of financial conflicts of interest. They should seek to ensure that financial consid-erations do not serve to diminish respect for the principles of this Policy or the scientific validity and transparency of research procedures.
Financial incentives have the potential to distort researchers’ judgment in ensuring the design and conduct of research is ethical. When researchers partner with or-ganizations whose primary motive is profit, they must be aware of the potential for conflicts of interest. Consideration for the profitability of the research may threaten the ethical integrity of research design and conduct. Not all research spon-sored by for-profit organizations gives rise to financial conflicts of interest.
However, REBs shall consider the potential for this type of conflict because its ability to undermine the ethical conduct of research has been empirically estab-lished.
As part of a research project submitted for REB review, researchers shall disclose all kinds and amounts of payment (financial or in-kind) to the researchers by spon-sors, commercial interests, and consultative or other relationships, as well as any other relevant information that may affect the project (e.g., donation to an institu-tion by a research sponsor). Researchers shall also supply all relevant documentation and identify strategies to prevent, disclose, minimize or otherwise manage conflicts.
The REB should examine budgets to ensure that there are no inappropriate pay-ments to be made or other unexplained expenses that may raise questions about conflict of interest. Further, payment provisions should be scrutinized to ensure they do not create ethically inappropriate incentives to recruit quickly, at the ex-pense of a careful review of the suitability of prospective participants.
Unreasonable payments or undue inducements may place the researcher, and some-times the institution, in a conflict between maximizing financial remuneration on the one hand and protecting participants and meeting the scientific requirements of the project on the other. Disclosure of the kinds and amounts of payments and other budgetary details encourages the researcher to identify and appropriately manage potential conflicts of interest and helps the REB to assess them. Manage-ment by institutions and/or REBs may include prohibiting certain forms of payment.
The perception of a conflict of interest may, in many cases, be as damaging as a real conflict. The REB should assess the likelihood that the researcher’s judgment may be inappropriately influenced, or perceived to be influenced, by private or per-sonal interests. It should then determine the magnitude of harm that is likely to result from such influence or from the perception of undue influence.
In addressing conflicts of interest, disagreements between the REB and the re-searcher may arise about the scope and reach of disclosure, including disclosure of new information to participants, or other aspects of managing the conflict. Reso-lution of disagreements should be guided by the paramount principles of Respect for Persons and Concern for Welfare of participants. If the researcher and the REB cannot resolve their disagreement they should use the institutional conflict of in-terest mechanisms to arrive at a solution.
Endnote
1Definition of “conflict of interest” based on Schedule 14 of the Memorandum of Understanding (MOU) on the Roles and Responsibilities in the Management of Federal Grants and Awards.
www.nserc-crsng.gc.ca/NSERC-CRSNG/Policies-Politiques/MOURoles-ProtocolRoles/index_eng.asp
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Chapter 8
MULTI-JURISDICTIONAL RESEARCH
Introduction
This chapter sets out options, procedures and considerations for the ethics review of multi-juris-dictional 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 in-stitutions 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 institu-tion (addressed in Article 6.3).
Research involving humans that may require the involvement of multiple institutions and/or mul-tiple 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 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 Application of Article 6.1);
(e) a research project conducted by a researcher at one institution that requires the limited col-laboration 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 in-stitution 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 irre-spective 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 in-volving 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 juris-diction 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 re-views 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 lim-ited 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 re-search ethics review.
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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 re-view 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 partic-ipating 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.
Chapter 8 – Multi-Jurisdictional Research
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 re-view, 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 re-search proposal on a case-by-case basis.
In either case, researchers shall ensure that the reviewing REB is provided with any relevant in-formation 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
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 re-view model from among those authorized by their institution.
Application 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 choos-ing the appropriate research ethics review model, the researcher and the REB should pay attention to the research context, and the characteristics of the popula-tions 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 in-stitution, researchers and REBs should consider the following:
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• the discipline and content area of the research, and the availability of appropri-ate experience and expertise within, or available to, the reviewing REB;
• the scope of the project to be reviewed and appropriateness of the proposed re-search ethics review model;
• the vulnerability of the study population overall and/or the particular charac-teristics 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 coun-tries;
• relationships between institutions and REBs, and conflict resolution mecha-nisms 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 re-search; 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 re-search 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 ethi-cally 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 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.
Chapter 8 – Multi-Jurisdictional Research
(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.
Application An institution is responsible for the ethical conduct and ethical acceptability of re-search undertaken by its faculty, staff or students regardless of where the rere-search 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 ad-dition 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 con-stitute 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 collabo-ration 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 commu-nity 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 design-ing 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 mech-anisms at the research site, and report their efforts to identify any other suitable
Researchers shall inform the REB of the absence of established ethics review mech-anisms at the research site, and report their efforts to identify any other suitable