UCI IRB USE ONLY: Assent Addendum v. May 2011
IMPORTANT: ALL SECTIONS ARE REQUIRED UNLESS OTHERWISE NOTED. BEFORE
FINALIZING & UPLOADING THIS DOCUMENT, REMOVE: THIS SECTION, ALL [RED
INSTRUCTIONAL TEXT] AND BLUE EXAMPLES.
UNIVERSITY OF CALIFORNIA, IRVINE
ASSENT ADDENDUM FOR FEMALE MINORS
[Title of Study]
[If the study title is overly-technical, consider adding a lay title here]
RESEARCH TEAM
Lead Researcher:
Name and Title
Department
Telephone number and e-mail address
24 Hour Telephone number [Required for medical studies and clinical investigations]
Faculty Sponsor [If not applicable, please remove]
Name and Title
Department
Telephone number and e-mail address
Other Researchers [If not applicable, please remove]
[List only those researchers qualified to be involved in the informed consent process
STUDY LOCATION(S):
WHAT IS THE PURPOSE OF THIS ADDENDUM?
This form is being given to all girls in the study who have reached puberty (have started their period),
whether or not they are sexually active.
You are being asked to sign this additional form because you are a girl who has had your period (this
is also called a menstrual cycle). Girls who have had their period and are having sex are able to
become pregnant (have a baby).
Because of the possible risk related to this research study, you cannot participate in this study if you are
pregnant or breast-feeding. 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.
WHAT ARE THE ADDITIONAL STUDY PROCEDURES FOR FEMALE MINORS?
If you and your parent(s)/legally authorized representative decide to participate in this study, you will
have some of your [specify: blood and / or urine] collected at different times in the study for the
purposes of pregnancy testing. This is because this study involves [specify: medications and / or
procedures] that can harm an unborn baby.
(Revise the following text as applicable)
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
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UCI IRB USE ONLY: Assent Addendum v. May 2011
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.
WHAT IF YOU HAVE QUESTIONS?
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.
DO YOU HAVE TO BE IN THE STUDY?
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. If you don't want to be in this study, you just have to tell the study
doctor. If you want to be in the study, you just have to tell them. You can say yes now and change your
mind later. It is up to you to decide.
WHAT WILL HAPPEN TO YOUR PREGNANCY TEST RESULTS?
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)
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UCI IRB USE ONLY: Assent Addendum v. May 2011
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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