Assents for children

YOUNGER AND OLDER CHILD VERSIONS

Although there are very formal requirements for the elements that must be present in a consent form, no such requirements exist for assents. This means that the investigator can propose assent content that they believe will best inform the child participants about the study. The length of the assent form should be proportional to the complexity of the study and the age of the participants.

Below are two templates that may be used as a basis of developing an age appropriate assent. The first is more suitable for a younger child. The second may be more suitable for an older child.

Replace the red text with language/content applicable to your study.

Example #1 – Younger Child Assent

Title of Study:

Principal Investigator(s):	Supervisor (if applicable):

Contact Information:	Contact Information:

I want to tell you about a research study I am doing. A research study is a way to learn more about something. I would like to find out more about [insert topic and describe goals in simple language]. You are being asked to join the study because [describe the reason(s) for inclusion].

If you agree to join this study, you will be asked to [describe activities, (e.g., questionnaires, interview) in words a child would know and understand. Also include the number of interactions / time frame in words easily understood by a child].

Describe possible risks (e.g., discomforts) in simple language.

Use any of the following statements that are appropriate:

I do not know if being in this study will help you.

I expect that the study will help you by [describe how].

I may learn something that will help other children with [insert topic under investigation] some day.

This study will help me learn more about [topic under investigation].

You do not have to join this study. It is up to you. You can say okay now and change your mind later. All you have to do is tell me you want to stop. No one will be mad at you if you don’t want to be in the study or if you join the study and change your mind later and stop.

Before you say yes or no to being in this study, I will answer any questions you have. If you join the study, you can ask questions at any time. Just tell me that you have a question.

If you have any questions about this study please feel free to contact [Insert researcher name and contact #]

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

Child’s name	Signature	Date

Principal Investigator or

Person obtaining Assent	Signature	Date

Example #2 – Older Child Assent

Title of Study:

Principal Investigator(s):	Supervisor (if applicable):

Contact Information:	Contact Information:

What is a research study?

A research study is a way to find out new information about something. Children do not need to be in a research study if they don’t want to.

Why are you being asked to be part of this research study?

You are being asked to take part in this research study because I am trying to learn more about (Insert name of what is studied here). I am asking you to be in the study because (state why the child is being asked to participate). About (enter #) children will be in this study.

If you join the study what will happen to you? (describe what takes place from the child’s point of view)

I want to tell you about some things that will happen to you if you are in this study. EXAMPLES BELOW

You will be in the study for (insert duration of participation).

We will need you to (name of activity) that will last (duration).

I will ask you to sit with me and (talk about some things/look at some pictures). It will take about (insert the duration) to do this.

I will ask you to answer some questions about (state the topic) that should take about (insert the duration).

Describe risks and discomforts using terms a child would know and understand; take into account a child’s fears.

Will the study help you? (Describe any benefits to the child from participation in the research or if there are none state so).

Will the study help others? (Describe any benefits to society from the research.)

This study might find out things that will help other children with (describe any possible benefits to the child) some day.

What do you get for being in the study?

(Describe any incentives provided for participation in the research.) You will get (enter amount or item) for (each activity/entire study). If no incentives are provided, delete this section.

Do you have to be in the study?

You do not have to be in the study. It’s up to you. No one will be upset if you don’t want to do this study. If you join the study, you can change your mind and stop being part of it at any time. All you have to do is tell me. It’s okay, the researcher and your parents won’t be upset.

Do your parents know about this study?

This study was explained to your parents and they said that I could ask you if you want to be in it. You can talk this over with them before you decide.

Who will see the information collected about you?

The information collected about you during this study will be kept safely locked up. Nobody will know it except the people doing the research.

The study information about you (will, will not) be given to your parents (or teachers). The researcher will not tell your friends or anyone else.

What if you have any questions?

You can ask any questions that you may have about the study. If you have a question later that you didn’t think of now, either you can call or have your parents call (insert researcher contact information).

Other information about the study.

If you decide to be in the study, please write your name below.

You will be given a copy of this paper to keep.

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

Child’s name	Signature	Date

Principal Investigator or

Person obtaining Assent	Signature	Date