Att L_Intoductory Letter

The National Birth Defects Prevention Study – Protocol #2087, Attachment 18

Introductory Letter (English), revised 1/5/07

Date

<Subject’s Name>

<Address>

<City, State Zipcode>

Dear Ms. <Last Name>:

The National Centers for Disease Control and Prevention and the <Center>, along with <seven> other states, are trying to understand why one out of every 33 babies are born with birth defects. To do this, we need to speak with women who delivered a baby without a birth defect as well as <mothers whose babies had birth defects/ women who had a pregnancy affected by a birth defect > as part of the National Birth Defect Prevention Study. We would like to invite you to join us in this important project.

If you agree to participate, you will be asked to complete a telephone interview that takes about an hour. The interview can be done in one call or in several shorter calls at a time that is convenient for you. We will ask you questions about your health, diet, and lifestyle during your recent pregnancy. Any information that could identify you will be kept private.

When the telephone interview is finished, you will receive a kit in the mail containing a soft <brush similar to a small toothbrush>. We are asking parents to collect cheek cells from themselves <and their infants> by rubbing the inside of the cheek with the soft <brush >. This sample will provide cell material for valuable genetic research. If you do not want to provide cheek cells, we would still like you to complete the telephone interview.

We will call you within two weeks to arrange the telephone interview. If you would rather call us to schedule an interview, please call our toll free number at <1-877-719-2027>.

We have enclosed a pamphlet with answers to the questions women commonly ask about the study and a Fact Sheet about your rights as a research subject. If you’d like more information, contact <Dr. Margaret Honein> at <(404) 498-4315>. Also enclosed is a $20 money order to thank you for your time. This money order is yours to keep whether or not you participate in the study. After the interview, a cheek cell kit will be sent with an additional $20 money order. And if you complete the entire study (interview plus the cheek cell sample), we will send you a third $20 money order when we receive your cheek cell sample to compensate you for your time.

Thousands of women are taking part in this national study that is being conducted in eight states. We hope you will help us with this important research so that more women can have healthy babies. Thank you for considering this request.

Sincerely,

<Dr. Jennita Reefhuis>

<Address>

Enclosures