(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 weren’t
in this research study. You won’t know
which one you get and Dr. ______ won’t 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 don’t want to be in
the research study, you are still going to get a needle stick today because you’re
sick.
3. If you aren’t getting better after 5 days,
Dr. ____________ will (tell them what to expect
such as being given another medicine or other treatment).
Sometimes
kids don’t feel good after they take the medicine. You might feel these things:
Ø a headache Ø get a rash on their skin
Ø An upset stomach
Ø Very sleepy
If you feel any of these things, be sure to tell your
mom or dad.
You don’t have to be in this research study if you
don’t 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 don’t understand.
q Yes, I will be in this research study. q No, I don’t want to do this.
_____________________________________________ ____________
Write your name on this line Date