minimize risks to individuals and communities partici- pating in, or potentially
p.000101: affected by, the research.
...
p.000103: decisions on a given proposal. Where the REB is uncertain about the appropriate course of action in a given research
p.000103: proposal, it should make contact with its counterpart REB in the re- search site or country. In the absence of formal
p.000103: reciprocity agreements between countries or institutions with respect to initial and continuing research ethics review,
p.000103: the REBs should engage in dialogue and may establish a specific mechanism, such as a joint subcommittee of the two REBs
p.000103: (e.g., for situations in which institutions collaborate regularly), to facilitate appropriate deliberation in order to
p.000103: reach a thoughtful and well-informed judgment on the ethical acceptability of a given re- search proposal (see Article
p.000103: 8.1).
p.000103:
p.000103: Endnote
p.000103:
p.000103:
p.000103: 1 See for example the United States Office for Human Research Protections (OHRP) registry of REBs (see References
p.000103: below), mainly in the area of health and biomedical research. It can serve as one re- source for identifying research
p.000103: ethics review bodies around the world.
p.000103:
p.000103: References
p.000103:
p.000103:
p.000103: • Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for
p.000103: Biomedical Research Involving Human Subjects. CIOMS: Geneva. 2002. www.cioms.ch/publications/layout_guide2002.pdf
p.000103: • Newfoundland and Labrador. Health Research Ethics Authority Act, S.N.L. 2006, c. H-1.2.
p.000103: http://assembly.nl.ca/Legislation/sr/statutes/h01-2.htm
p.000103: • Québec. Ministère de la Santé et des Services sociaux. Direction générale adjointe de l’évaluation, de la
p.000103: recherche et de l’innovation. Unité de l’éthique. Mécanisme encadrant l’examen éthique et le suivi continu des projets
p.000103: multicentriques. In effect since April 1, 2008. www.ethique.msss.gouv.qc.ca/site/fr_mecanismemulticentrique.phtml
p.000103: • U.S. Department of Health and Human Services. Office for Human Research Protections. International Compilation of
p.000103: Human Research Protections, 2010 Edition. www.hhs.gov/ohrp/international/HSPCompilation.pdf
p.000103: • ———. Federal-Wide Assurances Registry for Registered Organizations Operating Institutional Review Boards (IRBs)
p.000103: or Registered IRBs. ohrp.cit.nih.gov/search
p.000103: • World Medical Association. Declaration of Helsinki – Ethical Principles for Medical Research Involving Human
p.000103: Subjects. 2008. www.wma.net/en/30publications/10policies/b3/index.html
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103:
p.000103: 104 TCPS 2
p.000103:
p.000103: Chapter 9
p.000103: RESEARCH INVOLVING THE FIRST NATIONS, INUIT AND MÉTIS PEOPLES OF CANADA
p.000103:
p.000103: Introduction
p.000103: Preamble
p.000103: This chapter on research involving Aboriginal peoples in Canada, including Indian (First Nations1), Inuit and Métis
p.000103: peoples, marks a step toward establishing an ethical space for dialogue on common interests and points of difference
p.000103: between researchers and Aboriginal communities engaged in research.
...
p.000109:
p.000109: C. Applying Provisions of This Policy in Aboriginal Contexts
p.000109: Requirement of Community Engagement in Aboriginal Research
p.000109: Article 9.1 Where the research is likely to affect the welfare of an Aboriginal community, or communities, to
p.000109: which prospective participants belong, researchers shall seek engagement with the relevant community. The
p.000109: conditions under which engagement is required include, but are not limited to:
p.000109: (a) research conducted on First Nations, Inuit or Métis lands;
p.000109: (b) recruitment criteria that include Aboriginal identity as a factor for the entire study or for a subgroup in the
p.000109: study;
p.000109: (c) research that seeks input from participants regarding a community’s cultural heritage, artefacts, traditional
p.000109: knowledge or unique characteristics;
p.000109: (d) research in which Aboriginal identity or membership in an Aboriginal community is used as a variable for
p.000109: the purpose of analysis of the research data; and
p.000109: (e) interpretation of research results that will refer to Aboriginal communities, peoples, language, history or
p.000109: culture.
p.000109: Application Paragraph (a) refers to First Nations, Inuit and Métis lands that include Indian reserves, Métis
p.000109: settlements and lands governed under a self-government agreement or an Inuit or First Nations land claim agreement.
p.000109: Researchers should become informed about formal rules or oral customs that may apply in accordance with a particular
p.000109: First Nations, Inuit or Métis authority. In different jurisdictions, research activities may be regulated in various
p.000109: ways.
p.000109:
p.000109: 110 TCPS 2
p.000109:
p.000109: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000109:
p.000109: Paragraph (c) refers to cultural heritage, which includes, but is not limited to, First Nations, Inuit and Métis
p.000109: peoples’ relations with particular territories, material objects, traditional knowledge and skills, and intangibles
p.000109: that are transmitted from one generation to the next (e.g., sacred narratives, customs, representations or practices).
p.000109: Cultural heritage is a dynamic concept, in that materials, knowledge and practices are continuously adapted to the
p.000109: realities of current experience.
p.000109: Cultural heritage research such as archaeological research involving burial sites or sacred landscapes and handling of
p.000109: artefacts may raise ethical obligations important to the Aboriginal community that may not be addressed in academic
p.000109: research proposals. Researchers and communities should agree in advance on how to reconcile or address these
p.000109: divergent perspectives (see Articles 9.8 and 9.12).
p.000109: Appropriation of collective knowledge, treatment of such knowledge as a commodity to be traded, or making
p.000109: unauthorized adaptations for commercial purposes, may cause offence or harm to communities from which the knowledge
p.000109: originates. Such conduct has prompted initiatives in various countries and international agencies to address
...
p.000109: normally take the form of review and approval of a research proposal by a designated body. In less structured
p.000109: situations (e.g., a community of interest), a key consideration for researchers, prospective participants and REBs is
p.000109: determining the nature and extent
p.000109:
p.000109:
p.000109:
p.000109:
p.000109: TCPS 2
p.000111: 111
p.000111:
p.000111: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000111:
p.000111: of community engagement required. In some situations, if the REB is satisfied that participants are not identified with
p.000111: a community or that the welfare of relevant communities is not affected, the REB may waive the requirement of a
p.000111: community engagement plan (see Article 9.10). In these cases, consent of individuals is sufficient to
p.000111: participate.
p.000111: Communities lacking the infrastructure to support pre-research community engagement should not be deprived
p.000111: of opportunities to participate in guiding research affecting their welfare (see Article 9.14).
p.000111: The following list, which is not exhaustive, provides examples to illustrate the forms of community engagement that
p.000111: might be appropriate for various types of research.
p.000111: 1) Research directly involving a community on First Nations, Inuit or Métis lands with a formal governance structure.
p.000111: For example, a project that examines the incidence of diabetes in Pond Inlet, Nunavut, or the impact on Inuit health of
p.000111: contaminants in animals and plants used for country food.
p.000111: • Permission of the Nunavut Research Institute that carries authority to approve research in Nunavut is
p.000111: required. Agreement of the hamlet council in Pond Inlet will normally be a condition of approval. The local health
p.000111: committee may co-manage the project.
p.000111: 2) Research involving Aboriginal people who comprise a sizeable proportion of the study or community and where
p.000111: Aboriginal-specific conclusions are intended. For example, a comparative study of access to public housing in Prince
p.000111: Albert, Saskatchewan.
p.000111: • First Nations in the district, represented by their tribal council, the local Métis association, and urban
p.000111: Aboriginal and women’s organizations may partner with the Prince Albert city council to sponsor, implement and use the
p.000111: results of the housing study.
p.000111: 3) Research focusing on a larger community that is known to include Aboriginal people (regardless of their
p.000111: proportion), and where Aboriginal-specific conclusions are anticipated. For example, a study of student retention
p.000111: in high schools in the Sault Ste. Marie district of Ontario.
p.000111: • A committee representing First Nations, Métis organizations and urban Aboriginal people whose children may
p.000111: be affected by the study may be convened to advise the District Board of Education and the researchers involved.
p.000111: 4) Research involving Aboriginal people who comprise a sizeable proportion of the larger community that is the
p.000111: subject of research even if no Aboriginal- specific conclusions will be made. For example, research on
p.000111: employment
p.000111:
...
p.000111:
p.000111:
p.000111:
p.000111: TCPS 2
p.000113: 113
p.000113:
p.000113: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000113:
p.000113: whether culturally appropriate assistance is desired to interpret, or support compliance with, the research project.
p.000113: However, it should be noted that including markers of Aboriginal identity in data collection may reveal
p.000113: anomalies that warrant further, more targeted research, which, if followed up, would require community engagement.
p.000113: 8) Research based on publicly available information as defined by this Policy, for example, historical, genealogical
p.000113: or analytic research based on public records, or data available or accessible in accordance with legislation.
p.000113: • Such research does not involve the collection of data from communities directly or from living persons and is not
p.000113: subject to REB review (see Article 2.2). Community engagement is not required. Findings of such research nevertheless
p.000113: may have an impact on the identity or heritage of persons or communities. In order to minimize any harm,
p.000113: researchers should seek culturally informed advice before use of such data to determine if harms may result and if
p.000113: other considerations such as sharing of the research results should be explored with the original source community (see
p.000113: Article 9.15).
p.000113: Respect for First Nations, Inuit and Métis Governing Authorities
p.000113: Article 9.3 Where a proposed research project is to be conducted on lands under the jurisdiction of a First
p.000113: Nations, Inuit or Métis authority, researchers shall seek the engagement of formal leaders of the community, except as
p.000113: provided under Articles 9.5, 9.6 and 9.7.
p.000113: Research ethics review by the institutional REB and any responsible community body recognized by the First Nations,
p.000113: Inuit or Métis authority (see Articles 9.9 and 9.11) is required in advance of recruiting and securing consent of
p.000113: individuals.
p.000113: Application Formal leaders with governance responsibilities on First Nations, Inuit or Métis land are charged with
p.000113: protecting the welfare of the community. Article 8.3(b) applies in such cases, requiring ethics review of research
p.000113: proposals by both “(i) the REB at the Canadian institution under the auspices of which the research is being
p.000113: conducted, and (ii) the REB or other responsible review body or bodies, if any, at the research site.” A local
p.000113: authority may approve research or delegate responsibility for reviewing research proposals to a local or regional body
p.000113: (e.g., the local health board or a body like the Mi’kmaq Ethics Watch).
p.000113: Research involving multiple geographic communities raises complex issues of review and approval. Regional bodies
p.000113: or national organizations may facilitate research ethics review and make recommendations, but the decision to
p.000113: participate normally rests with the local communities.
p.000113: Engagement with formal leadership is not a substitute for seeking consent from individual participants, as required by
p.000113: Chapter 3.
p.000113:
p.000113:
p.000113: 114 TCPS 2
p.000113:
p.000113: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000113:
p.000113: Engagement with Organizations and Communities of Interest
p.000113: Article 9.4 For the purposes of community engagement and collaboration in research undertakings,
p.000113: researchers and REBs shall recognize Aboriginal organizations, including First Nations, Inuit and Métis
p.000113: representative bodies, and service organizations and communities of interest, as communities. They shall
p.000113: also recognize these groups through representation of their members on ethical review and oversight of projects, where
p.000113: appropriate.
p.000113: Application Organizational communities and communities of interest may exist within the boundaries of territorial
p.000113: communities. Overlapping interests in these cases are considered in Articles 9.5 and 9.6. A majority of persons who
...
p.000113: operating in rural or urban centres have been created to enhance the welfare of their own members or the populations
p.000113: that they serve. Organizations and communities of interest are potential partners in research on issues relevant
p.000113: to their communities, and are to be recognized as communities for the purposes of community engagement under this
p.000113: Policy.
p.000113: An organization may participate in research focusing on its members (e.g., the board and staff of a friendship centre),
p.000113: or it may facilitate ethical engagement with the population that it serves (e.g., the clientele of a health
p.000113: access centre). A community of interest (e.g., Aboriginal youth who use an urban service program) may designate a
p.000113: local organization to provide advice and ethical protection for a project in which they participate.
p.000113: Prospective participants may not necessarily recognize organizational communities or communities of interest as
p.000113: representing their interests. Where researchers and organizational communities or communities of interest collaborate
p.000113: in research (e.g., through a research agreement), prospective participants shall be informed about the extent of such
p.000113: collaboration (including how data will be shared) as part of the initial and ongoing consent process (see Article
p.000113: 3.2[i]).
p.000113: Complex Authority Structures
p.000113: Article 9.5 Where alternatives to securing the agreement of formal leadership are proposed for research on First
p.000113: Nations, Inuit or Métis lands or in organizational communities, researchers should engage community processes and
p.000113: document measures taken, to enable the REB to review the proposal with due consideration of complex
p.000113: community authority structures.
p.000113: Application Researchers and REBs should not assume that approval of a project by formal leaders is the only avenue
p.000113: for endorsing a project. In some communities and some domains of knowledge, authority to permit and monitor
p.000113: research rests with knowledge keepers designated by custom rather than by election or appointment.
p.000113:
p.000113:
p.000113:
p.000113: TCPS 2
p.000115: 115
p.000115:
p.000115: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000115:
p.000115: In First Nations settings, a confederacy council spanning several communities may be recognized as having authority
p.000115: over its members’ traditional knowledge. In an Inuit community, the hamlet council, an Elders’ circle, and a hunters
p.000115: and trappers organization may have overlapping responsibility and expertise with respect to the knowledge being sought.
p.000115: Métis Elders dedicated to conserving Michif language may assert their autonomy from political leaders, but choose to
p.000115: collaborate with educational or cultural agencies (see also Article 9.15).
p.000115: The preferred course is to secure approval for research from both formal leaders of a community and customary
p.000115: authority. This is especially important for outsiders to communities, whose presence or intentions might be challenged
p.000115: as inappropriate. Researchers should engage community processes, including the guidance of moral authorities such as
p.000115: Elders, to avert potential conflict. These measures should be documented to assist the REB in considering the community
p.000115: engagement processes proposed (see Article 9.10). Where no agreement exists between formal community leadership and
p.000115: customary authority regarding the conduct of the proposed research, researchers should inform the REB. When alternative
p.000115: community engagement processes are followed to endorse a project, all other ethical safeguards set out in this chapter
p.000115: remain applicable.
p.000115: Recognizing Diverse Interests within Communities
p.000115: Article 9.6 In engaging territorial or organizational communities, researchers should ensure, to the extent
p.000115: possible, that they take into consideration the views of all relevant sectors – including individuals and subgroups who
p.000115: may not have a voice in the formal leadership. Groups or individuals whose circumstances make them vulnerable
p.000115: may need or desire special measures to ensure their safety in the context of a specific research project. Those who
p.000115: have been excluded from participation in the past may need special measures to ensure their inclusion in research.
p.000115: Application Groups or individuals whose circumstances may make them vulnerable or marginalized within
p.000115: territorial or organizational communities should not be deprived of opportunities to participate in, and
p.000115: influence, research affecting their welfare. For example, people living with HIV/AIDS, impoverished youth or
p.000115: women who have suffered abuse may experience barriers to participation.
p.000115: Gender-based analysis is being applied in First Nations, Inuit and Métis organizations and communities to
p.000115: promote or restore recognition of women’s responsibilities in the conduct of community life – including decision
p.000115: making that directly affects their welfare. The legacy of patriarchal governance structures continues to pose
p.000115: challenges to women’s full participation. Approaches that are attentive to cultural considerations help to ensure the
p.000115: equitable participation and benefit of women throughout the life cycle of a research project (see Article 4.2).
p.000115: Research undertaken secretly or as a direct challenge to legitimate authority may increase risks to participants whose
p.000115: circumstances make them vulnerable, may deepen rifts within the community, and actually impede the advancement of
p.000115: social
p.000115:
p.000115: 116 TCPS 2
p.000115:
p.000115: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000115:
p.000115: justice. Strategies that have proven effective to secure the inclusion and promote the safety of diverse sectors within
p.000115: a community include: advocacy by moral authorities in the community; special measures to protect the identity of
p.000115: participants in small communities; identifying research questions that include rather than divide interest groups; or
p.000115: expanding the coverage of a project to multiple communities. In some cases, the risks to participants and communities
p.000115: involved with, or affected by, the proposed research outweigh the potential benefits likely to be gained, and the
p.000115: research should not be undertaken.
p.000115: Critical Inquiry
p.000115: Article 9.7 Research involving Aboriginal peoples that critically examines the conduct of public institutions,
p.000115: First Nations, Inuit and Métis governments, institutions or organizations or persons exercising authority over First
p.000115: Nations, Inuit or Métis individuals may be conducted ethically, notwithstanding the usual requirement of engaging
p.000115: community leaders.
p.000115: Application Considerations in conducting critical inquiry are discussed more fully in Article
p.000115: 3.6. As in the case of research involving groups whose circumstances make them vulnerable, or communities of interest
p.000115: within an Aboriginal community (see Article 9.6), researchers undertaking critical inquiry research will need to adopt
p.000115: appropriate approaches to ensure that cultural norms are respected, that the safety of participants is protected, and
p.000115: that potential harms to the welfare of the larger community are minimized to the extent possible. Researchers may
p.000115: need to consult culturally relevant regional or national Aboriginal organizations for guidance.
p.000115: For example, the Sisters in Spirit project of the Native Women’s Association of Canada (NWAC) that was launched in
p.000115: 2005 for a five-year period illustrates research of a national scope that incorporated a critical dimension. The
p.000115: project involved interviewing families of missing and murdered First Nations, Métis or Inuit women in urban and rural
p.000115: settings, and on First Nations territory. It examined, among other matters, the adequacy of public institutions and
...
p.000121: Where a community has adopted or adheres to a code of research practice, the agreement may set out responsibilities in
p.000121: accordance with that code and the specific requirements of the research project. In less formal circumstances, the
p.000121: agreement may be relatively brief, and subject to clarification as the project unfolds. The CIHR Guidelines for
p.000121: Health Research Involving Aboriginal People (2007) provide examples of elements that may be included in research
p.000121: agreements (see References at the end of this chapter).
p.000121: Research agreements are increasingly being recognized by academic institutions (and the researchers associated with
p.000121: them) as providing reference points for research ethics review process and approval on such elements as consent,
p.000121: confidentiality, and access to and use of information. Agreements that specify procedures for community
p.000121: research ethics review, included as part of the institutional ethics
p.000121:
p.000121: 122 TCPS 2
p.000121:
p.000121: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000121:
p.000121: application, can provide contextual information and guidance for REBs conducting initial review of applications, and
p.000121: continuing research ethics review throughout the project. Researchers should check with their institutions regarding
p.000121: signing authority for research agreements (see Article 9.18).
p.000121: Building relationships, clarifying the goals of a project, and negotiating agreements requires substantial investment
p.000121: of time and resources on the part of the community and the researcher. Development and participation costs incurred by
p.000121: the community and the researcher should be factored into proposals to the extent possible within funding guidelines.
p.000121: Community agreement that a research project may proceed is not a substitute for securing the consent of individuals
p.000121: recruited to participate in that project, in accordance with Chapter 3. Consent of prospective
p.000121: participants shall precede collection of, or access to, data or human biological materials. Consistent with the
p.000121: provisions of Article 3.12, if signed written consent is not culturally appropriate, the researcher shall inform the
p.000121: REB of alternative processes employed for seeking and documenting consent.
p.000121: Consent shall be given in accordance with the research agreement where one exists. Where research agreements provide
p.000121: that community partners will have limited or full access to identifiable personal data, the consent of participants to
...
p.000125: to Aboriginal candidates. The time required to establish collaborative relationships may be difficult to
p.000125: accommodate in the programs of students. Mentorship by experienced researchers who introduce students to
p.000125: communities and monitor their ethical practice can facilitate the trust- building process and advance student progress.
p.000125: Recognition of the Role of Elders and Other Knowledge Holders
p.000125: Article 9.15 Researchers should engage the community in identifying Elders or other recognized knowledge holders to
p.000125: participate in the design and execution of research, and the interpretation of findings in the context of cultural
p.000125: norms and traditional knowledge. Community advice should also be sought to determine appropriate recognition for the
p.000125: unique advisory role fulfilled by these persons.
p.000125: Application Within First Nations, Inuit and Métis communities, persons with special gifts carry varied roles and
p.000125: responsibilities in conserving and transmitting traditional knowledge and expressions of culture. They often are
p.000125: fluent in their traditional language. They model respectful relationships and may conduct ceremonies, pass on oral
p.000125: history, and offer guidance in community affairs. Their gifts are normally refined over a lifetime. Thus, Elders who
p.000125: have followed a rigorous path of learning over a long period are highly respected. Younger persons may also gain
p.000125: recognition as gifted knowledge holders.
p.000125: High regard by the community that knows the Elder or other knowledge holder is the most reliable indicator of an
p.000125: individual’s authority. Each community or nation has particular ways of approaching Elders or knowledge holders
p.000125: respectfully. In many First Nations this involves the presentation and acceptance of tobacco to symbolize entering into
p.000125: a relationship. In some communities, feasting or gift-giving is appropriate.
p.000125: Elders are now being recognized in research proposals and grant applications as providers of access to community
p.000125: networks, ethical guidance to researchers, and advice in interpreting findings in the context of traditional knowledge
p.000125: (see Article 9.17). Researchers should seek advice from the community and the Elders regarding the appropriate
p.000125: recognition of the contribution of Elders and knowledge holders, which may include providing honoraria, acknowledging
p.000125: contributions by name or, as directed, withholding the Elder’s identity in reports and publications.
p.000125: Privacy and Confidentiality
p.000125: Article 9.16 Researchers and community partners shall address privacy and confidentiality for communities and
p.000125: individuals early on in the community engagement process. The extent to which limited or full disclosure of personal
p.000125: information related to the research is to be disclosed to community partners shall be addressed in research
p.000125:
p.000125:
p.000125:
p.000125: 126 TCPS 2
p.000125:
p.000125: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000125:
p.000125: agreements where these exist. Researchers shall not disclose personal information to community partners without the
p.000125: participant’s consent, as set out in Article 3.2(i).
...
p.000135: questions, concepts, strategies, theories and ways to gather and engage with the data (e.g., emergent design research,
p.000135: see Article 10.5) requires a constant reflective approach and questioning by the researcher. Such flexibility,
p.000135: reflexivity and responsiveness contribute to the overall strength and rigour of data collection and analysis.
p.000135: (d) Diverse, Multiple and Often Evolving Contexts: Qualitative research takes place in a variety of contexts, each
p.000135: of which presents unique ethical issues. As knowledge is considered to be context-contingent in qualitative
p.000135: research, these studies tend to focus on particular individuals, sites or concepts that are empirically derived from
p.000135: other social settings. The researcher’s priority is to answer the research question stemming from the study of those
p.000135: individuals in a specific social setting at a specific time.
p.000135:
p.000135:
p.000135:
p.000135: 136 TCPS 2
p.000135:
p.000135: Chapter 10 – Qualitative Research
p.000135:
p.000135: Researchers sometimes engage in research that questions social structures and activities that create, or result in,
p.000135: inequality and injustice. Studies may involve participants who are in highly vulnerable circumstances because of the
p.000135: social and/or legal stigmatization that is associated with their activity or identity, and who may have little trust in
p.000135: the law, social agencies or institutional authorities. Regardless of the methodological approach, researchers
p.000135: who question social structures, or deal with the disempowered, may face pressures from authority figures. Research may
p.000135: also involve participants, such as business executives or government officials, who may be more powerful than the
p.000135: researchers.
p.000135: (e) Data Collection and Sample Size: There is generally a greater emphasis placed on depth of research than on
p.000135: breadth. Most qualitative researchers would emphasize gathering diverse but overlapping data on a limited number of
p.000135: cases or situations to the point of data saturation or thematic redundancy. Samples and research sites in these studies
p.000135: are chosen because they are viewed as particularly useful or rich sources of information for furthering one’s
p.000135: understanding of phenomena of interest, and not because the results may prove statistically significant. Participants
p.000135: are selected for their potential to inform theory development, and often selection of participants is guided by
p.000135: emerging patterns over the course of the data collection.
p.000135: A researcher may rely on multiple sources of information and data gathering strategies to enhance data quality.
p.000135: Researchers use a variety of methods for data gathering, including interviews, participant observation, focus groups
p.000135: and other techniques. In some cases, gathering of trustworthy data is best achieved by closeness and extended contact
p.000135: with participants. In other cases, researchers and participants may continue research exchanges through electronic or
p.000135: other means, after collection of data in the field. Qualitative studies of textual and image-based materials, such
p.000135: as published books, websites, interview transcripts, photographic images or video, use a variety of content
p.000135: analysis techniques.
p.000135: Appropriate treatments of data after they are gathered may vary greatly (see Article 10.5 and also Article 5.3). At the
...
p.000163: should be published. Sources of funding, any restrictions regarding public disclosure of trial data, institutional
p.000163: affiliations and conflicts of interest should be declared in publications.
p.000163: Institutions and REBs should require the satisfactory amendment or removal of any confidentiality clauses or
p.000163: publication restrictions that unduly limit either the content of the scientific information that may be disseminated or
p.000163: the timing of dissemination. Contracts should also ensure that principal investigators have the
p.000163:
p.000163:
p.000163:
p.000163:
p.000163: TCPS 2
p.000165: 165
p.000165:
p.000165: Chapter 11 – Clinical Trials
p.000165:
p.000165: necessary access to original trial data, and the opportunity to analyze them, to ensure that they can report trial
p.000165: findings fairly and accurately, particularly with respect to both efficacy and safety.
p.000165: Institutional and REB policies should ensure that sponsors’ legitimate interests are reasonably balanced against the
p.000165: researcher’s ethical and legal obligations to participants, and to the scientific and public good to disseminate
p.000165: data and research findings (see Chapter 7 with respect to Conflicts of Interest). It shall be understood that the
p.000165: welfare of participants takes precedence over the interests of both researchers and sponsors.
p.000165: Such policies should require that clinical trial research contracts be examined to ensure that contractual provisions
p.000165: comply with institutional policy standards. They should do all of the following:
p.000165: 1) require that confidentiality and publication clauses be submitted to a respon- sible authority (e.g., the REB or
p.000165: research administration) for a determination of their consistency with the policy;
p.000165: 2) require that any ethical concerns arising in the review be referred to the REB as an integral part of the
p.000165: research ethics review process;
p.000165: 3) provide that any proposed restrictions on publication include an ethically acceptable justification;
p.000165: 4) provide that all confidentiality and publication clauses:
p.000165: (a) be consistent with the researcher’s duty to share new information from clinical trials with REBs and trial
p.000165: participants in a timely manner (Section D);
p.000165: (b) be reasonable in terms of any limitations or restrictions on the publication or other dissemination or
p.000165: communication of information; and
p.000165: (c) permit researchers to access all trial data.
p.000165:
p.000165: Review of ethical aspects of researcher-sponsor contracts should be undertaken by an REB, or by or under the auspices
p.000165: of another competent institutional authority as an integral part of the research ethics review process. If done under
p.000165: the latter process, the review of contracts should be conducted in a manner that: (1) conforms to the special ethical
p.000165: duties, mandate and purposes of REB review; and (2) consults with the REB when necessary.
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165: 166 TCPS 2
p.000165:
p.000165: Chapter 11 – Clinical Trials
p.000165:
p.000165: In the review process, the onus to justify restrictions on dissemination or access to data should lie with the one
p.000165: seeking such restriction, usually the researcher or sponsor. The reasonableness of restrictions on either the content
p.000165: or timing of dissemination should be measured against the written institutional policies. For example, some existing
p.000165: institutional policies deem unacceptable any publication restrictions that exceed a time limit of three to six months
p.000165: after the close of the trial. Such policies should also address restrictions on the dissemination of
p.000165: particular kinds of information, such as information that may be considered proprietary or trade secrets.
p.000165: Restrictions on information that participants would reasonably consider relevant to their welfare (see Articles 11.7
p.000165: and 11.8), or that are required to give appropriate context to a manuscript or other publication, are seldom, if ever,
p.000165: justified.
p.000165:
p.000165:
p.000165: Endnotes
p.000165:
p.000165:
...
p.000183: (b) seek consent from individual family members.
p.000183: Application Recruitment of members of a family may take place in various ways: through (a) the researcher, (b) an
p.000183: individual participant, or (c) a third party on behalf of an individual participant. A family group, such as parents
p.000183: and a child, or several adult siblings, may all receive an invitation at the same time from the researcher to
p.000183: participate in genetic research. Alternatively, researchers may seek permission from an individual participant to
p.000183: contact family members to invite participation. It may be preferable for the participant to make initial contact with
p.000183: the family member, in
p.000183:
p.000183:
p.000183: 184 TCPS 2
p.000183:
p.000183: Chapter 13 – Human Genetic Research
p.000183:
p.000183: order to respect privacy interests or known sensitivities. The participant may prefer to identify a third party to
p.000183: inform family members about the opportunity to participate in genetic research. However, an approach by someone
p.000183: in a position of authority over family members may raise concerns about undue influence or manipulation.
p.000183: Refer to Chapter 3 for further guidance in regard to the voluntariness of consent.
p.000183: Family members may have conflicting views about participation in research, and some may have specific sensitivities or
p.000183: objections. Researchers should recognize the potential for conflict within families and be respectful of any known
p.000183: sensitivi- ties. Where researchers seek participation from children or other members of a fam- ily who may lack
p.000183: capacity to consent, the applicable provisions in Chapter 3 shall be followed.
p.000183: E. Genetic Research Involving Communities and Groups
p.000183: Article 13.6 Where researchers intend to recruit participants for genetic research based on their membership in
p.000183: specific communities or groups, it may be appropriate for re- searchers to discuss the research with community
p.000183: or group members, and/or their leaders, in addition to seeking consent from individual participants. In these cases,
p.000183: researchers shall provide details to the REB about their proposed methods for en- gaging in discussion.
p.000183: Application Some genetic research seeks to explore genetic variations within specific commu- nities or groups. Such
...
p.000187: conventional thought, freedom to express one’s opinion about the institution, its administration, or the system in
p.000187: which one works, and freedom from institutional censorship.
p.000187:
p.000187: Ad hoc advisor – A person with relevant and competent knowledge and expertise consulted by a research ethics board for
p.000187: a specific research ethics review, and for the duration of that review. The ad hoc advisor is not a member of the
p.000187: research ethics board.
p.000187:
p.000187: Agencies, the – Canada’s three federal research agencies: the Canadian Institutes of Health Research (CIHR); the
p.000187: Natural Sciences and Engineering Research Council of Canada (NSERC); and the Social Sci- ences and Humanities Research
p.000187: Council of Canada (SSHRC).
p.000187:
p.000187: Appeal – A process that allows a researcher to request a review of a research ethics board (REB) decision when, after
p.000187: reconsideration, the REB has refused ethics approval of the research.
p.000187:
p.000187: Appeal mechanism – A procedure established by an institution to promptly handle a researcher’s appeal of a research
p.000187: ethics board (REB) decision. An ad hoc or permanent appeal committee, which reflects a range of expertise and knowledge
p.000187: similar to that of the REB, is established or appointed by the same authority that established the REB.
p.000187:
p.000187: Authorized third party – Any person with the necessary legal authority to make decisions on behalf of a prospective
p.000187: participant who lacks the capacity to consent to participate, or to continue to participate, in a particular research
p.000187: project. In other policies/guidance they are also known as “authorized third party deci- sion makers.”
p.000187:
p.000187: Autonomy – The capacity to understand information and to be able to act on it voluntarily; the ability of individuals
p.000187: to use their own judgement to make decisions about their own actions, such as the decision to consent to participate in
p.000187: research.
p.000187:
p.000187:
p.000187:
p.000187: TCPS 2
p.000189: 189
p.000189:
p.000189: Glossary
p.000189:
p.000189: Biobank – A collection of human biological materials. It may also include associated information about individuals from
p.000189: whom biological materials were collected.
p.000189:
p.000189: Capacity – The ability of prospective or actual participants to understand relevant information presented (e.g. purpose
p.000189: of the research, foreseeable risks, and potential benefits), and to appreciate the potential con- sequences of any
p.000189: decision they make based upon this information.
p.000189:
p.000189: Clinical equipoise – The existence of a genuine uncertainty on the part of the relevant expert community about what
p.000189: therapy or therapies are most effective for a given condition.
p.000189:
p.000189: Clinical trial – Any investigation involving participants that evaluates the effects of one or more health- related
...
p.000195:
p.000195: Glossary
p.000195:
p.000195: Surgical trials – A clinical trial which compares the safety and/or efficacy of different surgical techniques.
p.000195:
p.000195: Therapeutic misconception – A misunderstanding, on the part of participants, of the purpose, benefits, and/or risks
p.000195: of clinical trials. Often participants do not understand that research is aimed primarily at producing knowledge and
p.000195: may not provide any therapeutic benefit to them.
p.000195:
p.000195: Traditional knowledge – The knowledge held by First Nations, Inuit and Métis peoples, the Aboriginal peoples of
p.000195: Canada. Traditional knowledge is specific to place, usually transmitted orally, and rooted in the experience of
p.000195: multiple generations. It is determined by an Aboriginal community’s land, environment, region, culture, and language.
p.000195: It may also include new knowledge transmitted to subsequent generations.
p.000195:
p.000195: Unanticipated issues – Issues that: occur during the conduct of research; may increase the level of risk to
p.000195: participants or have other ethical implications that may affect participants’ welfare; and were not anticipated by the
p.000195: researcher in the research proposal submitted for research ethics review.
p.000195:
p.000195: Undue influence – The impact of an unequal power relationship on the voluntariness of consent. This may occur when
p.000195: prospective participants are recruited by individuals in a position of authority over them (e.g. doctor/patient,
p.000195: teacher/student, employer/employee). See “Coercion.”
p.000195:
p.000195: Vulnerability – A diminished ability to fully safeguard one’s own interests in the context of a specific research
p.000195: project. This may be caused by limited capacity or limited access to social goods, such as rights, opportunities and
p.000195: power. Individuals or groups may experience vulnerability to different degrees and at different times, depending on
p.000195: their circumstances. See also “Autonomy.”
p.000195:
p.000195: Welfare – The quality of a person’s experience of life in all its aspects. Welfare consists of the impact on
p.000195: individuals and/or groups of factors such as their physical, mental and spiritual health, as well as their physical,
p.000195: economic and social circumstances.
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195: TCPS 2
p.000195:
p.000197: 197
p.000197:
p.000197:
p.000197:
p.000197: Index
...
p.000205: involving the elderly, 10, 47, 50
p.000205: involving human biological materials (see Human biological materials) involving human reproduction (see Human
p.000205: reproduction, materials related to) involving participants lacking capacity (see Capacity)
p.000205: involving women, 10, 47, 48-49, 116, 178-179
p.000205: minimal risk, 11, 23, 24-25, 37-39, 41, 51, 77-79
p.000205: multi-jurisdictional (see Multi-jurisdictional research) observational, 18-19, 118, 141-143
p.000205: partial disclosure, 37-39
p.000205: participant withdrawal, 28-30, 31, 61, 140, 186
p.000205: participatory, 123-125
p.000205: qualitative (see Qualitative Research) research ethics review, exempt from, 17-19
p.000205: research ethics review, requiring, 15-17, 119-121
p.000205: sponsored, 163-164
p.000205: stopping rules, 30-33
p.000205: unanticipated issues, 22, 34, 81, 161-163
p.000205: Research agreements, 121, 122-123, 126-127, 128-130, 131
p.000205: Research directives, 42-44 Research ethics
p.000205: core principles (see Core principles) framework, 7-13, 109-110
p.000205: importance, 7-8 Research ethics boards (REBs)
p.000205: ad hoc advisors, 24, 72, 73, 75, 120, 150
p.000205: appointment, 67-76
p.000205: authority, 67-70
p.000205: chair’s responsibilities, 74, 77-79
p.000205: composition, 70-75
p.000205: decision making, 68-69, 70, 79
p.000205: establishment, 67-76
p.000205: financial and administrative resources, 68-69, 74
p.000205: independence, 67, 68-69, 70-73, 93-94
p.000205: mandate, 67-70
p.000205: meetings and attendance, 75-76, 82-83 members (see Research ethics board members) membership requirements, 70-73
p.000205: multiple boards, 97-104
p.000205:
p.000205:
p.000205: TCPS 2
p.000207: 207
p.000207:
p.000207: Index
p.000207:
p.000207: quorum, 73, 74-75
p.000207: size, 70-72
p.000207: Research ethics board members appointment terms, 73-74
p.000207: chairs, 74, 77-79
p.000207: community members, 70, 72
p.000207: compensation, 94
p.000207: conflicts of interest, 69, 70-71, 78, 90, 93-94
p.000207: education and training, 74, 75, 76, 125
p.000207: ethics, members knowledgeable in, 70, 71
p.000207: expertise, 12, 70-75, 150
p.000207: law, members knowledgeable in, 70, 71-72
p.000207: substitute members, 72-73, 93 Research ethics review
p.000207: activities not requiring, 19-20 appeals, 84-85
p.000207: changes to approved research, 33-34, 82, 144-145, 150, 161, 163
p.000207: continuing, 21-22, 79-81
p.000207: delegated, 23, 24, 77-79, 82
p.000207: determining the level, 24-25, 77-79
p.000207: during publicly declared emergencies (see Publicly declared emergencies) full, 24, 74-76, 77-79, 82
p.000207: governance, 67-88
p.000207: initial, 76-77
p.000207: models, 98-101
p.000207: procedures, 76-83
...
General/Other / Undue Influence
Searching for indicator undue influence:
(return to top)
p.000199:
p.000199:
p.000199: TCPS 2 27
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: A. General Principles
p.000199: Consent Shall Be Given Voluntarily
p.000199: Article 3.1 (a) Consent shall be given voluntarily.
p.000199: (b) Consent can be withdrawn at any time.
p.000199: (c) If a participant withdraws consent, the participant can also request the with- drawal of their data or human
p.000199: biological materials.
p.000199: Application (a) The voluntariness of consent is important because it respects human dignity and means that
p.000199: individuals have chosen to participate in research according to their own values, preferences and wishes.
p.000199: The approach to recruitment is an important element in assuring voluntariness. In particular, how, when and where
p.000199: participants are approached, and who re- cruits them are important elements in assuring (or undermining) voluntariness.
p.000199: In considering the voluntariness of consent, REBs and researchers should be cognizant of situations where undue
p.000199: influence, coercion or the offer of incen- tives may undermine the voluntariness of a participant’s consent to
p.000199: participate in research.
p.000199: UndueXInfluence
p.000199: Undue influence and manipulation may arise when prospective participants are recruited by individuals in a position of
p.000199: authority. The influence of power re- lationships (e.g., employers and employees, teachers and students, commanding
p.000199: officers and members of the military or correctional officers and prisoners) on the voluntariness of consent should be
p.000199: judged from the perspective of prospec- tive participants, since the individuals being recruited may feel constrained
p.000199: to follow the wishes of those who have some form of control over them. This con- trol may be physical, psychological,
p.000199: financial or professional, for example, and may involve offering some form of inducement or threatening some form of
p.000199: deprivation. In such situations, the control exerted in a power relationship may place undue pressure on the
p.000199: prospective participants. At the extreme, there can be no voluntariness if consent is secured by the order of
p.000199: authorities.
p.000199: REBs and researchers should also pay particular attention to elements of trust and dependency in relationships (e.g.,
p.000199: between physician and patient or between professor and student). These relationships can impose undue influence on the
p.000199: individual in the position of dependence to participate in research projects. Any relationship of dependency, even a
p.000199: nurturing one, may give rise to undue in- fluence even if it is not applied overtly. There may be a greater risk of
p.000199: undue influence in situations of ongoing or significant dependency.
p.000199:
p.000199:
p.000199:
p.000199: 28 TCPS 2
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: Pre-existing entitlements to care, education and other services should not be prejudiced by the decision of whether or
p.000199: not to participate in, or to withdraw from, a research project. Accordingly, for example, a physician should ensure
p.000199: that continued clinical care is not linked to research participation. Similarly, where students do not wish to
p.000199: participate in research studies for course credits, they should be offered a comparable alternative.
p.000199: Coercion
p.000199: Coercion is a more extreme form of undue influence, involving a threat of harm or punishment for failure to
p.000199: participate. Coercion would negate the voluntariness of a decision to participate, or to remain, in a research project.
p.000199: Incentives
p.000199: Incentives are anything offered to participants, monetary or otherwise, for par- ticipation in research (incentives
p.000199: differ from reimbursements and compensation for injury, which are discussed in Article 3.2[j]). Because incentives are
p.000199: used to encourage participation in a research project, they are an important consid- eration in assessing
p.000199: voluntariness. Where incentives are offered to participants, they should not be so large or attractive as to encourage
p.000199: reckless disregard of risks. This is a particular consideration in the case of healthy volunteers for the early phases
p.000199: of clinical trials, as discussed in Article 11.1. The offer of incen- tives in some contexts may be perceived by
p.000199: prospective participants as a way for them to gain favour or improve their situation. This may amount to undue
p.000199: inducement and thus negate the voluntariness of participants’ consent.
p.000199: This Policy neither recommends nor discourages the use of incentives. The onus is on the researcher to justify to the
p.000199: REB the use of a particular model and the level of incentives. In considering the possibility of undue influence in re-
p.000199: search involving financial or other incentives, researchers and REBs should be sensitive to issues such as the economic
p.000199: circumstances of those in the pool of prospective participants, the age and capacity of participants, the customs and
p.000199: practices of the community, and the magnitude and probability of harms (see Chapter 4, Section B). Guardians and
p.000199: authorized third parties should not receive incentives for arranging the involvement in research of the individual they
p.000199: rep- resent. However, they may accept reasonable incentives or compensation on behalf of that individual, as long as
p.000199: these are suitable to the circumstances.
p.000199: (b) To maintain the element of voluntariness, participants shall be free to withdraw their consent to participate in
p.000199: the research at any time, and need not offer any reason for doing so. In some cases, however, the physical
p.000199: practicalities of the project may prevent the actual withdrawal of the participant partway through, for example, if
p.000199: the project involves only a single intervention, or if the termination of a medical research procedure may
p.000199: compromise the safety of the participant.
p.000199:
p.000199: TCPS 2 29
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: The participant should not suffer any disadvantage or reprisal for withdrawing nor should any payment due prior to the
...
p.000199: public emergency). All efforts should be made to en- sure that technical difficulties do not prevent the maintenance of
p.000199: quorum throughout the meeting. Use of such technologies requires the Chair to ensure active participa- tion of members
p.000199: not physically present. Institutions should consider developing written procedures for the occasional use of
p.000199: videoconferences or other technologies by an REB.
p.000199: In the design phase of their research prior to the formal ethics review process, re- searchers may consult informally
p.000199: with REBs. Such dialogue can establish the stage at which REB review and approval would be required, or facilitate the
p.000199: review. Such
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 75
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: informal meetings cannot, however, substitute for the formal review process. A schedule of REB meetings should be
p.000199: communicated to researchers for the planning of ethics review of their research.
p.000199: On occasion REBs may need to consult other resources within or outside the insti- tution for advice, and may invite
p.000199: experts to attend their meetings. REBs should consider whether the institutional functions of other individuals
p.000199: attending their meetings could exercise undue influence, or provide elements of power imbalances or coercion that would
p.000199: affect REB review, deliberations and decisions (see Articles
p.000199: 6.4 and 6.5 and Chapter 7).
p.000199: REBs should establish a process for the basis of arriving at decisions requiring full REB review. For example, they may
p.000199: arrive at decisions by consensus, and where this is not possible resort to a vote. REBs should hold general meetings,
p.000199: retreats and workshops to enhance educational opportunities that may benefit the overall operation of the REB, discuss
p.000199: any general issues arising out of the REB’s activities or revise relevant policies.
p.000199:
p.000199: B. Procedures for REB Review
p.000199:
p.000199: Initial Research Ethics Review
p.000199: Article 6.11 Researchers shall submit their research proposals, including proposals for pilot studies, for REB
p.000199: review and approval of its ethical acceptability prior to the start of recruitment of participants, access to data, or
p.000199: collection of human biological ma- terials. REB review is not required for the initial exploratory phase, which may
p.000199: involve contact with individuals or communities intended to establish research part- nerships or to inform the design
p.000199: of a research proposal.
p.000199: Application REB review and approval of the ethical acceptability of research is required before recruitment, formal
p.000199: data collection involving participants, access to data, or col- lection of human biological materials. Similarly, as an
...
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 95
p.000199:
p.000199: Chapter 7 – Conflicts of Interest
p.000199:
p.000199: The REB should examine budgets to ensure that there are no inappropriate pay- ments to be made or other unexplained
p.000199: expenses that may raise questions about conflict of interest. Further, payment provisions should be scrutinized to
p.000199: ensure they do not create ethically inappropriate incentives to recruit quickly, at the ex- pense of a careful
p.000199: review of the suitability of prospective participants. Unreasonable payments or undue inducements may place
p.000199: the researcher, and some- times the institution, in a conflict between maximizing financial remuneration on the one
p.000199: hand and protecting participants and meeting the scientific requirements of the project on the other. Disclosure of the
p.000199: kinds and amounts of payments and other budgetary details encourages the researcher to identify and appropriately
p.000199: manage potential conflicts of interest and helps the REB to assess them. Manage- ment by institutions and/or REBs
p.000199: may include prohibiting certain forms of payment.
p.000199: The perception of a conflict of interest may, in many cases, be as damaging as a real conflict. The REB should assess
p.000199: the likelihood that the researcher’s judgment may be inappropriately influenced, or perceived to be influenced, by
p.000199: private or per- sonal interests. It should then determine the magnitude of harm that is likely to result from such
p.000199: influence or from the perception of undue influence.
p.000199: In addressing conflicts of interest, disagreements between the REB and the re- searcher may arise about the scope and
p.000199: reach of disclosure, including disclosure of new information to participants, or other aspects of managing the
p.000199: conflict. Reso- lution of disagreements should be guided by the paramount principles of Respect for Persons and Concern
p.000199: for Welfare of participants. If the researcher and the REB cannot resolve their disagreement they should use the
p.000199: institutional conflict of in- terest mechanisms to arrive at a solution.
p.000199:
p.000199: Endnote
p.000199:
p.000199:
p.000199: 1 Definition of “conflict of interest” based on Schedule 14 of the Memorandum of Understanding (MOU) on the Roles and
p.000199: Responsibilities in the Management of Federal Grants and Awards. www.nserc-
p.000199: crsng.gc.ca/NSERC-CRSNG/Policies-Politiques/MOURoles-ProtocolRoles/index_eng.asp
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: 96 TCPS 2
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: Introduction
p.000199: Chapter 8
p.000199: MULTI-JURISDICTIONAL RESEARCH
p.000199: This chapter sets out options, procedures and considerations for the ethics review of multi-juris- dictional research
p.000199: either entirely within Canada, or in Canada and other countries. It is intended to facilitate the ethics review process
...
p.000199: of the popula- tions targeted by the research. The final decision regarding the selection of the appropriate model is
p.000199: the responsibility of the principal REB.
p.000199: When selecting from among research ethics review models authorized by their in- stitution, researchers and REBs should
p.000199: consider the following:
p.000199:
p.000199:
p.000199: 100 TCPS 2
p.000199:
p.000199: Chapter 8 – Multi-Jurisdictional Research
p.000199:
p.000199: • the discipline and content area of the research, and the availability of appropri- ate experience and expertise
p.000199: within, or available to, the reviewing REB;
p.000199: • the scope of the project to be reviewed and appropriateness of the proposed re- search ethics review model;
p.000199: • the vulnerability of the study population overall and/or the particular charac- teristics of the local population
p.000199: at individual sites, differences in values and cultural norms, and the level of risk associated with the research under
p.000199: review;
p.000199: • any relevant differences in laws and/or guidelines pertaining to the research in question if the institutions are
p.000199: in different provinces, territories and/or coun- tries;
p.000199: • relationships between institutions and REBs, and conflict resolution mecha- nisms related to REB decisions;
p.000199: • the potential for conflicts of interest and undue influence, including those that may arise from funding sources;
p.000199: • any differences in the standard of care normally followed, or access to services at the participating
p.000199: institutions that might be relevant to the conduct of the re- search; and
p.000199: • any operational issues that might affect the research.
p.000199:
p.000199: B. Ethics Review of Research Conducted outside the Institution
p.000199: Researchers affiliated with Canadian institutions are undertaking research at numerous sites within Canada and in
p.000199: countries around the world. Such research may be carried out with or without any collaboration with host institutions
p.000199: and local researchers. Most middle-income countries, and many low-income countries, have laws, policies or guidelines
p.000199: governing the ethical conduct of research involving humans, but some parts of the world do not have developed or
p.000199: widespread research ethics infrastructure.
p.000199: National and international standards for research involving humans are evolving continually, but methods for comparing
p.000199: the precise levels of protection afforded participants in different countries or jurisdictions, and by different
p.000199: institutions within those countries and jurisdictions, have not yet been developed. In exercising its responsibilities
p.000199: for the initial and continuing ethics review of re- search conducted under its auspices, the Canadian REB shall satisfy
...
p.000187: project. In other policies/guidance they are also known as “authorized third party deci- sion makers.”
p.000187:
p.000187: Autonomy – The capacity to understand information and to be able to act on it voluntarily; the ability of individuals
p.000187: to use their own judgement to make decisions about their own actions, such as the decision to consent to participate in
p.000187: research.
p.000187:
p.000187:
p.000187:
p.000187: TCPS 2
p.000189: 189
p.000189:
p.000189: Glossary
p.000189:
p.000189: Biobank – A collection of human biological materials. It may also include associated information about individuals from
p.000189: whom biological materials were collected.
p.000189:
p.000189: Capacity – The ability of prospective or actual participants to understand relevant information presented (e.g. purpose
p.000189: of the research, foreseeable risks, and potential benefits), and to appreciate the potential con- sequences of any
p.000189: decision they make based upon this information.
p.000189:
p.000189: Clinical equipoise – The existence of a genuine uncertainty on the part of the relevant expert community about what
p.000189: therapy or therapies are most effective for a given condition.
p.000189:
p.000189: Clinical trial – Any investigation involving participants that evaluates the effects of one or more health- related
p.000189: interventions on health outcomes.
p.000189:
p.000189: Coercion – An extreme form of undue influence, involving a threat of harm or punishment for failure to participate in
p.000189: research. See “Undue influence.”
p.000189:
p.000189: Collaborative research – Research that involves the cooperation of researchers, institutions, organizations and/or
p.000189: communities, each bringing distinct expertise to a project, and that is characterized by respectful relationships. See
p.000189: “Community-based research” and “Participatory research.”
p.000189:
p.000189: Community – A group of people with a shared identity or interest that has the capacity to act or express itself as a
p.000189: collective. A community may be territorial, organizational, or a community of interest.
p.000189:
p.000189: Community-based research – Research conducted at a community site that focuses not only on individuals but on the
p.000189: community itself. Community-based research may be initiated by the community independently or in collaboration with a
p.000189: researcher. See “Collaborative research” and “Participatory research.”
p.000189:
p.000189: Community engagement – A process that establishes an interaction between a researcher (or a research team) and a
p.000189: community with regard to a research project. It signifies the intent of forming a collaborative relationship between
p.000189: researchers and communities, although the degree of collaboration may vary depend- ing on the community context and the
p.000189: nature of the research.
p.000189:
p.000189: Concern for Welfare – A core principle of this Policy that requires researchers and research ethics boards to aim to
p.000189: protect the welfare of participants, and, in some circumstances, to promote that welfare in view of any foreseeable
...
p.000195: Stopping rules – Statistically significant end points and safety considerations for a clinical trial that are
p.000195: determined in advance, and, once reached, dictate that the trial must be terminated.
p.000195:
p.000195:
p.000195:
p.000195: 196 TCPS 2
p.000195:
p.000195: Glossary
p.000195:
p.000195: Surgical trials – A clinical trial which compares the safety and/or efficacy of different surgical techniques.
p.000195:
p.000195: Therapeutic misconception – A misunderstanding, on the part of participants, of the purpose, benefits, and/or risks
p.000195: of clinical trials. Often participants do not understand that research is aimed primarily at producing knowledge and
p.000195: may not provide any therapeutic benefit to them.
p.000195:
p.000195: Traditional knowledge – The knowledge held by First Nations, Inuit and Métis peoples, the Aboriginal peoples of
p.000195: Canada. Traditional knowledge is specific to place, usually transmitted orally, and rooted in the experience of
p.000195: multiple generations. It is determined by an Aboriginal community’s land, environment, region, culture, and language.
p.000195: It may also include new knowledge transmitted to subsequent generations.
p.000195:
p.000195: Unanticipated issues – Issues that: occur during the conduct of research; may increase the level of risk to
p.000195: participants or have other ethical implications that may affect participants’ welfare; and were not anticipated by the
p.000195: researcher in the research proposal submitted for research ethics review.
p.000195:
p.000195: Undue influence – The impact of an unequal power relationship on the voluntariness of consent. This may occur when
p.000195: prospective participants are recruited by individuals in a position of authority over them (e.g. doctor/patient,
p.000195: teacher/student, employer/employee). See “Coercion.”
p.000195:
p.000195: Vulnerability – A diminished ability to fully safeguard one’s own interests in the context of a specific research
p.000195: project. This may be caused by limited capacity or limited access to social goods, such as rights, opportunities and
p.000195: power. Individuals or groups may experience vulnerability to different degrees and at different times, depending on
p.000195: their circumstances. See also “Autonomy.”
p.000195:
p.000195: Welfare – The quality of a person’s experience of life in all its aspects. Welfare consists of the impact on
p.000195: individuals and/or groups of factors such as their physical, mental and spiritual health, as well as their physical,
p.000195: economic and social circumstances.
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
p.000195:
...
p.000199: confidentiality)
p.000199: Conflicts of interest
p.000199: clinical trials, 163-164
p.000199: definition, 89
p.000199: dual roles, 95, 149, 158
p.000199: financial, 95-96, 163-164
p.000199: incentives, 29-30, 52, 151, 164
p.000199: institutional, 89-90, 91-93
p.000199: research ethics board members, 69, 70-71, 78, 90, 93-94
p.000199: researchers, 91, 94-96
p.000199: Consent
p.000199: Aboriginal peoples, 109, 119, 123, 131
p.000199: alteration, 37-39
p.000199: authorized third parties, 27, 41-44 capacity to (see Capacity)
p.000199: clinical trials, 155, 158-159, 161-163
p.000199: coercion, 29
p.000199: and compensation, 29, 31, 33
p.000199: definition, 27
p.000199: documentation, 44-45
p.000199: evidence, 44-45, 140
p.000199: exceptions to requirement to seek, 37-40, 62-64, 85, 141-143, 172-175 free (see Consent: voluntary)
p.000199: general principles, 28-36
p.000199: general principles, departures from, 37-40
p.000199: human biological materials, 9, 28-30, 31, 171-175 human reproduction, materials related to, 177-179 incentives, 29-30,
p.000199: 31, 151
p.000199: individual medical emergencies, 39-40 informed, 27, 30-33
p.000199: modalities of expression, 140 ongoing, 27, 33-34, 137-138
p.000199: oral, 44, 140
p.000199: qualitative research, 137-138, 140, 141-144
p.000199: research directives, 42-44
p.000199: secondary use of human biological materials, 62-64, 130-132, 172-175
p.000199: secondary use of identifiable information, 62-64, 130-132 undue influence, 28-29
p.000199: voluntary, 27, 28-30, 31, 32
p.000199: withdrawal, 28-30, 31
p.000199: written, 44-45
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2
p.000201: 201
p.000201:
p.000201: Index
p.000201:
p.000201: Continuing research ethics review, 21-22, 79-81
p.000201: Core principles, 8-11
p.000201: Concern for Welfare, 8, 9-10, 109
p.000201: Justice, 8, 10-11, 47, 109-110
p.000201: interpretation, 13, 109-110
p.000201: Respect for Persons, 8-9, 27, 109
p.000201: Creative practice, 20
p.000201: Critical inquiry, 35-36, 117
p.000201: Cultural heritage, 110-111
p.000201: Cyber-material, 18
p.000201:
p.000201: D
p.000201: Data
p.000201: anonymized, 57
p.000201: anonymous, 57, 131-132
p.000201: collection, 64, 76-77, 137, 144-145
p.000201: destruction, 61
p.000201: linkage, 18, 19, 64-65, 131-132
p.000201: security, 61, 64-65
p.000201: withdrawal, 28-30, 31 (see also Information)
p.000201: Data safety monitoring board (DSMB), 160-161 Debriefing, 37-39, 143
p.000201: Design
p.000201: clinical trials, 149-156
p.000201: emergent, 144-145 Duty of care, 148-149
p.000201: E
p.000201: Elderly, as research participants, 10, 47, 50
p.000201: Elders, in Aboriginal communities, 119, 126
p.000201: Embryos, 15-17, 49, 176, 177-178
p.000201: Emergencies
p.000201: individual medical, 39-40
p.000201: publicly declared (see Publicly declared emergencies) Emergent design, 144-145
...
p.000207: multiple affiliations, 68, 97-101
p.000207: Respect for Persons, 8-9, 27, 109 Risk
p.000207: and benefits, 10, 11, 22-25, 41-42, 51, 157-158
p.000207: in clinical trials, 148, 157-159
p.000207: definition, 22-23
p.000207: minimal, 11, 23, 24-25, 37-39, 41, 51, 77-79
p.000207: to researchers, 25
p.000207:
p.000207:
p.000207: 208 TCPS 2
p.000207:
p.000207: Index
p.000207:
p.000207: S
p.000207: Scholarly review, 20-21
p.000207: Secondary use of human biological materials, 62-64, 119-121, 130-132, 172-175, 186 Secondary use of identifiable
p.000207: information
p.000207: Aboriginal peoples, 119-121, 130-132
p.000207: anonymous, 19
p.000207: consent, 62-64, 130-132
p.000207: definition, 19, 62
p.000207: genetic material, 186
p.000207: privacy, 62-64
p.000207: Security of information, 56, 60-61, 64-65 StemXcells
p.000207: Guidelines for Human Pluripotent Stem Cell Research, 179 pluripotent, 179
p.000207: Students, 25, 67-68, 77-79 Subjects (see Participants)
p.000207: T
p.000207: Therapeutic misconception, 148, 149, 158-159
p.000207: Third party consent (see Consent: authorized third parties) Trials (see Clinical trials)
p.000207: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) application, 11-13
p.000207: compliance with, 5-6
p.000207: interpretation, 13
p.000207:
p.000207: U
p.000207: Unanticipated issues, 22, 34, 81, 161-163
p.000207: Undue influence, 28-29
p.000207:
p.000207: V
p.000207: Vulnerability, 9, 10, 23, 47, 52, 116, 137, 148
p.000207:
p.000207: W
p.000207: Welfare (see Concern for Welfare)
p.000207: Withdrawal
p.000207: of consent, 28-30, 31
p.000207: of data, 28-30, 31
p.000207: of human biological materials, 28-30, 31, 172
p.000207: from research, 28-30, 31, 61, 140, 186
p.000207: Women
p.000207: as research participants, 10, 47, 48-49, 116, 178-179 pregnant, inclusion in research, 49
p.000207:
p.000207:
p.000207:
p.000207:
p.000207:
p.000207:
p.000207: TCPS 2
p.000209: 209
p.000209:
...
General/Other / cioms guidelines
Searching for indicator cioms:
(return to top)
p.000101:
p.000101:
p.000101: TCPS 2
p.000103: 103
p.000103:
p.000103: Chapter 8 – Multi-Jurisdictional Research
p.000103:
p.000103: context-sensitive approach to research ethics review embodied in this Policy, the Canadian REB should ensure that it
p.000103: has a clear understanding of the differing ra- tionales that might underlie divergent REB positions or
p.000103: decisions on a given proposal. Where the REB is uncertain about the appropriate course of action in a given research
p.000103: proposal, it should make contact with its counterpart REB in the re- search site or country. In the absence of formal
p.000103: reciprocity agreements between countries or institutions with respect to initial and continuing research ethics review,
p.000103: the REBs should engage in dialogue and may establish a specific mechanism, such as a joint subcommittee of the two REBs
p.000103: (e.g., for situations in which institutions collaborate regularly), to facilitate appropriate deliberation in order to
p.000103: reach a thoughtful and well-informed judgment on the ethical acceptability of a given re- search proposal (see Article
p.000103: 8.1).
p.000103:
p.000103: Endnote
p.000103:
p.000103:
p.000103: 1 See for example the United States Office for Human Research Protections (OHRP) registry of REBs (see References
p.000103: below), mainly in the area of health and biomedical research. It can serve as one re- source for identifying research
p.000103: ethics review bodies around the world.
p.000103:
p.000103: References
p.000103:
p.000103:
p.000103: • Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for
p.000103: Biomedical Research Involving Human Subjects. CIOMS: Geneva. 2002. www.cioms.ch/publications/layout_guide2002.pdf
p.000103: • Newfoundland and Labrador. Health Research Ethics Authority Act, S.N.L. 2006, c. H-1.2.
p.000103: http://assembly.nl.ca/Legislation/sr/statutes/h01-2.htm
p.000103: • Québec. Ministère de la Santé et des Services sociaux. Direction générale adjointe de l’évaluation, de la
p.000103: recherche et de l’innovation. Unité de l’éthique. Mécanisme encadrant l’examen éthique et le suivi continu des projets
p.000103: multicentriques. In effect since April 1, 2008. www.ethique.msss.gouv.qc.ca/site/fr_mecanismemulticentrique.phtml
p.000103: • U.S. Department of Health and Human Services. Office for Human Research Protections. International Compilation of
p.000103: Human Research Protections, 2010 Edition. www.hhs.gov/ohrp/international/HSPCompilation.pdf
p.000103: • ———. Federal-Wide Assurances Registry for Registered Organizations Operating Institutional Review Boards (IRBs)
p.000103: or Registered IRBs. ohrp.cit.nih.gov/search
p.000103: • World Medical Association. Declaration of Helsinki – Ethical Principles for Medical Research Involving Human
p.000103: Subjects. 2008. www.wma.net/en/30publications/10policies/b3/index.html
p.000103:
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p.000103: Chapter 9
p.000103: RESEARCH INVOLVING THE FIRST NATIONS, INUIT AND MÉTIS PEOPLES OF CANADA
p.000103:
p.000103: Introduction
p.000103: Preamble
p.000103: This chapter on research involving Aboriginal peoples in Canada, including Indian (First Nations1), Inuit and Métis
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p.000165: (August 2007). www.icmje.org/update_sponsor.html
p.000165: 4 CONSORT Statement: www.consort-statement.org/consort-statement (accessed April 19, 2010).
p.000165:
p.000165: References
p.000165:
p.000165:
p.000165: • Canada. Food and Drugs Act. Natural Health Products Regulations, Part 4: Clinical Trials Involving Human Subjects
p.000165: (SOR/2003-196) 5 June 2003. gazette.gc.ca/archives/p2/2003/2003-06-18/html/sor-dors196-eng.html
p.000165: • Canadian Institutes of Health Research. “Policy on Access to Research Outputs.” September 2007.
p.000165: www.cihr-irsc.gc.ca/e/34846.html
p.000165: • Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social
p.000165: Sciences and Humanities Research Council of Canada, Access to Research Results: Guiding Principles.
p.000165: www.science.gc.ca/default.asp?Lang=En&n=9990CB6B-1
p.000165: • Consolidated Standards of Reporting Trials: CONSORT Statement, and Explanation and Elaboration document.
p.000165: www.consort-statement.org
p.000165:
p.000165:
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p.000167: Chapter 11 – Clinical Trials
p.000167:
p.000167: • Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to
p.000167: the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. 1997.
p.000167: http://conventions.coe.int/Treaty/EN/Treaties/Html/164.htm
p.000167: • Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for
p.000167: Biomedical Research Involving Human Subjects. Geneva: 2002. www.cioms.ch/publications/layout_guide2002.pdf
p.000167: • Health Canada. Therapeutic Products Directorate. Medical Devices Bureau. Guidance documents.
p.000167: www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/index-eng.php
p.000167: • International Conference on Harmonisation. Guidance for Industry: Good Clinical Practice – Consolidated
p.000167: Guidelines, ICH Topic E6: Technical Requirements for the Registration of Pharmaceuticals for Human Use. 1996. Adopted
p.000167: by Health Canada in 1997.
p.000167: www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-eng.php
p.000167: • Ottawa Hospital Research Institute. Ottawa Statement on Trial Registration. http://ottawagroup.ohri.ca
p.000167: • United States. Food and Drug Administration. Food and Drug Administration Amendments Act of 2007. September 2007.
p.000167: • United States. National Institutes of Health. NIH Policy for Data and Safety Monitoring. Released 1998.
p.000167: www.grants.nih.gov/grants/guide/notice-files/not98-084.html
p.000167: • ———. Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials. Released 2000.
p.000167: www.grants.nih.gov/grants/guide/notice-files/not-od-00-038.html
p.000167: • World Medical Association. Declaration of Helsinki – Ethical Principles of Medical Research Involving Human
p.000167: Subjects. 2008. www.wma.net/en/30publications/10policies/b3/index.html
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General/Other / cultural difference
Searching for indicator culturally:
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p.000199: Benefits may be indirect, where the participation in research of an individual or group, or in a research project in-
p.000199: volving a community contributes to the advancement of knowledge that may lead to improved conditions for a group to
p.000199: which the participant belongs. Such knowledge may also inform other communities or society in general.
p.000199: Researchers should also be sensitive to the expectations and opinions of participants regarding potential benefits of
p.000199: the research. Prior to the commencement of the research, researchers should formally or informally discuss these
p.000199: expectations with individuals and/or groups, and outline the scope and nature of potential benefits that may accrue to
p.000199: participants during and after the research (see Article 9.13). REBs should be vigilant to ensure that the proposed
p.000199: distribution of benefits is fair, without imposing undue burdens on the researcher that would make it too difficult or
p.000199: costly to complete research.
p.000199: Researchers should normally provide copies of publications, or other research reports or products, arising from the
p.000199: research to the institution or organization – normally the host institution – that is best suited to act as a
p.000199: repository and disseminator of the results within the participating commu- nities. This may not be necessary in
p.000199: jurisdictions where the results are readily available in print or electronically. In general, researchers should ensure
p.000199: that participating individuals, groups and com- munities are informed of how to access the results of the research.
p.000199: Results of the research should be made available to them in a culturally appropriate and meaningful format, such as
p.000199: reports in plain language in addition to technical reports.
p.000199:
p.000199:
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p.000199:
p.000199:
p.000199: Chapter 5
p.000199: PRIVACY AND CONFIDENTIALITY
p.000199:
p.000199: Introduction
p.000199: There is widespread agreement about the interests of participants in protection of privacy, and the corresponding
p.000199: duties of researchers to treat personal information in a confidential manner. Indeed, the respect for privacy in
p.000199: research is an internationally recognized norm and ethical standard. Fun- damental rights and freedoms in the Canadian
p.000199: Constitution have been interpreted by the courts to include privacy protections. Privacy rights are protected in
p.000199: federal and provincial/territorial leg- islation. Model voluntary codes1 have also been adopted to govern access to,
p.000199: and the protection of, personal information. Some professional organizations have established codes that set out the
p.000199: conditions and obligations of their members regarding the collection, use and disclosure of personal information.
p.000199: Privacy risks in research relate to the identifiability of participants, and the potential harms they, or groups to
...
p.000111: co-investigators, or benefit from findings. For example, research focusing exclusively on contaminants in animals or
p.000111: plants in Nunavik that does not make inferences regarding food intake.
p.000111: • Research that involves the collection and analysis of tissue samples from animals or plants, and not involving
p.000111: human research participants, is not covered within the scope of this Policy and does not require institutional REB
p.000111: review. However, funding program guidelines and licensing requirements in the North may impose obligations
p.000111: to engage communities. Community customs or codes of research practice may require securing regional and local
p.000111: permission, and reporting findings to communities (see NSERC literature on the Northern Research Program for professors
p.000111: and students/fellows, and Article 9.8).
p.000111: 7) Research that incidentally involves a small proportion of Aboriginal individuals but is not intended to single
p.000111: out, or describe, characteristics of Aboriginal people, for example, a study of the effectiveness of therapies to
p.000111: control high blood pressure in a sample of hospital outpatients, which is not designed to collect Aboriginal-specific
p.000111: data.
p.000111: • Since Aboriginal participation is incidental rather than scheduled, community engagement is not
p.000111: required. If Aboriginal individuals self- identify during the collection of primary data, researchers should inquire
p.000111:
p.000111:
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p.000113:
p.000113: whether culturally appropriate assistance is desired to interpret, or support compliance with, the research project.
p.000113: However, it should be noted that including markers of Aboriginal identity in data collection may reveal
p.000113: anomalies that warrant further, more targeted research, which, if followed up, would require community engagement.
p.000113: 8) Research based on publicly available information as defined by this Policy, for example, historical, genealogical
p.000113: or analytic research based on public records, or data available or accessible in accordance with legislation.
p.000113: • Such research does not involve the collection of data from communities directly or from living persons and is not
p.000113: subject to REB review (see Article 2.2). Community engagement is not required. Findings of such research nevertheless
p.000113: may have an impact on the identity or heritage of persons or communities. In order to minimize any harm,
p.000113: researchers should seek culturally informed advice before use of such data to determine if harms may result and if
p.000113: other considerations such as sharing of the research results should be explored with the original source community (see
p.000113: Article 9.15).
p.000113: Respect for First Nations, Inuit and Métis Governing Authorities
p.000113: Article 9.3 Where a proposed research project is to be conducted on lands under the jurisdiction of a First
p.000113: Nations, Inuit or Métis authority, researchers shall seek the engagement of formal leaders of the community, except as
p.000113: provided under Articles 9.5, 9.6 and 9.7.
p.000113: Research ethics review by the institutional REB and any responsible community body recognized by the First Nations,
p.000113: Inuit or Métis authority (see Articles 9.9 and 9.11) is required in advance of recruiting and securing consent of
p.000113: individuals.
p.000113: Application Formal leaders with governance responsibilities on First Nations, Inuit or Métis land are charged with
p.000113: protecting the welfare of the community. Article 8.3(b) applies in such cases, requiring ethics review of research
p.000113: proposals by both “(i) the REB at the Canadian institution under the auspices of which the research is being
p.000113: conducted, and (ii) the REB or other responsible review body or bodies, if any, at the research site.” A local
p.000113: authority may approve research or delegate responsibility for reviewing research proposals to a local or regional body
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p.000115: participants in small communities; identifying research questions that include rather than divide interest groups; or
p.000115: expanding the coverage of a project to multiple communities. In some cases, the risks to participants and communities
p.000115: involved with, or affected by, the proposed research outweigh the potential benefits likely to be gained, and the
p.000115: research should not be undertaken.
p.000115: Critical Inquiry
p.000115: Article 9.7 Research involving Aboriginal peoples that critically examines the conduct of public institutions,
p.000115: First Nations, Inuit and Métis governments, institutions or organizations or persons exercising authority over First
p.000115: Nations, Inuit or Métis individuals may be conducted ethically, notwithstanding the usual requirement of engaging
p.000115: community leaders.
p.000115: Application Considerations in conducting critical inquiry are discussed more fully in Article
p.000115: 3.6. As in the case of research involving groups whose circumstances make them vulnerable, or communities of interest
p.000115: within an Aboriginal community (see Article 9.6), researchers undertaking critical inquiry research will need to adopt
p.000115: appropriate approaches to ensure that cultural norms are respected, that the safety of participants is protected, and
p.000115: that potential harms to the welfare of the larger community are minimized to the extent possible. Researchers may
p.000115: need to consult culturally relevant regional or national Aboriginal organizations for guidance.
p.000115: For example, the Sisters in Spirit project of the Native Women’s Association of Canada (NWAC) that was launched in
p.000115: 2005 for a five-year period illustrates research of a national scope that incorporated a critical dimension. The
p.000115: project involved interviewing families of missing and murdered First Nations, Métis or Inuit women in urban and rural
p.000115: settings, and on First Nations territory. It examined, among other matters, the adequacy of public institutions and
p.000115: services, Aboriginal and non-Aboriginal, to protect the women’s well-being and support families in their efforts to
p.000115: deal with their losses. The objective was to effect policy change and improve the safety and well-being of Aboriginal
p.000115: women in Canada. NWAC has published its commitment to participatory research and the principles and practices that
p.000115: protect the privacy and well-being of participants. The project built on NWAC’s ongoing efforts to develop meaningful
p.000115: research relationships reflecting Aboriginal ways of knowing.
p.000115: Respect for Community Customs and Codes of Practice
p.000115: Article 9.8 Researchers have an obligation to become informed about, and to respect, the relevant customs and
p.000115: codes of research practice that apply in the particular community or communities affected by their research.
...
p.000119: institution’s REB may not be required.
p.000119: In accordance with Article 8.4, communication between the institutional REB and the responsible agency in the community
p.000119: may assist in resolving inconsistencies between institutional policy and community customs and codes of research
p.000119: practice. Where a community research ethics review is required in addition to the mandatory institutional REB review,
p.000119: reconciling differences may require resubmission to one or both review bodies.
p.000119: Researchers and REBs should recognize that research ethics review by community bodies will often pursue purposes and
p.000119: apply criteria that differ from the provisions of this Policy. The express purpose of most Aboriginal community
p.000119: codes of research practice is to ensure the relevance of research undertakings to community needs and priorities,
p.000119: and respect for First Nations, Inuit and Métis identities, cultures and knowledge systems. While community
p.000119: codes of practice and research agreements typically share many of the goals of institutional policies, the
p.000119: approaches to achieving those goals may differ significantly. It is therefore inappropriate to insist on
p.000119: uniformity between community practices and institutional policies. For example, when researchers seek to interview
p.000119: Elders willing to share their knowledge according to traditional customs of consent, REBs should not impose language
p.000119: and processes that may be experienced as culturally inappropriate or awkward (see Article 3.12).
p.000119: In cases where REB review of research on topics related to Aboriginal peoples or affecting Aboriginal communities is
p.000119: regularly required, the REB membership should be modified to ensure that relevant and competent knowledge and
p.000119: expertise in Aboriginal cultures are available within its regular complement. Aboriginal scholars or members drawn from
p.000119: First Nations, Inuit or Métis communities may fill this role (see Article 6.4). For occasional review of Aboriginal
p.000119: research that is likely to affect the welfare of a community or communities, consultation with ad hoc advisors or
p.000119: delegation to a specialized or multi-institutional REB may be appropriate (see Articles 6.5 and Article 8.1).
p.000119: The membership of community review bodies of First Nations, Inuit or Métis communities will not necessarily duplicate
p.000119: the membership criteria set out in this Policy. In the context of scarce resources in community organizations, the same
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p.000119: personnel may be involved in reviewing the ethics of a proposal and co-managing the research project. An expectation
p.000119: that conflicts of interest will be managed by separating research ethics review and project management functions may
p.000119: impose unsupportable demands on small communities. In these circumstances, researchers and participating Aboriginal
p.000119: communities should address the ethical safeguards of the community and its members that can be best achieved in
p.000119: circumstances when multiple roles are assumed by the same person (see Chapter 7 and, in particular, Article 7.2).
p.000119: Requirement to Advise the REB on a Plan for Community Engagement
p.000119: Article 9.10 When proposing research expected to involve First Nations, Inuit or Métis participants,
p.000119: researchers shall advise their REB how they have engaged, or intend to engage, the relevant community.
p.000119: Alternatively, researchers may seek REB approval for an exception to the requirement for community engagement, on
p.000119: the basis of an acceptable rationale.
p.000119: Application In order for REBs to consider whether the form of community engagement chosen by the researcher is
p.000119: appropriate, they will require evidence in the form of one or more of the following: (a) a preliminary or formal
p.000119: research agreement between the researcher and the responsible body at the research site; (b) a written decision or
p.000119: documentation of an oral decision taken in a group setting to approve the proposed research or to decline further
p.000119: participation; and (c) a written summary of advice received from a culturally informed advisory group or ad hoc
p.000119: committee (e.g., an urban community of interest). Where community engagement is not being proposed, perhaps
p.000119: due to the nature of the research and the community context (see Articles 9.1 and 9.2), researchers shall provide a
p.000119: rationale acceptable to the REB.
p.000119: Provision of a research agreement is particularly emphasized in health research funded by CIHR (see CIHR Guidelines for
p.000119: Health Research Involving Aboriginal People in References at end of this chapter).
p.000119: Where a researcher has an ongoing relationship with a community, a letter from formal or customary leaders in the
p.000119: relevant community may signal approval, and suffice to proceed with the research.
p.000119: Where, under the provisions of Articles 6.11 and 10.1, a community signals during preliminary discussions with
p.000119: researchers, prior to REB review, that the research may proceed but that it does not want further community engagement,
p.000119: researchers shall document and present to the REB the steps they took to invite and facilitate engagement by the
p.000119: community. See Article 9.14 on how researchers may assist in capacity building.
p.000119: Although researchers shall offer the option of engagement, a community may choose to engage nominally or not at all,
p.000119: despite being willing to allow the research to proceed. A community may, for example, support a research project
p.000119: carried out
p.000119:
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p.000121: application, can provide contextual information and guidance for REBs conducting initial review of applications, and
p.000121: continuing research ethics review throughout the project. Researchers should check with their institutions regarding
p.000121: signing authority for research agreements (see Article 9.18).
p.000121: Building relationships, clarifying the goals of a project, and negotiating agreements requires substantial investment
p.000121: of time and resources on the part of the community and the researcher. Development and participation costs incurred by
p.000121: the community and the researcher should be factored into proposals to the extent possible within funding guidelines.
p.000121: Community agreement that a research project may proceed is not a substitute for securing the consent of individuals
p.000121: recruited to participate in that project, in accordance with Chapter 3. Consent of prospective
p.000121: participants shall precede collection of, or access to, data or human biological materials. Consistent with the
p.000121: provisions of Article 3.12, if signed written consent is not culturally appropriate, the researcher shall inform the
p.000121: REB of alternative processes employed for seeking and documenting consent.
p.000121: Consent shall be given in accordance with the research agreement where one exists. Where research agreements provide
p.000121: that community partners will have limited or full access to identifiable personal data, the consent of participants to
p.000121: this disclosure shall form part of the consent process. Access to confidential information provided by an individual is
p.000121: subject to privacy law.
p.000121: Researchers should be aware of the first language of Aboriginal participants and, if an Aboriginal language,
p.000121: researchers should make available translation by a knowledgeable person during the consent process, and
p.000121: during the conduct of research in accordance with the wishes of the participant (see Article 4.1).
p.000121: Researchers should be aware of the official status of Inuit languages in Inuit regions.
p.000121: Collaborative Research
p.000121: Article 9.12 As part of the community engagement process, researchers and communities should consider applying a
p.000121: collaborative and participatory approach as appropriate to the nature of the research, and the level of ongoing
p.000121: engagement desired by the community.
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p.000123: community-generated policies, programs, and services (see Article 9.8 and the Application of Article 9.11). Territorial
p.000123: and organizational communities and communities of interest may also seek to share in the benefits of research
p.000123: activities, which may include direct research grants, release time for project personnel, overhead levies on shared
p.000123: projects and commercializa- tion of research discoveries.
p.000123: Strengthening Research Capacity
p.000123: Article 9.14 Research projects should support capacity building through enhancement of the skills of community
p.000123: personnel in research methods, project management, and ethical review and oversight.
p.000123: Application Collaborative research approaches provide for reciprocal learning and for transfer of skills and
p.000123: knowledge between the community and the researcher. Researchers should foster education and training of community
p.000123: members to enhance their participation in research projects. Employing Aboriginal research assistants and
p.000123: translators is already common practice in community-based projects. Extending skills transfer through a program of
p.000123: training will support collaboration with institutions, and advance the capacity of communities to initiate and
p.000123: implement their own research. Collaborative research can also support building capacity of the research community to
p.000123: conduct culturally relevant research.
p.000123: Lack of engagement by communities may be due to inadequate financial or human resources. Communities vary widely in the
p.000123: level of human and material resources they have available to collaborate with research initiatives. Structural barriers
p.000123: may prevent access to, and participation in, research. For example, small, remote communities and many urban
p.000123: communities of interest have limited organizational resources to advise or collaborate in research. The least
p.000123: organizationally developed communities are the most vulnerable to exploitation. Research undertaken in these
p.000123: circumstances should strive to enhance capacity for participation.
p.000123: Funding programs that target the development of Aboriginal research and capacity building seek to generate
p.000123: significant research training opportunities. Funding criteria allow researchers to include in their grant
p.000123: applications stipends for
p.000123:
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p.000125: undergraduate, master’s or doctoral students, or post-doctoral researchers, as appropriate, with priority given
p.000125: to Aboriginal candidates. The time required to establish collaborative relationships may be difficult to
p.000125: accommodate in the programs of students. Mentorship by experienced researchers who introduce students to
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p.000129: information originate, prior to initiating secondary use where:
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p.000129: (a) secondary use has not been addressed in a research agreement and has not been authorized by the participants in
p.000129: their original individual consent; or
p.000129: (b) there is no research agreement; and
p.000129: (c) the data are not publicly available or legally accessible.
p.000129: Individual consent for the secondary use of identifiable information is required unless the REB agrees that either
p.000129: Articles 5.5 or 5.6, or Articles 12.3 or 12.4 may apply.
p.000129: Application Where the researcher can satisfy the REB that secondary use is consistent with an existing research
p.000129: agreement, the REB may require that the researcher engage the community from which the data or human biological
p.000129: materials and associated identifiable information originate – in accordance with the terms of the research agreement.
p.000129: New consent from individuals for secondary use is not required where the proposed secondary use is authorized by the
p.000129: REB in accordance with this Policy.
p.000129: Article 9.21 Where research relies only on publicly available information, or on legally accessible
p.000129: information as defined in Article 2.2, community engagement is not required. Where the information can be identified as
p.000129: originating from a specific community or a segment of the Aboriginal community at large, seeking culturally informed
p.000129: advice may assist in identifying risks and potential benefits for the source community.
p.000129: Application Research based only on publicly available information or legally accessible information as
p.000129: defined by this Policy, does not involve the collection of data from communities directly, or from living persons. As
p.000129: indicated in Chapter 2, REB review for this type of research is not required. Community engagement is not required.
p.000129: Examples are historical or genealogical research or statistical analysis.
p.000129: In these cases, researchers may not have any direct relationship with communities but their findings may, nevertheless,
p.000129: have an impact on the identity or heritage of persons or communities. In order to minimize any harm, researchers should
p.000129: seek culturally informed advice before the use of such data to determine if harms may result and if other
p.000129: considerations, such as sharing of the research results, should be explored with the original source community (see
p.000129: Article 9.15).
p.000129: Where access to publicly available information or legally accessible information leads to new research initiatives to
p.000129: collect additional information from identified communities or individuals, REB review is required. The provisions set
p.000129: out in Article 5.6 apply for new initiatives of this kind.
p.000129: Article 9.22 REB review is required where the researcher seeks data linkage of two or more anonymous datasets or
p.000129: data associated with human biological materials and there
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p.000131: is a reasonable prospect that this could generate information identifiable as originating from a specific
p.000131: Aboriginal community or a segment of the Aboriginal community at large.
p.000131: Application The REB may determine that community engagement is required to seek guidance on secondary use. Articles
p.000131: 5.5 and 5.6 or Articles 12.3 and 12.4 may apply.
p.000131: Consistent with Article 2.4, REB review is not required for research involving only anonymous datasets or anonymous
p.000131: human biological materials, and associated data, that cannot be identified as originating from a specific Aboriginal
p.000131: community or a segment of the Aboriginal community at large. Community engagement is not possible given that the data
p.000131: or human biological materials cannot be linked to a specific Aboriginal community or specific individuals. Where the
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General/Other / declaration of helsinki
Searching for indicator helsinki:
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p.000103: below), mainly in the area of health and biomedical research. It can serve as one re- source for identifying research
p.000103: ethics review bodies around the world.
p.000103:
p.000103: References
p.000103:
p.000103:
p.000103: • Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for
p.000103: Biomedical Research Involving Human Subjects. CIOMS: Geneva. 2002. www.cioms.ch/publications/layout_guide2002.pdf
p.000103: • Newfoundland and Labrador. Health Research Ethics Authority Act, S.N.L. 2006, c. H-1.2.
p.000103: http://assembly.nl.ca/Legislation/sr/statutes/h01-2.htm
p.000103: • Québec. Ministère de la Santé et des Services sociaux. Direction générale adjointe de l’évaluation, de la
p.000103: recherche et de l’innovation. Unité de l’éthique. Mécanisme encadrant l’examen éthique et le suivi continu des projets
p.000103: multicentriques. In effect since April 1, 2008. www.ethique.msss.gouv.qc.ca/site/fr_mecanismemulticentrique.phtml
p.000103: • U.S. Department of Health and Human Services. Office for Human Research Protections. International Compilation of
p.000103: Human Research Protections, 2010 Edition. www.hhs.gov/ohrp/international/HSPCompilation.pdf
p.000103: • ———. Federal-Wide Assurances Registry for Registered Organizations Operating Institutional Review Boards (IRBs)
p.000103: or Registered IRBs. ohrp.cit.nih.gov/search
p.000103: • World Medical Association. Declaration of Helsinki – Ethical Principles for Medical Research Involving Human
p.000103: Subjects. 2008. www.wma.net/en/30publications/10policies/b3/index.html
p.000103:
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p.000103: Chapter 9
p.000103: RESEARCH INVOLVING THE FIRST NATIONS, INUIT AND MÉTIS PEOPLES OF CANADA
p.000103:
p.000103: Introduction
p.000103: Preamble
p.000103: This chapter on research involving Aboriginal peoples in Canada, including Indian (First Nations1), Inuit and Métis
p.000103: peoples, marks a step toward establishing an ethical space for dialogue on common interests and points of difference
p.000103: between researchers and Aboriginal communities engaged in research.
p.000103: First Nations, Inuit and Métis communities have unique histories, cultures and traditions. They also share some core
p.000103: values such as reciprocity – the obligation to give something back in return for gifts received – which they advance as
p.000103: the necessary basis for relationships that can benefit both Aboriginal and research communities.
p.000103: Research involving Aboriginal peoples in Canada has been defined and carried out primarily by non-Aboriginal
p.000103: researchers. The approaches used have not generally reflected Aboriginal world views, and the research has not
p.000103: necessarily benefited Aboriginal peoples or communities. As a result, Aboriginal peoples continue to regard research,
p.000103: particularly research originating outside their communities, with a certain apprehension or mistrust.
p.000103: The landscape of research involving Aboriginal peoples is rapidly changing. Growing numbers of First Nations, Inuit and
p.000103: Métis scholars are contributing to research as academics and community researchers. Communities are becoming better
...
p.000167: the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. 1997.
p.000167: http://conventions.coe.int/Treaty/EN/Treaties/Html/164.htm
p.000167: • Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for
p.000167: Biomedical Research Involving Human Subjects. Geneva: 2002. www.cioms.ch/publications/layout_guide2002.pdf
p.000167: • Health Canada. Therapeutic Products Directorate. Medical Devices Bureau. Guidance documents.
p.000167: www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/index-eng.php
p.000167: • International Conference on Harmonisation. Guidance for Industry: Good Clinical Practice – Consolidated
p.000167: Guidelines, ICH Topic E6: Technical Requirements for the Registration of Pharmaceuticals for Human Use. 1996. Adopted
p.000167: by Health Canada in 1997.
p.000167: www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-eng.php
p.000167: • Ottawa Hospital Research Institute. Ottawa Statement on Trial Registration. http://ottawagroup.ohri.ca
p.000167: • United States. Food and Drug Administration. Food and Drug Administration Amendments Act of 2007. September 2007.
p.000167: • United States. National Institutes of Health. NIH Policy for Data and Safety Monitoring. Released 1998.
p.000167: www.grants.nih.gov/grants/guide/notice-files/not98-084.html
p.000167: • ———. Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials. Released 2000.
p.000167: www.grants.nih.gov/grants/guide/notice-files/not-od-00-038.html
p.000167: • World Medical Association. Declaration of Helsinki – Ethical Principles of Medical Research Involving Human
p.000167: Subjects. 2008. www.wma.net/en/30publications/10policies/b3/index.html
p.000167:
p.000167:
p.000167:
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p.000167:
p.000167:
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p.000167:
p.000167:
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p.000167:
p.000167:
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p.000167:
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p.000167:
p.000167:
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p.000167: Chapter 12
p.000167: HUMAN BIOLOGICAL MATERIALS INCLUDING MATERIALS RELATED TO HUMAN REPRODUCTION
p.000167:
p.000167: Introduction
p.000167: The use of materials originating from human bodies for research contributes greatly to the ad- vancement of knowledge.
p.000167: The sources of these materials can be from patients following diagnostic or therapeutic procedures, autopsy specimens,
p.000167: donations of organs or tissue from living or dead humans, body wastes (including urine, saliva, sweat) or abandoned
p.000167: tissue. Biological materials may also be sought from individuals for use in a specific research project. Once
p.000167: collected, biolog- ical materials may be held in biobanks to serve as a research resource for many years.
p.000167: Ethical considerations raised by research involving human biological materials centre on accept- able access to, and
p.000167: use of, the materials, potential privacy concerns arising from the handling of information derived from such materials,
p.000167: and the special status some individuals and groups accord to the human body and its parts. Because the significance of
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p.000151: therapy involved.
p.000151: REBs should be aware that trials involving psychotherapy may be more focused on effectiveness in real world conditions
p.000151: than on efficacy under tightly controlled conditions. For example, the research question may be how participants
p.000151: undergoing a particular therapy are functioning in their daily lives. The duration of these trials may be longer as a
p.000151: function of the therapeutic approach and the characteristics of the condition to which it is applied. Particular areas
p.000151: of concern are whether the principal investigator or others on the research team are sufficiently trained to provide
p.000151: the investigational therapy and whether there is any risk of a negative impact on participants’ mental health.
p.000151:
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p.000153:
p.000153: Issues of participant privacy and confidentiality may receive closer scrutiny in cases where people with specific
p.000153: psychological profiles are being recruited from the same institution as the researchers. Researchers shall indicate how
p.000153: recruitment, data collection and management, and compensation procedures have been designed to protect participant
p.000153: confidentiality (see Chapter 5).
p.000153: Surgical Trials
p.000153: Some of the issues surrounding the comparison of different surgical techniques are the appropriateness of the technique
p.000153: to the participants, whether the technique has been validated, whether the tools required have been approved for use in
p.000153: Canada, how well the experimental procedures have been explained to prospective participants, and whether it is
p.000153: appropriate to employ a control group that undergoes sham surgeries. When there is a crossover from medical to surgical
p.000153: treatment it can be difficult to assess whether participants’ health outcomes were due to the surgical intervention.
p.000153: The risk of subjecting participants to a potentially scientifically inconclusive trial needs to be weighed
p.000153: against the risk of subjecting them to a potentially harmful placebo intervention.
p.000153: REBs should be aware that it is possible that the principal investigators of surgical clinical trials need not,
p.000153: themselves, be a surgeon or technician trained in the procedure. For example, a biomechanical engineer who has
p.000153: developed a new type of skin graft material to aid in surgical repair, may conduct a surgical clinical trial, with the
p.000153: assistance of a surgical team, to compare the new material with an existing material.
p.000153:
p.000153: Placebo-Controlled Trials
p.000153: A clinical trial in which one or more intervention arms are compared with a placebo control group raises specific
p.000153: ethical issues. Where there is an established effective treatment, use of a placebo may deprive participants of needed
p.000153: therapy. It is the responsibility of the researcher or sponsor to provide justification to the REB for the choice of a
p.000153: placebo control group, as opposed to the other possible choices of control group (e.g., active control,
p.000153: wait-list control, dose-response and combination therapies). The following article sets out criteria for the use of
p.000153: a placebo control group to ensure that this type of clinical trial design is used only in situations
p.000153: that do not compromise the safety and welfare of participants.
p.000153: Article 11.2 (a) A new therapy or intervention should generally be tested against an established effective therapy.
p.000153: (b) As with all alternative choices of a control, a placebo control is ethically acceptable in a randomized controlled
p.000153: clinical trial only if:
p.000153: • its use is scientifically and methodologically sound in establishing the efficacy or safety of the test therapy or
p.000153: intervention; and
p.000153: • it does not compromise the safety or health of participants; and
p.000153:
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p.000153: • the researcher articulates to the REB a compelling scientific justification for the use of the placebo control.
p.000153: (c) For clinical trials involving a placebo control, the researcher and the REB shall ensure the general principles of
p.000153: consent are respected and that participants or their authorized third parties are specifically informed (see Article
p.000153: 3.2):
p.000153: • about any therapy that will be withdrawn or withheld for purposes of the research; and
p.000153: • of the anticipated consequences of withdrawing or withholding the therapy.
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p.000193: policies/guidance as “subject” or “research subject.”
p.000193:
p.000193: Participatory research – Research that includes the active involvement of those who are the subject of the research.
p.000193: Participatory research is usually action-oriented, where those involved in the research process collaborate to define
p.000193: the research project, collect and analyze the data, produce a final product and act on the results. See
p.000193: “Community-based research” and “Collaborative research.”
p.000193:
p.000193: Principal investigator – The leader of a research team who is responsible for the conduct of the research, and for the
p.000193: actions of any member of the research team.
p.000193:
p.000193:
p.000193:
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p.000193:
p.000193: Glossary
p.000193:
p.000193: Personal information – Identifiable information about an individual. See “Identifiable information.”
p.000193: Pharmaceutical trial – A clinical trial designed to test the safety and/or efficacy of a pharmaceutical product.
p.000193: A pharmaceutical product is any chemical substance intended for use in the medical diagnosis, cure, treatment, or
p.000193: prevention of disease, disorders, or other illness.
p.000193: Placebo-controlled trials – A clinical trial in which the safety or efficacy of one or more interventions are compared
p.000193: with a placebo control group.
p.000193: A placebo is an inactive substance or intervention that resembles the comparable active substance or intervention.
p.000193:
p.000193: Privacy – An individual’s right to be free from intrusion or interference by others.
p.000193:
p.000193: Privacy risks – The potential harms that participants, or the groups to which they belong, may experience from the
p.000193: collection, use, and disclosure of personal information for research purposes.
p.000193:
p.000193: Proportionate approach to research ethics review – The assessment of foreseeable risk to determine the level of
p.000193: scrutiny a research proposal will receive (i.e. delegated review for minimal risk research or full REB review for
p.000193: research above minimal risk), as well as the consideration of foreseeable risks, potential benefits, and ethical
p.000193: implications of the research in the context of initial and continuing review.
p.000193:
p.000193: Psychotherapy trials – A clinical trial testing the safety and/or efficacy of one or more psychotherapeutic approaches
p.000193: to behavioural disorders or other mental illness.
p.000193:
p.000193: Publicly declared emergency – An emergency situation which, due to the extraordinary risks it presents, has been
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p.000147: majority of clinical trials are classified as above minimal risk, and are reviewed accordingly. This is consistent with
p.000147: the principle of Concern for Welfare.
p.000147: As discussed in Chapter 2, Section B, the evaluation of possible harms that participants may experience due to their
p.000147: involvement in research is of primary importance. The magnitude and probability of these harms are described as
p.000147: foreseeable risks. In keeping with the principle of Respect for Persons, it is the responsibility of researchers to
p.000147: clearly describe all foreseeable risks and potential benefits of their research to prospective participants in the
p.000147: consent process (see Articles 11.4 and 11.5). It is the responsibility of the REB to weigh the foreseeable risks to
p.000147: participants against the potential benefits of the trial in the context of a proportionate approach to research ethics
p.000147: review, and to discuss with the researcher additional ways to eliminate or minimize risks.
p.000147:
p.000147: Clinical Equipoise
p.000147: In trials where participants are randomly assigned to different groups (e.g., treatment A; treatment B; no treatment),
p.000147: ethical issues relevant to the principle of Justice arise when one group may fare better or worse than another (see
p.000147: Article 11.2 on placebo-controlled clinical trials). For this reason, clinical equipoise may be considered as a
p.000147: starting point for the design and review of clinical trials. Clinical equipoise means a genuine uncertainty exists on
p.000147: the part of the relevant expert community about what therapy or therapies are most effective for a given
p.000147: condition. This uncertainty necessitates the conduct of research to determine the comparative therapeutic merits of
p.000147: existing interventions (not all of which may be represented in a given clinical trial). Clinical equipoise provides a
p.000147: link between the duty of care of a clinician with the need to do research to ensure that the therapies or interventions
p.000147: offered are demonstrably safe and effective.
p.000147:
p.000147: Duty of Care, Therapeutic Misconception and Dual Roles
p.000147: Because clinical trials often involve clinicians and patients who have become participants, the related issues of
p.000147: duty of care, therapeutic misconception and dual roles must be carefully considered at the design and conduct
p.000147: stages by researchers, and at the review stage by REBs.
p.000147: Duty of Care
p.000147: The duty of care in a medical context is the obligation of clinicians to act in the best interests of patients. In the
p.000147: context of clinical trials, researchers are concerned with the welfare of individual
p.000147:
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p.000147:
p.000147: participants, but are also focused on the generation of new knowledge that may or may not confer direct benefits on
p.000147: participants. Nevertheless, researchers do have a duty of care to ensure that the foreseeable risks to participants are
...
p.000149: circumstances may affect the perceptions of patients and their families as to the balance between the risks and
p.000149: potential benefits of the trial and thus may affect their decision whether to participate. Additionally,
p.000149: because participants in phase II trials may include patients who are unwell and frequently not working, the REB should
p.000149: ensure incentives for participation is not coercive, and patients do not accept risks they would otherwise
p.000149: refuse because of the incentives being offered. Researchers should be encouraged to consult with the REB at an early
p.000149: stage about any recruiting, consent or safety issues that arise.
p.000149: During the course of a phase II clinical trial, patients will have access to a new drug that may be efficacious
p.000149: (provide clinical benefit). Researchers shall: a) as part of the consent process, provide details on access to
p.000149: the new drug upon trial completion; and b) make reasonable efforts to secure continued access to the drug following
p.000149: the phase II trial, for those patients for whom the drugs appear to be efficacious.
p.000149: Phase III
p.000149: The REB should carefully examine phase III clinical trials to ensure that the care of patient-participants is not
p.000149: compromised in the random assignment to any arm of the trial (including the placebo arm – see Article 11.2).
p.000149: Researchers should also provide a plan for interim analysis of data, early unblinding of clinicians and/or patients,
p.000149: and/or ending the trial if the drug should prove effective or harmful. The REB should evaluate such plans with due
p.000149: consideration for the welfare of the participants and the group which is the focus of the research (see Article 3.2
p.000149: [l]).
p.000149: Researchers and the REB should also address the issue of continuing access to the experimental therapy after the trial
p.000149: closes. If the treatment benefits participants
p.000149:
p.000149:
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p.000151: and is safe, the proposal should state whether it will continue to be provided and under what conditions. REBs should
p.000151: be concerned about what provisions are possible to ensure that participants continue to receive adequate treatment.
p.000151: Phase IV
p.000151: Phase IV trials can be valuable for assessing the long-term safety and effectiveness of marketed drugs and devices.
p.000151: Earlier-stage trials are of limited duration, and subsequent research can identify side effects, toxicities, drug
p.000151: interactions and overall tolerance that may only emerge over time. However, in some cases, phase IV trials may be
p.000151: designed to serve primarily as marketing initiatives to encourage the prescription and continued use of an approved
p.000151: drug. For example, a clinician may be paid a per capita fee by a sponsor to collect data on the side effects and
...
p.000151: the investigational therapy and whether there is any risk of a negative impact on participants’ mental health.
p.000151:
p.000151:
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p.000153:
p.000153: Issues of participant privacy and confidentiality may receive closer scrutiny in cases where people with specific
p.000153: psychological profiles are being recruited from the same institution as the researchers. Researchers shall indicate how
p.000153: recruitment, data collection and management, and compensation procedures have been designed to protect participant
p.000153: confidentiality (see Chapter 5).
p.000153: Surgical Trials
p.000153: Some of the issues surrounding the comparison of different surgical techniques are the appropriateness of the technique
p.000153: to the participants, whether the technique has been validated, whether the tools required have been approved for use in
p.000153: Canada, how well the experimental procedures have been explained to prospective participants, and whether it is
p.000153: appropriate to employ a control group that undergoes sham surgeries. When there is a crossover from medical to surgical
p.000153: treatment it can be difficult to assess whether participants’ health outcomes were due to the surgical intervention.
p.000153: The risk of subjecting participants to a potentially scientifically inconclusive trial needs to be weighed
p.000153: against the risk of subjecting them to a potentially harmful placebo intervention.
p.000153: REBs should be aware that it is possible that the principal investigators of surgical clinical trials need not,
p.000153: themselves, be a surgeon or technician trained in the procedure. For example, a biomechanical engineer who has
p.000153: developed a new type of skin graft material to aid in surgical repair, may conduct a surgical clinical trial, with the
p.000153: assistance of a surgical team, to compare the new material with an existing material.
p.000153:
p.000153: Placebo-Controlled Trials
p.000153: A clinical trial in which one or more intervention arms are compared with a placebo control group raises specific
p.000153: ethical issues. Where there is an established effective treatment, use of a placebo may deprive participants of needed
p.000153: therapy. It is the responsibility of the researcher or sponsor to provide justification to the REB for the choice of a
p.000153: placebo control group, as opposed to the other possible choices of control group (e.g., active control,
p.000153: wait-list control, dose-response and combination therapies). The following article sets out criteria for the use of
p.000153: a placebo control group to ensure that this type of clinical trial design is used only in situations
p.000153: that do not compromise the safety and welfare of participants.
p.000153: Article 11.2 (a) A new therapy or intervention should generally be tested against an established effective therapy.
p.000153: (b) As with all alternative choices of a control, a placebo control is ethically acceptable in a randomized controlled
p.000153: clinical trial only if:
p.000153: • its use is scientifically and methodologically sound in establishing the efficacy or safety of the test therapy or
p.000153: intervention; and
p.000153: • it does not compromise the safety or health of participants; and
p.000153:
p.000153:
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p.000153:
p.000153: • the researcher articulates to the REB a compelling scientific justification for the use of the placebo control.
p.000153: (c) For clinical trials involving a placebo control, the researcher and the REB shall ensure the general principles of
p.000153: consent are respected and that participants or their authorized third parties are specifically informed (see Article
p.000153: 3.2):
p.000153: • about any therapy that will be withdrawn or withheld for purposes of the research; and
p.000153: • of the anticipated consequences of withdrawing or withholding the therapy.
p.000153: Application All clinical trials involve risk to participants. For all approved trials: a) the welfare of the
p.000153: participants needs to be upheld under the specific conditions of the trial; and
p.000153: b) the trial needs to be scientifically sound. Risks to the safety of participants can come from lack of efficacy or
p.000153: from undesirable side effects. These risks must be assessed for each treatment arm, including the experimental and
p.000153: control arm(s). The choice of control arm, which may range from currently approved treatments to placebo, placebo
p.000153: add-on, or no treatment, should, like all research, meet an acceptable risk-benefit ratio. As with other aspects of the
p.000153: trial design, the choice of control arm must be justified based on scientific, medical and methodological reasons.
p.000153: According to Article 11.2, researchers should consider a proven effective therapy as control if one is available. The
p.000153: implications of various choices of trial design directly affect the interpretability of trial results, and a trial that
p.000153: cannot return useful information is by definition not ethical. Good science is a necessary albeit
p.000153: insufficient condition for good ethics. To properly assess the ethics of placebo- controlled superiority design vs.
p.000153: active controlled non-inferiority design, an appreciation of the interplay of ethics and science is required (see
p.000153: Article 2.7). Conditions that work against carrying out a non-inferiority trial successfully include low
p.000153: and/or variable response to treatment, and high placebo response. The researcher must provide adequate justification
p.000153: for the use of a non-inferiority design.
p.000153: Participants in the test arm of a trial of a new therapy are not receiving proven effective therapy. Risks to the
p.000153: safety of participants can come from lack of efficacy or from undesirable side effects. These risks should be assessed
p.000153: for each treatment arm, including the experimental and control arm(s).
p.000153: The use of an active treatment comparator in a clinical trial of a new therapy is generally the appropriate trial
p.000153: design when an established effective therapy exists for the population and clinical indication under study.
p.000153: Great care should be taken to avoid abuse of placebo comparators. However, they are acceptable in any of the following
p.000153: situations:
p.000153:
p.000153:
p.000153:
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p.000155:
p.000155: 1) there are no established effective therapies for the population or for the indication under study;
p.000155: 2) existing evidence raises substantial doubt within the relevant expert community regarding the net therapeutic
p.000155: benefit of available therapies;
p.000155: 3) patients are resistant to the available therapies by virtue of their past treatment history or known medical
p.000155: history;
p.000155: 4) the trial involves adding a new investigational therapy to established effective therapies: established
p.000155: effective therapy plus new therapy vs. established effective therapy plus placebo;
p.000155: 5) patients have provided an informed refusal of established effective therapy, and withholding such therapy will not
p.000155: cause serious or irreversible harm.
p.000155: The determination of response satisfaction and refusal of treatment must take place outside the context of recruitment
p.000155: for the clinical trial and prior to offering trial participation to the prospective participant, and both must be
p.000155: documented.1
p.000155: The use of a placebo comparator in situation (5) is permitted because prospective trial participants are not using
p.000155: established therapies and therefore are not benefiting from therapy. For that reason, such participants would not be
p.000155: further disadvantaged if enrolled in a placebo-controlled trial than participants in a trial for whom there are no
p.000155: established effective therapies for the indication under study. Research proposals submitted to REBs shall include
p.000155: sufficient support and justification of the trial design and use of placebo comparator.
p.000155:
p.000155: Clinical Trial Registration
p.000155: There are compelling ethical reasons for the registration of all clinical trials. Registration improves researchers’
p.000155: awareness of similar trials so that they may avoid unnecessary duplication and thereby reduce the burden on
p.000155: participants. Registration also improves researchers’ ability to identify potential collaborators and/or gaps in
p.000155: research so that they may pursue new avenues of inquiry with potential benefits to participants and to society. Perhaps
p.000155: of most concern is the danger that some researchers or sponsors may only report trials with favourable outcomes.
p.000155: Failing to report the outcome of a trial or withholding negative findings is more difficult when all trials must be
p.000155: registered.
p.000155: The registration of clinical trials upholds the principles of Respect for Persons, Concern for Welfare, and Justice,
p.000155: by ensuring that the efforts of all participants in clinical trials are acknowledged, and by reducing the
p.000155: potential for endangerment of others through publication bias.
p.000155: Article 11.3 All clinical trials shall be registered before recruitment of the first trial participant in a
p.000155: recognized and easily web-accessible public registry.
p.000155: Application Clinical trial registries are intended to increase transparency and accountability by providing a
p.000155: record of clinical trials at the recruitment stage that can be used to locate publication of trial results (see Article
p.000155: 11.12). This helps prevent publication
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p.000165: the latter process, the review of contracts should be conducted in a manner that: (1) conforms to the special ethical
p.000165: duties, mandate and purposes of REB review; and (2) consults with the REB when necessary.
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
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p.000165: In the review process, the onus to justify restrictions on dissemination or access to data should lie with the one
p.000165: seeking such restriction, usually the researcher or sponsor. The reasonableness of restrictions on either the content
p.000165: or timing of dissemination should be measured against the written institutional policies. For example, some existing
p.000165: institutional policies deem unacceptable any publication restrictions that exceed a time limit of three to six months
p.000165: after the close of the trial. Such policies should also address restrictions on the dissemination of
p.000165: particular kinds of information, such as information that may be considered proprietary or trade secrets.
p.000165: Restrictions on information that participants would reasonably consider relevant to their welfare (see Articles 11.7
p.000165: and 11.8), or that are required to give appropriate context to a manuscript or other publication, are seldom, if ever,
p.000165: justified.
p.000165:
p.000165:
p.000165: Endnotes
p.000165:
p.000165:
p.000165: 1 These conditions are drawn from the recommendations of the Final Report of the National Placebo Working Committee on
p.000165: the Appropriate Use of Placebos in Clinical Trials in Canada (July 2004), with minor amendments approved by the
p.000165: Canadian Institutes of Health Research (CIHR) Standing Committee on Ethics. www.cihr-irsc.gc.ca/e/25139.html
p.000165: 2 World Health Organizations standards, International Clinical Trials Registry Platform. www.who.int/ictrp/en
p.000165: 3 International Committee of Medical Journal Editors, Sponsorship, Authorship, and Accountability
p.000165: (August 2007). www.icmje.org/update_sponsor.html
p.000165: 4 CONSORT Statement: www.consort-statement.org/consort-statement (accessed April 19, 2010).
p.000165:
p.000165: References
p.000165:
p.000165:
p.000165: • Canada. Food and Drugs Act. Natural Health Products Regulations, Part 4: Clinical Trials Involving Human Subjects
p.000165: (SOR/2003-196) 5 June 2003. gazette.gc.ca/archives/p2/2003/2003-06-18/html/sor-dors196-eng.html
p.000165: • Canadian Institutes of Health Research. “Policy on Access to Research Outputs.” September 2007.
p.000165: www.cihr-irsc.gc.ca/e/34846.html
p.000165: • Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social
p.000165: Sciences and Humanities Research Council of Canada, Access to Research Results: Guiding Principles.
p.000165: www.science.gc.ca/default.asp?Lang=En&n=9990CB6B-1
p.000165: • Consolidated Standards of Reporting Trials: CONSORT Statement, and Explanation and Elaboration document.
p.000165: www.consort-statement.org
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165:
p.000165: TCPS 2
p.000165:
p.000167: 167
p.000167:
...
p.000193: in epidemiological research.
p.000193:
p.000193: Ongoing research – Research that has received REB approval and has not yet been completed.
p.000193:
p.000193: Participant – An individual whose data, or responses to interventions, stimuli, or questions by a researcher are
p.000193: relevant to answering a research question; also referred to as “human participant,” and in other
p.000193: policies/guidance as “subject” or “research subject.”
p.000193:
p.000193: Participatory research – Research that includes the active involvement of those who are the subject of the research.
p.000193: Participatory research is usually action-oriented, where those involved in the research process collaborate to define
p.000193: the research project, collect and analyze the data, produce a final product and act on the results. See
p.000193: “Community-based research” and “Collaborative research.”
p.000193:
p.000193: Principal investigator – The leader of a research team who is responsible for the conduct of the research, and for the
p.000193: actions of any member of the research team.
p.000193:
p.000193:
p.000193:
p.000193:
p.000193: 194 TCPS 2
p.000193:
p.000193: Glossary
p.000193:
p.000193: Personal information – Identifiable information about an individual. See “Identifiable information.”
p.000193: Pharmaceutical trial – A clinical trial designed to test the safety and/or efficacy of a pharmaceutical product.
p.000193: A pharmaceutical product is any chemical substance intended for use in the medical diagnosis, cure, treatment, or
p.000193: prevention of disease, disorders, or other illness.
p.000193: Placebo-controlled trials – A clinical trial in which the safety or efficacy of one or more interventions are compared
p.000193: with a placebo control group.
p.000193: A placebo is an inactive substance or intervention that resembles the comparable active substance or intervention.
p.000193:
p.000193: Privacy – An individual’s right to be free from intrusion or interference by others.
p.000193:
p.000193: Privacy risks – The potential harms that participants, or the groups to which they belong, may experience from the
p.000193: collection, use, and disclosure of personal information for research purposes.
p.000193:
p.000193: Proportionate approach to research ethics review – The assessment of foreseeable risk to determine the level of
p.000193: scrutiny a research proposal will receive (i.e. delegated review for minimal risk research or full REB review for
p.000193: research above minimal risk), as well as the consideration of foreseeable risks, potential benefits, and ethical
p.000193: implications of the research in the context of initial and continuing review.
p.000193:
p.000193: Psychotherapy trials – A clinical trial testing the safety and/or efficacy of one or more psychotherapeutic approaches
p.000193: to behavioural disorders or other mental illness.
p.000193:
p.000193: Publicly declared emergency – An emergency situation which, due to the extraordinary risks it presents, has been
p.000193: proclaimed as such by an authorized public office (in accordance with legislation and/or public policy). Publicly
...
p.000197: Agencies, 5 Anonymity
p.000197: anonymized human biological materials, 170 anonymized information, 57
p.000197: anonymous human biological materials, 19, 131-132, 170
p.000197: anonymous information, 19, 57, 131-132
p.000197:
p.000197:
p.000197: TCPS 2
p.000199: 199
p.000199:
p.000199: Index
p.000199:
p.000199: Appeals, 83-85
p.000199: Assisted human reproduction (see Human reproduction, materials related to) Authorized third parties, 27, 41-44
p.000199: Autonomy, 8-9, 27, 40
p.000199:
p.000199: B
p.000199: Benefits, research
p.000199: equitable distribution, 10, 53
p.000199: mutual, 124-125
p.000199: and risk, 10, 11, 22-25, 41-42, 51, 157-158
p.000199: Biobanks, 175-176, 186
p.000199: Biological materials (see Human biological materials)
p.000199:
p.000199: C
p.000199: Canadian Charter of Rights and Freedoms, 12, 55 Capacity
p.000199: definition, 40-41
p.000199: diminished, 10, 41
p.000199: lack of, 9, 27, 39, 40-44, 47, 49-52, 171, 185, 187
p.000199: regaining, 39, 41, 43
p.000199: Children, 10, 34, 41-42, 47, 49-50, 51, 185, 187
p.000199: Chimeras, 179
p.000199: Clinical equipoise, 148 Clinical trials
p.000199: budgets, 164
p.000199: conflicts of interest, 163-164 consent, 155, 158-159, 161-163
p.000199: definition, 147
p.000199: design, 149-156
p.000199: dissemination of outcomes, 164-167 duty of care, 148-149
p.000199: medical device trials, 153 natural health product trials, 152 pharmaceutical trials, 150-152
p.000199: phases of pharmaceutical trials, 150-152 placebo-controlled trials, 154-156
p.000199: psychotherapy trials, 153
p.000199: registration, 149, 156-157
p.000199: reporting new information, 159-163 risk, 148, 157-159
p.000199: safety, 150, 157, 159-163
p.000199: surgical trials, 154
p.000199: therapeutic misconception, 148, 149, 158-159
p.000199: types, 149-156
p.000199: Coercion, 29
p.000199: Collaborative research, 123-124, 125-126, 128
p.000199:
p.000199:
p.000199:
p.000199: 200 TCPS 2
p.000199:
p.000199: Index
p.000199:
p.000199: Communities
p.000199: Aboriginal, 107-108, 109
p.000199: and genetic research, 181, 183-184, 185
p.000199: Compensation
p.000199: and consent, 29, 31, 33
p.000199: for research ethics board members, 94 Concern for Welfare, 8, 9-10, 109 Confidentiality (see Privacy and
p.000199: confidentiality)
p.000199: Conflicts of interest
p.000199: clinical trials, 163-164
p.000199: definition, 89
p.000199: dual roles, 95, 149, 158
p.000199: financial, 95-96, 163-164
p.000199: incentives, 29-30, 52, 151, 164
p.000199: institutional, 89-90, 91-93
p.000199: research ethics board members, 69, 70-71, 78, 90, 93-94
p.000199: researchers, 91, 94-96
p.000199: Consent
p.000199: Aboriginal peoples, 109, 119, 123, 131
p.000199: alteration, 37-39
p.000199: authorized third parties, 27, 41-44 capacity to (see Capacity)
p.000199: clinical trials, 155, 158-159, 161-163
...
General/Other / tri-council policy statement
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p.002010: TCPS2
p.002010:
p.002010:
p.002010:
p.002010: TRI-COUNCIL POLICY STATEMENT
p.002010:
p.002010: Ethical Conduct for Research Involving Humans
p.002010: 2010
p.002010:
p.002010: Canadian Institutes of Health Research
p.002010: Natural Sciences and Engineering Research Council of Canada Social Sciences and Humanities Research Council of Canada
p.002010:
p.002010:
p.002010:
p.002010:
p.002010: Please cite this document as follows:
p.002010:
p.002010: Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social
p.002010: Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for Research
p.002010: Involving Humans, December 2010.
p.002010:
p.002010: Note: For the most recent information on amendments, please consult the official online version of the TCPS at
p.002010: www.pre.ethics.gc.ca.
p.002010:
p.002010: Permission is granted to photocopy this material.
p.002010:
p.002010: © Her Majesty the Queen in Right of Canada (2010) Catalogue No: MR21-18/2010E-PDF
p.002010: ISBN 978-1-100-17237-81
p.002010:
p.002010:
p.002010:
p.002010: Table of Contents
p.002010: Acknowledgements
p.000001: 1
p.000001: INTRODUCTION
p.000005: 5
p.000005: Mandate of the Agencies 5
p.000005: Compliance with the Policy 5
p.000005: Chapter 1
p.000007: 7
p.000007: ETHICS FRAMEWORK
p.000007: 7
p.000007: A. Importance of Research and Research Ethics 7
p.000007: B. Core Principles 8
p.000007: C. How to Apply This Policy 11
p.000007: Chapter 2
p.000015: 15
p.000015: SCOPE AND APPROACH
p.000015: 15
p.000015: Introduction 15
p.000015: A. Scope of Research Ethics Review 15
p.000015: B. Approach to Research Ethics Board Review 22
p.000015: Chapter 3
...
p.000169: Chapter 13
p.000181: 181
p.000181: HUMAN GENETIC RESEARCH
p.000181: 181
p.000181: Introduction 181
p.000181: A. Application of Core Principles to Genetic Research 181
p.000181: B. Plans for Managing Information Revealed through Genetic Research 182
p.000181: C. Genetic Counselling 184
p.000181: D. Genetic Research Involving Families 184
p.000181: E. Genetic Research Involving Communities and Groups 185
p.000181: F. Genetic Material Banks 186
p.000181: G. Gene Transfer 186
p.000181: Glossary
p.000189: 189
p.000189: Index
p.000199: 199
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
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p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: iii
p.000199:
p.000199:
p.000199:
p.000199: Acknowledgements
p.000199: In August 2010, in accordance with its mandate, the Interagency Advisory Panel on Research Ethics (the Panel) submitted
p.000199: its final version of the 2nd edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans
p.000199: (TCPS 2) to the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of
p.000199: Canada (NSERC) and the Social Sciences and Humanities Research Council of Canada (SSHRC), or “the Agencies,” and
p.000199: recommended the Policy’s adoption. The Agencies approved this 2nd edition of the TCPS, which incorporates the changes
p.000199: they deemed appropriate.
p.000199: The Panel’s final version is a collaborative work. Over a period of almost three years, the TCPS was drafted and
p.000199: refined by the Panel and the Secretariat on Research Ethics (the Secretariat). The Policy has benefited from extensive
p.000199: public consultations with, and constructive criticism from, the research community of Canada. It would be impossible to
p.000199: individually thank the hundreds of people who have contributed to the revision process that has produced this Policy.
p.000199: But we would be remiss not to give credit to those volunteers and staff who have devoted countless hours of their
p.000199: attention and concern to develop this document that enhances the ethical conduct of research in Canada – and perhaps
p.000199: beyond.
p.000199: The conception and refinement of the TCPS was carried out by the current and recent members of the Panel and
p.000199: Secretariat, led by Susan Zimmerman, Executive Director of the Secretariat. The enormity of the task they faced was
p.000199: matched by their dedication and tireless commitment to the vigorous collegial process. They warrant special
p.000199: acknowledgement for their efforts.
p.000199: The development of this document has been a long process. The groundwork was laid by the first generation of Panel and
...
p.000199: Reading; Nicole St-Onge; Jolene Saulis; Brian Schnarch; Christine Trauttmansdorff; Andrea Williams;
p.000199: Saga Williams; Erin Wolski; Deborah Wright; Nancy Zukewitch
p.000199:
p.000199: Interagency Advisory Panel on Research Ethics – Technical Advisory Committee on Aboriginal Research (PRE-TACAR)
p.000199: Kelly Bannister; Marlene Brant Castellano; Caroline Desbiens; Brenda Elias; Willie J. Ermine; Minnie Gray; Eduardo
p.000199: Jovel; Carrielynn Lund; Roger Maaka; Ted Palys; Gail Valaskakis
p.000199:
p.000199: Subgroup on Procedural Issues for the TCPS (ProGroup)
p.000199: Judith Abbott; Chantal Beauvais; Michel Bergeron; Howard Brunt; Michael Enzle; Susan Hoddinott; Bernard Keating;
p.000199: Raymond Martineau; Patrick O’Neill; Heather Sampson; Janice Singer; Susan Sykes
p.000199:
p.000199: Social Sciences and Humanities Research Ethics Special Working Committee (SSHWC)
p.000199: Mary Blackstone; Lisa Given; Glenn Griener; Bernard Keating; Joseph Josy Lévy; Michelle McGinn; Kathleen Oberle;
p.000199: Patrick O’Neill; Michael Owen; Ted Palys; Deborah Poff; Keren Rice; Will van den Hoonaard
p.000199:
p.000199: Stem Cell Working Group
p.000199: Bernard Dickens; Paul Johnston; Samuel K. Ludwin; Ian Mitchell
p.000199:
p.000199: Translation Committee
p.000199: Michel Bergeron, Joseph Josy Lévy, Isabelle Mondou
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 3
p.000199:
p.000199:
p.000199:
p.000199: INTRODUCTION
p.000199:
p.000199: The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS or the Policy) is a joint policy
p.000199: of Canada’s three federal research agencies – the Canadian Institutes of Health Research (CIHR), the Natural Sciences
p.000199: and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council of Canada
p.000199: (SSHRC), or “the Agencies.”
p.000199: This Policy expresses the Agencies’ continuing commitment to the people of Canada to promote the ethical conduct of
p.000199: research involving humans. It has been informed, in part, by leading inter- national ethics norms, all of which may
p.000199: help, in some measure, to guide Canadian researchers, in Canada and abroad, in the conduct of research involving
p.000199: humans.
p.000199: This edition represents the first substantive change to the Policy since its adoption in 1998. It is a major revision,
p.000199: reflecting over a decade of experience in the application of the Policy by the re- search community to existing and
p.000199: emerging ethical issues and new areas of research. It also distils the experience of the Interagency Advisory Panel on
p.000199: Research Ethics (PRE or the Panel), which was created in 2001 primarily to steward the evolution and interpretation of
p.000199: this Policy, and to provide the Agencies with independent advice on issues related to the ethics of research involving
p.000199: humans. This edition, which replaces the original TCPS, draws on the advice provided to the Panel by its working groups
p.000199: and committees. As well, it reflects the significant and valuable input from the research community and all those who
...
p.000199: harmed by research, sometimes even dying as a result. Ethical principles and guidelines play an important role in
p.000199: advancing the pursuit of knowledge while protecting and respecting research participants in order to try to prevent
p.000199: such occurrences.
p.000199: People have also been gratified and have had their lives enriched by their participation in research, either because
p.000199: they may have benefited directly or because their participation has contributed to
p.000199:
p.000199: TCPS 2 7
p.000199:
p.000199: Chapter 1 – Ethics Framework
p.000199:
p.000199: the expansion of knowledge. Given the fundamental importance of research and of human partic- ipation in research, we
p.000199: must do all that we can as a society to ensure that research is conducted in an ethical manner so as to build public
p.000199: confidence and trust. By promoting and guiding the ethical conduct of research involving humans, this Policy seeks to
p.000199: contribute tangibly to these goals.
p.000199: No single document can provide definitive answers to all ethical issues that may arise in an undertaking as complex as
p.000199: research involving humans. This Policy aims to assist those who use it
p.000199: – researchers, sponsors, members of research ethics boards (REBs), participants, and the public – to identify ethical
p.000199: issues in the design, conduct and oversight of research and to point the way to arriving at reasoned and ethical
p.000199: responses to these issues.
p.000199: B. Core Principles
p.000199: Respect for human dignity has been an underlying value of the Tri-Council Policy Statement: Eth- ical Conduct for
p.000199: Research Involving Humans (TCPS or the Policy) since its inception. Despite clear recognition of its centrality in
p.000199: research ethics, the term lends itself to a variety of definitions and interpretations that make it challenging to
p.000199: apply.
p.000199: Respect for human dignity requires that research involving humans be conducted in a manner that is sensitive to the
p.000199: inherent worth of all human beings and the respect and consideration that they are due. In this Policy, respect for
p.000199: human dignity is expressed through three core principles – Re- spect for Persons, Concern for Welfare, and Justice.
p.000199: These core principles transcend disciplinary boundaries and, therefore, are relevant to the full range of research
p.000199: covered by this Policy.1
p.000199: Article 1.1 The guidelines in this Policy are based on the following three core principles:
p.000199: • Respect for Persons
p.000199: • Concern for Welfare
p.000199: • Justice
p.000199: These principles are complementary and interdependent. How they apply and the weight accorded to each will depend on
p.000199: the nature and context of the research being undertaken. Specific applica- tions are addressed in the following
p.000199: chapters.
p.000199: Respect for Persons
p.000199: Respect for Persons recognizes the intrinsic value of human beings and the respect and consider- ation that they are
p.000199: due. It encompasses the treatment of persons involved in research directly as participants and those who are
...
p.000131: word “band” in the name of their community. See Indian and Northern Affairs Canada, Terminology, available at www.ainc-
p.000131: inac.gc.ca/ap/tln-eng.asp.
p.000131: 2 www.nserc-crsng.gc.ca/NSERC-CRSNG/Policies-Politiques/MOURoles-ProtocolRoles/index_eng.asp
p.000131: 3 Constitution Act, 1982, s. 35. http://laws.justice.gc.ca/en/const/9.html#anchorsc:7-bo-ga:l_II
p.000131: 4 www.wipce2008.com/enews/pdf/wipce_fact_sheet_21-10-07.pdf
p.000131:
p.000131: References
p.000131:
p.000131:
p.000131: • Canadian Institutes of Health Research. CIHR Guidelines for Health Research Involving Aboriginal People. May
p.000131: 2007. www.cihr-irsc.gc.ca/e/29134.html
p.000131: • ———. CIHR Best Practices for Protecting Privacy in Health Research. September 2005.
p.000131: www.cihr-irsc.gc.ca/e/29072.html
p.000131: • First Nations Centre. OCAP: Ownership, Control, Access and Possession. Sanctioned by the First Nations
p.000131: Information Governance Committee, Assembly of First Nations. Ottawa: National Aboriginal Health Organization
p.000131: www.naho.ca/english/pub_research.php
p.000131: • First Nations Regional Longitudinal Health Survey (RHS). www.rhs-ers.ca/english
p.000131:
p.000131:
p.000131:
p.000131:
p.000131: 132 TCPS 2
p.000131:
p.000131: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000131:
p.000131: • Interagency Advisory Panel on Research Ethics. Aboriginal Research Ethics Initiative. “Issues and Options for
p.000131: Revisions to the Tri-Council Policy Statement: Ethical Conduct of Research Involving Humans (TCPS): Section 6: Research
p.000131: Involving Aboriginal Peoples.” February 2008.
p.000131: www.pre.ethics.gc.ca/eng/archives/policy-politique/reports-rapports/riap-rapa/
p.000131: • Inuit Tapiriit Kanatami (ITK) and Nunavut Research Institute (NRI). Negotiating Research Relationships with Inuit
p.000131: Communities: A Guide for Researchers. Edited by Scot Nickels, Jamal Shirley and Gita Laidler. ITK and NRI: Ottawa and
p.000131: Iqaluit. www.itk.ca/publications/negotiating-research-relationships-inuit-communities-guide- researchers
p.000131: • Nipingit: National Inuit Committee on Ethics and Research, a joint program of the Inuit Tuttarvingat the National
p.000131: Aboriginal Health Organization and Inuit Tapiriit Kanatami, Research and Research Ethics Fact Sheets.
p.000131: www.naho.ca/inuit/e/ethics/factsheets.php
p.000131: • Royal Commission on Aboriginal Peoples. Report of the Royal Commission on Aboriginal Peoples. “Ethical Guidelines
p.000131: for Research.” In Volume 5, Renewal: A Twenty-Year Commitment, Ottawa: Canada Communications Group. 1996. It can also
p.000131: be accessed at www.ainc-inac.gc.ca/ap/rrc-eng.asp
p.000131: • United Nations Educational, Scientific and Cultural Organization. Universal Declaration on Bioethics and Human
p.000131: Rights. Adopted October 19, 2005, by the 33rd session of the General Conference of UNESCO. 2005.
p.000131: http://unesdoc.unesco.org/images/0014/001461/146180e.pdf
...
p.000143:
p.000143: Chapter 10 – Qualitative Research
p.000143:
p.000143: advance of data collection. Rather, REBs should ensure that the data collection is conducted according to
p.000143: methodological requirements, and acknowledge that questionnaires or interview guides may change to adapt to emerging
p.000143: data or circumstances in the field.
p.000143: In emergent design, some resulting changes to the research design will not merit requiring additional REB review, as
p.000143: they are not necessarily significant changes to the approved research. Consistent with Article 6.15, where changes of
p.000143: data collection procedures would represent a change in the level of the risk that may affect the welfare of the
p.000143: participants, researchers shall seek approval from the REB prior to implementing such changes. Additional REB review
p.000143: and approval may be required (see Chapter 2 and Articles 6.14 and 6.15).
p.000143:
p.000143: References
p.000143:
p.000143:
p.000143: • Canadian Institutes for Health Research. CIHR Best Practices for Protecting Privacy in Health Research. September
p.000143: 2005. www.cihr-irsc.gc.ca/e/29072.html
p.000143: • Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social
p.000143: Sciences and Humanities Research Council of Canada, Access to Research Results: Guiding Principles.
p.000143: www.science.gc.ca/default.asp?Lang=En&n=9990CB6B-1
p.000143: • Canadian Institutes for Health Research, Natural Sciences and Engineering Research Council of Canada, and Social
p.000143: Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: Integrity in Research and
p.000143: Scholarship.
p.000143: www.nserc-crsng.gc.ca/NSERC-CRSNG/Policies-Politiques/tpsintegrity-picintegritie_eng.asp
p.000143: • National Health and Medical Research Council (Australia), Australian Research Council and Australian
p.000143: Vice-Chancellors’ Committee. National Statement on Ethical Conduct in Human Research. 2007.
p.000143: www.nhmrc.gov.au/PUBLICATIONS/synopses/e72syn.htm
p.000143: • Social Sciences and Humanities Research Council of Canada. SSHRC Research Data Archiving Policy.
p.000143: www.sshrc-crsh.gc.ca/site/apply-demande/policies-politiques/edata- donnees_electroniques-eng.aspx
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143:
p.000143: TCPS 2
p.000145: 145
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145:
p.000145: Introduction
p.000145: Chapter 11
p.000145: CLINICAL TRIALS
p.000145:
p.000145: This chapter focuses on the ethical issues involved in the design, review and conduct of clinical trials (as defined
p.000145: below). In particular, it addresses clinical trial design, therapeutic misconception, research-attributable risk, and
p.000145: other issues that may be unique to clinical trials. As clinical trials are, perhaps, the most regulated type of
p.000145: research – subject to provincial, national and international regulatory bodies – reference will be made to these
p.000145: regulations, where appropriate. However, the emphasis in this chapter is on ethical guidance, grounded in the core
...
p.000185: transfer, and any processes for long-term follow-up of participants. Guidance regarding inclusion in research (see
p.000185: Chapter 4) should be followed where gene transfer research involves children, or others who lack capacity to consent
p.000185: for themselves.
p.000185:
p.000185:
p.000185: Endnotes
p.000185:
p.000185:
p.000185: 1 In 2008, the U.S. National Institutes of Health amended its policy on publication of and access to data from
p.000185: genome-wide association studies. See National Institutes of Health, Modifications to Genome-Wide Association Studies
p.000185: (GWAS) Data Access, August 28, 2008, http://grants.nih.gov/grants/gwas/data_sharing_policy_modifications_20080828.pdf
p.000185: 2 Assisted Human Reproduction Act (2004, c. 2). http://laws.justice.gc.ca/eng/A-13.4
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185:
p.000185: TCPS 2
p.000187: 187
p.000187:
p.000187:
p.000187:
p.000187: Glossary
p.000187:
p.000187: This glossary is intended to assist readers in their understanding of the Tri-Council Policy Statement: Ethical Conduct
p.000187: for Research Involving Humans (TCPS), also referred to as “the Policy.” Definitions that have been provided in the main
p.000187: text of the Policy are also repeated here. Additional terms are defined in accordance with the purposes of the Policy.
p.000187: For more detailed descriptions of many terms it is best to read them in the context of the chapters in which they
p.000187: appear – consult the Index for the appropriate reference.
p.000187:
p.000187: Aboriginal peoples – Persons of Indian (First Nations), Inuit, or Métis descent, regardless of where they reside and
p.000187: whether or not their names appear on an official register. In the international context, the term comparable to
p.000187: Aboriginal peoples is Indigenous peoples.
p.000187:
p.000187: Academic freedom – The collective freedom of faculty and students to conduct research, and to disseminate ideas or
p.000187: facts without religious, political, or institutional restrictions. It includes freedom of inquiry, freedom to challenge
p.000187: conventional thought, freedom to express one’s opinion about the institution, its administration, or the system in
p.000187: which one works, and freedom from institutional censorship.
p.000187:
p.000187: Ad hoc advisor – A person with relevant and competent knowledge and expertise consulted by a research ethics board for
p.000187: a specific research ethics review, and for the duration of that review. The ad hoc advisor is not a member of the
p.000187: research ethics board.
...
p.000106: official agreements, 98, 100
p.000106: research ethics review models, 99-101 review mechanisms, 97-101
p.000106:
p.000106: O
p.000106: Observational research, 18-19, 118, 141-143
p.000106:
p.000106: P
p.000106: Participants
p.000106: autonomy, 8-9, 27, 40 capacity (see Capacity)
p.000106: children, 10, 34, 41-42, 47, 49-50, 51, 185, 187
p.000106: confidentiality, 56, 58-60, 126-128, 143-144, 186
p.000106: definition, 16
p.000106: elderly, 10, 47, 50
p.000106: as members of research ethics boards, 72 perspective, 12, 23, 28, 72, 161
p.000106: privacy, 55-56, 58-60, 126-128, 143-144, 171-172, 186
p.000106: recruitment, 11, 28, 76-77, 110, 158-159, 164, 184-185
p.000106: removal from research, 31, 33, 160 as research partners, 138
p.000106: vulnerability, 9, 10, 23, 47, 52, 116, 137, 148
p.000106: withdrawal from research, 28-30, 31, 61, 140, 186
p.000106: women, 10, 47, 48-49, 116, 178-179
p.000106: Participatory research, 123-125
p.000106: Performance review, 20
p.000106:
p.000106:
p.000106: TCPS 2
p.000205: 205
p.000205:
p.000205: Index
p.000205:
p.000205: Pilot studies, 76-77, 139
p.000205: Pluripotent stem cells, 179
p.000205: Policy, the (see Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans) Principal investigators,
p.000205: 27, 99, 153-154, 159, 162, 165-166
p.000205: Principles (see Core principles) Privacy and confidentiality
p.000205: Aboriginal peoples, 126-128
p.000205: data linkage, 18, 19, 64-65, 131-132
p.000205: definition, 55-56
p.000205: ethical duty, 56, 58-60
p.000205: identifiability of information, 56-57
p.000205: participant, 55-56, 58-60, 126-128, 143-144, 171-172, 186
p.000205: qualitative research, 138, 143-144
p.000205: research involving Aboriginal peoples, 126-128 safeguarding information, 60-61
p.000205: security, 56, 60-61, 64-65
p.000205: (see also Secondary use of human biological materials; Secondary use of identifiable information)
p.000205: Program evaluation, 20
p.000205: Proportionate approach to research ethics review, 11, 22, 24-25, 77-79, 82, 148
p.000205: Publicly available information, 17-18, 64-65, 131 Publicly declared emergencies, 85-88
p.000205: exceptions during, 87-88
p.000205: preparedness plans, 85-86
p.000205: research ethics review during, 87-88
p.000205:
p.000205: Q
p.000205: Qualitative research
p.000205: confidentiality, 138, 143-144
p.000205: consent, 137-138, 140, 141-144
p.000205: data collection, 137, 144 dissemination of results, 143-144 emergent design, 144-145
p.000205: exploratory phase, 76-77, 139
p.000205: nature of, 135-138
p.000205: observational, 18-19, 118, 141-143
p.000205: privacy, 138, 143-144
p.000205: timing of research ethics review, 139 Quality assurance, 20
p.000205: Quality improvement, 20
p.000205:
p.000205: R
p.000205: Reimbursement, 29, 31, 33 Research
...
p.000207: research requiring, 15-17, 119-121 scholarly review and, 20-21 scope, 15-22
p.000207: timing, 15, 76, 139
p.000207: Research participants (see Participants)
p.000207: Researchers
p.000207: academic freedom, 7, 11
p.000207: conflicts of interest, 91, 94-96
p.000207: dual roles, 95, 149, 158
p.000207: multiple affiliations, 68, 97-101
p.000207: Respect for Persons, 8-9, 27, 109 Risk
p.000207: and benefits, 10, 11, 22-25, 41-42, 51, 157-158
p.000207: in clinical trials, 148, 157-159
p.000207: definition, 22-23
p.000207: minimal, 11, 23, 24-25, 37-39, 41, 51, 77-79
p.000207: to researchers, 25
p.000207:
p.000207:
p.000207: 208 TCPS 2
p.000207:
p.000207: Index
p.000207:
p.000207: S
p.000207: Scholarly review, 20-21
p.000207: Secondary use of human biological materials, 62-64, 119-121, 130-132, 172-175, 186 Secondary use of identifiable
p.000207: information
p.000207: Aboriginal peoples, 119-121, 130-132
p.000207: anonymous, 19
p.000207: consent, 62-64, 130-132
p.000207: definition, 19, 62
p.000207: genetic material, 186
p.000207: privacy, 62-64
p.000207: Security of information, 56, 60-61, 64-65 StemXcells
p.000207: Guidelines for Human Pluripotent Stem Cell Research, 179 pluripotent, 179
p.000207: Students, 25, 67-68, 77-79 Subjects (see Participants)
p.000207: T
p.000207: Therapeutic misconception, 148, 149, 158-159
p.000207: Third party consent (see Consent: authorized third parties) Trials (see Clinical trials)
p.000207: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) application, 11-13
p.000207: compliance with, 5-6
p.000207: interpretation, 13
p.000207:
p.000207: U
p.000207: Unanticipated issues, 22, 34, 81, 161-163
p.000207: Undue influence, 28-29
p.000207:
p.000207: V
p.000207: Vulnerability, 9, 10, 23, 47, 52, 116, 137, 148
p.000207:
p.000207: W
p.000207: Welfare (see Concern for Welfare)
p.000207: Withdrawal
p.000207: of consent, 28-30, 31
p.000207: of data, 28-30, 31
p.000207: of human biological materials, 28-30, 31, 172
p.000207: from research, 28-30, 31, 61, 140, 186
p.000207: Women
p.000207: as research participants, 10, 47, 48-49, 116, 178-179 pregnant, inclusion in research, 49
p.000207:
p.000207:
p.000207:
p.000207:
p.000207:
p.000207:
p.000207: TCPS 2
p.000209: 209
p.000209:
...
Orphaned Trigger Words
p.002010: Involving Humans, December 2010.
p.002010:
p.002010: Note: For the most recent information on amendments, please consult the official online version of the TCPS at
p.002010: www.pre.ethics.gc.ca.
p.002010:
p.002010: Permission is granted to photocopy this material.
p.002010:
p.002010: © Her Majesty the Queen in Right of Canada (2010) Catalogue No: MR21-18/2010E-PDF
p.002010: ISBN 978-1-100-17237-81
p.002010:
p.002010:
p.002010:
p.002010: Table of Contents
p.002010: Acknowledgements
p.000001: 1
p.000001: INTRODUCTION
p.000005: 5
p.000005: Mandate of the Agencies 5
p.000005: Compliance with the Policy 5
p.000005: Chapter 1
p.000007: 7
p.000007: ETHICS FRAMEWORK
p.000007: 7
p.000007: A. Importance of Research and Research Ethics 7
p.000007: B. Core Principles 8
p.000007: C. How to Apply This Policy 11
p.000007: Chapter 2
p.000015: 15
p.000015: SCOPE AND APPROACH
p.000015: 15
p.000015: Introduction 15
p.000015: A. Scope of Research Ethics Review 15
p.000015: B. Approach to Research Ethics Board Review 22
p.000015: Chapter 3
p.000027: 27
p.000027: THE CONSENT PROCESS
p.000027: 27
p.000027: Introduction 27
p.000027: A. General Principles 28
p.000027: B. Departures from General Principles of Consent 37
p.000027: C. Capacity 40
p.000027: D. Consent Shall Be Documented 44
p.000027: Chapter 4
p.000047: 47
p.000047: FAIRNESS AND EQUITY IN RESEARCH PARTICIPATION 47
p.000047: Introduction 47
p.000047: A. Appropriate Inclusion 48
p.000047: B. Inappropriate Exclusion 48
p.000047: Chapter 5
p.000055: 55
p.000055: PRIVACY AND CONFIDENTIALITY 55
p.000055: Introduction 55
p.000055: A. Key Concepts 55
p.000055: B. Ethical Duty of Confidentiality 58
p.000055: C. Safeguarding Information 60
p.000055: D. Consent and Secondary Use of Identifiable Information for
p.000055: Research Purposes 62
p.000055: E. Data Linkage. 64
p.000055: TCPS 2 i
p.000055:
p.000055: Chapter 6
p.000067: 67
p.000067: GOVERNANCE OF RESEARCH ETHICS REVIEW 67
...
p.000089: B. Institutions and Conflicts of Interest 91
p.000089: C. Research Ethics Board Members and Conflicts of Interest 93
p.000089: D. Researchers and Conflicts of Interest 94
p.000089: Chapter 8
p.000097: 97
p.000097: MULTI-JURISDICTIONAL RESEARCH 97
p.000097: Introduction 97
p.000097: A. Review Mechanisms for Research Involving Multiple Institutions and/or Multiple Research Ethics Boards
p.000097: 97
p.000097: B. Review of Research Conducted outside the Institution 101
p.000097: Chapter 9
p.000105: 105
p.000105: RESEARCH INVOLVING THE FIRST NATIONS, INUIT AND
p.000105: MÉTIS PEOPLES OF CANADA
p.000105: 105
p.000105: Introduction 105
p.000105: A. Key Concepts and Definitions 107
p.000105: B. Interpreting the Ethics Framework in Aboriginal Contexts 109
p.000105: C. Applying Provisions of This Policy in Aboriginal Contexts 110
p.000105: Chapter 10
p.000135: 135
p.000135: QUALITATIVE RESEARCH
p.000135: 135
p.000135: Introduction 135
p.000135: A. Nature of Qualitative Research 135
p.000135: B. Research Ethics Review of Qualitative Research. 138
p.000135: Chapter 11
p.000147: 147
p.000147: CLINICAL TRIALS
p.000147: 147
p.000147: Introduction 147
p.000147: A. Key Concepts 148
p.000147: B. Clinical Trial Design and Registration 149
p.000147:
p.000147:
p.000147:
p.000147:
p.000147: ii TCPS 2
p.000147:
p.000147: C. Assessing Safety and Minimizing Risk 157
p.000147: D. Financial Conflicts of Interest 163
p.000147: E. Analysis and Dissemination of Clinical Trial Outcomes 164
p.000147: Chapter 12
p.000169: 169
p.000169: HUMAN BIOLOGICAL MATERIALS INCLUDING MATERIALS
p.000169: RELATED TO HUMAN REPRODUCTION 169
p.000169: Introduction 169
p.000169: A. Types of Human Biological Materials 169
p.000169: B. Collection of Human Biological Materials 170
p.000169: C. Consent and Secondary Use of Identifiable Human Biological
p.000169: Materials for Research Purposes 172
p.000169: D. Storage and Banking of Human Biological Materials 175
...
p.000199: participant. Participants will generally not understand the research in the same way and in the same depth as does the
p.000199: researcher. Historically, there have been instances in which this power imbalance has been abused, with resulting harm
p.000199: to participants.
p.000199: The Core Principles – Conclusion
p.000199: The importance of research and the need to ensure the ethical conduct of research requires both researchers and REB
p.000199: members to navigate a sometimes difficult course between the two main goals of providing the necessary protection of
p.000199: participants and serving the legitimate requirements of research. The three core principles that express the value of
p.000199: human dignity provide the compass for that journey. Their application will help ensure that a balance between these two
p.000199: goals is main- tained. Applying the core principles will also maintain free, informed and ongoing consent
p.000199: throughout the research process and lead to sharing the benefits of the research. These results will help to build and
p.000199: maintain the trust of participants and the public in the research process.
p.000199:
p.000199: C. How to Apply This Policy
p.000199: Proportionate Approach to REB Review
p.000199: This Policy aims to strike an appropriate balance between recognition of the potential benefits of research, and
p.000199: protection of participants from research-related harms, including injustices and breaches of Respect for Persons. Given
p.000199: that research involving humans spans the full spectrum of risk, from minimal to significant, a crucial element of REB
p.000199: review is to ensure that the level of scrutiny of a research project is determined by the level of risk it poses to
p.000199: participants (see Article 6.12). A reduced level of scrutiny applied to a research project assessed as minimal risk
p.000199: does not imply a lower level of adherence to the core principles. Rather, the intention is to ensure adequate
p.000199: protection of participants is maintained while reducing unnecessary impediments to, and facili- tating the progress of,
p.000199: ethical research. This approach is in keeping with the need to respect academic freedom and not to place unwarranted
p.000199: constraints upon it.
p.000199: In the context of both initial and continuing research ethics review, the REB assesses the ethical acceptability of a
p.000199: research project through consideration of the foreseeable risks, the potential benefits and the ethical implications of
p.000199: the project (see Article 2.9). These two steps constitute the proportionate approach to REB review that is recommended
p.000199: throughout the Policy.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: TCPS 2 11
p.000199:
p.000199: Chapter 1 – Ethics Framework
p.000199:
p.000199: Research Ethics and Law
p.000199: In addition to the principles and guidelines in this Policy, researchers are responsible for ascertaining
p.000199: and complying with all applicable legal and regulatory requirements with respect to consent and the protection of
p.000199: privacy of participants (see Chapter 5). These legal and regulatory requirements may vary depending on the jurisdiction
p.000199: in Canada in which the research is being conducted, and who is funding and/or conducting the research, and
p.000199: they may comprise constitutional, statutory, regulatory, common law, and/or international or legal requirements of
p.000199: jurisdictions outside of Canada. Where the research is considered to be a governmental activity, for example, standards
p.000199: for protecting privacy flowing from the Canadian Charter of Rights and Freedoms, federal privacy legislation and
p.000199: regulatory requirements would apply.
p.000199: The law affects and regulates the standards and conduct of research involving humans in a variety of areas, including,
...
p.000199: body, and if necessary, seek independent legal advice to help resolve any conflicts between law and ethics, and guide
p.000199: an appropriate course of action.
p.000199: This legal context for research involving humans is constantly evolving and varies from jurisdiction to jurisdiction.
p.000199: For this reason, REBs and researchers should be aware of applicable laws so they can identify legal issues that may
p.000199: occur in the conduct of research. REBs may satisfy this obligation through expertise among their members or through
p.000199: wider consultation. The researcher may seek independent legal advice when necessary.
p.000199: The Perspective of the Participant
p.000199: In designing and conducting research or reviewing the ethics of research, researchers and REBs must be mindful of the
p.000199: perspective of the participant. It may be necessary to consider the various contexts (e.g., social, economic, cultural)
p.000199: that shape the participant’s life, to properly evaluate the implications of the research in terms of the core
p.000199: principles.
p.000199: Appropriate Expertise for Review
p.000199: It is also important that research ethics review be appropriate to the disciplines, fields of research, and methods of
p.000199: the research being reviewed. This means that REBs must understand the discipline and method under review and be able to
p.000199: assess the research on its own terms. This Policy provides more direction concerning appropriate expertise in Articles
p.000199: 6.4 and 6.5.
p.000199:
p.000199:
p.000199:
p.000199: 12 TCPS 2
p.000199:
p.000199: Chapter 1 – Ethics Framework
p.000199:
p.000199: Interpreting This Policy
p.000199: This Policy contains both guidance for the interpretation of the principles of research ethics, as well as a number of
p.000199: mandatory requirements for researchers, institutions and members of REBs. Mandatory provisions are signalled by the use
p.000199: of the term “shall.” Guidance for the interpretation of the core principles is generally indicated by use of the term
p.000199: “should.”
p.000199: Evaluating the ethics of research involving humans is not, and cannot be, an exact science. The interpretation and
p.000199: application of the articles and principles to particular circumstances will always be a part of the exercise. The
p.000199: articles in this Policy are intended to provide guidance, and in some cases, to set out certain requirements. The
p.000199: application sections are intended to supplement the articles with further explanation and examples. Although they
p.000199: cannot guarantee identical decisions across REBs, they can ensure that researchers and REBs employing this Policy are
p.000199: operating within the same parameters and taking into account the same considerations as they design and evaluate
p.000199: research involving humans.
p.000199: At the end of some chapters, a section entitled “References” provides links to documents that contain further guidance
p.000199: on specific topics addressed in the chapter. These references are not meant to be exhaustive, but are offered to assist
p.000199: the reader who wishes to explore certain topics in greater detail.
p.000199: This Policy will continue to evolve in response to the emerging needs and suggestions of all those whom this Policy is
p.000199: intended to serve, including the research community, participants and the public.
p.000199: Definitions
p.000199: The definitions provided in this Policy are intended specifically and solely for the purposes of this Policy.
p.000199: Endnote
p.000199:
p.000199:
...
p.000199: research is completed:
p.000199: - establish an ad hoc independent peer review committee;
p.000199: - if the REB has the necessary scholarly expertise, assume complete responsibility for the scholarly review.
p.000199: In assuming this responsibility, the REB should not be driven by factors such as personal biases or preferences, and
p.000199: should not reject proposals because they are controversial, challenge mainstream thought, or offend powerful or vocal
p.000199: interest groups.
p.000199: REB Review Shall Be Continuing
p.000199: Article 2.8 Following initial REB review and approval, research ethics review shall continue throughout the life
p.000199: of the project in accordance with Article 6.14.
p.000199: Application The primary goal of REB review is to ensure the ethical acceptability of research involving humans that
p.000199: falls within the scope of this Policy. Following the initial REB review and approval, the ethics review shall continue
p.000199: to ensure that all stages of a research project are ethically acceptable in accordance with the principles of this
p.000199: Policy.
p.000199: Continuing ethics review by an REB provides those involved in the research process (in particular,
p.000199: researchers and REBs) with multiple opportunities to reflect
p.000199:
p.000199: TCPS 2 21
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
p.000199: on the ethical issues surrounding the research. This reflection can show whether the stated risks, or other unknown
p.000199: risks, were incurred and how they affected the individual and collective welfare of participants. This reflective
p.000199: practice is intended to enable both researchers and REBs to be more effective in protecting participants in current and
p.000199: future research. This practice is especially important in new and emerging fields, where the ethical implications are
p.000199: not yet well understood. Here, reflection should involve an ongoing dialogue among REBs and researchers, as
p.000199: appropriate, to enable the practices surrounding research ethics to evolve as needed to comply with the principles of
p.000199: this Policy.
p.000199: In the conduct of their approved research, should unanticipated issues arise that may increase the level of risk or
p.000199: have other ethical implications, researchers shall report them to their REB in a timely manner. Researchers shall also
p.000199: submit to their REBs in a timely manner requests for changes to their approved research. Further details are provided
p.000199: in Articles 6.14 to 6.16.
p.000199: B. Approach to REB Review
p.000199: This section introduces the concepts of risks and potential benefits of research (including a definition
p.000199: of minimal risk), as well as their balance in research ethics review and the conduct of research. It describes the
p.000199: proportionate approach to REB review: The REB tailors its level of scrutiny to the level of risk presented by the
p.000199: research, and assesses the ethical acceptability of the research through consideration of the foreseeable risks, the
p.000199: potential benefits and the ethical implications of the research, both at the stage of the initial review and throughout
p.000199: the life of the project (continuing ethics review).
p.000199: Concepts of Risks and Potential Benefits
p.000199: Potential Benefits
p.000199: Research involving humans may produce benefits that positively affect the welfare of society as a whole through the
p.000199: advancement of knowledge for future generations, for participants themselves or for other individuals. However, much
p.000199: research offers little or no direct benefit to participants. In most research, the primary benefits produced are for
p.000199: society and for the advancement of knowledge.
p.000199: Risks
p.000199: Because research is a step into the unknown, its undertaking can involve harms to participants and to others. Harm is
p.000199: anything that has a negative effect on the welfare of participants, and the nature of the harm may be social,
p.000199: behavioural, psychological, physical or economic.
p.000199: Risk is a function of the magnitude or seriousness of the harm, and the probability that it will occur, whether to
p.000199: participants or to third parties (as outlined below). A proper ethical analysis of research should consider both the
p.000199: foreseeable risk and the available methods of eliminating or mitigating the risk.
p.000199:
p.000199:
p.000199:
p.000199: 22 TCPS 2
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
...
p.000199: involving humans. The principle of Concern for Welfare imposes an ethical obligation to design, assess and conduct
p.000199: research in a way that protects participants from any unnecessary or avoidable risks. In their review, REBs should be
p.000199: concerned with an assessment that the potential research outcomes and potential benefits merit the risks.
p.000199: Risks and potential benefits may be perceived differently by different individuals and groups in society. Researchers
p.000199: and REBs should take this into account in designing and reviewing research. They should also recognize that researchers
p.000199: and participants may not always see the risks and potential benefits of a research project in the same way. In
p.000199: assessing risks and potential benefits for specific populations, researchers and REBs should understand the role of the
p.000199: culture, values and beliefs of the populations to be studied. In this regard REBs may consult ad hoc advisors as
p.000199: needed. Researchers and REBs may also consult guidelines that exist for conducting research with these populations (see
p.000199: Chapters 8, 9 and 10). Researchers shall demonstrate to their REBs that they have a reasonable understanding of the
p.000199: culture, values and beliefs of the population to be studied, and the likely effects of their research upon
p.000199: them. This could be demonstrated, for example, by referring to previous experience with conducting research with a
p.000199: similar population, or to published research on the effects of that type of research on the population being studied,
p.000199: or by presenting feedback from a community advisory group.
p.000199: Article 2.9 The REB shall adopt a proportionate approach to research ethics review such that, as a preliminary
p.000199: step, the level of review is determined by the level of risk presented by the research: the lower the level of risk,
p.000199: the lower the level of scrutiny (delegated review); the higher the level of risk, the higher the level of scrutiny
p.000199: (full board review). A proportionate approach to assessing the ethical acceptability of the research, at either level
p.000199: of review, involves consideration of the foreseeable risks, the potential benefits and the ethical implications of the
p.000199: research.
p.000199: Application The proportionate approach to REB review encompasses both the initial assessment of the level of risk
p.000199: to participants posed by a research project – used to determined the level of review (i.e., delegated or full REB
p.000199: review [see Articles 6.11 to 6.17])
p.000199: – and the approach to the actual review of the research project itself. While all research shall be reviewed in
p.000199: light of the core principles of this Policy, the proportionate approach to REB review is intended to direct the
p.000199: most intensive scrutiny, time and resources, and correspondingly, the most protection, to the most ethically
p.000199: challenging research.
p.000199: A proportionate approach to research ethics review starts with an assessment of the magnitude and probability of harms.
p.000199: Minimal risk research should normally receive delegated review and above-minimal risk research shall receive full REB
p.000199: review. Whether the review is delegated, full-board, initial or continuing, foreseeable risks and potential benefits
p.000199: should be considered as well as the ethical implications of the research. The proportionate approach to REB review
p.000199: requires that a project
p.000199:
p.000199:
p.000199:
p.000199: 24 TCPS 2
p.000199:
p.000199: Chapter 2 – Scope and Approach
p.000199:
p.000199: have a favourable balance of risks and benefits in order to receive REB approval. The REB should make this assessment
p.000199: in light of the context of the research – that is, elements of the research that may produce benefits or harms, or
p.000199: otherwise have an impact on the ethics of research. Regardless of the level of review selected, the review should
p.000199: include the necessary expertise.
p.000199: Both risks and potential benefits may span the spectrum from minimal to substantial. The concept of minimal
p.000199: risk (described above) provides a foundation for the proportionate approach to REB review. The various applications of
p.000199: the proportionate approach to REB review are addressed in Article 6.12.
p.000199: Risks to Researchers
p.000199: Risks in research are not limited to participants. In their conduct of research, researchers themselves
p.000199: may be exposed to risks that may take many forms (e.g., injury, incarceration). Risks to researchers may become a
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p.000199: to consent to on their own. They also allow existing participants to express their preference to continue to
p.000199: participate in research should they lose capacity. Research directives should be as specific as possible, and in the
p.000199: event of ambiguity or imprecision, should be interpreted narrowly. Individuals should be encouraged to periodically
p.000199: update their research directives and, if possible, construct directives in contemplation of specific types of research
p.000199: interventions. Research directives should be written, dated and witnessed, and include a declaration about the capacity
p.000199: of the individual at the time the directive was made.
p.000199:
p.000199: D. Consent Shall Be Documented
p.000199:
p.000199: Article 3.12 Evidence of consent shall be contained either in a signed consent form or in documentation
p.000199: by the researcher of another appropriate means of consent.
p.000199: Application Written consent in a signed statement from the participant is a common means of demonstrating consent,
p.000199: and in some instances, is mandatory (e.g., Health Canada regulations under the Food and Drugs Act, the Civil Code of
p.000199: Québec). However, there are other means of providing consent that are equally ethically acceptable. In some types of
p.000199: research, and for some groups or individuals, written signed consent may be perceived as an attempt to legalize or
p.000199: formalize the consent process and therefore may be interpreted by the participant as a lack of trust on the part of the
p.000199: researcher. In these cases, oral consent, a verbal agreement or a handshake may be required, rather than signing a
p.000199: consent form. In some cultures, the giving and receiving of gifts symbolizes the establishment of a relationship
p.000199: comparable to consent.
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: 44 TCPS 2
p.000199:
p.000199: Chapter 3 – The Consent Process
p.000199:
p.000199: Where consent is not documented in a signed consent form, researchers may use a range of consent procedures, including
p.000199: oral consent, field notes and other strategies, for documenting the consent process. Consent may also be demonstrated
p.000199: solely by the actions of the participant (e.g., through the return of a completed questionnaire). Where there are valid
p.000199: reasons for not recording consent in writing, the procedures used to seek consent must be documented (see Article
p.000199: 10.2).
p.000199:
p.000199: Whether or not a consent form is signed, it may be advisable to leave a written statement of the information conveyed
p.000199: in the consent process with the participant. For participants, it is evidence that they have agreed to participate in a
p.000199: particular research project. It may serve as a reminder to participants of the terms of the research project. It may
p.000199: also facilitate the ability of participants to consider and reconsider their involvement as the research proceeds.
p.000199: However, researchers should not leave any documentation with participants if it may compromise their safety or
p.000199: confidentiality. Additionally, in some cases it may not be appropriate to leave a written statement, such as in
p.000199: cultural settings where such written documentation is contrary to prevailing norms.
p.000199:
p.000199: Endnote
p.000199:
p.000199:
p.000199: 1 For example, see Article 21 of the Civil Code of Québec, which sets conditions for the conduct of research involving
p.000199: minors or adults who lack the capacity to consent.
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p.000199:
p.000199: TCPS 2 45
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p.000199:
p.000199:
p.000199: Chapter 4
p.000199: FAIRNESS AND EQUITY IN RESEARCH PARTICIPATION
p.000199:
p.000199: Introduction
p.000199: The principle of Justice holds that particular individuals, groups or communities should neither bear an unfair share
p.000199: of the direct burdens of participating in research, nor should they be unfairly excluded from the potential benefits of
p.000199: research participation. Inclusiveness in research and fair distribution of benefits and burdens should be important
p.000199: considerations for researchers, research ethics boards (REBs), research institutions and sponsors. Issues of fair and
p.000199: equitable treatment arise in deciding whether and how to include individuals, groups or communities in research, and
p.000199: the basis for the exclusion of some.
p.000199: This chapter addresses inclusion in research of individuals and groups that might be inappropriately excluded on the
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p.000199: administrative purposes, but which may be sought later for use in research. Chapter 12 provides further guidance on
p.000199: research involving secondary use of previously collected biological materials.
p.000199: Reasons to conduct secondary analyses of data include: avoidance of duplication in primary col- lection and the
p.000199: associated reduction of burdens on participants; corroboration or criticism of the conclusions of the original project;
p.000199: comparison of change in a research sample over time; appli- cation of new tests of hypotheses that were not available
p.000199: at the time of original data collection; and confirmation that the data are authentic. Privacy concerns and questions
p.000199: about the need to seek consent arise, however, when information provided for secondary use in research can be linked to
p.000199: individuals, and when the possibility exists that individuals can be identified in published reports, or through data
p.000199: linkage. Privacy legislation recognizes these concerns and permits sec- ondary use of identifiable information under
p.000199: certain circumstances.
p.000199: Article 5.5 Researchers who have not obtained consent from participants for secondary use of identifiable
p.000199: information shall only use such information for these purposes if the REB is satisfied that:
p.000199: (a) identifiable information is essential to the research;
p.000199: (b) the use of identifiable information without the participants’ consent is unlikely to adversely affect the
p.000199: welfare of individuals to whom the information relates;
p.000199: (c) the researchers will take appropriate measures to protect the privacy of indi- viduals, and to safeguard the
p.000199: identifiable information;
p.000199: (d) the researchers will comply with any known preferences previously expressed by individuals about any use of
p.000199: their information;
p.000199: (e) it is impossible or impracticable to seek consent from individuals to whom the information relates; and
p.000199: (f) the researchers have obtained any other necessary permission for secondary use of information for research
p.000199: purposes.
p.000199: If a researcher satisfies all the conditions in Article 5.5(a) to (f), the REB may ap- prove the research without
p.000199: requiring consent from the individuals to whom the information relates.
p.000199:
p.000199:
p.000199: 62 TCPS 2
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: Application This Policy does not require that researchers seek consent from individuals for the secondary use of
p.000199: non-identifiable information. In the case of secondary use of iden- tifiable information, researchers must obtain
p.000199: consent in accordance with applicable laws, unless the researcher satisfies all the requirements in Article 5.5.
p.000199: The exception to the requirement to seek consent in this article is specific to sec- ondary use of identifiable
p.000199: information. The terms of Article 3.7 address alteration of consent in other circumstances and do not apply here.
p.000199: Secondary use of information identifiable as originating from a specific Aboriginal community, or a segment of the
p.000199: Aboriginal community at large, is addressed in Ar- ticles 9.20 to 9.22.3
p.000199: “Impracticable” refers to undue hardship or onerousness that jeopardizes the con- duct of the research; it does
p.000199: not mean mere inconvenience. Consent may be impossible or impracticable when the group is very large or its
p.000199: members are likely to be deceased, geographically dispersed or difficult to track. Attempting to track and contact
p.000199: members of the group may raise additional privacy concerns. Financial, human and other resources required to contact
p.000199: individuals and seek consent may impose undue hardship on the researcher. In some jurisdictions, privacy laws may
p.000199: preclude researchers from using personal information to contact individuals to seek their consent for secondary use of
p.000199: information.4
p.000199: Privacy laws may also impose specific rules regarding disclosure of information for secondary use in research. These
p.000199: laws may require the individual or organization that has custody or control of requested personal information to obtain
p.000199: approval from a privacy commissioner or other body before disclosing information to researchers. They may
p.000199: also impose additional requirements such as information- sharing agreements that describe disclosure conditions. These
p.000199: requirements may include the stipulation that the researcher not publish identifiable information or contact
p.000199: individuals to whom the information relates.
p.000199: At the time of initial collection, individuals may have had an opportunity to express preferences about future uses of
p.000199: information, including research uses (see paragraph
p.000199: [d] in the Application of Article 3.2). Data custodians have an obligation to respect the individual’s expressed
p.000199: preferences. For example, where an individual does not want information used for future research, data custodians shall
p.000199: remove this infor- mation from any datasets used or made available for research.
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p.000199: ethical implications of the research, and suggest ways to minimize any associated risks. Discussion is not intended to
p.000199: serve as proxy consent. Rather, a goal of discussion is to seek input regarding the proposed research, such as the de-
p.000199: sign of the research, measures for privacy protection, and potential uses of findings.
p.000199:
p.000199: TCPS 2 63
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: Discussion may also be useful to determine whether or not the research will ad- versely affect the welfare of
p.000199: individuals to whom the information relates. Researchers shall advise the REB of the outcome of such discussions.
p.000199: The REB may require modifications to the research proposal based on these discussions.
p.000199: Article 5.6 When secondary use of identifiable information without the requirement to seek consent has been
p.000199: approved under Article 5.5, researchers who propose to contact individuals for additional information shall, prior to
p.000199: contact, seek REB approval of the plan for making contact.
p.000199: Application In certain cases, a research goal may be achieved only through follow up contact with individuals to
p.000199: collect additional information. Under Article 5.5, the REB may have approved secondary use without the requirement to
p.000199: seek consent, based, in part, on the impossibility or impracticability of seeking consent from all individuals whose
p.000199: information is proposed for use in research. Where contact with a sub-group is feasible, researchers may subsequently
p.000199: wish to attempt to make contact with some individuals to obtain additional information. Contact with individuals whose
p.000199: previously collected information has been approved for secondary use in research raises privacy concerns. Individuals
p.000199: might not want to be contacted by researchers or might be upset that identifiable information was disclosed to
p.000199: researchers without their consent. The potential benefits of follow-up contact must clearly outweigh the risks to
p.000199: individuals of follow-up contact, and the REB must be satisfied that the proposed manner of follow-up contact minimizes
p.000199: risks to individuals. The pro- posed plan shall explain who will contact individuals to invite their participation in
p.000199: the research (e.g., a representative of the organization that holds the individual’s information) and the nature of
p.000199: their relationship with those individuals. Researchers shall also ensure that a plan for follow-up contact complies
p.000199: with applicable privacy legislation. For example, some privacy laws prohibit researchers from contacting individuals
p.000199: unless the custodian of the information has first sought and obtained individuals’ consent to be contacted. Whenever
p.000199: possible, it is preferable that re- contact with participants be carried out by the custodian of the original data set.
p.000199: Researchers will need to seek consent from individual participants for any new data collection. Article 3.1 provides
p.000199: further guidance on consent and approaches to recruitment.
p.000199:
p.000199: E. Data Linkage
p.000199: Article 5.7 Researchers who propose to engage in data linkage shall obtain REB approval prior to carrying out the
p.000199: data linkage, unless the research relies exclusively on publicly available information as discussed in Article 2.2. The
p.000199: application for approval shall describe the data that will be linked and the likelihood that identifiable information
p.000199: will be created through the data linkage.
p.000199: Where data linkage involves or is likely to produce identifiable information, re- searchers shall satisfy the REB that:
p.000199:
p.000199:
p.000199: 64 TCPS 2
p.000199:
p.000199: Chapter 5 – Privacy and Confidentiality
p.000199:
p.000199: (a) the data linkage is essential to the research; and
p.000199: (b) appropriate security measures will be implemented to safeguard information.
p.000199: Application Growing numbers of databases and advancing technological capacity to link data- bases create new
p.000199: research opportunities, but also new privacy risks. In particular, linkage of de-identified or anonymized databases may
p.000199: permit re-identification of individuals. This article provides guidance for researchers who propose to carry out data
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p.000199: address those fields of research, disciplines and methodologies.
p.000199: Knowledgeable in Ethics
p.000199: Knowledge of ethics of research involving humans is key within the REB mem- bership as a whole. A member knowledgeable
p.000199: in ethics (Article 6.4[b]) needs to have sufficient knowledge to guide an REB in identifying and addressing ethics
p.000199: issues. A balance of ethics theory, practice and experience offers the most effective path to knowledge in ethics for
p.000199: REB membership. The kind and level of knowledge or expertise needed on the REB will be commensurate with the types and
p.000199: com- plexities of research the REB reviews. For example, a member knowledgeable in ethics serving on a social sciences
p.000199: and humanities REB may need to have different contextual and disciplinary knowledge in ethics than a member
p.000199: knowledgeable in ethics serving on a biomedical REB.
p.000199: Knowledgeable in the Law
p.000199: The role of the member knowledgeable in the law (Article 6.4[c]) is to alert REBs to legal issues and their
p.000199: implications (e.g., privacy issues), not to provide formal
p.000199:
p.000199: TCPS 2 71
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p.000199: Chapter 6 – Governance of Research Ethics Review
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p.000199: legal opinions or to serve as legal counsel for the REB. To avoid undermining the independence and credibility of the
p.000199: REB, the institution’s legal counsel or risk man- ager should not be a member of the REB. In-house legal counsel might
p.000199: be seen to identify too closely with the institution’s financial interest in having research go forward or, conversely,
p.000199: may be unduly concerned with protecting the institution from potential liability. Any external legal counsel hired on a
p.000199: case-by-case basis by the institution should not serve as a member of that institution’s REBs while working for the
p.000199: institution.
p.000199: An understanding of relevant legal issues and contexts is advisable for all REBs, although for non-biomedical research
p.000199: such insights may be sought from an ad hoc advisor whom the REB consults only for specific research projects. Where
p.000199: REBs review research on complex topics that regularly requires advice on legal issues, they should appoint a member
p.000199: knowledgeable in the relevant law. In some in- stances, the legal issues that may be identified by the REB will
p.000199: necessitate further scrutiny and even formal legal advice by the legal counsel to the institution. Legal liability is a
p.000199: separate issue for institutions to handle through mechanisms other than the REB.
p.000199: Community Member
p.000199: The community member shall not be affiliated with the institution. The community member requirement (Article 6.4[d]) is
p.000199: essential to help broaden the perspective and value base of the REB, and thus advances dialogue with, and
p.000199: accountability to, relevant communities. In addition to a broad-based representation from the com- munity, it is highly
p.000199: desirable that institutions seek to appoint former participants on REBs. Their experience as participants provides the
p.000199: REB with a vital perspective and an important contribution to the research ethics review process. It is advisable that
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p.000199: reviewers who are non-members or non-voting members of the REB must have experience, expertise and knowledge comparable
p.000199: to what is expected of an REB member.
p.000199: The REB may decide that its Chair or other REB member(s) may review and ap- prove categories of research that are
p.000199: confidently expected to involve minimal risk. Delegated reviewers may call on other reviewers within the REB or refer
p.000199: projects back to the full REB if they determine that full board review is required. Where delegates consider a negative
p.000199: decision (i.e., one that would refuse ethics approval), this decision shall be referred to the full REB for review and
p.000199: endorsement before communicating the decision to the researcher.
p.000199: An institution may decide that ethics review of course-based research activities in- tended solely for pedagogical
p.000199: purposes can be delegated to non-REB members at the institution’s department, faculty or equivalent level. Such
p.000199: pedagogical activities are normally required of students (at all levels) with the objective of providing them with
p.000199: exposure to research methods in their field of study. If these activities are used for the purposes of research (e.g.,
p.000199: as part of a researcher’s own research program), they should be reviewed by the regular institutional REB procedures.
p.000199: The REB should establish written procedures and set out criteria for determining which cat- egories of research
p.000199: proposals may be eligible for this type of review, and specify who is responsible for implementing and overseeing the
p.000199: approval mechanisms.
p.000199: In delegating research ethics review, the REB should carefully select delegated re- viewer(s) and ensure that all
p.000199: delegated reviewers who are not members of the REB have the appropriate experience, expertise, training and resources
p.000199: required to re- view the ethical acceptability of all aspects of the proposal in accordance with this Policy. In the
p.000199: selection of delegated reviewers, special attention should be given to the assessment of real, potential or perceived
p.000199: conflicts of interest (see Article 7.3).
p.000199: Examples of categories that may be delegated for research ethics review include:
p.000199: • research that is confidently expected to involve minimal risk;
p.000199: • minimal-risk changes to approved research;
p.000199: • annual renewals of approved minimal risk research;
p.000199: • annual renewals of more than minimal risk research where the research will no longer involve new
p.000199: interventions to current participants, renewal does not involve the recruitment of new participants, and
p.000199: the remaining research activities are limited to data analysis.
p.000199:
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p.000199: 78 TCPS 2
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p.000199: Chapter 6 – Governance of Research Ethics Review
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p.000199: An REB that implements a delegated review process shall require that the actions and decisions of the delegated
p.000199: reviewer(s) be well documented and formally re- ported to the full REB, in a timely and appropriate manner. Where the
p.000199: delegated review is conducted by non-voting members or non-members of the REB, this for- mal report shall be made
p.000199: through the Chair. This will permit the REB to maintain oversight over the decisions made on its behalf so as to
p.000199: protect the interests of par- ticipants. Accountability requires that, regardless of the review strategy, the REB
p.000199: continues to be responsible for the ethics of all research involving humans within its jurisdiction.
p.000199: Decision Making
p.000199: Article 6.13 REBs shall function impartially, provide a fair hearing to the researchers involved, and provide
p.000199: reasoned and appropriately documented opinions and decisions. REBs should make their decisions on the ethical
p.000199: acceptability of research in an efficient and timely manner, and shall communicate all approvals and refusals to
p.000199: researchers in writing, in print or by electronic means, in accordance with their procedures.
p.000199: Application The REB shall accommodate reasonable requests from researchers to participate in discussions about
p.000199: their proposals. The REB may also invite researchers to attend an REB meeting to provide further information about
p.000199: their proposal. In either case, the researchers shall not be present when the REB is making its decision. When an REB
p.000199: is considering a negative decision, it shall provide the researcher with all the reasons for doing so and give the
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p.000199: question) should not require immediate reporting to the REB, but may be summarized in annual status reports (see
p.000199: Article 6.14). In some types of qualitative research, for example, emergent design (see Article 10.5), the research
p.000199: design evolves over time, so adjustments to the research are to be ex- pected and need not be reported to the REB,
p.000199: unless they alter the level of risk or have other ethical implications for participants (see Article 6.16).
p.000199: The report to the REB should include a description of the unanticipated issue or incident, including details of how the
p.000199: researcher(s) dealt with the situation. Reports may be submitted by researchers, or in some cases by data safety
p.000199: monitoring boards (see Article 11.7 and 11.8). The point in reporting is to enable the REB and the re- searcher to
p.000199: better protect participants. Depending on the nature of the issue, and in consultation with researchers, REBs may
p.000199: require that researchers adjust their pro- cedures to prevent its recurrence during the research project.
p.000199:
p.000199:
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p.000199: Chapter 6 – Governance of Research Ethics Review
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p.000199: Requests for Changes to Approved Research
p.000199: Article 6.16 Researchers shall submit to their REBs in a timely manner requests for substantive changes to their
p.000199: originally approved research. REBs shall decide on the ethical ac- ceptability of those changes to the research in
p.000199: accordance with a proportionate approach to research ethics review.
p.000199: Application In general, it is not the size of the change that dictates the ethics review process, but rather the
p.000199: ethical implications and risk associated with the proposed change. In case of doubt on the potential impact of the
p.000199: change to approved research on the level of risk to participants, researchers should consult with their REBs. Changes
p.000199: that substantially alter the nature of the approved research may be assessed as a new research project and require a
p.000199: new REB review.
p.000199: In the conduct of their approved research, researchers should be aware of the re- quirement to report to their REB, in
p.000199: a timely manner, proposed changes from approved research that affect participants at any stage of the process
p.000199: including, but not limited to, changes to the consent form, changes to the tasks or interventions involved in the
p.000199: research, or changes to measures to protect privacy and confiden- tiality. Any substantive change to the research
p.000199: should not be implemented without documented approval by the REB, except when necessary to eliminate an imme- diate
p.000199: risk(s) to the participants.
p.000199: Requests for changes to approved research may receive delegated or full REB review depending on the level of risk to
p.000199: participants that the changes represent. REB evaluation of these requests can result in a change to the assessed risk
p.000199: of the research and a corresponding change in the level of continuing ethics review.
p.000199: REBs should give special attention to circumstances that may necessitate change in long-term research such as new
p.000199: knowledge, equipment or instruments, or new or revised applicable policies and laws that may develop over the lifetime
p.000199: of a re- search project.
p.000199: Record Keeping of REB Documents
p.000199: Article 6.17 REBs shall prepare and maintain comprehensive records, including all documen- tation related to the
p.000199: projects submitted to the REB for review, attendance at all REB meetings, and accurate minutes reflecting REB
p.000199: decisions. Where the REB denies ethics approval for a research proposal, the minutes shall include the reasons for this
p.000199: decision.
p.000199: Application REBs need to act, and to be seen to be acting, fairly and reasonably. Institutions shall provide REBs
p.000199: with the necessary resources to enable them to maintain com- plete study files, including the original research
p.000199: proposal, as well as annual and end-of-study reports. When deciding the retention period of their files, REBs should be
p.000199: guided by their institutional record-keeping policies and other relevant legal or
p.000199:
p.000199:
p.000199: 82 TCPS 2
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: regulatory requirements. Files, minutes and other relevant documentation shall be accessible to authorized
p.000199: representatives of the institution, researchers, sponsors and funders when necessary to assist internal and external
p.000199: audits, or research monitor- ing, and to facilitate reconsideration or appeals.
p.000199: The minutes of REB meetings shall clearly document the REB’s decisions, any dissents and the reasons for them. REB
p.000199: decisions should be supported by clear ref- erences (e.g., date of decision, title of project), documentary basis for
p.000199: decision (i.e., documents or progress reports received and reviewed), the plan for continuing ethics review and
p.000199: timelines, reasons for decisions, and any conditions or limitations attached to the approval. Providing reasons for REB
p.000199: decisions is optional when ethics approval is granted.
p.000199: REBs should have written procedures for its management of record keeping and other submitted reports. REBs shall
p.000199: maintain reports and decisions on unanticipated issues or changes to approved research, including details of how the
p.000199: researcher dealt with or is proposing to deal with the situation and the REB’s response or de- cision (see Articles
p.000199: 6.15 and 6.16).
p.000199: The research ethics administration should also maintain general records related to REB membership and qualifications of
p.000199: members (e.g., copies of curriculum vitae, participation in relevant research ethics training).
p.000199:
p.000199: C. Reconsideration and Appeals
p.000199: Where researchers do not receive ethics approval, or receive approval conditional on revisions that they find
p.000199: compromise the feasibility or integrity of the proposed research, they are entitled to reconsideration by the REB. If
p.000199: that is not successful, they may appeal using the established appeal mechanism in accordance with the institution’s
p.000199: procedures.
p.000199: Reconsideration of REB Decisions
p.000199: Article 6.18 Researchers have the right to request, and REBs have an obligation to provide, prompt reconsideration
p.000199: of decisions affecting a research project.
p.000199: Application Researchers and REBs should make every effort to resolve disagreements they may have through
p.000199: deliberation, consultation or advice. If a disagreement between the researcher and the REB cannot be resolved through
p.000199: reconsideration, the researcher shall have the option of appealing the REB decisions through the established appeal
p.000199: mechanism (see Article 6.19). REBs should establish timelines to promptly conduct reconsiderations and issue their
p.000199: decision.
p.000199: The onus is on researchers to justify the grounds on which they request reconsid- eration by the REB and to indicate
p.000199: any alleged breaches to the established research ethics review process, or any elements of the REB decision that are
p.000199: not supported by this Policy.
p.000199:
p.000199:
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p.000199: TCPS 2 83
p.000199:
p.000199: Chapter 6 – Governance of Research Ethics Review
p.000199:
p.000199: Appeal of REB Decisions
p.000199: Article 6.19 Institutions shall have an established mechanism and a procedure in place for promptly handling appeals
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p.000199: Conflict of interest policies and procedures should be developed in a transparent manner. The goal of these policies is
p.000199: to eliminate conflict of interest where possible, or alternatively, to identify and disclose real, potential or
p.000199: perceived institutional conflicts of interest, to make them transparent and open to scrutiny, and to provide mechanisms
p.000199: to minimize or otherwise manage them.
p.000199: Article 7.2 Institutions should ensure that real, potential or perceived institutional conflicts of interest that
p.000199: may affect research are reported to the REB through established con- flict of interest mechanisms. The REB shall
p.000199: consider whether the institutional conflict of interest should be disclosed to prospective participants as part of the
p.000199: consent process.
p.000199: Application Any member of an institution, a senior administrator, researcher, REB member or any other individual who
p.000199: is aware of potential sources of institutional conflicts of interest that may affect research should refer to the
p.000199: institutional policy for the ap- propriate steps to inform the REB. Institutional policies shall address when
p.000199: disclosure of conflicts of interest to the REB is required and how these conflicts should be evaluated and managed.
p.000199: Likewise, when a real, potential or perceived institutional conflict of interest is dis- closed and brought to its
p.000199: attention, the REB may be guided by the prescribed institutional mechanisms for managing the conflict. However, it is
p.000199: the REB that is responsible for deciding how these conflicts shall be managed. This includes re- quiring that
p.000199: researchers disclose institutional conflicts of interest that are relevant to participant consent. These decisions must
p.000199: be documented in accordance with Article 6.17.
p.000199:
p.000199: 92 TCPS 2
p.000199:
p.000199: Chapter 7 – Conflicts of Interest
p.000199:
p.000199: Community-based research involving small communities or community-based organizations with scarce human resources may
p.000199: present particular issues related to multiple roles of some individuals. In some cases, securing informed advice on
p.000199: cultural or other aspects of research rests with the researcher or the sponsoring institution, and requires engagement
p.000199: with a community advisor who may assume various roles in the research process. The same individual may be involved in
p.000199: providing preliminary information as well as reviewing the ethics of a research proposal at the community level
p.000199: and/or possibly co-managing the approved research. As outlined in Article 7.1, an approach relative to the level of
p.000199: risks, such as disclosure to the participants of the possible conflicts between multiple roles, may be sufficient to
p.000199: manage the conflict (see also Articles 9.6, 9.8 and 9.12).
p.000199:
p.000199: C. REB Members and Conflicts of Interest
p.000199: Article 7.3 When reviewing research proposals, REB members shall disclose real, potential or perceived conflicts
p.000199: of interest to the REB. When necessary, the REB may decide that some of its members must withdraw from REB
p.000199: deliberations and decisions.
p.000199: Application To maintain the independence and integrity of research ethics review, members of the REB must identify,
p.000199: eliminate, minimize or otherwise manage real, potential or perceived conflicts of interest. If an REB is reviewing a
p.000199: research project in which a member of the REB has a personal or financial conflict of interest (see Section A of this
p.000199: chapter), the member must disclose the nature of the conflict and absent themselves from any discussion or decision
p.000199: regarding that research project. In the event that a member’s conflict of interest and necessary withdrawal from the
p.000199: meet- ing will threaten the maintenance of quorum, the REB can ensure that a substitute member be in attendance to
p.000199: maintain quorum.
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p.000199: In addressing conflicts of interest, disagreements between the REB and the re- searcher may arise about the scope and
p.000199: reach of disclosure, including disclosure of new information to participants, or other aspects of managing the
p.000199: conflict. Reso- lution of disagreements should be guided by the paramount principles of Respect for Persons and Concern
p.000199: for Welfare of participants. If the researcher and the REB cannot resolve their disagreement they should use the
p.000199: institutional conflict of in- terest mechanisms to arrive at a solution.
p.000199:
p.000199: Endnote
p.000199:
p.000199:
p.000199: 1 Definition of “conflict of interest” based on Schedule 14 of the Memorandum of Understanding (MOU) on the Roles and
p.000199: Responsibilities in the Management of Federal Grants and Awards. www.nserc-
p.000199: crsng.gc.ca/NSERC-CRSNG/Policies-Politiques/MOURoles-ProtocolRoles/index_eng.asp
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
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p.000199:
p.000199:
p.000199: Introduction
p.000199: Chapter 8
p.000199: MULTI-JURISDICTIONAL RESEARCH
p.000199: This chapter sets out options, procedures and considerations for the ethics review of multi-juris- dictional research
p.000199: either entirely within Canada, or in Canada and other countries. It is intended to facilitate the ethics review process
p.000199: and ethical conduct of such research while ensuring that all participants are afforded the same respect and protection
p.000199: in accordance with the core principles of this Policy.
p.000199: Contemporary research often involves collaborative partnerships among researchers from multiple institutions or
p.000199: countries. It may call upon the participation of a number of local populations and involve multiple institutions and/or
p.000199: multiple research ethics boards (REBs).
p.000199: Collaborations in research may require institutions to adopt policies and procedures that permit arrangements for REB
p.000199: review by REBs at other institutions or external or independent REBs. To be effective, these review arrangements should
p.000199: ensure that research involving humans is designed, reviewed, and conducted in a way that is informed by the core
p.000199: principles of this Policy: Respect for Persons, Concern for Welfare, and Justice. These core principles should be
p.000199: balanced with a proportionate approach to the research ethics review process (described in Article 2.9) for research
p.000199: being undertaken in Canada or abroad. Multi-jurisdictional research should take into account other relevant policies,
p.000199: and applicable laws and regulations.
p.000199:
p.000199: A. Review Mechanisms for Research Involving Multiple Institutions and/or Multiple REBs
p.000199: This section primarily addresses the ethics review mechanisms for research involving multiple in- stitutions and/or
p.000199: multiple REBs. It is not intended to apply to ethics review mechanisms for research involving multiple REBs within the
...
p.000199: recruiting participants at different institutions;
p.000199:
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p.000199: (d) a research project conducted by a researcher who has multiple institutional affiliations (e.g., two universities, a
p.000199: university and a college, or a university and a hospital. See Application of Article 6.1);
p.000199: (e) a research project conducted by a researcher at one institution that requires the limited col- laboration of
p.000199: individuals affiliated with different institutions or organizations (e.g., statisticians, lab or X-ray
p.000199: technicians, social workers and school teachers); or
p.000199: (f) a research project that researcher(s) working under the auspices of a Canadian research in- stitution conduct in
p.000199: another province, territory or country.
p.000199:
p.000199: Adoption of Alternative Review Models – An Institutional Responsibility
p.000199: Article 8.1 An institution that has established an REB may approve alternative review models for research
p.000199: involving multiple REBs and/or institutions, in accordance with this Policy. The institution remains responsible for
p.000199: the ethical acceptability and ethical conduct of research undertaken within its jurisdiction or under its auspices
p.000199: irre- spective of where the research is conducted.
p.000199: Application As described in Chapter 6, institutions are accountable for research conducted under their auspices,
p.000199: irrespective of the location where it takes place. Where research in- volving humans requires the involvement of
p.000199: multiple institutions and/or multiple REBs, an institution may establish one or more, or a mix of models for research
p.000199: ethics review as described below. Institutions may also establish other models or arrangements that are appropriate for
p.000199: the research under review within their juris- diction or under their auspices. The ultimate responsibility for
p.000199: approving alternative research ethics review models for potential use by REBs and researchers remains with their
p.000199: individual institutions.
p.000199: In consultation with its REB(s), an institution may authorize its REB to accept re- views undertaken by an external REB
p.000199: of the ethical acceptability of research. This authorization should be based on an official agreement that includes,
p.000199: but is not lim- ited to, the following minimum components:
p.000199: • all institutions or equivalent organization(s) involved agree to (1) adhere to the requirements of this Policy,
p.000199: (2) formalize the cross-institutional agreement, and
p.000199: (3) document the existence of this agreement in their institutional policies;
p.000199: • the highest institutional level, the body that originally defined the jurisdiction of the REB and its
p.000199: relationship to other relevant bodies or authorities within the institution, makes the decision to allow an REB to
p.000199: recognize research ethics review decisions made by another REB (in accordance with Article 6.2); and
p.000199: • approvals based on cross-institutional agreement should be documented and reported to the full REB, through the
p.000199: REB Chair, in each institution. The point in reporting is informational. It should not necessarily trigger a duplicate
p.000199: re- search ethics review.
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p.000199: Researchers and REBs should use the research ethics review models defined by their institution (see Article 8.2) and
p.000199: facilitate coordination of the research ethics review process. Whatever model is chosen, roles and responsibilities of
p.000199: all involved in the process should be defined and agreed to at the outset. Continuing ethics re- view of research
p.000199: involving multiple institutions and/or multiple REBs should follow the same process outlined in Article 6.14.
p.000199:
p.000199: Research Ethics Review Models
p.000199: The following models for the ethics review of research involving multiple REBs and/or multiple institutions are
p.000199: intended to provide flexibility and efficiency, and avoid unnecessary duplication of review without compromising the
p.000199: protection of participants. All other provisions of this Policy remain applicable.
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p.000199: reviews or shared expertise.
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p.000199: Some provinces have introduced legislation or policies that designate one or more REBs for the review of certain types
p.000199: of research within the province (see References at the end of this chapter).
p.000199: In the official agreement between the selected REB and the institutions submitting research for ethics review, the
p.000199: external, specialized, or multi-institutional REB shall agree to adhere to this Policy. Roles and responsibilities
p.000199: should be clearly defined in the official agreement between the institution(s) delegating the review, and the
p.000199: institution or equivalent organization of the REB that will review the ethical acceptability of the research, or in the
p.000199: relevant legislation or policies. The external, specialized or multi-institutional REB may act as the responsible REB
p.000199: for any given re- view, if formally mandated as such by the institutions in question. Where relevant, agreements should
p.000199: specify how the external, specialized or multi-institutional REB will assure familiarity with particular populations
p.000199: that may be involved in the research. Review by an external, specialized or multi-institutional REB need not be
p.000199: preceded or followed by local REB review unless warranted to help ensure that local issues and values are taken into
p.000199: account.
p.000199: 3) Reciprocal REB Review
p.000199: Multiple institutions may enter into official agreements under which they will accept, with an agreed level of
p.000199: oversight, the research ethics reviews of each other’s REBs. This might involve specific agreements between
p.000199: institutions for sharing their workload. Alternatively, institutions may decide that reciprocity agreements should be
p.000199: established for the ethics review of each relevant re- search proposal on a case-by-case basis.
p.000199: In either case, researchers shall ensure that the reviewing REB is provided with any relevant in- formation about the
p.000199: local populations and circumstances that would ordinarily be available to the local REB, and that may have a bearing on
p.000199: its review. The reviewing REB might call upon local REBs to provide information in addition to that provided by the
p.000199: researchers.
p.000199:
p.000199: Selection of a Research Ethics Review Model Relevant to the Research Project
p.000199: Article 8.2 When planning a research project involving multiple institutions and/or multiple REBs, researchers and
p.000199: REBs should select the most appropriate research ethics re- view model from among those authorized by their
p.000199: institution.
p.000199: Application Sensitivity to context is a key issue in the application of the core principles of this Policy to the
p.000199: ethics review of research involving multiple institutions and/or REBs. Researchers should consider the alternative
p.000199: research ethics review models at the planning and design stage of their research, and should consult with their REB to
p.000199: facilitate the selection and coordination of the appropriate review model. In choos- ing the appropriate research
p.000199: ethics review model, the researcher and the REB should pay attention to the research context, and the characteristics
p.000199: of the popula- tions targeted by the research. The final decision regarding the selection of the appropriate model is
p.000199: the responsibility of the principal REB.
p.000199: When selecting from among research ethics review models authorized by their in- stitution, researchers and REBs should
p.000199: consider the following:
p.000199:
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p.000199: • the discipline and content area of the research, and the availability of appropri- ate experience and expertise
p.000199: within, or available to, the reviewing REB;
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p.000105: remains a living document.
p.000105: This chapter forms an integral part of this Policy to which institutions eligible to administer and receive research
p.000105: funding from any of the three research agencies agree to adhere as a condition of funding (see the Memorandum of
p.000105: Understanding on the Roles and Responsibilities in the Management of Federal Grants and Awards).2 It has drawn
p.000105: on prior work, both within Canada and internationally, that recognizes the interests of Aboriginal peoples who
p.000105: participate in research and are affected by its results. Some of that work has been done by the three agencies
p.000105: responsible for this Policy. In particular, the CIHR and its Institute of Aboriginal Peoples’ Health have engaged in
p.000105: extensive dialogue with community partners to develop the CIHR Guidelines for Health Research Involving
p.000105: Aboriginal People. The CIHR Guidelines remain an important source of additional guidance for health research involving
p.000105: Aboriginal peoples in Canada.
p.000105: SSHRC and NSERC, likewise, have developed program guidelines for research involving Aboriginal peoples and
p.000105: issues. Aboriginal entities at local, regional and national levels have published and implemented principles and codes
p.000105: governing research practice – including ethical protections – that emphasize collective rights, interests and
p.000105: responsibilities.
p.000105: This Policy provides guidance for research involving humans, as defined in Chapter 2. Other guidelines specific to
p.000105: particular programs, research domains and community settings may elaborate on the processes set out herein, or may
p.000105: address ethical concerns of broader scope than those covered in this Policy. Researchers and research ethics boards
p.000105: (REBs) are advised to consult reference documents that apply to their research undertaking. Examples of relevant
p.000105: resources are listed under References at the end of this chapter.
p.000105: Neither this Policy nor this chapter are meant to reflect or introduce any change to other Government of
p.000105: Canada policies with respect to the issues addressed in this chapter.
p.000105: Context
p.000105: The existing Aboriginal and treaty rights of the Aboriginal peoples of Canada, that is, the Indian, Inuit and Métis
p.000105: peoples of Canada, were recognized and affirmed in the Constitution Act, 1982.3
p.000105: This chapter acknowledges the unique status of the Aboriginal peoples of Canada. It interprets how the value of respect
p.000105: for human dignity and the core principles of Respect for Persons, Concern for Welfare, and Justice (as articulated in
p.000105: Chapter 1) apply to research involving Aboriginal peoples. It accords respect to Aboriginal peoples’ knowledge systems
p.000105: by ensuring that the various and distinct world views of Indian, Inuit and Métis peoples are represented in planning
p.000105: and decision making, from the earliest stages of conception and design of projects through to the analysis and
p.000105: dissemination of results. It affirms respect for community customs and codes of research practice to better ensure
p.000105: balance in the relationship between researchers and participants, and mutual benefit in researcher-community relations.
p.000105: The purpose of this chapter specifically, and the Policy in general, is to provide guidance to researchers on the
p.000105: ethical conduct of research involving Aboriginal peoples.
p.000105:
p.000105:
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p.000137: research relationships, and to define research collaborations with particular settings or communities. Activities
p.000137: may include, but are not limited to, determining research questions, methods, targeted sample and sample size, and
p.000137: addressing community-based concerns in the project design and data collection. REBs should be aware that dialogue
p.000137: between researchers and communities at the outset, and prior to formal REB review, is an integral component of the
p.000137: research design. Researchers may need to consult the REB informally when ethics issues arise prior to the data
p.000137: collection, or inform the REB of such issues over the course of the research.
p.000137: Qualitative research approaches involving a community, group or population of interest (e.g., marginalized or
p.000137: privileged groups) usually follow a process of prior dialogue, exchanges and negotiation of the research, which
p.000137: precedes the formal data collection involving participants. In community-based collaborative research, it may be
p.000137: desirable to engage the community before seeking REB review. For instance, in research in Aboriginal communities, it
p.000137: may be desirable to obtain permission to proceed from community leaders, Elders or representatives (see Chapter 9).
p.000137: Similarly, when designing community-based research involving individuals whose legal status is compromised, it may
p.000137: be desirable to consult with social service providers serving that population.
p.000137:
p.000137:
p.000137:
p.000137:
p.000137:
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p.000139:
p.000139: Modalities of Expression of Consent
p.000139: Article 10.2 Researchers shall explain in their research design the proposed procedures for seeking consent and the
p.000139: strategies they plan to use for documenting consent.
p.000139: Application As part of its research ethics review, REBs should consider the range of strategies for documenting
p.000139: the consent process that may be used by researchers using qualitative research approaches (see Article 3.12).
p.000139: Under a variety of circumstances, signed written consent is not appropriate in qualitative research. However, where
p.000139: there are valid reasons for not recording consent through a signed written consent form, the procedures used to seek
p.000139: and confirm consent must be documented.
p.000139: The consent process should be based on mutual understanding of the project goals and objectives between the
p.000139: participants and the researcher. The participant may perceive attempts to legalize or formalize the process as a
p.000139: violation of that trust. Qualitative researchers use a range of procedures to seek and document consent, including oral
p.000139: consent documented in field notes, and other forms of recording (a consent log, audio or video recordings, or other
p.000139: electronic means) Evidence of consent may also be documented via completed questionnaires (in person, by mail, or by
p.000139: email or other electronic means).
p.000139: REBs may need to consider the power relationship that might exist between researchers and participants, and
p.000139: whether a waiver of the requirement for signed written consent may affect the welfare of the participants. In cases
p.000139: where the participant holds a position of power, or routinely engages in communicative interactions similar
...
p.000141: anonymity is the exception. Researchers make the option for anonymity known to participants as part of the discussion
p.000141: around the nature and conditions of their consent.
p.000141: In some types of critical inquiry, anonymity would result in individuals in positions of power not being held
p.000141: accountable for their actions, and for how their exercise of power has implications for others. The safeguards for
p.000141: those in the public arena are through public debate and discourse, and through action in the courts for libel.
p.000141: In much other social science and some humanities research, it is primarily the harm that can result from violations of
p.000141: confidentiality that REBs and researchers need to address. This can pose a particular challenge in qualitative research
p.000141: because of
p.000141:
p.000141:
p.000141:
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p.000143: Chapter 10 – Qualitative Research
p.000143:
p.000143: the depth, detail, sensitivity and uniqueness of information obtained. The default approach is to maintain
p.000143: confidentiality of the research data. In some instances, participants may waive anonymity (e.g., if they wish to be
p.000143: identified for their contributions to the research). The researcher may accept the waiver of anonymity by the
p.000143: participant as long as such a waiver does not compromise the welfare of other participants (see Article 3.2(f) and the
p.000143: Application of Article 5.1). In some cases, the researcher may decide to maintain the anonymity of the participant in
p.000143: publications or dissemination of research results to ensure confidentiality of the data and anonymity of other
p.000143: participants.
p.000143: REBs need to be sensitive to whether anonymity, confidentiality or identification is relevant in any given research
p.000143: context, and acknowledge that individuals may want to be credited for their contribution by being named.
p.000143: Researchers and REBs should consult Chapter 3 and 5 for additional details and considerations (see also Chapter 9).
p.000143:
p.000143: Qualitative Research Involving Emergent Design
p.000143: In qualitative research, emergent design involves data collection and analysis that can evolve over the course of a
p.000143: research project in response to what is learned in earlier parts of the study. Specific questions or other elements of
p.000143: data collection may be difficult to anticipate, identify and articulate fully in the research proposal in advance of
p.000143: the project’s implementation.
p.000143: Article 10.5 In studies using emergent design in data collection, researchers shall provide the REB with all the
p.000143: available information to assist in the review and approval of the general procedure for data collection.
p.000143: Researchers shall consult with the REB when, during the conduct of the research, changes to the data collection
p.000143: procedures may present ethical implications and associated risks to the participants.
p.000143: Application Although initial research questions may be outlined in the formalized research proposal, REBs should be
p.000143: aware that it is quite common for specific questions (as well as shifts in data sources or discovery of data sources)
p.000143: to emerge only during the research project. Due to the inductive nature of qualitative research and the emergent design
p.000143: approach of the research, some of these elements may evolve as the project progresses.
p.000143: Researchers using emergent design shall provide the REB with all the available information to allow for a proportionate
p.000143: approach to research ethics review of the research project. In cases where final versions of a questionnaire or
p.000143: interview schedule have not been developed at the time of the ethics review of the research project, researchers
p.000143: should submit a draft set of sample questions, thematic categories or other outlines of the procedures to be
p.000143: followed in data collection. Final versions should be submitted as soon as they become available. REBs should not
p.000143: require researchers to provide them with a full questionnaire schedule in
p.000143:
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p.000143: advance of data collection. Rather, REBs should ensure that the data collection is conducted according to
p.000143: methodological requirements, and acknowledge that questionnaires or interview guides may change to adapt to emerging
p.000143: data or circumstances in the field.
p.000143: In emergent design, some resulting changes to the research design will not merit requiring additional REB review, as
p.000143: they are not necessarily significant changes to the approved research. Consistent with Article 6.15, where changes of
p.000143: data collection procedures would represent a change in the level of the risk that may affect the welfare of the
p.000143: participants, researchers shall seek approval from the REB prior to implementing such changes. Additional REB review
p.000143: and approval may be required (see Chapter 2 and Articles 6.14 and 6.15).
p.000143:
p.000143: References
p.000143:
p.000143:
p.000143: • Canadian Institutes for Health Research. CIHR Best Practices for Protecting Privacy in Health Research. September
p.000143: 2005. www.cihr-irsc.gc.ca/e/29072.html
p.000143: • Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social
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p.000147: Clinicians must take care not to create un- realistic expectations among participants with respect to the potential
p.000147: benefits of the research.
p.000147: To preserve the trust on which their professional relationships with patients and colleagues reside, researchers should
p.000147: take all necessary measures to separate their role as researcher from their role as clinician (e.g., enlist associates
p.000147: to recruit participants, rely on colleagues to determine when a patient should be withdrawn). It is important REBs
p.000147: appreciate the potential conflicts between these roles and the possible impact on the welfare of prospective
p.000147: participants.
p.000147:
p.000147: B. Clinical Trial Design and Registration
p.000147: This section discusses ethical issues associated with the design and registration of clinical trials. Guidance for the
p.000147: most common types of clinical trials (pharmaceuticals, medical devices) as well as other types of trials (natural
p.000147: health products, psychotherapy and surgery), is provided in sub- sections of the Application of Article 11.1. Though
p.000147: not all possible clinical trial designs are
p.000147:
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p.000149: represented in this section, the guidance provided can be applied and adapted as needed. Researchers are
p.000149: advised to consult the relevant provincial, national and international regulatory documents to design their clinical
p.000149: trial (see References at the end of the chapter). In all clinical trials, researchers and REBs should be aware of
p.000149: ethical issues including, but not limited to, registration, safety, selection and recruitment of participants,
p.000149: undue inducement, consent, dissemination of findings, and real, potential or perceived conflicts of interest.
p.000149: Article 11.1 In the design and review of a clinical trial, researchers and REBs shall consider the type of trial
p.000149: (e.g., pharmaceutical, natural health product, medical device, psychotherapy), its phase (if appropriate) and the
p.000149: corresponding particular ethical issues associated with it, in light of the core principles of this Policy.
p.000149: Application Each type of clinical trial has specific ethical issues that correspond to the risks faced by the
p.000149: participants. In a proposal submitted for research ethics review, the researcher shall clearly specify the type of
p.000149: trial proposed (and, where relevant, its phase), identify the foreseeable risks and potential benefits to participants,
p.000149: and show how this information will be clearly communicated to participants in the consent process (see Article 3.2).
p.000149: REBs reviewing clinical trials need to be familiar with the ethical issues raised by different phases, and by different
p.000149: types, of clinical trials. If an REB does not have members with the appropriate expertise to review a particular trial,
p.000149: then it shall seek out someone with the necessary expertise to consult as an ad hoc advisor (see Article 6.5).
p.000149: This guidance applies equally to continuing research ethics review, including requests to make changes to the method,
p.000149: statistical procedures, inclusion/exclusion criteria, or other elements of approved research, as required by this
p.000149: Policy (see Article 6.14 and 6.16).
p.000149: Pharmaceutical Trials
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p.000155: participants. Registration also improves researchers’ ability to identify potential collaborators and/or gaps in
p.000155: research so that they may pursue new avenues of inquiry with potential benefits to participants and to society. Perhaps
p.000155: of most concern is the danger that some researchers or sponsors may only report trials with favourable outcomes.
p.000155: Failing to report the outcome of a trial or withholding negative findings is more difficult when all trials must be
p.000155: registered.
p.000155: The registration of clinical trials upholds the principles of Respect for Persons, Concern for Welfare, and Justice,
p.000155: by ensuring that the efforts of all participants in clinical trials are acknowledged, and by reducing the
p.000155: potential for endangerment of others through publication bias.
p.000155: Article 11.3 All clinical trials shall be registered before recruitment of the first trial participant in a
p.000155: recognized and easily web-accessible public registry.
p.000155: Application Clinical trial registries are intended to increase transparency and accountability by providing a
p.000155: record of clinical trials at the recruitment stage that can be used to locate publication of trial results (see Article
p.000155: 11.12). This helps prevent publication
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p.000155:
p.000155: bias, that is, the selective publication of only those trials that yield results in support of an intervention. These
p.000155: registries, in addition to agency policies, editorial policies, ethical policy reforms, and revised national and
p.000155: institutional ethics policies and results disclosure requirements, contribute to a multi-faceted approach to eliminate
p.000155: non-disclosure. The collective goal is to reduce publication bias, and prevent the suppression of data in clinical
p.000155: research.
p.000155: Clinical trials shall be registered in a registry that is compliant with the criteria set by the World Health
p.000155: Organization (WHO)2 or International Committee of Medical Journal Editors (ICMJE)3 as of November 2010. Researchers
p.000155: shall provide the REB with the number assigned to the trial upon registration.
p.000155:
p.000155: C. Assessing Safety and Minimizing Risk
p.000155: Participants enrolled in clinical trials are commonly exposed to investigational therapies, interventions,
p.000155: drugs or devices, each of which carries specific, and possibly unknown, risks. Because of the nature of clinical
p.000155: interventions, the potential harms can be physical, psychological or social, and may cause lasting, irreparable damage.
p.000155: In accordance with the core principles, it is the responsibility of researchers and REBs to ensure that (a) foreseeable
p.000155: risks to participants are minimized, and appropriately evaluated alongside potential benefits, (b) participants are
p.000155: clearly informed as to the nature of these foreseeable risks and potential benefits, (c) participant safety is
p.000155: monitored and accurately reported, and (d) any new information that may impact on the welfare of participants, or their
p.000155: decision to remain involved in a trial, be shared appropriately.
p.000155: Article 11.4 Researchers and REBs should ensure that the foreseeable risk to participants in clinical trials is:
p.000155: (a) justified by the potential benefits to be gained; and (b) appropriately minimized.
p.000155: Application The researcher has a responsibility to present the proposed research in the context of a systematic
p.000155: review of the literature on that topic. Clinical trials should not be conducted unnecessarily on questions that have
p.000155: already been definitively answered.
p.000155: The proportionate approach to research ethics review (see Chapter 2, Section B) dictates that trials deemed to be of
...
p.000157: among researchers involved in a multi-site trial.
p.000157: Trials may also have sponsors who can be a source of new information. Sponsors may be the principal investigator
p.000157: (investigator-initiated trials), a research institution or another type of
p.000157:
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p.000159: organization (e.g., private company, not-for-profit association). When principal investigators receive new information,
p.000159: from the sponsor or any other source related to the trial, they are responsible for communicating this new information
p.000159: to their own REB, as well as to local site researchers, who must then inform their local REBs.
p.000159: The extent to which new information is shared with participants depends upon the nature of the information, and the
p.000159: REB’s evaluation of whether it affects the welfare or consent of some or all participants. In the case of multi-site
p.000159: trials (also known as multi-jurisdictional trials), the roles and responsibilities of the principal investigator,
p.000159: researchers and sponsor may vary depending on the model of research ethics review in use (see Chapter 8).
p.000159: Article 11.7 Researchers shall provide the REB with an acceptable plan for monitoring the safety of participants,
p.000159: including a plan for the tabulation, analysis and reporting of safety data, and the sharing of other new information in
p.000159: a form that permits REBs to interpret and respond appropriately.
p.000159: Application Researchers and REBs must ensure that every clinical trial proposal includes a plan to assess safety
p.000159: concerns and protect the ongoing safety of participants. The responsibility of establishing a safety monitoring plan is
p.000159: the responsibility of the researcher. This plan shall include the requirement that researchers provide REBs with clear
p.000159: and up-to-date information about the safety of participants taking part in clinical research. These summary reports
p.000159: should be provided promptly and include information about the context and significance of reported data to permit a
p.000159: fair interpretation and meaningful review by the REB for the protection of participants. When the REB
p.000159: requires additional information, the researcher shall provide it. If necessary, the REB may require that this
p.000159: evaluation shall be conducted by a qualified source, independent of any sponsor, who has no conflict of interest (see
p.000159: Chapter 7).
p.000159: Any safety monitoring plan should include a mechanism by which researchers may remove participants for safety reasons
p.000159: and by which clinical trials may be stopped or amended if they are found to be unsafe, or for reasons of futility
p.000159: (e.g., it is determined that the trial is unlikely to produce valid results) or efficacy (e.g., one or more
p.000159: interventions are found to be successful).
p.000159: A safety monitoring plan may (but need not) include the establishment of a data safety monitoring board (DSMB) or data
p.000159: safety committee (DSC).
p.000159: A DSMB is normally a multidisciplinary, expert advisory group that is responsible for safeguarding the interests of
p.000159: participants, by reviewing emerging data, assessing the safety and efficacy of trial procedures, and monitoring the
p.000159: overall conduct of a trial. Researchers must indicate, in their proposal for REB review, whether they or a DSMB will be
p.000159: communicating any new information to the REB over the course of the trial. Researchers must ensure that DSMB reports
p.000159: are sent to REBs in a timely manner.
p.000159:
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p.000159:
p.000159: The appointment of a DSMB does not alter the responsibilities of researchers and REBs to monitor participant safety. In
p.000159: the context of multi-site trials, when new information at one site may be relevant to participant welfare and consent
p.000159: at other sites, principal investigators must ensure that this information is shared with researchers at each
p.000159: site, and researchers must ensure that the REB also receives these reports (Article 11.8). The REB must be prepared to
p.000159: act upon these reports, especially where urgent action is required (see Article 11.9).
p.000159: Article 11.8 Researchers shall promptly report new information that may affect the welfare or consent of
p.000159: participants, to the REB, and to other appropriate regulatory or advisory bodies. When new information is relevant to
p.000159: participants’ welfare, researchers shall promptly inform all participants to whom the information applies (including
p.000159: former participants). Researchers shall work with their REB to determine which participants must be informed,
p.000159: and how the information should be conveyed.
p.000159: Application In the course of any type of clinical trial, new information may arise that is relevant to
p.000159: participants’ welfare and/or their ongoing consent to participate (see Article 2.8, Article 3.3, Articles 6.15 and
p.000159: 6.16, and Article 11.8) This new information may arise from unanticipated issues (e.g., adverse reactions to
p.000159: interventions) or from routine evaluations of participant health that occur in the context of the trial. It may pertain
p.000159: to all participants, or only to those in one arm of a trial, or only to one participant with a particular health issue.
p.000159: It may be information that arises from other related research that has repercussions for ongoing trials. To understand
p.000159: the particular relevance of new information, it should be considered from the perspective of the
p.000159: participant. Article 11.8 outlines the continuing duty of researchers to share new and relevant information
p.000159: regarding clinical trials with the REB and other relevant bodies, and with participants and their primary
p.000159: care clinicians, as indicated by the nature of the information. The more relevant, serious and urgent the information,
p.000159: the more promptly it should be disclosed.
p.000159: New information that arises outside the trial (e.g., new findings in other related research) must also be disclosed
p.000159: when that information is relevant to the participant’s ongoing consent to participation. Researchers should also
p.000159: promptly share new information about an intervention with other researchers or clinicians administering it to
p.000159: participants or patients, and with the scientific community – to the extent that it may be relevant to the general
p.000159: public’s welfare. New information thus covers a range of matters that includes, but is not limited to, the following:
p.000159: • changes to the research design;
p.000159: • evidence of any new risks;
p.000159: • unanticipated issues that have possible health or safety consequences for participants;
p.000159: • new information that decisively shows that the benefits of one intervention exceed those of another;
p.000159:
p.000159:
p.000159:
p.000159:
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p.000161: • new research findings, including relevant non-trial findings;
p.000161: • unanticipated problems involving lack of efficacy, recruitment issues or other matters determined to be serious
p.000161: enough to warrant disclosure; or
p.000161: • closure of trials at other sites for reasons that may be relevant to the welfare or consent of participants in
p.000161: the ongoing trial.
p.000161: The duty to report new information to the REB, along with the necessary analysis and evaluation to make the new
p.000161: information interpretable, lies with the researcher. In the case of newly discovered risks or unanticipated issues, the
p.000161: report shall also include a plan to eliminate or mitigate any increased risks to participants. The REB should encourage
p.000161: researchers to raise potentially relevant developments with the REB at an early stage to better determine the
p.000161: appropriate scope and timing of information sharing with participants and regulatory authorities.
p.000161: When new information is relevant to the welfare of all participants, then researchers and REBs have a duty
p.000161: to ensure that all participants are informed. Where new information affects only current participants in the trial, the
p.000161: REB may decide that former participants need not be informed. However, researchers may decide to voluntarily share this
p.000161: information with all participants if they choose.
p.000161: In multi-site clinical trials, when new information arises at one site that may affect participant welfare or consent
p.000161: at other sites, the researcher in charge of that site shall promptly inform the principal investigator of the
p.000161: trial. The principal investigator shall inform researchers at all other sites of the trial. It is the
p.000161: responsibility of the researcher in charge of each site to ensure their REB receives this information in a timely
p.000161: fashion.
p.000161: The welfare of participants must also be considered when a trial is unexpectedly discontinued. When a researcher, a
p.000161: sponsor or other body (institution, funding agency, regulatory body) stops or unblinds a clinical trial, or a part of a
p.000161: clinical trial, the principal investigator has an ethical and a regulatory responsibility to inform both clinical
p.000161: trial participants and the REB of the discontinuance or unblinding and the reasons for it. Any risks to
p.000161: participants that may arise from the closing of the trial must be communicated in writing to the REB and
p.000161: the participants, and the researcher shall indicate any measures that will be taken to mitigate these risks.
p.000161: New information affecting the welfare of former participants may arise after the completion of the trial or after the
p.000161: participants’ involvement is finished. If so, the researcher should share the information with the REB and
p.000161: other appropriate regulatory or advisory bodies. The REB and the researcher should consider whether, given
p.000161: its nature and urgency, the information would be relevant to any former participants’ welfare and informed choices, as
p.000161: well as to ongoing research elsewhere, and the general public. If so, reasonable steps should be taken by
p.000161:
p.000161:
p.000161:
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p.000161:
p.000161: researchers to inform former participants, and to publicly disclose the information, in a meaningful and timely manner.
p.000161: Article 11.9 REBs shall develop procedures to review safety reports and other new information arising from clinical
p.000161: trials that may affect the welfare or consent of participants, and to take appropriate steps in response.
p.000161: Application In accordance with Articles 11.7 and 11.8 and Articles 6.15 and 6.16, REBs can expect to receive safety
p.000161: reports and new information, including, but not limited to, unanticipated issues, changes to the research design and
p.000161: newly discovered risks. The reports are usually submitted by the local site researcher, who may also be the principal
p.000161: investigator, or by an established safety monitoring body, such as a DSMB (see Article 11.7).
p.000161: It is the REB’s responsibility to establish procedures for reviewing safety reports and new information, to determine
p.000161: how they will respond to increased risks to participants, and to be ready to implement these responses as needed.
p.000161: Responses shall be relative to the seriousness and likelihood of the risk to the welfare of participants within their
p.000161: jurisdiction. REBs may advise researchers as to the steps they must take to eliminate or mitigate newly
p.000161: reported risks, and how this information should be shared with participants (see Article 11.8). In exceptional
p.000161: cases, REBs may decide to suspend new recruitment, or to suspend all participant involvement in a trial pending further
p.000161: investigation.
p.000161:
p.000161: D. Financial Conflicts of Interest
p.000161: Clinical trials can be affected by all types of conflict of interest: personal, professional and/or institutional (as
p.000161: described in Chapter 7). Article 11.10 deals specifically with financial conflicts of interest that are of concern for
p.000161: sponsored clinical trials.
p.000161: Sponsored Research
...
p.000169: process. Chapter 3 provides guidance on research directives. REBs and researchers should be aware that provincial
p.000169: human tissue gift laws may provide a legal framework for the donation of tissue upon death.
p.000169:
p.000169: Article 12.2 To seek consent for use of human biological materials in research, researchers shall provide to
p.000169: prospective participants or authorized third parties, applicable information as set out in Article 3.2 as well as
p.000169: the following details:
p.000169: (a) the type and amount of biological materials to be taken;
p.000169:
p.000169:
p.000169:
p.000169:
p.000169:
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p.000171:
p.000171: (b) the manner in which biological materials will be taken, and the safety and invasiveness of the procedures for
p.000171: acquisition;
p.000171: (c) the intended uses of the biological materials, including any commercial use;
p.000171: (d) the measures employed to protect the privacy of and minimize risks to participants;
p.000171: (e) the length of time the biological materials will be kept, how they will be preserved, location of storage
p.000171: (e.g., in Canada, outside Canada), and process for disposal, if applicable;
p.000171: (f) any anticipated linkage of biological materials with information about the participant; and
p.000171: (g) the researchers’ plan for handling results and findings, including clinically relevant information and
p.000171: incidental findings.
p.000171: Application Chapter 3, especially Article 3.2, provides detailed guidance on the need for consent to participation
p.000171: in research. Article 12.2 provides additional guidance on information that prospective participants generally
p.000171: require to make an informed decision to donate biological materials for use in research. While all the basic guidelines
p.000171: of Chapter 3 regarding consent apply to research involving human biological materials, some deserve special attention.
p.000171: For example, explaining the potential for commercialization or financial conflict of interest is important, as some
p.000171: research with human biological materials may involve the possibility of significant commercial gain for researchers or
p.000171: sponsors. The process for requesting withdrawal of human biological materials from research shall also be
p.000171: clearly explained, along with an explanation of the conditions under which researchers would not be able to remove a
p.000171: participant’s data from the project. For instance, where participants request the withdrawal of their biological
p.000171: materials, information already derived from the materials and aggregated into findings cannot be withdrawn.
p.000171: Anonymization of human biological materials may also preclude subsequent withdrawal. Chapter 3 provides further
p.000171: guidance on handling incidental findings.
p.000171:
p.000171: C. Consent and Secondary Use of Identifiable Human Biological Materials for Research Purposes
p.000171: Chapter 5 provides detailed guidance on secondary use of information for research purposes (in particular, see Articles
p.000171: 5.5 and 5.6). The following section adapts the provisions in Chapter 5 to the specific context of research
...
p.000171: the current research purpose. A researcher may seek to use human biological
p.000171:
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p.000171:
p.000171: materials left over from a diagnostic examination or surgical procedure, or materials that were collected for an
p.000171: earlier project. Reasons to conduct secondary analyses include: avoidance of duplication in primary collection and
p.000171: the associated reduction of burdens on participants; corroboration or criticism of the conclusions of the
p.000171: original research; comparison of change in a research sample over time; application of new tests of hypotheses that
p.000171: were not available at the time of original collection; and confirmation that the data or materials are authentic.
p.000171: Privacy concerns and questions about the need to seek consent arise, however, when human biological materials provided
p.000171: for secondary use in research can be linked to individuals, and when the possibility exists that individuals can be
p.000171: identified in published reports, or through linkage of human biological materials with other data.
p.000171: Article 12.3 Researchers who have not obtained consent from participants for secondary use of identifiable human
p.000171: biological materials shall only use such material for these purposes if the REB is satisfied that:
p.000171: (a) identifiable human biological materials are essential to the research;
p.000171: (b) the use of identifiable human biological materials without the participant’s consent is unlikely to adversely
p.000171: affect the welfare of individuals from whom the materials were collected;
p.000171: (c) the researchers will take appropriate measures to protect the privacy of individuals and to safeguard
p.000171: the identifiable human biological materials;
p.000171: (d) the researchers will comply with any known preferences previously expressed by individuals about any use of their
p.000171: biological materials;
p.000171: (e) it is impossible or impracticable to seek consent from individuals from whom the materials were collected; and
p.000171: (f) the researchers have obtained any other necessary permission for secondary use of human biological materials for
p.000171: research purposes.
p.000171: If a researcher satisfies all the conditions in Article 12.3(a) to (f), the REB may approve the research without
p.000171: requiring consent from the individuals from whom the biological materials were collected.
p.000171: Application This Policy does not require that researchers seek consent from individuals for the secondary use of
p.000171: non-identifiable human biological materials. In the case of the secondary use of identifiable human biological
p.000171: materials, researchers must obtain consent in accordance with applicable laws, unless the researcher satisfies all the
p.000171: requirements in Article 12.3.
p.000171: The exception to the requirement to seek consent in this article is specific to secondary use of
p.000171: identifiable human biological materials. The terms of Article 3.7 address alteration of consent in other circumstances
p.000171: and do not apply here.
p.000171:
p.000171:
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p.000173:
p.000173: Secondary use of human biological materials identifiable as originating from a specific Aboriginal community, or a
p.000173: segment of the Aboriginal community at large, is addressed in Articles 9.20 to 9.22.1
p.000173: “Impracticable” refers to undue hardship or onerousness that jeopardizes the conduct of the research; it does
p.000173: not mean mere inconvenience.2 Consent may be impossible or impracticable when the group is very large or its members
p.000173: are likely to be deceased, geographically dispersed or difficult to track. Attempting to track and contact members of
p.000173: the group may raise additional privacy concerns. Financial, human and other resources required to contact individuals
p.000173: and seek consent may impose undue hardship on the researcher. In some jurisdictions, privacy laws may preclude
p.000173: researchers from using personal information to contact individuals to seek their consent for secondary use of
p.000173: information.
p.000173: At the time of initial collection, individuals may have had an opportunity to express preferences about future uses of
p.000173: their biological materials, including research uses (see paragraphs (d) and (i) in the Application of Article 3.2).
p.000173: Custodians that hold human biological materials have an obligation to respect the individual’s expressed preferences.
p.000173: Where an individual does not want biological materials used for future research, custodians should remove these
p.000173: biological materials from any collections used or made available for research. Alternatively, individuals may have made
p.000173: an express donation of biological materials for research in accordance with human tissue gift legislation.
p.000173: In cases where the proposed research involves issues of greater sensitivity (e.g., re- search involving stigmatizing
p.000173: conditions), an REB may require that researchers engage in discussion with people whose perspectives can help identify
p.000173: the ethical implications of the research, and suggest ways to minimize any associated risks. Discussion is not intended
p.000173: to serve as proxy consent. Rather, a goal of discussion is to seek input regarding the proposed research, such as the
p.000173: design of the research, measures for privacy protection, and potential uses of findings. Discussion may also be useful
p.000173: to determine whether the research will adversely affect the welfare of individuals from whom the biological materials
p.000173: were collected. Researchers shall advise the REB of the outcome of such discussions. The REB may require modifi-
p.000173: cations to the research proposal based on these discussions.
p.000173: Article 12.4 When secondary use of identifiable human biological materials without the requirement to seek
p.000173: consent has been approved under Article 12.3, researchers who propose to contact individuals for additional biological
p.000173: materials or information shall, prior to contact, seek REB approval of the plan for making contact.
p.000173: Application In certain cases, a research goal may be achieved only through follow-up contact with individuals to
p.000173: collect additional biological materials or information. Under Article 12.3, the REB may have approved secondary use
p.000173: without the requirement to seek consent based, in part, on the impossibility or impracticability of seeking consent
p.000173: from all individuals whose biological materials are proposed for use in
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p.000173:
p.000173: research. Where contact with a sub-group is feasible, researchers may subsequently wish to attempt to make contact
p.000173: with some individuals to obtain additional information or biological materials. Contact with individuals whose
p.000173: previously collected biological materials have been approved for secondary use in research raises privacy concerns.
p.000173: Individuals might not want to be contacted by researchers or might be upset that identifiable biological materials were
p.000173: disclosed to researchers without their consent. The potential benefits of follow-up contact must clearly outweigh the
p.000173: risks to individuals of follow-up contact, and the REB must be satisfied that the proposed manner of
p.000173: follow-up contact minimizes risks to individuals. The proposed plan should explain who will contact individuals to
p.000173: invite their participation in the research (e.g., a representative of the organization that holds the individual’s
p.000173: biological materials) and the nature of their relationship with those individuals. Researchers must also ensure that a
p.000173: plan for follow-up contact complies with applicable privacy legislation; for example, some privacy laws prohibit
p.000173: researchers from contacting individuals unless the custodian of the information has first obtained individuals’
p.000173: consent to be contacted. Whenever possible, it is preferable that re-contact with participants be carried out by the
p.000173: organization or the custodian holding the biological materials. Researchers will need to seek consent from individual
p.000173: participants for any new collection of data or biological materials. Article 3.1 provides further guidance on
p.000173: consent and approaches to recruitment.
p.000173:
p.000173: D. Storage and Banking of Human Biological Materials
p.000173: The collection and retention of human biological materials in biobanks creates an ongoing resource for research.
p.000173: Biobanks vary widely in their characteristics: some are very small, while others hold biological materials from
p.000173: thousands of individuals; they may be disease-specific or contain materials from a wide population base.
...
p.000179:
p.000179: Research may help us better understand the human genome, and genetic contributions to health and disease. It may lead
p.000179: to new approaches to preventing and treating disease. Individuals may benefit from learning about their genetic
p.000179: predispositions, if intervention strategies are available to prevent or minimize disease onset and mitigate symptoms,
p.000179: or to otherwise promote health. Genetic research also has the potential, however, to stigmatize individuals,
p.000179: communities or groups, who may experience discrimination or other harms because of their genetic status, or may be
p.000179: treated unfairly or inequitably.
p.000179:
p.000179: A. Application of Core Principles to Genetic Research
p.000179: Genetic information has implications beyond the individual because it may reveal information about biological relatives
p.000179: and others with whom the individual shares genetic ancestry. The participation of an individual in genetic research may
p.000179: therefore have ramifications for these other persons, communities or groups. In some cases, researchers specifically
p.000179: seek to conduct genetic research with members of families, communities or groups that requires particular attention to
p.000179: the social and cultural contexts in which participants live. Research with families, communities or groups may raise
p.000179: special considerations regarding recruitment of participants, consent processes, privacy and confidentiality.
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
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p.000181: Chapter 13 – Human Genetic Research
p.000181:
p.000181: Article 13.1 Guidance regarding a proportionate approach to research ethics review, consent, privacy,
p.000181: confidentiality, research with human biological materials and other ethical guidance described in earlier chapters of
p.000181: this Policy apply equally to human genetic research.
p.000181: Application In developing and reviewing proposals involving genetic research, researchers and REBs should refer to
p.000181: earlier chapters in this Policy, including consent in Chapter 3, privacy and confidentiality in Chapter 5, and human
p.000181: biological materials and mate- rials related to human reproduction in Chapter 12. Other chapters relevant to the
p.000181: specific research proposal should also be consulted, such as Chapter 9 concerning research involving Aboriginal peoples
p.000181: or Chapter 11 on clinical trials. This chapter does not reiterate guidance set out in earlier chapters. Rather, it
p.000181: focuses on issues that arise specifically in the context of human genetic research and provides guidance for managing
p.000181: information revealed through genetic research, provision of genetic counselling, participation of families, communities
p.000181: and groups in genetic research, banking of human biological materials, and research involving gene transfer.
p.000181:
p.000181: B. Plans for Managing Information Revealed through Genetic Research
p.000181: Article 13.2 Researchers conducting genetic research shall:
p.000181: (a) in their research proposal, develop a plan for managing information that may be revealed through their genetic
p.000181: research;
p.000181: (b) submit their plan to the REB; and
p.000181: (c) advise prospective participants of the plan for managing information revealed through the research.
p.000181: Application The types of information that may be revealed through genetic research – and the implications of this
p.000181: information for participants and their biological relatives – require that researchers and REBs ensure that an
p.000181: appropriate plan is in place for managing information. In some cases, genetic research may reveal known gene- disease
p.000181: associations or other information, including incidental findings, that may be clinically relevant for individuals (or
p.000181: their biological relatives) in treating or alleviating health conditions or risks. In other cases, research
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| HIV | HIV/AIDS |
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| access to information | Access to information |
| age | Age |
| another country | Other Country |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| belief | Religion |
| blind | visual impairment |
| breastfeeding | breastfeeding |
| child | Child |
| children | Child |
| cioms | cioms guidelines |
| coerce | Presence of Coercion |
| cognitive | Cognitive Impairment |
| control group | participants in a control group |
| criminal | criminal |
| culturally | cultural difference |
| degenerative | degenerative conditions |
| dependence | Drug Dependence |
| dependency | Drug Dependence |
| dependent | Dependent |
| diminished | Diminished Autonomy |
| disability | Mentally Disabled |
| disabled | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| educational | education |
| elderly | Elderly |
| embryo | embryo |
| emergencies | patients in emergency situations |
| emergency | Public Emergency |
| emergency situation | patients in emergency situations |
| employees | employees |
| ethnicity | Ethnicity |
| family | Motherhood/Family |
| fetus | Fetus/Neonate |
| fetuses | Fetus/Neonate |
| gender | gender |
| healthy volunteers | Healthy People |
| helsinki | declaration of helsinki |
| hiv/aids | HIV/AIDS |
| home | Property Ownership |
| illegal | Illegal Activity |
| illness | Physically Disabled |
| impaired | Cognitive Impairment |
| impairment | Cognitive Impairment |
| incapable | Mentally Incapacitated |
| incapacitated | Incapacitated |
| incapacity | Incapacitated |
| indigenous | Indigenous |
| infant | Infant |
| influence | Drug Usage |
| institutionalized | Institutionalized |
| language | Linguistic Proficiency |
| liberty | Incarcerated |
| linguistic | Linguistic Proficiency |
| low-income | Economic/Poverty |
| military | Soldier |
| minor | Youth/Minors |
| minority | Racial Minority |
| nation | stateless persons |
| native | Indigenous |
| necessities | Access to Social Goods |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| other country | Other Country |
| parents | parents |
| party | political affiliation |
| philosophy | philosophical differences/differences of opinion |
| physically | Physically Disabled |
| placebo | participants in a control group |
| police | Police Officer |
| political | political affiliation |
| poor | Economic/Poverty |
| poverty | Economic/Poverty |
| pregnant | Pregnant |
| prison | Incarcerated |
| prisoners | Criminal Convictions |
| property | Property Ownership |
| public official | public official |
| race | Racial Minority |
| religion | Religion |
| religious | Religion |
| restricted | Incarcerated |
| single | Marital Status |
| social goods | Access to Social Goods |
| social status | Economic/Poverty |
| social welfare | Access to Social Goods |
| stem cells | stem cells |
| sti | sexually transmitted disases |
| stigmatization | Threat of Stigma |
| stigmatized | Threat of Stigma |
| student | Student |
| substance | Drug Usage |
| threat | Threat of Stigma |
| trauma | Victim of Abuse |
| tri-council | tri-council policy statement |
| unconscious | Unconscious People |
| undue influence | Undue Influence |
| unemployment | Unemployment |
| union | Trade Union Membership |
| usage | Drug Usage |
| violence | Threat of Violence |
| volunteers | Healthy People |
| vulnerability | vulnerable |
| vulnerable | vulnerable |
| women | Women |
| youth | Youth/Minors |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| HIV | ['hiv/aids'] |
| abuse | ['trauma'] |
| access | ['necessities', 'socialXgoods', 'socialXwelfare'] |
| another country | ['otherXcountry'] |
| belief | ['religion', 'religious'] |
| child | ['children'] |
| children | ['child'] |
| cognitive | ['impaired', 'impairment'] |
| control group | ['placebo'] |
| dependence | ['dependency'] |
| dependency | ['dependence'] |
| disability | ['disabled'] |
| disabled | ['disability'] |
| drug | ['influence', 'substance', 'usage'] |
| education | ['educational'] |
| educational | ['education'] |
| emergencies | ['emergencyXsituation'] |
| emergency situation | ['emergencies'] |
| fetus | ['fetuses'] |
| fetuses | ['fetus'] |
| healthy volunteers | ['volunteers'] |
| hiv/aids | ['HIV'] |
| home | ['property'] |
| illness | ['physically'] |
| impaired | ['cognitive', 'impairment'] |
| impairment | ['cognitive', 'impaired'] |
| incapacitated | ['incapacity'] |
| incapacity | ['incapacitated'] |
| indigenous | ['native'] |
| influence | ['drug', 'substance', 'usage'] |
| language | ['linguistic'] |
| liberty | ['prison', 'restricted'] |
| linguistic | ['language'] |
| low-income | ['poor', 'poverty', 'socialXstatus'] |
| minor | ['youth'] |
| minority | ['race'] |
| native | ['indigenous'] |
| necessities | ['socialXgoods', 'socialXwelfare', 'access'] |
| officer | ['police'] |
| opinion | ['philosophy'] |
| other country | ['anotherXcountry'] |
| party | ['political'] |
| philosophy | ['opinion'] |
| physically | ['illness'] |
| placebo | ['controlXgroup'] |
| police | ['officer'] |
| political | ['party'] |
| poor | ['poverty', 'low-income', 'socialXstatus'] |
| poverty | ['poor', 'low-income', 'socialXstatus'] |
| prison | ['liberty', 'restricted'] |
| property | ['home'] |
| race | ['minority'] |
| religion | ['belief', 'religious'] |
| religious | ['belief', 'religion'] |
| restricted | ['liberty', 'prison'] |
| social goods | ['necessities', 'socialXwelfare', 'access'] |
| social status | ['poor', 'poverty', 'low-income'] |
| social welfare | ['necessities', 'socialXgoods', 'access'] |
| stigmatization | ['threat', 'stigmatized'] |
| stigmatized | ['threat', 'stigmatization'] |
| substance | ['drug', 'influence', 'usage'] |
| threat | ['stigmatization', 'stigmatized'] |
| trauma | ['abuse'] |
| usage | ['drug', 'influence', 'substance'] |
| volunteers | ['healthyXvolunteers'] |
| vulnerability | ['vulnerable'] |
| vulnerable | ['vulnerability'] |
| youth | ['minor'] |
Trigger Words
capacity
coercion
consent
cultural
developing
ethics
harm
justice
protect
protection
risk
self-determination
sensitive
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input