TCPS 2 - Chapter 8
The TCPS 2 (2018) has replaced TCPS 2 (2014) as the official human research ethics policy of the Agencies.
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- A. Review Mechanisms for Research Involving Multiple Institutions and/or Multiple Research Ethics Boards
- B. Review of Research Conducted Outside the Institution
This chapter sets out options, procedures and considerations for the ethics review of multi-jurisdictional research either entirely within Canada, or in Canada and other countries. It is intended to facilitate the ethics review process and ethical conduct of such research while ensuring that all participants are afforded the same respect and protection in accordance with the core principles of this Policy.
Contemporary research often involves collaborative partnerships among researchers from multiple institutions or countries. It may call upon the participation of a number of local populations and involve multiple institutions and/or multiple research ethics boards (REBs).
Collaborations in research may require institutions to adopt policies and procedures that permit arrangements for REB review by REBs at other institutions or external or independent REBs. To be effective, these review arrangements should ensure that research involving humans is designed, reviewed and conducted in a way that is informed by the core principles of this Policy: Respect for Persons, Concern for Welfare, and Justice. These core principles should be balanced with a proportionate approach to the research ethics review process (described in Article 2.9) for research being undertaken in Canada or abroad. Multi-jurisdictional research should take into account other relevant policies and applicable laws and regulations.
A. Review Mechanisms for Research Involving Multiple Institutions and/or Multiple REBs
This section primarily addresses the ethics review mechanisms for research involving multiple institutions and/or multiple REBs. It is not intended to apply to ethics review mechanisms for research involving multiple REBs within the jurisdiction or under the auspices of a single institution (addressed in Article 6.3).
Research involving humans that may require the involvement of multiple institutions and/or multiple REBs includes, but is not limited to, the following situations:
- a research project conducted by a team of researchers affiliated with different institutions;
- several research projects independently conducted by researchers affiliated with different institutions, with data combined at some point to form one overall research project;
- a research project conducted by a researcher affiliated with one institution, but that involves collecting data or recruiting participants at different institutions;
- a research project conducted by a researcher who has multiple institutional affiliations (e.g., two universities, a university and a college, or a university and a hospital. See Application of Article 6.1);
- a research project conducted by a researcher at one institution that requires the limited collaboration of individuals affiliated with different institutions or organizations (e.g., statisticians, lab or X-ray technicians, social workers and school teachers); or
- a research project that researcher(s) working under the auspices of a Canadian research institution conduct in another province, territory or country.
Adoption of Alternative Review Models – An Institutional Responsibility
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.
As described in Chapter 6, institutions are accountable for research conducted under their auspices, irrespective of the location where it takes place. Where research involving humans requires the involvement of multiple institutions and/or multiple REBs, an institution may establish one or more, or a mix of models for research ethics review as described below. Institutions may also establish other models or arrangements that are appropriate for the research under review within their jurisdiction or under their auspices. The ultimate responsibility for approving alternative research ethics review models for potential use by REBs and researchers remains with their individual institutions.
In consultation with its REB(s), an institution may authorize its REB to accept reviews undertaken by an external REB of the ethical acceptability of research. This authorization should be based on an official agreement that includes, but is not limited to, the following minimum components:
- all institutions or equivalent organization(s) involved agree to (1) adhere to the requirements of this Policy, (2) formalize the cross-institutional agreement, and (3) document the existence of this agreement in their institutional policies;
- the highest institutional level, the body that originally defined the jurisdiction of the REB and its relationship to other relevant bodies or authorities within the institution, makes the decision to allow an REB to recognize research ethics review decisions made by another REB (in accordance with Article 6.2); and
- approvals based on cross-institutional agreement should be documented and reported to the full REB, through the REB Chair, in each institution. The point in reporting is informational. It should not necessarily trigger a duplicate research ethics review.
Researchers and REBs should use the research ethics review models defined by their institution (see Article 8.2) and facilitate coordination of the research ethics review process. Whatever model is chosen, roles and responsibilities of all involved in the process should be defined and agreed to at the outset. Continuing ethics review of research involving multiple institutions and/or multiple REBs should follow the same process outlined in Article 6.14.
Research Ethics Review Models
The following models for the ethics review of research involving multiple REBs and/or multiple institutions are intended to provide flexibility and efficiency, and avoid unnecessary duplication of review without compromising the protection of participants. All other provisions of this Policy remain applicable.
1) Independent Ethics Review by Several REBs
This model follows the same research ethics review process as when the research only involves a single REB review. The REBs involved at each participating institution conduct an independent research ethics review and provide their separate decisions, either concurrently or sequentially. The level of ethics review for research that involves multiple REBs and/or institutions shall be proportionate to the risk involved in the research (see Article 6.12).
Ethics review of the proposed research at each collaborating institution helps to ensure that local issues and values are taken into consideration. This approach may be particularly important, though often more challenging, when there are relevant social or cultural differences between the participating institutions. When several REBs consider the same proposal from their own institutional perspectives, they may reach different conclusions on one or more aspects of the proposed research, that reflect local issues and values. REBs may therefore wish to coordinate their ethics review of research projects requiring multiple REB involvement, including conducting their research ethics reviews in a timely manner, and communicating any concerns that they may have with other REBs reviewing the same project. When multiple REBs are involved, the principal investigators should work with their REBs to formulate a strategy to address procedural inconsistencies or substantive disagreements that may arise among the participating REBs.
Where possible, researchers should provide their REB with the name and contact information of the other REBs that will also review the project to facilitate direct communication between the REBs, and help resolve disagreements that may arise.
2) Research Ethics Review Delegated to an External, Specialized or Multi-Institutional REB
Institutions may allow research on specialized content or research methods to be reviewed by an external, specialized or multi-institutional REB, where such a body exists. External, specialized or multi-institutional REBs may be established regionally, provincially/territorially or nationally, as necessary. Two or more institutions may choose to create a single joint REB, or to appoint an external REB, to which they delegate research ethics review. This delegation of review may be based on geographical proximity or other considerations such as resources, volume of reviews or shared expertise.
Some provinces have introduced legislation or policies that designate one or more REBs for the review of certain types of research within the province (see References at the end of this chapter).
In the official agreement between the selected REB and the institutions submitting research for ethics review, the external, specialized, or multi-institutional REB shall agree to adhere to this Policy. Roles and responsibilities should be clearly defined in the official agreement between the institution(s) delegating the review, and the institution or equivalent organization of the REB that will review the ethical acceptability of the research, or in the relevant legislation or policies. The external, specialized or multi-institutional REB may act as the responsible REB for any given review, if formally mandated as such by the institutions in question. Where relevant, agreements should specify how the external, specialized or multi-institutional REB will assure familiarity with particular populations that may be involved in the research. Review by an external, specialized or multi-institutional REB need not be preceded or followed by local REB review unless warranted to help ensure that local issues and values are taken into account.
3) Reciprocal REB Review
Multiple institutions may enter into official agreements under which they will accept, with an agreed level of oversight, the research ethics reviews of each other’s REBs. This might involve specific agreements between institutions for sharing their workload. Alternatively, institutions may decide that reciprocity agreements should be established for the ethics review of each relevant research proposal on a case-by-case basis.
In either case, researchers shall ensure that the reviewing REB is provided with any relevant information about the local populations and circumstances that would ordinarily be available to the local REB, and that may have a bearing on its review. The reviewing REB might call upon local REBs to provide information in addition to that provided by the researchers.
Selection of a Research Ethics Review Model Relevant to the Research Project
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.
Sensitivity to context is a key issue in the application of the core principles of this Policy to the ethics review of research involving multiple institutions and/or REBs. Researchers should consider the alternative research ethics review models at the planning and design stage of their research, and should consult with their REB to facilitate the selection and coordination of the appropriate review model. In choosing the appropriate research ethics review model, the researcher and the REB should pay attention to the research context, and the characteristics of the populations targeted by the research. The final decision regarding the selection of the appropriate model is the responsibility of the principal REB.
When selecting from among research ethics review models authorized by their institution, researchers and REBs should consider the following:
- the discipline and content area of the research, and the availability of appropriate experience and expertise within, or available to, the reviewing REB;
- the scope of the project to be reviewed and appropriateness of the proposed research ethics review model;
- the vulnerability of the study population overall and/or the particular characteristics of the local population at individual sites, differences in values and cultural norms, and the level of risk associated with the research under review;
- any relevant differences in laws and/or guidelines pertaining to the research in question if the institutions are in different provinces, territories and/or countries;
- relationships between institutions and REBs, and conflict resolution mechanisms related to REB decisions;
- the potential for conflicts of interest and undue influence, including those that may arise from funding sources;
- any differences in the standard of care normally followed, or access to services at the participating institutions that might be relevant to the conduct of the research; and
- any operational issues that might affect the research.
B. Ethics Review of Research Conducted outside the Institution
Researchers affiliated with Canadian institutions are undertaking research at numerous sites within Canada and in countries around the world. Such research may be carried out with or without any collaboration with host institutions and local researchers. Most middle-income countries, and many low-income countries, have laws, policies or guidelines governing the ethical conduct of research involving humans, but some parts of the world do not have developed or widespread research ethics infrastructure.
National and international standards for research involving humans are evolving continually, but methods for comparing the precise levels of protection afforded participants in different countries or jurisdictions, and by different institutions within those countries and jurisdictions, have not yet been developed. In exercising its responsibilities for the initial and continuing ethics review of research conducted under its auspices, the Canadian REB shall satisfy itself that the requirements of this Policy are met, both within the Canadian institution, and within the other country or research site. The Canadian REB shall take appropriate steps to ensure researchers are responsive to ethically relevant aspects of the research context.
- 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.
- 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:
- the REB at the Canadian institution under the auspices of which the research is being conducted; and
- the REB or other responsible review body or bodies, if any, at the research site.
An institution is responsible for the ethical conduct and ethical acceptability of research undertaken by its faculty, staff or students regardless of where the research is conducted (see Article 6.1). Thus, for a Canadian research institution, review of the ethical acceptability of the research by the institution’s REB is required, in addition to ethics review by an REB or other appropriately constituted review body with jurisdiction at the research site elsewhere in Canada, or outside Canada, if any. Approval of a research proposal by an REB at the research site does not constitute sufficient authorization to conduct the research without the approval of the relevant Canadian REB(s). Conversely, approval by the Canadian REB(s) is not sufficient authorization to begin the research without the approval of the REB or other appropriately constituted review body at the research site. Researchers shall obtain necessary approvals of the ethical acceptability of their research prior to the start of recruitment of participants, access to data, or collection of human biological materials, in accordance with Article 6.11.
Researchers may undertake research in Canada or abroad without formal collaboration with other academic institutions. In these cases, in addition to the REB review at their own institution, researchers may need to obtain access to the site and prospective participants from a responsible agency, where one exists. They shall inform the REB whether, or how, they will seek permission to proceed with the research at that site and with the target participants. Some organizations or groups have established mechanisms or guidelines (e.g., school boards, Aboriginal communities [see Chapter 9], correctional services, service agencies and community groups) to review requests for research prior to allowing access to their members, or access to data about them that are under their authority. When designing their research, researchers should consider these provisions. This article does not apply to research involving critical inquiry about organizations or institutions (see Article 3.6).
Researchers shall inform the REB of the absence of established ethics review mechanisms at the research site, and report their efforts to identify any other suitable review mechanisms in the other country.Footnote 1 When no appropriate mechanisms for research ethics review exist at the research site, researchers and REBs shall apply the core principles outlined in this Policy (see Chapter 1).
REBs should not prevent research from proceeding solely because the research cannot be reviewed and approved through a formal REB review process in another country or other jurisdiction. Under these circumstances, researchers should be aware of relevant cultural practices, such as those normally followed to seek entry into the relevant communities, and be respectful of them. Researchers shall inform the REB of their strategies to familiarize themselves with the relevant norms and cultural practices, and to minimize risks to individuals and communities participating in, or potentially affected by, the research.
Researchers and REBs should afford prospective participants in other countries no less protection and respect than what this Policy requires. Respect for Persons, Concern for Welfare, and Justice considered in the context of the particular research project and setting should guide researchers in the design of their research, and REBs in their research ethics review.
- The information to be provided to the researcher’s home REB will be determined by the provisions of the research ethics review model.
- 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.
Researchers and REBs should be aware of the research ethics requirements and the types of protections for research involving humans, including legal protection, afforded to participants at proposed research locations. Researchers and REBs should consult relevant reliable resources for details about governing laws or policies, and for information regarding appropriate REBs at the proposed research site in Canada or another country (see References at the end of this chapter). Applicable policies at the proposed site may differ considerably from this Policy, and therefore it is the responsibility of the researchers and REB(s) to ensure that, at a minimum, the provisions of this Policy, are followed.
Disagreements may arise when one of the REBs or equivalent review body (Canadian or foreign) grants ethics approval while the other does not. Such disagreements require open communication among the researchers and the REBs, or equivalent review bodies involved (see also Section A of this chapter). In keeping with the context-sensitive approach to research ethics review embodied in this Policy, the Canadian REB should ensure that it has a clear understanding of the differing rationales that might underlie divergent REB positions or decisions on a given proposal. Where the REB is uncertain about the appropriate course of action in a given research proposal, it should make contact with its counterpart REB in the research site or country. In the absence of formal reciprocity agreements between countries or institutions with respect to initial and continuing research ethics review, the REBs should engage in dialogue and may establish a specific mechanism, such as a joint subcommittee of the two REBs (e.g., for situations in which institutions collaborate regularly), to facilitate appropriate deliberation in order to reach a thoughtful and well-informed judgment on the ethical acceptability of a given research proposal (see Article 8.1).
- Council for International Organizations of Medical Sciences (CIOMS).International Ethical Guidelines for Biomedical Research Involving Human Subjects. CIOMS: Geneva. 2002.
- Newfoundland and Labrador. Health Research Ethics Authority Act, S.N.L. 2006, c. H-1.2.
- Québec. Ministère de la Santé et des Services sociaux. Direction générale adjointe de l’évaluation, de la recherche et de l’innovation. Unité de l’éthique. Mécanisme encadrant l’examen éthique et le suivi continu des projets multicentriques. In effect since April 1, 2008.
- U.S. Department of Health and Human Services. Office for Human Research Protections. International Compilation of Human Research Protections, 2010 Edition.
- Federal-Wide Assurances Registry for Registered Organizations Operating Institutional Review Boards (IRBs) or Registered IRBs.
- World Medical Association. Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. 2008.
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