Other: Pan-Canadian Single Research Ethics Review Initiative

Other:

Pan-Canadian Single Research Ethics Review Initiative

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.
  • Efficient 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…