N1 - Consent

Form Approved
OMB No. 0920-0010
Exp. Date: 01/31/2017
BD-STEPS– Protocol #2087
Introductory Telephone and Informed Consent (English), March 27, 2015

Table of contents:
Introductory Script and Informed Consent (Mother of Living Case/Control Child)……………… pg 2
Introductory Script and Informed Consent (Mother of Stillborn or Deceased Child or TAB)……. pg 6
Introductory Script and Informed Consent (Mother: Affected Pregnancy with Unk Outcome)…. pg 10
Revised Short Telephone Script: Interview Already Scheduled………………………………….. pg 14
CONTINUED Minor Script………………………………………………………………………. pg 15
Parent/Guardian of Minor Script and Informed Consent……………………………………….
pg 15

Public reporting burden of this collection of information is estimated to average 10 minutes, including the time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing
and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to
respond to a collection of information unless it displays a currently valid OMB control number. Send comments
regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing
this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333;
ATTN: PRA (0920-0010).

BD-STEPS
Introductory Telephone Script
and Informed Consent
Mother of Living Case Child or Living Control Child
Hello, may I speak with ? My name is and I am calling about a
health study being conducted by <>
IA INTERVIEWS SKIP TO YES, RECEIVED INFORMATION
Recently, we mailed you some information about the study. Did you receive the information?
[IF SUBJECT ASKS WHERE YOU ARE CALLING FROM OR WHO INTERVIEW CONTRACTOR IS,
STATE: “I am with RTI International; we conduct all the interviews for the study.”]
IF NO (DID NOT RECEIVE INFORMATION):
We are inviting mothers to take part in this study to discover clues about what causes birth defects. To do this, we
are interviewing mothers whose babies had birth defects as well as mothers of babies without birth defects. You
were selected from women who recently had a baby in . The study involves a telephone interview in which
we ask about your health, medications, and lifestyle. We would like you to participate in the study, but first we need
to send you the information about the study. May I get your current address to send you the information?
NO
[SKIP TO UNDECIDED SUBJECT SCRIPTS]
YES [RECORD ADDRESS.] Thank you. Your participation will help us understand more about
the causes of birth defects and their prevention. We will call you back in to answer
questions about the study and see if we can schedule an interview.
IF YES (RECEIVED INFORMATION) [IA SCRIPT RESUMES HERE],
RESPOND TO SUBJECT’S QUESTIONS, THEN CONTINUE READING SCRIPT.
This is a study to discover clues about what causes birth defects. The study is called the Birth Defects Study To
Evaluate Pregnancy exposureS or BD-STEPS, and for it we are interviewing women about their recent pregnancies.
BD-STEPS is a continuation of a previous study called the National Birth Defects Prevention Study. If you have
been pregnant before 2012 it is possible that you have participated in this earlier study that included an hour long
phone interview and cheek cell collection. Did you complete an interview for the National Birth Defects Prevention
Study?
NO/DK/RF [CONTINUE READING SCRIPT]
YES I can’t complete the interview today if you participated in the National Birth Defects Prevention
Study. But, sometimes the names of studies sound familiar. Would you like us to check our records to see if
you participated in the previous study and call you back later?
YES We will call you back as soon as our record check is complete and will give you a chance to
hear more about the study and decide then if you would like to participate. Is there a chance your
name has changed or you might have completed an interview under a different name? If so, please
let me know this name or these names. [RECORD NAME(S)] Thank you again for the time you’ve
spent speaking with me today.
NO
Thank you again for the time you’ve spent speaking with me today. If you change your mind
or if you have any questions, please call 1-888-743-7324. Thank you. Goodbye.”
IntroPhoneScript_March2015

2

INTERVIEWS WHEN MOM’S AGE IS UNKNOWN
OR KNOWN UNDER 18 (AR and NC only)
FOR ALL UNKNOWN AGE:
Before we get started, I need to ask your age. How old are you?
IF 18 YEARS OR OLDER (AR AND NC), CONTINUE TO REGULAR SCRIPT;
IF 15 YEARS OR OLDER (CA, GA, IA, NY, MA), CONTINUE TO REGULAR SCRIPT
IF UNDER 15 “We appreciate your consideration of participation in BD-STEPS. However, our
study procedures prevent us from including you in this study since you are under 15. Thank you again
for the time you’ve spent speaking with me today.”
NC ONLY
(SKIP ABOVE SCRIPT IF KNOWN UNDER 18):
We are interested in having you participate in the study. Because [IF KNOWN UNDER
18: “Our records show…”] you are younger than 18, we are required to ask, do you live with
a parent or guardian?

NO (DOES NOT LIVE WITH PARENT OR GUARDIAN), THEN
CONTINUE TO REGULAR SCRIPT;
YES (DOES LIVE WITH PARENT OR GUARDIAN), THEN CONTINUE
IF 15-17 YEARS (AR) OR 15-17 AND LIVING WITH PARENT (NC)
We are required to ask for your parent or guardian’s permission for you to participate in the study. In order for
them to make that decision, they would need to see the letter and brochure we sent to you. Are you willing to
show these materials to your parent or guardian and discuss your participation with them?

YES (WILLING TO SHARE WITH PARENT), see CONTINUED Minor Script (pg 15)
NO (NOT WILLING TO SHARE WITH PARENT), “Thank you for taking the time to talk to me
about this study today. If you change your mind or if you have any questions, please call 1-888-7437324. Thank you. Goodbye.”

The interview takes about 45 minutes (but we can do it in short sections). It covers a broad range of questions about:
 Your pregnancies
 Your health
 The prescription and non-prescription medicines you may have taken
 Your family background
 Your work
 Your lifestyle, and
 A few questions about your baby’s father
Some of the questions ask about sensitive issues such as sexually transmitted diseases and induced abortions.
Some women interviewed find it emotionally difficult to discuss their pregnancies. There is no other likely risk.
Taking part in the study will not benefit you or your family directly; however, the findings may help others in the
future to prevent birth defects.
IntroPhoneScript_March2015

3

We enclosed a question and answer sheet with the letter we sent you. Do you have any more questions?
ANSWER QUESTIONS
How did you get my name: We are interviewing mothers of babies who had birth defects as well as mothers of
babies without birth defects. Some babies were selected through the surveillance program which
tracks babies born with birth defects. State laws give us permission to review medical records when birth
defects are present. This is how we identified most mothers in the study. We selected mothers whose babies
don’t have birth defects randomly from women who gave birth in the same year. Thousands of women are
taking part in this study. Around 200 mothers of babies diagnosed with a birth defect and 75 mothers of
babies without birth defects will be interviewed each year in . We plan to conduct the study for
at least three years in .
Confidentiality and Certificate of Confidentiality: [REFER TO HUMAN SUBJECTS FACT SHEET.]
We will keep any identifying information that you provide during your interview confidential. This is assured
by a Certificate of Confidentiality that protects your legal rights under the Public Health Service Act (under
section 301[d] of the Public Service Act 42 U.S.C. 241[d]). The Certificate of Confidentiality prevents study
staff from being forced under a court order or other legal action to identify you or anyone else in this study.
This protection lasts forever (even after death) for any persons who were subjects in the research during any
time the certificate was in effect. However, you should understand that the investigators are not prevented
from reporting information obtained from you to authorities in order to prevent serious harm to yourself or
others. Records may be reviewed by officials checking on the quality of the research. Information about you
may be shared with other researchers when and if it has been approved by research review committees. We
will never use any names in reports or publications. If you would like a copy of the Certificate of
Confidentiality for this study, you may call , and a copy will
be sent to you.
Voluntary Participation: The study will give you different opportunities to participate, but all participants will
begin with a telephone interview. <> We might also ask
for your consent to review some of your medical records or for you to complete some additional questions
online. Participation in all parts of this study is voluntary, meaning that it is your choice to take part or not.
For instance, you can do the interview but decide not to <> allow your medical
records to be shared. You are free to withdraw from any or all parts of this study at any time. At any time in
the future, you may have your interview responses <> removed from the study (by
calling ).
Incentive for Interview: We enclosed a $20 gift card with your letter as a token of appreciation for your time
and interest (for the interview).
For More Information: If you’d like more information about the study, please contact . If you have questions about your rights as a subject in this research study,
please call the Office of the Deputy Associate Director for Science for CDC at 1-800-584-8814. Leave a
message including your name, phone number, and refer to Protocol #2087, and someone will call you back as
soon as possible.

You can choose not to participate. The decision not to participate will not affect the care or services you or your
family receives.
You can choose not to answer any specific questions. You are free to stop the interview at any time.
We will share your information with other researchers involved in this study, which may include health information
IntroPhoneScript_March2015

4

about you and your baby and personal information such as where you live. < [FOR CENTERS ELECTING TO

INCLUDE CO-SIBLING CONTROLS] If you are the mother of twins, triplets or other multiples, we will
also include some limited medical information such as sex, date of birth, gestational age, birth weight and
medical diagnoses on all babies from your pregnancy in our study. > Information will only be used for the
purpose of research, and it will be kept confidential. It will only be shared after appropriate approvals are obtained
by the study’s Data Sharing Committee and human research protection committees. We will never use any names or
addresses in reports or publications.
If you have any concerns about the study or how it is conducted, you may contact . If you have questions about your rights as a subject in this research study, please call <> OR <>.
Leave a message including your name, phone number, and refer to Protocol #2087, and someone will call you back
as soon as possible.
My supervisor may listen in from time to time to make sure I’m doing the best job I can. She may also record the
interview as part of her supervision. (If you agree to be interviewed, will it be O.K. for my supervisor to listen? [or
for us to record the interview]?)
YES (OK TO LISTEN IN): VERIFY NAME AND/OR BIRTHDATE OF CHILD. PROCEED WITH
INTERVIEW.
NO (NOT OK TO LISTEN): SET UP “NO MONITORING SIGNAL OR SIGN” FOR SUPERVISOR.
THEN VERIFY NAME AND/OR BIRTHDATE OF CHILD. PROCEED WITH INTERVIEW.
Do you wish to continue/be interviewed?
OR: When would be a convenient time to conduct the telephone interview?
PROBES:
Is there anything else you would like to ask?
We can start now and see how far we get.
We can do the interview in short sections such as 10 or 15-minute sessions, if that would be more convenient.
I can set an appointment with you to call back at a convenient time.
YES (WISH TO BE INTERIEWED LATER):
RECORD DATE AND TIME (INCLUDE TIME ZONE) OF APPOINTMENT.
VERIFY PHONE NUMBER: I need to verify your telephone number where you can be reached for the
interview.
CONFIRM: We have scheduled your appointment on at . Would you please call
us at our toll-free number 1-888-743-7324 if you need to change your appointment?
Would you like us to provide a reminder before your interview appointment?
IF YES, Would you like an email, text or voicemail reminder?
RECORD RESPONSE AND ADDRESS IN TRACKING
Thank you for agreeing to participate in BD-STEPS.

NO (DOES NOT WISH TO BE INTERVIEWED):
[It is fine if you prefer not to tell us, but may we ask you why you have decided not to participate?
If no: Thank you for taking the time to talk to me about the study.
If yes: What is your reason or reasons for not participating?]
[RECORD REASONS. REFER TO UNDECIDED SUBJECT SCRIPTS.]
Thank you for your time in talking with me about this study.
IntroPhoneScript_March2015

5

BD-STEPS
Introductory Telephone Script and Informed Consent
Mother of Stillborn or Deceased Child, or Therapeutic Abortion (TAB)
Hello, may I speak with ? My name is and I am calling about a
health study being conducted by and funded by the Centers for Disease Control and Prevention.
IA INTERVIEWS SKIP TO YES, RECEIVED INFORMATION
Recently, we mailed you some information about the study. Did you receive the information?
[IF SUBJECT ASKS WHERE YOU ARE CALLING FROM OR WHO INTERVIEWER CONTRACTOR
IS, STATE: “I am with RTI International; we conduct all the interviews for the study.”]
NO (DID NOT RECEIVE INFORMATION):
We are inviting families to take part in this study to discover clues about what causes birth defects. You were
selected from women who recently had a pregnancy affected by a birth defect. Your pregnancy was identified
through the surveillance program that tracks pregnancies affected by birth defects. We are sorry about your
loss and extend our deepest sympathy to you. We understand that it may be difficult for you to think and talk about
your experience. However, we are interested in factors that may help prevent birth defects and pregnancy problems
in the future. The study involves a telephone interview in which we ask about your health, medications and lifestyle.
We would like you to participate in the study, but we first need to send you the information about the study. May I
get your current address to send you the information?
NO

[SKIP TO UNDECIDED SUBJECT SCRIPTS]

YES [RECORD ADDRESS.] Thank you. Your participation will help us understand more about
the causes of birth defects and their prevention. We will call you back in to answer
questions about the study and see if we can schedule an interview.
YES (RECEIVED INFORMATION) [IA SCRIPT RESUMES HERE]:
RESPOND TO SUBJECT’S QUESTIONS, THEN CONTINUE READING SCRIPT.
This is a study to discover clues about what causes birth defects. The study is called the Birth Defects Study To
Evaluate Pregnancy exposureS or BD-STEPS, and for it we are interviewing women about their recent pregnancies.
BD-STEPS is a continuation of a previous study called the National Birth Defects Prevention Study. If you have
been pregnant before 2012 it is possible that you have participated in this earlier study that included an hour long
phone interview and cheek cell collection. Did you complete an interview for the National Birth Defects Prevention
Study?
NO/DK/RF [CONTINUE READING SCRIPT]
YES I can’t complete the interview today if you participated in the National Birth Defects Prevention
Study. But, sometimes the names of studies sound familiar. Would you like us to check our records to see if
you participated in the previous study and call you back later?
YES We will call you back as soon as our record check is complete and will give you a chance to
hear more about the study and decide then if you would like to participate. Is there a chance your
name has changed or you might have completed an interview under a different name? If so, please
let me know this name or these names. [RECORD NAME(S)] Thank you again for the time you’ve
spent speaking with me today.
NO
Thank you again for the time you’ve spent speaking with me today. If you change your mind
or if you have any questions, please call 1-888-743-7324. Thank you. Goodbye.”
IntroPhoneScript_March2015

6

INTERVIEWS WHEN MOM’S AGE IS UNKNOWN
OR KNOWN UNDER 18 (AR and NC only)
FOR ALL UNKNOWN AGE:
Before we get started, I need to ask your age. How old are you?
IF 18 YEARS OR OLDER (AR and NC) CONTINUE TO REGULAR SCRIPT;
IF 15 YEARS OR OLDER (CA, GA, IA, NY, MA) CONTINUE TO REGULAR SCRIPT
IF UNDER 15 “We appreciate your consideration of participation in BD-STEPS. However, our
study procedures prevent us from including you in this study since you are under 15. Thank you again
for the time you’ve spent speaking with me today.”
NC ONLY
(SKIP ABOVE SCRIPT IF KNOWN UNDER 18):
We are interested in having you participate in the study. Because [IF KNOWN UNDER
18: “Our records show…”] you are younger than 18, we are required to ask, do you live
with a parent or guardian?

NO (DOES NOT LIVE WITH PARENT OR GUARDIAN), THEN
CONTINUE TO REGULAR SCRIPT;
YES (DOES LIVE WITH PARENT OR GUARDIAN), THEN
CONTINUE
IF 15-17 YEARS (AR), OR 15-17 AND LIVING WITH PARENT (NC)
We are required to ask for your parent or guardian’s permission for you to participate in the study. In order for
them to make that decision, they would need to see the letter and brochure we sent to you. Are you willing to
show these materials to your parent or guardian and discuss your participation with them?

YES (WILLING TO SHARE WITH PARENT), see PARENT SCRIPT
NO (NOT WILLING TO SHARE WITH PARENT), “Thank you for taking the time to talk to
me about this study today. If you change your mind or if you have any questions, please call 1-888743-7324. Thank you. Goodbye.”
The interview takes about 45 minutes (but we can do it in short sections). It covers a broad range of questions about:
 Your pregnancies
 Your health
 The prescription and non-prescription medicines you may have taken
 Your family background
 Your work
 Your lifestyle, and
 A few questions about the baby’s father
Some of the questions ask about sensitive issues such as sexually transmitted diseases and induced abortions.
Some women interviewed find it emotionally difficult to discuss their pregnancies. There is no other likely risk.
Taking part in the study will not benefit you or your family directly; however, the findings may help others in the
future to prevent birth defects.
IntroPhoneScript_March2015

7

We enclosed a question and answer sheet with the letter we sent you. Do you have any more questions?
ANSWER QUESTIONS.
How did you get my name: We are interviewing women who had a pregnancy affected by a birth defect as well
as women whose pregnancies were not affected by a birth defect. You were selected from women who
recently had a pregnancy affected by a birth defect. Your pregnancy was identified through the
surveillance program that tracks pregnancies affected by birth defects. State laws give us permission to review
medical records when birth defects are present. This is how we identified most women in the study. We
selected women whose babies don’t have birth defects randomly from women who gave birth in the same year.
Thousands of women are taking part in this study. Around 200 mothers of babies diagnosed with birth defects
and 75 mothers of babies without birth defects will be interviewed in each year. We plan to conduct
the study for at least three years in .
Confidentiality and Certificate of Confidentiality: [REFER TO HUMAN SUBJECTS FACT SHEET.]
We will keep any identifying information that you provide during your interview confidential. This is assured
by a Certificate of Confidentiality that protects your legal rights under the Public Health Service Act (under
section 301[d] of the Public Service Act 42 U.S.C. 241[d]). The Certificate of Confidentiality prevents study
staff from being forced under a court order or other legal action to identify you or anyone else in this study.
This protection lasts forever (even after death) for any persons who were subjects in the research during any
time the certificate was in effect. However, you should understand that the investigators are not prevented
from reporting information obtained from you to authorities in order to prevent serious harm to yourself or
others. Records may be reviewed by officials checking on the quality of the research. Information about you
may be shared with other researchers when and if it has been approved by research review committees. We will
never use any names in reports or publications. If you would like a copy of the Certificate of Confidentiality for
this study, you may call , and a copy will be sent to you.
Voluntary Participation: The study will give you different opportunities to participate, but all participants will
begin with a telephone interview. We might also ask for your consent to review some of your medical records
or for you to complete some additional questions online. Participation in all parts of this study is voluntary,
meaning that you have the choice to take part or not. For instance, you can do the interview but decide not to
allow your medical records to be shared. You are free to withdraw from any or all parts of this study at any
time. At any time in the future, you may have your interview responses or biologic samples removed from the
study (by calling ).
Incentive for Interview: We enclosed a $20 gift card as a token of appreciation for your time and interest (for
the interview).
For More Information: If you’d like more information about the study, please contact . If you have questions about your rights as a subject in this research study,
please call the Office of the Deputy Associate Director for Science for CDC at 1-800-584-8814. Leave a
message including your name, phone number, and refer to Protocol #2087, and someone will call you back as
soon as possible.

You can choose not to participate. This decision will not affect the care or services you or your family receives.
You can choose not to answer any specific questions. You are free to stop the interview at any time.
We will share your information with other researchers involved in this study, which may include information about
your health and personal information such as where you live. < [FOR CENTERS ELECTING TO INCLUDE

CO-SIBLING CONTROLS] If you are the mother of twins, triplets or other multiples, we will also include
some limited medical information such as sex, date of birth, gestational age, birth weight and medical
IntroPhoneScript_March2015

8

diagnoses on all babies from your pregnancy in our study. >Information will only be used for the purpose of
research, and it will be kept confidential. It will only be shared after appropriate approvals are obtained by the
study’s Data Sharing Committee and human research protection committees. We will never use any names or
addresses in reports or publications.
If you have any concerns about the study or how it is conducted, you may contact . If you have questions about your rights as a subject in this research study, please call the Office
of the Deputy Associate Director for Science for CDC at 1-800-584-8814. Leave a message including your name,
phone number, and refer to Protocol #2087, and someone will call you back as soon as possible.
My supervisor may listen in from time to time to make sure I’m doing the best job I can. She may also record the
interview as part of her supervision. (If you agree to be interviewed, will it be O.K. for my supervisor to listen or for
us to record the interview?)
YES (OK TO LISTEN IN): VERIFY NAME AND/OR BIRTHDATE OF CHILD. PROCEED WITH
INTERVIEW.
NO (NOT OK TO LISTEN): SET UP “NO MONITORING SIGNAL OR SIGN” FOR SUPERVISOR.
THEN VERIFY NAME AND/OR BIRTHDATE OF CHILD. PROCEED WITH INTERVIEW.
Do you wish to continue/be interviewed?
OR: When would be a convenient time to conduct the telephone interview?
PROBES:
Is there anything else you would like to ask?
We can start now and see how far we get.
We can do the interview in short sections such as 10 or 15-minute sessions, if that would be more convenient.
I can set an appointment with you to call back at a convenient time.
YES (WISH TO BE INTERVIEWED LATER):
RECORD DATE AND TIME (INCLUDE TIME ZONE) OF APPOINTMENT.
VERIFY PHONE NUMBER: I need to verify your telephone number where you can be reached for the interview.
CONFIRM: We have scheduled your appointment on at . Would you please call us at our
toll-free number <1-888-743-7324> if you need to change your appointment?
Would you like us to provide a reminder before your interview appointment?
IF YES, Would you like an email, text or voicemail reminder?
RECORD RESPONSE AND ADDRESS IN TRACKING
Thank you for agreeing to participate in BD-STEPS.
NO (DOES NOT WISH TO BE INTERVIEWED):
It is fine if you prefer not to tell us, but may we ask you why you have decided not to participate?
If no: Thank you for taking the time to talk to me about the study.
If yes: What is your reason or reasons for not participating?
[RECORD REASONS. REFER TO UNDECIDED SUBJECT SCRIPTS.]

Thank you for your time in talking with me about this study.

IntroPhoneScript_March2015

9

BD-STEPS
Introductory Telephone Script
and Informed Consent
Mother: Affected Pregnancy with Unknown Outcome
Hello, may I speak with ? My name is and I am calling about a
health study being conducted by and funded by the Centers for Disease Control and Prevention.
IA INTERVIEWS SKIP TO YES, RECEIVED INFORMATION
Recently, we mailed you some information about the study. Did you receive the information?
[IF SUBJECT ASKS WHERE YOU ARE CALLING FROM OR WHO INTERVIEWER CONTRACTOR
IS, STATE: “I am with RTI International; we conduct all the interviews for the study.”]
NO (DID NOT RECEIVE INFORMATION):
We are inviting families to take part in this study to discover clues about what causes birth defects. You were
selected from women who recently had a pregnancy affected by a birth defect. We are interested in factors that may
help prevent birth defects and pregnancy problems. The study involves a telephone interview about your health,
medications, and lifestyle. We would like you to participate in the study, but first need to send you the information
about the study in more detail. May I get your current address to send you the information?
NO

[SKIP TO UNDECIDED SUBJECT SCRIPTS]

YES [RECORD ADDRESS.] Thank you. Your participation will help us understand more about
the causes of birth defects and their prevention. We will call you back in [time period] to answer
questions about the study and see if we can schedule an interview
YES (RECEIVED INFORMATION) [IA INTERVIEW RESUMES HERE]:
RESPOND TO SUBJECT’S QUESTIONS, THEN CONTINUE READING SCRIPT.
This is a study to discover clues about what causes birth defects. The study is called the Birth Defects Study To
Evaluate Pregnancy exposureS or BD-STEPS, and for it we are interviewing women about their recent pregnancies.
BD-STEPS is a continuation of a previous study called the National Birth Defects Prevention Study. If you have
been pregnant before 2012 it is possible that you have participated in this earlier study that included an hour long
phone interview and cheek cell collection. Did you complete the interview for the National Birth Defects Prevention
Study?
NO/DK/RF [CONTINUE READING SCRIPT]
YES I can’t complete the interview today if you participated in the National Birth Defects Prevention
Study. But, sometimes the names of studies sound familiar. Would you like us to check our records to see if
you participated in the previous study and call you back later?
YES We will call you back as soon as our record check is complete and will give you a chance to
hear more about the study and decide then if you would like to participate. Is there a chance your
name has changed or you might have completed an interview under a different name? If so, please
let me know this name or these names. [RECORD NAME(S)] Thank you again for the time you’ve
spent speaking with me today.
NO
Thank you again for the time you’ve spent speaking with me today. If you change your mind
or if you have any questions, please call 1-888-743-7324. Thank you. Goodbye.”
IntroPhoneScript_March2015

10

INTERVIEWS WHEN MOM’S AGE IS UNKNOWN
OR KNOWN UNDER 18 (AR and NC only)
FOR ALL UNKNOWN AGE:
Before we get started, I need to ask your age. How old are you?
IF 18 YEARS OR OLDER (AR AND NC) CONTINUE TO REGULAR SCRIPT;
IF 15 YEARS OR OLDER (CA, GA, IA, NY, MA) CONTINUE TO REGULAR SCRIPT
IF UNDER 15 “We appreciate your consideration of participation in BD-STEPS. However, our
study procedures prevent us from including you in this study since you are under 15. Thank you again
for the time you’ve spent speaking with me today.”
NC ONLY
(SKIP ABOVE SCRIPT IF KNOWN UNDER 18):
We are interested in having you participate in the study. Because [IF KNOWN UNDER 18:
“Our records show…”] you are younger than 18, we are required to ask, do you live with a
parent or guardian?

IF NO (DOES NOT LIVE WITH PARENT OR GUARDIAN), THEN
CONTINUE TO REGULAR SCRIPT;
IF YES (DOES LIVE WITH PARENT OR GUARDIAN), THEN
CONTINUE
IF 15-17 YEARS (AR) OR 15-17 AND LIVING WITH PARENT (NC)
We are required to ask for your parent or guardian’s permission for you to participate in the study. In order for
them to make that decision, they would need to see the letter and brochure we sent to you. Are you willing to
show these materials to your parent or guardian and discuss your participation with them?

YES (WILLING TO SHARE WITH PARENT), see PARENT SCRIPT
NO (NOT WILLING TO SHARE WITH PARENT), “Thank you for taking the time to talk to me
about this study today. If you change your mind or if you have any questions, please call 1-888-743-7324.
Thank you. Goodbye.”
The interview takes about 45 minutes (but we can do it in short sections). It covers a broad range of questions about:
 Your pregnancies
 Your health
 The prescription and non-prescription medicines you may have taken
 Your family background
 Your work
 Your lifestyle
 A few questions about the baby’s father
Some of the questions ask about sensitive issues such as sexually transmitted diseases and induced abortions.
Some women interviewed find it emotionally difficult to discuss their pregnancies. There is no other likely risk.
Taking part in the study will not benefit you or your family directly; however, the findings may help others in the
future to prevent birth defects.

IntroPhoneScript_March2015

11

We enclosed a question and answer sheet with the letter we sent you. Do you have any more questions?
ANSWER QUESTIONS.
How did you get my name: We are interviewing women with healthy babies as well as women who had a
pregnancy affected by a birth defect. You were selected from women who recently had a pregnancy affected
by a birth defect. Your pregnancy was identified through the surveillance program that tracks babies
with birth defects. (State laws give us permission to review medical records when birth defects are present.
This is how we identified most women in the study.) Women whose babies don’t have birth defects were
selected randomly from women who gave birth in the same year. Thousands of women are taking part in this
national study. Around 200 mothers of babies diagnosed with birth defects and 75 mothers of healthy babies
will be interviewed each year. We plan to conduct the study for at least three years in .
Confidentiality and Certificate of Confidentiality: [REFER TO HUMAN SUBJECTS FACT SHEET.]
We will keep any identifying information that you provide during your interview confidential. This is assured
by a Certificate of Confidentiality that protects your legal rights under the Public Health Service Act (under
section 301[d] of the Public Service Act 42 U.S.C. 241[d]). The Certificate of Confidentiality prevents study
staff from being forced under a court order or other legal action to identify you or anyone else in this study.
This protection lasts forever (even after death) for any persons who were subjects in the research during any
time the certificate was in effect. However, you should understand that the investigators are not prevented
from reporting information obtained from you to authorities in order to prevent serious harm to yourself or
others. Records may be reviewed by officials checking on the quality of the research. Information about you
may be shared with other researchers when and if it has been approved by research review committees. We
will never use any names in reports or publications. If you would like a copy of the Certificate of
Confidentiality for this study, you may call , and a copy
will be sent to you.
Voluntary Participation in Interview and Other Parts: The study will give you different opportunities to
participate, but all participants will begin with a telephone interview. We might also ask for your consent to
review some of your medical records or for you to complete some additional questions online. Participation
in all parts of this study is voluntary, meaning that it is your choice to take part or not. For instance, you can
do the interview but decide not to allow your medical records to be shared. You are free to withdraw from
any or all parts of this study at any time. At any time in the future, you may have your interview responses
removed from the study (by calling ).
Incentive for Interview: We enclosed a $20 gift card as a token of appreciation for your time and interest
(for the interview).
For More Information: If you’d like more information about the study, please contact . If you have questions about your rights as a subject in this research study,
please call the Office of the Deputy Associate Director for Science for CDC at 1-800-584-8814. Leave a
message including your name, phone number, and refer to Protocol #2087, and someone will call you back as
soon as possible.

You can choose not to participate. This decision will not affect the care or services you or your family receives.
You can choose not to answer any specific questions. You are free to stop the interview at any time.
We will share your information with other researchers involved in this study, which may include information about
your health and personal information such as where you live. < [FOR CENTERS ELECTING TO INCLUDE

CO-SIBLING CONTROLS] If you are the mother of twins, triplets or other multiples, we will also include
some limited medical information such as sex, date of birth, gestational age, birth weight and medical
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diagnoses on all babies from your pregnancy in our study. >Information will only be used for the purpose of
research, and it will be kept confidential. It will only be shared after appropriate approvals are obtained by the
study’s Data Sharing Committee and human research protection committees. We will never use any names or
addresses in reports or publications.
If you have any concerns about the study or how it is conducted, you may contact . If you have questions about your rights as a subject in this research study, please call the Office
of the Deputy Associate Director for Science for CDC at 1-800-584-8814. Leave a message including your name,
phone number, and refer to Protocol #2087, and someone will call you back as soon as possible.
My supervisor may listen in from time to time to make sure I’m doing the best job I can. She may also record the
interview as part of her supervision. (If you agree to be interviewed, will it be O.K. for my supervisor to listen or for
us to record the interview?)
YES (OK TO LISTEN IN): VERIFY NAME AND/OR BIRTHDATE OF CHILD. PROCEED WITH
INTERVIEW.
NO (NOT OK TO LISTEN): SET UP “NO MONITORING SIGNAL OR SIGN” FOR SUPERVISOR.
THEN VERIFY NAME AND/OR BIRTHDATE OF CHILD. PROCEED WITH INTERVIEW.

Do you wish to continue/be interviewed?
OR: When would be a convenient time to conduct the telephone interview?
PROBES:
Is there anything else you would like to ask?
We can start now and see how far we get.
We can do the interview in short sections such as 10 or 15-minute sessions, if that would be more convenient.
I can set an appointment with you to call back at a convenient time.
YES (WISH TO BE INTERVIEWED LATER):
RECORD DATE AND TIME (INCLUDE TIME ZONE) OF APPOINTMENT.
VERIFY PHONE NUMBER: I need to verify your telephone number where you can be reached for the interview.
CONFIRM: We have scheduled your appointment on at . Would you please call us at our
toll-free number <1-888-743-7324> if you need to change your appointment?
Would you like us to provide a reminder before your interview appointment?
IF YES, Would you like an email, text or voicemail reminder?
RECORD RESPONSE AND ADDRESS IN TRACKING
Thank you for agreeing to participate in BD-STEPS.

NO (DOES NOT WISH TO BE INTERVIEWED):
[(REVISED) It is fine if you prefer not to tell us, but may we ask you why you have decided not to participate?
If no: Thank you for taking the time to talk to me about the study.
If yes: What is your reason or reasons for not participating?]
[RECORD REASONS. REFER TO UNDECIDED SUBJECT SCRIPTS.]

Thank you for your time in talking with me about this study.

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BD-STEPS
Revised Short Telephone Script:
Interview Already Scheduled
[SHORT VERSION OF SCRIPT FOR WOMEN WHO ALREADY CONSENTED AT THE TIME THE
INTERVIEW WAS SCHEDULED – FULL CONSENT SCRIPT WAS PREVIOUSLY READ TO SUBJECT.
THE INTERVIEW BEGINS WITH THIS REMINDER.]

Hello, may I speak with ? My name is and I am calling for the
Birth Defects Study To Evaluate Pregnancy exposureS or BD-STEPS. Recently, you scheduled an interview
for this time. Is this still a convenient time to conduct the interview?
[IF SUBJECT ASKS WHERE YOU ARE CALLING FROM OR WHO Interviewer contractor IS, STATE:
“I am with RTI International; we conduct all the interviews for the study >
NO (NOT A CONVENIENT TIME):
When would be a more convenient time for me to call you to conduct the interview?
RECORD DATE AND TIME (INCLUDE TIME ZONE) OF NEW APPOINTMENT.
VERIFY PHONE NUMBER: I need to verify your telephone number where you can be reached for the
interview.
CONFIRM: We will call you on at on . Would you please
call us at our toll-free number <1-888-743-7324> if you need to change your appointment?
Would you like us to provide a reminder before your interview appointment?
IF YES, Would you like an email, text or voicemail reminder?
RECORD RESPONSE AND ADDRESS IN TRACKING
Thank you. We look forward to talking with you later.

YES (CONVENIENT TIME NOW):
Thank you for agreeing to participate. I want to remind you that:
All your answers are confidential.
You can choose not to answer any specific questions.
You are free to stop the interview at any time
IF NOT PREVIOUSLY ASKED:
My supervisor may listen in from time to time to make sure I’m doing the best job I can. She may also record the
interview as part of her supervision. (If you agree to be interviewed, will it be O.K. for my supervisor to listen or for
us to record the interview?)
IF YES (OK TO LISTEN IN): VERIFY NAME AND/OR BIRTHDATE OF CHILD. PROCEED WITH
INTERVIEW.
IF NO (NOT OK TO LISTEN): SET UP “NO MONITORING SIGNAL OR SIGN” FOR SUPERVISOR.
THEN VERIFY NAME AND/OR BIRTHDATE OF CHILD. PROCEED WITH INTERVIEW.

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BD-STEPS
CONTINUED Minor Script
IF YES (WILLING TO SHARE WITH PARENT):
Thank you very much. What is your parent or guardian’s name? Is that Mr. or Ms. or Mrs. or Dr.? ____
RELATIONSHIP: mother__, father__, stepmother__, stepfather__, guardian__, OTHER, SPECIFY______
When is a good time to speak to ?

Day _________ Time ________

Is there another phone number at which we could reach ?____________
Also, can call us at our toll-free number 1-888-743-7324 if she has any questions. I will call your
at the time and number you suggested. Thank you very much for your time.

BD-STEPS
Parent/Guardian of Minor Script
And Informed Consent
Hello, may I speak with _______? My name is and I am calling about a health study
being conducted by and funded by the Centers for Disease Control and Prevention.
[FOR LIVING CASE/CONTROL CHILD]:
We are inviting mothers to take part in this study to discover clues about what causes birth defects. To do this, we
are interviewing mothers whose babies had birth defects as well as mothers of babies without birth defects. [Your
daughter OR MOIB NAME] was selected from women who recently had a baby in .
[FOR STILLBORN OR DECEASED CHILD OR THERAPEUTIC ABORTION (TAB)]:
We are inviting women to take part in this study to discover clues about what causes birth defects. To do this, we are
enrolling women in hoping to discover clues about what causes birth defects. was selected from women who recently had a pregnancy affected by a birth defect. Her pregnancy was
identified through the surveillance program that tracks pregnancies affected by birth defects. We are sorry
about her loss and extend our deepest sympathy to your family. We understand that it may be difficult for her to
think and talk about her experience. However, we are interested in factors that may help prevent birth defects and
pregnancy problems in the future.
[FOR AFFECTED PREGNANCY WITH UNKNOWN OUTCOME]:
We are inviting mothers to take part in this study to discover clues about what causes birth defects. To do this, we
are interviewing mothers whose babies had birth defects as well as mothers of babies without birth defects. was selected from women who recently had a pregnancy affected by a birth defect.
We are interested in factors that may help prevent birth defects and pregnancy problems.
[IF SUBJECT ASKS WHERE YOU ARE CALLING FROM OR WHO INTERVIEW CONTRACTOR IS,
STATE: “I am with RTI International; we conduct all the interviews for the study.”]
The study involves a telephone interview about ’s health, diet, and lifestyle.
Since she is not yet 18, we are required to ask if you will allow her to participate in the study. We want to include
young women in our study because birth defects sometimes occur among their pregnancies, as well as those of older
women.
Recently we mailed a packet to asking her to participate in the research study.
Have you had a chance to look at the letter and information we sent to her?
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NO (HAVE NOT RECEIVED INFORMATION):
When would be a good time to call you back?

Day _____________ Time ____________

YES (HAVE RECEIVED INFORMATION): Would you like some more information about the study?
YES (WOULD LIKE MORE INFORMATION):
RESPOND TO PARENT/GUARDIAN’S QUESTIONS; ASK IF PARENT/GUARDIAN HAS
QUESTIONS.
NO (WOULD NOT LIKE MORE INFORMATION):
CONTINUE:
The interview takes about 45 minutes (but we can do it in short sections). It covers a broad range of
questions about:
 ’s pregnancies
 ’s health
 The prescription and non-prescription medicines may
have taken
 ’s family background
 ’s work
 ’s lifestyle, and
 A few questions about ’s baby’s father
Some of the questions ask about sensitive issues such as sexually transmitted diseases and induced abortions.
Some women interviewed find it emotionally difficult to discuss their pregnancies. There is no other likely risk.
Taking part in the study will not benefit or your family directly; however, the
findings may help others in the future to prevent birth defects.
can choose not to participate. The decision not to participate will not affect
the care or services or your family receives.
can choose not to answer any specific questions. is free to stop the interview at any time.
We will share your information with other researchers involved in this study, which may include health information
about …
’s baby…>
…and personal information such as where she lives. Information will only be used for the purpose of research, and it
will be kept confidential. It will only be shared after appropriate approvals are obtained by the study’s Data Sharing
Committee and human research protection committees. We will never use any names or addresses in reports or
publications.
If you have any concerns about the study or how it is conducted, you may contact . If you have questions about your rights as a subject in this research study, please call <> OR <>. Leave a message including your name, phone number, and refer to Protocol #2087, and someone will
call you back as soon as possible.
My supervisor may listen in from time to time to make sure I’m doing the best job I can. She may also record the
interview as part of her supervision. If does agree to be interviewed, will it be
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16

O.K. for my supervisor to listen [or for us to record the interview]?

YES (OK TO LISTEN IN): VERIFY NAME AND/OR BIRTHDATE OF CHILD. PROCEED WITH
INTERVIEW.
NO (NOT OK TO LISTEN): SET UP “NO MONITORING SIGNAL OR SIGN” FOR SUPERVISOR.
THEN VERIFY NAME AND/OR BIRTHDATE OF CHILD. PROCEED WITH INTERVIEW.

Do you give permission for [your daughter OR MOIB NAME> to participate in the interview?
NO (DOES NOT GIVE PERMISSION):
Thank you very much for your time. GO TO IF NO BELOW.
YES (GIVES PERMISSION):
Thank you. We appreciate your help in gathering information for this important study. May we confirm your
first and last name to indicate your consent in our records?
First Name: __________ Middle name/initial if provided: ___ Last Name:_________________________
What is your relationship to MOIB? Mother, Father, Stepmother, Stepfather, Guardian, or OTHER, SPECIFY?
We will call (MOIB NAME) to set up a convenient time to conduct the telephone interview, or if she is available
now, we can explain the study to her, or begin the interview if she wants to participate.
Time convenient for :
Day _________________ Time ____________________
RECORD DATE AND TIME (INCLUDE TIME ZONE).
VERIFY PHONE #: I need to verify the telephone number where (MOIB NAME) can be reached for the interview.
CONFIRM: She can call us at our toll-free number 1-888-743-7324 if she has any questions.
Thank you for your cooperation/help in the Birth Defects Study To Evaluate Pregnancy exposureS or BD-STEPS.
This is an important study to determine the causes of birth defects. It’s important to include young women because
birth defects among the pregnancies of young women as well as older women need to be studied.
IF NO: We would like to know for what reason or reasons you prefer that not participate.
[RECORD REASONS]
Thank you for your time in talking with me about this study.

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