Policy on Ethical Research Involving Humans

Preamble

Ambrose University has adopted the Tri-Council Policy Statement 2: Ethical Conduct for Research Involving Humans (TCPS-2) which can be found at http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc…. The following policy statement is for the most part an abridgement and adaptation of that document.

Guiding Principles

Ambrose University will integrate the following guiding ethical principles so that research involving human beings at Ambrose is sure to fall within the accepted parameters of Canadian research. These principles must function as a whole, so that human beings are protected from any violation that might occur if certain of the following principles were considered in isolation.

1. Respect for Human dignity: This principle is to be foremost in the researchers’ minds so that the integrity of the persons involved in the research may be preserved.
2. Respect for Free and Informed Consent: Ambrose researchers will ensure that all consent is free and informed.
3. Respect for Vulnerable Persons: Any research that involves vulnerable subjects should include special procedures to ensure that the interests of the individual are protected.
4. Respect for Privacy and Confidentiality: Ambrose researchers will endeavor to respect the privacy and confidentiality of the subjects of their research so that the subjects’ human dignity, as defined by themselves, is not violated. Other cultures being studied may have different standards of privacy and confidentiality than Canadian society; therefore, research must balance the subjects’ standards with the interests of the researcher.
5. Respect for Justice and Inclusiveness: All research will follow the principles and ethics of justice. Therefore ethical reviews will be fair and equitable. As well, research will seek to follow the principles of distributive justice by not discriminating against individuals or groups.
6. Balancing Harms and Benefits: Research at Ambrose must give thought to “Harms-benefit analysis” so that the human benefit of a given research project outweighs any possible harm. It is understood that the effects of research upon individuals cannot always be predicted with certainty; however, respect for human beings imposes ethical obligations on the design and conduct of research. Although these concerns apply most particularly to biomedical and health research, they also have implications for the social sciences and the humanities. For example, even apparently innocuous research projects, such as biographies, may include statements that harm reputations, and so they, too, need to be subjected to harms-benefit analysis.
7. Minimizing Harm: Research subjects must not be exposed to unnecessary risks, and so their participation must be essential to the research being undertaken. Thus, the researcher will subject them to the smallest number of tests required to ensure scientifically valid data.
8. Maximizing Benefit: Researchers will ensure that their data yield the maximum possible benefit for society.

The following pages contain the complete set of articles extracted directly from all 12 chapters printed in the TCPS-2 document for use as a quick reference.

1. ETHICS FRAMEWORK

Core Principles

Article 1.1 The guidelines in this Policy are based on the following three core principles: (p.6)

•  Respect for Persons
•  Concern for Welfare
•  Justice

2. SCOPE AND APPROACH

Research Requiring REB Review

The following article defines the general categories of research that require REB review in accordance with this Policy, subject to the exceptions set out further on in this Policy. These exceptions are distinct from research that is exempt from REB review, as described in Articles 2.2 to 2.4.

Article 2.1 The following requires ethics review and approval by an REB before the research commences: (p.13)
(a) research involving living human participants;
(b) research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. This applies to materials derived from living and deceased individuals.

Research Exempt from REB Review

Some research is exempt from REB review where protections are available by other means. This Policy allows the following exemptions from the requirement for REB review, as outlined below.

Article 2.2 Research that relies exclusively on publicly available information does not require REB review when: (p.15)
(a) the information is legally accessible to the public and appropriately protected by law; or
(b) the information is publicly accessible and there is no reasonable expectation of privacy.

Article 2.3 REB review is not required for research involving the observation of people in public places where: (p.17)
(a) it does not involve any intervention staged by the researcher, or direct interaction with the individuals or groups;
(b) individuals or groups targeted for observation have no reasonable expectation of privacy; and
(c) any dissemination of research results does not allow identification of specific individuals.

Article 2.4 REB review is not required for research that relies exclusively on secondary use of anonymous information, or anonymous human biological materials, so long as the process of data linkage or recording or dissemination of results does not generate identifiable information. (p.17)

Activities Not Requiring REB Review

The following distinguishes research requiring REB review from non-research activities that have traditionally employed methods and techniques similar to those employed in research. Such activities are not considered “research” as defined in this Policy, and do not require REB review. Activities outside the scope of research subject to REB review (see Articles 2.5 and 2.6), as defined in this Policy, may still raise ethical issues that would benefit from careful consideration by an individual or a body capable of providing some independent guidance, other than an REB. These ethics resources may be based in professional or disciplinary associations, particularly where those associations have established best practices guidelines for such activities in their discipline.

Article 2.5 Quality assurance and quality improvement studies, program evaluation activities, and performance reviews, or testing within normal educational requirements when used exclusively for assessment, management or improvement purposes, do not constitute research for the purposes of this Policy, and do not fall within the scope of REB review. (p.18)

Article 2.6 Creative practice activities, in and of themselves, do not require REB review. However, research that employs creative practice to obtain responses from participants that will be analyzed to answer a research question is subject to REB review. (p.18)

Relationship between Research Ethics Review and Scholarly Review

Article 2.7 As part of research ethics review, the REB shall review the ethical implications of the methods and design of the research. (p.19)

REB Review Shall Be Continuing

Article 2.8 Following initial REB review and approval, research ethics review shall continue throughout the life of the project in accordance with Article 6.14. (p.20)

Article 2.9 The REB shall adopt a proportionate approach to research ethics review such that, as a preliminary step, the level of review is determined by the level of risk presented by the research: the lower the level of risk, the lower the level of scrutiny (delegated review); the higher the level of risk, the higher the level of scrutiny (full board review). A proportionate approach to assessing the ethical acceptability of the research, at either level of review, involves consideration of the foreseeable risks, the potential benefits and the ethical implications of the research. (p.22)

3. THE CONSENT PROCESS

A. General Principles

Consent Shall Be Given Voluntarily

Article 3.1 (p. 26)

(a) Consent shall be given voluntarily.
(b) Consent can be withdrawn at any time.
(c) If a participant withdraws consent, the participant can also request the withdrawal of their data or human biological materials.

Consent Shall Be Informed

Article 3.2 Researchers shall provide to prospective participants, or authorized third parties, full disclosure of all information necessary for making an informed decision to participate in a research project. (p.28)

Consent Shall Be an Ongoing Process

Article 3.3 Consent shall be maintained throughout the research project. Researchers have an ongoing duty to provide participants with all information relevant to their ongoing consent to participate in the research. (p. 31)

Incidental Findings

Article 3.4 Researchers have an obligation to disclose to the participant any material incidental findings discovered in the course of research. (p.32)

Consent Shall Precede Collection of, or Access to, Research Data

Article 3.5 Research shall begin only after the participants, or their authorized third parties, have provided their consent. (p.33)

Critical Inquiry

Article 3.6 In critical inquiry, permission is not required from an institution, organization or other group in order to conduct research on them. If a researcher engages the participation of members of any such group without the group’s permission, the researcher shall inform participants of any foreseeable risk that may be posed by their participation. (p.33)

B. Departures from General Principles of Consent

Alterations to Consent Requirements

Article 3.7A The REB may approve research that involves an alteration to the requirements for consent set out in Articles 3.1 to 3.5 if the REB is satisfied, and documents, that all of the following apply: (p.35)

(a) the research involves no more than minimal risk to the participants;
(b) the alteration to consent requirements is unlikely to adversely affect the welfare of participants;
(c) it is impossible or impracticable (see Glossary) to carry out the research and to address the research question properly, given the research design, if the prior consent of participants is required;
(d) in the case of a proposed alteration, the precise nature and extent of any proposed alteration is defined; and
(e) the plan to provide a debriefing (if any) which may also offer participants the possibility of refusing consent and/or withdrawing data and/or human biological materials, shall be in accordance with Article 3.7B.

Debriefing in the Context of Alterations to Consent Requirements

Article 3.7B (p.38)

(a) Debriefing must be a part of all research involving an alteration to consent requirements (see Article 3.7A) whenever it is possible, practicable and appropriate.
(b) Participants in such research must have the opportunity to refuse consent and request the withdrawal of their data and/or human biological materials whenever possible, practicable and appropriate (see Article 3.1)

Consent for Research in Individual Medical Emergencies (p.41)

Article 3.8 Subject to all applicable legal and regulatory requirements, research involving medical emergencies shall be conducted only if it addresses the emergency needs of the individuals involved, and then only in accordance with criteria established in advance of such research by the REB. The REB may allow research that involves medical emergencies to be carried out without the consent of participants, or of their authorized third party, if all of the following apply:

(a) a serious threat to the prospective participant requires immediate intervention;
(b) either no standard efficacious care exists or the research offers a realistic possibility of direct benefit to the participant in comparison with standard care;
(c) either the risk is not greater than that involved in standard efficacious care, or it is clearly justified by the prospect for direct benefits to the participant;
(d) the prospective participant is unconscious or lacks capacity to understand the risks, methods and purposes of the research project;
(e) third party authorization cannot be secured in sufficient time, despite diligent and documented efforts to do so; and
(f) no relevant prior directive by the participant is known to exist. When a previously incapacitated participant regains decision-making capacity, or when an authorized third party is found, consent shall be sought promptly for continuation in the project, and for subsequent examinations or tests related to the research project.

C. Decision-Making Capacity (p.43)

Article 3.9 For research involving individuals who lack the capacity, either permanently or temporarily, to decide for themselves whether to participate, the REB shall ensure that, as a minimum, the following conditions are met:

(a) the researcher involves participants who lack the capacity to decide on their own behalf to the greatest extent possible in the decision-making process;
(b) the researcher seeks and maintains consent from authorized third parties in accordance with the best interests of the persons concerned;
(c) the authorized third party is not the researcher or any other member of the research team;
(d) the researcher demonstrates that the research is being carried out for the participant’s direct benefit, or for the benefit of other persons in the same category. If the research does not have the potential for direct benefit to the participant but only for the benefit of the other persons in the same category, the researcher shall demonstrate that the research will expose the participant to only a minimal risk and minimal burden, and demonstrate how the participant’s welfare will be protected throughout the participation in research; and (e) when authorization for participation was granted by an authorized third party, and a participant acquires or regains decision-making capacity during the course of the research, the researcher shall promptly seek the participant’s consent as a condition of continuing participation.

Article 3.10 Where an authorized third party has consented on behalf of an individual who lacks legal capacity, but that person has some ability to understand the significance of the research, the researcher shall ascertain the wishes of that individual with respect to participation. Prospective participants’ dissent will preclude their participation. (p.44)

Research Directives

Article 3.11 Where individuals have signed a research directive indicating their preferences about future participation in research in the event that they lose decision-making capacity or upon death, researchers and authorized third parties should be guided by these directives during the consent process. (p.45)

D. Consent Shall Be Documented

Article 3.12 Evidence of consent shall be contained either in a signed consent form or in documentation by the researcher of another appropriate means of consent. (p.46)

4. FAIRNESS AND EQUITY IN RESEARCH PARTICIPATION

A. Appropriate Inclusion (p.50)

Article 4.1 Taking into account the scope and objectives of their research, researchers should be inclusive in selecting participants. Researchers shall not exclude individuals from the opportunity to participate in research on the basis of attributes such as culture, language, religion, race, disability, sexual orientation, ethnicity, linguistic proficiency, gender or age, unless there is a valid reason for the exclusion.

B. Inappropriate Exclusion

Research Involving Women

Article 4.2 Women shall not be inappropriately excluded from research solely on the basis of gender or sex. (p.51)

Article 4.3 Women shall not be inappropriately excluded from research solely on the basis of their reproductive capacity, or because they are pregnant or breastfeeding. (p.51)

Research Involving Children (p.52)

Article 4.4 Children shall not be inappropriately excluded from research solely on the basis of their age or developmental stage. The inclusion of children in research is subject to Article 4.6.

Research Involving the Elderly (p.52)

Article 4.5 Elderly people shall not be inappropriately excluded from research solely on the basis of their age.

Research Involving Participants Who Lack Decision-Making Capacity

Article 4.6 Subject to applicable legal requirements, individuals who lack capacity to decide whether or not to participate in research shall not be inappropriately excluded from research. Where a researcher seeks to involve individuals in research who do not have decision-making capacity, the researcher shall, in addition to fulfilling the conditions in Articles 3.9 and 3.10, satisfy the REB that: (p.53)

(a) the research question can be addressed only with participants within the identified group; and
(b) the research does not expose the participants to more than minimal risk without the prospect of direct benefits for them; or
(c) where the research entails only minimal risk, it should at least have the prospect of providing benefits to participants or to a group that is the focus of the research and to which the participants belong.

Participants’ Vulnerability and Research

Article 4.7 Individuals or groups whose circumstances may make them vulnerable in the context of research should not be inappropriately included or automatically excluded from participation in research on the basis of their circumstances. (p.54)

5. PRIVACY AND CONFIDENTIALITY

A. Key Concepts (p. 57-58)

Privacy

Confidentiality

Security

Identifiable Information

Types of Information

B. Ethical Duty of Confidentiality

Article 5.1 Researchers shall safeguard information entrusted to them and not misuse or wrongfully disclose it. Institutions shall support their researchers in maintaining promises of confidentiality. (p. 60)

Article 5.2 Researchers shall describe measures for meeting confidentiality obligations and explain any reasonably foreseeable disclosure requirements (p. 61):

(a) in application materials they submit to the REB; and
(b) during the consent process with prospective participants.

C. Safeguarding Information (p. 62)

Article 5.3 Researchers shall provide details to the REB regarding their proposed measures for safeguarding information, for the full life cycle of information: its collection, use, dissemination, retention and/or disposal.

Article 5.4 Institutions or organizations where research data are held have a responsibility to establish appropriate institutional security safeguards. (p.63)

D. Consent and Secondary Use of Identifiable Information for Research Purposes (p. 64)

Article 5.5A Researchers who have not obtained consent from participants for secondary use of identifiable information shall only use such information for these purposes if they have satisfied the REB that: (p.64-65)

(a) identifiable information is essential to the research;
(b) the use of identifiable information without the participants’ consent is unlikely to adversely affect the welfare of individuals to whom the information relates;
(c) the researchers will take appropriate measures to protect the privacy of individuals, and to safeguard the identifiable information;
(d) the researchers will comply with any known preferences previously expressed by individuals about any use of their information;
(e) it is impossible or impracticable (see Glossary) to seek consent from individuals to whom the information relates; and
(f) the researchers have obtained any other necessary permission for secondary use of information for research purposes.

If a researcher satisfies all the conditions in Article 5.5A (a) to (f), the REB may approve the research without requiring consent from the individuals to whom the information relates.

Article 5.5B Researchers shall seek REB review, but are not required to seek participant consent, for research that relies exclusively on the secondary use of non-identifiable information. (p. 66)

Article 5.6 When secondary use of identifiable information without the requirement to seek consent has been approved under Article 5.5A, researchers who propose to contact individuals for additional information shall, prior to contact, seek REB approval of the plan for making contact. (p. 66)

E. Data Linkage (p. 67)

Article 5.7 Researchers who propose to engage in data linkage shall obtain REB approval prior to carrying out the data linkage, unless the research relies exclusively on publicly available information as discussed in Article 2.2. The application for approval shall describe the data that will be linked and the likelihood that identifiable information will be created through the data linkage.

Where data linkage involves or is likely to produce identifiable information, researchers shall satisfy the REB that:

(a) the data linkage is essential to the research; and
(b) appropriate security measures will be implemented to safeguard information.

6. GOVERNANCE OF RESEARCH ETHICS REVIEW

A. Establishment of Research Ethics Boards

Authority, Mandate and Accountability

Article 6.1 Institutions shall establish or appoint REB(s) to review the ethical acceptability of all research involving humans conducted within their jurisdiction or under their auspices, that is, by their faculty, staff or students, regardless of where the research is conducted, in accordance with this Policy. (p. 69)

Article 6.2 The highest body within an institution shall: establish the REB or REBs, define an appropriate reporting relationship with the REBs, and ensure the REBs are provided with necessary and sufficient ongoing financial and administrative resources to fulfil their duties. REBs are independent in their decision making and are accountable to the highest body that established them for the process of research ethics review. (p. 70)

Article 6.3 The institution shall grant the REB the mandate to review the ethical acceptability of research on behalf of the institution, including approving, rejecting, proposing modifications to, or terminating any proposed or ongoing research involving humans. This mandate shall apply to research conducted under the auspices or within the jurisdiction of the institution, using the considerations set forth in this Policy. (p. 71)

Article 6.4 The REB shall consist of at least five members, including both men and women, of whom: (p. 72)

(a) at least two members have expertise in relevant research disciplines, fields and methodologies covered by the REB;
(b) at least one member is knowledgeable in ethics;
(c) at least one member is knowledgeable in the relevant law (but that member should not be the institution’s legal counsel or risk manager). This is mandatory for biomedical research and is advisable, but not mandatory, for other areas of research; and
(d) at least one community member who has no affiliation with the institution.

It is advisable that each member be appointed to formally fulfil the requirements of only one of the above categories. To ensure the independence of REB decision making, institutional senior administrators shall not serve on the REB.

Ad Hoc Advisors

Article 6.5 The REB should have provisions for consulting ad hoc advisors in the event that it lacks the specific expertise or knowledge to review the ethical acceptability of a research proposal competently. (p. 75)

Terms of Appointment of REB Members

Article 6.6 In appointing REB members, institutions shall establish their terms to allow for continuity of the research ethics review process. (p. 75)

Article 6.7 In appointing and renewing REB members, institutions should consider the qualifications and expertise their REBs need. Institutions should provide REB members with necessary training opportunities to effectively review the ethical issues raised by research proposals that fall within the mandate of their REB. (p. 76)

REB Chair

Article 6.8 The REB Chair is responsible for ensuring that the REB review process conforms to the requirements of this Policy. (p. 76)

REB Quorum

Article 6.9 Institutions shall establish quorum rules for REBs that meet the minimum requirements of membership representation outlined in Article 6.4. When there is less than full attendance, decisions requiring full review should be adopted only when the members in attendance at that meeting have the specific expertise, relevant competence and knowledge necessary to provide an adequate research ethics review of the proposals under consideration. (p. 76-77)

REB Meetings and Attendance

Article 6.10 REBs shall have regular meetings to discharge their responsibilities, and shall normally meet face to face to review proposed research that is not assigned to delegated review. (p. 77)

B. Procedures for REB Review

Initial Research Ethics Review

Article 6.11 Researchers shall submit their research proposals, including proposals for pilot studies, for REB review and approval of its ethical acceptability prior to the start of recruitment of participants, access to data, or collection of human biological materials. REB review is not required for the initial exploratory phase, which may involve contact with individuals or communities intended to establish research partnerships or to inform the design of a research proposal. (p. 78)

Determining the Level of Research Ethics Review

Article 6.12 In keeping with a proportionate approach to research ethics review, the selection of the level of REB review shall be determined by the level of foreseeable risks to participants: the lower the level of risk, the lower the level of scrutiny (delegated review); the higher the level of risk, the higher the level of scrutiny (full board review). (p. 79)

Decision Making

Article 6.13 REBs shall function impartially, provide a fair hearing to the researchers involved, and provide reasoned and appropriately documented opinions and decisions. REBs should make their decisions on the ethical acceptability of research in an efficient and timely manner, and shall communicate all approvals and refusals to researchers in writing, in print or by electronic means, in accordance with their procedures. (p. 81)

Continuing Research Ethics Review

Article 6.14 The REB shall make the final determination as to the nature and frequency of continuing research ethics review in accordance with a proportionate approach to research ethics review. At minimum, continuing research ethics review shall consist of an annual status report (for multi-year research projects), and an end-of-study report (projects lasting less than one year). (p. 82)

Reports of Unanticipated Issues

Article 6.15 Researchers shall report to the REB any unanticipated issue or event that may increase the level of risk to participants, or has other ethical implications that may affect participants’ welfare. (p. 83)

Requests for Changes to Approved Research

Article 6.16 Researchers shall submit to their REBs in a timely manner requests for substantive changes to their originally approved research. REBs shall decide on the ethical acceptability of those changes to the research in accordance with a proportionate approach to research ethics review. (p. 84)

Record Keeping of REB Documents

Article 6.17 REBs shall prepare and maintain comprehensive records, including all documentation related to the projects submitted to the REB for review, attendance at all REB meetings, and accurate minutes reflecting REB decisions. Where the REB denies ethics approval for a research proposal, the minutes shall include the reasons for this decision. (p. 85)

C. Reconsideration and Appeals

Where researchers do not receive ethics approval, or receive approval conditional on revisions that they find compromise the feasibility or integrity of the proposed research, they are entitled to reconsideration by the REB. If that is not successful, they may appeal using the established appeal mechanism in accordance with the institution’s procedures.

Reconsideration of REB Decisions

Article 6.18 Researchers have the right to request, and REBs have an obligation to provide, prompt reconsideration of decisions affecting a research project. (p. 86)

Appeal of REB Decisions

Article 6.19 Institutions shall have an established mechanism and a procedure in place for promptly handling appeals from researchers when, after reconsideration, the REB has refused ethics approval of the research. (p. 86)

Article 6.20 The appeal committee shall have the authority to review negative decisions made by an REB. In so doing, it may approve, reject or request modifications to the research proposal. Its decision on behalf of the institution shall be final. (p. 87)

D. Research Ethics Review during Publicly Declared Emergencies

Preparedness Plans for Research Ethics Review during Publicly Declared Emergencies

Article 6.21 In collaboration with their researchers, institutions and their REBs should develop preparedness plans for emergency research ethics review. Research ethics review during publicly declared emergencies may follow modified procedures and practices. (p. 88)

Research Ethics Review Policy and Procedures during Publicly Declared Emergencies

Article 6.22 Research ethics policies and procedures for emergencies take effect once an emergency has been publicly declared. They should cease to apply as soon as is feasible after the end of the publicly declared emergency. (p. 89)

Respecting Core Principles: Limiting Exceptions

Article 6.23 REBs should give special care to requests for exceptions to the principles and procedures outlined in this Policy during publicly declared emergencies. (p. 90)

7. CONFLICTS OF INTEREST

A. Key Concepts

Institutional Conflict of Interest

REB Member Conflict of Interest

Research Conflict of Interest

B. Institutions and Conflicts of Interest

Article 7.1 Institutions shall develop and implement conflict of interest policies including procedures to identify, eliminate, minimize or otherwise manage conflicts of interest that may affect research. All parties (e.g., researchers, administrators, REB members) should act in a transparent manner in identifying and addressing conflicts of interest. Institutions should make their written conflict of interest policies and procedures publicly available to all members of the research enterprise, including participants, REBs, researchers, administrators and research sponsors. (p. 95)

Article 7.2 Institutions should ensure that real, potential or perceived institutional conflicts of interest that may affect research are reported to the REB through established conflict of interest mechanisms. The REB shall consider whether the institutional conflict of interest should be disclosed to prospective participants as part of the consent process. (p. 96)

C. REB Members and Conflicts of Interest

Article 7.3 When reviewing research proposals, REB members shall disclose real, potential or perceived conflicts of interest to the REB. When necessary, the REB may decide that some of its members must withdraw from REB deliberations and decisions. (p. 97)

D. Researchers and Conflicts of Interest

Article 7.4 Researchers shall disclose in research proposals they submit to the REB any real, potential or perceived individual conflicts of interest, as well as any institutional conflicts of interest of which they are aware that may have an impact on their research. Upon discussion with the researcher, the REB shall determine the appropriate steps to manage the conflict of interest. (p. 98)

8. Multi-Jurisdictional Research

A. Review Mechanisms for Research Involving Multiple Institutions and/or Multiple REBs (p. 101)

Adoption of Alternative Review Models – An Institutional Responsibility

Article 8.1 An institution that has established an REB may approve alternative review models for research involving multiple REBs and/or institutions, in accordance with this Policy. The institution remains responsible for the ethical acceptability and ethical conduct of research undertaken within its jurisdiction or under its auspices irrespective of where the research is conducted. (p. 102)

Research Ethics Review Models

Selection of a Research Ethics Review Model Relevant to the Research Project

Article 8.2 When planning a research project involving multiple institutions and/or multiple REBs, researchers and REBs should select the most appropriate research ethics review model from among those authorized by their institution. (p. 104)

B. Ethics Review of Research Conducted outside the Institution (p. 105-106)

Article 8.3

(a) Where research conducted under the auspices of a Canadian research institution and performed in whole or in part outside of Canada has been approved under a research ethics review model involving multiple institutions and/or REBs consistent with this Policy, the terms of that model apply.
(b) Subject to Article 8.3(a), research conducted under the auspices of a Canadian research institution and conducted outside its jurisdiction, whether elsewhere in Canada, or outside Canada, shall undergo prior research ethics review by both:
i. the REB at the Canadian institution under the auspices of which the research is being conducted; and
ii. the REB or other responsible review body or bodies, if any, at the research site.

Article 8.4 (p. 107)

(a) The information to be provided to the researcher’s home REB will be determined by the provisions of the research ethics review model.
(b) When conducting research outside the jurisdiction of their home institution, whether at a site abroad, or in Canada, researchers shall provide their home REBs with:
 the relevant information about the rules governing research involving humans and the ethics review requirements at the research site, where any exist;
 the names and contact information for the relevant REBs or comparable ethics bodies, if known, that will review the proposal at the research site; and
 relevant information about the target populations and circumstances that might have a bearing on the research ethics review by the researchers’ home REB.

9. Research Involving the First Nations, Inuit and MÉTIS PEOPLES OF CANADA

A. Key Concepts and Definitions
B. Interpreting the Ethics Framework in Aboriginal Contexts

Respect for Persons

Concern for Welfare

Justice

Research Involving Indigenous Peoples in Other Countries

C. Applying Provisions of This Policy in Aboriginal Contexts

Requirement of Community Engagement in Aboriginal Research

Article 9.1 Where the research is likely to affect the welfare of an Aboriginal community, or communities, to which prospective participants belong, researchers shall seek engagement with the relevant community. The conditions under which engagement is required include, but are not limited to: (p. 114)

(a) research conducted on First Nations, Inuit or Métis lands;
(b) recruitment criteria that include Aboriginal identity as a factor for the entire study or for a subgroup in the study;
(c) research that seeks input from participants regarding a community’s cultural heritage, artefacts, traditional knowledge or unique characteristics;
(d) research in which Aboriginal identity or membership in an Aboriginal community is used as a variable for the purpose of analysis of the research data; and
(e) interpretation of research results that will refer to Aboriginal communities, peoples, language, history or culture.

Nature and Extent of Community Engagement

Article 9.2 The nature and extent of community engagement in a project shall be determined jointly by the researcher and the relevant community, and shall be appropriate to community characteristics and the nature of the research. (p. 115)

Respect for First Nations, Inuit and Métis Governing Authorities

Article 9.3 Where a proposed research project is to be conducted on lands under the jurisdiction of a First Nations, Inuit or Métis authority, researchers shall seek the engagement of formal leaders of the community, except as provided under Articles 9.5, 9.6 and 9.7.

Research ethics review by the institutional REB and any responsible community body recognized by the First Nations, Inuit or Métis authority (see Articles 9.9 and 9.11) is required in advance of recruiting and securing consent of individuals. (p. 118)

Engagement with Organizations and Communities of Interest

Article 9.4 For the purposes of community engagement and collaboration in research undertakings, researchers and REBs shall recognize Aboriginal organizations, including First Nations, Inuit and Métis representative bodies, and service organizations and communities of interest, as communities. They shall also recognize these groups through representation of their members on ethical review and oversight of projects, where appropriate. (p. 119)

Complex Authority Structures

Article 9.5 Where alternatives to securing the agreement of formal leadership are proposed for research on First Nations, Inuit or Métis lands or in organizational communities, researchers should engage community processes and document measures taken, to enable the REB to review the proposal with due consideration of complex community authority structures. (p. 120)

Recognizing Diverse Interests within Communities

Article 9.6 In engaging territorial or organizational communities, researchers should ensure, to the extent possible, that they take into consideration the views of all relevant sectors – including individuals and subgroups who may not have a voice in the formal leadership. Groups or individuals whose circumstances make them vulnerable may need or desire special measures to ensure their safety in the context of a specific research project. Those who have been excluded from participation in the past may need special measures to ensure their inclusion in research. (p. 120)

Critical Inquiry

Article 9.7 Research involving Aboriginal peoples that critically examines the conduct of public institutions, First Nations, Inuit and Métis governments, institutions or organizations or persons exercising authority over First Nations, Inuit or Métis individuals may be conducted ethically, notwithstanding the usual requirement of engaging community leaders. (p. 121)

Respect for Community Customs and Codes of Practice

Article 9.8 Researchers have an obligation to become informed about, and to respect, the relevant customs and codes of research practice that apply in the particular community or communities affected by their research. Inconsistencies between community custom and this Policy should be identified and addressed in advance of initiating the research, or as they arise. (p. 122)

Institutional Research Ethics Review Required

Article 9.9 Research ethics review by community REBs or other responsible bodies at the research site will not be a substitute for research ethics review by institutional REBs, and will not exempt researchers affiliated with an institution from seeking REB approval at their institution, subject to Article 8.1. Prospective research and secondary use of data and human biological materials for research purposes is subject to research ethics review. (p. 124)

Requirement to Advise the REB on a Plan for Community Engagement

Article 9.10 When proposing research expected to involve First Nations, Inuit or Métis participants, researchers shall advise their REB how they have engaged, or intend to engage, the relevant community. Alternatively, researchers may seek REB approval for an exception to the requirement for community engagement, on the basis of an acceptable rationale. (p. 125)

Research Agreements

Article 9.11 Where a community has formally engaged with a researcher or research team through a designated representative, the terms and undertakings of both the researcher and the community should be set out in a research agreement before participants are recruited. (p. 126)

Collaborative Research

Article 9.12 As part of the community engagement process, researchers and communities should consider applying a collaborative and participatory approach as appropriate to the nature of the research, and the level of ongoing engagement desired by the community. (p. 128)

Mutual Benefits in Research

Article 9.13 Where the form of community engagement and the nature of the research make it possible, research should be relevant to community needs and priorities. The research should benefit the participating community (e.g., training, local hiring, recognition of contributors, return of results), as well as extend the boundaries of knowledge. (p. 128)

Strengthening Research Capacity

Article 9.14 Research projects should support capacity building through enhancement of the skills of community personnel in research methods, project management, and ethical review and oversight. (p. 129)

Recognition of the Role of Elders and Other Knowledge Holders

Article 9.15 Researchers should engage the community in identifying Elders or other recognized knowledge holders to participate in the design and execution of research, and the interpretation of findings in the context of cultural norms and traditional knowledge. Community advice should also be sought to determine appropriate recognition for the unique advisory role fulfilled by these persons. (p. 130)

Privacy and Confidentiality

Article 9.16 Researchers and community partners shall address privacy and confidentiality for communities and individuals early on in the community engagement process. The extent to which limited or full disclosure of personal information related to the research is to be disclosed to community partners shall be addressed in research agreements where these exist. Researchers shall not disclose personal information to community partners without the participant’s consent, as set out in Article 3.2(i). (p. 131)

Interpretation and Dissemination of Research Results

Article 9.17 Researchers should afford community representatives engaged in collaborative research an opportunity to participate in the interpretation of the data and the review of research findings before the completion of the final report, and before finalizing all relevant publications resulting from the research. (p. 132)

Intellectual Property Related to Research

Article 9.18 In collaborative research, intellectual property rights should be discussed by researchers, communities and institutions. The assignment of rights, or the grant of licences and interests in material that may flow from the research, should be specified in a research agreement (as appropriate) before the research is conducted. (p. 133)

Collection of Human Biological Materials Involving Aboriginal Peoples

Article 9.19 As part of community engagement, researchers shall address and specify in the research agreement the rights and proprietary interests of individuals and communities, to the extent such exist, in human biological materials and associated data to be collected, stored and used in the course of the research. (p. 134)

Secondary Use of Information or Human Biological Materials Identifiable as Originating from Aboriginal Communities or Peoples

Article 9.20 Secondary use of data and human biological material identifiable as originating from an Aboriginal community or peoples is subject to REB review.

Researchers shall engage the community from which the data or human biological materials and associated identifiable information originate, prior to initiating secondary use where: (p. 135)

(a) secondary use has not been addressed in a research agreement and has not been authorized by the participants in their original individual consent; or
(b) there is no research agreement; and
(c) the data are not publicly available or legally accessible.

Individual consent for the secondary use of identifiable information is required unless the REB agrees that either Articles 5.5A or 5.6, or Articles 12.3A or 12.4 may apply.

Article 9.21 Where research relies only on publicly available information, or on legally accessible information as defined in Article 2.2, community engagement is not required. Where the information can be identified as originating from a specific community or a segment of the Aboriginal community at large, seeking culturally informed advice may assist in identifying risks and potential benefits for the source community. (p. 135)

Article 9.22 REB review is required where the researcher seeks data linkage of two or more anonymous datasets or data associated with human biological materials and there is a reasonable prospect that this could generate information identifiable as originating from a specific Aboriginal community or a segment of the Aboriginal community at large. (p. 136)

10. Qualitative Research

A. Nature of Qualitative Research

General Approach and Methodological Requirements and Practices

(a) Inductive Understanding
(b) Diversity of Approaches
(c) Dynamic, Reflective and Continuous Research Process
(d) Diverse, Multiple and Often Evolving Contexts
(e) Data Collection and Sample Size
(f) Research Goals and Objectives
(g) Dynamic, Negotiated and Ongoing Consent Process
(h) Research Partnerships
(i) Research Results

B. Research Ethics Review of Qualitative Research

Timing of the REB Review

Article 10.1 Researchers shall submit their research proposals, including proposals for pilot studies, for REB review and approval of its ethical acceptability prior to the start of recruitment of participants, or access to data. Subject to the exceptions in Article 10.5, REB review is not required for the initial exploratory phase (often involving contact with individuals or communities) intended to discuss the feasibility of the research, establish research partnerships, or the design of a research proposal (see Article 6.11). (p. 143)

Modalities of Expression of Consent

Article 10.2 Researchers shall explain in their research design the proposed procedures for seeking consent and the strategies they plan to use for documenting consent. (p. 144)

Article 10.3 In research involving observation in natural environments or virtual settings where people have a reasonable or limited expectation of privacy, the researcher shall explain the need for an exception to the general requirement for consent. The REB may approve research without requiring that the researcher obtain consent from individuals being observed on the basis of the justification provided by the researcher and appropriate privacy protection. (p. 145)

Privacy and Confidentiality in the Dissemination of Research Results

Article 10.4 In some research contexts, the researcher may plan to disclose the identity of participants. In such projects, researchers shall discuss with prospective participants or participants whether they wish to have their identity disclosed in publications or other means of dissemination. Where participants consent to have their identity disclosed, researchers shall record each participant’s consent. (p. 147)

Qualitative Research Involving Emergent Design

In qualitative research, emergent design involves data collection and analysis that can evolve over the course of a research project in response to what is learned in earlier parts of the study. Specific questions or other elements of data collection may be difficult to anticipate, identify and articulate fully in the research proposal in advance of the project’s implementation.

Article 10.5 In studies using emergent design in data collection, researchers shall provide the

REB with all the available information to assist in the review and approval of the general procedure for data collection. Researchers shall consult with the REB when, during the conduct of the research, changes to the data collection procedures may present ethical implications and associated risks to the participants. (p.148)

11. Clinical Trials

A. Key Concepts

Risk and Proportionate Approach

B. Clinical Trial Design and Registration

Article 11.1 In the design and review of a clinical trial, researchers and REBs shall consider the type of trial (e.g., pharmaceutical, natural health product, medical device, psychotherapy), its phase (if appropriate) and the corresponding particular ethical issues associated with it, in light of the core principles of this Policy.(p.154)

Natural Health Product Trials

 Medical Device Trials
 Psychotherapy Trials
 Surgical Trials

Placebo-Controlled Trials

Article 11.2 (P.159)

(a) A new therapy or intervention should generally be tested against an established effective therapy.
(b) As with all alternative choices of a control, a placebo control is ethically acceptable in a randomized controlled clinical trial only if:

• its use is scientifically and methodologically sound in establishing the efficacy or safety of the test therapy or intervention; and
• it does not compromise the safety or health of participants; and
• the researcher articulates to the REB a compelling scientific justification for the use of the placebo control.

(c) For clinical trials involving a placebo control, the researcher and the REB shall ensure the general principles of consent are respected and that participants or their authorized third parties are specifically informed (see Article 3.2):

• about any therapy that will be withdrawn or withheld for purposes of the research; and
• of the anticipated consequences of withdrawing or withholding the therapy.

Clinical Trial Registration

Article 11.3 All clinical trials shall be registered before recruitment of the first trial participant in a publicly accessible registry that is acceptable to the World Health Organization (WHO) or the International Committee of Medical Journal Editors (ICMJE). (P.161)

C. Assessing Safety and Minimizing Risk

Article 11.4 Researchers and REBs should ensure that the foreseeable risk to participants in clinical trials is: (a) justified by the potential benefits to be gained; and (b) appropriately minimized. (161)

Article 11.5 When describing the foreseeable risks and potential benefits of research involving participants who are undergoing high-risk therapies, researchers should clearly indicate which risks are attributable to the research (including cumulative risks), and which risks the participants would normally be exposed to in the course of their clinical care. In their evaluation of risk, REBs should ensure that they are evaluating only those risks that are attributable to the research (including cumulative risks), and not compounding them with the risks attributable to clinical care. (P.162)

Article 11.6 REBs and clinical trial researchers should be conscious of the phenomenon of therapeutic misconception, and ensure that procedures for recruitment and consent emphasize which specific elements of a clinical trial are required for research purposes, as well as the differences between research and the standard clinical care patients might otherwise receive. (P.163)

Monitoring Safety and Reporting New Information

Article 11.7 Researchers shall provide the REB with an acceptable plan for monitoring the safety of participants, including a plan for the tabulation, analysis and reporting of safety data, and the sharing of other new information in a form that permits REBs to interpret and respond appropriately. (P.164)

Article 11.8 Researchers shall promptly report new information that may affect the welfare or consent of participants, to the REB, and to other appropriate regulatory or advisory bodies. New information must be submitted to the publicly accessible trial registry along with reports of findings once the trial is completed. Where possible, this information can be reported earlier to the registry in descriptions of study design, intervention, or an equivalent data field. When new information is relevant to participants’ welfare, researchers shall promptly inform all participants to whom the information applies (including former participants). Researchers shall work with their REB to determine which participants must be informed, and how the information should be conveyed. (P. 165)

Article 11.9 REBs shall develop procedures to review safety reports and other new information arising from clinical trials that may affect the welfare or consent of participants, and to take appropriate steps in response. (P.167)

D. Financial Conflicts of Interest

Sponsored Research

Article 11.10 Researchers and REBs should be aware of, and consider the possibility of, financial conflicts of interest. They should ensure that clinical trials are designed to meet appropriate standards of participant safety in accordance with the core principles of this Policy. Financial considerations shall not affect these standards or the scientific validity and transparency of trial procedures. (P.168)

Clinical Trial Budgets

Article 11.11 REBs shall ensure that clinical trial budgets are reviewed to ensure that conflicts of interest are identified and minimized, or otherwise managed. (P.168)

E. Analysis and Dissemination of Clinical Trial Outcomes

Article 11.12 With respect to research findings: (P.169)

(a) Institutions and REBs should take reasonable measures to ensure that sponsors, researchers and institutions publish or otherwise disseminate the analysis of data and interpretation of clinical trial results (i.e., the findings) in a timely manner without undue restriction.
(b) Any prohibition or undue limitation on the publication or dissemination of scientific findings from clinical trials is ethically unacceptable.
(c) Institutions should develop reasonable written policies regarding acceptable and unacceptable clauses in clinical trial research contracts relating to confidentiality, publication and access to data.

12. HUMAN BIOLOGICAL MATERIALS INCLUDING MATERIALS RELATED TO HUMAN REPRODUCTION

A. Key Concepts

Identifiable Human Biological Materials

Types of Human Biological Materials

B. Collection of Human Biological Materials

Article 12.1 Research involving collection and use of human biological materials requires REB review and: (p.177)

(a) consent of the participant who will donate biological materials; or
(b) consent of an authorized third party on behalf of a participant who lacks decision-making capacity, taking into account any research directive that applies to the participant; or
(c) consent of a deceased participant through a donation decision made prior to death, or by an authorized third party.

Article 12.2 To seek consent for use of human biological materials in research, researchers shall provide to prospective participants or authorized third parties, applicable information as set out in Article 3.2 as well as the following details: (p.178)

(a) the type and amount of biological materials to be taken;
(b) the manner in which biological materials will be taken, and the safety and invasiveness of the procedures for acquisition;
(c) the intended uses of the biological materials, including any commercial use;
(d) the measures employed to protect the privacy of and minimize risks to participants;
(e) the length of time the biological materials will be kept, how they will be preserved, location of storage (e.g., in Canada, outside Canada), and process for disposal, if applicable;
(f) any anticipated linkage of biological materials with information about the participant; and
(g) the researchers’ plan for handling results and findings, including clinically relevant information and incidental findings.

C. Consent and Secondary Use of Identifiable Human Biological Materials for Research Purposes

Article 12.3A Researchers who have not obtained consent from participants for secondary use of identifiable human biological materials shall only use such material for these purposes if they have satisfied the REB that: (p.179)

(a) identifiable human biological materials are essential to the research;
(b) the use of identifiable human biological materials without the participant’s consent is unlikely to adversely affect the welfare of individuals from whom the materials were collected;
(c) the researchers will take appropriate measures to protect the privacy of individuals and to safeguard the identifiable human biological materials;
(d) the researchers will comply with any known preferences previously expressed by individuals about any use of their biological materials;
(e) it is impossible or impracticable to seek consent from individuals from whom the materials were collected; and
(f) the researchers have obtained any other necessary permission for secondary use of human biological materials for research purposes. If a researcher satisfies all the conditions in Article 12.3A (a) to (f), the REB may approve the research without requiring consent from the individuals from whom the biological materials were collected.

Article 12.3B Researchers shall seek REB review, but are not required to seek participant consent, for research that relies exclusively on the secondary use of non-identifiable human biological materials. (p.180)

Article 12.4 When secondary use of identifiable human biological materials without the requirement to seek consent has been approved under Article 12.3A, researchers who propose to contact individuals for additional biological materials or information shall, prior to contact, seek REB approval of the plan for making contact. (p.181)

D. Storage and Banking of Human Biological Materials

Article 12.5 Institutions and researchers that maintain biobanks: (p.182)

(a) shall ensure that they have or use appropriate facilities, equipment, policies and procedures to store human biological materials safely, and in accordance with applicable standards; and
(b) shall establish appropriate physical, administrative and technical safeguards to protect human biological materials and any information about participants from unauthorized handling.

E. Research Involving Materials Related to Human Reproduction

Article 12.6 In addition to requirements in this chapter that apply to all research involving human biological materials, the following guidelines apply to research involving materials related to human reproduction: (p.183)

(a) Research using materials related to human reproduction in the context of an anticipated or ongoing pregnancy shall not be undertaken if the knowledge sought can reasonably be obtained by alternative methods.
(b) Materials related to human reproduction for research use shall not be obtained through commercial transaction, including exchange for services.

Research Involving Human Embryos

Article 12.7 Research on in vitro embryos already created and intended for implantation to achieve pregnancy is acceptable if: (p.184)

(a) the research is intended to benefit the embryo;
(b) research interventions will not compromise the care of the woman, or the subsequent fetus;
(c) researchers closely monitor the safety and comfort of the woman and the safety of the embryo; and
(d) consent was provided by the gamete donors.

Article 12.8 Research involving embryos that have been created for reproductive or other purposes permitted under the Assisted Human Reproduction Act, but are no longer required for these purposes, may be ethically acceptable if: (p.184)

(a) the ova and sperm from which they are formed were obtained in accordance with Article 12.7;
(b) consent was provided by the gamete donors;
(c) embryos exposed to manipulations not directed specifically to their ongoing normal development will not be transferred for continuing pregnancy; and
(d) research involving embryos will take place only during the first 14 days after their formation by combination of the gametes, excluding any time during which embryonic development has been suspended.

Research Involving Fetuses and Fetal Tissue

Article 12.9 Research involving a fetus or fetal tissue: (p.185)

(a) requires the consent of the woman; and
(b) shall not compromise the woman’s ability to make decisions regarding continuation of her pregnancy.

F. Research Involving Human Pluripotent Stem Cells

Stem Cell Oversight Committee (SCOC)

Article 12.10 Research involving human pluripotent stem cells that have been derived from an embryonic source and/or that will be grafted or transferred in any other form into humans or non-human animals requires review and approval by SCOC and an REB. The researcher shall provide evidence of SCOC approval to the REB. (p.186)

Consent

Chapter 3, especially Articles 3.1 to 3.5, provides detailed guidance on the need to seek consent for participation in research. The following articles provide additional guidance for situations that are unique to stem cell research.

Article 12.11 Embryos no longer needed for reproductive purposes may be donated for use in research (including research to derive and study human embryonic stem cells). Embryo donors and gamete donors, if these are different individuals, shall be advised of all available options in respect of the use of the embryos and their consent sought prior to the use. (p.188)

Article 12.12 At the time when the embryos are to be used for research to derive and study embryonic stem cells (and other human cells or cell lines of a pluripotent nature), consent of the embryo donors shall be sought again. Research shall not proceed unless consent is obtained. (p.188)

Article 12.13 When seeking consent for human embryonic stem cell research, in addition to the information outlined in Article 3.2 researchers shall provide to prospective research participants the following: (p.189)

(a) An explanation that the cell line(s) will be anonymized or coded;
(b) An assurance that prospective research participants are free to not participate and have the right to withdraw at any time before an anonymized or coded cell line is created;
(c) An explanation that the research could result in the production of a stem cell line that could be maintained for many years, distributed to other parts of the world, and used for various research purposes;
(d) An explanation that the research participants will not benefit directly financially from any future commercialization of cell lines; nor will there be any personal benefit in terms of dispositional authority over any embryonic cell lines created (i.e., there will be no directed donation of the cells or cell lines to particular individuals).

Creation of Excess Embryos

Article 12.14 Researchers shall not ask, encourage, induce or coerce members of the health care team to generate more embryos than necessary for the optimum chance of reproductive success. This is tantamount to creating embryos for research, which is prohibited under the Assisted Human Reproduction Act. (p.189)

National Registry

Article 12.15 All human pluripotent stem cell lines derived directly from embryos under the auspices of an institution that is eligible to receive Agency funds shall be listed with the national registry of human embryonic stem cell lines and made available by the researcher to other researchers, subject to reasonable cost-recovery charges. (p.189)

Privacy and Confidentiality

Article 12.16 All human pluripotent stem cell lines shall be anonymized or coded unless the research only involves the directed donation of induced pluripotent stem cells. (p.190)

Article 12.17 All researchers who make stem cell lines available to other academics shall ensure that the cell lines are anonymized or coded. (p.190)

Conflicts of Interest

Chapter 7 (in particular Articles 7.2 and 7.4) provides guidance on conflicts of interest. The following articles provide additional guidance for situations that are unique to stem cell research.

Article 12.18 Stem cell research teams shall not include members of the health care team treating and/or counselling prospective participants who could influence the prospective participants’ decisions to donate their embryos.

Article 12.19 When researchers or their institutions have, or acquire, financial interests in the outcome of the stem cell research including, but not limited to, income from commercial firms supporting their research, stock holdings in corporations supporting their research, or patents in products produced through their research, they shall disclose this information to SCOC, the REB and current and prospective research participants (see Articles 7.2 and 7.4 regarding institution and researcher conflicts of interest). In some instances, disclosure may not be a sufficient response to concerns about actual, perceived or potential conflicts of interest. Researchers and/or their institutions may be asked to remedy any possible distortion of proper procedures attributable to such conflicts.

Article 12.20 Copies of contracts between researchers, institutions and industry sponsors and any relevant budgetary information shall be provided to SCOC and the REB to examine and evaluate any potential or actual conflicts of interest and to ensure the right to publish in a timely manner without undue restriction.

End of Document