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Procedures – Ethical review of research projects

 
The HEC Montréal REB uses the Nagano software system to review and follow up on the ethics of research projects involving human subjects. Accordingly, all documents required by the REB for the submission and follow-up of your research project (declaration of ethical responsibility, research project declaration form, project renewal, project changes and project completion forms) must be submitted
electronically via Nagano.
 

To log in to Nagano, enter your HEC ID in the username field and use your HEC password.

To change the language of Nagano user interface for “English”, follow these steps :

  1. Click on your profile icon (the silhouette one) and then, click on the “ÉDITER” button;
  2. You will see the field “Langue de l’interface” : Select “Anglais”;
  3. Then, go at the bottom of the screen and click on the button “SAUVEGARDER”.

To submit a new project, once you have accessed the Nagano dashboard, click on the project icon (illustrated by a gear) and then click on the red “New project” button and answer the questions.

For information on the different steps to follow for project submission and follow-up (new project, project change, annual renewal, project completion), please refer to the appropriate sections below. 
 

Log in to Nagano


 

+  Initial submission of a research project to the REB

 
Procedure for submitting a new project to the REB

+  1. Check if your project requires ethics approval by the REB

See the section “What research projects are subject to REB review?


In case of doubt, contact the REB secretariat at 514-340-6051 or cer@hec.ca.

 

+  2. Determine who is responsible for submitting the project

The initial submission of the project must be done by the principal investigator, whether that person is a professor, researcher, master’s or doctoral student or a post-doctoral fellow.

If the project is being carried out by a master’s or doctoral student, the approval of the research supervisor(s) is required in Nagano.
 

Student projects that are part of a professor’s research project

If the researcher is a master’s or doctoral student whose project falls entirely within the broader research project of one of the School’s professors, it is the professor who is responsible for submitting his or her project in Nagano. The professor must indicate the name of the student(s) participating in the different phases of the research project in the appropriate section of the F1 declaration form.

If the professor’s research project has already obtained ethics certification and master’s or doctoral students are subsequently added to the research team, the professor must notify the REB using the form F8Request for Changes to the Research Project, in Nagano.

If a student’s project falls entirely within the scope of a professor’s research project, the ethics certification issued for the professor’s project is also valid for that of the student, provided that the REB has been informed.

Important: If the data collection conducted by the student as part of a professor’s research project does not fall entirely within the professor’s research project, the student must submit his or her data collection to the REB in Nagano.

Any student who submits a research project must be supervised by a HEC professor in order to obtain a certificate of ethics approval from the REB. It is not possible for a student to obtain a certificate of ethics approval as an independent researcher.

  

+  3. Log in to Nagano

Click here to log in to Nagano

To access Nagano, enter your HEC ID number and use your HEC password.

Recommended browsers: Google Chrome, Internet Explorer 8 or +, Safari 5 or +

 

For more information, see the guide Démarrer et naviguer dans Nagano”  (in French).

 

+  4. Verify/complete your profile in Nagano

Nagano uses data provided to it by HEC Montréal. However, some data may be incomplete, outdated or incorrect. This section of the system allows you to make changes to certain information. If there are errors in any of the non-modifiable sections of the system, contact your REB to make a request for additional changes.

The profile section allows users to update their personal information and to customize certain features offered by the system. This section can be accessed by clicking on the icon of a person at the top right of the screen.

The “Informations” tab will open automatically when you access your profile.

Simply click on the “Edit” button at the top right of the screen to verify or modify your personal information.

Once you have entered the information, save it by clicking on the “Save” button at the bottom of the screen.

 

+  5. Submit your project in Nagano

The first step is to create a new project in Nagano. Then, complete the appropriate electronic form for your project and attach the required appendices electronically.

Based on your answers to the initial questions, Nagano will determine the required form for your user type and the nature of the project.  The application will also indicate what appendices you need to attach to your submission based on the answers provided in the form.  

 

For more information, see the guide Création d’un nouveau projet dans Nagano (in French).

   

 

+  Submission to the REB of a funded research project

In compliance with the Agreement on the Administration of Agency Grants and Awards by Research Institutions signed by the School in order to allow its professors and students to receive research funding from the federal agencies, the Research Office will release grant funds and research contracts involving human subjects only after the certificate of ethics approval for the research projects concerned has been obtained or renewed.

Accordingly, when presenting a request to open a research account (CCS), it is mandatory for the professor/researcher to declare his or her project in Nagano, regardless of whether or not it involves human subjects. Depending on the type of project declared by the professor/researcher, Nagano will determine the appropriate form to be completed. In all four cases, the professor/researcher must agree to comply with the requirements of HEC Montréal’s Policy on Ethical Conduct for Research Involving Humans.

The table below indicates what type of project you need to select in Nagano based on your situation. For the detailed procedure on how to submit your project in Nagano, please refer to the section “Initial submission of a project to the REB” below.

 

Type of funded research project

Type of project to select in Nagano

Form(s) to be completed

Funded research project involving human subjects and for which the researcher is ready to begin data collection

Research project involving data on human subjects

F1 - Declaration Form for a Research Project Involving Data on Human Subjects

Funded research project involving human subjects for which data collection will begin later, but for which the researcher is requesting a partial release of research funds

Request to release funds prior to ethics approval

F2 – Request for Release of Funds for a Project That Will Involve Human Subjects

Once the F2 form has been assessed by the REB, the project will be exempted from the review process. You will be required to transfer it back to the REB office BEFORE beginning the project phase involving human subjects.  The procedure to follow is described in the section “Special cases” below.

Funded research project involving human subjects under the auspices of another university (in or outside Quebec), in which a co-investigator is a HEC Montréal professor

Funded research project under the auspices of another university

F5 - Project Under the Jurisdiction of Another REB

Funded research project not involving human subjects

Funded research project not involving human subjects

F3 - Declaration of Ethical Responsibility for a Research Project Not Involving Human Subjects

Once the F3 form has been assessed by the REB, the project will be exempted from the review process.  

 

+  Submission of a doctoral thesis project

All doctoral theses, regardless of whether or not they involve humans, must be submitted to the REB in Nagano using the form F4Declaration of Ethical Responsibility of a Doctoral Student, prior to approval of the student’s Phase II. For the detailed procedure on how to submit your project in Nagano, see the section “Initial submission of a research project to the REB” below.

Once the REB has reviewed the project, an email will be sent to the student, with an attached notice of the REB’s decision on the thesis proposal. It is important to keep this official notice and to forward it to the Ph.D. program office before submitting the Phase II form.

 

+  Processing time for a new project

Once you have submitted your form and all the required appendices in Nagano, the REB secretariat will check them to make sure your file is complete. If it is not, you will receive a notice by email as well as in your Nagano dashboard informing you of the missing elements.

Once your file is complete, it can take 4 to 6 weeks to obtain approval of your project and a certificate of ethics approval.

 

+  REB approval of a project

Once your project has been approved, you will receive a confirmation email with an attached notice of the REB’s decision and the certificate of ethics approval.

You will also be able to access these two official documents in Nagano, in the section “Documents officiels” (D.O.) of your project.
 

See the “Guide complet de l'utilisateur” for more information on following up on a project that has been submitted to the REB.

  

+  Project changes and annual renewal

  
Project changes

If changes are made to the research design of an ongoing project, the principal investigator must notify the REB using the form F8 Request for Changes to the Research Project, available in Nagano. Note that any substantive change to the research project must be submitted to the REB and approved by it BEFORE its implementation.

You can add a form to a project that has already received REB approval by logging in to your project page and selecting the project in question.

In the project screen, click on the “Forms” button and then click on the “New” button in the forms screen. Nagano will display the list of forms that you can add to an approved project. Simply select the form you need.


 

Annual renewal

Certificates of ethics approval confirming a research project’s compliance with the Policy on Ethical Conduct for Research Involving Humans issued by the HEC Montréal REB are valid for a maximum period of one year. Researchers are responsible for submitting the form F7Request for Annual Renewal of Ethics Certification BEFORE the date of expiry indicated on their certificate of ethics approval, in order for the REB to process the renewal.

The F7 form will be automatically added to the researcher’s project in Nagano approximately two months before expiry of the certificate. The researcher will receive a renewal reminder by email at the same time.

 

+  Project completion (Attestation of completed ethics approval)

At the end of the research project, the researcher is responsible for submitting a project completion report to the REB. Depending on whether the researcher is a professor or a student, he or she must submit the appropriate project completion form in Nagano so that the REB can issue an “Attestation of completed ethics approval.”

*It can take from 3 to 10 business days to process a project completion form.

 

To add the project completion form in Nagano to a project that has already been approved by the REB, simply access your project page (gear icon) and select the project in question.

In the project screen, click on the “Forms” button and then click on the “New” button in the forms screen. Nagano will display the list of forms that you can add to an approved project. Simply select the form that applies to your situation.

 

Completion of a professor’s project:

The professor who is the principal investigator on the project is responsible for completing and submitting the form F9Project Completion Form, in Nagano.
 

Completion of a student’s project that is fully part of a professor’s project::

The student is responsible for completing and submitting the form F9Project Completion Form, in Nagano.
 

Completion of a student’s project where the data collection is fully part of a professor’s project:

As soon as the student completes his or her project (i.e., BEFORE submitting his or her supervised project, master’s or doctoral thesis to the program office), the professor must notify the REB via Nagano, using the form F9aProject Completion Form for a Student Whose Data Collection Is Fully Part of a Researcher’s Approved Research Project.

When submitting a project to the program office, the student must include a copy of the official document issued by the REB confirming that the project has received ethics approval and that the REB was notified of the project’s completion. This document will be sent to the student by email once the REB has confirmed completion of the project.
 

Note: The professor can add a student as a user to his or her project in Nagano if he or she wants the student to personally complete the student project completion form. However, the professor should be aware that, by adding the student as a user to a project, the student gains access to the ENTIRE project. As such, the REB does not recommend this option. Please contact the REB secretariat for further details (514 340-6051).

 

+  Special cases: Resubmitting an exempted project to the REB

Following its assessment of your submission, the REB may determine that your research project does not require ethics review (ex., if the data collection does not involve humans) or that the ethics review can be deferred (ex., after obtaining a partial release of funds to perform steps prior to data collection involving humans).

In such cases, the REB will exempt your project from the review process by transferring it to a section in Nagano called “Out of Process Projects.” You will be notified of this decision by email, accompanied by an attached “Official document” explaining the REB’s decision.

However, a principal investigator may subsequently be required to resubmit his or her project to the REB if one of the following situations applies:

  1. A professor’s funded research project that has previously obtained a partial release of funds and that is now ready to begin data collection or to use data involving human subjects;
  2. A professor’s funded research project that has previously obtained a partial release of funds and where the professor wishes to apply for a new release of funds;
  3. A professor’s funded research project for which no human subjects were initially involved, but that now requires the addition of data collection involving human subjects;
  4. A doctoral student whose "Initial Declaration of Thesis" (Form F4) has been previously approved and is now ready to begin data collection or use data involving human subjects;
  5. A student’s doctoral thesis project for which no human subjects were initially involved, but that now requires the addition of data collection involving human subjects.

In all of the above cases, the principal investigator is personally responsible for resubmitting the exempted project to the REB.

 

+  Steps for resubmitting an exempted project to the REB

 
This example uses the case of a researcher who has already obtained a release of funds prior to obtaining ethics approval for his or her project. The researcher is now ready to begin data collection involving human subjects and must therefore complete the F1 declaration form in order to obtain ethics approval. These are the steps to follow:
 

(1) Go to the “Projets” section, in the list of your projects, under the category Out of Process Projects:
(2) Click on the project you want to transfer to the REB.

Once on your project’s screen: (3) click on the “Edit” button at the top right.

A pull-down menu will appear. Select (4) your user type and project type. 

For a professor:
Declaration of a research project involving data on human participants OR
Request for release of funds for a project that will involve human subjects

For a Ph.D. student:
Complete declaration: Ph.D. thesis involving data on human participants


Once you have completed this procedure, your project will be resubmitted to the REB office and you will be able to complete and submit the form Declaration Form for a Research Project Involving Data on Human Subjects  (F1 for a professor and F1a  for a student). Then simply wait for the REB to approve your project and issue a certificate of ethics approval.

   

Questions?

If you need help using Nagano, contact the REB secretariat at 514-340-6051 or cer@hec.ca.

 
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