The Assent Form is used when the investigator recruits subjects who, by age or circumstance, are not able to give legally effective informed consent. When legally effective informed consent cannot be obtained, the investigator should obtain the "assent" of the minor or cognitively impaired subject. This form documents the minor's or cognitively impaired subject's affirmative agreement, or assent, to participate in a research project. The investigator should respect the decision of a minor or cognitively impaired subject not to participate in a research project, even when the parent or legally authorized representative has consented.

If the investigator needs to use an Assent Form, it should be included with the Application. We have provided for your use an example of an Assent Form. You do not have to use the template if it does not meet the needs of the subjects. For older children the consent template may be a better choice. Please feel free to develop an asset form that works for your study.

Assent Form Example

Title of Project: Children's Exposure to Weed Killers.
Investigator: Do Right, PhD

"Weed killers" are something that people put on lawns to get rid of weeds. We want to find out 2 things:
How much have people been around weed killers?
How much do people know about weed killers?

Would you like to help us find the answer to these questions? If you want to help, you could write your answers to some questions we give you. Your parents can help you write your answers. The questions will ask things like "Do you go barefoot on grass?"

Give us a sample of your urine this month, and again in 1 year. We will give you a cup to pee into. You can do this in your own bathroom. We tell your parents how to help you do this. We will give you $5 when you give us the first cup of urine. We will give you another $5 when you give us the second cup of urine in 1 year.

We do not think that doing either of these 2 things will hurt you.

You don't have to help us. You can say "no" and no one will hurt you or be mad at you. Even if you say "yes" and want to help us today, you can change your mind at any time. Just tell us if you want to stop.

If you want to help us by answering questions and giving us some of your urine, print your name on the line.

________________________________________
Name
________________________________________	_____________
Investigator's signature	Date
[Reading level is between 3rd and 4th grade.]