Script for Informed Assent of Children
(this should be read to the children by the person collecting the data)
I am [name] and this is [name] and we are nursing students are Troy University.[JRM1] We are helping our teachers find out ways to help children be healthier.[JRM2] You can help us [JRM3]with this by being in our study.
First, we have some questions that we would like for you to answer about what you eat and how much activity you do. After you answer the questions we are going to take you to special stations we have set up to measure how healthy you are. At the first station we are going to measure how tall you are and ask you to stand on the scales so we can know how much you weigh. At the second station, we are going to measure the amount of skin you have on the back of your arm and lower leg using a special instrument called calipers [show the children the calipers and demonstrate how they are used]. At the third station, we will check your blood pressure and heart rate to see how strong your heart is. To check your blood pressure, we will place a cuff around the upper part of your arm. The blood pressure machine will pump up a small balloon in the cuff and will slowly let the air out of the balloon. [Show the students the machine and how it works.] At the fourth station, we are going to see how well you can do some simple exercise tests. We will ask you to show us how you can do a partial sit up, how well you can walk and run, and how well you can sit and reach. You may get tired during the exercising. [JRM4] At the last station, we are going to prick your finger to get a few drops of blood. Before we prick your finger, we will wipe it with an alcohol pad and then stick the side of your finger tip with a small needle. This may hurt.[JRM5] After we get the drop of blood, we will ask you to put some pressure on your finger where we made the prick with a small piece of gauze for a few minutes. Then we will put a small Band-Aid on your finger. We will use this sample of blood to measure how much sugar and cholesterol you have.” [JRM6]
Everything should take no longer than 30 minutes.[JRM7] If you are in our study we will give you a copy of your results so you and your parents can see how healthy you are. You will also help us learn how to help other children be healthy.[JRM8]
The only people who will see your results are us, our teachers and your school nurse. Your name will not be on the results that we see. [JRM9]
You do not have to do this and you can stop at any point or at any station along the way without getting into any trouble. If you decide to stop you can go back to your classroom. [JRM10]
Does anyone have any questions?
[JRM1]A statement identifying the researchers and their affiliation with TROY
[JRM2]A statement that the study involves research
[JRM3]An explanation of the purposes of the research
[JRM4]A description of any reasonably foreseeable risks or discomforts to the subject
[JRM5]A description of any reasonably foreseeable risks or discomforts to the subject
[JRM6]A description of the procedures to be followed
[JRM7]The expected duration of the subject's participation
[JRM8]
A description of any benefits to the subject or to others which may reasonably be expected from the research[JRM9]A detailed explanation describing the extentto which confidentiality of records identifying the subject will be maintained.
[JRM10]A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled