O - Intro Letter

AttO_IntroLetter_Nov5.docx

Birth Defects Study to Evaluate Pregnancy exposureS (BD-STEPS)

O - Intro Letter

OMB: 0920-0010

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BD-STEPS– Protocol #2087

Introductory Letter (English), 11/5/2013

January 28, 2021 


«motherfirstname» «motherlastname»

«Address1»

«Address2»

«City», «State» «Zip»


Dear Ms. «motherlastname»:


We invite you to participate in the Birth Defects Study To Evaluate Pregnancy exposureS (BDSTEPS). In <state>, this study is being conducted by <<state grantee and the State Birth Defects Monitoring Program> or <State grantee Birth Defects Monitoring Program>>. It is funded by the Centers for Disease Control and Prevention. The study will help us understand why one out of every 33 babies is born with a birth defect. We plan to speak with women who had pregnancies affected by birth defects as well as women whose babies did not have birth defects.


State laws give the <State Birth Defects Monitoring Program> permission to review medical records to study causes of birth defects. This is how we identified most women for the study. Women whose babies do not have birth defects were selected randomly from women who gave birth in the same year.

Our interviewers will call you soon to ask you to do a telephone interview that takes about 45 minutes. The interview can be done in one call or in several shorter calls at a time that is convenient for you. We are here

<Monday-Friday 9am – 9pm, Saturday 10am – 4pm, and Sunday 5pm – 9pm EST adjust times for appropriate time zone>. The interview asks about your health, medication use, and lifestyle during your recent pregnancy and the month before your pregnancy. We will keep any identifying information that you provide during your interview confidential.


After the interview is done, we will send you a kit in the mail to collect saliva (spit) samples. The kit contains easy-to-follow instructions and all the materials you need for collecting samples. <We will also ask for your consent to request a leftover newborn blood spot that was already collected shortly after your baby’s birth by the < Screening Program>. The saliva <<and blood-spot>> samples will allow us to study genetic (inherited) factors that may contribute to the causes of birth defects. If you do not want to provide saliva samples <<or allow us to request a leftover blood spot>>, we would still like you to do the telephone interview.


Our interviewers will call you within the next two weeks for the interview. Before then, if you have any questions, please feel free to call the interviewers at our toll free number, 1-888-743-7324, or email them at [email protected]. You may also call me at < insert local contact number>. If you do not want to participate, please let us know.

We’ve enclosed a $20 gift card as a token of appreciation for your time and interest. This is yours to keep whether or not you do the interview. Saliva collection kits will be sent after the interview and will include another $20 gift card. If you return your saliva kit to us, we will send you a third $20 gift card as a token of appreciation for your time and interest.


Thousands of women across the country are taking part in this important research. This study will help us better understand the causes of birth defects. We hope that you will be a part of this effort. Thank you for considering this request.


Sincerely,

< Insert PI name and local contact information >

Enclosures

File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
File TitleIntro letter Interview Case Live
AuthorKatherine G Seib
File Modified0000-00-00
File Created2021-01-28

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