Consent LA Adult

Attachment 8A-1(e)

CONSENT TO PARTICIPATE IN A RESEARCH STUDY

Los Angeles County Multi-Unit Housing Resident Survey -Adult Participant

SMOKE-FREE MULTI-UNIT HOUSING POLICIES RESEARCH 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 participate in 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:

1. Answer questions about your apartment unit and complex, apartment rules that limit where people can smoke, smoking habits, exposure to smoke from others at home, work, or in public places, and some background questions on your health. This will take about 30 minutes. If you do not want to answer a question, just say so, and the interviewer will move to the next one.

2. If children under the age of 18 live in this apartment, and you are the parent, guardian, foster parent, or the main caregiver for these children, we will ask you some questions about the children's exposure to smoke, and some background questions on their health. This will take about 15 minutes. 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. If you are not the parent, guardian, foster parent, or the main caregiver for these children, we will ask to speak to the person who is.

3. We will ask you to give a saliva sample so that we can test it in a lab. This sample will give us information about how much tobacco smoke you have breathed in within the past week. This is painless. All you will have to do is rinse your mouth with water 10 minutes before we do the test and later put a cotton swab under your tongue for a short time. The testing will take around 10 minutes total. You may choose not to do this and still stay in the study.

4. We will also ask that the child under 18 with the most recent birthday who is in the apartment today gives a saliva sample. 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 you can stay in the study.

5. We will ask you to show us the living room and kitchen of your apartment to look for area where smoke or other contaminants (such chemical smells, insects, mice) may enter the

building from the outside, the hallways, or other parts of the apartment. This will take about 10 minutes.

AS A TOKEN OF OUR APPRECIATION:

Your household will receive the following for participating in these activities:

1. $50.00 Visa gift card for answering the survey and letting us look at the living room and kitchen. (If an additional adult is needed to answer questions about children in the household, that person will receive a $10.00 Visa gift card).

2. $10.00 Visa gift card for giving a saliva sample. If both an adult and a child gives a saliva sample, there will be two (2) $10.00 gift cards.

3. If you complete these activities at the six-nine month follow-up visit, we will give the same thank you gifts for that visit (that is, a $50.00 Visa gift card for answering the survey and letting us look at the living room and kitchen; if an additional adult is needed to answer questions about children in the household, that person will receive a $10.00 Visa gift card for giving a saliva sample. If both an adult and a child gives a saliva sample, there will be two (2) $10.00 gift cards.

Your Possible Participation in an Additional Study Activity

Your apartment may be randomly selected to participate in air quality monitoring for seven days. A

random sample is one where everyone who participates in the study has the same chance of being

asked to be part of this activity. We will not know whether your apartment is selected for this part of the study until after you read and complete this consent form.

IF YOUR APARTMENT IS SELECTED:

1. We will ask to put several pieces of air monitoring equipment in your living room for seven (7)

days. This will require access to an electrical outlet for the week.

2. You do not have to do anything with the equipment. Please do not unplug the equipment at any time. We ask that you do not cover or block any air flow to the equipment.

3. We will ask you to fill out a record each day that includes:

• Who lived in the apartment that day, and the times they got up, went to bed, and were out of the apartment?

• Was there any tobacco smoke smell in the apartment?

• Were there other sources of smoke in the apartment that day?

• Were windows or door open for ventilation, fans, air conditioning or heating systems used during the day?

It will take us about 30 more minutes to set up the equipment and show you how to fill out a daily record sheet. We will come back seven days later to pick up the equipment and the records.

Your participation in this additional study activity is voluntary. You may refuse to participate in this activity and still remain in the study.

IF YOUR APARTMENT IS SELECTED:

You will be given a $75.00 Visa gift card when we pick up the equipment and records as a token of our appreciation. We will set up and pick up the equipment again in six to nine months. We will again give you a $75.00 Visa gift card as a thank you.

YOUR BENEFITS AND RISKS FROM PARTICIPATION IN THIS STUDY

You 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 may qualify.

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

We believe that your participation has minimal risks to you, the most significant being that you will be asked questions about personal issues such as smoking habits during this study and asked to give a saliva sample. If you do not wish to answer these questions or give a saliva sample, you do not have to do so.

Privacv

None of the information you share with us will be shared with the residents of this apartment complex or with your apartment'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.

All information you share will be kept private to the extent allowed by law. 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

1101Wootton 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 FUTURE 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 and 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

Name of Person Obtaining Signature _Date

Form Valid For Enrollment From

05/16/2013 w 05/15/2014

Los Angeles County-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 WRITTEN 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 DATE

GUARDIAN

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 SE VAYA A 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 0TILES 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. DECLARACI6N ACERCA DE LA RESPONSIBILIDAD POR DANOS FfSICOS, 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 POBLICA, A (213) 250·8675.

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

_________________________________________ ____________

FIRMA DEL SUJETO C) PERSONA RESPONSIBLE DATE FECHA

^{Form Valid For Enrollment From "" 212 11}

05/16/2013 05/15/2014

Los Angeles County-Public Health

Institutional Review Board .