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Draft 2nd Edition of the TCPS (December 2008)

Chapter 8

MULTI-JURISDICTIONAL RESEARCH

Modern 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 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 welfare, respect for autonomy and equal moral status for all humans. 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 Research Ethics Boards

This section primarily addresses research involving multiple sites and at least one institution that adheres to this Policy.

Institutions are accountable for research conducted under their auspices, irrespective of the location where it takes place. Prior ethics review of the proposed research at each collaborating institution affords the opportunity for local issues and values to be considered. However, multiple, independent reviews may lead to different decisions, which may delay or jeopardize the implementation of the research.

Research involving humans that may require the involvement of 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 research 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);
  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. Researcher(s) working under the auspices of a Canadian research institution but conducting research in another province, territory or country.
Adoption of Alternative Review Models is an Institutional Responsibility

Article 8.1 An institution that has established a research ethics board (REB) may define specific review models for research involving multiple REBs or institutions, in accordance with this Policy.

Application In addition to the traditional review processes (see Point 1, below), the following models for multiple REBs or multi-institutional review 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

The REBs involved at each participating institution conduct their independent research ethics review and provide their separate decisions, either concurrently or sequentially.

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. REBs may therefore wish to coordinate their review of projects requiring multiple REB involvement, and to communicate any concerns that they may have with other REBs reviewing the same project. When multiple REBs are involved, the REB of the principal investigator should define mechanisms to address inconsistencies or disagreements, defining criteria, roles and responsibilities.

Researchers should provide their REB with the name and contact information of the other REBs that will also review the project.

2. Research Ethics Review Delegated to a Specialized or Multi-institutional REB

Institutions allow research on specific content areas (e.g., clinical oncology research, research involving Aboriginal peoples) or research methods (e.g., qualitative research) to be reviewed by an external, specialized or multi-institutional REB, where such a body exists. In the agreements between the selected REB and the institutions submitting research for review, the specialized or multi-institutional REB must 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 pooling their resources to create a single joint REB to whom 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 that designates one or more REBs for the review of certain types of research within the province. In addition to other provisions, provincial legislation may require adherence to this Policy.

Roles and responsibilities should be clearly defined in the agreement between institutions or in the legislation. 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. Central review by a specialized or multi-institutional REB need not be preceded or followed by local REB review.

3. Reciprocal REB Review

Multiple institutions may enter into 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 of reviewing collaborative research.

Institutions may also decide that reciprocity agreements between institutions involved in such research are to be established for each research proposal on a case-by-case basis.

Whether the review is done by a single REB or reciprocal REB, 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. Otherwise, local REBs might be called upon to provide such information, in addition to the information provided by the researchers.

Article 8.2 Every institution remains responsible for the ethical acceptability of research undertaken within its jurisdiction or under its auspices, regardless of the model adopted for multi-jurisdictional review of any given research project.

Application The selection, establishment and implementation of alternative models for REB review is a collective/collaborative responsibility within and between the participating institutions, their REBs, and the investigators whose research is reviewed. Regardless of the review model adopted for any given research purpose, the institution remains responsible for the ethics review and for decisions regarding research involving human participants that is carried out under its auspices or within its jurisdiction, irrespective of the location where the research is conducted. The ultimate responsibility for the REB reviews and decisions remains with the individual institutions.

Alternative procedures can range from multiple reviews of the same project to accepting the review of other REBs constituted in accordance with this Policy. 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 must agree to adhere to the requirements of this Policy, and the cross-institutional agreement must be formalized and documented;
  • The decision to allow an REB to recognize decisions made by another institution’s REB must be made at the highest institutional level, by the body that originally defined the jurisdiction of the REB and its relationship to other relevant bodies or authorities (in accordance with Article 6.2 in Chapter 6 [“Governance of Research Ethics Review”]); 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 should use the review models defined by their institution and facilitate coordination of ethics review when submitting their proposal to the REB. Whatever model is chosen, roles and responsibilities of all involved in the process should be defined and agreed to at the outset. Institutions might decide to adopt different models for the review of different research projects.

Adoption of a Review Model Relevant to the Research Project is a Shared Responsibility Between Researchers and REBs

Article 8.3 Researchers and research ethics boards (REBs) should, together, determine which review model is the most appropriate for proposed research involving multiple institutions and REBs.

Application When planning for research involving multiple institutions and 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 alternative review models at the planning and design stage of their research, and they 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 in ethics review of research involving multiple institutions and REBs. In choosing the appropriate review model, the researcher and the REB should pay attention to characteristics of the populations targeted by the research and the research context. When choosing alternative REB review models, 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 potential for conflict of interest and undue influence, including from funding sources;
  • The scope of the project to be reviewed and appropriateness of the proposed review mechanism;
  • The vulnerability of the study population overall and the local population at individual sites, 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;
  • 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 need addressing.

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

Researchers affiliated with Canadian institutions are undertaking research in numerous countries around the world or sites within Canada. Such research may be carried out with or without any collaboration with host institutions and local researchers. Researchers should familiarize themselves with the rules applicable in the host institution and conduct their research in conformity with them. Most developed countries, and many developing countries, have laws, policies or guidelines governing the conduct of research involving humans. However, for some types of research, such formal frameworks or requirements for review do not exist.

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 must 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 8.4

  1. Subject to Article 8.4(b), 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 the research ethics board (REB) at the Canadian institution under whose auspices the research is being conducted and by the REB or similar body, where such exists, at the collaborating institution(s) in the host research site.
  2. 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 or REBs consistent with this Policy, the terms of that model apply.

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, where such exists. 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, 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 in Chapter 3 [“Free and Informed Consent”].)

In other cases, no such provisions or requirements exist. Researchers should inform the REB about the absence of any other review mechanisms available at the research site. In such cases, researchers and REBs should apply the core principles outlined in this Policy.

Some countries have not established formal ethics review mechanisms for some types of research. REBs should not prevent such research from proceeding solely because the research cannot be reviewed and approved through a formal REB review process in the foreign country. 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 and REBs should afford the prospective participants no less protection and respect than what this Policy requires. Respect for the welfare, autonomy and equal moral status of all humans 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 8.5 (a) Subject to Article 8.5(b), when conducting research outside the jurisdiction of their home institution, whether at a site abroad or in Canada, researchers should provide their home research ethics board(s) (REBs) with:

  • the relevant information on the rules governing human research and the ethics review requirements at the host site;
  • 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 researcher’s home REB.

(b) Where a review model involving multiple institutions and REBs is in place, the information to be provided to the home REB will be determined by the provisions of that model.

Application As Canada’s role in national and international research and research funding continues to grow, researchers and REBs should be aware of the research ethics requirements and the types of protection afforded to human research participants in proposed research locations. Researchers and REBs should consult relevant resources for details of policies and for appropriate REBs in the host country or research site in Canada (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 the provisions of this Policy for the particular research project are followed at such sites, within the host country or in Canada, at a minimum.

Subject to Article 8.5 (b), 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 investigator(s) and the REBs or equivalent review body involved. (See also Section A [“Review Mechanisms for Research Involving Multiple Institutions and Research Ethics Boards”], 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 country. 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 8.2).

C. Other Ethics Considerations When Reviewing Research Conducted Outside the Jurisdiction of the REB

Benefit Sharing and Obligations of Care for Research Participants and Communities

Researchers should consider the implications of the core principles for sharing the benefits of the research. (See Chapter 1 [“Ethics Framework”] and Chapter 9 [“Research Involving Aboriginal Peoples”].) They should be familiar with the social and economic circumstances in the host site or country. As well, they should anticipate, to the best of their ability, obligations of care that might arise in any given research proposal. In general, researchers should ensure that any services or care necessary to complete a given study, or to respond effectively to any foreseeable harms that may be experienced by research participants, are provided at the site of the research. But researchers should also anticipate, and prepare to the best of their ability and based on available resources, for demand for ancillary care that might arise in the course of the research. Joint planning with local collaborators and/or advisors can help to clarify the most likely nature of the ancillary care demand, as well as the most appropriate division of responsibility for meeting it, where appropriate.

Researchers should also be sensitive to the expectations and opinions of participants regarding potential benefits of the research, and they should arrive at agreements with the community about the scope and nature of the benefits that will be provided to participants and/or their communities during and after the research. The agreements should, to the extent possible, be explicit about the planned division of responsibilities for realizing these benefits. In many cases, benefits may be delivered most effectively in partnership with local organizations. Benefit sharing may, for example, take the form of information sharing, training for local personnel both in the host country and in Canada, or health care or similar services. Where applicable, these benefit-sharing agreements, whether formal or informal, should be submitted to the Canadian REB and the REB of the host site or country for review. Since researchers are not aid agencies, REBs should be vigilant to ensure that the proposed distribution of benefits is fair, without imposing undue burdens on the researcher that would make it too difficult or costly to complete the research reliably.

Researchers should pay special attention to cultural or other values that differ from their own. They should also take care not to create unrealistic expectations among participants with respect to the potential benefits of the research.

Researchers should normally provide copies of publications or other research reports arising from the research to the institution or organization - normally the host institution - that is best suited to act as a repository and disseminator of the results within the participating communities. This may not be necessary in countries when the results are readily available in print or electronically.

Protection of Research Participants in Authoritarian Countries

Various international conventions and treaties have espoused the position that researchers should be permitted free movement across national boundaries to conduct their research. REBs should, therefore, not veto research about authoritarian countries on the grounds that the regime or its agents have not given approval for the research project or have expressed a dislike of the researchers. REBs should, however, legitimately concern themselves with the safety of research participants and the security of research materials. (See Article 3.12 in Chapter 3 [“Free and Informed Consent”]. When copies of field material are provided to participants in countries with authoritarian regimes, researchers should concern themselves with commitments concerning anonymity and confidentiality of participants to ensure that human rights of the participants and the ethical principles set out in this Policy are not compromised. (See Articles 5.1 - 5.4 in Chapter 5 [“Privacy and Confidentiality”].)

Risks to Researchers

Researchers undertaking research in other countries may be exposed to risks of harm. They should consult the appropriate bodies within their institutions and abroad who may provide advice on conditions in other countries prior to starting the research.

In fulfilling their review role, REBs have access to details of the context within which the research takes place in other jurisdictions and countries, and which may raise safety concerns for the researcher. In those cases, and while it is not a formal part of their responsibilities, REBs may raise such concerns as part of their communication to the researchers of the results of the ethics review, and the REB should flag such concerns with the institution.

References