Saliva Collection Assent Children

Attachment 10A-1(e) 5.14.13

LA MUH Resident Survey- Child Assent for Saliva Sample

CONSENT TO PARTICIPATE IN A RESEARCH STUDY Resident- Child Assent for Saliva Sample Only Applies to Children Aged 7- 17

CDC SMOKE-FREE MULTI-UNIT HOUSING POLICIES STUDY

Please read and listen to this consent form carefully. Ask the staff member 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:

You are being asked to be part of a research study of people who live in apartments (also called multi­ unit housing) in Los Angeles County. The study lasts about one (1) year. If you agree to be part of this research study, we will ask you to do one thing now and again between six to nine (6-9) months later:

• Rinse your mouth with water 10 minutes before we start.

• Then, put a cotton swab under your tongue.

• This will not hurt, and you don't have to do this if you don't want to.

We are asking for your help because the Centers for Disease Control and Prevention (CDC) wants to learn how apartment complexes put into place rules about where people can or cannot smoke and how those rules affect residents' lives.

One of the things we'd like to know is whether you have breathed in tobacco smoke in the last few weeks. The saliva will be tested in a lab, and will tell us whether and how much smoke you may have breathed in. This information will be kept private.

Your Benefits and Risks from Participation in this Interview You will get a $10.00 Visa gift card for giving a saliva sample. Privacy

All your information will be kept private. It will not be shared with other residents or property managers.

All records will be stored in a locked file cabinet, which only project staff may access.

Your saliva will be stored in 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.

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:

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

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

15. Office for Human Research Protections

1101Wootton Parkway, Suite 200

Rockville, MD 20852

Toll-Free Telephone within the United States: (866) 447-4777

16. 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 FUTURE CARE AT THIS INSTITUTION.

• A COPY OF THE WRITIEN 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 ASSENT

The assent form has been read to me. My questions have been answered. I assent voluntarily to participate in this research study and I will receive a copy of this consent form for my records.

Name of Participant (Print) Signature Date

Name of Adult (Print) Signature ^Date

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

D Parent

D Guardian

D Foster Parent

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

Name of Person Obtaining ^{Signature Date}

Consent

Form Valid For Enrollment From

05/16/2013 • 05/15/2014

_{LosAngelesCounty-Public Health}

^{Institutional Review Board}

Note: Below is the document whose language must be included in all informed consent documents in California, or that must be signed as a separate document and included in the study records.

HUMAN RIGHTS IN MEDICAL STUDIES

CALIFORNIA LAW REQUIRES THAT YOU MUST BE INFORMED ABOUT:

1. THE NATURE AND PURPOSE OF THE STUDY.

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

3. DISCOMFORTS AND RISKS TO BE EXPECTED FROM THE STUDY.

4. BENEFITS TO BE EXPECTED FROM THE STUDY.

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

6. AVAILABILITY OF MEDICAL TREATMENT SHOULD COMPLICATIONS OCCUR.

7. THE OPPORTUNITY TO ASK QUESTIONS ABOUT THE STUDY OR THE

PROCEDURE.

8. THE OPPORTUNITY TO WITHDRAW AT ANY TIME WITHOUT AFFECTING YOUR FUTURE CARE AT THIS INSTITUTION.

9. A COPY OF THE WRITIEN CONSENT FORM FOR THE STUDY.

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

11. STATEMENT REGARDING LIABILITY FOR PHYSICAL INJURY, IF

APPLICABLE.

IF YOU HAVE ANY QUESTIONS OR CONCERNS REGARDING THESE RIGHTS OR THE CHARACTER OF THE STUDY, PLEASE FEEL FREE TO DISCUSS THEM WITH THE PERSON(S) CONDUCTING THE STUDY, OR YOU MAY CONTACT THE RESEARCH COMMITTEE CHAIRMAN, LOS ANGELES COUNTY DEPARTMENT OF PUBLIC HEALTH, AT (213) 250-8675.

_{I HAVE READ AND UNDERSTOOD MY RIGHTS FOR PARTICIPATION IN THE STUDY.}

SIGNATURE OF SUBJECT OR GUARDIAN

FIRMA DEL SUJETO 6 PERSONA RESPONSABLE

DATE FECHA

DERECHOS HUMANOS EN ESTUDIOS MEDICOS

LA LEY DEL ESTADO DE CALIFORNIA REQUIRE QUE UD. TIENE QUE ESTAR INFORMADO SOBRE:

1. LA NATURALEZA Y EL PROPOSITO DEL ESTUDIO.

2. LOS PROCEDIMIENTOS DEL ESTUDIO Y CUALQUIER FARMACO, APARATO 0 DISPOSITIVO QUE SEVAYAA UTILIZAR.

3. LAS MOLESTIAS Y LOS RIESGOS QUE SE ANTICIPAN DEL

ESTUDIO.

4. LOS BENEFICIOS QUE SE PUEDEN ESPERAR DEL ESTUDIO.

5. LOS PROCEDIMIENTOS ALTERNOS, FARMACOS 0

DISPOSITIVOS QUE PUEDEN SER UTILES Y LOS RIESGOS Y BENEFICIOS QUE ESTOS LLEVAN.

6. DISPONIBILIDAD DE TRATAMIENTO MEDICO EN CASO QUE OCURRAN COMPLICAIONES.

7. LA OPORTUNIDAD PARA HAGER CUALESQUEIRA PREGUNTAS SOBRE EL ESTUDIO 0 EL PROCEDIMIENTO.

8. LA OPORTUNIDAD PARA RETIRARSE DEL ESTUDIO EN CUALQUIER MOMENTO SIN AFECTAR SU ATENCION MEDICA

FUTURA EN ESTA INSTITUCION.

9. UNA COPIA DE ESTE CONSENTIMIENTO FIRMADO PARA EL ESTUDIO.

10. LA OPORTUNIDAD PARA CONSENTIR LIBREMENTE AL ESTUDIO SIN EL USO DE COERCION.

11. DECLARACION ACERCA DE LA RESPONSIBILIDAD POR DAI\iOS FISICOS, Sl ES APLICABLE.

Sl UD. TIENE CUALESQUEIRA PREGUNTAS 0 PREOCUPACIONES ACERCA DE ESTOS DERECHOS 0 EL CARACTER DEL ESTUDIO, POR FAVOR SIENTASE LIBRE PARA DICUTIRLOS CON LA(S) PERSONA(S) LLEVANDO A CABO EL ESTUDIO, 0 UD. PUEDE PONERSE EN CONTACTO CON EL PRESIDENTE DEL COMITE INVESTIGATIVO DEL CONDADO DE LOS ANGELES SALUD PUBLICA, A (213) 250·8675.

YO HE LEIDO ESTE DOCUMENTO Y ENTIENDO MIS DERECHOS PARA Ml PARTICIPACI6N EN EL ESTUDIO.

Form Valid For Enrollment From ""·212 11

05/16/2013 05/15/2014

Los Angeles County-Public Health

Institutional Review Board .