Approval steps before starting research
As in the entire Quebec Health and Social Services Network, research carried out with human participants, initiated by a CIUSSS researcher from West-Central Montreal, must obtain three levels of approval before its deployment within the institution is authorized by the «Personne Mandatée»(PM) of the CIUSSS: scientific approval, ethics approval and an approval of feasibility.
1) Science Review – This assessment is based on proper scientific and methodological practice. At the CIUSSS West-Central Montreal, a science review committee evaluates research protocols that have not already obtained a scientific review from granting agencies recognized by the MSSS (e.g. Canadian Institutes of Health Research).
2) Ethics Review – This assessment is based on proper ethical practice regarding the protection of participants in a research project. This ethics review is based on normative frameworks prescribed by the MSSS such as the Tri-Council Policy Statement (TCPS-2, 2022), the Ministerial Action Plan (MAP, 2007), the Civil Code of Quebec, and the Health and Social Services Act.
At the CIUSSS West-Central Montreal, the research ethics committee inclludes two committees:
• Medical/Biomedical REC(medical research, clinical trials, banks etc.)
• Psychosocial REC (psychosocial research, gerontology, etc.)
3) Feasibility Review – This assessment is based on an analysis of the availability of material and human resources (budget) necessary for the conduct of the project in the establishment, as well as on considerations specific to each of the departments concerned (e.g. priorities, relevance). This assessment falls under the departments wherein the research will be conducted.
If the study submission includes a request to access patient medical information or charts without consent, a Privacy Impact Assessment (known in French as an Évaluation des facteurs relatifs à la vie privée (EFVP)) review will be required.
These assessments fall under the departments relevant to where the research will be conducted or departments needed to support the research (pharmacy, imaging, laboratory etc.). Every study is different and the feasibility review elements will be conducted as applicable to each study.
►Institutional Authorization
After the scientific, ethical and feasibility review of the project, the PM of the institution - who is responsible for ensuring that the entire review process is compliant - decides whether or not to authorize the research. This is the final step which allows, or disqualifies, the start of research within the establishment.
The Research Review Office (RRO) supports and coordinates these evaluation processes through the Nagano platform.
