CHOC/MCHS/UCI VERSION 06-01-2013
ALL SECTIONS OF THE ASSENT ARE REQUIRED UNLESS NOT APPLICABLE TO THE RESEARCH.
LANGUAGE IN GREEN IS TO BE CUSTOMIZED BY THE REVIEWING SITE.
LANGUAGE IN RED IS INSTRUCTIONAL AND IS TO BE REMOVED.
BEFORE FINALIZING & UPLOADING THIS DOCUMENT,
REMOVE THIS BOX, ALL RED INSTRUCTIONAL TEXT & ENSURE ALL FINAL TEXT IS BLACK.
ASSENT TO BE IN A HUMAN RESEARCH STUDY
CHILDREN AGES 7-11
[Title of Study]
[If the study title is overly-technical, consider adding a lay title here]
1. We are doing a research study to learn more about [Complete this sentence using terminology
that children will understand]. We want to see if you would like to be in this study.
2. This study involves: [list in bullets the study procedures that the child will experience, using
terminology that children will understand]
3. Some of the things that happen in this study might hurt or make you feel uncomfortable. [List in
bullets risks and discomforts children might experience in the study, using terminology that
children will understand]
4. If something in the study hurts or makes you feel uncomfortable, it is important to tell us or your
parents.
5. If you are a girl who has had her period (also known as a menstrual cycle) we will ask you to sign
an Assent Addendum for Females. [Include this section if your study involves pregnancy testing.
Also complete the Assent Addendum for Female Minors]
6. We don’t know if being in this study will help you or not. What we learn from this study should
help others in the future. [Describe any possible benefits to the participant, to others or society,
using terminology that children will understand]
7. You can ask questions any time. You can ask now or you can ask later. You can talk to the
researchers, your mom and dad, or you can talk to someone else.
8. You can choose to be in this study or to not be in this study. No one will be mad at you if you
don't want to do this or if you change your mind.
9. You can contact [Researcher(s)] at [phone number] if you have any questions.
Signature of Minor
Age
Date
Printed Name of Minor
Signature of Researcher
Date
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CHOC/MCHS/UCI VERSION 06-01-2013
Printed Name of Researcher
A witness signature is required on this assent form only if: (Researchers: check which one
applies)
The subject has decision-making capacity, but cannot read, write, talk or is blind.
The IRB specifically mandated a witness signature for this study.
The witness must be impartial (i.e. not a member of the subject’s family, not a member of the study
team).
For the witness:
I confirm that the information in this assent form was accurately explained to and understood by the
subject or legally authorized representative and that informed assent was given freely.
___________________________________________________ __________________
Witness Signature
Date
(INSTRUCTION FOR RESEARCHERS: If no witness signature is required, this witness signature
section of the assent form may be left blank).
___________________________________________________
Printed Name of Witness
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CHOC/MCHS/UCI VERSION 06-01-2013
Child Subject's Bill of Rights
The rights listed below are the right of every individual asked to participate in a research study.
You have the right to:
1.
Be told why the research is being done.
2.
Be told about everything that will happen in the study and if there is a drug or device that will be
used.
3.
Be told what bad things may happen.
4.
Be told about any good things that may happen.
5.
Be told about any other choices you have instead of this research and about their good and bad
things.
6.
Be told about how we will take care of you if anything happens to you.
7.
Be encouraged to and given a chance to ask any questions.
8.
Be told that you can stop being in this study at any time without affecting the care you receive.
9.
Be given a copy of this signed and dated form.
10.
Not be pressured (pushed) to be in this study or to choose not to be in this study.
-------------------------------------------------------
If you have any concerns or questions about the research study you should contact the research team or
ask your parents.
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