Information sheet children 12-16 years old
[short study title]
Dear……. 
Are you taking part in a study? In this information sheet you can read more about the study and your rights. Read it carefully so that you know what you can decide. You can think carefully before you decide.
Your parents  will also receive information about the study. You can talk to them about the study. Together with them, you will make the decision if you want to take part in the study or not.
Questions andcontact information
Do you have any questions? Talk about them to your parents. Or ask the investigator. 
You can always call/ mail the investigator: [name, optional picture, contact details]. 
Do you want to talk to someone who isn’t involved with the study? Please contact: [name ] [Email/phone].

Space to write down your questions:

Tip: take a snapshot of your questions, so you have them with you when you go talk to the doctor/researcher	

About the study 
This study will be carried out in the [name hospital] / in X hospitals in the Netherlands in X countries. [X – or: approx. 50/100/et cetera] children and/ or young adults are taking part. The study has been reviewed and approved by [name MREC] . 

Why am I being asked to take part in this study?
[insert text, see examples in the guidance]

Background:
[insert text, see examples in the guidance]

How do I take part?
[insert text, see examples in the guidance]

[Table to insert pictures of procedures and devices if necessary].	[Table to insert pictures of procedures and devices if necessary].	
Explanatory caption	Explanatory caption	

About the medicinal product/the treatment [only if applicable]
[insert text, see examples in the guidance]

Discomforts
[insert text, see examples in the guidance]

Other than usual [only if applicable]
[insert text, see examples in the guidance]

Important to know:
•	[insert text, see examples in the guidance]
•	[insert text, see examples in the guidance]

Pros and cons:
•	[insert text, see examples in the guidance]
•	[insert text, see examples in the guidance]

Compensation
•	[insert text, see examples in the guidance]

Your rights
Do I have to take part in the study?
No, you can choose if you want to take part in the study or not. If you do not want to take part, you don’t have to, even if your parents would like you to. If you do decide to take part in the study, you sign the form. Even if you have started the study, you can change your mind at any time. You just have to tell the investigator you want leave the study. You don’t have to give a reason. 
[complete if applicable, see example texts in the guidance]

Withdraw permission
If you want to leave the study, you tell the investigator. This is called: withdrawing your permission. The information collected, will still be used for the study.  

Your details
 [adapt and complete text if applicable, see example texts in guidance]
For the study we need:
•	Personal details = information on who you are, e.g. your date of birth and where you live.
		
•	Medical data = (also a kind of personal details) information on your health, e.g. whether you are ill and if you use medication.
		
•	Your ‘blood, bone marrow, cerebrospinal fluid, stool, etc.’.[if applicable; adapt picture if needed]		
These three things are needed to carry out het study. Your parents or guardian will give us permission to make use of these data for the study. Would you like to know exactly what we do with your information? Ask your mum and dad, their information sheet provides details on this matter. You can also ask the investigator. 

Insurance [if applicable]
[insert text, see examples in the guidance]

Your decision
The form
Do you want to take part in the study? Please sign the consent form. We also need a signature from your parents or guardian.
[If applicable] You may also decide if give us permission to approach you for a follow-up study. Later on, we will give information about the new study, so you can decide if you want to take part or not.

More information?

Would you like to know more?

Please consult www.kindenonderzoek.nl

Op deze website staat ook de strip ‘Anne en de Groeneneuzengriep’ over onderzoek.

[invoegen welke termen/hoofdstukken van toepassing zijn voor de studie]

Annexes: [complete if applicable]
A.	Contact details 
B.	Overview of the study [if applicable]
C.	Consent form

Annex [X] Consent form:
-	I have understood the information. I was able to ask questions. My questions have been answered.
-	I was allowed sufficient time to decide whether or not to take part in the study.
-	I know that I do not have to take part in the study.
-	I understand that I can always change my mind and leave the study, if I wish to do so. 
-	I 	□ give 	□ do not give	permission to approach me for a follow-up study 

-	I 	□ do 	□ do not want to know which treatment I have had/ to which group I was assigned.	

I want to take part in this study.
Name participant:				
Signature:							Date	: __ / __ / __

Investigator’s statement:
I, the undersigned, have fully explained the details of the study to the participant named above
If any information becomes known during the study that could influence the subject's consent, I will inform him/her in time. 
Name  investigator (or the investigator’s representative)
Signature:							Date: __ / __ / __
-----------------------------------------------------------------------------------------------------------------
<if applicable> Additional information has been given by: 
Name:
Job title:
Signature:							Date: __ / __ / __
The subject is given a full information letter together with a signed version of the consent form.