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Revised Draft 2nd Edition of the TCPS (December 2009)

Chapter 8

MULTI-JURISDICTIONAL RESEARCH

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 and conduct of such research while ensuring that 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).

Collaborative research may require institutions to adopt policies and procedures that permit arrangements for REB review off-site at other institutions. 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 for research being undertaken in Canada or abroad.

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 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) a research project conducted by a team of researchers affiliated with different institutions;

(b) several research projects independently conducted by researchers affiliated with different institutions, with data combined at some point to form one overall research project;

(c) a research project conducted by a researcher affiliated with one institution, but that involves collecting data or recruiting research participants at different institutions;

(d) 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 Article 6.1);

(e) 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

(f) 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 is 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, but remains responsible for the ethical acceptability of research undertaken within its jurisdiction or under its auspices irrespective of where the research is conducted.

Application As described earlier 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 described below. Institutions may also establish other models or arrangements deemed appropriate for the research under review within their jurisdiction or under their auspices. The ultimate responsibility for approving alternative ethics review models for potential use by its REBs and researchers remains with the individual institutions.

An institution may authorize its REB to accept reviews of another institution’s REB if both institutions have an official agreement that includes at least the following components:

  • all institutions involved agree to adhere to the requirements of this Policy, formalize the cross-institutional agreement, and document the existence of such 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 decisions made by another institution’s REB (in accordance with Article 6.2); and
  • approvals based on cross-institutional agreements should be brought to the attention of the full REB in each institution, in the same way as decisions made by delegated review.

Researchers and REBs should use the review models defined by their institution (see Article 8.2) and facilitate coordination of ethics review. 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 for such research should follow the same process outlined in Article 6.14.

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 research participants. All other provisions of this Policy remain applicable.

1.   Independent Review by Several Single REBs

This follows the same review process for research that does not require the involvement of multiple REBs and/or institutions. The REBs involved at each participating institution conduct their independent research ethics review and provide their separate decisions, either concurrently or sequentially. The level of ethics review of research that may involve multiple REBs and/or institutions should 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, reflecting local considerations and values. REBs may therefore wish to coordinate their review of projects requiring multiple REB involvement, including conducting their 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 investigator should work with his/her REB 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 a 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. In the official agreement between the selected REB and the institutions submitting research for review, the specialized or multi-institutional REB shall agree to adhere to this Policy. Specialized or multi-institutional REBs may be established regionally, provincially/territorially or nationally, as necessary.

Another situation would include two or more institutions creating a single joint REB to which the research ethics review is delegated. Such a delegation may be based on geographical proximity or other considerations such as capacity, 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 below).

Roles and responsibilities should be clearly defined in the official agreement between the institution(s) delegating the review and the institution of the REB that will review the research, or in the relevant legislation or policies. The 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 specialized or multi-institutional REB will assure familiarity with particular populations that may be involved in the research. Review by a 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 ethics reviews of each other’s REBs. This might involve specific agreements between institutions for sharing the workload. Alternatively, institutions may decide that reciprocity agreements should be established for each relevant research proposal on a case-by-case basis.

In either case, researchers should 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 Review Model Relevant to the Research Project

Article 8.2 In accordance with their institutional policies and procedures, researchers and REBs should, together, determine which review model is the most appropriate for the proposed research involving multiple institutions and/or REBs.

Application When planning for research involving multiple institutions and/or multiple REBs, researchers and REBs should identify which review models have been approved by their institution and determine which one would be most relevant for the proposed research. Researchers should consider the alternative 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.

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. In choosing the appropriate review model, the researcher and the REB should pay attention to the research context and the characteristics of the populations targeted by the research.

Where the choice of review models is available, 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 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/countries;

  • relationships between institutions and REBs, and conflict resolution mechanisms related to REB decisions;

  • the potential for conflict of interests and undue influence, including from funding sources;

  • any differences in the standard of care or access to services that might be relevant to the conduct of the research, normally followed at the participating institutions; and

  • any operational issues that might affect the research.

B. Review of Research Conducted Outside an REB’s Jurisdiction

Researchers affiliated with Canadian institutions are undertaking research in 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 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 human participants are evolving continually, but methods for comparing the precise levels of protection afforded participants in different countries or jurisdictions, and 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 outside its jurisdiction, the Canadian REB shall satisfy itself that the requirements of this Policy are met, both within the Canadian institution and within the host country or site, taking appropriate steps to ensure they are responsive to ethically relevant aspects of the research context.

Article 8.3      

(a) Where research conducted under the auspices of a Canadian research institution and performed in whole or in part outside Canada is covered by an 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 prospective ethics review both by (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 host research site.

Application An institution is responsible for the ethical conduct 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 research by the institution’s REB is required in addition to review by an REB having jurisdiction at the research site in the host country or elsewhere in Canada, if any. Approval of a research proposal by an REB at the host 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 warrant to begin the research without the approval of the REB or other appropriately constituted review body at the host site.

In some cases, researchers undertake research in Canada or abroad without seeking formal collaboration with other academic institutions. In such 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 such exists. They should inform the REB whether or how they will seek permission to proceed with the research at that site and with the target research 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 individuals, or access to data about them, under their authority. When designing their research, researchers should consider such provisions. This article does not apply to research using critical inquiry about organizations or institutions. (See Article 3.6).

Researchers should inform the REB about the absence of established review mechanisms at the research site, and about their efforts to identify any other suitable review mechanisms in the host country1. When no appropriate mechanisms for research ethics review exist at the research site, researchers and REBs should 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 the foreign 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 should 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, including the risk of any social disruption that the research might cause or exacerbate. Additional guidance may be found in Chapter 4, Section D, and Chapter 9 of this Policy.

Researchers and REBs should afford the prospective participants 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 review.

Article 8.4 

(a) The information to be provided to the home REB will be determined by the provisions of the review model.

(b) When conducting research outside the jurisdiction of their home institution, whether at a site abroad or in Canada, researchers should provide their home REBs with:

  • the relevant information on the rules governing human research and the ethics review requirements at the host site, where such exist;

  • the names and contact information for the relevant REBs or comparable ethics bodies, if known, that will review the proposal at the host site; and

  • relevant information about the target populations and circumstances that might have a bearing on the ethical review by the researchers’ home REB.

Application Researchers and REBs should be aware of the research ethics requirements and the types of protection afforded to research participants at proposed research locations. Researchers and REBs should consult relevant resources for details about governing laws or policies, and for information regarding appropriate REBs at the proposed research site in Canada or in the host country. (See References below). 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 for the particular research project are followed at such sites, within the host country or in Canada.

Subject to Article 8.4(a), disagreements may arise when one of the REBs or equivalent review body (Canadian or foreign) grants 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 above). 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 host site or country. In the absence of formal reciprocity agreements between countries or institutions with respect to initial and continuing ethics review, the REBs should engage in dialogue and may even 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 a given research proposal. (See also Article 8.1).

Endnote

[1] See for example the United States Office for Human Research Protections (OHRP) registry of REBs (see Reference below), mainly in the area of health and biomedical research. It can serve as one resource for identifying research ethics review bodies around the world.

References