PRAMS Stillbirth Mail Introduction and Informed Consent (English)

Attachment 12c – Stillbirth Mail Introduction and Informed Consent - English

PRAMS Stillbirth Mail Introduction & Informed Consent - English

Introductory Card (mail, handwritten)

<DATE>

Dear Ms. <MOTHER’S LAST NAME>,

I am writing you from the <State> Department of Health.  From the information we have at the health department, I understand that you recently lost a baby.  I am so sorry for your loss.  I offer my deepest sympathy to you and your family during this time of grieving.  The loss of a baby is devastating, and it is our goal to prevent families from experiencing these losses in the future.

I would like to let you know about a project called <PROJECT NAME> to help us learn why stillbirths happen and how to improve the care that families like yours receive. In the next week, I will send you a survey about your experiences during your pregnancy. I hope that you will choose to answer these questions to help us to improve the services and care families like yours receive in <STATE>.

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

Sincerely,

<PROJECT COORDINATOR’S NAME>

<STATE> <PROJECT NAME> Project Coordinator

Informed Consent Document (mail)

Important Information About <PROJECT NAME>

Please Read Before Starting the Survey

• The <PROJECT NAME> 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 reduce the frequency of stillbirths and save future families from experiencing this devastating loss. Your answers will also be used to improve the care that families receive around the time of loss.

• We are asking all women in <STATE> who had a recent stillbirth to answer the same questions. Your name was identified from recent fetal death certificates.

• It takes about 20-25 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 to the extent allowed by law and will be used only for research. 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 <PROJECT NAME>. 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 <PROJECT NAME> will be used to plan programs to help prevent stillbirths 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 PROJECT NAME>, or if you want to answer the questions by telephone, please call <PROJECT COORDINATOR’S NAME>, <STATE> PROJECT NAME> Project Coordinator, at

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

The call is free.