IRB#
Assent of Child to Participate in a Research Study
NAME OF THE STUDY:
WHY ARE WE DOING THIS STUDY?
We are interested in studying[one or two short sentences]
WHY ARE WE ASKING YOU TO BE IN THIS STUDY?
You are being asked to be in this research study because [state reason simply].
IF YOU AGREE, WHAT WILL HAPPEN?
If you are in this study[state simply what will be done. If there are numerous procedures, set out in separate bullet points]
The Assent Form (if children age 10 and older will be included) must contain the following statement, if pregnancy is an exclusion criterion in the protocol. Delete paragraph if not applicable:
Females cannot be in the study if they are pregnant because they may be putting themselves and their baby at risk. They should not breastfeed a baby while on this study. If you are 12 years or older, or have had a menstrual period, you will be asked for a urine sample for a pregnancy test before and/or during the study. You will be told if you are pregnant. With your permission, your parents or guardians will also be told.
WILL THIS STUDY HURT?
Describe procedures that may hurt or be uncomfortable. For example: The blood testing might hurt a little but not very much. Some groups will have extra sessions for exercise training. This might cause some muscle aches but they should pass as your muscles get stronger. You will be asked to talk about your feelings with other kids your age. This may be difficult but you will never be forced to answer any questions that make you uncomfortable, in your group or on paper forms.
DO YOU HAVE TO BE IN THIS STUDY?
No, you do not have to be in this study. If you want to be in this study, then tell the study doctor. If you don’t want to, it’s o.k. to say no. The doctor will not be angry and will take care of you or members of your family just like before. You can say yes now and change your mind later. It’s up to you.
DO YOU HAVE ANY QUESTIONS?
You can ask questions any time. You can ask now. You can ask later. You can talk to me or you can talk to someone else. If you do not understand something, please ask the doctor to explain it to you again.
Signing your name below means that you want to be in the study.
Signature of ChildDate
version date
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