(use an abbreviated or simplified study title)
Dr. __________† is doing a research study to try and find out how a new medicine works in kids who have (name of condition in common term).† You are being asked if you want to be in this research study because you have (name of condition).
If you decide that you want to be in this research study, this is what will happen to you:
1.†† Dr. ______ will give you some medicine to take for the next 5 days.† It might be the new medicine or it might be the medicine that you would get if you werenít in this research study.† You wonít know which one you get and Dr. ______ wonít know what you get either.†
2.†† You will have to have a needle stick today (like a shot) to take some blood out of your arm.† Dr. _______ has to take some more blood out of your arm in 5 days to find out if the medicine you are taking is making you better.† Even if you donít want to be in the research study, you are still going to get a needle stick today because youíre sick.
3.†† If you arenít getting better after 5 days, Dr. ____________ will (tell them what to † expect such as being given another medicine or other treatment).
Sometimes kids donít feel good after they take the medicine.† You might feel these things:
ō a headache ō get a rash on their skin
ō a headache
ō get a rash on their skin
ō An upset stomach††††††††††††††††††††††††††††
ō Very sleepy†††
If you feel any of these things, be sure to tell your mom or dad.
You donít have to be in this research study if you donít want to.† Nobody will be mad at you if you say no.† Even if you say yes now and change your mind after you start doing this study, you can stop and no one will be mad.
Be sure to ask Dr. ______ to tell you more about anything that you donít understand.
q †††Yes, I will be in this research study.† †† q††††† No, I donít want to do this.
Write your name on this line††††††††††††††††††††††††††††††††††††††††††††††††††††††††††††††††† Date