BD-STEPS– Protocol #2087
Saliva Introductory Letter Living (English), 11/5/2013
Ms. «motherfirstname» «motherlastname»
«address1»
«address2»
«city», «state» «zip»
Dear Ms. «motherlastname»:
Recently, you completed a telephone interview for the Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS). This study will help us learn more about the causes of birth defects.
Birth defects researchers across the country are working on this study in partnership with the Centers for Disease Control and Prevention.
To better understand genetic factors that may contribute to birth defects, we are asking parents to collect saliva (spit) samples from themselves and their child using the enclosed kit. Saliva samples are collected from children by rubbing the inside of their cheeks with soft sponges. Saliva samples are collected from parents by spitting into a funnel connected to a small collection tube. <<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>. For every baby born in <State>, a few drops of blood are dried on a card to test for rare conditions. After the tests are done, there are usually some blood spots leftover.>> The saliva <<and blood-spot>> samples will allow us to study genetic factors that may contribute to the causes of birth defects.
You or your family’s participation is voluntary, meaning you can choose to take part or not. And, you may withdraw your samples at any time.
Please read the enclosed information called “Informed Consent for Saliva Samples.” If you choose to participate in the study, please sign the consent form and return it with your saliva samples. A second copy of the consent form is enclosed for your records. We’ve included a $20 gift card to thank you for your time, which you can use even if you don’t participate. We will send you an additional $20 gift card after we receive the saliva samples to thank you for the time you took to complete the study.
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 contact name and local contact number>.
Thank you for helping us to better understand and prevent birth defects.
Sincerely,
<Insert local PI name and local contact>
Enclosures
| File Type | application/msword |
| File Title | Form G |
| Author | Gayle Robertson |
| Last Modified By | Newsome, Kimberly (CDC/ONDIEH/NCBDDD) |
| File Modified | 2013-11-06 |
| File Created | 2013-11-06 |