Form 1c Survey

OMB# 0925-0543
Exp.06/30/2010

LIFE Study Screening Questionnaire
Selected Male with Female Partner Version
Q1. Hello, my name is ___________, and I am calling from _______________. I am trying to
reach (selected man’s first and last name) about an important health-related study that we
are conducting. May I please speak with him
If unavailable (Proceed to Q2) .................................................................................1
If speaking (Skip to Q3) ...........................................................................................2
If available (Skip to Q3a) .........................................................................................3
Wrong number (Thank and end call) .......................................................................8
Refused (Probe for reason, thank and end call)........................................................9
Reason for refusal:_______________________________________________
Q2.

Could you please tell me when would be a good time to reach him?
Indicate day/time (Thank and end call):_____________________________
Refused (Thank and end call)...................................................................................9
Reason for refusal:__________________________________________

Q3. (If selected man is speaking) As I mentioned, I am calling from _____________, and we
are contacting (anglers/men) in the area to see if they would be interested in participating in
a study about how the environment might affect a couple’s ability to have a baby. To help
me determine if you are eligible to participate in this important project, I’d like to ask you a
few questions. This short interview will take about 5 to 10 minutes to complete. Is now a
good time for you?
No
Yes

.....................................................................................................................0
.....................................................................................................................1

Refused (Thank and end call)...................................................................................9
Reason for refusal:____________________________________________
Q3a. (When selected man comes to the phone) Hello, my name is ___________, and I am
calling from ___________________. We are contacting (anglers/men) in the
_____________ area to see if they would be interested in participating in a study about how
the environment might affect a couple’s ability to have a baby. To help me determine if
you are eligible to participate in this important project, I’d like to ask you a few questions.
This short interview will take about 5 to 10 minutes to complete. Is now a good time for
you?
No
Yes

.....................................................................................................................0
.....................................................................................................................1

Refused (Thank and end call)...................................................................................9
Reason for refusal:____________________________________________

OMB# 0925-0543
Exp.06/30/2010

Q4. I’d like to schedule a time to call you back to complete the short interview. What is the best
time to reach you?
Specify day/time: ________________________ (Thank and terminate)
9999

Refused (Probe for reason, thank and terminate)
Reason:_______________________________

Q5. Before I begin, I would like to take a moment to provide you with some additional
information about the interview.
(Read informed consent passage – see Appendix A, Male Consent Passage)
Do you have any questions?
0
1

No (Continue to Q6)
Yes (Answer questions, verify that respondent understands answers, and continue
to Q6)

Q6. By agreeing to participate in this interview, you are indicating that:
•
•
•
•

You have had the purpose of the interview explained to you;
You have had the risks and benefits of participation explained to you;
You have had the opportunity to ask questions about things that you did not
understand;
You willingly give your consent to voluntarily participate.

Are you willing to participate in this short interview?
0
1

No (Probe for reason, thank and terminate)
Reason:___________________________
Yes (Continue to Q7)

Q7. Are you at least 18 years of age?
0
1

No (Thank and terminate)
Yes (Continue to Q8)

If 0 in Q7: Inform respondent that we are only enrolling men aged 18 years or older.
Q8. Do you have a wife or female partner with whom you have a committed relationship?
0
1

No (Thank and terminate)
Yes (Continue to Q9)

If 0 in Q8: Inform respondent that we are only enrolling couples. If your situation
changes and you would like to learn more about the study, please call us at XXX-XXXXXXX.

OMB# 0925-0543
Exp.06/30/2010

Q9. Is your wife or partner between the ages of 18 and 40 years old?
0
1

No (Thank and terminate.)
Yes (Continue to Q10)

Q10. Which of the following best describes your current marital status? Are you (read 1-4)?
1
2
3
4

Married
Single, but living as a couple
Single, not living as a couple
Divorced/widowed/separated

Q11. Have you ever been told by a doctor that it would be impossible for you to father a child
without medical help?
0
1
2

No (Skip to transition statement before Q13)
Told that “it might be difficult” (Continue to Q12)
Yes (Continue to Q12)

8

Don’t know (Obtain contact information and follow-up in one week)

Q12. Is this because you have had a vasectomy, sometimes called a V-section or having your
tubes tied, or is there some other reason?
1
2

Vasectomy (Probe to see if reversed. If yes, continue. If no, thank and
terminate.)
Some other reason
Specify:____________________________________________________
(Thank and terminate. This response should be reviewed by a supervisor for
possible eligibility and the woman should be re-contacted as appropriate.)

Q13. Based on your answers, you may be eligible to participate in an important research project
called the LIFE Study. Since we are enrolling couples in this study, may I please speak to
your wife/partner so that I may ask her a few questions to help me determine if she is also
eligible for participation?
0
1

Not available (Continue)
Available (Skip to Q15)

9

Refused (Probe for reason, thank and terminate)
Reason:_______________________________

Q14. Can you please tell me your wife/partner’s name and when would be a good time to reach
her?
Specify name: __________________________________
Specify day/time: _______________________________ (Thank and terminate)
9999

Refused (Probe for reason, thank and terminate)
Reason:_______________________________

OMB# 0925-0543
Exp.06/30/2010

Q15. (When wife/partner is reached) Hello, my name is ___________, and I am calling from
___________________. We are contacting couples in the _____________ area to see if
they would be interested in participating in a study about how the environment might affect
a couple’s ability to have a baby. To help me determine if you are eligible to participate in
this important project, I’d like to ask you a few questions. This short interview will take
about 5 to 10 minutes to complete. Is now a good time for you?
No
Yes

.....................................................................................................................0
.....................................................................................................................1

Refused (Thank and end call)...................................................................................9
Reason for refusal:__________________________________________
Q16. I’d like to schedule a time to call you back to complete the short interview. What is the
best time to reach you?
Specify day/time: ________________________ (Thank and terminate)
9999

Refused (Probe for reason, thank and terminate)
Reason:_______________________________

Q17. Before I begin, I would like to take a moment to provide you with some additional
information about the interview.
(Read informed consent passage – see Appendix B, Female Consent Passage)
Do you have any questions?
0
1

No (Continue to Q18)
Yes (Answer questions, verify that respondent understands answers, and continue
to Q18)

Q18. By agreeing to participate in this interview, you are indicating that:
•
•
•
•

You have had the purpose of the interview explained to you;
You have had the risks and benefits of participation explained to you;
You have had the opportunity to ask questions about things that you did not
understand;
You willingly give your consent to voluntarily participate.

Are you willing to participate in this short interview?
0
1

No (Probe for reason, thank and terminate)
Reason:___________________________
Yes (Continue to Q19)

OMB# 0925-0543
Exp.06/30/2010

Q19. Are you currently pregnant?
0
1

No (Continue)
Yes (Thank and terminate)

8

Don’t know (Obtain contact information and follow-up in one week.)

If Q19=1: Inform respondent that we are currently seeking couples that are thinking
about trying to have a baby, rather than those that are already pregnant.
Q20. Have you ever been told by a doctor that it would be impossible for you to get pregnant
without medical help?
0
1

No (Skip to Q22)
Yes (Continue to Q21)

8

Respondent was advised by a doctor not to get pregnant
Reason:______________________________________
(Thank and terminate. This response should be reviewed
by a supervisor for possible eligibility and the woman should be re-contacted as
appropriate.)

Q21. Which of the following reasons best describes why it would be impossible for you to get
pregnant without medical help? If there is more than one reason, please indicate all that
apply.
1
2
3
4
5

Your uterus (womb) is missing or has been removed (Thank and terminate)
Both of your ovaries are missing or have been removed (Thank and terminate)
Both of your fallopian tubes are missing or have been removed
(Thank and terminate)
You have had a tubal sterilization (i.e., tubes tied, clamped, etc.)
(Probe to see if reversed. If yes, continue. Otherwise, thank and terminate.)
Some other reason
Specify:________________________________________________________
(Thank and terminate. This response should be reviewed by a supervisor for
possible eligibility and the woman should be re-contacted as appropriate.)

Q22. In the 12 months, how many days on average have there been between the start of one
menstrual period (first day of bleeding) and the next menstrual period (first day of
bleeding)?
0
Have not had a period in the past 12 months
1-365 Specify days (Probe for approximate number of days)
999
Too irregular to know
If Q22=0 or Q22 (<21 or >42 days) or Q22=999 then thank and terminate (Inform
respondent that we are only enrolling women with menstrual cycles that are typically 21
to 41 days long). Otherwise, continue.

OMB# 0925-0543
Exp.06/30/2010

The last few questions relate to birth control use and your feelings about becoming pregnant.
Q23. Which of the following statements best describes your current feelings about becoming
pregnant?
1
2
3
4

I am open to becoming pregnant at any time (Continue)
I don’t wish to get pregnant now, but I would like to get pregnant
within the next six months (Continue)
I would like to get pregnant sometime in the future, but not in the next six
months (Thank and terminate. Request permission to recontact in three
months regarding study eligibility.)
I do not ever wish to get pregnant (Thank and terminate)

Q24. In the past 12 months, have you received any type of birth control shot, such as
Depo-Provera?
0
1

No (Continue to Q25)
Yes (Thank and terminate)

If 1 in Q21: Inform respondent that women who received a birth control shot in the last
year are ineligible for the study.
Q25. Which of the following statements best describes your use of birth control in the past
month? By birth control, I mean anything that you might have done to prevent pregnancy.
1
2
3
4
5

I did not have sexual intercourse in the past month because I did not want to
become pregnant (Eligible, skip to paragraph before Q27)
I did not have sexual intercourse in the past month for other reasons (Eligible,
skip to paragraph before Q27)
I didn’t use any birth control when I had sexual intercourse (Continue to Q26)
I used birth control every time that I had sexual intercourse in order to avoid
getting pregnant (Eligible, skip to paragraph before Q27)
I used birth control when I thought there was a risk of getting pregnant (Eligible,
skip to paragraph before Q27)

Q26. When did you and your partner last use some form of birth control?
00
Have never used birth control
01-98 Specify months: __________
If Q26=00 or Q26>02 months, thank and terminate.
Otherwise eligible, continue. (Eligible)

OMB# 0925-0543
Exp.06/30/2010

Thank you for your cooperation in answering my questions. Based on your answers, you and
your husband (partner) are eligible to participate in our important research project, the LIFE
Study. We are currently seeking couples for this study who are thinking about trying to become
pregnant within the next six months. If you and your partner choose to participate in the LIFE
Study, you will be asked to keep a journal and complete a series of questionnaires as you try to
get pregnant. As an incentive for participation, we will provide you with a digital fertility
monitor that will help you to identify your fertile period. The monitor will be yours to keep, even
after the study has been completed. You will also be given free home pregnancy test kits so that
you can learn that you are pregnant as soon as possible. In addition, if you and your husband
(partner) are willing to provide us with specimens such as blood and urine for the measurement of
environmental pollutants, you will each be paid up to $75.
Q27. I’d like to have our research nurse contact you so that she can explain additional details
about the study and possibly schedule a time to meet with you and your husband (partner).
Would it be okay if I ask her to give you a call?
0
1

No, respondent not interested (Continue to Q28)
Yes, respondent is interested in learning more (Skip to Q29)

Q28. Which of the following reasons best describes why you are not interested in learning more
about this important study. Please tell me all that apply. Is it that:
1
2
3
4

You are too busy
You are not interested in participating in a research project
You don’t think that your husband (partner) will be interested in participating
Some other reason, please specify: ____________________________________

If Q28=1 or Q28=2 or Q28=3 or Q28=4 then thank and terminate.
Q29. I’d like to verify your phone number. I have your number listed as (read phone
number). Is that correct?
0
1

No, Specify correct number: ________________________
Yes

Q30. Is this the best number at which to reach you?
0
1

No, Specify best number: _______________________
Yes

Q31. What is the best time to reach you?
Specify day/time: ____________________________

OMB# 0925-0543
Exp.06/30/2010

Appendix A – Informed Consent Passage, Males
TITLE OF PROJECT: Eligibility Interview for the Longitudinal Investigation of Fertility and the
Environment (LIFE) Study
PRINCIPAL INVESTIGATOR: PI of Individual Study Site
******************************************************************************
PURPOSE OF STUDY OR RESEARCH:
The purpose of this project is to identify eligible couples who might be interested in participating
in a study focusing on how lifestyle and the environment might affect a couple’s ability to have a
baby.
ELIGIBILITY:
You were selected to be interviewed because you are a man residing in the ____________ area
(who has purchased a fishing license).
SPONSOR:
The study is being conducted by Individual Study Site and two participating federal agencies, the
National Institute of Child Health and Human Development, and the Centers for Disease Control
and Prevention.
PROCEDURES:
Your participation in this project is entirely voluntary and initially will require only a 5 to 10
minute telephone interview. The telephone interview will be scheduled at a time that is
convenient for you. Following the telephone interview, you may be asked to participate further.
POSSIBLE RISKS AND DISCOMFORTS:
You may find that some of our questions are personal, especially the questions related to your
reproductive history and pregnancy intentions. In addition, some people are concerned that their
personal information might be shared with others.
CONFIDENTIALITY:
Your responses to the interview will be kept strictly confidential. The information will be kept in
a locked file. Only the personnel authorized by the Individual Study Site principal investigator
will have access to this locked file. Information you provide will only be used for this project and
your individual responses will not be shared with others. When the results of this project are
reported, the women who participated will not be named or identified in any way. This study has
been approved by the Ethics Review Board at each participating institution.
POSSIBLE BENEFITS:
If you agree to participate in this interview, there may or may not be any direct benefit to you.
We hope that the information gained will help us to identify eligible couples who might be
interested in participating in an important study that will help us learn more about how lifestyle
and the environment might affect a couple’s ability to have a baby.

OMB# 0925-0543
Exp.06/30/2010

REFUSAL OR WITHDRAWAL OF PARTICIPATION:
Participation is entirely voluntary. You are free to refuse to answer any question and may
terminate your participation at any time during the interview process.
REQUEST FOR MORE INFORMATION:
You may ask questions about the study at any time. If, during the interview or later, you have
questions about this project, you should contact the Principal Investigator, PI of Individual Site, at
(XXX) XXX-XXXX.
******************************************************************************
VERBAL CONSENT:
This is to certify that I have explained to __________________ the purpose of this research, the
procedures required, and the risks and benefits of participation to the best of my ability.
___________________________
Research Assistant

_________________________
Date

OMB# 0925-0543
Exp.06/30/2010

Appendix B – Informed Consent Passage, Females
TITLE OF PROJECT: Eligibility Interview for the Longitudinal Investigation of Fertility and the
Environment (LIFE) Study
PRINCIPAL INVESTIGATOR: PI of Individual Study Site
******************************************************************************
PURPOSE OF STUDY OR RESEARCH:
The purpose of this project is to identify eligible couples who might be interested in participating
in a study focusing on how lifestyle and the environment might affect a couple’s ability to have a
baby.
ELIGIBILITY:
You were selected to be interviewed because you are a woman residing in the ____________
area.
SPONSOR:
The study is being conducted by Individual Study Site and two participating federal agencies, the
National Institute of Child Health and Human Development, and the Centers for Disease Control
and Prevention.
PROCEDURES:
Your participation in this project is entirely voluntary and initially will require only a 5 to 10
minute telephone interview. The telephone interview will be scheduled at a time that is
convenient for you. Following the telephone interview, you may be asked to participate further.
POSSIBLE RISKS AND DISCOMFORTS:
You may find that some of our questions are personal, especially the questions related to your
reproductive history and pregnancy intentions. In addition, some people are concerned that their
personal information might be shared with others.
CONFIDENTIALITY:
Your responses to the interview will be kept strictly confidential. The information will be kept in
a locked file. Only the personnel authorized by the Individual Study Site principal investigator
will have access to this locked file. Information you provide will only be used for this project and
your individual responses will not be shared with others. When the results of this project are
reported, the women who participated will not be named or identified in any way. This study has
been approved by the Ethics Review Board at each participating institution.
POSSIBLE BENEFITS:
If you agree to participate in this interview, there may or may not be any direct benefit to you.
We hope that the information gained will help us to identify eligible couples who might be
interested in participating in an important study that will help us learn more about how lifestyle
and the environment might affect a couple’s ability to have a baby.

OMB# 0925-0543
Exp.06/30/2010

REFUSAL OR WITHDRAWAL OF PARTICIPATION:
Participation is entirely voluntary. You are free to refuse to answer any question and may
terminate your participation at any time during the interview process.
REQUEST FOR MORE INFORMATION:
You may ask questions about the study at any time. If, during the interview or later, you have
questions about this project, you should contact the Principal Investigator, PI of Individual Site, at
(XXX) XXX-XXXX.
******************************************************************************
VERBAL CONSENT:
This is to certify that I have explained to __________________ the purpose of this research, the
procedures required, and the risks and benefits of participation to the best of my ability.
___________________________
Research Assistant

_________________________
Date

OMB# 0925-0543
Exp.06/30/2010
Public reporting burden for this collection of information is estimated to average 10 minutes per response, 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: NIH,
Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-XXXX).