Consent LA

Attachment 6A-1(e)

CONSENT TO PARTICIPATE IN A RESEARCH STUDY

Los Angeles County Multi-Unit Housing Operator Survey

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. This research data will be collected and analyzed by: 1) Healthy Housing Solutions, a research and evaluation firm that specializes in how the homes we live in effect children's and adults' health; 2) Westat, a survey research firm; and 3) the Los Angeles Department of Public Health's Tobacco Control and Prevention Program.

You are being asked to participate in a research study of multi-unit housing operators in Los Angeles County that will last about one (1) year. 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. There are several aspects to your involvement in this research:

1. You will be asked to respond to a questionnaire asking about your property's characteristics, existing smoking-related policies, secondhand smoke-related issues, smoke-free housing policy­ related costs, and your own opinions about smoke-free policies. We will also ask some background information about you, such as your age, education, race or ethnicity, income, and smoking status. 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.

2. The interviewers will also ask for copies of any written materials that your apartment complex gives tenants about smoke-free policies (such as lease agreements and statements about charges for damages or costs to renovate at turnover a unit that had smokers in it). You may wish to review your records for the last six months to help you answer these questions.

3. We will ask you to show us the outside and common areas of the complex to look at signs for designated smoking and non-smoking areas and areas where smoke or other contaminants may enter the building from the outside.

4. Finally, we will ask you to identify the numbers of occupied apartment units (but not residents' names or phone numbers), so we can randomly sample residents to participate in a comparable survey.

The interview will last about 45 minutes, and we estimate it will take another 15-30 minutes to walk around the apartment complex. At the end of the interview, you will be given a $75. 00 Visa gift card as a token of our appreciation. We will repeat this process in six to nine months.

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. If you do not wish to answer these questions, you do not have to do so.

There are no medical treatments associated with your participation in this research. However, if you have any questions about the study, or injury that you believe might have been associated with your participation, you may contact Carol Kawecki, Senior Project Manager, Healthy Housing Solutions at

443-538-4183 or 877-312-3046, ext. 238. There is no medical compensation associated with this study. If you believe you have experienced an injury, please contact your medical provider for treatment.

Privacy

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

All records will be stored in a locked file cabinet, which only project staff may access. Your personal identifying information (name, address, phone number) will be kept separate from your questionnaire responses. Serial numbers will be assigned to respondents before to creating an electronic record. An electronic data file containing personal identifiers and linkage information will be set up and stored in a password-protected computer in a locked room. Only authorized individuals can access this linkage file. Electronic study data are backed up at regular intervals on a secured hard drive in an offsite host-based system. Computers are maintained in secure areas, with access limited to authorized personnel. User manuals will be created to facilitate data management and analysis. All personnel who will have access to the study data will be trained and made aware of their responsibilities for protecting the data. Access to data is "role-based" and on a "need-to-know" basis. The project manager will be responsible for authorizing access privileges for each user.

All information you share will be kept private to the extent allowed by law. By this we mean that certain people and organizations may need to see, copy, or use your information so that they can do their part in the study. They are called 'authorized users.' Authorized users can be given limited access to your information. These may include the research team, the organizations that funded this research, or other government agencies that participate in research or protect your rights as a study participant. These data will not include your name or address to help protect your privacy. Only the senior staff at Healthy Housing Solutions, Westat, and LACDPH will have access to your name and data.

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

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

^Consent Form Valid For Enrollment From

05/16/2013 _{to 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 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 COMMITIEE 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 PROP6SITO DEL ESTUDIO.

2. LOS PROCEDIMIENTOS DEL ESTUDIO Y CUALQUIER FARMACO, APARATO 0 DISPOSITIVO QUE SE VAYAA 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 ATENCI6N MEDICA FUTURA EN ESTA INSTITUCI6N.

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

10. LA OPORTUNIDAD PARA CONSENTIR LIBREMENTE AL ESTUDIO

SIN EL USO DE COERCI0N.

11. DECLARACI6N ACERCA DE LA RESPONSIBILIDAD POR DANOS 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

05/16/2013 05/15/2014

Los Angeles County-Public Health

Institutional Review Board