Example 2_1


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

Signature of Participant ____________________ Date _____________

Signature of Investigator ____________________ Date ____________