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THE TEXT IN RED IS FOR GUIDANCE. DELETE OR REPLACE RED TEXT BEFORE SUBMITTING THE FINAL VERSION WITH THE IRB APPLICATION. THE FINAL VERSION SHOULD NOT HAVE ANY RED TEXT.
California State University, Long Beach ()
SAMPLE ASSENT FORM FOR CHILDREN 7 TO 12 YEARS THAT IS
REQUESTED AFTER PARENTAL/GUARDIAN PERMISSION IS OBTAINED
Assent to be in a Research Study for Children 7-12 Years of Age
[INSERT STUDY TITLE]
PROVIDE THE ASSENT FORM TO THE CHILD. TELL THE CHILD YOU WILL READ THE FORM OUTLOUD AS THEY CAN READ ALONG SILENTLY.
Hello, [Introduce yourself and your affiliation with ] why do you think I am meeting and talking with you?
I want to tell you about a research study I am doing. A research study is when a person called an investigator collects information to learn more about something. An example of a research study is collecting information about how often teachers catch colds. I am doing a research study to learn more about kids [describe study population] and [briefly describe research topic]. After I tell you about it, I will ask if youd like to be in this study. Your [reference the parent/guardian who gave permission] said it was okay for me to ask you to be in the study.
Why am I doing this study?
I am doing this study to find out about [research topic], so I am getting information from lots of kids like you [describe inclusion criteria for study such as age range or grade or school].
There will be about [Approximate number] kids in the study.
What will happen to you if you are in this study?
If you say yes to be in the study, these activities will happen: [Describe study activities in meaningful terms, if there will be photos, video or audio recording. Describe if photos, video or audio recording are optional or required.]
Will anything good happen for me by being in the study?
[Describe any direct benefits or indirect benefits]
IF NO COMPENSATION/INCENTIVES ARE OFFERED DELETE THE ITEM BELOW AND STATE THAT YOU WILL NOT GET ANYTHING FOR BEING IN THE STUDY
Will you get anything for being in the study?
If you finish the study, you can get [describe any compensation/incentives, value, when given out, etc.]
Do you have any questions?
You can ask me questions any time during the study. You can ask now. You can ask me later. You can talk to me, or you can talk to someone else working on the study.
Do you have to be in this study?
No, you dont have to be in the study. No one will be mad at you if you dont want to do this. If you start the study and you want to stop, just tell me or [your parent/guardian]. If you say yes or say no to being in the study, it wont affect your grades.
Do you have any more questions about the study?
Do you want to be in this study?
If you dont want to be in this study, just tell me no.
CHOOSE ONE OF THE TWO OPTIONS BELOW FOR OBTAINING CHILD ASSENT
**
SIGNATURE OF CHILD IS NOT REQUIRED, BUT DOCUMENTATION OF ASSENT IS REQUIREDEITHER WITH THIS FORM OR ON THE PARENTAL PERMISSION FORMINDICATING THE CHILD HAS BEEN GIVEN ABOVE INFORMATION AND HAS VERBALLY AGREED TO TAKE PART IN THE STUDY.
Option 1: If childs assent will be documented on the Parental Permission form delete the SIGNATURE OF PERSON CONDUCTING ASSENT DISCUSSION section below.
Option 2: If assent will be documented on this assent form, keep the SIGNATURE OF PERSON CONDUCTING ASSENT DISCUSSION section below.
SIGNATURE OF PERSON CONDUCTING ASSENT DISCUSSION
I have explained the study to ______________________ (print name of child here) in language he or she can understand, and the child has agreed to be in the study.
[If photos, audio/video recording are optional include the child/s choices below.]
Is it okay for [PI name] to take pictures of you for this study? Yes & N o &
I s i t o k a y f o r [ P I n a m e ] t o a u d i o - r e c o r d y o u f o r t h i s s t u d y ? Y e s & N o &
I s i t o k a y f o r [ P I n a m e ] t o v i d e o - r e c o r d y o u f o r t h i s s t u d y ? Y e s & N o &
O b t a i n i n g t h e c h i l d s s i g n a t u r e , p r i n t e d n a m e o r m a r k i s o p t i o n al.
Name of Child
Signature or mark of ChildDate
By signing this form, you are agreeing that your questions about the study have been answered and you agree take part in this study.
OR
I have explained the study to ______________________ (print name of child here) in language he or she can understand, and the child has DECLINED to be in the study.
____________________________________________
Print Name of Person Conducting Assent Discussion
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