Submit a request

For evaluation and approval by the REB

All research projects must be approved BEFORE recruitment of participants, accessing data and collecting samples can begin. The CER cannot retroactively evaluate research involving humans.

Please provide the REB with all documentation to be given to participants in French only or in both official languages, depending on the type of participant targeted:

  1. for patients, this documentation MUST BE written in both official languages;
  2. for staff, students, residents and physicians, this documentation MAY BE written in French only since French is the language of work.

  • consent forms
  • information sheets
  • recruitment tools (poster, templates with Hôpital Montfort logo New ! or ISM logoNew !, emails, telephone script, etc.)
  • interview guides
  • measuring tools (specify for the REB if the tools are validated or have been translated by the research team)
  • Please note that it is now mandatory to submit a request to the Horizon Recherche Montfort Nouveau ! to obtain a file number from the Institut du Savoir Montfort (ISM) for any research project or quality improvement project at the Montfort Hospital BEFORE being able to submit a request for ethics approval and thus obtain an ethics file number or a letter of exemption from ethics review from the REB. 

List of documents to be submitted for ethics evaluation

Please note that the following categories of modifications corresponds to types of request that can be submitted to the REB, each option will help you ensure that the request is complete before it is submitted:

For the submission of a new request for approval to the REB.


The principal investigator or is designate is required to submit for evaluation and approval a complete research proposal to the REO of l’Hôpital Montfort within the published deadlines. A cover page listing all documents and the version date of each document must also be submitted with the application. The list to ensure that your proposal is complete is available below. Upon receipt the REO will confirm that all required documents have been submitted.

Document Checklist

  1. Checklist to confirm that submission to the Research Ethics Board (REB) is complete
  2. Application Form, duly completed, dated and signed, or initial submission form from another REB
  3. Consent form used
  4. Information sheet or recruitment text (advertising, notice, poster and templates, etc.)
  5. Research tools (questionnaire, survey, interview guide, group discussion guide, etc.)
  6. Research protocol, as applicable
  7. Research project suitability evaluation
  8. Confidentiality agreement concerning the protection of research data by all persons having access to research data
  9. Certificate of completion of the online training TCPS2 for all members of the research team
  10. Application form for clinical chart review, as applicable and Information Service Fee form Under review !
  11. Billing form for clinical trials (available in French only at this time)

Other documents that may be required

  1. Decisions and requests by other research ethics boards
  2. Changes made to the research project following such decisions
  3. The Ethics Certificate, as applicable
  4. Exemption request form instead of the submission form if the type of project does not require the ethics review of a REB. Please note that it is up to the Montfort REB to exempt a project from the ethics review process (available in French only at this time).

Only the electronic version of the documents is required

Due to current circumstances, the complete file, along with related forms and documents, must be submitted in electronic format only to the secretariat at this time. Please note for the electronic version, the documents must be separate and not attached one after the other as one document.

To submit a request for a project that has been approved by the REB (modification, annual removal, final report or file closure).


Amendment to research protocol

Les chercheurs doivent présenter sans délai  

Researchers shall, without delay, submit to their REBs requests for substantive changes to their originally approved research, or to produce a declaration of unforeseen items, if applicable (TCPS 2, art. 6.15, art. 6.16). A cover page listing all modified or new added documents and the version date of each document must also be submitted with the application.

Major amendments :

Minor amendments:

Annual renewal of the ethics approval

Ethics approval certificate renewal :

  • To request an annual renewal of the ethics approval certificate, please submit this application form New !
  • For any late renewal request, i.e. submitted after the end date of the ethics approval, this form must also be submitted to the REB.

Final report or file Closure Request

Submission of a final report of a project or a completion report :

  • To submit a final report or to request a file closure, please fill out this application form. New !

For all request to review or to appeal the REB's decision.


Reconsideration

Researcher(s) that is (are) in disagreement with an REB recommendation or decision, may request a meeting with the Research Ethics Office (REO) to explain their perspective in regard with the decision rendered (TCPS 2, Article 6.18). This meeting will provide the team an impartial opportunity for discussing their point of view. The REB Chair who is involved in the discussion(s), may uphold, reject or issue modified version of the REB’s decision. The REO will send to the researcher(s) the decision resulting from these discussions as soon as possible.
Every attempt will be made to reach a resolution by this informal route. The researcher and the REB must have fully exhausted the reconsideration process, and the REB must have issued a final decision before the appeal process initiated by submitting a written request to the REO.

Appeal

According to the TCPS 2 (see Article 6.19), researchers have the right to be heard by a qualified REB and this type of request will only be considered on alleged non respect of Hôpital Montfort REB procedures for example a conflict of interest or when there is significant disagreement over an interpretation. The mechanism to initiate an appeal process is described in the PFN 402B. The form to appeal the REB’s decision must be submitted to the REO within thirty (30) days following the receipt of the decision being disputed. Furthermore, the person will need to justify the grounds underpinning their request. The applicant may submit additional information to the file that had the initial ethics review.

The Appeal Board needs to function impartially and to provide each person involved in the scenario the possibility to express their perspective or an explanation of the reasons for or against the decision on the subject. The appeals request will be reviewed in accordance with the REB procedures (institutional policies, SOP and PFN) as well as the current laws, regulations and regulations that are applicable. The committee may consult specialist with a specific expertise in the domain if it is considered necessary.

The decision rendered by the Appeal Board on behalf of the institution will be final and the decision will bind the researcher(s) responsible for the project. The decision is communicated in writing to the researcher and the REB whose decision was appealed. The file that was constituted will be stored confidentially in the REO.

Within five days (5) of receipt of a proposal for review the Research Ethics Office (REO) will confirm you by email if your proposal is complete. Please note that an incomplete submissions will not be accepted, you will be informed and the proposal will be returned to the researcher, which will delay its review.

All approvals are for one year for all type of research projects. Four weeks prior to the approval expiration date, investigators should submit to the REO an annual report or a final report in order to request approval renewal or to close the file.

What is the reading comprehension grade level of the information and consent form? Please include a description of the methodology used to make the determination of the form that would be presented to participants being recruited.

Four different systems have been used to determine the level of difficulty or reading of a text:

  1.  The Scolarius: www.scolarius.com (only available for French texts at this time) is a free readability tool developed by Influence Communication. It allows the user to know if the level of difficulty of his text corresponds to the level of understanding of the targeted clientele. A score between 50 and 89, corresponds to the primary level of education, between 90 an 119 at the high school level, 120 and 149 at the college level, from 150 to 189 at the university level.
  2. The Flesch Reading Ease. The test rates text on a 100-point scale; the higher the score, the easier it is to understand. The recommended score is between 60-70 (90 -100 is considered comprehensible by the average 5th grader; 60-70 is considered comprehensible by the average 8th-9th grader; 0-30 is considered comprehensible by college/university graduates).
  3. The Flesch-Kincaid Grade Level. The test rates text similarly to the Flesch Reading Ease, but corresponding to the level of comprehension according to the U.S School Grade System. (The score corresponds to the grade of a student in the United States, e.g: a score of 4.3 would mean comprehensible by a fourth grader)
  4. The Simple Measure of Gobbledegook Index (S.M.O.G, 1999) as suggested in the COREB common guidelines.

Please conduct a readability evaluation of your informed consent document by using one of th four tools above. The REB reserves the right to request improvements in readability as suited to the participant population. Report the readability score in the submission form.

Click the following link access Microsoft Office’s Help Page on how to ”Test Your Document’s Readability” for the Flesch Reading Ease and Flesch-Kincaid Grade Level Systems.