Informed Consent Template Instructions (delete this section and the other instructions/options
throughout this document before finalizing your consent form):
1. You may use this template or any other format as long as you cover all elements
listed on the Informed Consent Checklist.
2. If you choose to use this template, you do not have to submit the Informed Consent
Checklist to the IRB.
3. Write in language appropriate to the subjects you are studying. Use lay terms. Use
appropriate size font for special populations (elderly).
4. Please leave enough of a margin on the bottom of the page to allow for the IRB’s
official approval stamp. You must use the stamped copy when you make copies for
the subjects to sign so that you can show you used the version approved by the IRB.
5. If this is a multi-phase study where subject involvement may change or confidential
information may be handled differently as the study progresses, you may use one
consent form as long as you fully describe how things will change for each phase.
Consent to Participate in a Research Study
(Title of the Study Here)
What Is The Research About?
You are being invited to take part in a research study about ____________. If you take
part in this study, you will be one of about _______ people to do so.
Who Is Doing The Study?
The person in charge of this study is ___________ (PI) of the University of North
Carolina Wilmington. If the researcher is a student, add the following statement. UNCW
student, ___________ , will be gathering and analyzing the information for the study. If
relevant, add the following statement. There may be other people on the research team
assisting at different times during the study. If there will be student research assistants,
state this here.
Do Any Of The Researchers Stand To Gain Financially Or Personally From This
Research?
This research is being funded by ______________ (if applicable, name of funding
agency). None of the researchers participating in this study stand to gain financially or
personally. (If any of the researchers stand to gain financially or personally, other than
the grant award, explain the gain.)
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What Is The Purpose Of This Study?
Describe the purpose of the study.
By doing this study we hope to learn__________.
Where Is The Study Going To Take Place And How Long Will It Last?
The research procedures will be conducted at ________ (state the general facility, such
as UNCW). You will need to come to ___________ (state where the research will be
conducted, including building and room number) ________times during the study. Each
visit will take about ______ hours/minutes. The total amount of time you will be asked
to volunteer for this study is _______ minutes/hours over the next ______
days/weeks/months.
What Will I Be Asked To Do?
Describe all procedures in lay language, using simple terms and short sentences. Include
a time line for procedures that involve more than one visit.
If using randomization, describe this in lay terms. For example, “This is like tossing a
coin to determine who will be in which group.”
If subjects will be audio or videotaped, describe what will be involved, how tapes will be
stored, who will have access to them, and when they will be destroyed.
Are There Reasons Why I Should Not Take Part In This Study?
Only include this section if relevant.
State in lay language reasons why a subject could be excluded from the study. If your
study includes the administration of any substance other than wholesome food, you must
include the following statement. You may not participate in this study if you are pregnant
or if you think you may be pregnant.
What Are The Possible Risks And Discomforts?
If the research involves no more than minimal risks to the subject, include the following
statement. To the best of our knowledge, the things you will be doing have no more risk
of harm than you would experience in everyday life.
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If the research involves any procedures that could cause possible physical harm, describe
the risks in lay terms.
If the research involves any procedures that could cause possible emotional or mental
harm, include the following statement. Although we have made every effort to minimize
this, you may find some of the questions we ask (or some procedures we ask you to do)
to be upsetting or stressful. If so, we can tell you about some people who may be able to
help you with these feelings.
If relevant, include the following statement. In addition to the risks listed above, you (or
your embryo or fetus if you become pregnant) may experience a risk or side-effect that
we cannot predict. During the course of this research, if we find out any new reason why
you may no longer wish to participate, we will provide you with that information.
Will I Benefit From Taking Part In This Study?
You will not get any personal benefit from taking part in this study.
Do I Have To Take Part In This Study?
If you decide to take part in the study, it should be because you really want to volunteer.
There will be no penalty and you will not lose any benefits or rights you would normally
have if you choose not to volunteer. No one on the research team will behave any
differently toward you if you choose not to participate in the study. You can stop at any
time during the study and still keep the benefits and rights you had before volunteering.
What Will It Cost Me To Participate?
There are no costs associated with taking part in this study.
Will I Receive Any Payment Or Reward For Taking Part In This Study?
You will not receive any payment or reward for taking part in this study.
OR
You will receive ______ for taking part in this study. If you should have to stop
participating before the study is over, you will be paid based on the amount of time you
were in the study or you will still receive the full amount, the gift certificate, etc.
Who Will See The Information I Give?
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Your information will be combined with information from other people taking part in the
study. When we write up the study to share it with other researchers, we will write about
the combined information. You will not be identified in any published or presented
materials (optional statement: unless you have specifically given me permission to
identify you).
If the study is anonymous, with no identifying characteristics linked to the information
gathered in any way, include the following. This study is anonymous. That means that no
one, not even members of the research team, will know that the information you gave
came from you.
If the study is confidential, with names linked to the information gathered, include the
following. We will make every effort to prevent anyone who is not on the research team
from knowing that you gave us information or what that information is. Describe in
simple terms the effort you are making to protect the confidentiality of the information,
for example, names being kept separate from information, assigning ID numbers with
lists linking names and ID numbers kept in a locked file cabinet, information linked to
names kept in a locked file cabinet.
However, there are some circumstances in which we may have to show your information
to other people. We may be required to show information that identifies you to people
who need to be sure that we have done the research correctly, such as the UNCW
Institutional Review Board and (if relevant) the research funding agency. If relevant,
include the following statement. Moreover, the law may require us to show your
information in court, or to tell authorities if you have abused a child or are a danger to
yourself or others.
Can My Taking Part In The Study End Early?
If you decide to take part in the study you still have the right to decide at any time that
you no longer want to continue. There will be no penalty and no loss of benefits or rights
if you stop participating in the study. No one on the research team will behave any
differently to you if you decide to stop participating in the study.
If relevant, add the following statement. We will notify you if you should no longer
participate in this study.
What Happens If I Get Hurt Or Sick During The Study?
Only include this section if relevant.
For research involving more than minimal risk, include the following. If you believe you
are injured because of something that is done during the study, you should call ________
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(PI) at _______ (phone number) immediately. We will make sure you receive any
needed care or treatment. However, it is important for you to understand that the
University of North Carolina Wilmington will not pay for the cost of any care or
treatment that might be necessary because you get hurt or sick while taking part in this
study. That cost will be your responsibility.
What If I Have Questions?
Before you decide whether or not to participate in the study, please ask any questions that
come to mind now. Later, if you have questions about the study, you can contact the
investigator, _________ (PI) at ________ (phone number). If you have any questions
about your rights as a research participant, contact Dr. Candace Gauthier, Chair of the
UNCW Institutional Review Board, at 910-962-3558.
What Else Do I Need To Know?
I am required by federal law to provide you with a copy of this informed consent form.
Other optional statements:
You may request a copy of the project summary or final report.
Research Participant Statement and Signature
I understand that my participation in this research study is entirely voluntary. I may
refuse to participate without penalty or loss of benefits. I may also stop participating at
any time without penalty or loss of benefits. I have received a copy of this consent form
to take home with me.
___________________________________
Signature of person consenting to take part
in the study
________________
Date
___________________________________
Printed name of person consenting to take
part in the study
___________________________________
Name of person providing information to
the participant
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________________
Date