Project review process
There are three kinds of reviews to which all research projects are submitted.
After your file is received, five (5) copies will be sent to the scientific review board of the RNQ (CES-RNQ). The CES-RNQ will meet to evaluate projects. The CES-RNQ holds monthly meetings. After your project have been reviewed, the CES-RNQ will inform you of its decision by mail. There are four possible decisions:
Accepted without reservations
Your project will be automatically forwarded to the CER-VN for ethics review. When you receive confirmation of the ethics approval, you may start booking time on the MRI scanner.
Accepted with reservations
Your project is conditionnaly approved. You will have to answer the questions asked by the CES-RNQ satisfactorily within two weeks of receiving the letter from the CES-RNQ. Your project will still be evaluated by the CER-VN, which will give you its final answer after receiving the approval from the CES-RNQ. After you receive approval from both the CES-RNQ and the CER-VN, you may start booking time on the MRI scanner.
Refused with comments
Your project will need to be resubmitted and address the CES-RNQ’s comments. Your project will not be forwarded to the CER-VN for ethics review.
Your project is refused by absence of scientific basis.
Evaluation criteria for the scientific reviewing board
- Appropriate litterature review
- Subjects: sample size, inclusion and exclusion criteria
- Measuring instruments / tasks
- Control for confounding variables
- Statistical analyses
- Specificity and relevance of spin-off
- Text clarity and coherence
The Comité d’éthique de la recherche Vieillissement-Neuroimagerie (CER-VN) is attached to the administrative boards of the RNQ’s partners establishments.
Competence of the CER-VN
The CER-VN’s mandate covers all the investigators who want to use the experimental platform of the Unité de neuroimagerie fonctionnelle, particularly the 3 Teslas magnetic resonance imaging, within the scope of a research project involving human subjects.
The CER-VN plays a role of protector of the dignity, safety, well-being and the rights of the research subjects. As such, it ascertains that the research projects are conform to ethical norms before authorizing their implementation or their continuation. It also continuously oversee the ethics of the approved research projects.
As a result, the CER-VN has the power to approve, modify or interrupt or reject any research project proposal under its purview.
The CER-VN is also responsible for the the follow-up of ongoing research projects, notably with regards to adverse effects reports, therapeutic incidents reports, stage reports, premature ending of project reports, yearly reports, final report and also the evaluation and approval of proposed modifications to ongoing research projects.
The CER-VN is completely independant for the evaluation and follow-up of research projects.
Every research project is subjected to a preliminary evaluation to ascertain their compliance to the CER-VN’s requirements. If the project is incomplete or does not comply with the CER-VN’s requirements, the president will contact the investigator.
Only the admissible research projects will be added to the meeting’s agenda.
The research project will be subject to evaluation by the administrative entity of the concerned establishment. The scope of this evaluation are the financial and contractual aspects of the project.
This entity’s mandate is to ascertain the project’s monetary and material feasibility, verify their contractual aspects when required, to ensure that all of the research direct costs are present in the research budget, identify conflicts of interest and suggest appropriate actions to solve them.
Institutional propriety evaluation
The institutional propriety evaluation is mandatory in every health establishment where the research protocol will be conducted. This evaluation is done on :
- The agreement between the project and the establishment’s orientations
- The practical capacity of the establishment to host the project
- The possibility that persons identified as potential subjects be unduly solicited
Even in the advent of an approval from the research ethics board, an establishment may refuse that certain research project be conducted on their site. Also, an establishment may ask that the research protocol be modified in order to comply with their requirements. The principal investigator must then inform the board’s president and include the establishment’s refusal letter.
An establishment decision regarding the institutional propriety of a research project is final and can not be appealed.