CHOC/MHS/UCI VERSION 06-01-2013
ALL SECTIONS OF THE ASSENT ARE REQUIRED UNLESS NOT APPLICABLE TO THE RESEARCH.
THE ASSENT ADDENDUM FORM: 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 FORM ADDENDUM FOR FEMALE MINORS
CHILDREN AGES 7-11
[Title of Study]
[If the study title is overly-technical, consider adding a lay title here]

This form is for all girls in this study who have reached puberty (have started their period).

Girls who have had their period are able to become pregnant (have a baby).

You cannot be in this study if you are pregnant or breast-feeding because there could be more
risks to you and the baby.

You will have a pregnancy test before you begin this study. If the test shows that you are
pregnant, you cannot participate in this study.

You will have some of your [specify: blood and / or urine] collected at different times in the study
to test for pregnancy.

If you are sexually active, you must agree to use an approved method of birth control during the
study. Your study doctor or nurse will discuss acceptable methods of birth control with you such
as a condom or a pill that prevents pregnancy. If you are having sex, but are not sure if the type
of sex that you are having can cause you to have a baby, you can ask the study doctor to explain.
You can also ask the study doctor about other ways to prevent pregnancy.

If you think that you might be pregnant, you must stop using the study medicine immediately, and
you must notify the study doctor or the study team.

You can ask questions any time. You can ask now or you can ask later. You can talk to the
study doctor, your mom and dad, or you can talk to someone else on the study team.

You do not have to be in the study even if you have already signed the main study Assent Form.

No one will be mad at you if you don't want to take the pregnancy test. If you don’t take the
pregnancy test, you cannot be in this study.

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.
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CHOC/MHS/UCI VERSION 06-01-2013
Per California Law, pregnancy test results will be provided to your parent or guardian only with
your permission.
The study doctor will not discuss the results of your pregnancy test with your parent or guardian unless
you say it is ok by providing your initials below:
If you agree that it is o.k. for the study team to give your pregnancy test results to your parent or
guardian, please provide your initials here: _________
If you do not want the study team to give your pregnancy test results to your parent or guardian,
please provide your initials here: _________
Signature of Minor
Age
Date
Printed Name of Minor
Signature of Researcher
Date
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 assent was given freely.
___________________________________________________
Witness Signature
__________________
Date
(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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