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:

This file was generated: 2020-12-01 05:01:49

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

Vulnerability TypeVulnerabilityIndicator# Matches
PoliticalCriminal Convictionsprisoners4
PoliticalIllegal Activityillegal1
PoliticalIndigenousindigenous15
PoliticalIndigenousnative1
Politicalcriminalcriminal3
Politicalpolitical affiliationparty37
Politicalpolitical affiliationpolitical10
Politicalstateless personsnation6
Politicalvulnerablevulnerable23
Politicalvulnerablevulnerability16
HealthCognitive Impairmentcognitive6
HealthCognitive Impairmentimpaired2
HealthCognitive Impairmentimpairment4
HealthDrug Dependencedependence1
HealthDrug Dependencedependency3
HealthDrug Usagedrug18
HealthDrug Usageinfluence13
HealthDrug Usagesubstance3
HealthDrug Usageusage2
HealthHIV/AIDSHIV3
HealthHIV/AIDShiv/aids0
HealthHealthy Peoplehealthy volunteers1
HealthHealthy Peoplevolunteers1
HealthMentally Disableddisabled1
HealthMentally Disableddisability2
HealthMentally Incapacitatedincapable2
HealthMotherhood/Familyfamily23
HealthPhysically Disabledillness7
HealthPhysically Disabledphysically2
HealthPregnantpregnant4
HealthUnconscious Peopleunconscious1
Healthbreastfeedingbreastfeeding4
Healthdegenerative conditionsdegenerative1
Healthpatients in emergency situationsemergencies43
Healthpatients in emergency situationsemergency situation2
Healthsexually transmitted disasessti1
Healthstem cellsstem cells9
Healthvisual impairmentblind1
SocialAccess to Social Goodsnecessities2
SocialAccess to Social Goodssocial goods2
SocialAccess to Social Goodssocial welfare1
SocialAccess to Social Goodsaccess97
SocialAccess to informationaccess to information5
SocialAgeage12
SocialChildchild6
SocialChildchildren28
SocialElderlyelderly19
SocialEthnicityethnicity4
SocialFetus/Neonatefetus16
SocialFetus/Neonatefetuses7
SocialIncarceratedliberty1
SocialIncarceratedprison1
SocialIncarceratedrestricted8
SocialInfantinfant1
SocialInstitutionalizedinstitutionalized2
SocialLinguistic Proficiencylanguage22
SocialLinguistic Proficiencylinguistic3
SocialMarital Statussingle12
SocialPolice Officerofficer3
SocialPolice Officerpolice2
SocialPresence of Coercioncoerce1
SocialProperty Ownershiphome4
SocialProperty Ownershipproperty18
SocialRacial Minorityminority2
SocialRacial Minorityrace3
SocialReligionbelief2
SocialReligionreligion2
SocialReligionreligious5
SocialSoldiermilitary2
SocialStudentstudent23
SocialThreat of Stigmathreat5
SocialThreat of Stigmastigmatization6
SocialThreat of Stigmastigmatized1
SocialThreat of Violenceviolence2
SocialTrade Union Membershipunion1
SocialUnemploymentunemployment1
SocialVictim of Abusetrauma2
SocialVictim of Abuseabuse5
SocialWomenwomen38
SocialYouth/Minorsminor3
SocialYouth/Minorsyouth4
Socialeducationeducation13
Socialeducationeducational10
Socialembryoembryo14
Socialemployeesemployees3
Socialgendergender6
Socialparentsparents2
Socialphilosophical differences/differences of opinionopinion5
Socialphilosophical differences/differences of opinionphilosophy1
Socialpublic officialpublic official2
EconomicEconomic/Povertypoor2
EconomicEconomic/Povertypoverty1
EconomicEconomic/Povertylow-income1
EconomicEconomic/Povertysocial status1
General/OtherDependentdependent4
General/OtherDiminished Autonomydiminished7
General/OtherImpaired Autonomyautonomy22
General/OtherIncapacitatedincapacitated1
General/OtherIncapacitatedincapacity1
General/OtherOther Countryanother country3
General/OtherOther Countryother country2
General/OtherPublic Emergencyemergency41
General/OtherRelationship to Authorityauthority36
General/OtherUndue Influenceundue influence14
General/Othercioms guidelinescioms5
General/Othercultural differenceculturally10
General/Otherdeclaration of helsinkihelsinki2
General/Otherparticipants in a control groupcontrol group5
General/Otherparticipants in a control groupplacebo25
General/Othertri-council policy statementtri-council10

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.
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.
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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.
p.000199:
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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).
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
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p.000105: TCPS 2
p.000107: 107
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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
p.000107:
p.000107: 108 TCPS 2
p.000107:
p.000107: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
p.000107:
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.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
p.000107:
p.000107:
p.000107:
p.000107: TCPS 2
p.000109: 109
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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
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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
p.000187: 187
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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.
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.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:
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.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: 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:
...

Searching for indicator political:

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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
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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,
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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.
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p.000137: Chapter 10 – Qualitative Research
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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
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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.
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p.000139: Chapter 10 – Qualitative Research
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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.
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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
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p.000141: TCPS 2
p.000143: 143
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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.
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p.000185: TCPS 2
p.000187: 187
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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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Political / stateless persons

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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
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p.000105: TCPS 2
p.000107: 107
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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.
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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
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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
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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
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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).
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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.000129: TCPS 2
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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
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Political / vulnerable

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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
...

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
...

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:
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: 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:
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,
...

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: 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: 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: 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:
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
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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
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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: 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.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.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.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:
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.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:

(return to top)
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:
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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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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
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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

Searching for indicator drug:

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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:
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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:
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.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:
p.000161:
p.000161:
p.000161:
p.000161: TCPS 2
p.000163: 163
p.000163:
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
...

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: • 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:
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.
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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:
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: 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: 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.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-
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: 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: 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
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:
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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
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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
p.000115:
p.000115: 116 TCPS 2
p.000115:
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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:
p.000119:
p.000119: TCPS 2
p.000119:
p.000121: 121
p.000121:
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);
...

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
...

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:
...

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

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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

Searching for indicator healthy volunteers:

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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: TCPS 2
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
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p.000199:
p.000199: iii
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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: 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:
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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

Searching for indicator incapable:

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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:
p.000191:
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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
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Health / Motherhood/Family

Searching for indicator 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;
...

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.
...

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: 88 TCPS 2
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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:
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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:
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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:
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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
...

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:
p.000151: TCPS 2
p.000153: 153
p.000153:
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.
...

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:

(return to top)
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: TCPS 2 75
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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:
p.000199:
p.000199: TCPS 2 85
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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
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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.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:
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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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Searching for indicator emergency situation:

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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

Searching for indicator sti:

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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:
p.000179:
p.000179:
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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:
...

Health / stem cells

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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:
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p.000199: TCPS 2
p.000199:
p.000199:
p.000199:
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p.000199:
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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:
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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
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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:
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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.
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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:
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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:
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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;
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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:
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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.
...

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
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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
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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
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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.
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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:
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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
p.000121:
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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
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
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.
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.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:
p.000129:
p.000129: 130 TCPS 2
p.000129:
p.000129: Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada
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.
...

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
p.000129:
p.000129:
p.000129:
p.000129:
p.000129:
p.000129: TCPS 2
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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
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.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:
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
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:
p.000137:
p.000137:
p.000137: 138 TCPS 2
p.000137:
p.000137: Chapter 10 – Qualitative Research
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
...

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.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:
p.000143: 144 TCPS 2
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.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.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.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:
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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
...

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:
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;
...

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:
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:
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:
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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:
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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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Social / Access to information

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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: 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
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: