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 www.mcgill.ca/research/researchers/compliance/human/
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APPLICATION GUIDELINES FOR ETHICS REVIEW
Research Ethics Board Mandate - 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.
Determining which REB to apply to - 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.
What Needs to be Reviewed? 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
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.
Renewals - 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.
Closing a Project - 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.
Amendments - 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.
Adverse Events/Unanticipated Issues - 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.
New Information- Researchers must promptly report to the REB any new information that may affect the welfare or consent of participants.
Record- keeping - 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 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).
Informed Consent Guidance - 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
- 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/video-tape 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 ’ 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.