[NOTE: Text that appears in BLUE is "help text" and will NOT be included in the printed ICD!]

[The consent form heading should reference the names of only those institutions that are participating in the protocol.  DELETE the institutions that are NOT involved in the research.]

 [Use this form for children ages 7-12, or older children who have the mental abilities of a 7-12 year old.  The language must be written at a 1st or 2nd grade level.]

Title of Study:[Include the exact title of the protocol.  Exceptions require CCI approval.  If you are NOT using the exact title, provide justification for the changes when submitting your CCI Research Application.]    

Principal Investigator (Researcher): [Enter PI’s name here.] 

Phone Number of Investigator: [Enter phone number (including area code) of PI here.  Use a number that has frequent monitoring to ensure that messages will be returned in a timely manner.]  

Purpose: (Why are you here?) [In VERY simple terms, give the purpose of the study here.] 

[Sample language for a drug study.  MODIFY or REPLACE as required for your protocol.]You are not feeling well and we want to help find out more about your sickness and help us understand which medicine may help you and other children feel better.
Procedures: (What will happen?)[Explain in simple language what tests or procedures will be performed.] 

[Sample language for a drug study.  MODIFY or REPLACE as required for your protocol.]We will give you some medicine to take at home.  We ask you to come back to see the doctor one time each week for the next eight weeks.  When you come back, the doctor will take some of your blood, about ½ teaspoon.   The doctor will clean you arm and stick your arm with a needle. The doctor or nurse may ask you to pee into a cup so that we can test your urine. You may also be asked some questions about how you feel.

Risks: (Will it hurt?)[Inform the child if there may experience pain, discomfort, uncomfortable feelings, etc.]

[Sample language for a drug study.  MODIFY or REPLACE as required for your protocol.]No, the test is safe and does not hurt. OR,  Yes, the needle stick may hurt a little.  OR,  The questions may make you sad or embarrass you. 

Benefits: (How may it help you?)[Explain if there is or is not any direct benefit to the child. If there is no direct benefit, this must be stated in the first sentence.]

[Sample language for a drug study.  MODIFY or REPLACE as required for your protocol.]The research study may help you feel better.  Also, the information the researchers learn may help other children in the future.

Alternative Procedures: (Can you say "No"?)[Explain what the child’s alternatives may be.]

[Choose one or more of the following as applicable:]
[Sample language for studies which involve tests.  Insert the name of the test between the words “the”  and “if”.]
Yes.  You do not have to do the  if you do not want to. 
[Sample language for most studies.]You can stop at any time you want.
[Sample language for questionnaire studies.]You do not have to answer any question that makes you feel uncomfortable or sad. 
[Sample language.  Include in assent documents.]No one will be upset with you if you say “no” or if you say “yes” and then change your mind.

You have been told about the research study.
You have been told what you have to do.
You have been told that you do not have to do any of the tests if you do not want to.
You have also been told that you can stop any time you want, even after you begin.

The signature section is specially formatted - please do not modify.

Name of Child   Signature of Child   Date
Name of Parent or Guardian   Signature of Parent or Guardian   Date
Name of Person Conducting the Informed Consent Process   Signature of Person Conducting the Informed Consent Process   Date