Joint Statement on Clinical Trial Oversight in Canada

Health Canada - Canadian Institutes of Health Research - Canadian Association of Research Ethics Boards

Published: May 27, 2020

Health Canada (HC) and the Canadian Institutes of Health Research (CIHR), with the collaboration and participation of the Canadian Association of Research Ethics Boards (CAREB), recognize the urgent need to conduct clinical trials to evaluate the safety and efficacy of a drug, a vaccine or a medical device in treating, preventing, mitigating or diagnosing COVID-19.

Health Canada is responsible for the review and authorization of clinical trials in Canada. This authorization requires that a Research Ethics Board (REB) approve the trial before it is initiated. In the context of COVID-19, clinical trial reviews by both Health Canada and REBs have been prioritized.

As a federal funding agency, CIHR is committed to supporting the highest levels of ethics and excellence in health research. Specific to COVID-19, CIHR and the Tri-Agency Secretariat on Responsible Conduct of Research (SRCR) are working with the research community and Health Portfolio partners to facilitate Canada's research response to the pandemic.

CAREB is a national organization which aims to represent the interests of Canadian REBs and to reflect REB perspectives and concerns.

Initial discussions have taken place between Health Canada, CIHR, SRCR, CAREB and Provincial/Territorial (P/T) representatives, to explore facilitating COVID-19 clinical trial review and implementation.

Building on these discussions, we are pleased to announce a new initiative to have monthly engagement sessions on clinical trial oversight and implementation in Canada. These sessions will be led by Health Canada and will have participation from CIHR, CAREB and REBs that frequently review clinical trials in Canada. Through this initiative, policy makers, regulators, funders and oversight bodies will collaborate and share information on clinical trials. This pan-Canadian initiative will aim to make the clinical trial process more efficient and give Canadians timely access to promising therapeutic products for COVID-19, without compromising the safety of participants or the reliability of trial findings.

Health Canada, CIHR and CAREB would like to take this opportunity to recognize and thank REBs for their work to facilitate the ethics reviews of COVID-19 clinical trials. It will be important that these collaborative efforts continue for the duration of the crisis, and that this experience informs ongoing efficiencies in the clinical trial regulatory framework moving forward. We would like to also encourage COVID-19 prioritization to carry over to implementation at clinical trial sites, to help ensure that trials launch as quickly as possible across the country.

Find the most current versions of the list of drug clinical trials and list of medical device clinical trials related to COVID-19 approved in Canada. These lists are updated as new trials are approved.