BACKGROUND
On May 27, 2020 Health Canada, the Canadian Institutes of Health Research (CIHR) and the Canadian Association of Research Ethics Boards (CAREB-ACCER) published a “Joint Statement on Clinical Trial Oversight in Canada” in response to the COVID-19 pandemic and the need to prioritize both Health Canada and REB review of COVID-19 clinical trials. In addition, initial discussions between Health Canada, CIHR, the Secretariat on the Responsible Conduct of Research (SRCR), CAREB-ACCER and various Provincial/Territorial representatives explored ways to facilitate COVID-19 clinical trial review and implementation.
Since this time, Health Canada has launched and leads a series of engagement sessions to bring together policy-makers, regulators, funders and oversight bodies (including REBs) on clinical trials (oversight and implementation) in the context of COVID-19.
The 3rd engagement session in this series is scheduled for September 10, 2020 (1:30pm – 3:30pm EST) and will include a panel discussion entitled “COVID-19 Clinical Trial Review and Oversight: Experiences of Canadian REBs” that will cover the following areas:
- Approval of alternate consent practices (other than written informed consent)
- Implementing flexibility for different types of Qualified Investigators
- Other Interim Order flexibilities REBs have had experience with
REQUEST FOR PANELISTS
If you/your REB has experience reviewing COVID-19 clinical trials involving alternate approaches authorized under the Health Canada Clinical Trials Interim Order and you are interested in sharing your experiences as a panelist during the 3rd Health Canada Engagement Session on Clinical Trial Oversight and implementation in the Context of COVID-19 being held on September 10, 2020 please email Delilah Ofosu-Barko, President CAREB-ACCER at delilah.ofosu-barko@thp.ca.
Deadline: end of business day on Wednesday September 2, 2020.
Panelists will receive a table of Benefits and Flexibilities as prepared by Health Canada to support the discussion.