Minor’s Initials

Institutional Review Board

American University of Beirut

Faculty of Medicine

Bliss Street

Beirut, Lebanon

Tel: (01) 350-000 ext. 5445

CHILD PARTICIPANT ASSENT FORM
(approximate ages 7-12)

[TEXT FOUND THROUGHOUT THIS DOCUMENT IN BOLDFACE AND BRACKETS OFFERS GUIDANCE AND SUGGESTIONS. DELETE THIS TEXT AND REPLACE IT WITH THE APPROPRIATE WORDING FOR YOUR PROJECT.]

Project Title: [Title]

Protocol Number:

Principal Investigator(s):

Address:

Phone:

Site where the study will be conducted:

We want to tell you about a research study we are doing. A research study is a special way to find out about something. We are trying to find out more about [purpose of study in simple language]. You are being asked to join the study because [insert the name of medical condition or other reasons for inclusion].

If you decide that you want to be in this study, this is what will happen. [Describe procedures (blood withdrawal, giving medications, etc…) in words a child would know and understand Include number of visits and time frame. For example:

1.  Dr. ______will give you some medicine to take for the next 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. We will take some blood from you. We will use a clean needle. We will take the blood from your arm. We will take about (specify in tablespoons). This is done to find out if the medicine you are taking is making you better. And even if you don’t want to do the research study, you are still going to get a needle stick today because you’re sick.]

Can anything bad happen to me?

We want to tell you about some things that might hurt or upset you if you are in this study. [Describe risks – e.g., painful procedures, other discomforts, things that take a long time. For example: The needle we use to take the blood may hurt. You might get a bruise on your arm.]

Can anything good happen to me?

We don’t know if being in this research study will help you feel better or get well. But we hope to learn something that will help other people some day.

Do I have other choices?

You can choose not to be in this study

Will anyone know I am in the study?

We won’t tell anyone you took part in this study. When we are done with the study, we will write a report about what we found out. We won’t use your name in the report.

What happens if I get hurt?

[Describe that the subject’s parents/legal guardians have been given information on what to do if the subject is injured during the study]

[For treatment studies only:] If you don’t want to be in this study, we will tell you about the other things we can do for you. Even if you decide not to be in this study, we will still take care of you.

You will receive [payment should be age appropriate such as gift certificates and not cash] for being in this research study.

Before you say yes to be in this study; be sure to ask Dr. ______to tell you more about anything that you don’t understand.

What if I do not want to do this?

You don’t have to be in this study. It’s up to you. If you say yes now, but you change your mind later, that’s okay too. All you have to do is tell us.

If you want to be in this study, please sign or print your name.

 Yes, I will be in this research study.  No, I don’t want to do this.

______

Child’s name signature of the child Date & Time

______

Person obtaining Assent signature Date & Time

Institutional Review Board

Version # , Date

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