Must be printed on institutional letterhead
Project Title: {Put the title of your project here}
Principal Investigator:
{List the Principal Investigator here}
E.g. Jane Smith, MD, Department, Institution
Letter of Information
1. Invitation to Participate
{Provide an invitation to participate and explain to the potential participant WHY they
are being targeted for recruitment}
E.g. You are being invited to participate in this research study {indicate what the
research study is about} because you {indicate why they are being asked to
participate}.
2. Purpose of the Letter
{Outline what the purpose of this letter is here}
E.g. The purpose of this letter is to provide you with information required for you
to make an informed decision regarding participation in this research.
3. Purpose of this Study
{Outline what the purpose of this study is here}
E.g. The purpose of this study is to {indicate why the study is being done here
and your objectives}.
4. Inclusion Criteria
{Outline the inclusion criteria from your protocol submission for this study here,
providing the information on what age group and any other specific inclusion criteria
that is required for the study}
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E.g. Individuals who {indicate what the inclusion criterion are} are eligible to
participate in this study.
5. Exclusion Criteria
{Outline what specific criteria based on your protocol submission will exclude someone
from the study here}
E.g. Individuals who are {indicate what the exclusion criterion are} are not
eligible to participate in this study.
6. Study Procedures
{Outline what activities / procedures that you will be asking the study participants to do
/ perform here.}
E.g. If you agree to participate, you will be asked to {insert what they will be
asked to do here}. It is anticipated that the entire task will take {inset how long
here}, over {inset number of sessions here}. The task(s) will be conducted in the
{insert location here}. There will be a total of {insert number of local and total
participants here as applicable}.
7. Possible Risks and Harms
{Outline any possible risks and harms here as per your protocol submission, or if none,
indicate it here.}
E.g. The possible risks and harms to you include {insert risks and harms here}.
Or
There are no known or anticipated risks or discomforts associated with
participating in this study.
8. Possible Benefits
{Outline any possible benefits to the participants and to society as per your protocol
submission here. You may indicate there are no benefits to the participant but there
should always be societal benefits}
E.g. The possible benefits to participants may be {insert benefits here}. The
possible benefits to society may be {insert societal benefits here}.
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OR
You may not directly benefit from participating in this study but information
gathered may provide benefits to society as a whole which include {insert
societal benefits here}.
9. Compensation
{Outline any compensation that will be provided to the research participant}
E.g. You will be compensated {insert what the compensation is, if applicable} for
your participation in this study. If you do not complete the entire study you will
still be compensated at a pro-rated amount of {indicate the pro-rated amount
and how it will be offered}.
OR
You will not be compensated for your participation in this research.
10. Voluntary Participation
Participation in this study is voluntary. You may refuse to participate, refuse to answer
any questions or withdraw from the study at any time with no effect on your future
(care/academic status/employment etc).
{Please only select the above choices in the brackets which apply to your study /
participants)
11. Confidentiality
{Describe the protection of the participant’s privacy, method of storing research data, and
who may have access to study records.} Examples below marked with a * may not be
applicable to your study. Please see the Letter of Information Guidelines to see all forms of
required wording for this section of the letter to ensure that you choose the wording
applicable to your study.
E.g., All data collected will remain confidential and accessible only to the
investigators of this study. If the results are published, your name will not be
used. *If you choose to withdraw from this study, your data will be removed and
destroyed from our database. *While we will do our best to protect your
information there is no guarantee that we will be able to do so. The inclusion of
your initials and your date of birth may allow someone to link the data and
identify you. * Representatives of The University of Western Ontario NonPage 3 of 6
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Must be printed on institutional letterhead
Medical Research Ethics Board may contact you or require access to your studyrelated records to monitor the conduct of the research.
12. Contacts for Further Information
{Instructions on whom (name and phone number) to contact regarding any questions or
concerns that may be raised by participating in the study or questions that may be raised by
being a research participant.}
E.g. If you require any further information regarding this research project or your
participation in the study you may contact {inset name, number, and email for
Principle Investigator and, if applicable, Co-Investigators or Administrative
Contact here / student researcher.}
You must also include:
E.g. If you have any questions about your rights as a research participant or the
conduct of this study, you may contact The Office of Research Ethics (519) 6613036, email: ethics@uwo.ca.
13. Publication
{Outline the ways in which the results will be published and if appropriate, how the
participants will be informed of the results.}
E.g. If the results of the study are published, your name will not be used. If you
would like to receive a copy of any potential study results, please contact {insert
contact name(s) here}.
OR
E.g. If the results of the study are published, your name will not be used. If you
would like to receive a copy of any potential study results, please provide your
name and contact number on a piece of paper separate from the Consent Form.
14. Consent
{Indicate how the participant will be consented to participate in the study}
Alternate method of consent
E.g. Completion of the survey is indication of your consent to participate.
OR
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Must be printed on institutional letterhead
E.g. Completion of the survey is indication of your consent to participate.
OR
E.g. You indicate your voluntary agreement to participate by responding to the
questions.
OR
Written Consent
Include a Consent Form with this letter that the participant will sign. This does
not need to be indicated in the letter.
This letter is yours to keep for future reference.
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Must be printed on institutional letterhead
Consent Form
Project Title: {Insert the project title here}
Study Investigator’s Name: {Insert name here}
I have read the Letter of Information, have had the nature of the study explained
to me and I agree to participate. All questions have been answered to my
satisfaction.
Child’s Name: (if applicable)
______________________________________________
Participant’s Name (please print):
_______________________________________________
Participant’s Signature:
_______________________________________________
Date:
_______________________________________________
Parent / Legal Guardian / Legally Authorized Representative (if applicable) Print: __________
Parent / Legal Guardian / Legally Authorized Representative (if applicable) Sign: ___________
Parent / Legal Guardian / Legally Authorized Representative (if applicable) Date: ___________
Person Obtaining Informed Consent (please print):
_____________________________
Signature:
_____________________________
Date:
_____________________________
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