SAMPLE ASSENT FORM (AGES 7-12):
GRADE 2 READING LEVEL
STUDY OF ______________
Investigators: [LIST NAMES, POSITIONS, DEPARTMENTAL AFFILIATIONS, AND TELEPHONE NUMBERS OF INVESTIGATORS]
Investigators' statement
PURPOSE AND BENEFITS
You have a disease called ___________. We want to see if your blood is different from people who don't have _______. This is a science study. Maybe we will learn more about what causes ________.
PROCEDURES
If it's okay with you, we will take some blood from you. We will use a clean needle. We will take the blood from your arm. We will take about two tablespoons of blood. We will send the blood to a lab for tests. We also want to look at your medical record. We want to see how the doctors have treated your __________.
RISKS, STRESS, AND DISCOMFORT
The needle we use to take the blood may hurt. You might get a bruise on your arm.
OTHER INFORMATION
We won't tell anyone you took part in this study. Your name will not be on the sample of blood we take. You don't have to take part in this study if you don't want to. No one will be mad at you. We will give you a copy of this paper to keep.
| ____________________________________ | ____________ | |
|---|---|---|
| Signature of investigator | Date |
Subject's statement:
This research study has been explained to me. I agree to take part in this study. I have had a chance to ask questions. If I have more questions, I can ask the doctor.
| ____________________________________ | ____________ | |
|---|---|---|
| Signature of subject | Date |