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pdfAttachment 11b
Consent Materials
A. Home Interview Study Statement ....................................................................................... 11b-2
B. Mobile Exam Center Consent Booklet................................................................................ 11b-3
C. Detailed List of NHANES Blood and Urine Tests .......................................................... 11b-18
D. Child 7- to 11-Year-Old Exam Assent .............................................................................. 11b-20
11b-1
11b-A
Home Interview Study Statement
Welcome to the National Health and Nutrition Examination Survey (NHANES). You have been selected
to be part of this study, which includes an interview and a health exam. This study is sponsored by
the National Center for Health Statistics, part of the Centers for Disease Control and Prevention.
The information collected in this interview will be extremely valuable in understanding the health and
nutrition of people in the United States. As a thank you for your time and effort, you will receive a $25
debit card for completing the interview.
You will be asked some questions about health, medical conditions, foods eaten, and prescription
medicine. We will also ask questions about your household, such as smoking behavior, consumer
behavior, food security, and income. We may ask some households to provide a sample of their tap
water. Depending on age, the interview will take about 30-60 minutes.
Taking part in this interview is voluntary. You may choose to skip any question you don’t wish to
answer or end the interview at any time without penalty. Everything you tell us is private. By federal
law, we must follow strict procedures to protect your information. We will keep your information
confidential, which means your answers will not be connected to your name or anything else that can
identify you as a participant. We advise you not tell others you or your child was selected for NHANES
to further protect your confidentiality.
If you have questions about the survey, you can make a toll-free call to the NHANES National Field
Manager at 800-344-1386, Monday-Friday, 9:00 AM-5:00 PM Eastern Time. If you have questions about
your rights about being in the survey, call the Ethics Review Board at the National Center for Health
Statistics, toll free, at 1-800-223-8118. Please leave a brief message with your name and phone number.
Say that you are calling about {Protocol #}. Your call will be returned as soon as possible.
Assurance of Confidentiality. We take your privacy very seriously. All information that relates to or describes identifiable characteristics of
individuals, a practice, or an establishment will be used only for statistical purposes. NCHS staff, contractors, and agents will not disclose
or release responses in identifiable form without the consent of the individual or establishment in accordance with section 308(d) of the
Public Health Service Act (42 U.S.C. 242m(d)) and the Confidential Information Protection and Statistical Efficiency Act or CIPSEA (44 U.S.C.
3561- 3583). In accordance with CIPSEA, every NCHS employee, contractor, and agent has taken an oath and is subject to a jail term of up
to five years, a fine of up to $250,000, or both if he or she willfully discloses ANY identifiable information about you. In addition to the above
cited laws, NCHS complies with the Federal Cybersecurity Enhancement Act of 2015 (6 U.S.C. §§ 151 and 151 note), which protects federal
information systems from cybersecurity risks by screening their networks.
{OMB NUMBER}
{OMB EXP DATE}
33 HomeIntStudyStat-V1
11b-2
11b-B
Mobile Exam Center Consent Booklet
Thank you for participating today! Please review this
whole booklet and ask any questions you have before
signing your consent forms. Here is some helpful
information about what will happen today.
• Your health exam may take about 2 hours.
• Our health staff will review the exams and tests
with you and ask you some health questions to
ensure that they are done safely.
• Our staff will ask you to change into a shirt and
pants specifically designed for the exam.
• Our health staff will then take you through the
Mobile Exam Center to complete your exams.
We will explain each exam to you before we start
and answer all your questions as we go along.
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During your visit to the NHANES Mobile Exam Center...
Health Measures
Depending on your age, we may:
• Measure your height, weight, the size of your waist and chest, and
the length of your arms
• Take your blood pressure
• Test your eyesight, hearing, and breathing
• Ask you to swab your genitals to check for a virus
• Check your teeth and ask you to rinse your mouth with
mouthwash
• Offer you a bone density exam to test for osteoporosis, a disease
that can weaken your bones
Health Interviews
If you are 12 to 64 years old, we will ask you to do the survey in
private on a touch screen computer. We may ask you questions about
tobacco, alcohol, drugs, health conditions, and health behaviors.
Blood Sample
Our experienced health technician will draw your blood. Depending on
your age, we may test your blood sample for blood sugar levels, red
and white blood cell counts, cholesterol, allergies, viruses like hepatitis,
and environmental exposures, such as lead and mercury. The full list of
tests we may perform on your blood sample is included on the Detailed
List of NHANES Blood and Urine Laboratory Tests.
Urine Sample
We will ask you to provide a urine sample. Depending on your age,
we may test your urine to check your kidney health, and whether you
have been exposed to certain environmental chemicals. NHANES
does not test for illegal drug use.
If appropriate, we will test your urine to see if you are pregnant. The
full list of tests we may perform on your urine is included on the
Detailed List of NHANES Blood and Urine Laboratory Tests.
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After your visit to the NHANES Mobile Exam Center...
Some activities will take place after your exam today. We will explain these before
you leave.
Dietary Interviews
We will schedule your dietary interview if you haven’t already
scheduled or completed it. For children under 12, we will ask a
person who is knowledgeable about the child’s diet to complete an
interview or help the child answer questions about what they ate
and drank. If you are 12 years of age or older, you can answer the
questions yourself. We will ask an adult in your family about shopping
for food in a separate interview.
Future Contact
We may need to contact you in the future. To be able to contact you,
we will check with agencies such as the U.S. Post Office for updates to
your home address. We may contact you in the future to ask you to be
part of other public health studies. Your participation in future studies
is voluntary. At that time, you will receive detailed information about the
study, your rights, and the benefits and risks of participating.
Results
Today we will give you results if you completed exams for:
•
•
•
•
•
Blood pressure
Height and weight
Oral health exam
Complete Blood Count (CBC)
Hearing and vision exam
Your results will be available in 3 to 4 months on the NHANES
secure participant portal.
The Detailed List of NHANES Blood and Urine Laboratory Tests
lists all of the laboratory tests that may be done on your samples
and the results that will be shared with you.
If you have questions about getting your results, please call
800-344-1386.
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NHANES Overview
Is participation voluntary?
The National Health and Nutrition Examination
Survey (NHANES) is conducted by the National
Center for Health Statistics (NCHS), which is
part of the Centers for Disease Control and
Prevention (CDC) and the U.S. Department
of Health and Human Services (HHS). We
designed the survey to learn about the health
and nutrition of people in the United States.
You may choose to be in the survey, and you
may allow your child to be in it, too, if they
are eligible. That is your choice. There is no
penalty if you refuse any exam or decide not to
answer any question. You are free to drop out
at any time.
Our survey is unique. It combines interviews
with health measurements that are done in
special Mobile Exam Centers. These centers
travel across the country, each with their
own highly trained teams of health staff. The
teams use the most up-to-date methods and
equipment for health exams and lab tests.
Are the tests safe?
NHANES exams and tests are safe. We will
not ask you to do any test that is not safe for
you to do. Some tests may cause you slight
discomfort. Examples are not eating for 8 hours
before coming to the exam or giving a blood
sample by having a small amount of blood
drawn from a vein in your arm with a needle.
Below are some questions that NHANES
participants often ask.
Some of the NHANES exams and tests are
usually done with people who have specific
health problems. Your results may show
something abnormal but do not represent an
illness. If you take your results to your health
care provider, they may recommend other
tests that may or may not identify health a
concern. You will be responsible for any costs
associated with these additional tests.
Why is this health survey
important?
We use the data gathered in this survey to
find out the number of people with certain
health problems—for example, diabetes
and high blood pressure. We look at diet
and other habits that affect health, such as
smoking and exercise.
For people 45 years of age and older, we will
perform a bone density scan that involves
low-dose x-rays. Radiation exposure during
this test is less than a cross-country airline
flight or the same as a few days of natural
background radiation.
NHANES provides health and nutrition
information about people of all ages in the
United States. The data are also used by those
who design health programs and services.
Adults who have started their menstrual
period will be given a urine pregnancy test.
Those with a positive pregnancy test or who
tell us they are pregnant will not have the
bone density scan.
Why should you take part in the
exams?
There are many benefits to taking part in the
NHANES exams. You will receive:
•
•
•
•
Medical errors and injuries are rare. The
NHANES program cannot provide money or
other compensation if they occur. However,
if you believe you have been harmed by
taking part in NHANES, we want to know
about it. Please call us at 1-800-452-6115.
Free health tests and results
A token of thanks for your time and effort
A chance to learn more about your health
A chance to contribute to an important
survey that evaluates the health of people
in the United States
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Can I tell my family and friends I
participated in NHANES?
You also have a right to file a claim under
the Federal Tort Claims Act (28 U.S. Code §
2674) with the CDC. We can provide you with
information about this process. You must file
the claim within 2 years after the date you
became aware of the personal injury, loss of
property, or other damage.
How will I get my results?
It is your decision whether you tell others you
(and/or) your child participated in NHANES.
We will ask you to provide contact information
for close relatives or friends in the event we
are unable to contact you, but we advise that
you do not tell others that you (and/or) your
child participated in NHANES to further protect
your confidentiality.
You will get reports of your results—some
today and some later. You will not receive
results to some lab tests because doctors and
health professionals are still learning about
what these tests mean for health.
Will my information be kept
private?
Yes! We respect your privacy. Public laws keep
all information you give private.
Test results will be available in your secure
portal within 3 to 4 months after your exam.
Please tell us if you need a different way to
receive your results.
None of your information will be shared with
your family, personal doctor, or anyone who
does not have permission to see the data.
You will receive a notification to check your
secure portal when all of your results are
ready. If the exam or test shows an urgent
health problem, we will notify you quickly. If an
urgent problem is found through your lab tests,
we will notify you to check your secure portal.
NHANES does not cover the cost of any health
care you may decide to get after your exam. If
you have questions about your results, please
call 800-344-1386.
We keep your survey data safe and secure.
When we share data with our collaborators to
help prepare and process the data, we do so
in a way that protects your privacy as required
by law. We protect your rights as a participant.
We cannot identify you or your family without
permission. However, if we find signs of abuse
during an exam, we will report it to the local
department of social services or the police.
Assurance of Confidentiality
We take your privacy very seriously. All information that relates to or describes identifiable
characteristics of individuals, a practice, or an establishment will be used only for statistical
purposes. NCHS staff, contractors, and agents will not disclose or release responses in
identifiable form without the consent of the individual or establishment in accordance with
section 308(d) of the Public Health Service Act (42 U.S.C. 242m(d)) and the Confidential
Information Protection and Statistical Efficiency Act or CIPSEA (44 U.S.C. 3561-3583). In
accordance with CIPSEA, every NCHS employee, contractor, and agent has taken an oath and
is subject to a jail term of up to five years, a fine of up to $250,000, or both if he or she willfully
discloses ANY identifiable information about you. In addition to the above cited laws, NCHS
complies with the Federal Cybersecurity Enhancement Act of 2015 (6 U.S.C. §§ 151 and 151
note) which protects federal information systems from cybersecurity risks by screening their
networks.
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How are NHANES data used?
More questions?
Each participant’s responses are combined
with the responses of thousands of other
people and reported in overall numbers to see
the “big picture” on our nation’s health.
Visit the NHANES participant website at
www.cdc.gov/nhanes.
Our staff can discuss other questions
or concerns you might have or give you
information on local resources that can help
you. You can also call 800-344-1386 for more
facts about the survey.
NHANES has been used in important national
reports. One of these reports highlights the
food people in the United States eat. Another
tracks the number of people who have
health conditions like high blood pressure or
diabetes. Studies using NHANES data can be
found on our website: www.cdc.gov/nhanes.
You can call our Chief Medical Officer, Dr.
Duong Nguyen of the U.S. Public Health
Service, to discuss your results or any aspect
of the survey. He can be reached at {PHONE
NUMBER}, Monday–Friday, 8:00 a.m.–4:30
p.m. ET. You may call him regarding any harm
to you from this survey. You can also get
answers to your questions by writing to Dr.
Nguyen at 3311 Toledo Rd., Hyattsville, MD
20782-2064.
Many federal agencies, universities, and other
public and private groups use NHANES data,
and these data may be reported in journals,
at major scientific meetings, or through other
news media. They use the data to help find
new cures and treatments for diseases and
disabilities. The aim is to make the health of all
people better. None of these reports will ever
use data that can identify any person who took
part in the survey.
If you have questions about your rights as a
participant in this study, please call the Ethics
Review Board at the National Center for Health
Statistics, toll-free, at 1-800-223-8118. Please
leave a brief message with your name and
phone number, and say that you are calling
about Protocol (#{PROTOCOL NUMBER}) for
NHANES 2025-2026. Your call will be returned
as soon as possible.
What will happen to my scans
and images?
Your scans and images will be safely secured
as with all your other data. As better ways
to look at these images are developed in the
future some of your tests, like images of eyes
or your bone density tests, may be read again
and stored securely. We will not report any
new results to you.
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Frequently Asked Questions About Future Health Studies
Why will samples be kept for
future health studies?
What studies will be done with
the samples?
We store some of the blood and urine samples
from people who complete NHANES exams
for future health studies. If you agree to it,
your samples may be used to help us better
understand health conditions.
At this time, no specific studies are planned
besides the tests included in the NHANES
exam. As scientists learn more about health
and disease, other studies may be conducted
with stored samples. There may be many
additional studies on these samples. Since we
won’t ask your permission for future studies,
we can’t be sure you would agree to them. But
we only approve studies that are important for
public health.
Your participation in future health studies is
voluntary, and no loss of benefits will result if
you refuse.
How long will you keep my
samples?
The use of your data and biospecimens may
lead to new tests, drugs, devices, or other
products or services with commercial value.
These products or services could be patented
and licensed. There are no plans to provide
any payment to you should this occur.
Samples will be kept for as long as they can
be used or until they aren’t needed any more.
By choosing yes to storing your samples, you
are agreeing to help public health research
in the years and decades to come. You can
request that your or your child’s samples be
removed at any time.
Who can use the stored samples
for further study?
How can I have my stored
samples removed and not used
in any future studies?
Researchers from federal agencies,
universities, and other scientific centers,
such as companies that invent and produce
medicines and vaccines, can submit proposals
to use the stored specimens.
You can request that your samples be
removed from storage at any time. If you want
your samples removed and not used for future
studies, call us toll-free at 800-344-1386.
How will my information be
protected when used in future
studies?
The NHANES program will always know which
samples belong to you but we will not share
any information that could identify you with
other researchers. We are required by federal
law to keep your information private.
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Frequently Asked Questions About Future Health Studies
Will I receive results from any
future testing of my samples?
Science and medicine are continually
advancing. New tests and new ways of looking
at results will be developed in the future.
We can’t predict what tests will be done or
what the results will mean for your health.
Since testing of samples will be done only for
study purposes, the NHANES program will
not contact you or your family with results
from these future studies. We will describe
the completed studies on the CDC NHANES
biospecimens website, which can be accessed
here: https://www.cdc.gov/nchs/nhanes/
biospecimens/biospecimens.htm
What are the benefits and risks
for allowing my samples to be
used for future studies?
You will not directly benefit but by allowing
your samples to be used, you may help
improve the health of people in the future.
Researchers may use facts like your race,
ethnic group, and sex in their studies. This
data helps researchers learn if the things that
affect health are the same in different groups
of people.
However, there is a risk that some people
may use the information to treat groups of
people differently. There is the possibility
that someone may try to misuse samples
or misrepresent the results of the study. All
proposals are reviewed before any samples
are allowed to be used to prevent this from
happening.
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Consent Forms
The next pages are copies of the NHANES consent
forms that you will fill out and sign today.
Please save this booklet for your records. You will
not get a copy of your signed form.
If you have any questions after today, please call us.
• General questions about NHANES:
800-344-1386
• Any harm you feel you experienced:
1-800-452-6115 (ask for Dr. Duong Nguyen,
NHANES Chief Medical Officer)
• Questions about your rights as a
participant in NHANES: 1-800-223-8118
(NCHS Ethics Review Board—Mention
NHANES, protocol number {PROTOCOL
NUMBER})
Thank You!
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ADULT CONSENT
for Examination at the Mobile Examination Center and Future Studies
By checking the box below, I confirm that I have reviewed the NHANES Consent Video (or someone
explained the content of the video to me). I have also received the Examination Consent Booklet, which
explains the nature and purpose of the survey. I have been given a chance to ask questions, and my
questions have been answered.
□
I freely choose to take part in the Examination at the NHANES Mobile Examination Center.
NHANES stores a portion of the blood and urine collected as part of this study for use in future health
studies that may help find new ways to prevent, monitor, and treat many diseases. Participants who agree
to allow NHANES to store their samples for this purpose will not be asked to provide additional informed
consent and will not be contacted with results from these future studies.
□
□
YES, I allow my blood and urine samples to be stored for use in future health studies.
NO, I do not allow my blood and urine samples to be stored for use in future health studies.
Participant Signature
Date
Participant Name (Print First, Middle, and Last Name)
Assurance of Confidentiality. We take your privacy very seriously. All information that relates to or describes
identifiable characteristics of individuals, a practice, or an establishment will be used only for statistical purposes.
NCHS staff, contractors, and agents will not disclose or release responses in identifiable form without the consent of
the individual or establishment in accordance with section 308(d) of the Public Health Service Act (42 U.S.C.
242m(d)) and the Confidential Information Protection and Statistical Efficiency Act or CIPSEA (44 U.S.C. 35613583). In accordance with CIPSEA, every NCHS employee, contractor, and agent has taken an oath and is subject to
a jail term of up to five years, a fine of up to $250,000, or both if he or she willfully discloses ANY identifiable
information about you. In addition to the above cited laws, NCHS complies with the Federal Cybersecurity
Enhancement Act of 2015 (6 U.S.C. §§ 151 and 151 note) which protects Federal information systems from
cybersecurity risks by screening their networks.
10
11b-12
MINORS 12–17 CONSENT/ASSENT
for Examination at the Mobile Examination Center and Future Studies
By checking the box below, I confirm that I have reviewed the NHANES Consent Video (or someone
explained the content of the video to me). I have also received the Examination Consent Booklet, which
explains the nature and purpose of the survey. I have been given a chance to ask questions, and my
questions have been answered.
Consent from Parent/Legal Guardian:
□ I freely choose to let my child take part in the examination at the NHANES Mobile Examination
Center.
Consent for Survey Participant who is 12–17 years old:
□ I freely choose to take part in the examination at the NHANES Mobile Examination Center.
NHANES stores a portion of the blood and urine collected as part of this study for use in future health
studies that may help find new ways to prevent, monitor, and treat many diseases. If you give us
permission to keep your samples for future studies, we will not contact you about these studies or their
results.
Consent from Parent/Legal Guardian:
□ YES, I allow my child’s blood and urine samples to be stored for use in future health studies.
□ NO, I do not allow my child’s blood and urine samples to be stored for use in for future health studies.
Assent from Survey Participant who is 12–17 years old:
□ YES, I allow my samples to be stored for use in future health studies.
□ NO, I do not allow my samples to be stored before use in future health studies.
Date
Participant Signature
Participant Name (Print First, Middle, and Last Name)
Date
Parent/Legal Guardian Signature
Parent/Legal Guardian Name (Print First, Middle, and Last Name)
Relationship to Participant
Assurance of Confidentiality. We take your privacy very seriously. All information that relates to or describes
identifiable characteristics of individuals, a practice, or an establishment will be used only for statistical purposes.
NCHS staff, contractors, and agents will not disclose or release responses in identifiable form without the consent of
the individual or establishment in accordance with section 308(d) of the Public Health Service Act (42 U.S.C.
242m(d)) and the Confidential Information Protection and Statistical Efficiency Act or CIPSEA (44 U.S.C. 35613583). In accordance with CIPSEA, every NCHS employee, contractor, and agent has taken an oath and is subject to
a jail term of up to five years, a fine of up to $250,000, or both if he or she willfully discloses ANY identifiable
information about you. In addition to the above cited laws, NCHS complies with the Federal Cybersecurity
Enhancement Act of 2015 (6 U.S.C. §§ 151 and 151 note) which protects Federal information systems from
cybersecurity risks by screening their networks.
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MINORS 7–11 CONSENT/ASSENT
for Examination at the Mobile Examination Center and Future Studies
Parent/Legal Guardian Consent: By checking the box below, I confirm that I have reviewed the NHANES
Consent Video (or someone explained the content of the video to me). I have also received the
Examination Consent Booklet, which explains the nature and purpose of the survey. I have been given a
chance to ask questions, and my questions have been answered.
□
I freely choose to let my child take part in the examination at the NHANES Mobile Examination
Center.
Assent for Survey Participant who is 7-11 years old: Your parent/legal guardian says you can take part in
this special survey. You have just read about the survey in these materials. If you want to take part in the
survey, check the box below.
□
I freely choose to take part in the examination at the NHANES Mobile Examination Center.
NHANES stores a portion of the blood and urine collected as part of this survey for use in future health
studies that may help find new ways to prevent, monitor, and treat many diseases. If you give us
permission to keep your samples for future studies, we will not contact you about these studies or their
results.
Consent from Parent/Legal Guardian:
□ YES, I allow my child’s blood and urine samples to be stored for use in future health studies.
□ NO, I do not allow my child’s blood and urine samples to be stored for use in for future health studies.
Assent from Survey Participant who is 7-11 years old:
□ YES, I allow my blood and urine samples to be stored for use in future health studies.
□ NO, I do not allow my blood and urine samples to be stored for use in future health studies.
Participant Signature
Date
Participant Name (Print First, Middle, and Last Name)
Parent/Legal Guardian Signature
Date
Parent/Legal Guardian Name (Print First, Middle, and Last Name)
Relationship to Participant
Assurance of Confidentiality. We take your privacy very seriously. All information that relates to or describes
identifiable characteristics of individuals, a practice, or an establishment will be used only for statistical purposes.
NCHS staff, contractors, and agents will not disclose or release responses in identifiable form without the consent of
the individual or establishment in accordance with section 308(d) of the Public Health Service Act (42 U.S.C.
242m(d)) and the Confidential Information Protection and Statistical Efficiency Act or CIPSEA (44 U.S.C. 35613583). In accordance with CIPSEA, every NCHS employee, contractor, and agent has taken an oath and is subject to
a jail term of up to five years, a fine of up to $250,000, or both if he or she willfully discloses ANY identifiable
information about you. In addition to the above cited laws, NCHS complies with the Federal Cybersecurity
Enhancement Act of 2015 (6 U.S.C. §§ 151 and 151 note) which protects Federal information systems from
cybersecurity risks by screening their networks.
12
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MINORS 0–6 CONSENT
for Examination at the Mobile Examination Center and Future Studies
By checking the box below, I confirm that I have reviewed the NHANES Consent Video (or someone has
explained the content of the video to me). I have also received the Examination Consent Booklet, which
explains the nature and purpose of the survey. I have been given a chance to ask questions, and my
questions have been answered.
□
I freely choose to let my child take part in the examination at the NHANES Mobile Examination
Center.
NHANES stores a portion of the blood and urine collected as part of this study for use in future health
studies that may help find new ways to prevent, monitor, and treat many diseases. Participants who agree
to allow us to store their samples for this purpose will not be asked to provide additional informed
consent and will not be contacted with results from these future studies.
Consent from Parent/Legal Guardian:
□ YES, I allow my child’s blood and urine samples to be stored for use in future health studies.
□ NO, I do not allow my child’s blood and urine samples to be stored for use in future health studies.
Participant Name (Print First, Middle, and Last Name)
Parent/Legal Guardian Signature
Date
Parent/Legal Guardian Name (Print First, Middle, and Last Name)
Relationship to Participant
Assurance of Confidentiality. We take your privacy very seriously. All information that relates to or describes
identifiable characteristics of individuals, a practice, or an establishment will be used only for statistical purposes.
NCHS staff, contractors, and agents will not disclose or release responses in identifiable form without the consent of
the individual or establishment in accordance with section 308(d) of the Public Health Service Act (42 U.S.C.
242m(d)) and the Confidential Information Protection and Statistical Efficiency Act or CIPSEA (44 U.S.C. 35613583). In accordance with CIPSEA, every NCHS employee, contractor, and agent has taken an oath and is subject to
a jail term of up to five years, a fine of up to $250,000, or both if he or she willfully discloses ANY identifiable
information about you. In addition to the above cited laws, NCHS complies with the Federal Cybersecurity
Enhancement Act of 2015 (6 U.S.C. §§ 151 and 151 note) which protects Federal information systems from
cybersecurity risks by screening their networks.
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ADULTS WITH LEGAL GUARDIANS OR PROXIES CONSENT
for Examination at the Mobile Examination Center and Future Studies
By checking the box below, I confirm that I have reviewed the NHANES Consent Video (or someone
explained the content of the video to me). I have also received the Examination Consent Booklet which
explains the nature and purpose of the survey. I have been given a chance to ask questions, and my
questions have been answered.
Consent from Legal Guardian/Proxy:
□ I freely choose to let the Survey Participant take part in the examination at the NHANES Mobile
Examination Center.
Consent for Survey Participant:
□ I freely choose to take part in the examination at the NHANES Mobile Examination Center.
NHANES stores a portion of the blood and urine samples collected as part of this study for use in future
health studies that may help find new ways to prevent, monitor, and treat many diseases.
Participants who agree to allow NHANES to store their samples for this purpose will not be asked to
provide additional informed consent and will not be contacted with results from these future studies.
Consent from Legal Guardian/Proxy:
□ YES, I allow the Survey Participant’s blood and urine samples to be stored for use in
future health studies.
□ NO, I do not allow the Survey Participant’s blood and urine samples to be stored for use
in future health studies.
Consent from Survey Participant:
□ YES, I allow my blood and urine samples to be stored for use in future health studies.
□ NO, I do not allow my blood and urine samples to be stored for use in future health studies.
Participant Signature
Date
______________________________________________________
Participant Name (Print First, Middle and Last Name)
Legal Guardian/Proxy Signature
Date
______________________________________________________
Legal Guardian/Proxy Name (Print First, Middle and Last Name)
______________________________________________________
Relationship to Participant
14
11b-16
Assurance of Confidentiality – We take your privacy very seriously. All information that relates to or describes
identifiable characteristics of individuals, a practice, or an establishment will be used only for statistical purposes.
NCHS staff, contractors, and agents will not disclose or release responses in identifiable form without the consent of
the individual or establishment in accordance with section 308(d) of the Public Health Service Act (42 U.S.C.
242m(d)) and the Confidential Information Protection and Statistical Efficiency Act or CIPSEA (44 U.S.C. 35613583). In accordance with CIPSEA, every NCHS employee, contractor, and agent has taken an oath and is subject to
a jail term of up to five years, a fine of up to $250,000, or both if he or she willfully discloses ANY identifiable
information about you. In addition to the above cited laws, NCHS complies with the Federal Cybersecurity
Enhancement Act of 2015 (6 U.S.C. §§ 151 and 151 note) which protects Federal information systems from
cybersecurity risks by screening their networks.
15
11b-17
11b-C
Detailed List of NHANES Blood and Urine Laboratory Tests
Your samples will be tested only if your age falls within the range shown in parentheses.
• Some tests are only run on a random sample of participants.
For example, if it says 1/2 participants 6+, that means that of all the
NHANES participants who are 6 years of age and older, half will have
their samples tested for this particular test.
• Participants will be sent the results of all tests marked with one diamond.
You will not receive results to some lab tests because doctors and health
professionals are still learning about what these tests mean for health. If a
diamond is not present, those results will not be sent to participants.
• Tests with two diamonds will only be completed if another test is
positive. If this test is done, the result will be sent to the participant.
• Some of the NHANES exams and tests are usually done with people
who have specific health problems. Your results may show something
abnormal but do not represent an illness. If you take your results to
your health care provider, they may recommend other tests that may or
may not identify health a concern. You will be responsible for any costs
associated with these additional tests.
Allergy Tests (1+) ♦
• Total IgE
• Alpha-gal
• Alternaria alternata (mold)
• Aspergillus fumigatus (mold)
• Bermuda grass
• Birch
• Blattella Germanica (German
cockroach)
• Cat epithelium and dander
• Cladosporium herbarum
• Common ragweed
• Cow’s milk
• D. farina (dust mite)
• D. pteronyssinus (dust mite)
• Dog dander
• Egg
• Mouse urine proteins
• Oak
• Peanut
• Penicillium
• Russian thistle
• Shellfish (shrimp)
• White oak
Biochemical Profile (12+) ♦
• Alanine aminotransferase (ALT)
• Albumin
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Alkaline phosphatase (ALP)
Aspartate aminotransferase (AST)
Bicarbonate
Blood urea nitrogen (BUN)
Calcium
Chloride
Creatinine
Cystatin C
Gamma glutamyl transaminase
(GGT)
Glucose, refrigerated
Iron
Lactate dehydrogenase (LDH)
Magnesium
Potassium
Sodium
Total bilirubin
Total protein
Triglycerides
Uric acid
Blood Pressure Biomarkers
(2+)
• Aldosterone
• Angiotensin I and II
• Angiotensin 1–9
• Angiotensin 1–7
11b-18
Environmental Profile
in Blood
• Terpenes (1/2 participants 5+)
Infectious Disease Profile
• HPV Oral rinse and genital
swab (14-64)
• Hepatitis C RNA (5+) ♦♦
Diabetes Profile (12+)
• Fasting glucose ♦
• Insulin
• Hemoglobin A1c ♦
Environmental Profile in Blood
• Acrylonitrile (5+)
• Butyrylcholinesterase (5+) ♦
• Cotinine and metabolites (2+)
• Perfluoroalkyl & polyfluoroalkyl
substances (1/2 participants 12+)
• Polybrominated diphenyl ethers
(1/2 participants 12+)
• Polychlorinated biphenyls (PCBs)
and dioxins (1/2 participants 12+)
• Polychlorinated dibenzo-p-dioxins
and dibenzofurans (1/2 participants
12+)
• Terpenes (1/2 participants 5+)
• Metals in blood (1+) ♦
○ Cadmium
○ Lead
○ Manganese
○ Total & speciation mercury
○ Selenium
Environmental Profile in Urine
(3–4 & 1/2 participants 5+)
• Flame-retardant metabolites
• Insect repellents: DEET metabolites
• Neonicotinoids insecticide
biomarkers
• Organophosphate insecticides:
Diakyl phosphate metabolites
• Perchlorate, nitrate, thiocyanate
• Phthalates and personal care and
consumer products
• Polycyclic aromatic hydrocarbons
• Pyrethroids herbicides & OP
metabolites
• Tobacco-specific nitrosamines
Environmental Profile in Urine
(3–4 & 1/2 participants 5+) (cont.)
• Trace metals/elements
○ Antimony
○ Arsenic ♦
○ Arsenic speciated
○ Barium
○ Cadmium
○ Cesium
○ Cobalt
○ Chromium ♦
○ Iodine
○ Lead
○ Manganese
○ Total & speciation mercury
○ Molybdenum
○ Nickel ♦
○ Strontium
○ Thallium
○ Tin
○ Tungsten
○ Uranium
Infectious Disease Profile
• Enterovirus D68 antibody (1–11)
• Hepatitis A antibody (5+)
• Hepatitis B antigen ♦
• Hepatitis B DNA (5+) ♦♦
• Hepatitis B core antibody (5+) ♦
• Hepatitis B surface antibody (2–4) ♦
• Hepatitis C antibody ♦
• Hepatitis C RNA (5+) ♦♦
• Hepatitis C genotype (5+) ♦♦
• Hepatitis D antibody (5+) ♦♦
• Hepatitis D antigen (5+) ♦♦
• Hepatitis E antibody (5+)
• HPV oral rinse and Genital swab
(14-64)
Inflammatory Disease Profile (1+)
• High sensitive C-reactive protein
(CRP)
Kidney Disease Profile
• Albumin creatinine ratio (ACR), urine
(3+) ♦
• BUN in biochemical profile (12+) ♦
• Creatinine in biochemical profile
(12+) ♦
• Creatine and albumin in urine (3+)
• Estimated glomerular filtration rate
(eGFR), urine (3+) ♦
Lipid Profile (5+) ♦
• Calculated low density lipoprotein
(LDL) cholesterol ♦
• High density lipoprotein (HDL)
cholesterol ♦
• Total cholesterol ♦
• Triglycerides ♦
Liver Disease Profile (12+)
• ALT ALP, AST, GGT (in biochemical
profile) ♦
• Free fatty acids (fasting)
• Fructose (fasting)
• Total bilirubin (in biochemical profile) ♦
Hemoglobin variants including B,
C, D, E, F, and S (12+) ♦
Nutritional Laboratory Tests
• Alpha-1-acid glycoprotein (AGP)
(1–4, females 12–49)
• Complete blood count (1+) ♦
• Dietary polyphenols in urine (3-4 &
1/2 participants 5+)
• Fatty acids (RBC) (5+)
• Ferritin (1–4, females 12–49) ♦
• Folate in serum and RBC (females,
12–49) ♦
• Methylmalonic acid (MMA) (5+) ♦
• Soluble transferrin receptor
(1–4, females 12–49)
• Transferrin (1–4, females 12–49)
• Vitamin B1 & B2 (5+) ♦
• Vitamin B6 & 12 (5+) ♦
• Vitamin D (1+) ♦
Pregnancy Test
• Urine pregnancy test (females
18–59) ♦
11b-19
Reproductive Hormone Panel ♦
• 17α-hydroxyprogesterone (2+)
• Androstenedione (2+)
• Anti-Müllerian hormone
(female, 5+)
• Dehydroepiandrosterone (DHAS)
(2+)
• Estradiol (2+)
• Estrone (2+)
• Estrone sulfate (2+)
• Follicle stimulating hormone (FSH)
(5+)
• Luteinizing hormone (LH) (5+)
• Progesterone (2+)
• Sex hormone binding globulin
(SHBG) (2+)
• Testosterone (2+)
Thyroid Hormone Panel ♦
• Free Thyroxine (FT4) ( 2+)
• Thyroid peroxidase antibodies (12+)
• Thyroglobulin antibodies (12+)
• Thyroid stimulating hormone (TSH)
(2+)
• Thyroid stimulating hormone
receptor antibody (12+)
• Total Thyroxine total T4 (12+)
• Total Triiodothyronine (Total T3)
(12+)
Volatile Organic Compound (VOC)
• Blood (12+)
• Urine (3–4 & 1/2 participants 5+)
11b-D
This flyer explains the study and what we will ask you to do.
Your NHANES Exam
The National Health and Nutrition
Examination Survey looks at the health of
people in the United States.
We go all around the country to see people
like you.
The Nation’s Mobile Health Survey
If you take part, you will learn some things
about yourself. You will also help us learn a
lot about kids in the United States.
You will change into special clothes
for the exam.
We will see how much you weigh
and how tall you are.
If you are 8 years old or older, we will take your blood pressure and pulse.
This feels a little like your arm getting a hug.
11b-20
We will look at your teeth.
We will take your blood and
have you pee in a cup.
We will check your eyes and ears.
We will test how your lungs work.
We will send you and your
parents a report of your exam.
Our staff will answer any questions you have.
We would like you to take an exam in our Mobile Exam Center. The visit will take
about 2 hours. You do not have to do this if you do not want to. You can also stop
at any time and you do not have to do any tests that you do not want to.
36 MECAssentBroch7-11yrOlds-V1
11b-21
File Type | application/pdf |
File Title | Microsoft Word - Attachment_Template.docx |
Author | mmyers |
File Modified | 2024-06-18 |
File Created | 2024-06-18 |