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What research projects are subject to REB review?

          

Research projects requiring ethics approval

Research projects not subject to ethics approval

Projects conducted as part of professional programs of study

Who is responsible for reporting?

Research projects involving multiple institutions

When to submit a research project?
 


 

 Research projects requiring ethics approval


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.

See the section Procedures: Ethical review of research projects for detailed information on the steps to follow when submitting a project to the REB.

 

 Research projects not subject to ethics approval


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.

 

 

 Projects conducted as part of professional programs of study


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:

  1. 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.
  2. 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.
  3. Collection or consultation of data involving Aboriginal peoples.
  4. Collection of data with the use of behavioral manipulation, deception or deceit.
  5. Collection of data that could compromise the physical or psychological integrity of the participants, students or professors. 

 

 Who is responsible for reporting?


The principal investigator, whether a professor, researcher, master’s or doctoral student or post-doctoral fellow, is responsible for completing and submitting the appropriate submission form(s) for his or her project via Nagano. If the researcher is a master’s or doctoral student, the signature of the research director or co-director must be included on the form in Nagano.

If the researcher is a master’s or doctoral student whose project falls entirely within a broader research project led by a professor at the School, the professor must clearly indicate the name(s) of the student(s) participating in the various phases of the research project when submitting the project via Nagano.

If any master’s or doctoral students join the research team of a professor whose research project has already received ethics approval, the professor must inform the REB of this fact using the form F8 – Request for Changes to the Research Project, available 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. In this case, once the student has completed his or her project (i.e., BEFORE submitting the supervised project, master’s or doctoral thesis to his or her program director), the professor must notify the REB via Nagano, using the form F9a – Project Completion Form for a Student Whose Data Collection Is Fully Part of a Researcher’s Approved Research Project.

When submitting a supervised project, master’s or doctoral thesis to their program director, students must provide a copy of the ethics certificate issued for the professor’s project as well as the REB-approved project completion form appropriate for their situation.

In all cases, if the data collection conducted by a student in the context of a professor’s research project is not fully included in that project, the student must personally submit his or her data collection to the REB for approval via Nagano.

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

  

 

Research projects involving multiple institutions

 
 

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 pour la reconnaissance des certificats d’éthique des projets de recherche à risque minimal.

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 F5Project 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. 

 

 When to submit a research project?


The researcher must complete and sign the form(s) and appendices related to his or her research project and submit them to the REB BEFORE commencing the collection and/or consultation of documents and/or databases involving human subjects. No one shall engage in the collection, pre-testing and/or consultation of documents and/or databases involving human subjects before having obtained a certificate of ethics approval from the REB.

It can take an average of four to six weeks between the submission of a completed application and the issuing of the certificate of ethics approval.

Certificates of ethics approval 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, in Nagano, in order to obtain the annual renewal of their ethics certificate BEFORE the expiry date indicated on the certificate of ethics approval.

If changes are made to the research design of an ongoing project, the principal investigator must notify the REB to determine whether new project documents must be completed in order to obtain a new certificate of ethics approval. Any significant alteration of the research project must be submitted to the REB and approved by it BEFORE it is implemented.

Once the research project has been completed, the researcher is responsible for submitting a project completion report to the REB using the form F9Project Completion Form, in Nagano.

 

Important information for funded professors:

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.

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.

 

 
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