Checklist for LOI and CF with Examples
1. Letter of Information
2. Example of Letter of Information
3. Consent Form
4. Example of Consent Form
5. Example of Combined LOI and CF
6. Required Statements
Depending on the type of research study being conducted, these requirements may change
subtly. For most applications, the following requirements apply.
[top]
Letter of Information (LOI):
1. written in lay language
2. researchers and institutions identified
3. identified as a research project
4. statement that research project has received ethics clearance (see Appendix 1)
5. invitation to participate
6. statement explaining procedures/method involved
7. statement explaining if any special research techniques are to be employed
8. statement explaining anticipated time duration for participation
9. statement concerning potential risks identified
10. statement regarding benefits (see Appendix 1)
11. statement explaining voluntary nature of the study
12. statement that they can withdraw during the study if they change their mind
13. statement explaining how they can terminate their participation
14. statement about what information is being collected, who will have access to personal
identifying information (if collected), how participant privacy and confidentiality will be
safeguarded, whether research data will be shared or archived, and how it will be
disseminated
Reviewed 2016FEB25
p1
15. details of any incentive or financial compensation/reimbursement
16. statement regarding contacts (see Appendix 1)
[top]
Example of a Letter of Information:
"An Attentive Hearing Aid for Hearing-Impaired Individuals"
Letter of Information
This letter is an invitation to participate in a research study about an assistive listening device
that is being conducted by [researcher(s)] at the Queen’s University and has been granted
clearance by the General Research Ethics Board according to Canadian research ethics principles
(http://www.ethics.gc.ca/default.aspx) and Queen's University policies
(http://www.queensu.ca/urs/research-ethics). This research study has received funding from [e.g.,
CIHR, NSERC, SSHRC].
The aim of this research study is to evaluate a new type of assistive listening device to see if it
will help people hear better.
The study will involve having participants watch a number of videos. We will first ask you to use
a standard hearing aid while watching some of the videos. Then we will ask you to use the new
assistive technology that uses a head-mounted eye-tracking camera. Using this camera, the
system is able to tell which video you are watching. It will automatically amplify the volume of
the video as needed. At the end of each session, we ask that you answer a number of questions
in order to test your recall of the information presented in the videos.
The experimental session will take less than one hour. You might feel a slight discomfort from
wearing the head-mounted eye-tracking camera. If you do please let the researcher know. It
might only be that an adjustment is required. We will also be asking you some questions about
your general health that may make you feel uncomfortable talking about it. You are not required
to answer any questions that you do not want to answer. Your participation is voluntary and you
can discontinue your participation in the study at any time by informing the researcher present.
You can withdraw your answers from the study up to 1 month after your participation in the
study by contacting the researcher using the contact information below or on the Consent Form.
Some of the information we will be collecting from you is information about your age, gender,
and general state of health. The information you provide us with will be de-identified and given a
code so that no one will be able to identify you from the information unless they have the
Reviewed 2016FEB25
p2
participant code key. All personal information will be kept private and confidential and only the
[principal investigator or list who will have access] will have access to the participant code key.
Any personal contact information and the participant code key will be destroyed after it is no
longer required to authenticate study results. No personal information will ever be made public,
for example, in publications or when the de-identified data is shared or archived.
[top]
We would like to show our gratitude to you for taking the time to participate in our study by
offering you a $10 gift card to Tim Horton’s. We would also like to share with you our study
results when they are ready for publication. If you are interested in receiving a copy please let
[the researcher] know at the end of the study or you can contact [the researcher] to request it
later.
Should you have further questions about the research study please contact [the researcher] at
[phone number] or [email]. If you have any ethical concerns or complaints, you may contact the
Chair of the Queen’s University General Research Ethics Board at 1-844-535-2988 or
chair.GREB@queensu.ca .
[top]
Consent Form:
1. title of research project
2. statement that participant has read letter of information and has had their questions
answered to their satisfaction
3. statement that participant understands participation in the study
4. statement that participant understands voluntary nature
5. statement that participant understands confidentiality measures
6. place for name of participant’s name and signature
7. statement that participant understands sources of contact
[top]
Reviewed 2016FEB25
p3
Example of a Consent Form:
Consent Form
“TITLE OF PROJECT”
Name (please print clearly): ________________________________________
I have read the Letter of Information and have had any questions answered to my satisfaction.
I understand that I will be participating in the study called [title of research study]. I understand
that this means that I will be asked to do [X, Y, and Z].
I understand that my participation in this study is voluntary and I may withdraw at any time
during my participation in the study. If after participating in the study I wish to withdraw my
answers from the study I may do so within [X period of time].
I understand that every reasonable effort will be made to protect my privacy and maintain the
confidentiality of my personal information now and in the future. I understand that my personal
information will be removed from the research data and replaced with a participant code so that I
cannot be linked to the information without the participant code key. To protect my privacy and
confidentiality I understand that only [researcher(s) name(s)] will have access to the participant
code key and any information that can link the research data to me and my answers. I understand
that this information will be stored in a secure location and that every reasonable effort will be
taken to protect my privacy and confidentiality. [Either] I understand that my personal
information will be destroyed after it is no longer needed to authenticate the research data. [Or
for data that will be archived] I understand that the research data will be archived and possibly
shared with other researchers after this research study is finished but no personal information
will be shared. I understand that the research data may also be published in professional journals
or presented at scientific conferences, but any such presentations will be of general findings and
will never breach individual confidentiality.
I understand that there is no compensation [or state compensation, reimbursement, enticement
agreement] for participation in this research study but that a copy of the findings will be made
available to me if I so choose.
I am aware that should I have further questions about the research study that I can contact [the
researcher] at [phone number] or [email]. Or if I have any ethical concerns or complaints, I may
Reviewed 2016FEB25
p4
contact the Chair of the Queen’s University General Research Ethics Board at 1-844-535-2988
or chair.GREB@queensu.ca .
I have read the above statements and freely consent to participate in this research:
Signature: _____________________________________ Date: _______________________
[top]
Reviewed 2016FEB25
p5
Example of a Combined LOI and CF:
[top]
(FOR PARTICIPANTS IN ON-LINE SURVEYS)
<<Title of Research Project>>
This study is being conducted by [researcher’s names] from the [department] at Queen’s University and
has been granted clearance by the General Research Ethics Board according to Canadian research ethics
principles (http://www.ethics.gc.ca/default.aspx) and Queen's University policies
(http://www.queensu.ca/urs/research-ethics).
The purpose of the study is to [in one or two sentences]. The study [explain methodology]. It will
require approximately [time] minutes to complete.
There are no known risks to participation in this research [unless identified in the application]. Your
participation in this procedure is completely voluntary. You may withdraw from this study at any time
without any consequences by [explain how to exit – e.g., closing the browser]. Once you submit your
answers and close your browser you will no longer be able to withdraw your answers from the study (If a
course credit, explain that it will not have any impact on their academic standing at Queen’s University.
[“Regardless of whether withdraw or continue, participation will not impact your grades or allow you to
be identified by your instructors”]. You will be [given $$ or _ course credit] for your participation in this
study whether you complete it or not.
Your answers will be kept private and confidential [and/or anonymous]. Your personal information will
be removed from the research data and destroyed when it is no longer needed to authenticate the research
results. Any personal information will be stored in a password-protected file in a secure location and only
the [name of researcher(s)] will have access to your personal information. The research data will not
include any personal identifying information and will be archived for possible future use by other
researchers. The research data may be published in professional journals or presented at scientific
conferences but the information will be in a composite form and the researchers will have no ability to
trace the information back to you.
Any questions about study participation may be directed to the [research investigator] at [contact info].
If you have any ethical concerns or complaints, you may contact the Chair of the Queen’s University
General Research Ethics Board at 1-844-535-2988 or chair.GREB@queensu.ca.
If you understand and accept these conditions, please indicate your electronic consent by selecting yes or
no.
Yes
No
I consent to participate
I do not consent
*** You should print this form for your records***
Reviewed 2016FEB25
p6
Appendix 1
Required Statements for LOI or LOI/CF
[top]
Standard Clearance Phrase:
1. This study has been granted clearance by the General Research Ethics Board according to
Canadian research ethics principles (http://www.ethics.gc.ca/default.aspx) and Queen's
University policies (http://www.queensu.ca/urs/research-ethics).
Choice of Wording for Contact Information:
2. If you have any ethical concerns or complaints, you may contact the Chair of the Queen’s
University General Research Ethics Board at 1-844-535-2988 or
chair.GREB@queensu.ca.
Benefits Statement:
3. There may not be any benefit for you but your participation is likely to help us find the
answer to … [the research question]. There may not be any benefit to the society at this
stage of the research, but future generations are likely to benefit.
OR
4. There may not be any benefit to you by taking part in this study, but it will contribute to
this research. Your participation in this study is helping us understand ... Although you
may not directly benefit from taking part in this study, information from this study will
contribute to the advancement of scientific knowledge and may help other people in the
future.
OR
5. We cannot guarantee or promise that you will receive any direct benefits from being in
the study. The results of the study will however, contribute to a better understanding …
[research question]. The study has the potential to influence policy directions and
services in relation to ….
OR
Reviewed 2016FEB25
p7
6. By your participation, you are helping to contribute to the research to scientific research
in this area.
OR
7. By participating, you will be able to add to your knowledge about how to conduct
research in this area….
[top]
Reviewed 2016FEB25
p8