Research Ethics Board (REB)
Faculty of Agricultural and Environmental Sciences
Application for Ethics Approval for Research Involving Human Participants
www.mcgill.ca/macdonald/research/compliance/human
(please refer to application guidelines found at the end of this form)
Project Title:
Principal Investigator:
Department:
Phone #:
Email:
Status:
Faculty □
Ph.D. Student □
Postdoctoral
Fellow □
Master’s Student □
Undergraduate □
Type of Research:
Faculty Research □
Thesis □
Other (specify) □
Honours Thesis □
Faculty Supervisor (for student PIs):
Independent Study Project □
Course Assignment (course name and #) □
_____________________
Other (specify) □
______________________________
Email:
Co- Investigator(s) (list name/status/affiliation):
List all funding sources for this project and project titles (if different from the above). Indicate the Principal Investigator of
the award if not yourself.
Awarded:
Pending:
Principal Investigator Statement: I will ensure that this project is conducted in accordance with the policies and procedures
governing the ethical conduct of research involving human participants at McGill University. I allow release of my nominative
information as required by these policies and procedures.
Principal Investigator Signature: ______________________________
Date: _____________
Faculty Supervisor Statement: I have read and approved this project and affirm that it has received the appropriate academic
approval. I will ensure that the student investigator is aware of the applicable policies and procedures governing the ethical conduct of
research involving human participants at McGill University and I agree to provide all necessary supervision to the student. I allow
release of my nominative information as required by these policies and procedures.
Faculty Supervisor Signature: ___________________________________ Date: ______________
(for student PI)
NOTE: Ethics review and approval of research involving humans must be obtained
prior to the commencement of a project, this includes undergraduate class
projects/assignments involving human participants.
FAES REB contact: Lynda McNeil, Manager, Research Ethics at 514-398-6831 or Lynda.mcneil@mcgill.ca
(July 2014)
Respond directly on this form to each question under each section (1-8). Do not delete any of the text under each heading. Do
not omit or reorder any questions. Forms with incomplete sections will be returned.
1. Purpose of the Research
a) Describe the proposed project and its objectives, including the research questions to be investigated (one –two page
maximum).
b) What is the expected value or benefits of the research?
c) How do you anticipate disseminating the results (e.g. thesis, presentations, internet, film, publications)?
2. Recruitment of Participants/Location of Research
a) Describe the participant population and the approximate number of participants needed.
b) Describe how and from where they will be recruited. Attach a copy of any advertisement, letter, flier, brochure or oral
script used to solicit potential participants (including information sent to be sent to third parties).
c) Describe the setting in which the research will take place.
d) Describe any compensation participants may receive for participating.
3. Other Approvals
When doing research with various distinct groups of participants (e.g. school children, cultural groups, institutionalized
people, other countries), organizational/community/governmental permission is sometimes needed. If applicable, how will
this be obtained? Include copies of any documentation to be sent.
4. Methodology/Procedures
Provide a sequential description of the methods and procedures to be followed to obtain data. Describe all methods that
will be used (e.g. fieldwork, surveys, interviews, focus groups, standardized testing, video or audiotaping. Attach copies of
questionnaires or interview guides etc.
5. Potential Harms and Risks
a) Describe any known or foreseeable harms, if any, that the participants or others might be subject to during or as a
result of the research. Harms may be psychological, physical, emotional, social, legal, economic, or political.
b) In light of the above assessment of potential harms, indicate whether you view the risks as acceptable given the value
or benefits of the research.
c) Outline the steps that may be taken to reduce or eliminate these risks.
d) If deception is used, justify the use of the deception and indicate how participants will be debriefed or justify why they
will not be debriefed.
6. Privacy and Confidentiality
a) Describe the degree to which the anonymity of participants and the confidentiality of data will be assured and the
specific methods to be used for this, both during the research and in the release of findings.
b) Describe the use of data coding systems and how and where data will be stored. Describe any potential use of the data
by others.
FAES REB contact: Lynda McNeil, Manager, Research Ethics at 514-398-6831 or Lynda.mcneil@mcgill.ca
(July 2014)
c) Who will have access to identifiable data?
d) What will happen to the identifiable data after the study is finished?
e) Indicate if there are any conditions under which privacy or confidentiality cannot be guaranteed (e.g. focus groups;
mandatory reporting), or, if confidentiality is not an issue in this research, explain why.
7. Informed Consent Process
a) Describe the oral and/or written procedures that will be followed to obtain informed consent from the participants.
Attach all consent documents, including information sheets and scripts for oral consents.
b) If written consent will not be obtained, justification must be provided.
8. Other Concerns
a) Indicate if the participants are a captive population (e.g. prisoners) or are in any kind of conflict of interest
relationship with the researcher such as being students, clients, patients or family members. If so, explain how you will
ensure that the participants do not feel pressure to participate or perceive that they may be penalized for choosing not to
participate.
b) Comment on any other potential ethical concerns that may arise during the course of the research.
FAES REB contact: Lynda McNeil, Manager, Research Ethics at 514-398-6831 or Lynda.mcneil@mcgill.ca
(July 2014)
DO NOT SUBMIT THIS SECTION WITH YOUR APPLICATION
MCGILL UNIVERSITY
RESEARCH ETHICS BOARDFACULTY OF AGRICULTURAL AND ENVIRONMENTAL SCIENCES
_____________________________________________________________________
APPLICATION GUIDELINES FOR ETHICS REVIEW
General Information and Completing the Application
GENERAL INFORMATION
The University has 5 Research Ethics Boards and each of the affiliated hospitals has its own. The Research Ethics Board
– Faculty of Agricultural and Environmental Sciences (REB-FAES) serves all units of the Faculty for research involving
competent adults. Research involving participants under 18 or adults not competent to consent on their own must be
submitted to the REB-III for review. Research involving medically invasive measures, procedures or interventions
must be submitted to the Faculty of Medicine REB for review.
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 these participants. The policies and practices of the REB are
governed by the McGill Policy on the Ethical Conduct of Research Involving Human Participants. All research involving
human participants must be done in accordance with the Tri-Council Policy Statement: Ethical Conduct For Research
Involving Humans, the McGill policy, the REB guidelines, as well as any other applicable regulations such as the Quebec
Civil Code.
Contact Information - Any questions may be directed to the Manager, Research Ethics at 514-398-6831 or at
Lynda.mcneil@mcgill.ca. All researchers are advised to go to the website at
www.mcgill.ca/macdonald/research/compliance/human/ which contains general information, forms, guidelines and
policies.
What Needs to be Reviewed? All research involving human participants conducted by University affiliated faculty,
students or staff, conducted on campus or elsewhere, requires review and approval by the REB before the research may
begin. This includes all funded (granting agencies/ contracts) and non-funded research, including student course
assignments. Research involving human participants may include, but is not limited to, projects where data are derived
from:
1) the collection of information through any interaction or intervention with a living individual
2) the secondary use of data previously collected from human participants
3) identifiable private information about an individual
4) human remains, cadavers, human organs, tissues and biological fluids, embryos or fetuses
The examples listed are not intended to represent an exhaustive inventory of research requiring review and, conversely,
some activities apparently falling into these categories may be exempted from review. The researcher is responsible for
consulting with the REB to clarify what types of research must be reviewed and what exceptions may exist . Ethics
approval must be received before the research is begun.
Continuing Review - Ethics approvals are only valid for one year and must be renewed on an annual basis. This
requires the submission of a Request for Renewal 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.
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 is not obtained and the current approval has expired.
Amendments - The Amendment Form can be used to notify the REB of any revisions or modifications to be made to a
currently approved research project. These modifications must be reviewed and approved by the REB before they can be
FAES REB contact: Lynda McNeil, Manager, Research Ethics at 514-398-6831 or Lynda.mcneil@mcgill.ca
(July 2014)
implemented. This form is also to be used to notify the REB of changes such as the addition of co-investigators or new
funding sources and titles.
Unanticipated Issues - Investigators must also inform the REB of any unanticipated issues that occur during the conduct
of research that may increase the level of risk for participants or have other ethical implications that may affect a
participant’s rights or welfare.
All forms are available at www.mcgill.ca/macdonald/research/compliance/human/.
APPLICATIONS FOR NEW PROJECTS
The most recent version of the application on the website must be used. Older versions will not be accepted.
Applications MUST be submitted by email. DO NOT send a hard copy. All signatures must be in place.
Scanned signatures are accepted and must be sent from the researcher’s McGill email.
Submit only ONE file (do not send multiple attachments) containing all necessary documents such as the
application, recruitment posters, consent forms, surveys etc.. The submission must be paginated with all
appendices clearly labelled. Send to lynda.mcneil@mcgill.ca
Please take note of the following points before you submit your ethics application, in order to ensure that your
application is properly filled out. Incomplete applications will be returned and cause delays in turnaround time.
1. All applications must be signed by the applicant who is the Principal Investigator, and if a student, by the supervisor
as well. Applications with missing signatures will be returned.
2. It is important to list all co-investigators/collaborators to indicate who is authorized to conduct research under the
ethics approval. This does not negate the need for external researchers to also obtain ethics approval from their own
institutions. Changes to the principal investigator or any co-investigators must be submitted on an Amendment form.
3. All funding sources for this project (grants or contracts) must be listed as well as the exact project title of the
grant/contract (or the reference number). This is very important since funds cannot be released if the project title
on the ethics certificate doesn’t match that of the grant /contract and there is no explicit reference made to the
appropriate funding source. It should be indicated who the holder of the award is, if it isn’t the applicant. An
Amendment form must be filled out to report any changes or additions to titles or funding sources to a currently
approved project.
4. The application form is designed to preclude the need to submit a complete grant application or thesis proposal but
you must include enough information in each section to provide the reviewers with adequate detail to conduct an
effective review. The reviewers can request a complete grant/thesis proposal if they feel it is necessary to properly
conduct the review.
5. Be sure to attach, as applicable, all 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 scripts, consent
forms, information letters, questionnaires ( if standard ones then just list the names) and interview guides. These
documents must always include the name of the University, the department, contact information, and if a student, the
faculty member’s name must also be listed.
6. Informed consent should be thought of as a process rather than a form. The purpose of "informed consent" is to
make certain that research participants are truly volunteers, and that they know what they are getting into before
volunteering. 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 the potential participant. 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
FAES REB contact: Lynda McNeil, Manager, Research Ethics at 514-398-6831 or Lynda.mcneil@mcgill.ca
(July 2014)
necessary to ask questions of the participant in order to be sure that the information is understood. The process of
obtaining informed consent must be thoughtfully detailed in the REB application.
The consent form documents the consent process and the length and detail will depend on the research and the
participants involved and what information is required to enable them to give informed consent. The following
information is the minimum required in a consent form. Consult Chapter 3 of the TCPS for further guidance.
a) the researcher’s name, department and University, and contact information
b) student researchers must be identified as such and the supervisor’s name and contact information must be
indicated
c) the contact information for a third party not involved in the research. This sentence must be included on
all consent documents – ‘If you have any questions or concerns about your rights or welfare as
a participant in this research study, please contact the Manager, Research Ethics at
lynda.mcneil@mcgill.ca or at 514-398-6831”.
d) a brief description of the research project and its purpose
e) description of exactly 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.
f) indicate if the participant will be audio-taped or videotaped and what the disposition of the tapes will be;
if the tapes will be used outside of the research group e.g in the classroom or at conferences etc.; will their
name be used. Explicit yes/no check-offs must be provided for each option.
g) how and to what degree confidentiality will be maintained, including how identifiable data a will be kept
secure and who will have access to the data.
h) describe any potential benefits (or state that there are none) and foreseeable discomforts and/or potential
risk of harm to the participant (e.g. emotional stress, economic harm ; physical discomfort etc.) and how
these will be managed.
i)
a statement that indicates that participation is voluntary, they may withdraw at any time for any reason
(any limitations to withdrawing need to be indicated), they may refuse to answer any question; when
treatment or services are involved, include a statement indicating that a decision not to participate will not
affect the availability of services offered or if a student, that their academic standing will not be affected.
j)
a description of any compensation provided.
k) all anticipated uses of the data must be indicated including potential future uses in other related research
projects by the researcher or other researchers not involved in this specific project.
l)
separate yes/no check-off options need to be provided for all options as applicable such as agreeing to be
audio/video-taped/photographed; for these to be made publically available; to be identified in publications
etc.
m) any other information particular to your project necessary for the participant to be able to make an
informed decision
n) a copy of the consent form must be left with the participant and one retained by the researcher. For online
studies, the consent document should prompt the participant to print or save a copy of the consent.
The language in the information letters, consent forms or oral scripts must be tailored to the population being addressed.
This sometimes requires different forms/process for different groups of people within the same project (e.g. children and
parents; government officials; illiterate participants).
FAES REB contact: Lynda McNeil, Manager, Research Ethics at 514-398-6831 or Lynda.mcneil@mcgill.ca
(July 2014)
Written consent is normally required, unless otherwise justified such as when it may be culturally inappropriate or an
illiterate population is involved. If written consent will not be obtained, you must still provide a copy of the script that
will be used to obtain verbal consent from the participants. Witness signatures are generally not required.
CONSENT FORM EXAMPLES
The REB does not prescribe a particular format or wording for a consent form. It must be written in a style appropriate to
the research and participants involved. The following are only examples and are not to be used as a template.
Example 1. CONSENT FORM
McGill University
Title of Research: xxxx
Researcher: xxxx, Ph.D. candidate, Dept.
Contact Information: Tel:; email:
Student Supervisor: xxxx; tel:email
Purpose of the research: To describe and explain the evolution of the relationship between the Canadian state and
refugee claimants in Canada between 1985 and 1996. In particular, the study investigates the effects of the international
refugee regime, the domestic legal structure and the actions of domestic non-state actors on the policy-making process.
This research represents the core phase of the writing of my dissertation. Like all such works, the finished text will be
available to the public. The information may also be used in other analyses that I write on Canadian refugee policy.
What is involved in participating: I will ask you a few questions relating to your participation in and /or evaluation of
the making of Canadian inland refugee policy. The time and length of the interview will be at your own convenience
although I do not expect it will take longer than one hour.
Your participation is entirely voluntary and you can choose to decline to answer any question or even to withdraw at any
point from the project. Anything you say will only be attributed to you with your permission, otherwise the information
will be reported in such a way as to make direct association with yourself impossible. Only I will have access to any
identifiable information. I would like to audio-tape the interview. This will be only to ensure accuracy and the tape will be
destroyed once the interview has been transcribed. All identifiable paper materials will be kept in a locked location only
accessible to myself. All electronic materials will be kept on an encrypted file on my password protected computer.
Please contact me at the coordinates listed above if you have any questions about this study.
Your signature below serves to signify that you agree to participate in this study.
Consent: I wish to be identified in the report ____YES
I agree to be audiotaped ____YES ____NO
_____NO
I have read the above information and I agree to participate in this study
Signature: __________________
Printed Name: ______________________
Date: _______________________
----------------------------------------------------------------------------------------------------------------------------------If you have any questions or concerns about your rights or welfare as a participant in this research study, please contact
the Manager, Research Ethics at 514-398-6831 or Lynda.mcneil@mcgill.ca.
FAES REB contact: Lynda McNeil, Manager, Research Ethics at 514-398-6831 or Lynda.mcneil@mcgill.ca
(July 2014)
Consent Form Example 2: printed on letterhead
This is to invite you to participate in a study entitled “xxxx” which is being conducted by Prof xxx, in the dept of XXX
at McGill University with funding from the Social Sciences and Humanities Research Council. The purpose of this
research is to investigate regional and social variation in Canadian English.
Your participation in the study will entail an oral interview, lasting approximately one hour, to be conducted by a member
of Prof xxx’s research team, which will be tape-recorded in its entirety.
In this interview you will be asked to provide demographic data about yourself (e.g. residential history, ethnicity,
occupation, education and language background); to read lists of words; to compare the pronunciation of pairs of words
and to talk about my opinions on current issues.
Your participation is voluntary and you may choose not to participate or withdraw at any time or refuse to answer any
question you don’t want to. You will receive $20 in compensation for your time.
Your name will never be revealed in written or oral presentations and no record will be kept of your name. Portions of the
interview may be played in linguistic classes or conference presentations for demonstration purposes connected with
linguistic analysis but your name will never be associated with the recording.
All identifiable information, including the tapes, will only be accessible to members of Prof xxx’s research team and will
be kept by Prof. xxx under secure conditions.
You may contact Prof. xxx at tel#; email; if you have any questions about the study.
If you have any questions or concerns about your rights or welfare as a participant in this research study, please contact
the Manager, Research Ethics at 514-398-6831 or lynda.mcneil@mcgill.ca.
_____________________________________________________________________________________
I agree to be tape-recorded ____YES _____NO
I agree that the tape may be used as described above ____YES _____NO
Participant’s signature________________
Participant’s printed name ____________
FAES REB contact: Lynda McNeil, Manager, Research Ethics at 514-398-6831 or Lynda.mcneil@mcgill.ca
(July 2014)