What research projects are subject to Research Ethics Board review?

In order to comply with TCPS 2 requirements, researchers belonging to the HEC Montréal community are required to submit to the REB any research project involving the participation of humans or the use of data concerning human subjects.

Research projects are deemed to include, notably, projects that give rise to the writing of a supervised project in the context of a specific research mandate, a master’s or doctoral thesis, a scientific or professional article or a case used for research purposes. 

Collection of data from human subjects 

Any research project involving the direct collection of information from human subjects must be declared to the REB. This includes any investigation that necessitates a consultation with persons for the purpose of obtaining research data, whether personal or otherwise.

Examples include data gathered by means of a face-to-face or telephone interview, self-administered questionnaire, audio or video recording, photography, group discussions (on Internet or otherwise), participant and non-participant observations, experiments, etc.

Consultation of documents or databases concerning human subjects that are not in the public domain

• Projects involving the linkage of two or more datasets or databases involving human subjects, whether publicly accessible or not, must be declared to the REB.
• Projects involving the use of data or databases containing identifiable information on human subjects that are not in the public domain must be declared to the REB. Moreover, if the researcher plans to re-use the data or databases containing identifiable information for a new research project, even where the initial project was approved by the REB, the new project must be declared to the REB. This is considered secondary use of identifiable information. Researchers who did not obtain participants’ consent for the secondary use of identifiable information can only use such information for this purpose under certain conditions. If this applies to your project, please contact the REB.
• Projects using data that do not give a researcher access to identifiable information, but where the data are kept by a third party, must be approved by the REB. This is considered secondary use of non-identifiable information.

Use of publicly accessible information

Research that relies exclusively on publicly available information does not require REB review if one or more of the following conditions are met:

• the information is legally accessible to the public and appropriately protected by law; OR
• the information is legally accessible to the public and there is no reasonable expectation of privacy; OR
• data linkage of publicly accessible information does not give rise to new forms of identifiable information.

Observation of people in public places

The observation of individuals in public places does not require REB review if the following conditions are met:

• the research does not involve an intervention planned by the researcher or direct interaction with the individuals or groups;
• the individuals or groups targeted for observation have no reasonable expectation of privacy; and
• the dissemination of research results does not allow identification of specific individuals.

Secondary use of anonymous information

Research projects relying exclusively on the secondary use of anonymous information are not subject to REB review. Data are considered to be anonymous if the information never had identifiers associated with it, if the information is irrevocably stripped of direct identifiers and if no code is kept allowing future re-identification. However, if a researcher conducts data linkage of two or more datasets involving human subjects, a review by the REB will be required.

Studies conducted for purposes of assessment, management or quality improvement

Quality assurance and quality improvement studies, program evaluation activities and performance reviews, or testing within the context of normal educational requirements when used exclusively for assessment, management or improvement purposes, do not constitute research for the purposes of the TCPS 2 and, therefore, do not fall within the scope of REB review.

Quels types de travaux de recherche réalisés dans un cours doivent être déclarés au CER?

Selon la nouvelle version de l'EPTC2 (2018), les CER doivent maintenant évaluer les activités de recherche impliquant des sujets humains qui font partie d’un cours, et ce même si l’objectif principal est pédagogique. L'EPTC2 définit ces activités comme étant des activités pédagogiques qui sont habituellement imposées aux étudiants (de tous les niveaux) afin de leur permettre de se familiariser avec les méthodes de recherche de leur domaine d’études (p. ex. des techniques d’entrevue). 

Par conséquent, tout professeur responsable d’un cours qui exige de ses étudiants la réalisation de travaux de recherche impliquant une collecte de données ou l'utilisation de données concernant des personnes doit déclarer le protocole de recherche dans Nagano et en obtenir l’approbation par le CER avant la mise en œuvre des travaux de ses étudiants.

Types de travaux étudiants ne nécessitant pas d'évaluation par le CER

1. Le recours à des données faisant partie du domaine public. 
2. L’observation de personnes dans des lieux ou des environnements virtuels publics.
3. Les activités artistiques qui intègrent une pratique créative.
4. L’utilisation secondaire de renseignements anonymes sur des êtres humains qui ne créera pas de renseignements identificatoires.  
5. Des activités consacrées à l’assurance et à l’amélioration de la qualité ou à l’évaluation de programmes et de rendement d’une organisation dont les données ne seront pas diffusées à l’extérieur du contexte du cours et de l’organisation.
6. Des activités pédagogiques se déroulant pendant un cours et pour lesquelles des données sur les étudiants eux-mêmes sont utilisées et qui ne seront pas diffusées à l’extérieur du contexte du cours.
7. Des activités pédagogiques pour lesquelles les étudiants utilisent des données auxquelles ils ont eu accès en raison de leur expérience personnelle et dont l’utilisation ne créera pas de données identificatoires et qui ne seront pas diffusées à l’extérieur du contexte du cours.

Déclaration des protocoles dans Nagano

C'est le professeur responsable du cours qui doit déclarer un projet dans Nagano pour chacun des protocoles nécessitant une évaluation par le CER. Vous pouvez accéder à Nagano à l'adresse cer.hec.ca en utilisant votre matricule HEC et votre mot de passe centralisé HEC.

1. Dans votre tableau de bord, créer un nouveau projet en cliquant sur le menu « Mes projets ».
2. Cliquer ensuite sur le bouton « Nouveau projet ». (Si vous avez plus d’un protocole à déclarer, vous devez créer un projet pour chacun.)
3. Choisir le type utilisateur « Professeur-chercheur » et le type de projet « Protocole exigé aux étudiants pour leurs travaux de recherche dans un cours » dans la liste déroulante.
   Les options « champ d’application » et « utilisateurs » sont facultatifs.
4. Une fois le projet créé, vous devrez ensuite remplir et déposer le formulaire 1d qui y sera associé.

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The HEC Montréal REB considers that integration projects, supervised research projects, consulting projects and their equivalent carried out by students at the end of their MBA, EMBA, Professional Master’s, Specialized Graduate Diploma (D.E.S.S.), short graduate program or certificate program do not constitute research for the purposes of articles 2.1 and 6.12 of the TCPS 2, with the exception of activities that still require ethics review, as presented below.

The REB considers that, in general, projects involving the collection or use of data involving humans as part of courses offered within these programs do not constitute research for the purposes of Article 2.1 of the TCPS 2, with the exception of activities that still require ethics review. However, the professor in charge of the course is responsible for determining whether these projects require ethics review.

In cases where such projects are part of a professor’s research project, the professor is responsible for including the research involving human subjects in the file he or she submits to the REB, since this research is conducted in the context of a project under his or her supervision.

If the data collected in the context of such student projects are ultimately used in a research project under the auspices of the School, ethics approval will be necessary to obtain authorization for the secondary use of these data.

Activities that still require ethical review by the REB

• Collection or analysis of data involving human subjects relating to topics, information, or sensitive situations that expose participants, students, their professor or the School in a high risk situation.
• Collection of data from participants who are vulnerable or incapable of giving consent such as minors, patients, people with intellectual disabilities, people linked to illicit activities.
• Collection or consultation of data involving Aboriginal peoples.
• Collection of data with the use of behavioral manipulation, deception or deceit.
• Collection of data that could compromise the physical or psychological integrity of the participants, students or professors.

Projects conducted by researchers affiliated with Quebec universities

In the above case, if the research project is deemed to involve minimal risk, the HEC Montréal REB will comply with the Entente intervenue entre les universités québécoises (PDF, 467 Ko).

If the principal investigator on the project is affiliated with HEC Montréal, he or she must follow the normal procedure for submitting the project in Nagano. Once approval has been issued by the HEC Montréal REB, the principal investigator informs the co-investigators’ REBs of this decision.

If the principal investigator on the project is affiliated with another Quebec university, he or she must submit the project to his or her home university. Once approval has been issued by the principal investigator’s REB, the principal investigator informs the co-investigators’ REBs of this decision.

Projects with a principal investigator from a university outside Quebec and a co-investigator from HEC Montréal

It is the principal investigator from the university outside Quebec who must first submit the project to his or her ethics review board. Once ethics approval has been granted by the principal investigator’s home institution, the co-investigator from HEC Montréal must in turn submit the project to the HEC Montréal REB before any recruitment or data collection can take place.

The project must be submitted via Nagano using form F5 – Project Under the Jurisdiction of Another REB. The co-investigator from HEC Montréal must attach a file to the form containing all the documents submitted by the principal investigator to his or her home institution’s REB, along with the certificate of ethics approval.

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 issued or renewed.

At that time, the professor/researcher will be informed of the obligation to submit his or her research project to the REB via Nagano, regardless of whether or not it involves human subjects. Depending on the type of project submitted, Nagano will determine the appropriate form to be completed. The professor/researcher must agree to comply with the requirements of HEC Montréal’s Policy on Ethical Conduct for Research Involving Humans (PDF, 345 KB).

As soon as the Research Ethics Board has approved the duly completed form submitted by the grant holder via Nagano, the research funds will be released and an email will be sent to inform the researcher that his or her budget is available.