Minor’s Initials
Institutional Review Board
American University of Beirut
Faculty of Medicine
Bliss Street
Beirut, Lebanon
Tel: (01) 350-000 ext. 5445
CHILD PARTICIPANT ASSENT FORM
(approximate ages 7-12)
[TEXT FOUND THROUGHOUT THIS DOCUMENT IN BOLDFACE AND BRACKETS
OFFERS GUIDANCE AND SUGGESTIONS. DELETE THIS TEXT AND REPLACE IT WITH
THE APPROPRIATE WORDING FOR YOUR PROJECT.]
Project Title:
[Title]
Protocol Number:
Principal Investigator(s):
Address:
Phone:
Site where the study will be conducted:
We want to tell you about a research study we are doing. A research study is a special way to find out
about something. We are trying to find out more about [purpose of study in simple language]. You are
being asked to join the study because [insert the name of medical condition or other reasons for
inclusion].
If you decide that you want to be in this study, this is what will happen. [Describe procedures (blood
withdrawal, giving medications, etc…) in words a child would know and understand Include
number of visits and time frame. For example:
1. Dr. ______ will give you some medicine to take for the next
days. It might be the new
medicine or it might be the medicine that you would get if you weren’t in this research study.
You won’t know which one you get and Dr. ______ won’t know what you get either.
2. We will take some blood from you. We will use a clean needle. We will take the blood from
your arm. We will take about (specify in tablespoons). This is done to find out if the medicine
you are taking is making you better. And even if you don’t want to do the research study,
you are still going to get a needle stick today because you’re sick.]
Can anything bad happen to me?
We want to tell you about some things that might hurt or upset you if you are in this study. [Describe
risks – e.g., painful procedures, other discomforts, things that take a long time. For example: The
needle we use to take the blood may hurt. You might get a bruise on your arm.]
Institutional Review Board
Version # , Date
Protocol #
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Minor’s Initials
Can anything good happen to me?
We don’t know if being in this research study will help you feel better or get well. But we hope to learn
something that will help other people some day.
Do I have other choices?
You can choose not to be in this study
Will anyone know I am in the study?
We won’t tell anyone you took part in this study. When we are done with the study, we will write a report
about what we found out. We won’t use your name in the report.
What happens if I get hurt?
[Describe that the subject’s parents/legal guardians have been given information on what to do if
the subject is injured during the study]
[For treatment studies only:] If you don’t want to be in this study, we will tell you about the other
things we can do for you. Even if you decide not to be in this study, we will still take care of you.
You will receive [payment should be age appropriate such as gift certificates and not cash] for being
in this research study.
Before you say yes to be in this study; be sure to ask Dr. ______ to tell you more about anything that you
don’t understand.
What if I do not want to do this?
You don’t have to be in this study. It’s up to you. If you say yes now, but you change your mind later,
that’s okay too. All you have to do is tell us.
If you want to be in this study, please sign or print your name.
No, I don’t want to do this.
__________________________
Child’s name
___________________
signature of the child
____________
Date & Time
__________________________
Person obtaining Assent
Institutional Review Board
Version # , Date
Protocol #
___________________
signature
____________
Date & Time
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