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pdfInformed Consent Form – Fathers
OMB Control Number: 0925-0593
Expiration Date: 07/31/2013
v20101109
What You Should Know About Joining the
National Children’s Study Vanguard Study
Informed Consent Form
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Centers for Disease Control and Prevention
U.S. ENVIRONMENTAL PROTECTION AGENCY
Informed Consent Form – Fathers
OMB Control Number: 0925-0593
Expiration Date: 07/31/2013
v20101109
What You Should Know About
Joining the National Children’s Study
Vanguard Study
Informed Consent Form
Public reporting burden for this collection of information is estimated to average 40 minutes per response in conjunction with
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What You Should Know About Joining the National
Children’s Study Vanguard Study
The mother of your child has joined the National Children’s Study, an important
research study to improve the health and well-being of our nation’s children.
Because fathers play an important part in their children’s lives, we are hoping you
will agree to join the Study, too.
The goal of the Study is to improve the health and well-being of all children.
With your help, the National Children’s Study will help us learn more about
how our physical, social, and family environments affect the health, growth, and
development of our children.
The National Children’s Study has several stages. Different stages of the Study will
run at the same time. We are currently in the first stage, called the Vanguard Study.
The Vanguard Study will help us decide on the design of the next stage, called the
Main Study.
We hope you will join thousands of fathers from across the United States in helping
us to learn information that will help improve our children’s health. Although what
we learn in the Vanguard Study may not help you or your family right now, the
things we learn may help people in the future.
Joining the Vanguard Study is your choice. You can decide to join or not to join. If
you do join, you can leave at any time for any reason. You can decide not to answer
certain questions or give certain samples.
Sponsors
The National Children’s Study is led by the Eunice Kennedy Shriver National Institute of
Child Health and Human Development of the National Institutes of Health (NIH) in
collaboration with a consortium of federal government partners. Study partners include
the National Institute of Environmental Health Sciences of the NIH, and the Centers for
Disease Control and Prevention, and the Environmental Protection Agency.
2 | What You Should Know About Joining the National Children’s Study Vanguard Study
What is the goal of the National Children’s Study?
The goal of the National Children’s Study is to improve the health of all children in
the United States.
The Study will help us learn more about how our community and our physical
environment (including air and dust), social environment (our neighborhoods and
communities), and family environment:
Affect how children grow, and
Help children stay healthy.
The Study will look at how our genes act together with our surroundings to
influence health, growth, and development.
The National Children’s Study has several stages. The first stage is called the
Vanguard Study. The next stage is called the Main Study.
What we do—the questions we ask and the procedures we use—during the
Vanguard Study may be different from what we do in the Main Study.
The Vanguard Study will help us decide what questions and procedures will work
best in the Main Study.
As we progress through the Vanguard Study, we will use what we learn to help us
decide what will work best for the rest of the Vanguard Study. That is why what
we do as part of the Vanguard Study will change over time.
We will use what we learn in the Vanguard Study and in the Main Study to achieve
our goal of improving the health of all children.
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Why is the National Children’s Study
important?
How many children will be in the
National Children’s Study?
The National Children’s Study is important
because it will help us understand how we can
improve our children’s health.
About 5,000 children will be in the Vanguard
Study.
The National Children’s Study is the largest
research study of children’s health and
development in the history of the United States.
With your help, we can learn more about how
our physical environment, social environment,
and family environment affects children’s health,
growth, and development while they are young
and when they become adults.
The Study may also help us better understand
why some children develop obesity, diabetes,
autism, learning disabilities, or heart disease.
What kind of study is the National
Children’s Study?
The National Children’s Study is an observational study. That means we will follow children
from birth to age 21 by:
Visiting with you at home.
Asking questions about you and where you
live and work.
Collecting samples from you like blood,
urine, and saliva.
Involving you and your child’s mother in
the Study because we know that parents are
important to the health of their children.
As an observational study, we will not:
Ask you to change what you normally do.
Ask you to take any medicines or drugs.
About 100,000 children from all over the United
States will be in all parts of the Study.
We are also asking mothers and fathers to join
the Study.
How long will the National Children’s
Study last?
The National Children’s Study will get
information from mothers and fathers before,
during, and after pregnancy.
4 | What You Should Know About Joining the National Children’s Study Vanguard Study
“Because the Study will change over time, different families may be
asked to take part in different Study activities.”
The Study will follow children until they
are 21 years old. Each time that we visit, we
will explain what we are doing and ask your
permission to do it. We will give you a visit
information sheet that describes everything we
want to do during the visit.
What is involved in taking part in the
National Children’s Study?
If you join the National Children’s Study, we
will visit you at home to get information about
you, your health, and where you live.
Because the Study will change over time,
different families may be asked to take part in
different Study activities.
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Each time that we visit, we will explain what
we are doing and ask your permission to do
it. We will give you a visit information sheet
that describes everything we want to do during
the visit.
How many visits should I expect?
We plan to visit you once at home during your
partner’s pregnancy. We also may ask to visit you
at home again.
Between visits, we will call, e-mail, or send you
surveys from time to time to keep in touch and
find out about you.
What kinds of information and
samples will the National Children’s
Study collect?
The National Children’s Study will visit
your home to collect information about you,
your health, and your physical, social, and
family environment.
We may take your body measurements like
height, weight, and blood pressure.
We may ask you to answer questions and fill
out forms.
If there are questions you do not want to answer,
you can skip them and still be in the Study.
We may ask for your permission to look at your
health information and medical records during
the time of the Study.
If you change your mind after you give
us permission, we will stop getting new
information from your medical records, but
we may keep using the information we have
already gotten.
During some visits, we may ask for your
permission to collect samples, like your blood,
hair, urine, and saliva.
Before we ask for any samples, we will explain
what type of samples we want, how much we
will need, and how we will collect them.
During some visits, trained National Children’s
Study staff will:
Use a needle to collect a small amount of
blood from a vein in your arm.
Cut a small sample of hair from the back
of your head.
6 | What You Should Know About Joining the National Children’s Study Vanguard Study
We may also ask you to get some samples
by collecting:
A small amount of your urine in a cup.
A small amount of your saliva 3 times a
day for 2 days.
Some of your toenail clippings.
If there are samples you do not want to give us,
you can skip them and still be in the Study.
What about genetic information?
If you agree, we will get information about your
genes. We will get this information from the
blood, saliva, and other samples you give us.
We will also ask questions about your family
medical history.
Genetic information is collected to help us learn
how genes affect our children’s health and how
our physical environment and experiences affect
the way our genes work.
Some people worry that research about genetic
causes of disease may give information not only
about themselves but about family members.
There is always some chance that technology
could be developed that would make it possible
to reveal your identity or that of your family
members. We will make every effort to prevent
this. We will continue to review and improve the
ways we keep your information private.
Some people are sensitive about genetic
information for cultural or religious reasons.
If you do not want us to conduct genetic tests,
let us know. You can tell us not to collect your
genetic information and still be in the Study.
The Study will not do the genetic testing right
away. We will store and test those samples in
the future.
Future genetic testing of samples may sometimes be done together with other approved
researchers who receive permission from the
Study. We may share your information directly
with researchers or we may share it through a
secure national research database. The goals of
these future studies will be similar to the goals
of the National Children’s Study.
To answer the Study’s research questions, we
may also look at your genetic information
together with information from other research
studies and information sources.
What will the National Children’s
Study do with all this information?
The National Children’s Study may use the
information and samples we get from you in
several ways.
We will store your information and samples
along with those of other people in the
Study indefinitely.
“To answer the Study’s research questions, we may also look at your
genetic information together with information from other research
studies and information sources.”
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and store for the Study. You will not receive
any money that may result from such new
technologies or products.
We may also combine the information we
receive from you for this Study with information
from other research studies to answer our
research questions.
By agreeing to be in the Study, you are agreeing
to allow possible use of your information and
samples for future studies on child and maternal
health and disease.
These studies might be done by other approved
researchers. The goals of these future studies
will be similar to the goals of the National
Children’s Study.
How experiences during early life may affect
our children’s health.
An independent group of doctors, scientists,
and community members will make sure that
your information and samples will only be used
to meet the goals of the National Children’s
Study. The Independent Study Monitoring and
Oversight Committee, or iSMOC, will make
sure that your information and samples will only
be used to:
How genes, surroundings, and experiences
work together to affect growth, development,
and health.
Help us better understand children’s health
and growth.
Researchers may use this information to find out:
How conditions that appear later in
childhood and adulthood begin in early
childhood.
What we learn early in the Study may lead to
more questions about our children’s health.
We may use the information we get from you
to answer those questions, too.
In the future, scientists could develop new
technologies or products based on the
information and samples we collect from you
Answer questions about why some children
are likely to get certain diseases.
How can I find out about the results
of the Study?
We will share what we learn from the Study
as a whole. We will keep in touch through
newsletters, on our Web site, and in other ways.
We will share some of the information we learn
about you with you when it is available.
8 | What You Should Know About Joining the National Children’s Study Vanguard Study
If we know the results from tests we do during
a visit, we will share them with you then. For
example, we will tell you information about
your height, weight, and blood pressure.
We plan to test most of your samples in the
future.
At this time, we do not know when these
tests will be done, which tests will be done,
and when information from the tests will
be available.
Most of the tests we will do on the samples
will be to help us understand how the
physical, social, and family environments,
genes, and other factors affect health
and disease. These tests will not provide
information about your health status.
A committee of doctors, scientists, and
community members (the iSMOC) will
advise the Study on which tests may provide
information about participants’ health.
When test results related to your health are
available, we may ask you if you want to
learn about them.
How will the Study protect my
information?
We will protect your privacy and keep your
information safe by:
Using a number code to label your samples
and other information.
Keeping your number code separate
from your name, address, and other
personal information. We will look at your
information using the number code and not
your personal information.
Keeping your test results and other
information in a secure computer database.
Storing samples and other information in a
secure place. We will limit and keep track
of access to your samples to make sure they
are safe.
Researchers who want to use your information
must:
Get certified by the National Children’s Study
and the federal government.
Get permission to use your information. A
group of doctors, scientists, and community
members (the iSMOC) will make sure that
your information and samples will only be
used to meet the goals of the Study. The goals
are to better understand child health and
growth and to learn about why some children
are more likely to get diseases.
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Sign an affidavit of nondisclosure. This
means promising to use your information
only for research. They must also agree not to
share your information with anyone who has
not made this same promise.
Protect your information by reporting it only
as part of a group.
We will track researchers to make sure they are
keeping your information safe.
We will regularly review all of the ways we keep
your information and samples safe to keep
improving how we protect your privacy.
The U.S. Department of Health and Human
Services (HHS) gave the National Children’s
Study a legal document, called a Certificate of
Confidentiality. This means the Study cannot
be forced by a court order or subpoena to give
out information that might identify you in
any court.
When might the Study have to give
out my information?
If we learn that you or someone else is harming
you, your child, or others around you, we may
be required by law to report this to the police or
a social services agency in your community.
If you give someone or an organization written
permission to see the information you gave
the Study, we cannot use the Certificate of
Confidentiality to protect your information
from that person or organization.
What are the possible benefits of
being in the National Children’s Study?
Taking part in the National Children’s Study
may not help you or your family right now.
But the Study may help us learn things about
health that could benefit all of us—including
your children and grandchildren—in the years
to come.
If you need medical or social services, we will
give you names and contact information for
people and agencies that can try to help. But the
Study cannot and will not pay for your health
care or mental health services.
What are the possible risks or burdens
to me and to my community from
being in the National Children’s Study?
The immediate risks from the Study are the
same as those in routine health care.
Some of the questions we ask and some of the
ways we get samples may be uncomfortable. If
you are uncomfortable, you can skip any part
of the Study. You are in charge.
Giving a blood sample may cause a small
amount of pain. People sometimes feel brief
pain when blood is taken, and there is a very
small risk of infection, bruising, bleeding,
or fainting.
A visit to your home will probably take
2 to 3 hours. We will schedule these visits
at a convenient time, but they may interrupt
your daily routine. You can change the date
or time of any scheduled visit at any time.
10 | What You Should Know About Joining the National Children’s Study Vanguard Study
There is a possibility that specific Study findings
will be associated with particular racial and
ethnic groups.
Will I be paid for being in the National
Children’s Study?
We will give you about $25 to $100 in cash
or gift certificates to thank you each time you
participate in a Study visit.
From time to time, we may also give you small
gifts like a tote bag, picture frame, or other small
items to thank you for being in the Study.
What if I want to leave the National
Children’s Study?
You can leave the Study at any time. You
also can leave the Study for a short time and
come back.
We may learn information about adoption or
the biological parents of your child. We will not
give out any information about parentage to you
or any other members of your family.
If you leave the Study, we will not ask for any
new information, but we will keep using the
information and samples you have already
given us.
Although we are taking many steps to protect
your information, there is always a chance
that your information or identity could be
disclosed. We will continue to review and
improve the ways we keep your information
private. To protect your information, we will
keep your name and address separate from our
information files.
If you want us to destroy or return of any of
your unused samples, you can ask us to do so
and we will.
We will get information about your health, your
community, and your race and ethnicity. We
will make files with this information available to
approved researchers. In addition to the risks to
individuals, the risks of providing information
about racial or community groups are unknown.
Leaving the Study will not affect your access
to health care or any other benefits you may
be receiving, like those from Social Security,
Medicaid, WIC, or the Supplemental Nutrition
Assistance Program.
What if I move?
We hope you will tell us if you are planning to
move so you can still be part of the Study in
your new home.
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If you move and forget to tell us, we will try
to get in touch with you. We will use the
information you have given us about family
members and friends, as well as publicly
available information.
The information we collect is for research
purposes only. Being part of the Study does
not take the place of your usual doctor or
clinic visits.
If we get in touch with you, we will ask if you
want to continue to be part of the Study.
If I join the National Children’s Study,
will I have to join other studies?
Will it cost me anything to be in the
National Children’s Study?
If you join the National Children’s Study, you
do not have to join any other studies. We may
invite you to be in other studies connected with
the National Children’s Study.
No. There is no cost to you for being in the
National Children’s Study.
The Study will pay for all tests and procedures
done as part of the Study. Any future tests
done on your samples will also be paid for by
the Study.
If you are invited to be in other studies, you can
always say no.
Will the media be interested in my
participation in the National Children’s
Study?
Does the National Children’s Study
pay for health care for my family
or me?
The National Children’s Study will not tell
the media anything about the identities of
Study participants.
The Study cannot and will not pay for health
care or mental health services for you or your
family. If you need medical or social services, we
will give you names and contact information for
people and agencies that can try to help.
Because of the importance of the Study
reporters may go to communities where the
Study is being done. They may ask participants
if they want to talk about their experiences
with the Study.
“The information we collect is for research purposes only. Being
part of the Study does not take the place of your usual doctor or
clinic visits.”
12 | What You Should Know About Joining the National Children’s Study Vanguard Study
If you are contacted by reporters, you can decide
if you want to talk to them. If you do talk to a
reporter, they can write about anything you tell
them. What you say will be public information.
The organization that the reporter works for will
have control over any information and material
you give them.
If you talk with the media about your or your
child’s experience with the Study, your role
and your child’s role as Study participants will
be public knowledge. When this information
becomes public, it will be harder for the Study
to protect the privacy of your information
and information about other participants from
your community.
Who can I contact if I have questions
about the National Children’s Study?
If you have questions now, you can ask the
Study representative who gave you this informed
consent form.
If you have any other questions about your
rights as a Study participant, now or in the
future, you can contact the people listed on
the page that we will ask you to sign.
Important things to remember about
joining the National Children’s Study
After reading this informed consent form, we hope you will decide
to join the National Children’s Study.
We will ask you to sign a page that says you have decided to join
the Study.
If you join the Study now, you can quit at any time.
You decide what questions to answer. You can also decide what
samples to give. If you decide not to answer some questions or give
some samples, you still can be in the Study.
Before you decide, you may want to talk with your family, friends, or
doctor about joining the Study.
Thank you for taking the time to learn about the National Children’s Study.
http://www.nationalchildrensstudy.gov
v7/13/2013
National Children’s Study: Vanguard Study
Informed Consent for Fathers Study Participation
I have received the informed consent form, “What You Should Know about Joining the National Children’s Study Vanguard
Study,” which explains the nature and purpose of the Study.
I understand that I can leave the Study at any time and for any reason and then rejoin later.
I understand that if there is a question I do not want to answer, a sample that I do not want to provide, or a part of the Study
I do not want to do, I can skip it and still be in the Study.
I understand that my biological samples will be stored in a secure facility and that the Study will protect access to my samples.
I understand that these samples may be used for a variety of tests in the future, including genetic tests.
I understand that I will not routinely get results back from tests done on the samples I give to the Study.
I have asked and received answers to all my questions about the Study. I understand that I can ask more questions at any time.
Yes
No
I give my permission for the Study to collect biological samples from me.
I give my permission for the Study to use my biological samples to obtain my genetic information.
I choose to join the National Children’s Study.
Participant
Printed Legal Name of Participant:
Signature of Participant:
Date of Birth:
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Parent/Legal Guardian (if participant is a non-emancipated minor)
I have received the informed consent form, “What You Should Know About Joining the National Children’s Study Vanguard Study,” which
explains the nature and purpose of the National Children’s Study. I give my permission for _______________________________ to
(Printed Name of Child)
to take part in the Study if he agrees to be part of it.
Printed Legal Name of Parent/Legal Guardian:
Signature of Parent/Legal Guardian:
Date:
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Witness (if required)
I observed the interviewer explain “What You Should Know about Joining the National Children’s Study Vanguard Study” to the
participant and he signed or marked this form.
Signature of Witness:
Date:
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Printed Name of Person Obtaining Consent:
Signature of Person Obtaining Consent:
Date:
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If you have questions about this study, you may call the local numbers listed on the label below.
For Office Use Only:
Study Participant (Adult or Emanicipated Minor Only)
Parent/Legal Guardian (if Participant is minor)
SO keep top copy. Give participant bottom copy.
Place Label Here
Both
Insert local contact information label here.
This space is slightly smaller than Avery address label 5663 (4.25” x 2”).
http://www.nationalchildrensstudy.gov
| File Type | application/pdf |
| File Modified | 2011-02-11 |
| File Created | 2011-02-10 |