Hospital-based Maternal Assent - English

MATERNAL ASSENT PRAMS-ZPER Page 3 of 3

PR DEPARTMENT OF HEALTH

MATERNAL, CHILD AND ADOLESCENT HEALTH DIVISION

ASSENT FORM FOR PARTICIPATION IN

ZIKA POSPARTUM EMERGENCY RESPONSE SURVEY (PR-ZPER)

Assent Form for Children 7 to 14 years old

TITTLE OF THE STUDY: Puerto Rico Pregnancy Risk Assessment Monitoring System Zika Pospartum Emergency Response (PRAMS-ZPER)

PROTOCOL NUMBER: B1020117

INVESTIGATORS: Manuel I. Vargas Bernal, Principal Investigator and personnel of PR Department of Health.

PLACE: The study will take place in 33 birthing hospitals in Puerto Rico with 100 or more births in 2016.

TELEPHONE NUMBERS: Maternal, Child and Adolescent Health Division: (787) 765-2929 extension 4672, 4805, 4804 and 4806.

This assent form can be difficult to understand and may have information that you do not understand. Please, feel free to ask to the interviewer to clarify any questions that you may have about this study. Also you may ask the interviewer to talk with you privately or ask her to read this assent form to you.

What is the study about?

We are conducting a study called “Zika Postpartum Emergency Response Survey” (ZPER). This study investigates what information pregnant women in Puerto Rico have about Zika infection. Also, this study collects information such as: Zika virus and related attitudes and behaviors among women who recently had a live birth including and their interactions with health care providers.

What is going to happen with me on this study?

Young people like you may participate on this study. You will be asked to complete a survey with some questions. Your participation is completely voluntary; no one can force you to participate. The purpose of the study is to collect information through a questionnaire about your pregnancy and about Zika.

Why was I selected to participate in this study?

You were selected because you were pregnant and had a baby in one of the 33 hospitals chosen to participate in the survey.

What do I have to do?

You would have to answer a survey (in paper or electronic form) that has questions about your pregnancy and other questions related to Zika virus infection. You will decide what form of the questionnaire you want to use to answer the survey. It will take only 20 minutes for you to answer. Your questionnaire can be linked with other sources of information of the PR Department of Health.

After you complete the survey, the interviewer will give you the opportunity to receive a short educational intervention that will take aproximately 15 minutes. The educational intervention will provide information about things you can do or expect after the birth of your new baby.

You may be contacted by phone 2 to 6 months after you complete this survey to answer some follow-up questions. The follow-up questions will focus on your feelings and experiences after you leave the hospital.

Your participation in the this survey is voluntary.

How many persons will be in this study?

Around 3,500 women and young people like you that had a baby were selected to participate in the study.

Can something bad happen to me?

Nothing bad will happen to you. You only have to answer some questions that the interviewer will provide you in paper or electronic form. But if you feel uncomfortable answering some questions you do not need to answer them.

What good things can come from this study?

The information you provide will help improve the services related with the prevention of Zika virus infection. We may apply for funding opportunities to bring education about how to prevent Zika virus infection in the community including pregnant women.

Do I have other options?

You can decide which questions you want to answer. You can also leave any questions you do not want to answer blank, you can leave the questionnaire blank or decide not to participate in the study.

What happens if I don’t want to participate in the study?

If you decide to participate in the study, you can sign this consent and answer the questionnaire that the interviewer gives you. If you do not want to participate just let the interviewer know about your decision.

If you want to participate in this study, we need you to sign this assent form in the line below. Signing this assent means that you want to participate in this study. Even though you have signed this assent, you can leave the study at any moment if you do not wish to continue.

SIGNS FOR THE STUDY

Participant’s Name & Middle Name (Print letter)

Participant’s (Paternal) Last Name (Print letter)

Participant’s (Maternal) Last Name (Print letter)

x_________________________________________________________ _____ /_____ /________

Participant’s Signature Date (month/day/year)

“I was present when__________________________ read this consent and said that she or he wanted

^{Participant’s Name}

to participate in this study”

__________________________________________________________

Interviewer/Surveyor Printed Name

x_________________________________________________________ _____ /_____ /________

Interviewer/Surveyor Signature Date (month/day/year)