Informed consent

OMB control number 3041-0116

INFORMED CONSENT FORM

Permission for Child-Resistant

Cigarette Lighter Study

Please read this consent form carefully. Ask as many questions as you like before you decide whether you want your child to test a lighter.

This study will be conducted by: {Insert Company Name}

{Insert Company Address}

{Insert Company Phone Number}

1. PURPOSE OF STUDY: The U.S. Consumer Product Safety Commission (U.S. CPSC) requires that most types of lighters be child-resistant, which means that they are difficult for children under five to use. The purpose of this study is to test one brand of cigarette lighter to make sure it is child-resistant. The lighters used in the test do not have any fuel and cannot make a flame. These special lighters make a noise or other signal if a child is able to make them work.

2. PROCEDURE: The study will be at your child’s school or daycare center. A tester will work with two children at a time. The tester will ask the children to try to make the signal with their special lighter. If the children are not able to make the signal in five minutes, the tester will use each of their lighters one time to show them how it works. The tester will ask the children to try again for five more minutes. If a child is able to make the lighter work, the tester takes the lighter and thanks the child for helping. After the test, the tester talks to the children and asks them to promise not to try to use a real lighter.

To help make sure that the lighter is tested correctly, we may take a picture or video of the tester showing your child how to use the lighter.

So that we can be sure whether the children are able to use the lighter, please do not talk to your child about lighters before the study. After the test, we will send you a letter telling you whether your child was able to work the lighter.

3. POSSIBLE RISKS: We have tested lighters for {insert # of years} with no injuries to anyone. It is possible, however, that your child could learn how to use the test lighter, and may be more able to use other lighters. It is also possible that a minor scratch or scrape could occur during the test. There should not be additional risks to your child associated with participation in this study.

4. POSSIBLE BENEFITS: The long-term benefit of this study is fewer fires started by young children playing with real lighters. Your child’s school may also receive money or other help if your child tests a lighter.

5. ELIGIBILITY: Your child must be between 3 years 6 months and 4 years and 3 months of age on the day of the test and must NOT have tested a cigarette lighter before.

6. PARTICIPATION/WITHDRAWAL FROM STUDY: You are free to choose whether your child tests a lighter, and your child can stop testing at any time. You do not have to let your child test a lighter to use the school/daycare. In addition, the tester can stop the test at any time.

7. CONFIDENTIALITY: We will report the results of the study to the company that makes or sells the lighter and to the U.S. CPSC. Your name, your child's name, and any information you give us will be kept private. Neither we, the lighter company, nor the U.S. CPSC will give this information to anyone for any purpose without your permission.

8. FOR MORE INFORMATION: If you have any questions about this study, please call the Study Director, {Insert name and phone number}.

9. AUTHORIZATION: I have read this form or had someone read and explain it to me. I understand the information in this form. My child is between 3 years 6 months and
   4 years 3 months, and I volunteer him/her to participate in this study.

To be completed only by authorizing parent or legal guardian Please use black or blue ink
I give permission for my child to test a cigarette lighter.
Parent/Legal Guardian signature:		Today’s Date:
Parent/Legal Guardian printed name:		Phone #:		(month/day/year)
Relationship to child:	(first) (last)
	(mother, father, or legal guardian)
Child’s printed name:
Child’s date of birth:	(first) (last)	Child’s sex:		M F (please circle one)
	(month / day / year)
Name of School:
My child is at school on the following days:	Mon Tue Wed Thu Fri (please circle all that apply)	In the: AM PM AM/PM (please circle one)

Office use only	Lighter Firm:		Site name:
	Lighter Model:
	Lighter No.:		Site address:
	Date of Test:		Tester Signature:
	Tester Printed Name: