Mandatory Training
A role of the Research Ethics Board (REB) is to promote research excellence, more specifically in the evaluation and the approval of research project that will make Hôpital Montfort a hospital of choice.
This practice has for objective to achieve the highest ethical standards to protect the participant in clinical research (justice, respect and well-being) and to standardize the REB practices. The tutorial is reviewing the first eight (8) chapters of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2- 2018), they are describing general practices to protect human subjects participating in research. This is a minimal requirement, since for interventional project or clinical trials the research team have the obligation to complete additional training in order to comply with the laws and regulations governing those research.
It is the responsibility of the primary investigator to ensure that their research team members complete the on-line tutorial. The tutorial is available in both official languages.
When will this training requirement be effective?
As of January 1, 2015 REB all REB approval (new submission, annual renewal approvals of ongoing research studies and request for modification) will only be granted to those who have provided the Ethics Office with appropriate certification of training for themselves and all of their research staff.
Who needs to complete the TCPS2 Tutorial?
- Employees of Hôpital Montfort
- Members of the hospital medical staff and practitioners with privileges
- Researchers affiliated with “Institut du Savoir Montfort” (ISM) and Ottawa University
- Students
Please note
There are additional requirements for researchers and their team when they are running a clinical trails.
Project type | TCPS2 | GCP | Division 5 |
All study submissions to REB |
X |
||
Study submission for non-regulated clinical trials |
X |
X |
|
Study submissions for Phase I – IV or natural health product regulated clinical trials |
X |
X |
X |