We recently revisited the Montreal tuberculosis outbreak wherein we identified IRB Forum Shopping as the root cause of this tragedy. IRB Forum Shopping is an under-researched yet highly-relevant ethical issue in the context of the North American governance of clinical research. Essentially, it is the practice of choosing an IRB based on the relative ease […]
On July 30, 2014, Health Canada announced that the Office of Clinical Trials of the Therapeutic Products Directorate (TPD) will cease issuance of ‘Acknowledgement of Notification’ letters for Clinical Trial Application Notifications (CTA-Ns) on September 1, 2014. What does this mean for your clinical trial? First off, this change applies only to clinical trials involving […]
When conducting clinical trials in Canada, a Sponsor must generally possess, for each clinical trial site, a Research Ethics Board Attestation (REBA), which provides administrative information regarding the research ethics board (REB) as well as a certification that its composition, operations and decisions are in compliance with Canadian regulations. A REBA must also be completed […]
