Core Thank You 2

BD-STEPS– Protocol #2087

Att27 Interview Thank You and Infectious Disease and optional MULTIPLE Bloodspot Intro Letter (English) BD2, November 19,2020

July 20, 2024

Ms. «motherfirstname» «motherlastname»

«address1»

«address2»

«city», «state» «zip»

Dear Ms. «motherlastname»:

On behalf of the Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS), we want to thank you for allowing us to interview you for our study. Your willingness to participate has been most valuable to us and will be of value to other women and children in the future. <We have included a $30 gift card to thank you for your time.> You can continue to participate in BD-STEPS, which will help us better understand what causes birth defects and other pregnancy problems.

<<All except NC: To help us understand more about how infectious diseases before and during pregnancy may contribute to birth defects and other pregnancy problems, we are asking for your permission to request your infectious disease information that was already reported by your physician to the <INSERT State Health Department/Agency>. Please read the enclosed information called “Informed Consent for Release of Infectious Disease Results.” If you choose to participate, please sign the consent form and return it to us in the postage-paid envelope. A second copy of the consent form is enclosed for your records. After we receive the signed consent form, we will mail you a $10 gift card as a token of appreciation for your time and interest.>

<NC only: To help us understand more about how infectious diseases before and during pregnancy may contribute to birth defects and other pregnancy problems, we are asking for your permission to request your infectious disease information that was already reported by your physician to the <INSERT State Health Department/Agency>. Please read the enclosed information called “Informed Consent for Release of Infectious Disease Results” and “This release is for the NC Division of Public Health Communicable Disease Branch.” If you choose to participate, please sign the consent form and the release form and return them to us in the postage-paid envelope. A second copy of both forms are enclosed for your records. After we receive the signed consent and release forms, we will mail you a $10 gift card as a token of appreciation for your time and interest.>>

<<We are also asking for your permission to request some of the leftover heel stick blood that was already collected shortly after your babies’ birth by the < Screening Program>. Since your baby was part of a <twin/triplet/multiple> birth, we would also like to request some of the leftover newborn bloodspots from your baby’s <twin/triplet/multiple> live born sibling<>. Multiple births are especially informative for researchers who study genetics and birth defects. You can decide to share the leftover newborn bloodspots for <one/some> but not <both/all> of your <twins/triplets/multiples>.

<All except NC: Please read the enclosed information called “Informed Consent for Release of Leftover Newborn Bloodspots For Mothers of Multiples.” If you choose to participate, please sign the consent form and return it to us in the postage-paid envelope. A second copy of the consent form is enclosed for your records. After we receive the signed consent form, we will mail you a $10 gift card as a token of appreciation for your time and interest.>

<NC only: Please read the enclosed information called “Informed Consent for Release of Leftover Newborn Bloodspots For Mothers of Multiples” and “This authorization is for the NC State Laboratory of Public Health.” If you choose to participate, please complete and sign both the consent form and an authorization form for each child for whom you wish to provide permission and return them to us in the postage-paid envelope. A second copy of the consent form and authorization form are enclosed for your records. After we receive the signed consent form and authorization form, we will mail you a $10 gift card as a token of appreciation for your time and interest.>>

<<AR & MA only: Also, we may invite you soon or in the future to participate in other parts of BD-STEPS. Some parts may include a gift card for your time.>>

To keep participants informed, we publish an electronic newsletter every year that updates participants on the progress of the study. You can access this newsletter at www.BDSTEPS.org.

<<All except NC: If you have any questions, please contact one of our study staff at 1-888-743-7324 or you can contact me at <Local PI/Study Coordinator contact name and local contact number>.

<NC only: If you have any questions about the study or if you need assistance completing the forms, please contact the North Carolina Project Director, Diana Urlaub, at 1‑877‑204‑5994.>>

Thank you for helping us to better understand and prevent birth defects and other pregnancy problems.

Sincerely,

<Insert local PI name and local contact>

Enclosures