2.c Informed consent-Texas

Longitudinal Investigation of Fertility and the Environment Study (LIFE Study)
FEMALE CONSENT FORM
Introduction
The Longitudinal Investigation of Fertility and the Environment (LIFE) Study is a
research study being conducted by Texas A&M System Health Science Center’s School
of Rural Public Health and is sponsored by the National Institute of Child Health and
Human Development. Researchers from Johns Hopkins University in Maryland and
Research Triangle Institute in North Carolina are working together with the School of
Rural Public Health in this study. This consent form explains the research study I am
being asked to join. I will review this form carefully and ask any questions about the
study before I agree to join. I may also ask questions at any time after joining the study.
Purpose of Research Project:
The LIFE Study is trying to find out if exposures to some types of chemicals found in the
environment might make it harder for couples to have a baby. Chemicals will be
measured in blood and urine from the study couples, and will be used to see if a longer
time is needed to get pregnant when a woman or man has higher levels of these
chemicals. The study will also look for associations of these chemicals to infertility,
pregnancy loss, length of gestational period, and infant birth size. The study will take
into account lifestyle factors that could potentially influence the results.
Couples in this area and the other 2 study areas will meet the following requirements:
1. The woman is between the ages of 18 and 40 years
2. The man is between the ages of 18 and 60 years
3. Neither partner has been surgically sterilized
4. Neither partner has a known medical condition that could result in infertility
5. The couple resides in a geographic area of interest to the study
6. The couple is ready to attempt to become pregnant in the next 3 to 6 months
It is anticipated that a total of 800 couples will participate in this study across the three
different geographic locations.
The study is funded by the federal government, through the National Institute for Child
Health and Human Development, which is part of the National Institutes of Health.
Procedures:
I have been asked to participate in this study because either I or my partner are in the
Texas Parks and Wildlife Department’s Angler database and I am a female between the
ages of 18 and 40 years. My partner and I are either planning to stop any current
contraception within the next 6 months, or have not used any method of birth control for
the past two months, and are planning on actively trying to become pregnant. Neither I,
nor my partner, have been diagnosed with any infertility problems and we can both
communicate in English, Spanish, or Vietnamese.
Date_________ Initial____

Page 1 of 12

By agreeing to participate in this study, I understand that I will be asked to donate various
biological samples. These include one 23 ml (about 1 ½ tablespoons) sample of blood, 3
samples of urine totaling about 8 ounces, or one cup, and 2 saliva samples. I will also be
asked to answer a questionnaire at the beginning of the study, as well as fill out a brief
daily journal while trying to become pregnant and during the first 4 weeks of pregnancy.
Pregnant women will then be asked to fill out a weekly journal throughout the remainder
of pregnancy. I will be visited multiple times at my home as outlined in the following
paragraphs. The entire duration of my and my partner’s participation from enrollment to
completion of the study could range from 9 to 21 months depending on whether or not I
become pregnant and the course of the pregnancy.
During the first visit, I will be asked to complete the initial questionnaire, which should
require approximately 30 minutes to finish. This questionnaire will collect information
regarding my job history, medical history, gynecologic history, reproductive history,
family health history, lifestyle factors, and demographic information. Following the
interview, body size measurements will be taken, including your weight, height and waist
and hip circumferences, requiring approximately 2 minutes of your time.
I will also be trained in how to use an electronic fertility monitor, pregnancy tests and
daily journals. The daily journals will ask for information about my lifestyle
characteristics, reproductive habits, and menstrual cycles. It should take about 3-5
minutes of my time each day. These journals can either be mailed in each week at no cost
to myself or completed using the Internet if I have a suitable home computer. The choice
is mine. I will be taught how to collect a saliva sample at a later date and how to mail it
back to study staff. This collection will occur at 2 different times in the future.
At the end of the first visit, I will be asked to provide samples of both blood and urine. A
blood sample will be drawn by an individual trained in this procedure. A pregnancy test
will be performed using the urine sample to ensure that I am not currently pregnant. The
entire initial visit should require about 1 hour of your time.
On the second visit, I will be asked to provide another sample of urine. Staff members
will also review the use of the fertility monitor and pregnancy test kit with me.
Additional home visits will occur to permit the staff to review the training, bring supplies,
give compensation for donating the samples, and to collect the monitor information.
These visits will be much shorter in duration than the initial visit, requiring
approximately 20-30 minutes to complete.
If and when I have a positive pregnancy test, staff members will make another visit.
During this visit, I will be asked to give a final urine sample, and will be instructed on
how to fill out a short weekly journal during the course of my pregnancy. The completion
of this journal should take 3-5 minutes each day and I will be asked to mail in the diary
card once a month at no cost to myself or enter the information over the Internet. This
journal, like the previous one, will collect information about my lifestyle and
Date_________ Initial____

Page 2 of 12

reproductive habits and general health during pregnancy. Fertility monitor information
will be collected during this visit by staff and an incentive will be given at this stage of
the study. After the baby is born, I will be asked to provide information about pregnancy
outcomes. This information will be collected in the final follow up visit, when a
completion gift will also be presented to me.
If I have been enrolled in the study for 6 months, and have not become pregnant, I will
then be asked to provide a final sample of urine. I will continue with my participation in
the study in the same way as before until 12 months have passed, or I become pregnant
and have delivered.
My name will be placed on file at the research site to allow for recruitment for future
studies, unless I decide now or at any other time during the study, to refuse. I have
checked one of the following options about my wishes to have my name kept on file.
______ I do not want my name to be kept on file for future study recruitment.
______ I will allow my name to be kept on file for future study recruitment.
My biological samples will also be kept in storage for future analysis, possibly related to
other studies, unless I decide now or at any other time during this study, to refuse. I have
checked one of the following options about my wishes to have my samples stored.
_____ I do not wish to have my samples stored and used for future studies.
_____ I will allow my samples to be stored and used for future studies.
Risks/Discomforts:
There are few physical risks or discomforts that are possible with my participation. I will
be asked to provide a blood sample and some people do experience bruising and /or slight
discomfort during and after the blood draws.
This study will ask me to discuss personal sensitive information. Some people may find
this difficult or embarrassing. I do not have to answer any questions that I am
uncomfortable answering. As a result of participating in this research, you may gain
knowledge about your own or your partner's fertility that you did not expect. Some
people may find this knowledge uncomfortable or embarrassing.
There is a risk of sensitive personal information being passed along to those outside the
study. However, the Confidentiality section below describes the measures being taken by
the study staff to make that risk as small as possible.
Benefits:
There will be no direct benefit to me or my partner if I agree to participate in this research
project. However, I may gain a better understanding of my own fertility and reproductive
cycles. There may be benefit to other couples in the future who are trying to become
pregnant.

Date_________ Initial____

Page 3 of 12

Alternatives for Participation:
I may decline to participate in any portion of the study at any time during the study. By
choosing not to be a part of the study, I have the option of attempting to become pregnant
outside the study either with or without the aid of a commercially available fertility
monitor as used in this study. Any supportive information on pregnancy found on the
study web site is accessible to the general public.
Confidentiality:
Research staff will do their best to protect my personal privacy and the confidentiality of
my information. Interviews will be done in a private setting and specimens will be
collected at home. Maintaining my privacy depends on protecting personal identifiers
such as my name, address and telephone number. Only the researchers at the site that
enrolled me know my personal identifiers and will be able to contact me. I will be given
a unique code that is used when submitting my journal entries and specimens. No
personal identifiers other than my birth date are stored in the study’s central computer
system. If I decide to submit journal entries over the Internet, that information will not
include personal identifiers and will be unreadable by others who are not part of the
research study. Despite these precautions, total privacy cannot be guaranteed.
Every effort will be made to protect the confidentiality of the information provided
insofar as it is legally possible. Under certain conditions, people in charge of making
sure that the research is done properly may review my study records. This might include
people from the local institutional review board and the Federal Office for Human
Research Protections. All of these people are also required to keep my identity
confidential.
The study researchers might voluntarily disclose your identify if it is necessary to protect
me or others from serious harm. It might be necessary to reveal my identity in situations
of child abuse, reportable communicable diseases, possible threat to self or others, or
reportable levels of toxic chemicals in the environment (for example, lead exposure).
To help protect my privacy, a Certificate of Confidentiality from the National Institutes
of Health has been obtained. With this Certificate, the researchers cannot be forced to
disclose information that may identify me, even by a court subpoena, in any federal, state,
or local civil, criminal, administrative, legislative, or other proceedings. The researchers
will use the Certificate to resist any demands for information that would identify me,
except as explained below.
The Certificate cannot be used to resist a demand for information from personnel of the
United States Government that is used for auditing or evaluation of Federally funded
projects.
I understand that a Certificate of Confidentiality does not prevent me or a member of my
family from voluntarily releasing information about me or my involvement in this
research. If a physician, insurer or other person gets my written permission/approval to

Date_________ Initial____

Page 4 of 12

receive research information, the researchers may not use the Certificate to withhold that
information.
In general, findings from this study may increase scientific understanding of
environmental exposures and how they may effect human reproduction or development.
Only non-identifying information from many couples will be used in publications or
released for study by other research investigators.
Compensation:
I will receive payment for giving biological samples during home visits according to the
following schedule. During the 1st visit, I will receive a total of $30: $25 for blood and
$5 for urine. During the 2nd visit, I will receive a total of $25: $20 for saliva samples that
have been received and $5 for urine. During any additional visits, I will be given $20 for
any saliva samples that have been received by the study staff. If a urine sample is
collected during pregnancy, I will be given $5 when the sample is received. During the
1st visit after pregnancy has occurred, my partner and I will receive a pregnancy related
book and after the birth of my baby, we will receive a baby gift. Couples who do not
conceive during 12 cycles of attempting to become pregnant will receive a gift at the end
of 12 at-risk cycles.
All fertility monitors, monitor test sticks, pregnancy kits, journals and courier charges or
mail postage will be provided at no cost to myself. The fertility monitor and unused
monitor test sticks and pregnancy test kits will remain in the hands me and my partner
upon our completion of the study.
Voluntariness:
My participation in this research project is completely voluntary. I have the right to
withdraw from the research study at any time. I should ask the principal investigator
listed below any questions you may have about this research study. I may ask him/her
questions in the future if you do not understand something that is being done.
Persons to Contact:
If I want to talk to anyone about this research study because I think I have not been
treated fairly or think I have been hurt by joining the study, or I have any other questions
about the study, I should call the principal investigator, Anne M. Sweeney, PhD by phone
at (979) 458-0068 or email at [email protected]. I may also contact one of
Anne’s research associates, Cortney Ferguson, MPH by phone at (979) 458-2809 or
email at [email protected].
This research study has been reviewed by the Institutional Review Board-Human
Subjects in Research, Texas A&M University. For research-related problems or
questions regarding subjects’ rights, I can contact the Institutional Review Board through
Dr. Michael W. Buckley, Director of Research Compliance, Office of Vice President for
Research at (979) 845-8585 ([email protected]).

Date_________ Initial____

Page 5 of 12

Texas A&M System Health Science Center’s School of Rural Public Health and the
Federal government do not have any program to provide compensation to I if you
experience injury or other bad effects which are not the fault of the investigators.
If I have read this document and I have been given the chance to ask any questions now
or at a later time or if the document has been read and explained to me and I agree to be
in this study, please sign or make your mark below. I will be given a copy of this consent
form to keep for my records.
Print Name of Subject:_____________________________________________________
________________________________________________
Signature or Mark of Subject or Legally Authorized
Representative

_______________
Date

________________________________________________
Signature of Person Obtaining Consent

_______________
Date

________________________________________________
Witness to Consent if Subject Unable to Read or Write
(Must be different than the person obtaining consent)

_______________
Date

Date_________ Initial____

Page 6 of 12

Longitudinal Investigation of Fertility and the Environment Study (LIFE Study)
MALE CONSENT FORM
Introduction
The Longitudinal Investigation of Fertility and the Environment (LIFE) Study is a
research study conducted by Texas A&M System Health Science Center’s School of
Rural Public Health and is sponsored by the National Institute of Child Health and
Human Development. Researchers from Johns Hopkins University in Maryland and
Research Triangle Institute in North Carolina are working with the School of Rural
Public Health in this study. This consent form explains the research study I am being
asked to join. I will review this form carefully and ask any questions about the study
before I agree to join. I may also ask questions at any time after joining the study.
Purpose of Research Project:
The LIFE Study is trying to find out if exposures to some types of chemicals found in the
environment might make it harder for couples to have a baby. Chemicals will be
measured in blood and urine from the study couples, and will be used to see if a longer
time is needed to get pregnant when a woman or man has higher levels of these
chemicals. The study will also look for associations of these chemicals to infertility,
pregnancy loss, length of gestational period, and infant birth size. The study will take
into account lifestyle factors that could potentially influence the results.
Couples in this area and the other 2 study areas will meet the following requirements:
1. The woman is between the ages of 18 and 40 years
2. The man is between the ages of 18 and 60 years
3. Neither partner has been surgically sterilized
4. Neither partner has a known medical condition that could result in infertility
5. The couple resides in a geographic area of interest to the study
6. The couple is ready to attempt to become pregnant in the next 3 to 6 months
It is anticipated that a total of 800 couples will participate in this study across the three
different geographic locations.
The study is funded by the federal government, through the National Institute for Child
Health and Human Development, which is part of the National Institutes of Health.
Procedures:
I have been asked to participate in this study because either I or my partner are in the
Texas Parks and Wildlife Department’s Angler database and I am a male of at least 18
years of age. My partner and I are either planning to stop any current contraception
within the next 6 months, or have not used any method of birth control for the past two
months, and are planning on actively trying to become pregnant. Neither I nor, my
partner, have been diagnosed with any infertility problems and we can both communicate
in English, Spanish, or Vietnamese.
Date_________ Initial____

Page 7 of 12

By agreeing to participate in this study, I understand that I will be asked to donate various
biological samples. These include one 23 ml (about 1 ½ tablespoons) sample of blood, 2
samples of urine totaling about 8 ounces, or one cup, and 2 semen samples. I will also be
asked to answer a questionnaire at the beginning of the study, as well as fill out a brief
daily journal while my partner is trying to become pregnant. I will be visited multiple
times at my home as outlined in the following paragraphs. The entire duration of my and
my partner’s participation from enrollment to completion of the study could range from 9
to 21 months depending on whether or not my partner becomes pregnant and the course
of the pregnancy.
During the first visit, I will be asked to complete the initial questionnaire, which should
require approximately 30 minutes to finish. This questionnaire will collect information
regarding my job history, medical history, reproductive history, family health history,
lifestyle factors, and demographic information. Following the interview, body size
measurements will be taken, including my weight, height and waist and hip
circumferences, requiring approximately 2 minutes of your time.
The daily journal will ask for information about my lifestyle characteristics and
reproductive habits. It should take about 3-5 minutes of my time each day. These
journals can either be mailed in each week at no cost to myself or completed using the
Internet if I have a suitable home computer. The choice is mine. I will be taught how to
collect a semen sample and how to send it back to the laboratory. This collection will
occur one more time in the future.
At the end of the first visit, I will be asked to provide samples of both blood and urine. A
blood sample will be drawn by an individual trained in this procedure. The entire initial
visit should require about 1 hour of my time. Two semen collection kits will be left with
me and I will collect one semen specimen after 2 days of abstinence from ejaculation.
The kit will be returned to the laboratory in the provided packaging by Fedex courier.
On the second visit, I will be asked to provide another sample of urine. Following that
visit, I will collect a second semen sample after 2 days of abstinence and send it to the
laboratory. Collection of this sample will be timed to occur during my partner’s menses,
when fertility would be low.
Additional home visits will occur to permit the staff to review the training, bring supplies,
give compensation for donating the samples, and to collect my partner’s monitor
information. These visits will be much shorter in duration than the initial visit, requiring
approximately 20-30 minutes to complete.
If and when my partner has a positive pregnancy test, staff members will make another
visit. My partner will be asked to provide another urine sample and will be instructed in
completing a journal during pregnancy. Fertility monitor information will be collected
during this visit by staff and an incentive will be given at this stage of the study. I will
not be asked for further samples on these visits and my journal entries will not continue
after your partner is pregnant. After the baby is born, my partner will be asked to
Date_________ Initial____

Page 8 of 12

provide information about birth size. This information will be collected in the final follow
up visit, when a completion gift will also be presented to my partner.
Participation in the study will continue until 12 months have passed, or my partner
becomes pregnant and has delivered.
My name will be placed on file at the research site to allow for recruitment for future
studies, unless I decide now or at any other time during the study, to refuse. I have
checked one of the following options about my wishes to have my name kept on file.
______ I do not want my name to be kept on file for future study recruitment.
______ I will allow my name to be kept on file for future study recruitment.
My biological samples will also be kept in storage for future analysis, possibly related to
other studies, unless I decide now or at any other time during this study, to refuse. Please
check one of the following options about your wishes to have your samples stored.
_____ I do not wish to have my samples stored and used for future studies.
_____ I will allow my samples to be stored and used for future studies.

Risks/Discomforts:
There are few physical risks or discomforts that are possible with my participation. I will
be asked to provide a blood sample and some people do experience bruising and /or slight
discomfort during and after the blood draws.
This study will ask me to discuss personal sensitive information. Some people may find
this difficult or embarrassing. I do not have to answer any questions that I am
uncomfortable answering. As a result of participating in this research, I may gain
knowledge about my own or my partner's fertility that you did not expect. Some people
may find this knowledge uncomfortable or embarrassing.
There is a risk of sensitive personal information being passed along to those outside the
study. However, the Confidentiality section below describes the measures being taken by
the study staff to make that risk as small as possible.
Benefits:
There will be no direct benefit to me or my partner if I agree to participate in this research
project. However, I may gain a better understanding of my own fertility. There may be
benefit to other couples in the future who are trying to become pregnant.
Alternatives for Participation: I may decline to participate in any portion of the study
at any time during the study. By choosing not to be a part of the study, I have the option
of attempting to father a pregnancy with my partner outside the study either with or
without the aid of a commercially available fertility monitor as used in this study. Any
supportive information on pregnancy found on the study web site is accessible to the
general public.

Date_________ Initial____

Page 9 of 12

Confidentiality:
Research staff will do their best to protect my personal privacy and the confidentiality of
my information. Interviews will be done in a private setting and specimens will be
collected at home. Maintaining my privacy depends on protecting personal identifiers
such as my name, address and telephone number. Only the researchers at the site that
enrolled me know my personal identifiers and will be able to contact me. I will be given
a unique code that is used when submitting my journal entries and specimens. No
personal identifiers other than my birth date are stored in the study’s central computer
system. If I decide to submit journal entries over the Internet, that information will not
include personal identifiers and will be unreadable by others who are not part of the
research study. Despite these precautions, total privacy cannot be guaranteed.
Every effort will be made to protect the confidentiality of the information provided
insofar as it is legally possible. Under certain conditions, people in charge of making
sure that the research is done properly may review my study records. This might include
people from the local institutional review board and the Federal Office for Human
Research Protections. All of these people are also required to keep my identity
confidential.
The study researchers might voluntarily disclose my identify if it is necessary to protect
me or others from serious harm. It might be necessary to reveal my identity in situations
of child abuse, reportable communicable diseases, possible threat to self or others, or
reportable levels of toxic chemicals in the environment (for example, lead exposure).
To help protect my privacy, a Certificate of Confidentiality from the National Institutes
of Health has been obtained. With this Certificate, the researchers cannot be forced to
disclose information that may identify me, even by a court subpoena, in any federal, state,
or local civil, criminal, administrative, legislative, or other proceedings. The researchers
will use the Certificate to resist any demands for information that would identify me,
except as explained below.
The Certificate cannot be used to resist a demand for information from personnel of the
United States Government that is used for auditing or evaluation of Federally funded
projects.
I understand that a Certificate of Confidentiality does not prevent me or a member of my
family from voluntarily releasing information about yourself or your involvement in this
research. If a physician, insurer or other person gets my written permission/approval to
receive research information, the researchers may not use the Certificate to withhold that
information.
In general, findings from this study may increase scientific understanding of
environmental exposures and how they may effect human reproduction or development.
Only non-identifying information from many couples will be used in publications or
released for study by other research investigators.

Date_________ Initial____

Page 10 of 12

Compensation:
I will receive payment for giving biological samples during home visits according to the
following schedule. During the 1st visit, I will receive a total of $30: $25 for blood and
$5 for urine. During the 2nd visit, I will receive a total of $25: $20 for one semen sample
that has been received and $5 for urine. During the next visit, I will be given $20 for the
second semen sample that has been received by the study staff. During the 1st visit after
pregnancy has occurred, my partner and I will receive a pregnancy related book and after
the birth of my baby, we will receive a baby gift. Couples who do not conceive during 12
cycles of attempting to become pregnant will receive a gift at the end of 12 at-risk cycles.
All fertility monitors, monitor test sticks, pregnancy kits, journals and courier charges or
mail postage used in this study will be provided at no cost to myself. The fertility
monitor and unused monitor test sticks and pregnancy test kits will remain in the hands of
the couple upon their completion of the study.
Voluntariness:
My participation in this research project is completely voluntary. I have the right to
withdraw from the research study at any time. I should ask the principal investigator
listed below any questions you may have about this research study. I may ask him/her
questions in the future if I do not understand something that is being done.
Persons to Contact:
If I want to talk to anyone about this research study because I think I have not been
treated fairly or think I have been hurt by joining the study, or I have any other questions
about the study, I should call the principal investigator, Anne Sweeney, PhD at (979)
458-0068 or by email [email protected]. I may also contact one of Anne’s
research associates, Cortney Ferguson, MPH by phone at (979) 458-2809 or by email at
[email protected].
This research study has been reviewed by the Institutional Review Board-Human
Subjects in Research, Texas A&M University. For research-related problems or
questions regarding subjects’ rights, I can contact the Institutional Review Board through
Dr. Michael W. Buckley, Director of Research Compliance, Office of Vice President for
Research at (979) 845-8585 ([email protected]).
Texas A&M System Health Science System’s School of Rural Public Health and the
Federal government do not have any program to provide compensation to you if you
experience injury or other bad effects which are not the fault of the investigators.
If I have read this document and have been given the chance to ask any questions now or
at a later time or if the document has been read and explained to me and I agree to be in
this study, please sign or make your mark below. I will be given a copy of the signed
consent form to keep for my records.
Print Name of Subject:_____________________________________________________
Date_________ Initial____

Page 11 of 12

________________________________________________
Signature or Mark of Subject or Legally Authorized
Representative

_______________
Date

________________________________________________
Signature of Person Obtaining Consent

_______________
Date

________________________________________________
Witness to Consent if Subject Unable to Read or Write
(Must be different than the person obtaining consent)

_______________
Date

Date_________ Initial____

Page 12 of 12