PRAMS Livebirth Mail Introduction and Informed Consent (English)

Attachment 12a – Livebirth Introduction and Informed Consent – English

PRAMS Livebirth Mail Introduction & Informed Consent - English

Introduction (pre-letter, no web)

<DATE>

Ms. <MOTHER’S FIRST AND LAST NAME>

<STREET ADDRESS>

<CITY, ST ZIP>

Dear Ms. <MOTHER’S LAST NAME>,

We would like to ask for your help in a project called the Pregnancy Risk Assessment Monitoring System (PRAMS for short). PRAMS is a survey that asks women about things that can happen before, during, and after pregnancy. All mothers in <STATE> are eligible to be selected for PRAMS, including those who had healthy pregnancies and those who did not. Finding out why some babies are born healthy and others are not can help us create a better future for mothers and babies.

You will be getting your PRAMS survey from the <STATE> Department of Health in the mail in the next week, along with information that tells more about the project. <To thank you for your time and help, we will also send you a small gift.>

We do not always know if a mother has lost her baby. If your baby has died, we are truly sorry about your loss and offer our sympathy to you and your family. Your answers are especially important. What we learn from you could help other mothers and babies in the future.

Again, you should get a packet with a survey in the next week. If you have any questions about the project, please call me at our toll-free number, 1-800-<###-####>.

Sincerely,

<PROJECT COORDINATOR’S NAME>

<STATE> PRAMS Project Coordinator

Introduction (pre-letter, mentions web option)

<DATE>

Ms. <MOTHER’S FIRST AND LAST NAME>

<STREET ADDRESS>

<CITY, ST ZIP>

Dear Ms. <MOTHER’S LAST NAME>,

We would like to ask for your help in a project called the Pregnancy Risk Assessment Monitoring System (PRAMS for short). PRAMS is a <STATE> Department of Health survey that asks women about things that can happen before, during, and after pregnancy. All mothers in <STATE> are eligible to be selected for PRAMS. We survey mothers who had healthy pregnancies as well as mothers who had complications such as preterm birth and infant death. Finding out why some babies are born healthy and others are not can help us create a better future for all mothers and babies.

Very few mothers are selected for the PRAMS survey so your answers are especially important. We invite you to complete your survey online as soon as you can. The survey is easy to use and your privacy is protected. Simply visit the survey website by scanning the QR code with a mobile device or entering the web address, and enter your User ID and personal passcode below:

Website: https://prams.cdc.gov User ID: <MOMID> Passcode: <PassCode>

You will be getting a PRAMS survey from the <STATE> Department of Health in the mail in the next week in case you prefer to complete a paper copy. It contains information that tells more about the project. <To thank you for your time and help, we will also send you a small gift.>

If you have any questions about the project, please call me at our toll-free number, 1-800-<###-####><or email <SITE_EMAIL>>.

Sincerely,

<PROJECT COORDINATOR NAME>

<STATE> PRAMS Project Coordinator

Informed Consent Document (mail)

Important Information About PRAMS

Please Read Before Starting the Survey

• The Pregnancy Risk Assessment Monitoring System (PRAMS) is a research project sponsored by the Centers for Disease Control and Prevention and the <NAME OF HEALTH DEPARTMENT>.

• The purpose of the study is to find out why some babies are born healthy and others are not.

• We are asking <NUMBER> women in <STATE> to answer the same questions. All of your names were picked by a computer from recent birth certificates.

• It takes about <25-35/25-42 minutes> to answer all questions. Some questions may be sensitive, such as questions about smoking or drinking during pregnancy.

• You are free to do the survey or not. If you don't want to participate at all, or if you don't want to answer a particular question, that's okay. There is no penalty or loss of benefits for not participating or answering all questions.

• Your survey may be combined with information the health department has from other sources.

• If you choose to do the survey, your answers will be kept private and will be used only to answer questions related to the purpose of this study.  This is so because this study has been given a Certificate of Confidentiality.  This means that we may not share information that may identify you in legal suits or proceeding, even if a court orders us to do so, unless you say it’s okay. <OPTIONAL STATE-SPECIFIC LANGUAGE BASED ON STATE REPORTING REQUIRMENTS SUCH AS child abuse, elder abuse, harm to self and others. For example: But under the law, we must report to the state suspected cases of child abuse or elder abuse or if you tell us you are planning to cause serious harm to yourself or others.>

• If you are currently in jail, your participation in the study will have no effect on parole.

• Your name will not be on any reports from PRAMS. The booklet has a number so we will know when it is returned.

• Your answers will be grouped with those from other women. What we learn from PRAMS will be used to plan programs to help mothers and babies in <STATE>.

• If you have any questions about your rights in the project, please call <NAME OF A PERSON AT YOUR LOCAL IRB OFFICE> at <PHONE NUMBER>.

If you have questions about PRAMS, or if you want to answer the questions by telephone, please call <PROJECT COORDINATOR=S NAME>, <STATE> PRAMS Project Coordinator, at

1-800-<###-####>.

The call is free.