TCPS 2 (2022) – Chapter 8: Multi-Jurisdictional Research

Introduction

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 Research Ethics Boards

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:

  1. a research project conducted by a team of researchers affiliated with different institutions;
  2. several research projects independently conducted by researchers affiliated with different institutions, with data combined at some point to form one overall research project;
  3. a research project conducted by a researcher affiliated with one institution, but that involves collecting data or recruiting participants at different institutions;
  4. 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);
  5. 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
  6. 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

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.

Application

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, institutions are strongly encouraged to establish mechanisms for streamlining the ethics review process using 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.

In consultation with its REB(s), an institution may authorize its REB(s) to accept reviews undertaken by an external REB of the ethical acceptability of research.

For more than minimal risk research, this authorization should be based on an official agreement that includes, but is not limited to, the following components:

In the official agreement between the institution of the REB selected to review and the institutions submitting research for ethics review, the reviewing REB (i.e., the one designated to conduct the ethics review) shall agree to adhere to this Policy. The reviewing REB may act as the responsible REB for any given review, if formally mandated as such by the institutions in question.

Official agreements are not required for the ethics review of minimal risk research (see Model 3, Single Research Ethics Board Review for Minimal Risk Research).

In general, REBs, in consultation with researchers, should use the authorized research ethics review models to determine the most appropriate process of ethics review for the research based on considerations outlined in Article 8.2. Whatever model is chosen, roles and responsibilities of all involved in the review process should be defined and agreed to at the outset. Continuing ethics review of research involving multiple institutions and/or multiple REBs should also be determined at the outset and be consistent with Article 6.14.

Where research ethics review models are adopted, the reviewing REB should assure familiarity with the particular populations that may be involved in the research. Researchers and local REBs should bring to the reviewing REB's attention, particular characteristics of the local population at individual sites, differences in values and cultural norms, or relevant differences in laws or guidelines that may have a bearing on the review. Duplication of ethics review that is not anticipated to provide additional protections for research participants – for example, based on local population characteristics, relevant social or cultural norms or values – is unnecessary.

Some provinces have introduced legislation or policies that designate one or more REBs for the review of certain types of research (including more than minimal risk) within the province (see References at the end of this chapter). Any existing legislation or policies that designate REBs for the ethics review of research supersede the research ethics review models outlined below.

Research Ethics Review Models for Multi-Jurisdictional Research

The following models for the ethics review of research involving multiple REBs and/or multiple institutions are intended to provide flexibility and efficiency and to prevent unnecessary duplication of review without compromising the protection of participants. Institutions are strongly encouraged to establish mechanisms for streamlining the ethics review process using the following models or a mix of models.

  1. Research Ethics Review Delegated to an External, Specialized or Multi-Institutional Research Ethics Board

    Institutions may allow research 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 in an area of research interest.

  2. Reciprocal Research Ethics Board 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 ethics review on a case-by-case basis.

  3. Single Research Ethics Board Review for Minimal Risk Research

    Under this model, minimal risk research that falls under the auspices or jurisdiction of multiple REBs or institutions subject to the TCPS may follow alternative research ethics review models without the requirement to enter into official agreements. It is normally the lead principal investigator's REB that determines whether the risk level of the research meets the definition of "minimal risk" in this Policy (defined in Chapter 2, Section B). REBs may develop their own mechanisms and procedures under which they will coordinate and manage the operationalization of this model.

    The reviewing REB must be affiliated with an institution eligible to administer Agency funds. The reviewing REB may follow the delegated ethics review process of minimal risk research outlined in Article 6.12. Typically, the reviewing REB would also conduct the continuing ethics review of the research outlined in Articles 6.14. Other local REBs – where the research falls under their auspices or jurisdiction – fulfill their responsibility under Article 6.1 by indicating and documenting their acceptance of the reviewing REB's decision.

    Accepting the ethics review of minimal risk research by external REBs builds on trust relationships, collaboration, and communication amongst REBs and institutions. It builds on the proportionate approach to research ethics review outlined in this Policy (Chapter 1, Section C).

  4. Independent Ethics Review by More than One Research Ethics Board

    In this model, the REBs involved at each participating institution conduct an independent research ethics review and provide their separate decisions, either concurrently or sequentially, similar to the process of single site REB review. The level of ethics review for research that involves multiple REBs and/or institutions shall be proportionate to the risk involved in the research (Article 6.12).

    When it is anticipated that independent ethics review by more than one REB is likely to add substantive protections for research participants, 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 conduct ethics reviews of the same research project, 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. REBs should take an active role in striving to resolve any substantive disagreements with other REBs. Where possible, researchers should provide their REBs 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.

    Typically, duplication of REB review is not likely to add substantive protections for research participants and may result in delays that prevent or postpone access to potential benefits of research. This model should be a last resort for ethics review of research of all risk levels as it does not result in a streamlined ethics review process and is not anticipated to add to participant protections except where, for example, local population characteristics, relevant social or cultural norms, or values impact participant risk. When the research is limited to minimal risk, this model can rarely be justified.

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 institutions.

Application

In the absence of other existing models or legislation that designate REBs for the ethics review of certain types of research, model 3 – Single Research Ethics Board Review for Minimal Risk Research as described in the Application of Article 8.1 – is the preferred model for streamlining ethics review of minimal risk research.

When evaluating which is the most appropriate and relevant alternative model to streamline research ethics review for a research project(s), researchers and REBs should consider the following:

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 REBs to facilitate the selection and coordination of the appropriate review model. In choosing the appropriate research ethics review model, the researcher and the REBs should pay attention to the research context and the characteristics of the populations targeted by the research. In consultation with the principal investigator, the REB selects the appropriate alternative research ethics review model (see Article 8.1). REBs should document the process followed in selecting an alternative research ethics review model from those models authorized by their institution. If a disagreement occurs regarding the selection of the appropriate alternative research ethics review model, the REB – typically the principal investigator's REB – makes the final decision.

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.

Article 8.3

  1. 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.
  2. 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:
    1. the REB at the Canadian institution under the auspices of which the research is being conducted; and
    2. the REB or other responsible review body or bodies, if any, at the research site.

Application

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 (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 institutions, 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, Indigenous communities [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 (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 (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 jurisdiction. Under these circumstances, researchers should be aware and respectful of relevant cultural practices, such as those normally followed to seek entry into the relevant communities. 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.

Article 8.4

  1. The information to be provided to the researcher's home REB will be determined by the provisions of the research ethics review model.
  2. When conducting research outside the jurisdiction of their home institutions, 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;
    • 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.

Application

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 an 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 (Article 8.1).

References

Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Health-Related Research Involving Humans, 2016. Retrieved on August 10, 2022.

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, Cadre de référence des établissements publics du réseau de la santé et des services sociaux pour l'autorisation d'une recherche menée dans plus d'un établissement [ PDF (591 KB) - external link ] (only in French), updated April 1st, 2016. Retrieved on August 10, 2022.

Newfoundland and Labrador House of Assembly, Health Research Ethics Authority Act, S.N.L. 2006, amended in 2011 and 2012, c. H-1.2. Retrieved on August 10, 2022.

United States Department of Health and Human Services, Office for Human Research Protections, International Compilation of Human Research Standards, 2018. Retrieved on August 10, 2022.

United States Department of Health & Human Services, Office for Human Research Protections (OHRP) Database for Registered IORGs & IRBs, Approved FWAs, and Documents Received in Last 60 Days. Retrieved on August 10, 2022.

World Medical Association, Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, 2013. Retrieved on August 10, 2022.

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