Child Consent - English

Attachment 8A-3

CONSENT TO PARTICIPATE IN A RESEARCH STUDY

Resident – Child Health Questions Only

SMOKE-FREE MULTI-UNIT HOUSING POLICIES STUDY

Please read this consent form carefully and take time to ask the staff as many questions as you would like. Reading this form and talking to the study staff may help you decide whether or not to participate.

Purpose and Procedures:

The U.S. Centers for Disease Control and Prevention (CDC) is sponsoring a research study to learn how apartment complexes put into place rules about where people can or cannot smoke and how those rules affect residents’ life and health.

You are being asked to be part of a research study of residents of apartment complexes in Los Angeles County. If you agree to be part of this research study, we will interview you now, and between six to nine (6-9) months later, at a time that is convenient for you. If you agree to participate, you will:

• Answer questions about the health of children in your household. If you do not want to answer a question, just say so, and the interviewer will move to the next one. You may also stop the interview at any time.

• Allow us to get a saliva sample from the child with the most recent birthday who is present today. This is painless. All you will have to do is ask your child to rinse his/her mouth with water 10 minutes before we do the test. Later, you will hold a cotton swab under his/her tongue for a short time, if the child cannot hold it him/herself. The testing will take around 10 minutes. The child may choose not to do this and your household can stay in the study.

The interview will last about 15 minutes. At the end of the interview, you will be given a $10.00 Visa gift card. If the child gives a saliva sample, we will give you another $10.00 Visa gift card. We will gift the same compensation if you and your child complete these activities at the next visit in six to nine months.

Your Benefits and Risks from Participation in this Interview

You or your child will not receive any direct benefits from taking part in this study. If you wish, we can give you information on local stop smoking programs for which you or your family may qualify. We will not provide any medications or doctors’ services as part of this project.

Although you may not directly benefit from your involvement in this survey, by helping us test the survey questions, you can help increase understanding of how no-smoking rules can be applied in other communities.

We believe that you and your children’s participation has few risks, the most significant being that you will be asked questions about personal issues during this study such your children’s specific health conditions. These types of personal questions sometimes may make some people uncomfortable. You do not need to answer any question that makes you feel uncomfortable. If you do not wish to allow your child to give a saliva sample, you do not have to do so.

None of the information you share with us will be shared with the management of this apartment complex. Your rent or housing status will not be affected by your participation in this research.

Privacy

None of the information you share with us will be shared with the residents of this apartment complex or with your property’s management. Your personal identifying information (name, address, phone number) will be kept separate from your questionnaire responses. All records will be stored in a locked file cabinet or a password-protected computer file, which only authorized project staff may access.Only those staff working on this study will know your name and data.

The saliva will be stored in low-temperature freezers at Los Angeles County Department of Public Health headquarters for up to three years (3) for possible later study. After three (3) years, the saliva samples will be disposed of using biohazard containers.

Being a study volunteer

Entering a research study is voluntary.

• You may always say no. You do not have to take part in the study.

• If you start a study, you may stop at any time. You do not need to give a reason.

• If you do not want to be in a study or you stop the study at a later time, you will not be penalized or lose any benefits.

If you stop, you should tell the study staff and follow the instructions they may give you.

Your part in the research may stop at any time for any reason, such as:

• The sponsor or the study staff decides to stop the study.

• You do not follow the study rules.

• You decide to stop.

You may be asked to stop the study even if you do not want to stop.

NEW INFORMATION about the study

You will be told about any new information found during the study that may affect whether you want to continue to take part.

Who to Contact:

You may ask questions about the information on this form or about the study in general at any time. You may contact Carol Kawecki, Healthy Housing Solutions at 443-539-4183 or 877-312-3046, ext. 238.

If you have questions about your rights as a research participant, you may contact:

1. US Dept. of Health and Human Services Institutional Review Board:

2. Westat Institutional Review Board Administrator, Sharon Zack, at 800-937-8281, ext. 8828.

3. Office for Human Research Protections
   1101 Wootton Parkway, Suite 200
   Rockville, MD 20852
   Toll-Free Telephone within the United States: (866) 447-4777

4. LACDPH Institutional Review Board Administrator:

J. Walton Senterfitt, PhD, RN, MPH
Chair, Administrator and Compliance Officer
Institutional Review Board
Los Angeles County Department of Public Health
313 N. Figueroa St., Room 127
Los Angeles, CA 90012
213-989-7075 or 213-250-8675

CALIFORNIA LAW REQURES THAT YOU MUST BE INFORMED ABOUT:

• THE NATURE AND PURPOSE OF THE STUDY.

• THE PROCEDURES IN THE STUDY AND ANY DRUG OR DEVICE TO BE USED.

• DISCOMFORTS AND RISKS TO BE EXPECTED FROM THE STUDY.

• BENEFITS TO BE EXPECTED FROM THE STUDY.

• ALTERNATIVE PROCEDURES, DRUGS OR DEVICES THAT MIGHT BE HELPFUL AND THEIR RISKS AND BENEFITS.

• AVAILABILITY OF MEDICAL TREATMENT SHOULD COMPLICATIONS OCCUR.

• THE OPPORTUNITY TO ASK QUESTIONS ABOUT THE STUDY OR THE PROCEDURE.

• THE OPPORTUITY TO WITHDRAW AT ANY TIME WITHOUT AFFECTING YOUR FTUTURE CARE AT THIS INSTITUTION.

• A COPY OF THE WRITTEN CONSENT FORM FOR THE STUDY.

• THE OPPORTUNITY TO CONSENT FREELY TO THE STUDY WITHOUT THE USE OF COERCION.

• STATEMENT REGARDING LIABILITY FOR PHYSICAL INJURY, IF APPLICABLE.

STATEMENT OF CONSENT

I have read the consent form. My questions have been answered. I consent voluntarily to participate in this research study. I give permission for my child between the ages of two (2) and seven (7) to provide a saliva sample, if that child is selected to provide a sample. I also give permission for project staff to review the saliva assent form with my older child, if he/she selected to provide a sample. I will receive a copy of this consent form for my records.

I am not giving up any legal rights by signing this form. Nothing in this is intended to change any applicable federal, state, or local laws.

_____________________________ ___________________________ ____________

Name of Participant (Print) Signature Date

Relationship to children in this household. (Please check all that apply).

• Parent

• Guardian

• Foster Parent

• Primary Caregiver During the Time the Child is in the Apartment

____________________________ ___________________________ ____________

Name of Person Obtaining Signature Date

Consent