PROJECT EVALUATION


Project review process

There are three kinds of reviews to which all research projects are submitted.

1 – Scientific review

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 CMER-RNQ 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 CMER-RNQ, 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 CMER-RNQ, 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 CMER-RNQ for ethics review.

Categorically refused

Your project is refused by absence of scientific basis.

Evaluation criteria for the scientific reviewing board

  1. Appropriate litterature review
  2. Objectives
  3. Hypotheses
  4. Methodology
  5. Subjects: sample size, inclusion and exclusion criteria
  6. Recruiting
  7. Measuring instruments / tasks
  8. Control for confounding variables
  9. Statistical analyses
  10. Schedule
  11. Specificity and relevance of spin-off
  12. Text clarity and coherence

2 – Ethics review

The Regroupement Neuroimagerie/Québec’s research ethics board (CMER-RNQ) is attached to the administrative boards of the RNQ’s partners establishments.

Competence of the CMER-RNQ

The CMER-RNQ’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 CMER-RNQ 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 CMER-RNQ has the power to approve, modify or interrupt or reject any research project proposal under its purview.

The CMER-RNQ 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 CMER-RNQ is completely independant for the evaluation and follow-up of research projects.

Preliminary evaluation

Every research project is subjected to a preliminary evaluation to ascertain theri compliance to the CMER-RNQ’s requirements. If the project is incomplete or does not comply with the CMER-RNQ’s requirements, the president will contact the investigator.

Only the admissible research projects will be added to the meeting’s agenda.

3 – Administrative and institutional propriety evaluation

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 :

  1. The agreement between the project and the establishment’s orientations
  2. The practical capacity of the establishment to host the project
  3. 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.