Download Consent Form Template - Health Research Ethics Authority

April, 2009
How to Use the Consent Template

Read the Guidelines for Consent Forms found on the HREA website:
www.hrea.ca

Required language given in bold type must not be substituted without the permission of the HREB.

Directions in red type must be replaced with study specific language and acceptable wording and the red
type deleted. Ensure that guidance/directions in red font have been deleted from the consent form prior
to submission to the ethics committee.

Red Italics sections are to be deleted if not relevant to protocol.
After modifying these areas, font color should be changed to black, without italics, and bold
(except headings).
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 (April 2009 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 must be used where applicable.
Plain language principles must be 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
Responsibilities (Q12)
Withdrawal from study (Q13)
New information (Q14)
Compensation & Injury (Q15)
Privacy and confidentiality (Q16)
Rights (Q17)
Financial interest (Q18)
Questions or problems (Q19)
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:
Consent version:
Study name:
-1-
Patient Initials: ________
April, 2009
(letterhead)
Consent to Take Part in a Clinical Trial
TITLE:
PROTOCOL TITLE:
Study Doctors:
Phone number:
SPONSOR:
Part A: General information
Introduction
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].
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
We do not know if taking part in this study will help you. You may feel better. On the other hand, it
might not help you at all. It might even make you feel worse. We can’t always predict these things. We
will always give you the best possible care no matter what happens.
You cannot take part in this research study if you are:
 Taking part in another drug study at this time
 If you have finished another drug study in the last 30 days (unless otherwise stated in protocol)
 If you have been in another research study in the last year you should tell the study doctor.
Consent version:
Study name:
-2-
Patient Initials: ________
April, 2009
Part B. Explaining this trial
1.
Why am I being asked to join this study?
Give a brief statement of why this particular person was considered as a possible candidate for the
trial.
2.
What is being tested?
Briefly describe the drug, device or procedure indicating whether it is experimental and/or
approved by FDA and/or Health Canada (if applicable) and give the number of people who, to
date, have been exposed to the item being evaluated.
3.
How many people will take part in this study?
Briefly describe, usually in one sentence, where the study is being done, e.g. Newfoundland,
Canada, North America, world-wide and how many people are expected to take part in total and
locally.
4.
What is the purpose of this study?
Briefly describe the objectives or purpose of the study. One sentence will normally suffice.
5.
How long will I be in the study?
Briefly summarize in one or two sentences, how many visits will be required, how long the visits
will last, and the duration of the study. [Example: “You will be expected to come to the clinic for
20 visits over the next 24 months. Each visit will last 1-2 hours.”]
6.
How is the trial being done?
Briefly describe the design of the trial including randomization, blinding and unblinding
procedures as applicable. [Examples: “You will be assigned like the flip of a coin...”; “1 in 3 or 2
in 3 persons in the trial will receive the study drug.”; “neither you nor your doctor will know
which drug you are receiving”; “your doctor will be given this information if it is required.”]
7.
What will happen if I take part in this trial?
Summarize what will happen to a person who takes part in the study.
 Procedures, tests, etc. which would not be expected in the course of normal patient
management.
 Any audio or videotaping
 Any photography
Consent version:
Study name:
-3-
Patient Initials: ________
April, 2009
Details of procedures (e.g., an explanation of heart monitoring or ultrasound, etc.) and the
schedule of visits should be put in the form of a grid immediately after the signature page. An
example of a grid is given below:
Screening visit
1st visit: Jun 1
2nd visit: Aug 1
3rd visit: Nov 1
4th visit: Feb 1
8.
Questionnaire
Blood test
Urine test
Physical exam
Questionnaire
Blood test
Blood test
Questionnaire
Blood test
CT scan
Questionnaire
Blood test
Are there risks to the study?
To date, (insert number) people have taken this drug. Below is a list of side effects seen in this
group. It is important to remember that there may be side effects that are not known at this time.
Potential risks of being in the study – physical, emotional, social – should be explained. Bulleted
lists in simple language often suffice. 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)
When relevant, explain the ramifications of potential harms, e.g. abnormal liver function, and
whether they are reversible.
9.
What About Pregnancy and Breast feeding?
The following is an approved statement on pregnancy and breast feeding for female participants.
If you require a statement to address male issues, samples are available on the HREA website.
There may be unknown risks or side effects to a fetus or nursing child.
You should not become pregnant or breast-feed while taking part in this study.
If you chose to take part and if you are able to become pregnant
 You will be required to provide a blood and/or a urine sample(s) for a pregnancy test (s).
 You will be required to use a reliable form of birth control. The doctor will discuss this
with you.
Consent version:
Study name:
-4-
Patient Initials: ________
April, 2009
If you become pregnant while taking part in this study or within 30 days of stopping the study
drug
 You must notify the doctor immediately.
 If you are taking study drug, it will be stopped immediately.
 The doctor will tell the sponsor. They may want to know the outcome of your pregnancy.
10.
Are there other choices?
Briefly outline the usual management options for those who decide not to enter the study including
whether the drug is available outside the trial.
11.
What happens at the end of the study?
Choose one of the following statements that best applies to what participants can expect at the end
of this study
 At the end of this study this drug may not be available to you because the research will not be
complete.
OR
 At the end of this study the sponsor may provide the drug free of charge for a limited time.
However, at the end of that time you will be expected to pay for the drug as you usually do.
OR
 At the end of this study you will be expected to pay for the drug as you usually do.
12.
What are my responsibilities?
If you take part in this study you will be expected to:
 come to all visits as planned
 follow the directions of the study doctor
 report all medications that you are taking or plan to take
 report any changes in your health
 report any problems you think might be related to taking part in the study
13.
Can I be taken out of the trial without my consent?
Yes. You may be taken out of the study at any time if:
 the drug does not work for you
 you do not follow the directions of the study doctor or research nurse
 if your study doctor feels side effects are harming your health
 there is new information which shows being in this study may not be in your best interest
 you become pregnant
 (sponsor) or Health Canada or the ethics committee or your study doctor decides to stop
the study
14.
What about new information?
Consent version:
Study name:
-5-
Patient Initials: ________
April, 2009
It is possible that we will get new information about a new treatment while you are in the study.
You will be told about any new information that might affect your health or willingness to stay in
the study. You will be asked whether you want to continue taking part in this trial.
15.
Will it cost me anything?
Compensation
You will not be paid to be in the study. You may get a small amount of money to cover expenses
for study visit days. Please bring your receipts with you. There is no charge for the study
(drug/device/procedure as applicable) or for any tests. You may have to pay for other drugs
(depending on your drug plan) such as those prescribed to treat or prevent side effects.
Research Related Injury
If you become ill or injured as a direct result of taking part in this study, medical care will be
available at no additional cost to you.
OR (for Phase IV Post-Marketing Studies) if applicable
The medicine you will take in this study has already been approved for use in Canada. In the event
that you suffer injury as a direct result of taking part in this study, normal legal rules on
compensation will apply.
16.
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.
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 study doctor and 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 record and study records and information that
identify you. This might include
 people and companies working for and/or with the sponsor in and outside of Canada.
(You may ask to see the list of persons working with the sponsor)
 the research ethics board for quality purposes
 Health Canada
 Food and Drug Administration, (FDA) from the USA (if applicable)
 Other regulatory authorities located outside of Canada (if applicable)
Consent version:
Study name:
-6-
Patient Initials: ________
April, 2009
They can look at your records only when one of the research team is present.
Use of your study information.
The research team will collect and use only the information they need to judge the safety and
usefulness of the (drug, device /procedure – chose the appropriate option). The research team will
disclose your information to the sponsor of this study. The sponsor and companies working with
or for the sponsor will use information about you collected from this study only for scientific
research and drug development purposes.
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)
 date of birth
 sex
 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 kept as long as required by law. This could be 25 years or
more.
If you decide to withdraw from the study, the information collected up to that time will continue to
be used by the sponsor. It may not be removed.
After your part in this study ends, we may continue to review your health records. We may want
to follow your progress and to check that the information we collected is correct.
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 have the right to see the information that has been collected about you.
If the study is ‘blinded’, you cannot see this information until the study ends. This is to prevent either
you or your doctor from knowing which study treatment you received until the results are reported. (If
this study is not a blinded study please remove the reference to blinding i.e. everything after the first
statement)
17.
What are my rights?
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
Consent version:
Study name:
-7-
Patient Initials: ________
April, 2009
rights. Researchers or agencies involved in this research study still have their legal and
professional responsibilities.
You can talk to someone who is not involved with the study at all. They can tell you about your
rights as a participant in a research study. This person can be reached through:
Office of the Health Research Ethics Board (HREA) at 709-777-6974
Email: [email protected]
18.
Declaration of financial interest
The investigator, Dr (Insert name) and the research staff will be paid by the sponsor for their
work on this study. The sponsor will be paying for all the costs of conducting this study. There will
be no charges to your private insurance or to MCP.
19.
What about questions or problems?
If you have any questions about taking part in this study, you can ask your doctor. You can also
meet with the doctor who is in charge of the study here at this institution. That person is:
Insert Study Doctor’s Name and Phone Number
After you have signed this consent form, you will be given a copy.
Consent version:
Study name:
-8-
Patient Initials: ________
April, 2009
Signature Page
Study title:
Name of principal investigator:
To be filled out and signed by the participant:
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
I agree that the research team may audio/video tape our interviews.[If applicable]
I understand that it is my choice to be in the study and that I may not benefit.
I agree that the study doctor, the study sponsor or a regulatory agency
may read the parts of my hospital records relevant to the study.
I understand how my privacy is protected and my records kept confidential.
Please check as appropriate:
Yes { } No { }
Yes { } No { }
Yes { } No { }
Yes { } No { }
Yes { } No { }
Yes { } No { }
I agree to take part in this study.
Yes { } No { }
Yes { } No { }
Yes { } No { }
Yes { } No { }
Yes { }
No { }
_________________________________________________________________________________
Signature of participant
Name printed
Year Month Day
_________________________________________________________________________________
Signature of person authorized
Name printed
Year Month Day
as substitute decision maker [If applicable]
_________________________________________________________________________________
Signature of person conducting
Name printed
Year Month Day
the consent discussion
_________________________________________________________________________________
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
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
Name Printed
Year Month Day
Consent version:
Study name:
-9-
Patient Initials: ________
April, 2009
Telephone number:
Consent version:
Study name:
_________________________
-10-
Patient Initials: ________
April, 2009
Please delete this page if not applicable.
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 Minor Participant
Study title:
Name of principal investigator:
To be filled out and signed by the parent/guardian:
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 my child/ward from the study
 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]
I understand that it is my choice for child/ward to be in the study and that he/she
may not benefit.
I agree that the study doctor, the study sponsor or a regulatory agency
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
I consent for my child/ward
Yes { } No{ }
Yes { } No { }
Yes { } No { }
Yes { }
No { }
to take part in this study.
Print Name
Signature of parent/guardian
________
Year Month Day
Name printed
Signature of person conducting
the consent discussion
Name printed
_____________________
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
Consent version:
Study name:
-11-
_________________________________
Year Month Day
Patient Initials: ________
April, 2009
Telephone number:
Consent version:
Study name:
_________________________
-12-
Patient Initials: ________
April, 2009
To be signed by the minor participant [if appropriate]
Study title:
Name of principal investigator:
Assent of minor participant):
Signature of minor participant
Year Month Day
Name printed
Age
Consent version:
Study name:
-13-
Patient Initials: ________