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:
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.
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).
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:
Ethics approval certificate renewal :
Submission of a final report of a project or a completion report :
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.
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:
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.