HBREB Assent Form Sample

- Assent Form -
(Flesch-Kincaid Grade Level = 3)

Study Title: Add the approved study title and the alternate lay title (if applicable).

Principal Investigator: (Insert name, credentials and affiliations)

Sponsor/Funder(s): (Insert the name of the sponsor or funder(s) of the research)

Study Coordinator: (Insert name)

What is a research study?

Research can help us learn new things. It can help us learn more about disabilities. In a research study we can test new ideas and ask new questions to try to find answers. This may help us make treatments and technology better for kids and youth.

Why do you want to talk to me?

Introduce yourself and then explain that the participant is being invited to participate in a research study.
Introduce the nature and purpose of the research and use simplified language that the child may be familiar with.

For example:My name is ______. I am part of a research team at the Bloorview Research Institute. I asked you to see me because I am inviting you to participate in a research study. I wanted to show you a brand new device for wheelchairs. The device is called Embrace. The reason we call it Embrace is because it hugs you like the seat belt you use on your wheelchair.

What do I need to do?

Explain how the participant will be involved in the study including methods and procedures.
Explainhow long the participant will be in the study and what exactly they will have to do.

For example: I was wondering whether you would like to try Embrace to see if you like it. You only need to use it for a littlewhile and then you can use your other seat again.

If you want to try Embrace, we will make you another seat just like the one you have now. We will take the seat you use now out of your wheelchair and put the new seat on instead. This way, you can try the new seat in your chair for a couple of weeks. After a couple of weeks we will ask you some questions to see what you think about the new seat.

If your study is a randomized clinical trial, include a description of the trial interventions and describe how participants will be assigned to each intervention(e.g. by chance like flipping a coin). Include which interventions are standard of care and which are investigational. Also provide information onalternative procedures that may be available to a child.

Consider including additional sections, such as: “Could I get better by being in this study?”, “Are there any other treatments for me?”

Ifyour study requires the collection of human biological material (blood, saliva, etc.), include the type and amount being taken as well as how it is being taken. Include the risks of collection and how the risk will be managed. Also include how long materials will be kept, how they will be stored, and how incidental findings will be dealt with.

Consider including additional sections, such as: “What will happen to my [blood/saliva/etc.]?”, “Will I learn anything new about me?”

What are the good and bad things about doing this?

Explain in appropriate language all the foreseeable risks and any potential benefits about being in this study.
If there are no foreseeable risks please state that you don’t think there are any bad things.
If there are no direct benefits please state that you do not think there will be any good things that happen to the participantfrom being in the study or that it will not help them.

For example: We don’t think that there are any bad things about being in the research study. If you don’t want to try this new seat, that’s okay. You don’t need to do this. If you or your parents decide not to participate, we won’t ask you again.

We think that being in this research may help you because you might like the new seat better than your old seat belt. If you do, you can keep the new one.

We don’t think that being in this research will help you. A good thingabout this researchis that with your help we hope we will learn something new. We hope that someday it will help other kidswho use a wheelchair like you do.

Will anyone know that I did this study?

Explain that anything that the participant says or does will be kept confidential.
Explain how the research results of the research will be shared.

For example: We won’t share anything you said with anyone who is not part of this research study. No one else will know it was you who said these things. When the research study is done, we will tell you what we found out by sending you a letter. We will also tell other people what we found out so we can share what we learned.

Ifthere is a possibility that the researcher may find out information that puts the child’s well-being into question, state that this information would be shared with people to help the child.

Do I have to do this?

Explain that participation is voluntary and that the participants do not have to be part of the study, and that they can change their mind at any time. Explain that this will not affect any services they get at Holland Bloorview.
Explain that the child can withdraw from the research study at any time, explain how to withdraw and indicate that no one will be upset with their decision to do so.
Explain if there are any instances where a researcher may withdraw the participant. If applicable, state that it may be impossible to withdraw from a study, if your study uses anonymized data/samples or other methods that prevent removal of data from the study or a database.

For example:If you do not want to try this new seat, that’s okay. You can tell your parents or me that you don’t want to take part in this research study. That will be okay. This will not changehow I treat you the next time you see me.

If you say yes now, you can change your mind later. You can tell me that you want to stop being in the research study and we will stop. That will be okay. No one will be angry or upset with you if you change your mind.

What if I am not sure?

Explain that the participant’sparents also know about the study and if the participanthas questions they should ask the researcher or their parents.

For example: Your parents know about this study. Ask them questions if you don’t understand what this is about. You can also talk to me and ask me questions about the research study before you decide whether or not you want to be involved.

Signature Page:

Include a statement that the participantindicated that s/he discussed the study information with the researcher, had all questions answered, and agrees to participate in the study. Add a space to allow the participantto print his/her name, sign, and date the statement if capable. If the participant is unable to sign the form theresearcher must document the child’s assent indication.

Please see sample signature page below.

ASSENT FORM

Study Title (Alternate Lay Title)

I was explained the study by ______(Person Obtaining Assent) and s/he answered all my questions. I agree to participate in the study.

______
Participant’s Name (Printed)

______
Signature (Optional)

______
Date

I discussed this form with ______(Participant’s Name) and s/he agreed to participate in the study.

______
Person Obtaining Assent

______
Signature

______
Date

March 2018 Page 1 of 4