The Research Ethics Quality Assurance program is offered by the Research Review Office and serves the entire West Central Montreal Health research community.
Our program is two-fold:
These components are aimed at optimizing the ethical, regulatory and safety aspects of any research involving human participants. Our Quality Assurance Program is intended to support and aid researchers and their staff in the process of conducting research in compliance with the highest standards.
Our monitoring visits are usually conducted on site and include the review of the following: Study files, Source documentation including clinical charts, patient diaries, Case Report Forms (CRFs), Serious Adverse Event (SAE) report, consent forms and REC correspondence.
This program is based in the articles 2.8 and 6.14 of the Canadian Tri-Council Policy Statement for Ethical Conduct for Research Involving Humans, which states that “Research is subject to continuing research ethics review from the date of initial REB approval throughout the life of the project” (Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, December 2014). Our program is also based on the “Plan d’action ministériel en éthique de la recherche et en intégrité scientifique” which states that “Research Ethics Committees will be responsible for preparing and setting up an ethical monitoring mechanism for current research projects” (translated from French, Plan d’action ministériel en éthique de la recherche et en intégrité scientifique, 1998).
We highly recommend that all members of the research community follow these training modules to clearly understand the issues relating to research ethics:
Should you have any questions regarding our Quality Assurance Program, or the Research Review Office do not hesitate to contact us.