HREB Version: June 2014
How to Use the Consent Template

Read the General Consent Guidelines found on the HREA website
Instructions
Red Font:
When developing your consent from this template, pay special attention to areas that are red
font. These areas are intended to be tailored to specifically describe your research project and
provide direction on what information is to be provided in each section and how it should be
presented. They are included as part of standard format to ensure that these elements are
considered in the development of your consent form.
Red Italicized Font:
The areas that are red italicized font are optional elements and may not apply to your study.
They should be modified or deleted as needed.
After modifying these areas, font color should be changed to black, and italics replaced with
regular font so that all text is in regular font (except headings which should always be bolded
black font).
Bold Font:
The bold areas are standard language and should not be modified. However, when developing
your consent form, the bold font should be replaced with regular font for the text in these
sections. The headings are to remain in bold as per the format of the entire consent form. .
Please delete this page from your consent document before submitting it for review to the ethics
committee.
Version date:
-1-
Subject’s Initials: ________
HREB Version: June 2014
CHECKLIST
This checklist is to be completed and submitted with this consent form.
It is to be removed from the final version of the consent document.
Most recent version of consent template (June 2014) has been used
Footer includes consent version, study name, line for patient initials
Font size no less than 12 [except for footer]
Left justification of text
Grade 9 or lower reading level. Assessed reading level is: __________
Accepted definitions for specialized terms used where applicable
Plain language principles used for study specific wording – no jargon, no acronyms,
short words, short sentences, active voice and, where appropriate, bulleted lists
Standard, required wording (in bold type) has been used in the following sections:
Yes
No
Introduction
Benefits (Q6)
Liability Statement (Q7)
Privacy and confidentiality (Q8)
Questions or problem (Q9)
Signature page
Signature page for minor/assenting participants if applicable
If you have answered No to any of the above, please give the rationale for these
changes below:
TCPS2 guidelines provide a list of the information required for informed consent. Please refer
to TCPS2, Chapter 3, available at: http://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/chapter3-chapitre3/.
The HREB Policy Manual provides detailed information on specific consent issues including:
consent to research in emergency health situations; the use of substitute decision makers; assent
for children; research involving special populations (children, cognitively impaired); managing
consent in situations of difficult power relationships; and community consent to research
involving Aboriginal communities. Please refer to the HREB Policy Manual on the HREA
website: www.hrea.ca
Version date:
-2-
Subject’s Initials: ________
HREB Version: June 2014
( Insert your letterhead)
Consent to Take Part in Research
TITLE:
INVESTIGATOR(S):
SPONSOR: [if applicable]
You have been invited to take part in a research study. Taking part in this study is voluntary. It
is up to you to decide whether to be in the study or not. You can decide not to take part in the
study. If you decide to take part, you are free to leave at any time. This will not affect your
[Choose one: usual health care/normal treatment; or delete line if not appropriate].
Before you decide, you need to understand what the study is for, what risks you might take and
what benefits you might receive. This consent form explains the study.
Please read this carefully. Take as much time as you like. If you like, take it home to think about for
a while. Mark anything you do not understand, or want explained better. After you have read it,
please ask questions about anything that is not clear.
The researchers will:




discuss the study with you
answer your questions
keep confidential any information which could identify you personally
be available during the study to deal with problems and answer questions
1.
Introduction/Background:
Very briefly give the background to the study and why the study is important to the participant
group, targeted population or the community at large.
2.
Purpose of study:
Briefly describe the objectives or purposes of the study. One sentence will normally suffice.
3.
Description of the study procedures:
Summarize what will happen to a person who takes part in the study in terms of procedures, tests,
etc. which would not be expected in the course of normal patient management or a participant’s
everyday life. These would include filling out questionnaires, taking part in an interview or focus
group, giving a blood or urine sample, having an x-ray, etc.
Version date:
-3-
Subject’s Initials: ________
HREB Version: June 2014
If there are multiple interactions over time, the information can often be presented as a table. The
table outlining visits, telephone calls, etc. should be provided in a separate section immediately
before the signature page.
4.
Length of time:
If relevant, briefly describe how many visits of what length will be required and how long the study will
last [“You will be expected to participate in three interviews over the next six months at a place of your
convenience. Each interview will last 1-2 hours.]
5.
Possible risks and discomforts:
Potential risks of being in the study – physical, emotional, social – should be explained. Bulleted
lists in simple language often suffice. If relevant, risks should be categorized as





very common (1 or more in every 10 people)
common [1 or more in every 100 people)
uncommon (1 or more in every 1000 people)
rare (1 or more in every 10,000 people)
very rare ( less than 1 in every 10,000 people)
Risks may also include those associated with the disclosure of a diagnosis or screening test result in
the case of genetic conditions. If there is potential risk that a participant would be emotionally
disturbed, the investigator must be qualified to deal with this situation or must describe the
procedure for immediately addressing the situation.
6.
Benefits:
It is not known whether this study will benefit you.
7.
Liability statement:
Signing this form gives us your consent to be in this study. It tells us that you understand the
information about the research study. When you sign this form, you do not give up your legal
rights. Researchers or agencies involved in this research study still have their legal and
professional responsibilities.
8.
What about my privacy and confidentiality?
Protecting your privacy is an important part of this study. Every effort to protect your
privacy will be made. However it cannot be guaranteed. For example we may be required by
law to allow access to research records. A copy of this consent will be put in your health
record. If you agree, your family doctor will be told that you are taking part in this study.
The following language is to be used when focus group discussions are planned as part of the study.
Version date:
-4-
Subject’s Initials: ________
HREB Version: June 2014
Protecting your privacy is an important part of this study. Every effort to protect your privacy will be
made. However it cannot be guaranteed. Other people taking part in this focus group may know your
name and hear your comments. All members of the focus group will be reminded to

respect the privacy of each member of the group

treat all information shared with the group as confidential
When you sign this consent form you give us permission to
 Collect information from you
 Collect information from your health record
 Share information with the people conducting the study
 Share information with the people responsible for protecting your safety
Access to records
The members of the research team will see health and study records that identify you by
name.
Other people may need to look at your health records and the study records that identify you
by name. This might include the research ethics board. You may ask to see the list of these
people. They can look at your records only when supervised by a member of the research
team.
Use of your study information
The research team will collect and use only the information they need for this research
study.
This information will include your
(The following is a sample list of what should be included here and must be modified to ensure it
includes all of the information collected in the study)
 age
 sex
 family history
 medical conditions
 medications
 the results of tests and procedures you had before and during the study
 information from study interviews and questionnaires
Your name and contact information will be kept secure by the research team in
Newfoundland and Labrador. It will not be shared with others without your permission.
Your name will not appear in any report or article published as a result of this study.
Information collected for this study will be kept for five years (or fill in the appropriate time).
If you decide to withdraw from the study, the information collected up to that time will
continue to be used by the research team. It may not be removed (or replace with, the
information collected up to that time will be destroyed). This information will only be used
for the purposes of this study.
After your part in this study ends, we may continue to review your health records to check that
the information we collected is correct.
Version date:
-5-
Subject’s Initials: ________
HREB Version: June 2014
Information collected and used by the research team will be stored (name the appropriate
location). (Name the appropriate person) is the person responsible for keeping it secure.
Your access to records
You may ask the study doctor or researcher (indicate as appropriate) to see the information
that has been collected about you.
9.
Questions or problems:
If you have any questions about taking part in this study, you can meet with the investigator
who is in charge of the study at this institution. That person is: XXXXX
Principal Investigator’s Name and Phone Number
Or you can talk to someone who is not involved with the study at all, but can advise you on
your rights as a participant in a research study. This person can be reached through:
Ethics Office
Health Research Ethics Authority
709-777-6974 or by email at [email protected]
10. Declaration of financial interest, if applicable
The investigator, Dr. xxxx is receiving an honorarium for helping to conduct this study.
After signing this consent you will be given a copy.
Version date:
-6-
Subject’s Initials: ________
HREB Version: June 2014
Signature Page
Study title:
Name of principal investigator:
To be filled out and signed by the participant:
Please check as appropriate:
Yes { } No { }
Yes { } No { }
Yes { } No { }
Yes { } No { }
Yes { } No { }
Yes { } No { }
I have read the consent [and information sheet].
I have had the opportunity to ask questions/to discuss this study.
I have received satisfactory answers to all of my questions.
I have received enough information about the study.
I have spoken to Dr. _________ and he/she has answered my questions
I understand that I am free to withdraw from the study
 at any time
 without having to give a reason
 without affecting my future care [student status, etc.]
I understand that it is my choice to be in the study and that I may not benefit.
I understand how my privacy is protected and my records kept confidential
I agree that the study doctor or investigator may read the parts of my hospital
records which are relevant to the study.
I agree to be video/audio taped
I agree to take part in this study.
___________________________________ _____________________
Signature of participant
Name printed
Yes { } No { }
Yes { } No { }
Yes { } No { }
Yes { }
No { }
Yes { }
No { }
_______________
Year Month Day
_
__________________________________ ______________________ ________________
Signature of person authorized as
Name printed
Year Month Day
Substitute decision maker, if applicable____________________________________
__________________________________ ______________________ ________________
Signature of witness (if applicable)
Name printed
Year Month Day
To be signed by the investigator or person obtaining consent
I have explained this study to the best of my ability. I invited questions and gave answers. I believe that
the participant fully understands what is involved in being in the study, any potential risks of the study
and that he or she has freely chosen to be in the study.
___
Signature of investigator
Telephone number:
Version date:
_____________________Name printed
Year Month Day
_________________________
-7-
Subject’s Initials: ________
HREB Version: June 2014
If this is to be printed as a double sided signature page, the parental consent should be on the front and the
minor assent on the back.
Signature Page for Parent/Guardian
Study title:
Name of principal investigator:
To be filled out and signed by the parent/guardian:
I have read the consent [and information sheet].
Please check as appropriate:
Yes { } No { }
I have had the opportunity to ask questions/to discuss this study.
Yes { } No { }
I have received satisfactory answers to all of my questions.
Yes { } No { }
I have received enough information about the study.
Yes { } No { }
I have spoken to Dr. _________ and he/she has answered my questions
Yes { } No { }
I understand that I am free to withdraw my child/ward from the study
Yes { } No { }
 at any time
 without having to give a reason
 without affecting future care
I agree that the research team may audio/video tape interviews.[If applicable]
Yes { } No{ }
I understand that it is my choice for child/ward to be in the study and that he/she
may not benefit.
Yes { } No { }
I agree that the study doctor, the study sponsor or a regulatory agency
Yes { } No { }
may read the parts of my child/ward’s hospital records relevant to the study.
I understand how my child/ward’s privacy is protected and records kept confidential Yes { } No { }
I agree that my child/ward’s family doctor can be notified of participation in this study
I consent for my child/ward
Yes { } No { }NA { }
to take part in this study.
Print Name
Signature of parent/guardian
Name printed
Signature of person conducting
the consent discussion
Name printed
________
Year Month Day
_____________________
Year Month Day
___________________________________________________________________________________
Signature of witness [If applicable]
Name printed
Year Month Day
To be signed by the investigator:
I have explained this study to the best of my ability. I invited questions and gave answers. I believe that
the parent/guardian fully understands what is involved in being in the study, any potential risks of the
study and that he or she has freely chosen for the child/ward to be in the study.
___________________________________
Signature of investigator
Name Printed
Version date:
-8-
_________________________________
Year Month Day
Subject’s Initials: ________
HREB Version: June 2014
To be signed by the minor participant [if appropriate]
Study title:
Name of principal investigator:
Assent of minor participant:
I understand the purpose of this research
I understand that it is my decision to take part in this study. I can stop taking part if I chose.
I understand that taking part in this research may not help me.
I understand that there may be risks to participating in this study.
I agree that I will take part in this study
Signature of minor participant
Year Month Day
Name printed
Age
Version date:
-9-
Subject’s Initials: ________