Example 2_1

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Sample Assent Form

Fictitious Toothpaste Study

We are asking if you are willing to use our new toothpaste, because we are trying to learn more about how to prevent cavities in kids your age. Because you have had 3 or more cavities in the last year, we are asking if you want to be in a study. It seems like some kids have teeth that never get cavities, and other kids get lots of them. We hope that our new toothpaste will help kids who seem to get a lot of cavities from getting so many cavities in the future. But we won't know if the toothpaste works until we try it.

If you agree to be in this study, we will ask you to brush your teeth with our toothpaste after breakfast, after dinner, and right before you go to bed. We will ask you to come in to see a dentist in our office once a month to take a quick look at your teeth. We will give your mom or dad all the toothpaste that you will need for the three months that you are in our study.

You may not like the new toothpaste. The new toothpaste might not work as well as the kind you are using now. If it does work, you may not have as may cavities in the future.

You will still have the same dentist if you say no to being in this study. And, if you change you mind during the study, you can always go back to your regular toothpaste. Being in this study is totally up to you, and no one will be mad at you if you don't want to do it.

You can ask any questions that you have about this study. If you have a question later that you didn't think of now, you can ask us next time.

Signing here means that you have read this paper or had it read to you and that you are willing to be in this study. If you don't want to be in this study, don't sign. Remember, being in this study is up to you, and no one will be mad at you if you don't sign this or even if you change your mind later.

Signature of Participant ____________________ Date _____________

Signature of Investigator ____________________ Date ____________



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