MCGILL UNIVERSITY
RESEARCH ETHICS BOARD OFFICE (REB-I, II, III,FAES)
845 Sherbrooke Street West|James Administration Bldg., rm 429|Montreal, QC H3A 0G4|Tel:514-398-6193/6831 w ww.mcgill.ca/research/researchers/compliance/human/
_______________________________________________________________________________________________
- The mandate of the REB is to determine the ethical acceptability of research involving human participants, with the primary objective of protecting the rights and welfare of participants. All research involving human participants is reviewed in accordance with the Tri-Council Policy
Statement: Ethical Conduct for Research Involving Humans , the McGill Policy on the Ethical Conduct of Research
Involving Human Participants , and REB specific policies and procedures as well as any other applicable federal and provincial regulations relevant to the type of research being conducted.
- All research involving human participants conducted at McGill or conducted by University affiliated faculty, students or staff, conducted on campus or elsewhere, requires review and approval by the appropriate REB. This includes all funded (granting agencies/ contracts) and non-funded research as well as course-based research.
Researchers normally apply to the REB based on their department or faculty affiliation.
The Research Ethics Board-I (REB-I) serves the following areas: Faculty of Law, Faculty of Arts except
Linguistics, Social Work and school of Information Studies, Faculty of Engineering, Desautels Faculty of
Management, School of Continuing Studies, Faculty of Religious Studies and the Faculty of Science except
Psychology, for the review of research involving competent adults.
The Research Ethics Board-II (REB-II) serves the following areas: Linguistics, Psychology, School of
Information Studies, Schulich School of Music, the School of Social Work and the Faculty of Education, for research involving competent adults.
The Research Ethics Board-III (REB-III) serves all faculties except the Faculties of Medicine and Dentistry for the review of research involving minors or adults not competent to consent, including research that falls under
Article 21 of the Quebec Civil Code.
The FAES Research Ethics Board serves all units of the Faculty of Agricultural and Environmental Sciences.
Exceptions - Research involving medically invasive measures, procedures or interventions must be submitted to the Faculty of Medicine REB for review even if the researcher would normally apply to one of the above REBs.
Research conducted in or recruiting from any of the following McGill affiliated institutions, must be reviewed by the REB of that institution (MUHC, Douglas, St.Mary’s, Jewish General Hospital, CRIR). Researchers are advised to contact the REB office if in doubt about which REB to apply to.
Research involving living human participants or involving human biological materials, human embryos, fetuses, fetal tissue, reproductive materials and stem cells (applies to living or deceased individuals) requires review and approval by the REB before the research can start . A participant is defined by the Tri-Council Policy Statement as ‘those individuals whose data, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question’.
Research involving human participants that does not need review includes
1) research that relies exclusively on publically available information when the information is legally accessible to the public through a gatekeeper or the information is publically accessible and there is no reasonable expectation of privacy
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MCGILL UNIVERSITY
RESEARCH ETHICS BOARD OFFICE (REB-I, II, III,FAES)
845 Sherbrooke Street West|James Administration Bldg., rm 429|Montreal, QC H3A 0G4|Tel:514-398-6193/6831 w ww.mcgill.ca/research/researchers/compliance/human/
2) observational research in public (natural or virtual) spaces where there is no intervention staged by the researcher or any direct interaction with individuals or groups and those targeted for observation have no reasonable expectation of privacy and dissemination of results does not allow for identification of individuals
3) research involving individuals who are not themselves the focus of the research but can provide information on organizational policies, statistical reports, practices etc. ex. public relations officers or public officials. Individuals who are asked for their personal opinions about organizations, or who are observed in their work setting for the purposes of research, would be considered participants and REB review would be needed.
4) research that relies exclusively on secondary use (was collected for a purpose other than the current research purpose) of anonymous (never had any identifiers as opposed to anonymized where identifiers have been removed) information/ biological materials.
Researchers must always consult with the REB to clarify what types of research must be reviewed and what exceptions may exist .
- Ethics approvals are only valid for a maximum of one year and must be renewed if the research will be ongoing .
This requires the submission of a Renewal Request form. Renewal requests should be made 2-3 weeks before the current approval expires. A project’s approval expires automatically if a renewal request is not received before the current approval expires. No research activities may be conducted under an expired approval. Funding agencies’ policies require that research funds be frozen when there is no valid ethics approval in place for ongoing research.
- When data collection is finished and a project no longer requires ethics approval, a Study
Closure form must be submitted to properly close the project. This is especially important for funded projects where funds will be frozen if an official Study Closure form is not obtained and the current approval has expired.
- The Amendment Form can be used to notify the REB of any additions or modifications to be made to a currently approved research project including, but not limited to, changes to the consent process or form, study measures, recruitment process or documents, the study population or location of the research. Substantive changes that have ethical implications must be reviewed and approved by the REB before they can be implemented. This form should also be used to notify the REB of administrative changes such as the addition of co-investigators or new funding sources and titles. Significant or numerous changes to study methods, participant populations or the research question will require the submission of a complete new application.
- Investigators must also inform the REB of any serious adverse events experienced by participants.
Any serious or unexpected adverse events experienced by a participant in conjunction with the research, which affects the risk-benefit ratio of the project, must be reported immediately to the REB. Such events are not limited to physical harm but can include social, emotional or economical harms.
Reasonable judgment should be used to determine what constitutes a serious event. Any unanticipated issues, whether minor or serious in magnitude, that may increase the risk level to participants or that may have other ethical implications must be reported to the REB.
- Researchers must promptly report to the REB any new information that may affect the welfare or consent of participants.
- The McGill Regulation on the Conduct of Research says that original data must be maintained for a period of at least 7 years from the date of publication if there are no specific sponsor or regulatory requirements. Researchers are responsible for ensuring that all data is maintained in accordance with the confidentiality and security promised to the study participants. Researchers are responsible for being aware of any
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MCGILL UNIVERSITY
RESEARCH ETHICS BOARD OFFICE (REB-I, II, III,FAES)
845 Sherbrooke Street West|James Administration Bldg., rm 429|Montreal, QC H3A 0G4|Tel:514-398-6193/6831 w ww.mcgill.ca/research/researchers/compliance/human/ specific data retention requirements applicable to their particular research (e.g. funding agencies, Health Canada).
In particular, in compliance with measure 9 of the
Plan d’action ministériel
, a principal investigator conducting projects involving human participants within institutions that fall under the responsibility of the Ministry of Health and Social Services, such as hospitals or CSSSs, is required to maintain a list of participants for at least a period of one year after the project ends. The list must include the name of the person, contact information for the participant; the REB project number, and the start and end date of the project. This requirement doesn’t extend to projects where participants will be completely anonymous, or where only a records review will be conducted (e.g. medical chart reviews).
- Research can only begin only after the participants, or their authorized third parties, have provided their consent.
The Principal Investigator (PI) is responsible for ensuring that the consent process is followed. The PI is also responsible for the actions of any member of the research team involved in the consent process. Researchers have an ongoing duty to provide participants and REBs with all information relevant to participants’ ongoing consent to participate in the research.
The process of obtaining informed consent must be thoughtfully detailed in the REB application . The purpose of informed consent is to ensure that research participants voluntarily participate understanding the purpose of the research and its risks and benefits. A clearly written, informative document is essential to informed consent, but there is more to it than that. Consent forms do not replace a thoughtful discussion with the participants. What are participants going to be told about the research before they even see the consent form? That information can increase understanding greatly, so researchers need to think carefully about what information they are going to provide and how this information can best be given to potential participants. How and when participants will be asked to consent is also an important part of the process. Depending on the complexity of the material and the abilities of the participants, it might be necessary to ask questions of the participant in order to be sure that the information is understood. The potential participants need to know what the purpose is, what they are expected to do, as well as what the potential harms and benefits and alternatives (if applicable) are to participating. Participants must be informed of any possible conflicts of interest on the part of researchers, their institutions or sponsors.
Written consent is normally required, unless otherwise adequately justified such as when it may be culturally inappropriate or an illiterate population is involved. It may be acceptable in such cases to obtain oral consent. If written consent will not be obtained, the REB must still be provided with a copy of the script that will be used to obtain verbal consent from the participant. When appropriate, it is advisable to still leave a written statement of the information conveyed during the consent process. The procedures used to seek consent must always be documented by the researcher.
Consent forms should normally be printed on departmental letterhead. The language in the information letters, consent forms or oral consent scripts must be tailored to the population being addressed. This sometimes requires different forms for different groups of people within the same project (e.g. children and parents; government officials; illiterate populations). The REB does not prescribe a particular format for a consent form. The length and detail of the form will depend on the research being conducted, the participants involved and the information required to enable them to give informed consent. The following information is the minimum required in a consent form.
- the name of the student, department and the university; identity of the funder or sponsor
- student researchers must be identified as such and the supervisor’s name and contact information must be indicated
- a clear statement that the person is being invited to participate in a research study
- a description of the research project, its purpose and anticipated dissemination of results (e.g. thesis, publications and conferences, internet, film)
- description of what the participant will be asked to do (e.g. be interviewed, fill out a questionnaire, be a focus group participant), the location, frequency/number of procedures, and time involved
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MCGILL UNIVERSITY
RESEARCH ETHICS BOARD OFFICE (REB-I, II, III,FAES)
845 Sherbrooke Street West|James Administration Bldg., rm 429|Montreal, QC H3A 0G4|Tel:514-398-6193/6831 w ww.mcgill.ca/research/researchers/compliance/human/
- indicate if the participants will be audio-taped or videotaped and how the tapes will be used (e.g. just for the researcher, for teaching, at public presentation)
- description of how and to what degree confidentiality will be maintained, including how the data will be kept secure and who will have access to the confidential data; if the data will be shared, for example, deposited with a community or used for a new or existing databank, details on the type of data, potential uses, user access, security of data, and retention period must be described
- description of any potential benefits (or state that there are none) and foreseeable discomforts and/or potential risks of harm to the participant (harms may be emotional, psychological, physical, social or economic) and explain how these will be managed
- a statement that indicates that participants are under no obligation to participate, they may withdraw at any time (if a limitation to withdrawal of their data at any point this must be explained), they may refuse to answer any question; when treatment or services are involved, include a statement indicating that a decision to participate or not to participate will not affect the availability of services offered or if a student, that their academic standing will not be affected
- a description of any compensation/incentive for the participants
- a separate yes/no check-off option needs to be provided for the following: permission to audio/videotape or photograph and the options for use of any of these; permission to be identified
- the presence of any real, potential or perceived conflicts of interest on the part of the researchers involved, their institutions or the research sponsors
- any other information particular to the project that is necessary for the participant to be able to make an informed decision
- the statement ‘If you have any questions or concerns regarding your rights or welfare as a participant in this research study, please contact the McGill Ethics Officer at 514-398-6831 or lynda.mcneil@mcgill.ca
’ must be included on all consent forms
- a copy of the consent form must be left with the participant and one retained by the researcher
When the participants involved are not competent to consent for themselves, an authorized third party must give consent. However, individuals who lack legal capacity to consent may still be able to verbally or physically agree or disagree to participate. Researchers are asked to provide an assent script that will be used with these participants to explain the project and what is expected of them. Assent forms are normally used with children 7 and older.
Children aged 13 or older are normally expected to give assent by signing an assent form. The assent form needs to be written at an age appropriate level.
Researchers are directed to consult the relevant sections of the Tri-Council Policy Statement: Ethical Conduct for
Research Involving Humans for a thorough discussion of the requirements for the consent process.
- These guidelines apply to all new and existing data repositories to be used for human participant research. A data bank includes any systematic collection of data and can include personal and medical data, genetic data as well as biological material (cells, tissues, organs, blood, saliva and other substances).
While all data collected or used for research involving human participants potentially constitute a databank, these guidelines are intended primarily for management of those banks and repositories that serve the needs of multiple research projects and/or multiple research groups.
1. Management
The holder of the bank refers to the individuals, groups, and institutions that created the bank. The institution is responsible for ensuring that the databank has appropriate administration. The administrator (individual or institution) of the data bank is responsible for its operation according to this policy, and includes privacy, confidentiality and appropriate access by users.
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MCGILL UNIVERSITY
RESEARCH ETHICS BOARD OFFICE (REB-I, II, III,FAES)
845 Sherbrooke Street West|James Administration Bldg., rm 429|Montreal, QC H3A 0G4|Tel:514-398-6193/6831 w ww.mcgill.ca/research/researchers/compliance/human/
Researchers have access to the bank as limited by the nature of the consent given by participants.
As governed by this policy, researchers are responsible to the Research Ethics Board (REB), to the Institution and to the Administrator with whom they will sign an agreement establishing, for example, the type of access (e.g user or user/contributor), as well as ensuring confidentiality and clarifying any potential intellectual property rights.
Researchers, institutions and sponsors can acquire intellectual property rights over inventions derived from the use of the databank.
The creation and/or use of data banks must be reviewed by a McGill Approved Research Ethics Board ( see
Appendix II, Policy on the Ethical Conduct of Research Involving Human Participants, for list of these REBs )
2. Collection of data and recruitment of participants
As part of a research project
An REB with authority in the McGill jurisdiction is to review and approve the creation and use of the data bank before collection begins. Unless specifically provided for in the consent document, data collected are not to be used for purposes other than for those initially requested. Only the data directly pertaining to the study are to be collected and stored. Data are to be collected legally and in good faith.
Data are to be collected with the participants’ consent. The consent form should contain information addressing the following:

Informing the participant of the use and lifetime of the bank;
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Identifying information and its potential traceability;
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Length of storage and disposition of data;
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Requesting whether or not the participant may be contacted again for further research;
What happens to data at the end of the project (i.e. coded data; destroyed or rendered anonymous so that all identifiers which would allow the participant to be retraced are deleted);
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The possibility or not for the participant to withdraw consent and an explanation of what happens to the stored data once consent has been withdrawn;
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Describing the potential benefits or lack of benefits for the participants;
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Describing the possible risks for the participants;
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Disclosing incidental findings that could affect the well-being of the participants or their relatives, particularly while the research findings are linkable with the participants’ identity;
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Describing confidentiality, and how it will be maintained (e.g. who has key code to data; where the data will be stored; and type of security measures taken);
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Restricting access to researchers or research teams involved in the study and conditional to approval by the administrator;
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Keeping data confidential within the limits of the law or within the limits set by the consent of the participant;
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The potential uses for the data including potential development of intellectual property and commercial uses.
Secondary (research) use of nominal, coded or anonymized data already collected
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REB approval is required for secondary use of existing research data or for the use of data collected for other purposes (e.g. school records). Participant consent for use of secondary data is subject to the rules
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MCGILL UNIVERSITY
RESEARCH ETHICS BOARD OFFICE (REB-I, II, III,FAES)
845 Sherbrooke Street West|James Administration Bldg., rm 429|Montreal, QC H3A 0G4|Tel:514-398-6193/6831 w ww.mcgill.ca/research/researchers/compliance/human/ and regulations of the REB, the McGill Policy on the Ethical Conduct of Research Involving Human
Participants , the Tri-Council Policy Statement and the requirements of any other relevant agency.
3. Storage and safekeeping of data
Identification of the data:
The data can either be:

Nominative - Containing elements that allow for participant’s identification, either by name, or by identifiers, or can reasonably be deducted from a combination of identifiers. Secondary code lists cannot be created;
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Coded - The confidentiality of the data will be protected by assigning them a specific code. A code will link the participant to the sample. Decoding can only be performed by the principal researcher or an individual authorized by the former; or
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Anonymized - The confidentiality of the data will be protected by rendering them anonymous; in other words, after the sample is taken, all identifiers which would allow the participant to be retraced will be deleted. The researcher may decide to include specific information with the sample (such as age, sex, demographic data, etc.); this information, however, must not allow the participant to be identified or retraced;
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Anonymous/non-nominative – Data is originally collected without identifiers.
Security of data bank
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A list of all internal users (members of the research team) and all external users (persons or organizations) is to be kept and the criteria for accessing the data are to be defined. This is to be overseen by the
Administrator.
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Security mechanisms that prevent non-authorized persons from accessing data are to be implemented (i.e. coding, double-coding, encryption, anonymization, lock and key, etc.)
Length of storage
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All data are to be kept for the defined period of time as outlined in the consent document.
Nominative/coded data should only be retained as long as is necessary to fulfill the research purposes after which they which they will be destroyed, or rendered anonymous.
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Anonymous data can be kept for an indefinite period of time.
4. Access to and use of data
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Any use of data for research is to be approved by an REB.
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Use of data is limited to the purposes originally requested, unless otherwise indicated in the consent document (e.g. The consent document discloses the possible future secondary use of data for other purposes).
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Access is restricted to researchers or research teams approved by the administrator as consistent with the original purpose of the data bank.
Secondary use of data
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Secondary use of data is to be approved by an REB.
Third party access
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If the personal data is coded, it is not to be made available to third parties such as employers, governmental organizations, insurance companies or educational institutions. However, for research monitoring and
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MCGILL UNIVERSITY
RESEARCH ETHICS BOARD OFFICE (REB-I, II, III,FAES)
845 Sherbrooke Street West|James Administration Bldg., rm 429|Montreal, QC H3A 0G4|Tel:514-398-6193/6831 w ww.mcgill.ca/research/researchers/compliance/human/ regulatory purposes, members of REBs, government officials, or other legally authorized parties may consult the data.
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If the personal information is rendered anonymous (i.e. stripped of all identifiers), third party access to the data is generally acceptable in accordance with the provisions of this policy and may be obtained through
REB approval.
5. Commercialization
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The consent document must indicate that intellectual property might derive from the use of the bank with potential commercialization of results by researchers and institutions;
Agreement as how to share any intellectual property rights must be part of the agreement signed by users;
All research involving human participants must be conducted in accordance with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans as well as any other federal, provincial or agency regulations particular to the type of research being conducted. All researchers must be familiar with the McGill Policy on the Ethical Conduct of Research Involving Human Participants as well as the policies and procedures of the REB.
Researchers should submit their application well in advance of the date which they hope to start their research.
Approval time varies according to several factors including the complexity of the application, revisions to be made, and the overall number of applications being submitted to the REB for review and could take approximately 3-8 weeks.
The University does not release funds for projects involving human participants until a valid ethics approval is provided. For funded projects, the title on the ethics submission should be that of the grant/contract. If it isn’t the same, there must be an explicit reference to the agency and grant/contract title in order to avoid difficulties in the release of funds. An ethics submission may be supported by more than one grant. All funding sources for the project (grants or contracts) must be indicated on the ethics application. The holder of the funding must also be indicated if not the applicant of the ethics submission. An Amendment form can be filled out to report any changes or additions to titles or funding sources to a currently approved project.
All applications must be signed by the applicant who is the Principal Investigator (PI), and if the PI is a student, by the McGill faculty supervisor as well. The Principal Investigator’s signature affirms that he/she will conduct the project in accordance with the policies and procedures governing the ethical conduct of research involving human at McGill. The supervisor’s signature affirms that he/she has read and approved the project, that it has received the appropriate academic approval and that the supervisor is responsible for providing the necessary supervision to the student.
All co-investigators/collaborators and their affiliation must be listed. It is important to note that no research should take place until all investigators have obtained their own institutional approvals. An Amendment form can be filled out to add additional investigators as necessary.
Application forms must include all supporting documents such as recruitment ads (including information that is sent to third parties such as when requesting access to a school or another organization), letters of invitation, oral consent scripts, consent forms, information letters. These documents must always include the name of the
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MCGILL UNIVERSITY
RESEARCH ETHICS BOARD OFFICE (REB-I, II, III,FAES)
845 Sherbrooke Street West|James Administration Bldg., rm 429|Montreal, QC H3A 0G4|Tel:514-398-6193/6831 w ww.mcgill.ca/research/researchers/compliance/human/
University, the department, the researcher’s name, contact information, and if a student, the faculty supervisor’s name and contact information must also be listed. All test instruments must be provided (if standard instruments then just list the names and provide the web link) as well as surveys and interview guides. Submit the application as a single document with any appendices such as consent forms, questionnaires etc. included at the end of the application and number each page.
All student research requires ethics review and approval including course-based research projects. A course instructor may apply for ethics approval submitting one application for the whole class if the research question and methodology will be similar across all students. If not, individual applications will need to be made. The course instructor is responsible for providing the necessary supervision to each student researcher throughout the project, to ensure that all procedures performed under the research project will be conducted in accordance with the approved proposal and in accordance with all applicable policies and guidelines.
All submission instructions and deadlines and forms can be found on the website. See the website for information on drop-in consultation sessions.
Location: The REB Office is located at 845 Sherbrooke Street West, James Administration Bldg. rm 429,
Montreal QC, H3A 0G4; Fax: 514-398-4644; Website: www.mcgill.ca/research/researchers/compliance/human
Staff: Lynda McNeil, Manager, Research Ethics – for information on education offerings, University policies and procedures, REB-III and FAES submissions
Tel: 514-398-6831; Email: lynda.mcneil@mcgill.ca
Deanna Collin, Ethics Review Administrator – for information on REB-I and REB-II submissions
Tel: 514-398-6193; Email: deanna.collin@mcgill.ca
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