Other:Pan-Canadian Single Research Ethics Review Initiative

Sponsor(s)

The Canadian Institutes of Health Research (CIHR)

Ethics review for multi-site, multi-jurisdictional clinical trials in Canada is often fragmented and uncoordinated, with significant variability and unpredictability in overall timelines. This can delay access to innovative medical interventions for patients and limit broad participant reach which can hinder the recruitment of diverse and representative trial populations. Extended start-up periods also increase costs and reduce efficient use of resources.

Research Ethics Board (REB) practices for Tri-Agency-funded human research in Canada are guided by the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS), which also provides principles for multi-jurisdictional research and describes alternative acceptable models of streamlined REB review. Despite this guidance, adoption of streamlined review models remains inconsistent, and many institutions still require separate reviews, perpetuating variability and extended timelines. While some provinces and networks have adopted streamlined models, these solutions remain regional and do not constitute a pan-Canadian solution, which has long been called for by the clinical research community.

A pan-Canadian solution is one that is national in scope and inclusive of all provinces and territories.

A pan-Canadian streamlined REB review approach is critical to reduce duplication, improve coordination, enable faster and more consistent trial activation across the country, and maintain Canada’s competitiveness in clinical research.

This Funding

Opportunity (FO) will provide funding for one team that will implement an efficient, high-quality, and sustainable research ethics review system for multi-site, multi-jurisdictional clinical trials in Canada. The initiative is expected to include as many jurisdictions as possible and work within the federated Canadian system.

The application must incorporate all the following design elements:

- Features:
- Formal mechanisms for participating institutions to delegate the REB review and oversight, including continuing review, to another REB.
- Strict, internationally competitive timelines for submission, review, and communication.
- Productive submission and communication processes for all participating sites, in both English and French, including the use of technology to support interoperability with other information exchange platforms, where required, to enable participation of a maximal number of jurisdictions and institutions.
- Compliance with all regulatory requirements, jurisdictional privacy laws, the TCPS and demonstrated leadership in implementing other applicable best practices.




- Procedures and criteria to select and onboard REBs to the initiative, including assessing the quality of review processes, adherence to TCPS and its provisions for research involving Indigenous Peoples.
- Procedures and criteria for establishing or assigning the REB(s) of record for multi-site trials.
- A workplan to build towards a fully pan-Canadian system that is flexible enough to include as many jurisdictions as possible and has mechanisms to work in a federated review model alongside other existing models in jurisdictions unable to fully participate due to constraints from existing legislation, policies or agreements.
- Mechanisms to resolve substantive disagreements among participating REBs when more than one REB review is required due to participant protection or legal/regulatory/jurisdictional requirements.

- Governance:

- Roles and responsibilities of key players and governance structures.
- Mechanisms for decision making, oversight, and dispute and conflict resolution.
- Concrete strategies to ensure the governance upholds the principles of equity, diversity and inclusion (EDI), Indigenous rights, and patient / community engagement. This includes but is not limited to the engagement and inclusion of multi-sectoral and diverse partners.
- Participation of CIHR, in its oversight capacity, strictly as a non-voting ex officio observer on the highest governance committee, with no authority over operational approvals or decision making.

- Programming:

- Implement a streamlined ethics review system that meets the requirements outlined in this funding opportunity.
- Align processes and initiatives to achieve the greatest possible pan-Canadian reach.
- Become fully sustainable by the end of the grant period, with no or minimal CIHR funding needed.
- Include a plan for independent evaluation, consisting of a developmental evaluation within the first three months of funding and an independent formal evaluation—completed by the end of the grant—that will assess project progress, governance, and provide recommendations for continued evolution of the pan-Canadian initiative.

NOTE

CIHR will establish a CIHR Oversight Committee that will monitor initiative progress, at the overall initiative level, against the milestones and objectives as outlined in the application for funding.



This will include reviewing reports from the funded team, identifying any concerns with overall progress, and identifying potential linkages with other initiatives.

Role and Contributions of Applicant Partners

CIHR recognizes that a broad range of partners may be relevant to this opportunity and it is expected that the applicant describes the role of all applicant partners and how/if they will contribute to the project. Any consideration of risk and/or conflict of interest must be explained, as appropriate.

Funds Available

CIHR and partner(s) financial contributions are subject to availability of funds. Should CIHR or partner(s) funding levels not be available or decrease due to unforeseen circumstances, CIHR and partner(s) reserve the right to reduce, defer or suspend financial contributions to the grant received as a result of this funding opportunity.
- The total amount available for this funding opportunity is $5,000,000 over up to 29 months, enough to fund 1 grant.
- Funding beyond 15 months will be conditional and will depend on demonstrated need and the outcome of the CIHR Oversight process (see Conditions of Funding ).

For more information on the appropriate use of funds, refer to Allowable Costs.
- The specific objective of this funding opportunity is to strengthen Canada’s clinical trial ecosystem and infrastructure, and position Canada as a competitive destination for global clinical trials by fostering the implementation of an efficient, high-quality, and sustainable research ethics review system for multi-site, multi-jurisdictional clinical trials in Canada, regardless of sponsor and source of funding, that:
- Operates as a pan-Canadian system, accessible across all jurisdictions, subject to any local legislative or policy-related considerations; and
- Is designed to avoid duplication of ethics reviews that are not anticipated to provide additional protections for research participants in accordance with TCPS; and
- Provides for alternative approaches, as needed, through collaborative engagement, to establish a federated model that will work with the constraints of jurisdictional processes and legislation where applicable.

For an application to be eligible, all the requirements stated below must be met:
- The Nominated Principal Applicant (NPA) must be an independent researcher or a knowledge user , affiliated with a Canadian postsecondary institution and/or its affiliated institutions (including hospitals, research institutes and other non-profit organizations with a mandate for health research and/or knowledge mobilization).
- In addition to the NPA, the applicant team must include a minimum of ten (10) people across a minimum of eight (8) provinces or

📌 Other: Pan-Canadian Single Research Ethics Review Initiative (Canada)
🏢 Researchnet Recherchenet
📍 Canada