Appendix B

Appendix B
Other Respondent Materials

Appendix B.1
Informed Consent

Appendix B

B.1.1–1

National Children’s Study Pilot—Evaluation of Consent Methods
Background
The NCS is designed to examine the effects of environmental influences on the health and
development of children across the United States. The data from the study will facilitate the
improved health and well being of children. The study plans for a sample of more than 100,000
children, with individual data collection extending from the pre-natal stage to the age of 21.
Across the 21 years of data collection, participants will provide data multiple times through a
multi-mode data collection design that includes self-response to different types of paper
questionnaires, keeping diary records, responding to interviewer-administered automated
questionnaires (in-person and by telephone), environmental samples taken from their home,
physical examinations, blood pressure readings, and various biospecimens including blood,
urine, saliva, and hair samples. When children are born to participating mothers, person-level
data collection activities will focus on the child, the actual target sample unit.
Participation in the study will require a lot of time and effort from respondents, as well as the
potential to experience slight discomforts in completing some of the measures such as blood or
urine samples or vaginal swabs. Given these requirements, the study design includes a fairly
rigorous consent process that incorporates an assessment of how well the sampled person
(initially, the pregnant woman) understands what is expected of her. The consent process
includes two components: (1) overall consent to the study based on a broad understanding of
the measures taken in the study over the 21-year period, including how individual results will be
handled and privacy protected, and (2) verbal consent given at each visit or exam covering the
specific activities to be conducted during that visit.
Because of the need to ensure that sampled persons fully understand what their participation
will require, the consent process in and of itself requires a time-investment. Similarly, the
description of the various measures, especially some of the biological sample collections, can
be difficult and perhaps even viewed as intimidating. Thus the consent process itself could
serve as a barrier to participation.
The primary objective of the consent methods evaluation contained in the NCS pilot is to
determine whether two methods for obtaining study consent result in different study enrollment

1

Appendix B

B.1.1–2

rates. Screening and enrollment begin in July of 2008 for the first wave of PSUs in the pilot, and
in November 2008 for the second wave of PSUs in the pilot.
Evaluative Conditions and Procedures
As stated, this evaluation will assess what effect, if any, the method of communication for
providing the overall consent information for the survey has on enrollment rates. The test
manipulates two different methods for communicating the consent information and obtaining
consent:
•

An interactive video that provides the overall study consent information and obtains
consent at the end of the video using an electronic signature.

•

A hard-copy booklet of the overall study consent information reviewed with an
interviewer. The interviewer asks the person to give consent on a signature page
included at the end of the booklet.

About half the English- and Spanish-speaking women eligible for the pilot study will complete
the consent process in the interactive video condition. The other half will complete the consent
process using the hard-copy booklet. (The evaluation will not include women who speak a
language other than English or Spanish.) The Information Management System (IMS) will
randomly assign households to a condition, outside of the control of the interviewer.
Interviewers will ask women for their (verbal) consent to participate in the consent evaluation. If
any respondent indicates that she does not want to participate in the consent evaluation, she will
receive the video condition as the default. Respondents in both conditions will receive a hardcopy of the consent information to keep for their records.
Description of video condition
The interactive consent video includes several features to help potential respondents
understand what participating in the NCS entails. First, the video includes a brief (2–3
minute) introduction to the study that provides the goals and motivations for the NCS as
a whole. Second, at different points, the video asks potential respondents to answer
knowledge questions about several critical aspects of the study pertinent to informed
consent. The interactive question–answer process built into the video may facilitate
understanding of what participating in the NCS means. Lastly, the media itself may

2

Appendix B

B.1.1–3

increase comprehension for potential participants who may have difficulty reading a 10page consent booklet.
However, the video also may introduce some barriers to participation in the study. First,
depending on how well potential respondents do in answering the questions embedded
in the video, the video could last more than 30 minutes. Second, the knowledge
questions may seem like a test to potential respondents, perhaps discouraging them
from continuing to participate. Lastly, by using a video to communicate the consent
information, the interviewer is somewhat removed from the process, which may make it
awkward or less easy for the respondent to ask questions. Similarly, since the
interviewer is somewhat removed from this early interaction with respondents,
interviewers in the video condition have less opportunity to build rapport with the
respondent and less time to directly assess the respondents interest and ability to
participate.
Description of hard-copy booklet condition
The other half of the eligible woman in the pilot study will receive the overall consent
materials as a paper booklet, similar to a more traditional consent approach. The
booklet contains the same substantive content as that contained in the video condition
though the exact language reflects a printed rather than video medium. The format
reflects the NHANES design using a question–answer presentation and, like NHANES,
assumes interviewers will read through the booklet with respondents. (If the respondent
indicates a preference for reading the consent booklet on her own, the interviewer does
not have to read it aloud with her.) The amount of time required to read through the
booklet will vary, depending on the respondents’ level of reading comprehension and the
interviewers’ skill at reading through the materials and answering questions. To some
extent the length of time can be “customized” to fit the situation though the interviewer
must always cover the full set of questions and answers in the booklet.
The booklet also provides the interviewer with more opportunity to directly interact with
the respondent and continue to develop the rapport between them. The greater amount
of direct interaction may also provide the interviewer with more information about the
respondent’s interests in the study and ability to participate in the study. The interviewer

3

Appendix B

B.1.1–4

can then use this information to guide the discussion throughout the visit, perhaps aiding
his/her ability to persuade a reluctant respondent to participate.
On the other hand, reading through a 10-page document may take more effort and
concentration on the potential respondents’ part to stay engaged. Additionally, as noted
earlier, the document may prove difficult for potential respondents with lower levels of
literacy.
In both conditions, if the screener interview identifies a household with a woman in her first
trimester of pregnancy, the interviewer doing the pregnancy screening will leave a short
promotional DVD that provides information about the study goals and discusses the importance
of the study in terms of contributing to the health and well-being of children. Thus potential
respondents in each condition will have equal opportunity to view the promotional materials
before the arrival of the interviewer who completes the consent process and initiates the first
data collection. (This data collection interviewer will contact the household to set up the first
appointment with the target woman. When setting up the appointment the interviewer can ask
the potential respondent if she has any questions about the DVD, thus reminding her of the
opportunity to watch the DVD prior to the appointment).
Upon arrival, the interviewer who conducts the consent process will reintroduce herself, answer
any questions the respondent may have and then get verbal consent to proceed with the
consent evaluation. The interviewer’s laptop will contain the script for this verbal consent
process as well as a set of Frequently Asked Questions (FAQs) to help answer any questions
the respondent might have about the evaluation.
After obtaining verbal consent to participate in the evaluation, the interviewer will proceed with
the overall study consent completing the video or booklet consent materials as appropriate.
Once the participant signs the electronic (video treatment) or hard-copy (booklet treatment)
consent page, the interviewer still must provide the detailed information about each component
of data collection associated with the first trimester visit and obtain the respondents verbal
consent for each component. (The overall study consent addresses the various types of data
collection more generally throughout the many years of the study.) In both conditions, the
detailed information about each component of data collection for the visit is given on the “Visit
Information Card” or VIC.

4

Appendix B

B.1.1–5

In both conditions, the interviewer will review the VIC with the participant before beginning the
data collection. In addition to discussing the individual components of the T1 data collection, the
VIC reminds respondents that their participation is voluntary and they may decline to participate
in any of the data collection components. The VIC informs women that during this first year of
the study, we will ask for their thoughts on how well some of the Study procedures and materials
work and that information from this first year of the Study will be used to make improvements for
the coming years.
After completing the booklet or video consent, the interviewer will go over the VIC covering the
interviews, questionnaires, diary and medical visit log and obtain verbal consent to proceed with
the T1 interview.
General Study Design
The study will include only English- and Spanish-speaking women in their first trimester of
pregnancy as identified in the pregnancy screener. (Data collection will start with the first
trimester visit for women who enroll at that point in their pregnancy). The evaluation does not
include women who are not pregnant at the time of the screening interview because they
complete slightly different consent materials. Of the women asked to complete the consent
process after completing the screening interview, we estimate between 55% and 65% will be in
their first trimester of pregnancy.
Table 1 shows the number of consent opportunities anticipated by February through June 2009
in the pilot areas for women identified as in their first trimester in the screening interview. In
order to inform design and procedures for the National Children Study, results of this test must
be available sometime between March and June 2009, depending on the anticipated complexity
of modifications to the NCS consent materials and procedures resulting from the evaluation.

5

Appendix B
Table 1:

B.1.1–6
The estimated number of consent opportunities in each condition, by different
possible ending months in 2009.
Video

Booklet

Consent

Consent

February

239

239

March

298

298

April

355

355

May

385

385

June

403

403

Month (in 2009) complete evaluation

If data collection for the consent evaluation ends in February, about 239 women will have had
the opportunity to review the video consent materials and about 239 women will have had the
opportunity to review the booklet consent materials. If we continue with the data collection
through May, each condition will include approximately 385 women. Table 2 shows the
estimated size of the difference in enrollment rates detectable at 80% power and a 90%
confidence interval, assuming 50% as the enrollment rate for the condition with the highest
enrollment rate under a simple random sample. The size of the difference detectable at 80%
power and a 95% confidence interval ultimately will be larger when reflecting the impact of
clustering. Thus, even with extending the evaluation through June, the small number of cases
will result only in statistically significant differences if enrollment between the two conditions
differs by more than 10%.

6

Appendix B
Table 2:

B.1.1–7
The detectable difference in enrollment rates with 80% power and a 90%
confidence interval under the assumption of simple random sampling.
Enrollment

Enrollment

Rate;

Rate;

Detectable

evaluation

Condition 1

Condition 2

Difference

February

50%

36.9%

13.1%

March

50%

38.3%

11.7%

April

50%

39.3%

10.7%

May

50%

39.7%

10.3%

June

50%

39.9%

10.1%

Month (in 2009) complete

As indicated above, respondents will be randomly assigned to condition, though the unit of
implementation still needs discussion. The only currently known requirement is that all women
in the same household receive the same treatment. However, from an implementation
perspective, assignment to each group will likely reflect some level of geographic clustering in
order to manage the demands placed upon any individual interviewer, and similarly contain the
costs of implementation.
In addition to measuring whether the two consent conditions impact enrollment differentially, the
study also will measure differences in comprehension and in several aspects of the
respondent’s subjective experience with the consent process. Interviewers will ask all women
who complete the consent process (regardless of whether they ultimately give consent) to
respond to a short set of questions covering the consent material via a self-administered paper
questionnaire. The initial few questions on the questionnaire collect feedback on format and
presentation of the consent materials, as well as general attitude about the study. Following
those questions, the respondent will complete a short set of questions to assess
comprehension. The questionnaires contain essentially the same questions for both conditions,
with only slight wording differences necessary to reflect the appropriate video or booklet
condition. (Appendix A1_video and A2_booklet contain the draft questionnaires.)
Respondents who decide not to enroll in the study after reviewing the consent materials also will
complete an evaluation questionnaire for their condition, but the questionnaires for non-enrolled
women are shorter. Rather than asking details about the consent materials she reviewed, the

7

Appendix B

B.1.1–8

non-enrolled questionnaire includes questions to assess how much of the consent process she
completed, and why she chose not to participate in the study, as well as a couple of additional
opinion questions about the study in general. Women who enroll in the study will answer the
same opinion questions but at a later point in the data collection, not as part of the consent
evaluation questionnaire. (See attachments A3_video_notenrolled and A4_booklet_notenrolled.)
The interviewer will ask the enrolled respondents to complete the consent questionnaire after
completing the T1-first visit near the checkout process. The visit is expected to last about 3
hours on average and we anticipate that some respondents will prefer to continue with some
portion of the data collection components on another day. If the respondent does prefer to
continue on another day, the consent evaluation will be completed on the day the remaining
components are completed. If the respondent refuses to complete any further components of
the visit, the consent evaluation will be completed during the checkout process for that day. The
interviewer will record in the Information Management System on what date the respondent
completed the consent evaluation questionnaire (relative to when she reviewed the consent
materials) and what data collection components she completed before filling out the evaluation
questionnaire.
Regardless of the consent condition, most respondents will complete a self-administered paper
questionnaire collecting feedback on their consent process, at about the same point in the
interview (i.e., after completing all data collection components of the T1 visit). With each
respondent completing an evaluation questionnaire, we can calculate a standard score for each
respondent comparable across conditions. Additionally, to assess differences in retention of the
consent information, interviewers will ask respondents to complete the comprehension
questions again at the end of data collection for the third trimester visit (T3 visit). The next
section defines the specific research questions addressed with this design.

8

Appendix B

B.1.1–9

Specific Research Questions and Evaluation Measures
The following table shows the specific research questions addressed by this study, as well as
the measures proposed to answer the questions.

1.

2.

Research Question
Does the method of communicating the consent
information—an interactive video versus a booklet
reviewed with an interviewer—differentially impact
enrollment rates?

Evaluation Measure
(Statistical) comparison of
enrollment rates between the two
groups.

Does the method of communicating the consent
information—an interactive video versus a booklet
reviewed with an interviewer—result in differences in the
amount and types of information understood by the
respondent? Are their differences in retention of the
consent information by the method of communication?

(Statistical) comparison of percent
of women in each group who
answer each set of knowledge
questions correctly. Answers

collected at the T1 visit will assess
initial comprehension. Answers
collected at the end of the T3 visit
will assess knowledge retention.
(Statistical) comparison of mean
score for comprehension by consent
group.

3.

Does the study attrition rate differ by consent condition?

4.

How do respondents rate the consent materials in
regards to several characteristics such as: how
engaging they find the materials; appropriateness of the
level of detail provided in the consent materials; clarity of
the materials; importance of the consent materials in
their decision to participate; how the consent method
impacts their interaction with the interviewer; and an
open-ended comment section
Do the consent conditions differ in the amount of time
needed to complete the consent process? If so, is the
length of time needed to complete the process related to
the decision to participate?

5.

— will also look at by whether the
woman actually gave consent
(Statistical) comparison of attrition
rates between the two groups at
each of the subsequent data
collection visits prior to the birth
visit.
Comparisons of ratings for each
characteristic between consent
conditions.

Comparison of the average time to
complete the consent process.

Interviewers in both conditions will
enter the time to administer the
consent materials into the IMS for
each case.

9

Appendix B
6.

Do the respondents’ attitudes about the survey topic and
objective correlate with their decision to participate in the
survey? What differences exist, if any, in enrollment
rates by consent condition when controlling for attitude
about the survey?
* Those who chose not to enroll after reviewing the
consent materials will complete a slightly modified
questionnaire as those who do enroll. The non-enrolled
questionnaire only includes one critical knowledge
question, a question about how much of the consent
process they completed, a couple of opinion questions
about the consent process, and one additional question
from a satisfaction questionnaire that study participants
complete at a later point.

B.1.1–10
By condition, measure correlation
between enrollment and responses
to questions asked on a separate
questionnaire that respondents will
complete at the T1 follow-up visit
when study staff come to pick up the
environmental equipment. (This

other questionnaire will be used to
evaluate the outreach and
promotion activities, as well as
general satisfaction with their study
experiences to date.)

The evaluation also may include feedback collected by interviewer debriefing data or comments
collected from observers on a structured questionnaire as additional sources of information
about the consent process. The debriefing will ask interviewer’s for their perceptions of how the
consent process influenced the rapport between herself and the respondent, if at all, as well as
collect feedback on ease or difficulty of implementing the two different consent processes.

10

Appendix B

B.1.2.a–1

National Children’s Study
PRECONCEPTION VERSION Script
Based on Script 06-11-2007
T1-S1
Your neighborhood is one of many communities across the United States that has been
chosen to take part in an important research study.
It’s called the National Children’s Study, and its goal is to improve the health and well
being of our nation’s children. We need both pregnant women and women who are not
pregnant to volunteer to be part of this Study.
Because, your community has been selected to be part of the National Children’s Study,
we’re inviting you to take part.
Here’s more on what the Study is all about…

ALEXANDER:
The National Children’s Study is our effort to understand one of
the great mysteries in pediatrics today: What role does environment play in causing
diseases that we don’t know the cause of otherwise?
JONES:
The study was conceived to look at child development from preconception all the way through until they’re 21 years old. We have not ever done this.
SCHEIDT:
Doctors today need to know about the causes of ongoing epidemics of
important childhood diseases such as asthma
MADDOX: Infant mortality.
CHENG:
Obesity.
SCHEIDT:
Diabetes.
GUERRA:
Any number of risk-taking behaviors.
CHENG:
Learning disabilities.
SHANNON: Cardiovascular disease.
SCHEIDT:
And even injuries.
MADDOX: We are asking individuals to participate in this study as volunteers.
ALEXANDER:
It will involve 100,000 children and families over the course of 21
years.
CHENG:
Those 100,000 children will represent 100,000 mothers, 100,000 fathers,
aunts and uncles, in communities scattered all across the United States. And from this,
we will learn very important lessons about health and about disease.
SCHEIDT:
In addition, we will learn how the environment affects our genes and how
genes affect children’s health and development
Consent Video Script for Preconception Women/DRAFT 12/18/07

Appendix B

B.1.2.a–2

SHANNON: This study is large enough and rigorous enough to answer very important
questions and really make a difference in the health of children.
GUERRA:
It will give us information and evidence that will provide better
explanations and understanding for so many conditions that today are affecting not just
an individual or groups of individuals, but entire populations.
MADDOX: It will be a representation of the nation’s children, which means that it will
include children from all socioeconomic groups, and children from all races and ethnic
groups.
JONES:
As a participant, they’re going to tell you a lot about the study. You can
go home; you can talk it over with your family members so that everybody knows what
this is going to be like.
CHENG:
A child’s health is very much dependent not only on the child’s
social and physical environment, but also on how genetics and the environment
interact. We’re going to learn a lot from the National Children’s Study.

T1-S2
You’re probably wondering why we’re asking you to be in a study of children’s health.
You’re not pregnant now, and you may not be trying to get pregnant. But things around
you now – like the air you breathe and the water you drink – might influence the health
and development of your future children, if you ever do get pregnant.
So we’d like to collect some information about your health and environment, and to
keep in touch with you in case you get pregnant in the future.

T1-S3
Then, if you do get pregnant, we’ll come back and ask you to take part in more of the
National Children’s Study. At that point, we hope you will enroll yourself and your
future child in the full study.
T1-S4
We’ve put together some information to help you decide if you want to volunteer to
participate in this first part of the Study.
Use the stylus to move through the information.
Consent Video Script for Preconception Women/DRAFT 12/18/07

Appendix B

B.1.2.a–3

ƒ

To move forward, touch the NEXT button.

ƒ

To move backward, touch the BACK button.

If you have any questions, the Study representative will be happy to answer them for
you.
Touch the NEXT button now, to continue.

T1-S5
The overall purpose of the study is to help researchers learn what things in the
environment may affect children’s health, growth, and development, and what may
cause children to develop diseases later when they are adults. To do that, the National
Children’s Study will be studying women before and during pregnancy and children
from the time they are born until they are 21 years old.

T1-S6
Some things affect children’s health, before the Mom becomes pregnant, so that’s why
we are inviting women to participate in the Study, even before they become
pregnant…..even before they may be thinking about becoming pregnant.
T1-S7
Later, if you do become pregnant, we hope you will let us know. At that point, we can
discuss your interest in taking part in the full study and enrolling your child as well.
But for now, we are only asking if you are willing to take part in the “pre-pregnancy”
part of the Study.

Consent Video Script for Preconception Women/DRAFT 12/18/07

Appendix B

B.1.2.a–4

T1-S8
The Study is being conducted as a partnership among local institutions in your
community and three federal agencies. The three federal agencies are the National
Institutes of Child Health and Human Development, which is part of the National
Institutes of Health; the Centers for Disease Control and Prevention; and the
Environmental Protection Agency.

T1-S9
This is the local institution in your community.
Your local sponsor has established its own Study Center with a team of
community members, health professionals, and others trained to carry out the
national study in your community.
T1-S10
Taking part in the Study is your choice. You can choose not to take part. And if you
do take part, you can leave at any time.
If you decide not to take part in the Study, or you take part and later stop, you will not
lose any benefits (like health insurance or health care) to which you are already entitled.
If you do take part in the Study, we may learn things that may help people in the future,
but may not help you or your family personally.

Consent Video Script for Preconception Women/DRAFT 12/18/07

Appendix B

B.1.2.a–5

T2-S1
If you decide to join the Study, we will come to your home to collect information about
you, your health, and your environment.
The visit will last about 2 to 3 hours.
Its purpose is to ask questions about things that might affect your health, like “Is there a
history of diabetes in your family?” Or, “How well do you sleep at night?”
T2-S2
During the visit, we’d also like to examine you to get body measurements, like height
and blood pressure.
TS-S3
And we’ll collect samples from you, like blood, urine, hair and saliva.
T2-S4
And from your home,
…like air, dust,
…water and soil.

T2-S5
We’d like to schedule the visit, so that it would occur in the next few weeks, at a time
that is good for you.
If you give us permission to come to your home, we will explain exactly what we’re
going to do, and we will ask you if it’s okay to do it.
If there’s something you don’t want to do, or that you don’t want us to do, you can skip
that part and still be in the Study. Or you can leave the Study at any time.

Consent Video Script for Preconception Women/DRAFT 12/18/07

Appendix B

B.1.2.a–6

T2-S6
In addition to this home visit, we would also like to stay in touch with you in case you
get pregnant.
If you agree to be in this part of the study, we will contact you from time to time to ask
you a few questions. We will phone, and we may try to reach you by mail or computer
as well.
T2-S7
If your situation changes, we will change how often we contact you. For example, if
many months pass and you don’t get pregnant, we will call you less often. Or if you
decide you do want to try to get pregnant, we will call you more often, and visit you
again.
T2-S8
The information you give us will be stored with information from all the other women
in the Study. Doctors and researchers will use all this information, which they call
“data,” to look for patterns or relationships between environment and health. These
patterns will give researchers clues about what causes many diseases.
Written data—like your answers to questions and your height measurements—will be
stored in computers, and studied by researchers.
The samples we collect from you will be stored so they can be tested.

T2-S9
Some tests on your samples will be done right away. Others will be performed at a
later date. Samples will be stored for at least the duration of the study, so we can do
many other tests.
Right now we can’t tell you what all of those future tests might be, because science is
always improving and new tests are always being developed. But we can tell you that
Consent Video Script for Preconception Women/DRAFT 12/18/07

Appendix B

B.1.2.a–7

before any new kinds of tests are done on your samples, a Study Committee of doctors,
scientists, and community members will make sure the tests relate to child health,
growth and development and to improving our understanding of why some children are
more likely to get diseases when they grow up.
If you decide to join the Study and agree to give us samples, you will be allowing us to
test those samples both now and in the years ahead.

T2-S10
The Study also plans to look at DNA, or genes, the basic building blocks of our
bodies, because doctors know that genes affect the health, growth, and
development of children, and that the environment affects how genes work. If
you agree to participate in the Study, you do not have to agree to this part of the
study. We will ask your permission for the genetic part separately.

T3-S1
You might be wondering: What do I get out of all this? What’s in it for me?
There may be no direct benefit to you or your family. But the Study could
uncover important new medical knowledge that could benefit all of us in the years
to come—maybe even your children and grandchildren. That’s something we
think you might feel proud to be a part of.
As the Study unfolds, our scientists will learn a lot about children in general, and why
some children are more likely than others to get certain diseases when they grow up.
We might learn things like what causes asthma or what contributes to making children
do well in school. We are also likely to learn about what promotes healthy pregnancies
and how to reduce miscarriages and premature births.
And, as we make these discoveries, we will share them with you.

Consent Video Script for Preconception Women/DRAFT 12/18/07

Appendix B

B.1.2.a–8

T3-S2
We will send out news through newsletters, a Web site, and other means, and we will
publish this information in books and magazines.
T3-S3
That’s all about health in general, but we will also give you some medically
important information we learn—from the exams we’ve done or from the samples
we’ve taken—about you and your environment. Hopefully, this will keep you
better informed about your health and your environment. Later, if you decide to
participate in the full Study with your future child, we will also provide medically
important information we may discover about your child.
We will give you reports about the routine information we are collecting. In addition, if
our research shows something that is a medically important for you or your family, and
there is something you could do about it, we’ll let you know, so that you can follow up
with your doctor. If you need the help of medical or social services, we can give you
names and contact information. But keep in mind, the Study will not pay for any
medical treatment. We will only tell you what we learn and give you names of people
and agencies that can help you.
T4-S1
The risks of this study are very low. It’s an observational study, which means we will
collect information and do some routine medical exams and take some samples.
The Study does not include any experimental drugs or medicines.
Even though the risks are low, there are some things that might be a risk or discomfort
to you, if you decide to join the Study.

Consent Video Script for Preconception Women/DRAFT 12/18/07

Appendix B

B.1.2.a–9

T4-S2
You might feel uncomfortable about some of the questions we ask. If so, you can skip
those questions. You will be in charge, and you can decide which questions to answer.
T4-S3
People sometimes feel brief pain when blood is taken, and there’s a very small risk of
infection, bruising, or bleeding. The professionals who will take your blood are trained
to make you feel comfortable.

T4-S4
Having us come to your home for a visit may be an inconvenience. The visit may
interrupt your daily routine and other people living in your home may also be affected.
To minimize this, we will set up the visit at a time that works for you, and we will be
happy to change the date or time if you need to.

T4-S5
If we learn that a child is being neglected or abused, then we must report this to the
proper authorities.
T4-S6
As we’ve said, if any of your tests or samples indicate something that is medically
important for you to know about, and that you could do something about, we’ll let
you know. Information like that can be beneficial. But it can also be upsetting.
And, because of the information we’ve shared with you, you might decide to
spend money to undergo additional tests, which might not ultimately reveal a
significant problem.

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Appendix B

B.1.2.a–10

T4-S7
We will not share all environmental test results with you, but if any of our tests show
known chemical or other kinds of known health hazards in or around your home, we’ll
let you know.
Knowing about home health hazards can be a good thing, because if you know about it,
you may be able to fix it.
But there is also a risk to getting this information.

T4-S8
Some federal and state laws require homeowners to tell potential renters or buyers
about certain health hazards, like lead or mold. That means if you own your home, and
we tell you about a home health hazard, you may be required to report that hazard when
you sell or rent your home.

T5-S1
Giving personal information to anyone always involves some risk. Therefore this Study
will make every effort to protect the identities of all participants.
To protect your personal information, we will:
•

Label your samples and other information with a unique number code, so our labs
will not know whose samples they are testing

•

Separate your number code from your name, address, and other identifying
information

T5-S2
•

Store your test results and other information in a computer database protected by
sophisticated security technology

•

Report only group information, not individually identifiable information
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Appendix B

B.1.2.a–11

T5-S3
In addition to taking all these steps to protect your privacy, we have obtained a legal
document designed to protect the privacy of people who take part in research studies.
The document is called a Certificate of Confidentiality. It will help protect your
information from people who are not part of the Study.

T5-S4
Certificates of Confidentiality help make sure that the Study researchers cannot be
forced to tell anyone who is not connected with the Study—including the courts—about
your participation or your personal information without your written consent.
We have described the steps we will take to protect your confidentiality. We will do
everything we can to ensure that your personal health information is never revealed to
anyone outside the Study.
T6-S1
We understand that your time is valuable and we appreciate your helping us. The Study
will pay you for your time spent during any home visit when someone from the Study
Center comes to ask you questions and take samples. Payment for each visit will be
about $50 depending on the amount of time and effort involved.
T6-S2
From time to time, we may also give you small gifts—like, a T-shirt, a tote bag, or a
music CD—to thank you for your efforts.

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Appendix B

B.1.2.a–12

T7-S1
NARRATOR V/O
Finally, we’d like to answer some common questions people may have
about being in the study.
OTHER VOICE
What if I want to leave the Study early?
NARRATOR V/O
You can leave the Study at any time without penalty. You can also leave
the Study for a short time and then rejoin it. Leaving the Study will not
affect your access to health care in any way. The Study also has the right to
end your participation at any time.
T7-S2
OTHER VOICE
What happens to my samples and information if I leave the Study?
NARRATOR V/O
If you do leave the Study, no new information will be collected from you, but data and
samples that have already been collected will continue to be analyzed. If you want us
to get rid of any of those samples, you may ask us to destroy them.
T7-S3
OTHER VOICE
What if I move?
NARRATOR V/O
We hope you’ll tell us if you are planning to move so you can keep working with the
Study in your new home. If you move and forget to tell us, we will look for you using
the information you’ve given us about family members and friends, as well as publicly

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Appendix B

B.1.2.a–13

available information about you. If we are able to find you, we will ask you if you want
to continue to be in the Study.

T7-S4
OTHER VOICE
Will it cost me anything to take part in the Study?
NARRATOR V/O
No. There is no cost to you—all the tests and procedures related to the Study will be
paid for by the Study. Any future tests done on your samples will also be paid for by the
Study.
T7-S5
OTHER VOICE
Does the Study provide health care for me or my family?
NARRATOR V/O
No, the Study is not able to pay for your health care. Study procedures are for research
purposes only, and taking part in the Study is not a substitute for your usual visits to the
doctor. The Study also does not affect your health insurance coverage.
T7-S6
OTHER VOICE
Will data from this study be used in other ways?
NARRATOR V/O
Yes. At certain points during the Study we will remove all personal identifiers and
create what is called a public use data set—a set of totally anonymous data that
scientists and researchers can use to study other things. Anyone outside the Study who
uses the public use data will not be able to connect the information to a specific person.

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Appendix B

B.1.2.a–14

T7-S7
OTHER VOICE
In addition to the tests the National Children’s Study will do on my samples, would
these samples be used in any other way?
NARRATOR V/O
It is possible that scientists could create new medicines or health products in the future
based on stored study samples. In agreeing to participate in this Study, you are also
agreeing to allow possible future use of your biological materials for these kinds of
purposes.
T7-S8
OTHER VOICE
If I take part in this study, will I have to be part of other studies?
NARRATOR V/O
No. But you may be invited to be in other studies connected with the National
Children’s Study. For any other studies, you will be asked for your permission, and
you can always say “no thanks.”

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Appendix B

B.1.2.a–15

C1-S1
In order to conduct the Study, we will need information from your medical records. The
Study will also ask your doctors for information about your health and will seek
information about any visits you may have made to the emergency room or to other
health facilities. To get this kind of personal health information, we need your
permission.
If you agree to allow us to obtain and use your personal health information, you have
the right to change your mind and withdraw your permission at any time, by submitting
a letter to the Study Coordinator at ___________. Once the Study Coordinator has
received your withdrawal letter, no new information from your medical records will be
collected. However, information that has already been collected may still be studied.

C1-S2
Some people feel differently about genetic information than other kinds of information.
So we will be asking you specifically to agree to genetic analysis of your samples.
However, if you do not agree to the genetic aspect of the Study, you can still take part
in the rest of the Study.
Some of the genetic analyses we would like to do may be done right away. Others may
be done in the future, as the Study learns more, or as new tests and techniques are
developed.
Because results of individual tests can be very difficult to interpret, the National
Children’s Study will not give genetic information about you to you or to anyone else.
In the unlikely case that the Study learns something from this genetic information that
is important to your health or your family’s health, and if there is something you could
do about it, we will tell you that the information is available. In that case, we will give
you the option of learning more about it.

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Appendix B

B.1.2.a–16

C1-S3
Let’s pause now so that you can ask the Study Representative any questions you may
have.
In addition, before deciding, you may wish to discuss what you have learned about
the pre-pregnancy part of the National Children’s Study with your family, friends,
or your doctor.
If you have more questions about the research or about your rights as a research
participant, contact any of the following.

C1-S4
Please check one of the boxes below to indicate whether you would like to
volunteer to participate in the pre-pregnancy part of National Children’s Study:
• I am ready to participate in the Pre-Pregnancy part of the National
Children’s Study
• I need more time to think about participation in the Study. I’d like to
discuss it some more in the future.
• I do not wish to participate in the Pre-Pregnancy part of the National
Children’s Study.
Click Next, when you have made your choice.
On the next screen, you will be asked for your signature. If you sign, you are
agreeing to take part in a research study. This means that you have completed this
informational program, and that you have made the decision to be in the PrePregnancy part of the Study voluntarily.

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Appendix B

B.1.2.a–17

C1-S5
If you are ready to volunteer participate in the Pre-Pregnancy part of the National
Children’s Study, you may do so now. By signing below, you are indicating the
following:
• I have completed the informational program about the Pre-Pregnancy part
of the National Children’s Study.
• I understand what is involved, and what the risks and benefits are if I join.
•

I understand that I am also giving my permission for the National
Children’s Study to obtain and use my personal health information.

• I understand that I may leave the Study at any time.
• I have asked and received answers to all my questions about the Study.
• I understand that I may ask further questions at any time and that I will get
a paper copy of the consent form for my records.

And, please check one of these two boxes:
• I also give permission to the National Children’s Study to collect and
analyze genetic information about me.
• At this time, I do not give permission for the National Children’s Study to
collect and analyze genetic information about me.

I voluntarily agree to participate in the Pre-Pregnancy part of the National
Children’s Study.

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Appendix B

B.1.2.a–18

C1- DEFER
Thank you.
We understand that you have not agreed to participate in the National Children’s Study
at this time, but that you are still open to learning more about it in the future.
The Study staff person visiting with you today will talk with you about when we might
contact you again.
If you like, we can leave you some materials to review yourself or with your family.

C1- DECLINE
Thank you for being willing to hear about the National Children’s Study. We’d very
much like to know why you’ve chosen not to participate. Please select any or all of the
choices below.
I’m not interesting in participating because:
•

I don’t think my husband or boyfriend will want me to do this.

•

I don’t think other family members will want me to do this

•

I don’t want someone visiting my home

•

I don't want the Study to have access to my medical records

•

I don’t want the Study staff to examine me or take samples

•

I don’t want the Study staff to take samples from my yard or home environment

•

I just don't feel like it

•

Or for another reason. Please tell the recruiter, who will record your answer

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Appendix B

B.1.2.a–19

EARLY_EXIT
You clicked the EXIT button – are you sure you want to exit the program?

CLOSING_OPT-IN
Thanks again!
We are very pleased that you’ve agreed to participate in the Pre-Pregnancy part of the
National Children’s Study!

CLOSING_OPT-OUT1
Thank you for your time thinking about participation in the National Children’s Study!
We look forward to talking with you again in the future.

CLOSING_OPT-OUT2
Thank you for your time thinking about participation in the National Children’s Study!

Consent Video Script for Preconception Women/DRAFT 12/18/07

Appendix B

B.1.2.b–1

Draft 5-25-07/Consent Brochure/P1 Visit

MAKING AN INFORMED CHOICE ABOUT BEING IN
THE NATIONAL CHILDREN’S STUDY
Your neighborhood is one of many communities across the United States that has been
chosen to take part in an important research study. It is called the National Children’s
Study, and its goal is to improve the health and well-being of our nation’s children.
We are asking you to take part in this study for two reasons. First, because you live in a
neighborhood that has been selected; and second, because you may become pregnant and
have a baby. We are asking you to join thousands of women and their babies from across
the United States to learn things that may help many people in the future, even if the
information may not help you or your family personally, right now.
Sponsors:
The National Children’s Study is a partnership between (LOCAL CENTER) and other local
institutions in your community, and is lead by the U.S. Department of Health and Human
Services through the National Institutes of Health (NIH), the Centers for Disease Control and
Prevention (CDC), and the U.S. Environmental Protection Agency (EPA).
Joining the Study is your choice. You can decide not to join. If you do join, we hope you and
your child will remain in the study for the full 21 years, but you can leave for any reason at any
time.

1

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B.1.2.b–2

Draft 5-25-07/Consent Brochure/P1 Visit

What is the purpose of the National Children’s Study?
The goal of the National Children’s Study (NCS) is to improve the health and well-being of the
nation’s children. The Study aims to understand how the environment affects children’s health,
growth, and development. We also are interested in how the environment interacts with a
person’s characteristics, such as genes, to prevent disease and promote health.
What kind of study is the National Children’s Study?
The NCS is an observational study, which means that we will be collecting information about
you and your child and your child’s environment. Studying this information will allow us to find
out which things in the environment offer special benefits for child development and which are
associated with illness or disease. Observational studies do not involve asking you to change
what you normally do. We will not be asking you or your child to try out new drugs or
experimental treatments of any kind.
Why is the National Children’s Study important?
This is the largest and most detailed study in history to learn about the health and development of
children in the United States. We will learn what things in the environment affect whether or not
children will develop diseases, both while they are young and also later, when they become
adults. Finally, there are new medical conditions that weren’t around 30 or 40 years ago, or not
at the levels we now see: obesity, diabetes, autism, learning disabilities, to name just a few. The
National Children’s Study will help us understand why and what we can do about these
problems.
How many people will be in the National Children’s Study?
The Study will include about 100,000 women and their babies from all over the United States.
Fathers will also be asked to participate. In this area, we expect to study about 1,000 women and
their babies.
How long will the National Children’s Study last?
We hope you and your child will stay in the Study until your child turns 21 years old. You will
start in the Study during your pregnancy, and your child will start when he or she is born.
What is involved in being in the National Children’s Study?
We will schedule visits with you and your child to collect information about your health and
environment. Some of these visits will take place in your home, and others will be at the Study
Center.
The first visit will take place in your home if you become pregnant. There will be other visits
while you are pregnant that will take place at the Study Center.
2

Appendix B

B.1.2.b–3

Draft 5-25-07/Consent Brochure/P1 Visit

When you give birth, we will visit you and your baby in the hospital, or wherever you give birth,
to get information about the birth and to ask you questions about your plans.
When your baby is little, we will visit you and your baby in your home and also invite you and
your baby to the Study Center. When your child gets a little older, you and your child will come
to the Study Center for visits.
We also might ask you about any places where your child spends a lot of time, like daycare, a
babysitter’s home, a school, or a grandparent’s house. We might also want to visit those places.
Between visits, we will contact you from time to time. We may ask you some questions on the
telephone, or we may send you questions in the mail or by computer.
How will the National Children’s Study collect information?
There are several ways we will collect information: We will ask you questions, ask you to
complete forms, do physical exams, collect samples, collect information from medical records,
and take pictures and videos of your child.
We also may ask you to keep track of certain things you do—like what you eat.
We also will ask you to obtain some samples of things like urine, or drinking water in your
home, or breast milk (if you are breast feeding), and mail them back to us in postage-paid
containers that we will provide.
As your child grows older, you also may be asked to complete other types of activities. Before
every visit, we will give you details and describe exactly what the visit will involve.
What kinds of information will be collected?
If you become pregnant, we will ask you questions about things that might affect your
pregnancy. We will ask about your medical history, about the foods you eat, and your thoughts
about different topics.
While you are pregnant, we will measure your height, weight, and blood pressure, and do one or
two ultrasounds which may be in addition to the tests you receive from your doctor. If your
doctor does an ultrasound, we will want to look at that as well.
When you give birth, we will examine, measure, and take pictures of your baby. As your child
grows up, we will continue to follow your child’s health, growth, and development.
We also will examine you and your child and do some tests. These exams and tests do not
replace the regular visits you have with your own doctors.
Finally, we will want to collect biologic samples from you and your child, as well as samples
from your home environment.

3

Appendix B

B.1.2.b–4

Draft 5-25-07/Consent Brochure/P1 Visit

The biologic samples we collect—like blood, urine, hair, and saliva—will tell us about your
health. The environmental samples—like dirt, air, dust, and drinking water—will help us learn
what in the environment might affect your health.
Our trained staff will make these collections as easy as possible for you.
For blood samples, we will use a small needle in your or your child’s arm. For urine samples,
we will give you a plastic container. There’s even a special container to collect urine from
babies. For hair samples, we’ll ask you for a few hairs from your head and your child’s. When
your baby is born, we will work with your doctor and hospital to obtain a sample of blood from
the umbilical cord, and a sample of the cord and the afterbirth or placenta, and your baby’s first
bowel movement.
To test the air in your home, we will leave an air pump in your home for a few days, and then
come back to pick it up. To test the dust or water in your home, or the soil around your home,
we will collect small samples. Some of these samples you’ll be able to collect yourself with a kit
and return to us at the Study Center.
We hope you will want to participate in all parts of the Study, but if you don’t want to give
certain samples, answer certain questions, or have certain types of exams, that is fine—you can
say no at any time and for any reason, and you can still be part of the Study.
How many visits should I expect?
If you become pregnant, there will be several visits while you are pregnant, one when you give
birth, and the rest —about 10 or 12 in total—will be spread out over the next 21 years.
Will the Study need access to my medical records and my child’s
medical records?
Yes, we will want to get information from your medical records when you give birth, because we
want to learn how your delivery went.
Later, we will want to look at your child’s medical records, such as records of doctor and
emergency room visits, to learn about your child’s health, illnesses, accidents, injuries, and
vaccinations. The Study also may ask your doctors to provide personal health information about
you and your child. You will be asked to sign a separate authorization form giving us permission
to obtain copies of these types of medical records from your doctor or hospital. This kind of
information will help us learn your child’s health.
If you agree to allow us to obtain and use your personal health information and your child’s, you
have the right to change your mind and withdraw your permission at any time by submitting a
letter to the Study Coordinator (whose contact information is presented on page X of this
document). Once the Study Coordinator has received your withdrawal letter, no new
information from your medical records or your child’s will be collected. However, information
that has already been collected may still be studied.

4

Appendix B

B.1.2.b–5

Draft 5-25-07/Consent Brochure/P1 Visit

What will happen to all this information?
The information you give us will be stored with information from all other women and children
in the Study. Doctors and researchers will use all this information, which they call “data,” to
look for patterns or relationships between children’s environments and their health.
Written data—like your answers to questions and your height measurements—will be stored in
computers. The samples we collect from you and your child will be stored so that they can be
tested. We plan to store these samples at least for the 21 years of the study.
Some tests on these samples will be done in a few weeks or months. Other tests will be
performed years later. Right now, we do not know what all of those future tests might be,
because science is always improving and new tests are always being developed. But we can tell
you that before any new kinds of tests are done on your samples, they will be evaluated by a
Study Committee of doctors, scientists, and community members to make sure the tests only
relate to child health, growth, and development, or to why some children are more likely to get
diseases when they grow up.
If you decide that you and your child will join the Study and agree to give us samples, you will
be allowing us to test those samples both now and in the years ahead.
Will you be obtaining genetic information about me and my child?
Yes, but only if you give us specific permission to do so.
In addition to telling us about your current health, the samples you provide us, like blood or
saliva, also can enable us to look at your DNA or genes. Collecting samples that allow us to
look at both genes and the environment is important, because genes affect children’s health and
development, and the environment affects how genes work. By collecting both genetic and
environmental information, the Study will learn a great deal about children’s health and
development.
Some people feel differently about genetic information than other kinds of information. So we
will be asking you specifically to agree to genetic testing on your and your child’s samples.
However, if you do not agree to the genetic part of the Study, you can still be in the rest of the
Study.
We will not be doing the genetic testing until some time in the future, as the Study learns more,
or as new tests and techniques are developed.
Because individual genetic results can be very difficult to interpret, the Study will not give
genetic information about you or your child to you or to anyone else. In the unlikely case that
the Study learns something from this genetic information that is important to your health or your
family’s health, and if there is something you could do about it, we will then tell you that the
information is available. In that case, we will give you the option of learning more about it.

5

Appendix B

B.1.2.b–6

Draft 5-25-07/Consent Brochure/P1 Visit

What are the possible benefits of being in the National Children’s
Study?
There may be no direct benefit to you or your family. But the Study could help provide
important new medical knowledge that could benefit all of us in the years to come—maybe even
your children and grandchildren. That’s something we think you might feel proud to be a part of.
However, there may be some indirect benefits. First, we will share some of our findings with
you. As the Study goes on, our scientists will learn a lot about children in general, and why
some children are more likely than others to get certain diseases when they grow up. We will
learn things like what helps children do well in school and in relationships with other people.
We will publish this information in books and magazines. We also will share it with you through
newsletters, a Web site, and other means.
We also will give you reports about the routine information we collect about you and your child
and your environment. And, if our research shows something that is medically important and
that you could do something about, we will let you know, so that you can follow-up with your
doctor.
If you need the help of medical or social services, we can give you names and contact
information. But keep in mind that the Study will not pay for any medical treatment. We will
only tell you what we learn, and give you the names of people or agencies that can help you.
What are the possible risks or burdens to me and my child from
being in the National Children’s Study?
The risks of this study are very low. It’s an observational study only. It does not include any
experimental drugs or medicines or treatments. However, there are some minimal risks and
possible discomforts.
You might feel uncomfortable about some of the questions we ask. If so, you can skip those
questions. You will be in charge, and you can decide which questions to answer.
But we do hope you will share some private information with us, because it is important to make
this study successful. We will carefully protect what you tell us. Your data will be linked to a
number, not your name, so the people who later look at your answers cannot identify you
personally.
Another risk—a very small one—has to do with giving blood samples. People sometimes feel
brief pain when blood is taken, and there is a very small risk of infection, bruising, or bleeding.
The professionals who will take your blood are trained to make you feel comfortable.
Home visits are likely to take 2 to 3 hours, but we will schedule the visits at a time that is good
for you. Having to go to the Study Center and having us come to your home may interfere with
your daily routine. Other people living in your home also may be affected by the visits. To
minimize this, we will schedule visits at a time that works for you, and we will be happy to
change the date or time if you need to.

6

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B.1.2.b–7

Draft 5-25-07/Consent Brochure/P1 Visit

If, during our visits, we learn that you or your child are in danger, or are a danger to yourselves
or others, then we must report this to the proper authorities.
As we have said, if any of your tests or samples indicate something that is medically important
for you to know about, we will let you know. Information like that can be helpful. But it also
can be upsetting to some people. And, because of the information we have shared with you, you
might decide to spend money to undergo additional tests, which might not end up finding any
problems.
We will not share all results with you, but if any of our tests show chemical or other kinds of
known environmental health hazards in or around your home, we will let you know. Knowing
about a home environmental health hazard can be a good thing, because if you know about it,
you may be able to fix it. But there also is a risk to getting this information. Some federal and
state laws require homeowners to tell potential renters or buyers about certain health hazards,
like lead or mold. That means if you own your home, and we tell you about a home health
hazard, you may be required to report that hazard when you sell or rent your home.
How will my privacy be protected?
The Study will make every effort to protect the identities of all participants. We will use a
unique number code and separate your name, your child’s name, and other things that could
identify either of you from the samples and other information you give us. The stored data will
have only these numbers, not names, so that individuals cannot be identified.
The Study will store information in a computer database protected by very effective computer
security methods. Your data will be combined with data collected from all the other tens of
thousands of people in the Study. All the information, including yours and your child’s, will be
confidential and reported only as a group. Specific data about you personally, or about your
child, will never be reported in any Study publication.
In addition to taking all these steps to protect your and your child’s privacy, there is one more
thing we have done. We have obtained a legal document called a Certificate of Confidentiality.
This will help protect your information from people who are not part of the Study. Certificates
of Confidentiality are intended to assure that the Study researchers cannot be forced to tell
anyone who is not connected with the Study— including the courts—about your participation or
your personal information without written consent from you.
Will I be paid for being in the National Children’s Study?
We will pay you for time spent in study-related activities, like a home or Study Center visit, and
for answering questions. Payments for each set of activities will be about $50, depending on the
amount of time and effort involved. We will pay you for each completed set of activities even if
you, or your child, do not finish the whole study.
You will also be paid for your expenses related to visits to the Study Center—for example, travel
expenses or parking.
7

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B.1.2.b–8

Draft 5-25-07/Consent Brochure/P1 Visit

From time to time, we also will give you or your child small gifts—like a T-shirt, a tote bag, or a
music CD—to thank you for helping us.
What if I want to leave the National Children’s Study?
We hope you will stay in the Study for the entire 21 years, but you or your child can leave the
Study at any time without penalty. You also can leave the Study for a short time and then rejoin
later. Leaving the Study will not affect your access to health care or your relationship with this
institution in any way. The Study also has the right to end your participation at any time.
If you do leave the Study, no new information will be collected from you or your child, but
samples and data which have already been collected will continue to be studied. If you want us
to get rid of those samples, you may ask us to destroy them by submitting a letter to the Study
Coordinator (whose contact information is presented on page X of this document).
When my child gets older, will he or she be able to decide whether
to continue in the National Children’s Study?
Yes. Young children and adolescents will be asked their permission to continue in the Study.
When the children become legal adults (at about age 18, depending on your state law), they will
be asked to sign a document themselves, like this one, to indicate whether they wish to continue
or not.
What if I move?
We hope you will tell us if you are planning to move, so you can continue to be in the Study in
your new home. If you move and forget to tell us, we will try to learn your new address or
phone number by using the information you have given us about family members and friends, as
well as publicly available information about you. If we are able to find you, we will ask you if
you want to continue in the Study.
Will it cost me anything to be in the National Children’s Study?
No. There is no cost to you. All tests and activities related to the Study will be paid for by the
Study. Any future tests done on your samples will also be paid for by the Study.

8

Appendix B

B.1.2.b–9

Draft 5-25-07/Consent Brochure/P1 Visit

Does the National Children’s Study pay for health care for me or my
family?
No. The Study is not able to pay for your health care. Study activities are for research purposes
only, and taking part in the Study does not take the place of your usual visits to the doctor.
Will data from the National Children’s Study be used in other ways?
Yes. At certain points in the Study, we will make what is called a public use data set. That data
set will not include any information that could identify individual people in the Study. Scientists
and researchers can use the public use data sets to try to learn more about children’s health.
Anyone outside the Study who uses the public use data set will not be able to connect it to a
specific person.
In addition to the tests the National Children’s Study will do on our
samples, will our samples be used in any other way?
It is possible that scientists could create new medicines or health products in the future based on
stored study samples. In agreeing to be in this study, you also are agreeing to allow possible
future use of your and your child’s biological materials for these kinds of purposes.
If I take part in the National Children’s Study, will I have to be part
of other studies?
No. But you may be invited to be in other studies connected with the National Children’s Study.
If so, we will ask your permission.
Who can I contact if I have further questions?
Feel free to ask the Study Representative, who has talked to you about being in the Study, any
questions you have. Also, if you have any questions about the Study or about your or your
child’s rights of being in the Study, now or in the future, you may contact any of the following:

9

Appendix B

B.1.2.b–10

Draft 5-25-07/Consent Brochure/P1 Visit

National contact:
Local contact #1(Study coordinator or PI):
Local contact #2 (IRB):
On the next page, you will be asked to indicate your consent to participate and to sign
the consent document. Before signing, you may wish to discuss what you have learned
about the National Children’s Study with your family, friends, or your doctor. Thank
you for taking the time to learn about this important Study.
Participant’s Statement
•

I have read “Making an Informed Choice about being in the National Children’s
Study”.

•

I understand what is involved, and what the risks and benefits are, if my child and I
join the Study.

•

I understand that I am also giving my permission for the National Children’s Study
to obtain and use my personal health information and my child’s.

•

I understand that my child and I may leave the Study at any time.

•

I have asked and received answers to all my questions about the Study.

•

I understand that I may ask further questions at any time, and that I will receive a
copy of this consent form for my records.

I freely choose to be in the National Children’s Study, and I give permission for my
child to participate in the Study as well.
And, please check one of these two boxes:

I also give permission to the National
Children’s Study to collect and test
genetic information about me and my child.
At this time, I do not give permission
for the National Children’s Study to
collect and test genetic information
about me and my child.

10

Appendix B

B.1.2.b–11

Draft 5-25-07/Consent Brochure/P1 Visit

Printed Name of Participant: _______________________________________________
Signature of Participant: ___________________________________________________
Date: ________________________
----------------------------------------------------------------------------------------------------------------------Printed Name of Person Obtaining Consent: ___________________________________
Signature of Person Obtaining Consent: _______________________________________
Date: ________________________
THANK YOU

11

Appendix B

B.1.2.c–1
OMB #: ________________
Expiration Date: _________

Visit Information Card for Pre-Pregnancy Visit
When you gave your permission to be part of the National Children’s Study (NCS), we told you all
about what it means to be in the study. This card tells you more details about what we would like to
do at this study visit.
Interview
We will ask you some questions which should take about 30 minutes. The questions will be about
such things as your home, the people who live with you, any pets you have, your jobs, your activities,
your health, and any medicines you take.
Physical Measures
We also will ask to do the following:
ƒ

Measure parts of your body including your arm, hip, and waist, and the skin on the back of
your arm and upper back. You will not have to undress for us to take these measurements.

ƒ

Measure your weight and height.

ƒ

Measure your blood pressure.

ƒ

Give you a report to keep which shows your height, weight, body mass index, heart rate, and
blood pressure.

Biological Specimens
We also will ask do the following:
ƒ

Ask you for a sample of your urine.

ƒ

Ask you to collect 3 vaginal swabs. You will do this yourself in complete privacy using cotton
swabs.

ƒ

Collect less than 2 ounces of your blood using a small needle. Two ounces is approximately
four tablespoons.

ƒ

Collect a small sample of your hair.

ƒ

Provide you with some pregnancy tests and instructions to begin using the tests the first day
of your missed period.

ƒ

Provide you with instructions and a urine cup to collect a urine sample the first morning after
you have a positive pregnancy test. We will ask you to freeze the sample, and we will collect
the urine cup within 7 days.

Your urine and hair may be tested for a variety of environmental exposures. The vaginal swabs
may be tested for measures of infection and inflammation. These measures will be done at a
later time and you will not receive the results of these tests.
On the same day that we collect your blood, we will test a small sample for hemoglobin and
calculate your hematocrit levels. Your hemoglobin/hematocrit results will be sent to you within
several weeks. However, if anything abnormal is detected, you will be notified sooner. The rest of
your blood will be stored for future analyses, which may include measures of environmental

P1 Visit

Appendix B

B.1.2.c–2
OMB #: ________________
Expiration Date: _________

Visit Information Card for Pre-Pregnancy Visit
exposure, hormone and nutrient levels, and measures of infection and inflammation. You will not
receive the results of the tests that may be done in the future.
Environmental Samples
We also will do the following:
ƒ

Test the air in your home for chemicals and dust using an air pump and an air badge. We will
leave these in your home for about a week, and then we will come back to pick them up.

ƒ

Look at the environment inside and outside your home. If you want to, you can walk with us
while we do this.

ƒ

Collect dust from the floor of your home that will be tested for pesticides at a later time. We
will choose the rooms where we collect the dust using Study rules.

You will not receive the results of any of these tests.
Questionnaires and Other Forms for You to Complete
We will give you two forms to fill out on your own. These forms ask questions about what you eat.
We will pick up the forms from you when we return to get the equipment we need to leave here.
Also, when we return to pick up the equipment, we will ask you to complete a short form about your
thoughts on all of the things we did at this visit.
Compensation
After we have completed the interview part of the visit and collected all initial environmental and
biological specimens, we will give you $80 for your time. We also will give you $20 once we have
received the environmental and biologic specimens and the questionnaires and other forms.
We would like to remind you that being in this Study is voluntary. You can decide to be in the Study
or not. You have the right to not answer any question, or to ask us not to take any sample or
measurement that you do not want us to take. If you decide not to participate, it will not affect any
benefits which you receive now, or may receive in the future.
If you have any further questions about this Study visit, I can try to answer them, or you can call my
supervisor at xxx-xxx-xxxx.

P1 Visit

Appendix B

B.1.3.a–1

National Children’s Study
DRAFT CONSENT VIDEO SCRIPT FOR PREGNANT WOMEN
Based on Script 06-11-2007

T1-S1

Your neighborhood is one of many communities across the United States that has
been chosen to take part in an important research study. It’s called the National
Children’s Study, and its goal is to improve the health and well being of our
nation’s children.
We’re asking you to take part in the National Children’s Study for two reasons:
first, because you live in a neighborhood that has been selected to take part; and
second, because you’re pregnant.
Here’s more on what the Study is all about.
ALEXANDER: The National Children’s Study is our effort to understand one of the
great mysteries in pediatrics today: What role does environment play in causing diseases
that we don’t know the cause of otherwise?
JONES:
The study was conceived to look at child development from preconception all the way through until they’re 21 years old. We have not ever done this.
SCHEIDT:
Doctors today need to know about the causes of ongoing epidemics of
important childhood diseases such as asthma.
MADDOX: Infant mortality.
CHENG:
Obesity.
SCHEIDT:
Diabetes.
GUERRA:
Any number of risk-taking behaviors.
CHENG:
Learning disabilities.
SHANNON: Cardiovascular disease.
SCHEIDT:
And even injuries.
MADDOX: We are asking individuals to participate in this study as volunteers.
ALEXANDER: It will involve 100,000 children and families over the course of 21 years.
CHENG: Those 100,000 children will represent 100,000 mothers, 100,000 fathers, aunts
and uncles, in communities scattered all across the United States. And from this, we will
learn very important lessons about health and about disease.
SCHEIDT:
In addition, we will learn how the environment affects our genes and how
genes affect children’s health and development.
1

Appendix B

B.1.3.a–2

SHANNON: This study is large enough and rigorous enough to answer very important
questions and really make a difference in the health of children.
GUERRA:
It will give us information and evidence that will provide better
explanations and understanding for so many conditions that today are affecting not just
an individual or groups of individuals, but entire populations.
MADDOX: It will be a representation of the nation’s children, which means that it will
include children from all socioeconomic groups and children from all races and ethnic
groups.
JONES:
As a participant, they’re going to tell you a lot about the study. You can
go home; you can talk it over with your family members so that everybody knows what
this is going to be like.
CHENG:
A child’s health is very much dependent not only on the child’s
social and physical environment, but also on how genetics and the environment
interact. We’re going to learn a lot from the National Children’s Study.

T1-S2

The National Children’s Study is a partnership between local institutions in your
community and three federal agencies. The federal agencies are The National
Institute of Child Health and Human Development, which is part of the National
Institutes of Health; the U.S. Environmental Protection Agency; and the Centers
for Disease Control and Prevention.

T1-S3
This is the local institution in your community.
There is a Study Center with a team of community members, health professionals
and others trained to carry out the national study in your local area.

2

Appendix B

B.1.3.a–3

T1-S4

We’d like to tell you more about what’s involved, so you can decide whether you
want to be in the Study and enroll your child.
This presentation will take about 30 minutes. We’ll show you some video and ask
you a few questions to make sure that we’ve explained things clearly.

T2-S1

If you decide to join the Study, we will schedule visits with you and your child,
and if it is okay with you, your child’s father, to collect information about your
health and environment.
At each visit, we will explain exactly what we are going to do, so if there is
something you do not want to do, you can tell us. The first visit when you are
pregnant will be at your home. Most or all of the other visits during the course of
your pregnancy will be at the Study Center.
When you give birth, we will visit you and your baby in the hospital to get
information about the birth, to examine your baby, and to take pictures or videos
of your child.
When your baby is little, we will visit you and your baby in your home and also
invite you to the Study Center. When your child gets a little older, you’ll come to
the Study Center for visits.
We also might ask you about any places where your child spends a lot of time, like
daycare, school, or a grandparent’s house. We might also want to visit those
places.
3

Appendix B

B.1.3.a–4

Between scheduled visits, we will contact you from time to time. We may ask you
some questions on the phone, or may send you questions in the mail or by
computer.
Altogether there will be a total of about 15 visits spread out over the 21 years of
the Study.

T2-S2

There are several ways we will collect information from you—we’ll ask questions,
do physical exams, collect samples, collect information from medical records, and
take pictures or videos of your child.
First, we’ll ask you questions about things that might influence your pregnancy.
We could ask about your medical history, or about the foods you eat, or your
thoughts about different topics.
When you are pregnant, we will measure things like your height, weight, and
blood pressure, and do one or two ultrasounds to look at the growth of the baby
inside. These tests may be in addition to the tests you normally receive from your
doctor. If your doctor does an ultrasound, we will want to look at that also.
When you give birth, we’ll examine and measure and take pictures of your baby.
And as your child grows up, we’ll continue to follow your child’s health, growth,
and development.
We’ll also examine you and your child, and do some simple tests. These exams
and tests do not replace the regular visits you have with your own doctors.
Finally, we’ll want to collect samples from you, your child, and your environment.

4

Appendix B

B.1.3.a–5

Some of the samples we collect—like blood, urine, a vaginal swab, hair, and
saliva—will tell us about your health. Other samples—like dirt, air, dust, and
water—will help us learn what might affect your health.
Our trained staff will make these collections as easy as possible.
For blood samples, we will use a small needle in your or your child’s arm.
For urine samples, we’ll give you a plastic container. There’s even a special
container to collect urine from babies.
For hair samples, we’ll ask you for a few hairs from your head and your child’s.
And when your baby is born, we will work with your doctor and hospital to obtain
a sample of blood from the umbilical cord and a sample of the cord and the
afterbirth or placenta.
To test the air in your home, we will leave a device in your home for a few days,
and then come back to pick it up.
To test the dust or water in your home, or the soil around your home, we will
collect small samples. Some of these samples you’ll be able to collect yourself,
with a kit, and return to us at the Study Center.
We hope you will want to participate in all parts of the Study, but if you don’t
want to give certain samples, answer certain questions, or have certain types of
exams, that’s fine—you can say no, at any time, and for any reason, and you can
still be part of the Study.
Ok, let’s review…
We want to be sure we’ve explained the Study as clearly as possible, by pausing to
ask a few questions.

5

Appendix B

B.1.3.a–6

T2Q1-Q
Touch the box that best describes:
The length of the National Children’s Study
• 1 year
• 10 years
• 21 years

T2Q1-F1
No, the Study will last more than 1 year. Try again.
T2Q1-F2
No, the Study will last more than 10 years. Try again.

T2Q1-F3
Right! If you decide to take part, the Study will follow you through your
pregnancy and then you and your child for 21 years. If you decide to join, you can
change your mind and stop at any time.
Okay, here’s another question:
T2Q2-Q
If you decide to join, your role will be to give the local Study Center information
about your health and your environment.

6

Appendix B

B.1.3.a–7

Touch the box that best describes:
Something you will be asked to do
• Take experimental medicines
• Run on a treadmill
• Give samples

T2Q2-F1
No, the Study Center will not ask you to take experimental medicine, although we
may ask you about what medicines you take. Try again.

T2Q2-F2
No, you will not have to run on a treadmill, although you may be asked to stand on
a scale so that Study staff can weigh you. Try again.
T2Q2-F3
Right! You and your child will be asked to give samples of things like blood and
urine from your bodies and dust and water from your home. The Study Center
will also ask you questions and do physical exams and tests.

T2Q3-Q
Now touch the box that best describes:
What happens if you don’t want to give a sample
• I can still be in the Study
• I will have to leave the Study
• I’m not allowed to say no
7

Appendix B

B.1.3.a–8

T2Q3-F1
Right! You may choose not to give a sample, answer a question, or have a
physical exam for any reason, and you can still be in the Study.
Great, now I’m going to explain a little more about the Study.

T2Q3-F2
Not true. If you don’t want to give a sample, you can say no and you will not have
to leave the Study. Try again.
T2Q3-F3
Not true. You can say no for any reason, and at any time. Try again.
T2-S3

The information you give us will be stored with information from all the other
women and children in the Study. Doctors and researchers will use all this
information, which they call “data,” to look for patterns or relationships between
children’s environments and their health. These patterns will give researchers
clues about what causes many diseases.
Written data—like your answers to questions and your height measurements—will
be stored in computers, and studied by researchers.
The samples we collect from you and your child will be tested.
Some tests will be done right away. Others will be performed at a later date.
Samples will be stored at least for the duration of the entire study so that we can
do many other tests.

8

Appendix B

B.1.3.a–9

Right now we can’t tell you what all of those future tests might be because science
is always improving and new tests are always being developed. But we can tell
you that before any new kinds of tests are done on your samples, they’ll be
evaluated by a Committee of doctors, scientists, and community members, to
make sure the tests only relate to child health, growth, and development, or why
some children are more likely than others to get diseases when they grow up.
If you decide that you and your child will join the Study and agree to give us
samples, you will be allowing us to test those samples both now and in the years
ahead.
The Study also plans to look at DNA, or genes, the basic building blocks of our
bodies. Doctors know that genes affect the health, growth, and development of
children, and that the environment affects how genes work. That is why we plan
to analyze the genes of all study participants. As we will explain later, if you
agree to participate in the Study, you do not have to agree to this part of the study.
One other aspect of participation is that the Study needs to get information from
your medical records when you give birth, because we want to learn how things
during your pregnancy and at the time of delivery can affect the health of your
child, like the type of delivery or medications that you get at the hospital.
Later, we will want to look at your child’s medical records, such as records of
doctor and emergency room visits, to learn about your child’s health, illness,
accidents, injuries, and vaccinations. This kind of information will help us study
possible relationships between your environment and your child’s health.
Let’s try a couple more questions…

9

Appendix B

B.1.3.a–10

T2Q4-Q

If you decide to take part, the Study Center will schedule visits to collect
information about your health, your child’s health, and environment.
Touch the box that best describes:
Places where you will have visits
• Only in your home
• Only at the Study Center
• In your home and at the Study Center

T2Q4-F1
Not quite. You will have visits in your home, but this is not the only place you’ll
meet with Study staff. Try again.
T2Q4-F2
Not quite. You will have visits at the Study Center, but this is not the only place
you’ll meet with Study staff. Try again.
T2Q4-F3
Right! Most visits will be in your home or at the Study Center. You will have
about 15 visits over the course of the Study. There will be several while you are
pregnant, one when you give birth, and the rest spread out over 21 years.
T2Q5-Q
I want to make sure I was clear about what will happen to blood and urine and
other samples if you join the Study.

10

Appendix B

B.1.3.a–11

Touch the box that best describes:
What the Study Center will do with the samples we collect from you and your
child
• Test them right away, and then destroy them
• Test some right away, and store the rest for possible future uses
• Store them, but never test them

T2Q5-F1
It’s true that your samples and your child’s may be tested right away, but they
won’t be destroyed. Try again.
T2Q5-F2
Right! If you agree to participate in the National Children’s Study, researchers
will test you and your child’s samples, and will also store them for possible future
tests. Ok, now that you understand what participation would involve, I’m going to
explain some of the risks and benefits of participating in the Study.
T2Q5-F3
Your and your child’s samples will be stored, but they will also be tested. Try
again.
T3-S1

You might be wondering: What do I get out of all this? What’s in it for me?
There may be no direct benefit to you or your family. But the Study could
uncover important new medical knowledge that could benefit all of us in the years

11

Appendix B

B.1.3.a–12

to come—maybe even your children and grandchildren. That’s something we
think you might feel proud to be a part of.
As the Study unfolds, our scientists will learn a lot about children in general, and
why some children are more likely than others to get certain diseases when they
grow up. We might learn things like what causes asthma or what contributes to
making children do well in school. And, we will share our discoveries with you.
We will send out news through newsletters, a Web site, and other means, and we
will publish this information in books and magazines.
That’s all about child health and development in general, but we will also give you
some information we learn—from the exams we’ve done or from the samples
we’ve taken—about you, your child, and your environment. Hopefully, this will
keep you better informed about your health and your environment.
We will give you reports about the routine information we are collecting about
you and your child. Also, if our research shows something that is medically
important and that you could do something about, we’ll let you know, so that you
can follow up with your doctor.
If you need the help of medical or social services, we can give you names and
contact information.
But keep in mind that the Study will not pay for any medical treatment. We will
only tell you what we learn, and give you the names of people or agencies that can
help you.

12

Appendix B

B.1.3.a–13

T3Q1-Q
Let’s go over that one more time…
Touch the box that best describes:
An indirect benefit you will receive if you participate in the Study
• Payment for health care
• Medically important information specific to my family and my
environment
• Personal information about other women and children in the Study

T3Q1-F1
No, the Study is not able to pay for your health care. Try again.
T3Q1-F2
Right! If you participate in the National Children’s Study, you’ll receive news of
the Study’s discoveries as well as some results of your own and your child’s
exams. What’s more, if we learn of any known dangers, which you could do
something about, we will share that information with you too.
T3Q1-F3
No, the Study will not give you any personal information about other people in the
Study, and will not share your personal information with anyone else – that
information will be kept confidential. Try again.

13

Appendix B

B.1.3.a–14

T4-S1

The risks of this study are very low. It’s an observational study, which means we
will collect information from you, your child, and other participants over a number
of years. This study does not include any experimental drugs or medicines.
Let’s go over the things that might be a risk or discomfort to you, if you decide to
join the Study.

T4-S2

One thing is that you might feel uncomfortable about some of the questions we
ask. If so, you can skip those questions. You will be in charge, and you can
decide which questions to answer.
T4-S3

Another risk – a very small one – has to do with giving blood samples. People
sometimes feel brief pain when blood is taken, and there’s a very small risk of
infection, bruising, or bleeding. The professionals who will take your blood are
trained to make you feel comfortable.
T4-S4

Home visits are likely to take two to three hours, and the visits may be
inconvenient. Having to go to the Study Center and having us come to your home

14

Appendix B

B.1.3.a–15

may interfere with your daily routine. Other people living in your home may also
be affected by the visits.
To minimize this, we will set up visits at a time that works for you, and we will be
happy to change the date or time if you need to.

T4-S5

If you tell us, or we observe, that a child is being abused or neglected, then we
must report this to the proper authorities.

T4-S6

As we’ve said, if any of your tests or samples indicate something that is medically
important for you to know about, we’ll let you know. Information like that can be
beneficial. But it can also be unsettling.
And, because of the information we’ve shared with you, you might decide to
spend money to undergo additional tests, which might not ultimately reveal a
significant problem.

T4-S7

We will not share all environmental test results with you, but if any of our tests
show known chemical or other kinds of known health hazards in or around your
home we’ll let you know.

15

Appendix B

B.1.3.a–16

Knowing about a home health hazard can be a good thing, because if you know
about it, you may be able to fix it.
But there is also a risk to getting this information. Some federal and state laws
require homeowners to tell potential renters or buyers about certain health hazards,
like lead or mold. That means if you own your home, and we tell you about a
home health hazard, you may be required to report that hazard when you sell or
rent your home.

T4-S8

The Study will make every effort to protect the identities of all participants.
We will use a unique number code, and separate your and your child’s name—and
things that could identify either of you—from the samples and other information
you give us. The stored data will only have these code numbers, not names, so
that individuals cannot be identified.
The Study’s Coordinating Center will store information in a computer database
protected by sophisticated security technology. Your data will be combined with
data collected from all the participants in the Study—tens of thousands of people.
All the information—including yours and your child’s—will be confidential and
reported only as a group. Specific data about you personally, or about your child,
will never be reported in any Study publication.
In addition to taking all these steps to protect your and your child’s privacy,
there’s one more thing we have done.
We have obtained a legal document designed to protect your privacy. The
document is called a Certificate of Confidentiality. It will help protect your
information from people who are not part of the Study.

16

Appendix B

B.1.3.a–17

Certificates of Confidentiality are intended to assure that the Study researchers
cannot be forced to tell anyone who is not connected with the Study—including
the courts—about your participation or your personal information, without your
written consent.

T4Q1-Q
I‘d like to review some things we’ve discussed.
Touch the box that best describes:
The main reason the National Children’s Study is hoping you will volunteer to
participate
• Because I will directly benefit
• To help scientists discover new knowledge that can enhance children’s
health
• To receive health care

T4Q1-F1
No, you are not likely to benefit directly from participation in the study. However,
as we’ve mentioned, there may be some indirect benefits to your family, like
hearing from the Study about new discoveries for protecting children’s health or
being alerted to a known health hazard, if we discover one. Try again.
T4Q1-F2
Right. The main reason to participate in the Study is to know that you are
contributing to a landmark effort that will bring benefits to generations of future
American children.

17

Appendix B

B.1.3.a–18

T4Q1A-F3
No. Participation in the Study will not affect your health care in any way. You
will need to continue receiving health care services in the usual way you have
been doing. The Study does not offer health care nor pay for it. Try again.

T4Q2-Q
Now I would like to review some of the risks we just went over.
Touch the box that best describes:
A possible risk of participating in this study.
• I might learn about health risks that might prompt me to spend money on
tests that might not ultimately reveal a problem.
• I might learn something about others in the study that would upset me.
• I might have to answer questions I don’t want to answer.

T4Q2-F1
Right. Information about health risks can be helpful, particularly if there is
something that can be done to correct the problem. But, because of the
information we’ve shared with you, you might decide to spend money on
additional tests, which might not ultimately reveal a significant problem.
T4Q2-F2
No, we will never provide you or anyone else with specific information about
other individuals in the study. Try again.

18

Appendix B

B.1.3.a–19

T4Q2-F3
You will never have to answer questions you do not wish to answer. You can
always tell the interviewer that you want to pass on a question. Try again.
T4Q3-Q
Now touch the box that best describes:
What the Study will do if they learn that a child is being abused or neglected
• Nothing
• Tell the proper authorities
• Make me leave the Study

T4Q3-F1
No, Study team members won’t sit by and do nothing. Try again.
T4Q3-F2
Right! If Study team members learn that a child is being abused or neglected, the
Study will tell the proper authorities as required by law.
T4Q3-F3
No, you won’t have to leave the Study. Try again.

19

Appendix B

B.1.3.a–20

T4Q4-Q
Now touch the box that best describes:
What the Certificate of Confidentiality will do
• Remove your name and personal identifiers from all Study files
• Protect the privacy of your data from people outside the Study
• Prevent the Study from reporting harm or abuse

T4Q4-F1
No, your personal information will be kept on file by the Study. But your name
and personal identifiers will be removed from all your data, so the researchers
won’t know whose data they are looking at. Try again.
T4Q4-F2
Right! The Certificate of Confidentiality will protect your privacy by preventing
the government, courts, health insurance agencies, and others not connected with
the Study from seeing your personal information.
Good job, we’re almost done.
T4Q4-F3
No. If the Study learns that someone is being hurt or is in danger, they are
required to report this information no matter what. The Certificate of
Confidentiality does not protect against this. Try again.

20

Appendix B

B.1.3.a–21

T5-S1

Let’s talk about payment for your time. We will pay for time spent in Studyrelated activities, like a home or Study Center visit, and for answering
questionnaires. Payments for each activity will be about $50, depending on the
amount of time and effort involved. You will be paid for each completed task,
even if you or your child don’t finish the whole study.
T5-S2

From time to time, we will also give you or your child small gifts—like a T-shirt,
a tote bag, or a music CD—to thank you for helping us.
T5-S3

You will also be paid for any expenses related to visits to the Study Center—for
example, travel expenses or parking.
T6-S1

NARRATOR (V/O)
Finally, we’d like to answer some common questions people have about being part
of the Study.
OTHER VOICE
What if I want to leave the Study early?
21

Appendix B

B.1.3.a–22

NARRATOR (V/O)
We hope you will stay in the Study for the entire 21 years, but you or your child
can leave the Study at any time without penalty. You can also leave the Study for
a short time and then rejoin it. Leaving the Study will not affect your access to
health care in any way. The Study also has the right to end your participation at
any time.
If you do leave the Study, no new information will be collected from you or your
child, but data and samples that have already been collected will continue to be
analyzed. If you want us to get rid of any of those samples, you may ask us to
destroy them.

T6-S2

[NEW] OTHER VOICE
When my child gets older will he or she be able to decide whether to continue in
the Study?
NARRATOR (V/O)
Yes. Children and adolescents will be asked their permission to continue in the
Study. When the children become legal adults (at about age 18 depending on your
state law), they will be asked to fully consent for themselves, indicating whether
they wish to continue or not.

T6-S3

OTHER VOICE
What if I move?
22

Appendix B

B.1.3.a–23

NARRATOR (V/O)
We hope you’ll tell us if you are planning to move so you can keep working with
the Study in your new home. If you move and forget to tell us, we will look for
you using the information you’ve given us about family members and friends, as
well as publicly available information about you. If we are able to find you, we
will ask you if you want to continue to be in the Study.

T6-S4

OTHER VOICE
Will it cost me anything to take part in the Study?
NARRATOR (V/O)
No. There is no cost to you—all the tests and procedures related to the Study will
be paid for by the Study. Any future tests done on your samples will also be paid
for by the Study.

T6-S5

OTHER VOICE
Does the Study pay for health care for me or my family?
NARRATOR (V/O)
No, the Study is not able to pay for your health care. Study procedures are for
research purposes only, and taking part in the Study is not a substitute for your
usual visits to the doctor.

23

Appendix B

B.1.3.a–24

T6-S6

OTHER VOICE
Will data from this study be used in other ways?
NARRATOR (V/O)
Yes. At certain points during the Study we will remove all personal identifiers
and create what is called a public use data set—a set of totally anonymous data
that scientists and researchers can use to study other things. Anyone outside the
Study who uses the public use data will not be able to connect the information to
any specific person.

T6-S7

OTHER VOICE
In addition to the tests the National Children’s Study will do on our samples,
would our samples be used in any other way?
NARRATOR (V/O)
It is possible that scientists could create new medicines or health products in the
future based on stored study samples. In agreeing to participate in this study, you
are also agreeing to allow possible future use of yours and your child’s biological
materials for these kinds of purposes.

24

Appendix B

B.1.3.a–25

T6-S8
OTHER VOICE
If I take part in this study, will I have to be part of other studies?
NARRATOR (V/O)
No. But you may be invited to be in other studies connected with the National
Children’s Study. For any other studies, you will be asked for your permission
and you can always say “no thanks!”

T7-S1 [NEW]
NARRATOR (V/O)
Here is some additional information for you to look over.

THIS IS WHERE CENTERS MAY INSERT ADDITIONAL INFORMATION
AND/OR CENTER-SPECIFIC INFORMATION, SUCH AS CENTER’S
POLICY CONCERNING PROVIDING COMPENSATION IN CASE OF
INJURY RESULTING FROM PARTICIPATION

25

Appendix B

B.1.3.a–26

C1-S1
NARRATOR (V/O)
The purpose of the Study is to learn how things in the environment affect
children’s health, growth, and development. In order to accomplish this goal, we
need your permission to obtain personal health information about you and your
child.
For example, when your child is born, someone from your local Study Center will
look at your medical records for information about your pregnancy and delivery,
including all tests and exams, and for information about your child’s birth and
health. As the Study continues, the Study Center will collect information about
your child’s visits to the doctor or hospital to learn about health, illness, accidents,
injuries, and vaccinations.
If you agree to allow us to obtain and use your personal health information and
your child’s, you have the right to change your mind and withdraw your
permission at any time, by submitting a letter to the Study Coordinator. Once the
Study Coordinator has received your withdrawal letter, no new information from
your medical records or your child’s will be collected. However, information that
has already been collected may still be studied.

C1-S2
Some people feel differently about genetic information than other kinds of
information. So we will be asking you specifically to agree to genetic analysis on
your and your child’s samples. However, if you do not agree to the genetic aspect
of the Study, you can still take part in the rest of the Study.
Some of the genetic analyses we would like to do may be done right away. Others
may be done in the future, as the Study learns more, or as new tests and techniques
are developed.

26

Appendix B

B.1.3.a–27

Because results of individual tests can be very difficult to interpret, the National
Children’s Study will not give genetic information about you or your child to you
or to anyone else. In the unlikely case that the Study learns something from this
genetic information that is important to your health or your family’s health, and if
there is something you could do about it, we will tell you that the information is
available. In that case, we will give you the option of learning more about it.
C1-S3
Let’s pause now so that you can ask the Study Representative any questions you
may have.
In addition, before deciding, you may wish to discuss what you have learned about
the National Children’s Study with your family, friends, or your doctor.
If you have more questions about the research or about yours, or your child’s,
rights as a research participant, contact any of the following.

C1-S4
Please check one of the boxes below to indicate whether you would like to
volunteer to be part of the National Children’s Study:
• I am ready to participate in the National Children’s Study
• I need more time to think about participation in the Study. I’d like to
discuss it some more in the future.
• I do not wish to participate in the National Children’s Study.
• Click Next, when you have made your choice.

27

Appendix B

B.1.3.a–28

On the next screen, you will be asked for your signature. If you sign, you are
agreeing that both you and your child will participate in a research study. This
means that you have completed this informational program about the Study and
that you have made this decision voluntarily.

C1-S5
If you are ready to volunteer to be part of the National Children’s Study, you may
do so now. By signing below, you are indicating the following:
• I have completed the informational program about the National Children’s
Study.
• I understand what is involved, and what the risks and benefits are if my
child and I join.
•

I understand that I am also giving my permission for the National
Children’s Study to obtain and use my personal health information and my
child’s.

• I understand that my child and I may leave the Study at any time.
• I have asked and received answers to all my questions about the Study.
• I understand that I may ask further questions at any time and that I will get
a paper copy of the consent form for my records.

And, please check one of these two boxes:
• I also give permission to the National Children’s Study to collect and
analyze genetic information about me and my child.

28

Appendix B

B.1.3.a–29

• At this time, I do not give permission for the National Children’s Study to
collect and analyze genetic information about me and my child.
I voluntarily agree to join the Study, and I give permission for my child to
participate in the Study as well.

C1-DEFER
Thank you.
We understand that you have not agreed to participate in the National Children’s
Study at this time, but that you are still open to learning more about it in the
future.
The Study staff person visiting with you today will talk with you about when we
might contact you again.
If you’d like, we can leave you some materials to review yourself or with your
family.

C1-DECLINE
Thank you for being willing to hear about the National Children’s Study. We’d
very much like to know why you’ve chosen not to participate. Please select any or
all of the choices below.
I’m not interesting in participating because:
•

I don't want to commit to something for 21 years

•

I don’t think my husband or boyfriend will want me to do this.

•

I don’t think my family will want me to do this.

•

I don’t want someone visiting my home

29

Appendix B
•

B.1.3.a–30

I don’t want the Study to have access to my or my child’s personal health
information

•

I don’t want the Study staff to examine me or my child

•

I don’t want the Study staff to take samples from me or my child

•

I don’t want the Study staff to take samples from my yard or home
environment

•

I just don't feel like it

•

Or for another reason. Please tell the recruiter, who will record your answer

EARLY_EXIT
You clicked the EXIT button—are you sure you want to exit the program?
CLOSING_OPT-IN
Thanks again!
We are very pleased that you’ve agreed to participate in the National Children’s
Study!

CLOSING_OPT-OUT1
Thank you for your time thinking about participation in the National Children’s
Study!
We look forward to talking with you again in the future.

CLOSING_OPT-OUT2
Thank you for your time thinking about participation in the National Children’s
Study!

30

Appendix B

B.1.3.b–1
Consent Brochure
T1 Visit

MAKING AN INFORMED CHOICE ABOUT BEING IN
THE NATIONAL CHILDREN’S STUDY
Your neighborhood is one of many communities across the United States which has been chosen
to take part in an important research study. It is called the National Children’s Study, and its
goal is to improve the health and well being of our nation’s children.
We are asking you to take part in this study for two reasons. First, because you live in a
neighborhood that has been selected; and second, because you are pregnant. We are asking you
to join thousands of women and their babies from across the United States to learn things that
may help many people in the future, even if the information may not help you or your family
personally, right now.
Sponsors:
The National Children’s Study is a partnership between (LOCAL CENTER) and other local
institutions in your community, and is led by the U.S. Department of Health and Human Services
through the National Institutes of Health (NIH), the Centers for Disease Control and Prevention
(CDC), and the U.S. Environmental Protection Agency (EPA).
Joining the Study is your choice. You can decide not to join. If you do join, we hope you and your
child will remain in the study for the full 21 years, but you can leave for any reason at any time.

1

Appendix B

B.1.3.b–2
Consent Brochure
T1 Visit

What is the purpose of the National Children’s Study?
The goal of the National Children’s Study (NCS) is to improve the health and well being of the
nation’s children. The Study aims to understand how the environment affects children’s health,
growth, and development. We also are interested in how the environment interacts with a person’s
characteristics, such as genes, to prevent disease and promote health.
What kind of study is the National Children’s Study?
The NCS is an observational study, which means that we will be collecting information about you and
your child, and your child’s environment. Studying this information will allow us to find out which
things in the environment offer special benefits for child development and which are associated with
illness or disease. Observational studies do not involve asking you to change what you normally do.
We will not be asking you or your child to try out new drugs or experimental treatments of any kind.
Why is the National Children’s Study important?
This is the largest and most detailed study in history to learn about the health and development of
children in the United States. We will learn what things in the environment affect whether or not
children will develop diseases, both while they are young and also later, when they become adults.
Finally, there are new medical conditions that weren’t around 30 or 40 years ago, or not at the levels
we now see: obesity, diabetes, autism, learning disabilities, to name just a few. The National
Children’s Study will help us understand why, and what we can do about these problems.
How many people will be in the National Children’s Study?
The Study will include about 100,000 women and their babies from all over the United States. Fathers
also will be asked to participate. In this area, we expect to study about 1,000 women and their babies.
How long will the National Children’s Study last?
We hope you and your child will stay in the Study until your child turns 21 years old. You will start in
the Study during your pregnancy, and your child will start when he or she is born.
What is involved in being in the National Children’s Study?
We will schedule visits with you and your child, and if it is OK with you, your child’s father, to collect
information about your health and environment. Some of these visits will take place in your home,
and others will be at the Study Center.
The first visit when you are pregnant is at your home. The other visits when you are pregnant will be
at the Study Center.
When you give birth, we will visit you and your baby in the hospital or wherever you give birth to get
information about the birth and to ask you questions about your plans.

2

Appendix B

B.1.3.b–3
Consent Brochure
T1 Visit

When your baby is little, we will visit you and your baby in your home and also will invite you and
your baby to the Study Center. When your child gets a little older, you and your child will come to the
Study Center for visits.
We also might ask you about any places where your child spends a lot of time, like daycare, a
babysitter’s home, a school, or a grandparent’s house. We might also want to visit those places.
Between visits, we will contact you from time to time. We may ask you some questions on the
telephone, or we may send you questions in the mail or by computer.
How will the National Children’s Study collect information?
There are several ways we will collect information: We will ask you questions, ask you to complete
forms, do physical exams, collect samples, collect information for medical records, and take pictures
and videos of your child.
We may also ask you to keep track of certain things you do—like what you eat.
We also will ask you to obtain some samples of things like urine, or drinking water in your home, or
breast milk (if you are breast feeding), and mail them back to us in postage-paid containers that we
will provide.
As your child grows older, you also may be asked to complete other types of activities. Before every
visit, we will give you details and describe exactly what the visit will involve.
What kinds of information will be collected?
First, we will ask you questions about things that might affect your pregnancy. We will ask about
your medical history, the foods you eat, and your thoughts about different topics.
While you are pregnant, we will measure your height, weight, and blood pressure and do one or two
ultrasounds that may be in addition to the tests you receive from your doctor. If your doctor does an
ultrasound, we will want to look at that as well.
When you give birth, we will examine, measure, and take pictures of your baby. As your child grows
up, we will continue to follow your child’s health, growth, and development.
We also will examine you and your child, and do some tests. These exams and tests do not replace the
regular visits you have with your own doctors.
Finally, we will want to collect biologic samples from you and your child, and samples from your
home environment.
The biologic samples we collect—like blood, urine, hair, and saliva—will tell us about your health.
The environmental samples—like dirt, air, dust, and drinking water—will help us learn what in the
environment might affect your health.
Our trained staff will make these collections as easy as possible for you.

3

Appendix B

B.1.3.b–4
Consent Brochure
T1 Visit

For blood samples, we will use a small needle in your or your child’s arm. For urine samples, we will
give you a plastic container. There’s even a special container to collect urine from babies. For hair
samples, we’ll ask you for a few hairs from your head and your child’s. When your baby is born, we
will work with your doctor and hospital to obtain a sample of blood from the umbilical cord and a
sample of the cord and the afterbirth or placenta, as well as your baby’s first bowel movement.
To test the air in your home, we will leave an air pump in your home for a few days and then come
back to pick it up. To test the dust or water in your home, or the soil around your home, we will
collect small samples. Some of these samples you’ll be able to collect yourself with a kit and return to
us at the Study Center.
We hope you will want to participate in all parts of the Study, but if you don’t want to give certain
samples, answer certain questions, or have certain types of exams, that is fine—you can say no, at any
time, and for any reason, and you can still be part of the Study.
How many visits should I expect?
If you become pregnant, there will be several visits while you are pregnant, one when you give birth,
and the rest—about 10 or 12 in total—will be spread out over the next 21 years.
Will the Study need access to my medical records and my child’s medical
records?
Yes, we will want to get information from your medical records when you give birth, because we want
to learn how your delivery went.
Later, we will want to look at your child’s medical records, such as records of doctor and emergency
room visits, to learn about your child’s health, illnesses, accidents, injuries, and vaccinations. The
Study also may ask your doctors to provide personal health information about you and your child.
You will be asked to sign a separate authorization form giving us permission to obtain copies of these
types of medical records from your doctor or hospital. This kind of information will help us learn
about your child’s health.
If you agree to allow us to obtain and use your personal health information and your child’s, you have
the right to change your mind and withdraw your permission at any time by submitting a letter to the
Study Coordinator (whose contact information is presented on page X of this document). Once the
Study Coordinator has received your withdrawal letter, no new information from your medical records
or your child’s will be collected. But information that has already been collected may still be studied.
What will happen to all this information?
The information you give us will be stored with information from all other women and children in the
Study. Doctors and researchers will use all this information, which they call “data,” to look for
patterns or relationships between children’s environments and their health.

4

Appendix B

B.1.3.b–5
Consent Brochure
T1 Visit

Written data—like your answers to questions and your height measurements—will be stored on
computers. The samples we collect from you and your child will be stored so that they can be tested.
We plan to store these samples at least for the 21 years of the study.
Some tests on these samples will be done in a few weeks or months. Other tests will be done years
later. Right now, we do not know what all of those future tests might be, because science is always
improving and new tests are always being developed. But we can tell you that before any new kinds
of tests are done on your samples, they will be evaluated by a Study Committee of doctors, scientists,
and community members to make sure the tests only relate to child health, growth, and development,
or why some children are more likely to get diseases when they grow up.
If you decide that you and your child will join the Study and you agree to give us samples, you will be
allowing us to test those samples both now and in the years ahead.
Will you be obtaining genetic information about me and my child?
Yes, but only if you give us specific permission to do so.
In addition to telling us about your current health, the samples you provide us, like blood or saliva,
also can enable us to look at your DNA or genes. Collecting samples that allow us to look at both
genes and the environment is important, because genes affect children’s health and development, and
the environment affects how genes work. By collecting both genetic and environmental information,
the Study will learn a great deal about children’s health and development.
Some people feel differently about genetic information than other kinds of information. So we will be
asking you specifically to agree to genetic testing on your and your child’s samples. However, if you
do not agree to the genetic part of the Study, you can still be in the rest of the Study.
We will not be doing the genetic testing until some time in the future, as the Study learns more, or as
new tests and techniques are developed.
Because individual genetic results can be very difficult to interpret, the Study will not give genetic
information about you or your child to you or to anyone else. In the unlikely case that the Study learns
something from this genetic information that is important to your health or your family’s health, and if
there is something you could do about it, we will then tell you that the information is available. In that
case, we will give you the option of learning more about it.
What are the possible benefits of being in the National Children’s Study?
There may be no direct benefit to you or your family. But the Study could help provide important new
medical knowledge that could benefit all of us in the years to come—maybe even your children and
grandchildren. That’s something we think you might feel proud to be a part of.
However, there may be some indirect benefits. First, we will share some of our findings with you. As
the Study goes on, our scientists will learn a lot about children in general, and why some children are
more likely than others to get certain diseases when they grow up. We will learn things like what
5

Appendix B

B.1.3.b–6
Consent Brochure
T1 Visit

helps children do well in school and in relationships with other people. We will publish this
information in books and magazines. We also will share it with you through newsletters, a Web site,
and other means.
We also will give you reports about the routine information we collect about you and your child and
your environment. And, if our research shows something that is medically important and that you
could do something about, we will let you know, so that you can follow up with your doctor.
If you need the help of medical or social services, we can give you names and contact information.
But keep in mind that the Study will not pay for any medical treatment. We only will tell you what we
learn and give you the names of people or agencies that can help you.
What are the possible risks or burdens to me and my child from being in
the National Children’s Study?
The risks of this study are very low. It’s an observational study only. It does not include any
experimental drugs or medicines or treatments. However, there are some minimal risks and possible
discomforts.
You might feel uncomfortable about some of the questions we ask. If so, you can skip those
questions. You will be in charge, and you can decide which questions to answer.
But we do hope you will share some private information with us because it is important to make this
study successful. We will carefully protect what you tell us. Your data will be linked to a number, not
your name, so the people who later look at your answers cannot identify you personally.
Another risk—a very small one—has to do with giving blood samples. People sometimes feel brief
pain when blood is taken, and there is a very small risk of infection, bruising, or bleeding. The
professionals who will take your blood are trained to make you feel comfortable.
Home visits are likely to take two to three hours, but we will schedule the visits at a time that is good
for you. Having to go to the Study Center and having us come to your home may interfere with your
daily routine. Other people living in your home also may be affected by the visits. To minimize this,
we will schedule visits at a time that works for you, and we will be happy to change the date or time if
you need to.
If, during our visits, we learn that you or your child are in danger, or are a danger to yourselves or
others, then we must report this to the proper authorities.
As we have said, if any of your tests or samples indicate something that is medically important for you
to know about, we will let you know. Information like that can be helpful. But it also can be upsetting
to some people. And, because of the information we have shared with you, you might decide to spend
money to undergo additional tests, which might not end up finding any problems.
We will not share all results with you, but if any of our tests show chemical or other kinds of known
environmental health hazards in or around your home, we will let you know. Knowing about a home
environmental health hazard can be a good thing, because if you know about it, you may be able to fix
it. But there also is a risk to getting this information. Some federal and state laws require
homeowners to tell potential renters or buyers about certain health hazards, like lead or mold. That

6

Appendix B

B.1.3.b–7
Consent Brochure
T1 Visit

means if you own your home and we tell you about a home health hazard, you may be required to
report that hazard when you sell or rent your home.
How will my privacy be protected?
The Study will make every effort to protect the identities of all participants. We will use a unique
number code and separate your name, your child’s name, and other things that could identify either of
you from the samples and other information you give us. The stored data will have only these
numbers, not names, so that individuals cannot be identified.
The Study will store information in a computer database protected by very effective computer security
methods. Your data will be combined with data collected from all the other tens of thousands of
people in the Study. All the information, including yours and your child’s, will be confidential and
reported only as a group. Specific data about you personally or about your child will never be reported
in any Study publication.
In addition to taking all these steps to protect your and your child’s privacy, there is one more thing we
have done. We have obtained a legal document called a Certificate of Confidentiality. This will help
protect your information from people who are not part of the Study. Certificates of Confidentiality are
intended to assure that the Study researchers cannot be forced to tell anyone who is not connected with
the Study—including the courts—about your participation or your personal information without
written consent from you. However, if we learn during our visits that you or your child are in danger,
or are a danger to yourselves or others, then we must report this to the proper authorities.
Will I be paid for being in the National Children’s Study?
We will pay you for time spent in study-related activities, like a home or Study Center visit, and for
answering questions. Payments for each set of activities will be about $50, depending on the amount
of time and effort involved. We will pay you for each completed set of activities even if you or your
child do not finish the whole study.
You also will be paid for your expenses related to visits to the Study Center—for example, travel
expenses or parking.
From time to time, we will also give you or your child small gifts—like a T-shirt, a tote bag, or a
music CD—to thank you for helping us.
What if I want to leave the National Children’s Study?
We hope you will stay in the Study for the entire 21 years, but you or your child can leave the Study at
any time without penalty. You also can leave the Study for a short time and rejoin later. Leaving the
Study will not affect your access to health care or your relationship with this institution in any way.
The Study also has the right to end your participation at any time.
7

Appendix B

B.1.3.b–8
Consent Brochure
T1 Visit

If you do leave the Study, no new information will be collected from you or your child, but samples
and data that already have been collected will continue to be studied. If you want us to get rid of those
samples, you may ask us to destroy them by submitting a letter to the Study Coordinator (whose
contact information is presented on page X of this document).
When my child gets older, will he or she be able to decide whether to
continue in the National Children’s Study?
Yes. Young children and adolescents will be asked their permission to continue in the Study. When
the children become legal adults (at about age 18 depending on your state law), they will be asked to
sign a document themselves, like this one, to indicate whether they wish to continue or not.
What if I move?
We hope you will tell us if you are planning to move, so you can continue to be in the Study in your
new home. If you move and forget to tell us, we will try to learn your new address or phone number
by using the information you have given us about family members and friends, as well as publicly
available information about you. If we are able to find you, we will ask you if you want to continue in
the Study.
Will it cost me anything to be in the National Children’s Study?
No. There is no cost to you. All tests and activities related to the Study will be paid for by the Study.
Any future tests done on your samples will also be paid for by the Study.
Does the National Children’s Study pay for health care for me or my
family?
No. The Study is not able to pay for your health care. Study activities are for research purposes only,
and taking part in the Study does not take the place of your usual visits to the doctor.
Will data from the National Children’s Study be used in other ways?
Yes. At certain points in the Study, we will make what is called a public use data set. That data set
will not include any information that could identify individual people in the Study. Scientists and
researchers can use the public use data sets to try to learn more about children’s health. Anyone
outside the Study who uses the public use data set will not be able to connect it to a specific person.
8

Appendix B

B.1.3.b–9
Consent Brochure
T1 Visit

In addition to the tests the National Children’s Study will do on our
samples, will our samples be used in any other way?
It is possible that scientists could create new medicines or health products in the future based on stored
study samples. In agreeing to be in this study, you also are agreeing to allow possible future use of
your and your child’s biological materials for these kinds of purposes.
If I take part in the National Children’s Study, will I have to be part of
other studies?
No. But you may be invited to be in other studies connected with the National Children’s Study. If
so, we will ask your permission.
Who can I contact if I have further questions?
Feel free to ask the Study Representative, who has talked to you about being in the Study, any
questions you have. Also, if you have any questions about the Study or about your or your child’s
rights of being in the Study, now or in the future, you may contact any of the following:
National contact:
Local contact #1 (Study coordinator or PI):
Local contact #2 (IRB):
On the next page, you will be asked to indicate your consent to participate and to sign the
consent document. Before signing, you may wish to discuss what you have learned about
the National Children’s Study with your family, friends, or your doctor. Thank you for
taking the time to learn about this important Study.

9

Appendix B

B.1.3.b–10
Consent Brochure
T1 Visit

Participant’s Statement
•

I have read “Making an Informed Choice About Being in the National Children’s Study.”

•

I understand what is involved and what the risks and benefits are if my child and I join
the Study.

•

I understand that I am also giving my permission for the National Children’s Study to
obtain and use my personal health information and my child’s.

•

I understand that my child and I may leave the Study at any time.

•

I have asked and received answers to all my questions about the Study.

•

I understand that I may ask further questions at any time, and that I will receive a copy of
this consent form for my records.

I freely choose to be in the National Children’s Study, and I give permission for my child to
participate in the Study as well.
And, please check one of these two boxes:

I also give permission to the National
Children’s Study to collect and test
genetic information about me and my child.
At this time, I do not give permission
for the National Children’s Study to
collect and test genetic information
about me and my child.

Printed Name of Participant: _______________________________________________
Signature of Participant: ___________________________________________________
Date: ________________________
----------------------------------------------------------------------------------------------------------------------Printed Name of Person Obtaining Consent: ___________________________________
Signature of Person Obtaining Consent: _______________________________________
Date: ________________________
THANK YOU
10

Appendix B

B.1.3.c–1
OMB #: ________________
Expiration Date: _________

Visit Information Card for Pregnancy Visit
When you gave your permission to be part of the National Children’s Study (NCS), we told you all
about what it means to be in the study. This card tells you more details about what we would like to
do at this study visit.
Interview
We will ask you some questions which should take about one hour. The questions will be about such
things as your home, the people who live with you, household products you use, whether you have
any pets, as well as about your jobs, your activities, your health, your pregnancy, your baby’s father
and your plans for your child. In the last part of the interview, we will ask to answer some questions
using our computer. You can listen to the questions privately using headphones, you can listen
without headphones, or you can have the interviewer read the questions to you.
Physical Measures
We also will do the following:
ƒ Measure parts of your body including your arm, head, and the skin on the back of your arm
and upper back. You will not have to undress for us to take these measurements.
ƒ Measure your weight, your standing height and your sitting height.
ƒ Measure your blood pressure.
ƒ Give you a report to keep which shows your height, weight, heart rate, and blood pressure.
Biological Specimens
We also will do the following:
ƒ Ask you for a sample of your urine.
ƒ Ask you to collect 3 vaginal swabs. You will do this yourself in complete privacy using cotton
swabs.
ƒ Collect less than 2 ounces of your blood using a small needle. Two ounces is approximately
four tablespoons.
ƒ Collect a small sample of your hair.
ƒ

Give you a kit with straws to collect 6 samples of your saliva over the next 2 days. We will
ask you to freeze the samples, and we will collect them when we come back to pick-up some
equipment we will leave here.

Your urine and hair may be tested for a variety of environmental exposures. The vaginal swabs may
be tested for measures of infection and inflammation. Your saliva may be measured for cortisol, a
chemical your body produces when you are under stress. These measures will be done at a later
time and you will not receive the results of these tests.
On the same day that we collect your blood, we will test a small sample for hemoglobin and calculate
your hematocrit levels. Your hemoglobin and hematocrit results will be sent to you within a few
weeks. However, if anything abnormal is found, you will be told sooner. The rest of your blood will be
stored for future tests, which may include tests for environmental exposure, hormones, nutrients, and
measures of infection and inflammation. You will not receive the results of the tests that may be done
in the future.
Environmental Samples
We also will do the following:

T1 First Visit

Appendix B

B.1.3.c–2
OMB #: ________________
Expiration Date: _________

Visit Information Card for Pregnancy Visit
ƒ

Test the air in your home for chemicals, metals, and dust using an air pump and air badges.
We will leave these in your home for about a week, and then we will come back to pick them
up.

ƒ

Look at the environment inside and outside your home. If you want to, you can walk with us
while they do this.

ƒ

Collect dust from the floor of your home that will be tested at a later time for things some
people can be allergic to, as well as chemicals and pesticides. We will choose the rooms
where we collect the dust using Study rules.

ƒ

In some homes, a small amount of water will be collected and tested for chemicals.

You will not receive the results of any of these tests.
Questionnaires and Other Forms for You to Complete
If you have already had an ultrasound done or if you are scheduled to have an ultrasound done soon,
you may be asked to read and sign a form before the end of the visit. By signing this form, you will
give the Study permission to get a copy of your ultrasound results. If you have not had an ultrasound
done and one is not scheduled to be done, we will schedule one for you. The purpose of this
ultrasound is to make some measurements of your infant that will provide an estimate of your infant’s
age.
We also will give you several forms to complete on your own after we leave. These include:

ƒ
ƒ
ƒ
ƒ

Two forms about what you eat.
A Pregnancy Diary to write down the name of medicines you take, any illness you
experience, and some types of food you eat, such as fish and nuts.
A Pregnancy Medical Care Log to keep track of doctor’s visits.
A 3-Day Time and Place Diary for you to make a note of where you spend your time during
the week and on the weekend.

At the end of this visit, we will ask you to fill out a short form with a few questions about your thoughts
on the information we gave you when we asked for your permission to be in the Study.
We will pick up most of these forms up from you when we return to get the equipment we need to
leave here. We will not collect the Pregnancy Diary or the Pregnancy Medical Care Log from you
because you will be using those for the entire time you are pregnant. Also, when we return to pick up
the environmental equipment, we will ask you to complete a short form about your thoughts on all of
the things we did at this visit.
Compensation
After we have completed the interview part of the visit and collected all initial environmental and
biological specimens, we will give you $80 for your time. We also will give you $20 once we have
received the environmental and biologic specimens and the questionnaires and other forms.
We would like to remind you that being in this Study is voluntary. You can decide to be in the Study
or not. You have the right to not answer any question, or to ask us not to take any sample or
measurement that you do not want us to take. If you decide not to participate, it will not affect any
benefits which you receive now, or may receive in the future.
If you have any further questions about this Study visit, I can try to answer them, or you can call my
supervisor at xxx-xxx-xxxx.

T1 First Visit

Appendix B

B.1.3.c–3
OMB #: ________________
Expiration Date: _________

Visit Information Card for Pregnancy Visit
When you gave your permission to be part of the National Children’s Study (NCS), we told you all
about what it means to be in the study. This card tells you more details about what we would like to
do at this study visit.
Interview
We will ask you some questions which should take about one hour. The questions will be about such
things as your home, the people who live with you, any products you use, whether you have any
pets, as well as about your jobs, your activities, and your health. In the last part of the interview, you
will be asked to answer some questions using our computer. You can listen to the questions privately
using headphones, without headphones, or you can have the interviewer read the questions to you.
Physical Measures
We also will do the following:
ƒ

Measure parts of your body including your arm, head, and the skin on the back of your arm
and upper back. You will not have to undress for us to do this.

ƒ

Measure your weight, your standing height, and your sitting height.

ƒ

Measure your blood pressure.

ƒ

Give you a report to keep which shows your height, weight, heart rate, and blood pressure.

Biological Specimens
We also will do the following:
ƒ

Ask you for a sample of your urine.

ƒ

Ask you to collect 3 vaginal swabs. You will do this yourself in complete privacy using cotton
swabs.

ƒ

Collect less than 2 ounces of your blood using a small needle. Two ounces is approximately
four tablespoons.

ƒ

Collect a small sample of your hair.

ƒ

Give you a kit with straws to collect 6 samples of your saliva over the next 2 days. We will
ask you to freeze the samples, and we will collect them when we come back to pick up some
equipment we will leave here.

Your urine and hair may be tested for a variety of environmental exposures. The vaginal swabs may
be tested for measures of infection and inflammation. Your saliva may be measured for cortisol, a
chemical your body produces when you are under stress. These measures will be done at a later
time and you will not receive the results of these tests.
On the same day that we collect your blood, we will test a small sample for hemoglobin and calculate
your hematocrit levels. Your hemoglobin and hematocrit results will be sent to you within a few
weeks. However, if anything abnormal is found, you will be told sooner. The rest of your blood will be
stored for future tests, which may include tests for environmental exposure, hormones, nutrients, and
measures of infection and inflammation. You will not receive the results of the tests that may be done
in the future.

T1 Prior Visit

Appendix B

B.1.3.c–4
OMB #: ________________
Expiration Date: _________

Visit Information Card for Pregnancy Visit
Environmental Samples
We also will do the following:
ƒ

Test the air in your home for chemicals, metals, and dust using an air pump and air badges.
We will leave these in your home for about a week, and then we will return to pick them up.

ƒ

Look at the environment inside and outside your home. You can walk with the study staff
while they do this, but it is not required.

ƒ

Collect dust from the floor of your home that will be tested at a later time for things some
people can be allergic to, as well as chemicals and pesticides. The technician will choose the
rooms where the dust will be collected using Study guidelines.

ƒ

In some homes, a small amount of water will be collected and tested for chemicals.

You will not receive the results of any of these tests.
Questionnaires and Other Forms for You to Complete
If you already have had an ultrasound done or if you are scheduled to have an ultrasound done soon,
you may be asked to read and sign a form before the end of the visit. By signing this form, you will
give the Study permission to get a copy of the ultrasound results. If you have not had an ultrasound
done and one is not scheduled to be done, we will schedule one for you. The purpose of this
ultrasound is to make some measurements of your infant that will provide an estimate of your infant’s
age. The ultrasound will not look for anything out of the ordinary and will not be used to make any
diagnoses. The ultrasound is for research purposes only and does not replace a regular visit to your
health care provider. You will receive a picture from your baby’s ultrasound.
We also will give you two forms to complete on your own after we leave. These include:
ƒ

A Pregnancy Diary to write down the name of medicines you take, any illness you
experience, and some types of food you eat, such as fish and nuts.

ƒ

A Pregnancy Medical Care Log to keep track of doctor’s visits.

ƒ

A 3-Day Time and Place Diary for you to make a note of where you spend your time during
the week and on the weekend.

We will pick up the 3-Day Time and Place Diary from you when we come back to get the equipment
we need to leave with you. We will not collect the Pregnancy Medical Care Log or Pregnancy Diary
from you because you will be using those for the entire time you are pregnant. Also, when we return
to pick up the equipment, we will ask you to complete a short form about your thoughts on all of the
things we did at the visit.
Compensation
After we have completed the interview part of the visit and collected all initial environmental and
biological specimens, we will give you $80 for your time. We will also give you $20 once we have
received the environmental and biologic specimens and the questionnaires and other forms.
We would like to remind you that being in this Study is voluntary. You can decide to be in the Study
or not. You have the right to not answer any question, or to ask us not to take any sample or
measurement that you do not want us to take. If you decide not to participate, it will not affect any
benefits which you receive now, or may receive in the future.

T1 Prior Visit

Appendix B

B.1.3.c–5
OMB #: ________________
Expiration Date: _________

Visit Information Card for Pregnancy Visit
If you have any further questions about this Study visit, I can try to answer them, or you can call my
supervisor at xxx-xxx-xxxx.

T1 Prior Visit

Appendix B

B.1.3.d–1
OMB #: ________________
Expiration Date: _________

Visit Information Card for Pregnancy Visit
When you gave your permission to be part of the National Children’s Study (NCS), we told you all
about what it means to be in the study. This card tells you more details about what we would like to
do at this study visit.
Physical Measures
We will do an ultrasound to collect measurements of your infant. It will provide information on your
child’s growth and body composition. The ultrasound will not look for anything out of the ordinary and
will not be used to make any diagnoses. The ultrasound is for research purposes only and does not
replace a regular visit to your health care provider. You will receive a picture from your baby’s
ultrasound.
Compensation
You will not receive any cash payments for your participation in this study activity.
We would like to remind you that being in this Study is voluntary. You can decide to be in the Study
or not. You have the right to not answer any question, or to ask us not to take any sample or
measurement that you do not want us to take. If you decide not to participate, it will not affect any
benefits which you receive now or may receive in the future.
If you have any further questions about this Study visit, I can try to answer them, or you can call my
supervisor at xxx-xxx-xxxx.

T2 Visit

Appendix B

B.1.3.e–1
OMB #: ________________
Expiration Date: _________

Visit Information Card for Pregnancy Visit
When you gave your permission to be part of the National Children’s Study (NCS), we told you all
about what it means to be in the study. This card tells you more details about what we would like to
do at this study visit.
Interview
We will ask you some questions which should take about one hour. The questions will be about such
things as your home, the people who live with you, any products you use, whether you have any
pets, as well as about your jobs, your activities, and your health. In the last part of the interview, you
will be asked to answer some questions using our computer. You can listen to the questions privately
using headphones, you can listen without headphones or you can have the interviewer read the
questions to you.
Physical Measures
We also will do the following:
ƒ

Measure parts of your body including your arm, and the skin on the back of your arm and
upper back. You will not have to undress for us to do this.

ƒ

Measure your weight and your blood pressure.

ƒ

Give you a report to keep which shows your weight, heart rate, and blood pressure.

In addition, we will do an ultrasound to collect measurements of your infant. It will provide information
on your child’s growth and body composition. The ultrasound will not look for anything out of the
ordinary and will not be used to make any diagnoses. The ultrasound is for research purposes only
and does not replace a regular visit to your health care provider. You will receive a picture from your
baby’s ultrasound.

Biological Specimens
ƒ

Prior to this visit, you were given instructions on fasting (not eating or drinking) for purposes
of the blood draw. Some measurements are best done on blood samples collected after
fasting and we asked you to fast for 9 hours prior to this visit.

ƒ

Prior to this visit, you were given a kit with straws in it to collect 6 samples of your saliva and
asked to freeze the samples and then bring them with you to this visit.

We also will do the following:

ƒ

Collect 2 ounces of your blood using a small needle. Two ounces is approximately four
tablespoons. We will provide you with a snack after we have finished collecting your blood
sample.

ƒ

Ask you for a urine sample.

ƒ

Collect a small sample of your hair

ƒ

Ask you to collect 3 vaginal swabs. You will do this yourself in complete privacy using cotton
swabs.

ƒ

Ask you to cut or clip your toenails from all toes on both of your feet.

T3 Prior Visit

Appendix B

B.1.3.e–2
OMB #: ________________
Expiration Date: _________

Visit Information Card for Pregnancy Visit
Your urine, hair, and toenails may be tested for a variety of environmental exposures. The vaginal
swabs may be tested for measures of infection and inflammation. Your saliva may be measured for
cortisol, a chemical your body produces when you are under stress. These measures will be done at
a later time and you will not receive the results of these tests.
On the same day that we collect your blood, we will test a small sample for hemoglobin and calculate
your hematocrit levels. Your hemoglobin and hematocrit results will be sent to you within a few
weeks. However, if anything abnormal is found, you will be told sooner. The rest of your blood will be
stored for future tests, which may include tests for environmental exposure, hormones, nutrients, and
measures of infection and inflammation. You will not receive the results of the tests that may be done
in the future.
Environmental Samples
We ask that you sample the air and settled dust in your home. We will give you instructions with the
sample collection kits and ask that you mail the samples back to us. We will have a lab test the air
samples for chemicals and the settled dust will be saved for additional tests later on. You will not
receive the results of these tests.
Questionnaires and Other Forms for You to Complete
We will give you several forms to complete on your own after we leave. These include:

ƒ

Two forms about what you eat.

ƒ

A 3-Day Time and Place Diary for you to make a note of where you spend your time during
the week and on the weekend.

We will give you a pre-paid envelope to mail these forms back to us once you are done filling them
out.
At the end of this visit, we may ask you to fill out a short form with a few questions about your
thoughts on the information we gave you when we asked for your permission to be in the Study. We
also will ask you to complete a short form about your thoughts on all the things we did at the visit.
Compensation
After we have completed the interview part of the visit and collected all physical measurements and
biological specimens, we will give you $80 for your time. We also will give you $20 once we have
received the environmental and biologic specimens and the questionnaires and other forms.
We would like to remind you that being in this Study is voluntary. You can decide to be in the Study
or not. You have the right to not answer any question, or to ask us not to take any sample or
measurement that you do not want us to take. If you decide not to participate there will be no loss of
benefits to which you are otherwise entitled.
If you have any further questions about this Study visit, I can try to answer them, or you can call my
supervisor at xxx-xxx-xxxx.

T3 Prior Visit

Appendix B

B.1.3.e–3
OMB #: ________________
Expiration Date: _________

Visit Information Card for Pregnancy Visit
When you gave your permission to be part of the National Children’s Study (NCS), we told you all
about what it means to be in the study. This card tells you more details about what we would like to
do at this study visit.
Interview
We will ask you some questions which should take about one hour. The questions will be about such
things as your home, the people who live with you, any products you use, whether you have any
pets, as well as about your jobs, your activities, and your health. In the last part of the interview, we
will ask to answer some questions using our computer. You can listen to the questions privately
using headphones, you can listen without headphones, or you can have the interviewer read the
questions to you.
Physical Measures
We also will do the following:
ƒ Measure parts of your body including your arm, head, and the skin on the back of your arm
and upper back. You will not have to undress for us to take these measurements.
ƒ Measure your weight, your standing height and your sitting height.
ƒ Measure your blood pressure.
ƒ Give you a report to keep which shows your height, weight, heart rate, and blood pressure.
In addition, we will do an ultrasound to collect measurements of your infant. It will provide information
on your child’s growth and body composition. The ultrasound will not look for anything out of the
ordinary and will not be used to make any diagnoses. The ultrasound is for research purposes only
and does not replace a regular visit to your health care provider. You will receive a picture from your
baby’s ultrasound.
Biological Specimens
ƒ

Before this visit, you were asked to fast (not eat or drink) so that we could do a blood draw.
Some measurements are best done on blood samples collected when you have not had
anything to eat or drink for awhile and we asked you to fast for 9 hours prior to this visit.

We also will do the following:
ƒ Ask you for a sample of your urine.
ƒ Ask you to collect 3 vaginal swabs. You will do this yourself in complete privacy using cotton
swabs.
ƒ Collect less than 2 ounces of your blood using a small needle. Two ounces is approximately
four tablespoons.
ƒ Collect a small sample of your hair.
ƒ

Ask you to cut or clip your toenails from all toes on both of your feet.

ƒ

Give you a kit with straws in it to collect 6 samples of your saliva over the next 2 days. We
will ask you to freeze the samples, and we will collect them when we come back to pick up
some equipment we will leave here.

Your urine, hair and toenails may be tested for a variety of environmental exposures. The vaginal
swabs may be tested for measures of infection and inflammation. Your saliva may be measured for
cortisol, a chemical your body produces when you are under stress. These measures will be done at
a later time and you will not receive the results of these tests.

T3 First Visit

Appendix B

B.1.3.e–4
OMB #: ________________
Expiration Date: _________

Visit Information Card for Pregnancy Visit
On the same day that we collect your blood, we will test a small sample for hemoglobin and calculate
your hematocrit levels. Your hemoglobin and hematocrit results will be sent to you within a few
weeks. However, if anything abnormal is found, you will be told sooner. The rest of your blood will be
stored for future tests, which may include tests for environmental exposure, hormones, nutrients, and
measures of infection and inflammation. You will not receive the results of the tests that may be done
in the future.
Environmental Samples
We also will do the following:
ƒ

Test the air in your home for chemicals, metals, and dust using an air pump and air badges.
We will leave these in your home for about a week, and then we will come back to pick them
up.

ƒ

Look at the environment inside and outside your home. If you want to, you can walk with us
while we do this.

ƒ

Collect dust from the floor of your home that will be tested at a later time for things some
people can be allergic to, as well as chemicals and pesticides. We will choose the rooms
where we collect the dust using Study rules.

ƒ

In some homes, a small amount of water will be collected and tested for chemicals.

You will not receive the results of any of these tests.
Questionnaires and Other Forms for You to Complete
If you have already had an ultrasound done or if you are scheduled to have an ultrasound done soon,
you may be asked to read and sign a form before the end of the visit. By signing this form, you will
give the Study permission to get a copy of your ultrasound results. If you have not had an ultrasound
done and one is not scheduled to be done, we will schedule one for you. The purpose of this
ultrasound is to make some measurements of your infant that will provide an estimate of your infant’s
age.
We also will give you two forms to complete on your own after we leave. These include:

ƒ
ƒ
ƒ
ƒ

Two forms about what you eat.
A Pregnancy Diary to write down the name of medicines you take, any illness you
experience, and some types of food you eat, such as fish and nuts.
A Pregnancy Medical Care Log to keep track of doctor’s visits.
A 3-Day Time and Place Diary for you to make a note of where you spend your time during
the week and on the weekend.

At the end of this visit, we will ask you to fill out a short form with a few questions about your thoughts
on the information we gave you when we asked for your permission to be in the Study.
We will pick up most of these forms up from you when we return to get the equipment we need to
leave here. We will not collect the Pregnancy Diary or the Pregnancy Medical Care Log from you
because you will be using those for the entire time you are pregnant. Also, when we return to pick up
the equipment, we will ask you to complete a short form about your thoughts on all of the things we
did at this visit.

T3 First Visit

Appendix B

B.1.3.e–5
OMB #: ________________
Expiration Date: _________

Visit Information Card for Pregnancy Visit
Compensation
After we have completed the interview part of the visit and collected all initial environmental and
biological specimens, we will give you $80 for your time. We will also give you $20 once we have
received the environmental and biologic specimens and the questionnaires and other forms.
We would like to remind you that being in this Study is voluntary. You can decide to be in the Study
or not. You have the right to not answer any question, or to ask us not to take any sample or
measurement that you do not want us to take. If you decide not to participate, it will not affect any
benefits which you receive now, or may receive in the future.
If you have any further questions about this Study visit, I can try to answer them, or you can call my
supervisor at xxx-xxx-xxxx.

T3 First Visit

Appendix B

B.1.4.a–1
OMB #: ________________
Expiration Date: _________

Visit Information Card for Birth Visits
When you gave your permission to be in the National Children’s Study (NCS), we told you all about
what it means to be in the Study. This card tells you more details about what we would like to do
during or around the time your baby is born.
When your baby is born, we will visit you in the hospital to get some information and samples from
you and your baby. In order to do that, hospitals, clinics, and birthing centers are working with us,
and we will let them know that you are part of the National Children’s Study.
Around the Time of Delivery
Biological Specimens—Mother
We will do the following:
ƒ

Collect less than 2 ounces of blood from your arm using a small needle. Two ounces is about
four tablespoons.

ƒ

Collect blood from the umbilical cord. If you have decided to store your cord blood at a cord
blood back, no cord blood will be collected.

ƒ

Collect the umbilical cord and the placenta.

Your placenta and the cord blood will be stored for future tests which may include measures of
environmental exposure, hormones, nutrients, and measures of infection and inflammation. The
umbilical cord and the placenta samples may be tested for chemicals and certain proteins. These
measures will be done at a later time and you will not receive the results of these tests.
Before Discharge
If you and your baby go home before we can do all the physical measures or give you the forms to
complete on your own, we will call you in a month to set up a time to visit you at your home.
Biological Specimens—Child
Sometime during your stay in the hospital, clinic, or birthing center, and before you leave the
hospital, we will collect meconium from your child’s diaper. Meconium is your child’s first set of bowel
movements.
We also will work with the hospital, clinic, or birthing center to collect a small portion of blood from
your baby’s heel. This is a routine blood collection done at birth.
Your child’s meconium and blood will be stored for future tests which may include measures of
environmental exposure. These measures will be done at a later time and you will not receive the
results of these tests.
Biological Specimens—Mother
If you are planning to nurse, we will give you a breast milk collection kit and a breast pump before
you leave and ask you to collect some of your breast milk when your baby is 1 month old. We will ask
you to freeze the sample and then mail it to us. We will give you everything you need to pack up the
sample and pay for the shipping.

B1/B2 Visits

Appendix B

B.1.4.a–2
OMB #: ________________
Expiration Date: _________

Visit Information Card for Birth Visits
Your breast milk will be stored for future tests which may include measures of environmental
exposures, hormones, nutrients, and measures of infection and inflammation.
Physical Measures—Child
Before your discharge, we also will do the following:
ƒ

Measure your child’s length, weight and head circumference.

ƒ

Observe your child’s physical condition at birth and take photographs that will later be
examined to confirm your child’s physical condition. You will not receive the results of this
procedure.

ƒ

Conduct a developmental examination of your child that looks at newborn muscle tone and
skin tone, reflexes, movement, behavior, and responses to sights and sounds. You will not
receive the results of this procedure.

Questionnaires and Other Forms for You to Complete
We will update your contact information and give you an Infant Medical Provider Visit Log to keep
track of your child’s doctor’s visits.
Other Activities
At this visit or at a later visit to the hospital, we will make notes from your medical chart about what
happened during your delivery and hospital stay.
Compensation
After we have collected the visit specimens and completed the visit activities, you will receive $20 for
your time. We will also give you a small gift for you baby.
We would like to remind you that being in this Study is voluntary. You can decide to be in the Study
or not. You have the right to not answer any question, or to ask us not to take any sample or
measurement that you do not want us to take. If you decide not to be in the Study, it will not affect
any benefits which you receive now, or may receive in the future.
If you have any further questions about these Study activities, I can try to answer them, or you may
call my supervisor at xxx-xxx-xxxx.

B1/B2 Visits

Appendix B

B.1.4.b–1
OMB #: ________________
Expiration Date: _________

Visit Information Card for Post Birth Visit
When you gave your permission to be part of the National Children’s Study (NCS), we told you all
about what it means to be in the study. This card tells you more details about what we would like to
do at this study visit.
Interview
We will ask you some questions and give you some activities to do which should take about an hour
and fifteen minutes. The questions will be about such things as how you have adjusted to having
your new baby, including your stress, amount of sleep, feelings, who cares for your child, how you
parent, your baby’s behavior, and your family support. We also will ask about your home, the people
who live with you, your jobs, your health, any pets you have, products you use around your house,
and any medicines your baby takes. We’ll also bring some toys with us and ask you to use them
while you play with your baby. As you play, we will record you and your baby with a video camera.
Finally, we will ask you to do a few activities, such as reading to us, and answering some questions
about things you read.
Physical Measures
We also will ask to do the following:
ƒ

Measure parts of your baby’s body including his or her head, arm, thigh, stomach, and waist,
and the skin on the back of his or her arm and upper back.

ƒ

Measure your baby’s weight, height, and his or her length lying down.

ƒ

Look at your baby’s skin and take photos of his or her face.

ƒ

Give you a report to keep which shows your baby’s length lying down and his or her weight.

Biological Specimens
We also will do the following:
ƒ

Give you a NCS diaper to collect a sample of your baby’s urine during the visit.

ƒ

Give you 2 saliva sample collection kits: one for you and one for another adult who spends
the most time with your baby. Each person should use only one kit. Each kit has straws in it
to collect 6 samples of saliva over the next 2 days. We will ask you to freeze the samples,
and we will collect all 12 of them when we come back to pick-up some equipment we will
leave here.

ƒ

Give you a breast milk collection kit and ask you to collect some of your breast milk, if you
are still nursing, some time during the next 5 days. We will ask you to freeze the sample, and
we will collect it when we come back to pick up some equipment we will leave here.

Your baby’s urine and your breast milk may be tested for a variety of environmental exposures.
The saliva may be measured for cortisol, a chemical your body produces when under stress.
These tests will be done at a later time and you will not receive the results of these tests.

6-Month Visit

Appendix B

B.1.4.b–2
OMB #: ________________
Expiration Date: _________

Visit Information Card for Post Birth Visit
Environmental Samples
We also will do the following:
ƒ

Test the air in your home for chemicals, metals, and dust using an air pump and an air
badge. We will leave these in your home for about a week, and then we will come back to
pick them up.

ƒ

Look at the environment inside and outside your home. If you want to, you can walk with us
while we do this.

ƒ

Collect dust from the floor of your home that will be tested for pesticides at a later time. We
will choose the rooms where we collect the dust using Study rules.

ƒ

In some homes, a small amount of water will be collected and tested for chemicals.

ƒ

Collect dirt from your yard that will be stored and tested at a later time.

You will not receive the results of any of these tests.
Questionnaires and Other Forms for You to Complete
We will also give you several forms to complete on your own after we leave. These include:

ƒ
ƒ

Two forms about what you are feeding your baby.
A form about your feelings and how you and your husband or partner divide up household
work.

(IF APPLICABLE: We also will leave a form for your husband or partner to do on his own after we
leave. It has questions about his family background, your relationship, his jobs, his health, his
feelings including how he feels about your baby and how he parents.)
We will pick up these forms from you when we return to get the equipment we need to leave here.
Compensation
After we have completed the interview part of the visit and collected all initial environmental and
biological specimens, we will give you $80 for your time. We also will give you $20 once we have
received the environmental specimens and the questionnaires and other forms.
We would like to remind you that being in this Study is voluntary. You can decide to be in the Study
or not. You have the right to not answer any question, or to ask us not to take any sample or
measurement that you do not want us to take. If you decide not to participate, it will not affect any
benefits which you receive now, or may receive in the future.
If you have any further questions about this Study visit, I can try to answer them, or you can call my
supervisor at xxx-xxx-xxxx.

6-Month Visit

Appendix B

B.1.4.c–1
OMB #: ________________
Expiration Date: _________

Visit Information Card for Post Birth Visit
When you gave your permission to be part of the National Children’s Study (NCS), we told you all
about what it means to be in the study. This card tells you more details about what we would like to
do at this study visit.
Interview
We will ask you some questions and give you and your child some activities to do which should take
about an hour and a half. The questions will be about such things as your home, your jobs, any pets
you have, the television programs and movies you watch, your financial situation, who cares for your
child, how you parent, you and your child’s health, words your child understands or says, and any
medicines your child takes. We will bring some toys with us to the visit and ask you to play with your
child. As you play, we will record you and your child with a video camera. We also will do a series of
activities with your child to see how your child communicates, how your child can move his or her
body and hold small objects, and the ways your child notices, understands, and remembers things
he or she sees or hears.
Physical Measures
We also will ask to do the following:
ƒ

Measure parts of your child’s body including his or her head, arm, thigh, stomach, and waist,
and the skin on the back of his or her arm and upper back.

ƒ

Measure your child’s weight, height, and his or her length lying down.

ƒ

Measure your child’s blood pressure.

ƒ

Look at your child’s skin and take photos of his or her face.

ƒ

Give you a report to keep which shows your child’s length lying down, height, heart rate, and
his or her blood pressure.

Biological Specimens
We also will do the following:
ƒ

Give you a NCS diaper to collect a sample your child’s urine during the visit.

ƒ

Collect less than 2 ounces of your child’s blood using a small needle. Two ounces is
approximately four tablespoons.

ƒ

Collect a small sample of your child’s hair.

ƒ

Give you a kit to collect 4 samples of your child’s saliva over the next 2 days. We will ask you
to freeze the samples, and we will collect them when we come back to pick up some
equipment we will leave here.

Your child’s urine and hair may be tested for a variety of environmental exposures. Your child’s
saliva may be measured for cortisol, a chemical your child’s body produces when he or she is
under stress. These measures will be done at a later time and you will not receive the results of
these tests.

12-Month Visit

Appendix B

B.1.4.c–2
OMB #: ________________
Expiration Date: _________

Visit Information Card for Post Birth Visit
Environmental Samples
We will also do the following:
ƒ

Test the air in your home for chemicals, metals, and dust using an air pump and an air
badge. We will leave these in your home for about a week, and then we will come back to
pick them up.

ƒ

Look at the environment inside and outside your home. If you want to, you can walk with us
while they do this.

ƒ

Collect dust from the floor of your home that will be tested for pesticides at a later time. We
will choose the rooms where we collect the dust using Study rules.

ƒ

In some homes, a small amount of water will be collected and tested for chemicals.

ƒ

Collect dirt from your yard that will be tested at a later time.

You will not receive the results of any of these tests.
Questionnaires and Other Forms for You to Complete
We also will give you several forms to complete on your own after we leave. These include:

ƒ
ƒ
ƒ

Two forms about what you are feeding your child.
A form about your relationship with your husband or partner, your personal safety, your
stress levels, and your child’s feelings and behavior.
A Child 3-Day Time and Place Diary for you to make a note of where your child spends time
during the week and on the weekend.

We will pick up these forms from you when we return to get the equipment we need to leave here.
Compensation
After we have completed the interview part of the visit and collected all initial environmental and
biological specimens, we will give you $80 for your time. We also will give you $20 once we have
received the environmental specimens and the questionnaires and other forms.
We would like to remind you that being in this Study is voluntary. You can decide to be in the Study
or not. You have the right to not answer any question, or to ask us not to take any sample or
measurement that you do not want us to take. If you decide not to participate, it will not affect any
benefits which you receive now, or may receive in the future.
If you have any further questions about this Study visit, I can try to answer them, or you can call my
supervisor at xxx-xxx-xxxx.

12-Month Visit

Appendix B

B.1.5.a–1

National Children’s Study
FATHER’S CONSENT TOOL Audio Recording Script
Based on Script 06-11-2007
T1-S1
As you know, your partner has decided to participate in an important research study to
improve the health and well being of our nation’s children. It’s called the National
Children’s Study. We’re hoping you will agree to join the Study, too. We’d like to
give you some information about the Study, so you can decide whether or not you
would like to join.
The overall purpose of the study is to help doctors and scientists learn what things in
the environment may affect children’s health, growth, and development, and what may
cause children to develop diseases later when they are adults. To do that, the National
Children’s Study will be studying mothers and fathers before and during pregnancy and
children from the time they are born until they are 21 years old. We will also want to
follow the parents of each child because we know that parents are important to the
health of their children.
Here’s more on what the Study is all about:

T1-S2
The National Children’s Study is being conducted as a partnership among local
institutions in your community and three federal agencies. The three federal agencies
are the National Institute of Child Health and Human Development, which is part of
the National Institutes of Health; the Centers for Disease Control and Prevention; and
the Environmental Protection Agency.

Father’s Consent Video Script/DRAFT 12/18/07

Appendix B

B.1.5.a–2

T1S3
This is the local institution in your community.
There is a Study Center with a team of community members, health professionals,
and others trained to carry out the national study in your community.
T2-S1
As the future father of a child in the Study, we’re hoping you will become involved.
We’d like to visit you once in your home during the pregnancy to ask you some
questions…
T2-S2
…to examine you to get body measurements, like height, weight and blood pressure,
and to…
T2-S3
… collect blood and urine samples from you.

T2-S4
We’d like to schedule the visit, so that it would occur in the next few weeks, at a time
that is good for you.
When we come to your home, we will explain exactly what we’re going to do, and we
will ask you if it’s okay to do it.
If there’s something you don’t want to do, you can skip that part and still be in the
Study.

Father’s Consent Video Script/DRAFT 12/18/07

Appendix B

B.1.5.a–3

T2-S5
In addition to this home visit, we would also like to stay in touch with you from time to
time to ask some questions about your health and your relationship to your child.
We will phone or reach you by mail or computer.
If you feel uncomfortable about any questions we ask, you can skip those questions.
You will be in charge, and you can decide which questions to answer.
You are also free to stop participating in the Study at any time.

T2-S6
The information you give us will be stored with information from all the participants in
the Study. Doctors and researchers will use all this information, which they call “data,”
to look for patterns or relationships between children’s environments and their health.
These patterns will give researchers clues about what causes many diseases.
Written data—like your answers to questions and your height measurements—will be
stored in computers and studied by researchers.
The samples we collect from you will be stored so they can be tested.

T2-S7
Some tests on your samples will be done right away. Others will be performed at
a later date. Samples will be stored at least for the duration of the entire study so
that we can do many other tests.
Right now we can’t tell you what all of those future tests might be because science is
always improving and new tests are always being developed.

Father’s Consent Video Script/DRAFT 12/18/07

Appendix B

B.1.5.a–4

But we can tell you that before any new kinds of tests are done on your samples, a
Committee of doctors, scientists, and community members will make sure the tests
relate to child health, growth, and development and to improving our understanding of
why some children are more likely to get diseases when they grow up.
If you decide to join the Study and agree to give us samples, you will be allowing us to
test those samples both now and in the years ahead.

T2-S8
The Study also plans to look at DNA, or genes, the basic building blocks of our
bodies. Doctors know that genes affect the health, growth, and development of
children, and that the environment affects how genes work. That is why we hope
to analyze the genes of all study participants. As we will explain later, if you agree
to participate in the Study, you do not have to agree to this part of the study.

T3-S1
You might be wondering: “What’s in it for me?”
There may be no direct benefit to you or your family. But the Study could
uncover important new medical knowledge that could benefit all of us in the years
to come—maybe even your children and grandchildren. That’s something we
think you might feel proud to be a part of.
As the Study unfolds, our scientists will learn a lot about children in general, and why
some children are more likely than others to get certain diseases when they grow up.
We might learn things like what causes asthma or what contributes to making children
do well in school. We are also likely to learn about what promotes healthy pregnancies
and how to reduce miscarriages and premature births.
And, as we make these discoveries, we will share them with you.

Father’s Consent Video Script/DRAFT 12/18/07

Appendix B

B.1.5.a–5

T3-S2
We will send out news through newsletters, a Web site, and other means, and we will
publish this information in books and magazines.
T3-S3
In addition, if our research shows something that would be medically important for you
to know about yourself, and if there is something you could do about it, we’ll let you
know, so that you can follow up with your doctor.
T4-S1
The risks of this study are very low. It’s an observational study, which means that
researchers will watch participants over time and do some routine medical exams and
take some samples.
The Study does not include any experimental drugs or medicines.
Even though the risks are low, there are some things that might be a risk or discomfort
to you, if you decide to join the Study.
T4-S2
People sometimes feel brief pain when blood is taken, and there’s a very small risk of
infection, bruising, or bleeding. The professionals who will take your blood are trained
to make you feel comfortable.

T4-S3
Having us come to your home for a visit may be an inconvenience. The visit may
interrupt your daily routine and other people living in your home may also be affected.
To minimize this, we will set up the visit at a time that works for you, and we will be
happy to change the date or time if you need to.

Father’s Consent Video Script/DRAFT 12/18/07

Appendix B

B.1.5.a–6

T4-S4
If we learn that a child is being neglected or abused, then we must report this to the
proper authorities.
T4-S5
As we’ve said, if any of your tests or samples indicate something that is medically
important for you to know about, and that you could do something about, we’ll let
you know. Information like that can be beneficial. But it can also be unsettling.
And, because of the information we’ve shared with you, you might decide to
spend money to undergo additional tests, which might not ultimately reveal a
significant problem.

T5-S1
Giving personal information to anyone always involves some risk. Therefore this Study
will make every effort to protect the identities of all participants.
To protect your personal information, we will:
•

Label your samples and other information with a unique number code, so our labs
will not know whose samples they are testing

•

Separate your number code from your name, address, and other identifying
information

T5-S2
•

Store your test results and other information in a computer database protected by
sophisticated security technology

•

Report only group information, not individually identifiable information

Father’s Consent Video Script/DRAFT 12/18/07

Appendix B

B.1.5.a–7

T5-S3
In addition to taking all these steps to protect your privacy, we have obtained a legal
document, designed to protect the privacy of people who take part in research studies.
The document is called a Certificate of Confidentiality. It will help protect your
information from people who are not part of the Study.

T5-S4
Certificates of Confidentiality help make sure that the Study researchers cannot be
forced to tell anyone who is not connected with the Study—including the courts—about
your participation, or your personal information without your written consent.
We have described the steps we will take to protect your confidentiality. We will do
everything we can to ensure that your personal health information is never revealed to
anyone outside the Study.

T6-S1
We understand that your time is valuable and we appreciate your helping us. The Study
will pay you for your time spent during the home visit and for answering future
questions. Payment for each task will be about $50, depending on the amount of time
and effort involved.
T7-S1
OTHER VOICE
What happens to the samples and information I provide?

Father’s Consent Video Script/DRAFT 12/18/07

Appendix B

B.1.5.a–8

NARRATOR (V/O)
Data and samples will be stored for at least the duration of the Study. Some will be
analyzed right away, but others may not be analyzed until a later time. If you want us
to get rid of any of those stored samples, you may ask us to destroy them

T7-S2
OTHER VOICE
Will it cost me anything to take part in the Study?
NARRATOR (V/O)
No. There is no cost to you—all the tests and procedures related to the Study will be
paid for by the Study. Any future tests done on your samples will also be paid for by the
Study.

T7-S3
OTHER VOICE
Does the Study provide health care for me or my family?
NARRATOR (V/O)
No, the Study is not able to pay for health care. Study procedures are for research
purposes only, and taking part in the Study is not a substitute for your usual visits to the
doctor. The Study also does not affect your health insurance coverage.

T7-S4
OTHER VOICE
Will data from this study be used in other ways?

Father’s Consent Video Script/DRAFT 12/18/07

Appendix B

B.1.5.a–9

NARRATOR (V/O)
Yes. At certain points during the Study we will remove all personal identifiers and
create what is called a public use data set—a set of totally anonymous data that
scientists and researchers can use to study other things. Anyone outside the Study who
uses the public use data will not be able to connect the information to any specific
person.

T7-S5
OTHER VOICE
In addition to the tests the National Children’s Study will do on my samples, would
these samples be used in any other way?
NARRATOR (V/O)
It is possible that scientists could create new medicines or health products based on
stored samples. In agreeing to participate in this study, you are also agreeing to allow
possible future use of your biological materials for these kinds of purposes.
T7-S6
OTHER VOICE
If I take part in this study, will I have to be part of other studies?
NARRATOR (V/O)
No. But you may be invited to be in other studies connected with the National
Children’s Study. If so, we will ask your permission.
T8-S1
Here is some additional information for you to look over.

Father’s Consent Video Script/DRAFT 12/18/07

Appendix B

B.1.5.a–10

C1-S1
Some people feel differently about genetic information than other kinds of information.
So we will be asking you specifically to agree to genetic analysis of your samples.
However, if you do not agree to the genetic aspect of the Study, you can still take part
in the rest of the Study.
Some of the genetic analyses we would like to do may be done right away. Others may
be done in the future as the Study learns more or as new tests and techniques are
developed.
Because results of individual tests can be very difficult to interpret, the National
Children’s Study will not give genetic information about you to you or to anyone else.
In the unlikely case that the Study learns something from this genetic information that
is important to your health or your family’s health, and if there is something you could
do about it, we will tell you that the information is available. In that case, we will give
you the option of learning more about it.
C1-S2
Let’s pause now so that you can ask the Study Representative any questions you may
have.
In addition, before deciding, you may wish to discuss what you have learned about
the fathers’ part of the National Children’s Study with your family, friends, or
your doctor.
If you have more questions about the research or about your rights as a research
participant, contact any of the following.

Father’s Consent Video Script/DRAFT 12/18/07

Appendix B

B.1.5.a–11

C1-S3
Please check one of the boxes below to indicate whether you would like to
volunteer to participate in the fathers’ part of the National Children’s Study:
•

I am ready to participate in the fathers’ part of the National Children’s Study

•

I need more time to think about participation in the Study. I’d like to discuss it
some more in the future.

•

I do not wish to participate in the fathers’ part of the National Children’s Study.

Click Next when you have made your choice.

On the next screen, you will be asked for your signature. If you sign, you are
agreeing to take part in a research study. This means that you have completed this
informational program, and you have decided to volunteer to be in the fathers’ part
of the Study.

C1-S4
If you are ready to volunteer to participate in the fathers’ part of the National
Children’s Study, you may do so now. By signing below, you are indicating the
following:
•

I have completed the informational program about the fathers’ part of the National
Children’s Study.

•

I understand what is involved, and what the risks and benefits are if I join.

•

I understand that I may leave the Study at any time.

•

I have asked and received answers to all my questions about the Study.

•

I understand that I may ask further questions at any time and that I will get a paper
copy of the consent form for my records.

Father’s Consent Video Script/DRAFT 12/18/07

Appendix B

B.1.5.a–12

And, please check one of these two boxes:
•

I also give permission for the National Children’s Study to collect and analyze
genetic information about me.

•

At this time, I do not give permission for the National Children’s Study to collect
and analyze genetic information about me.

I voluntarily agree to participate in the fathers’ part of the National Children’s
Study.

C1- DEFER
Thank you.
We understand that you have not agreed to participate in the fathers’ part of the
National Children’s Study at this time, but that you are still open to learning more about
it in the future.
The Study staff person visiting with you today will talk with you about when we might
contact you again.
If you like, we can leave you some materials to review yourself or with your family.

C1- DECLINE
Thank you for being willing to hear about the National Children’s Study. We’d very
much like to know why you’ve chosen not to participate. Please select any or all of the
choices below.
I’m not interested in participating because:
•

I don’t think my wife or girlfriend will want me to do this

•

I don’t think other family members will want me to do this

•

I don’t want someone visiting me at my home
Father’s Consent Video Script/DRAFT 12/18/07

Appendix B

B.1.5.a–13

•

I don’t want the Study staff to examine me or take samples

•

I just don't feel like it

•

Or for another reason. Please tell the recruiter, who will record your answer

EARLY_EXIT
You clicked the EXIT button—are you sure you want to exit the program?

CLOSING_OPT-IN
Thanks you!
We are very pleased that you’ve agreed to participate in the father’s part of the National
Children’s Study!

CLOSING_OPT-OUT1
Thank you for your time thinking about participation in the National Children’s Study!
We look forward to talking with you again in the future.

CLOSING_OPT-OUT2
Thank you for your time thinking about participation in the National Children’s Study!

Father’s Consent Video Script/DRAFT 12/18/07

Appendix B

B.1.5.b–1
OMB #: ________________
Expiration Date: _________

Visit Information Card for Father Pregnancy Visit
When you gave your permission to be part of the National Children’s Study (NCS), we told you all
about what it means to be in the study. This card tells you more details about what we would like to
do at this study visit.
Interview
We will ask you some questions which should take about 45 minutes. The questions will be about
such things as your home, the people who live with you, your health and any medicines you take,
and about your thoughts and feelings.
Physical Measures
We will do the following:
ƒ

Measure parts of your body including your arm, hip, and waist, and the skin on the back of
your arm and upper back. You will not have to undress for us to do this.

ƒ

Measure your weight, your standing height and your sitting height.

ƒ

Measure your blood pressure.

ƒ

Give you a report to keep which shows your height, weight, body mass index, heart rate, and
blood pressure.

Biological Samples
We also will do the following:
ƒ

Ask you for a sample of your urine.

ƒ

Collect less than 1 ounce of your blood using a small needle. One ounce is approximately
two tablespoons.

ƒ

Collect a small sample of your hair.

ƒ

Ask you to cut or clip your toenails from all toes on both of your feet

Your blood, urine, hair, and nails will be stored and may be tested in the future for a variety of
environmental exposures. These measurements will be done at a later time and you will not receive
the results of these tests.
Questionnaires and Other Forms for You to Complete
We will give you a questionnaire to fill out yourself about diseases and health conditions that you or
your close relatives may have had. We will give you a pre-paid envelope to mail this questionnaire
back to us once you are done filling it out.

T1 Father Visit

Appendix B

B.1.5.b–2
OMB #: ________________
Expiration Date: _________

Visit Information Card for Father Pregnancy Visit
Compensation
After we have completed the interview part of the visit and collected the physical and biological
specimens, we will give you $80 for your time. We also will give you $20 once we have received the
questionnaire from you.
We would like to remind you that being in this Study is voluntary. You can decide to be in the Study
or not. You have the right to not answer any question, or to ask us not to take any sample or
measurement that you do not want us to take. If you decide not to participate, it will not affect any
benefits which you receive now, or may receive in the future.
If you have any further questions about this Study visit, I can try to answer them, or you can call my
supervisor at xxx-xxx-xxxx.

T1 Father Visit

Appendix B

B.1.5.c–1
OMB #: ________________
Expiration Date: _________

Visit Information Card for Father’s Post Birth Visit
When you gave your permission to be part of the National Children’s Study (NCS), we told you all
about what it means to be in the study. This card tells you more details about what we would like to
do at this study visit.
Interview
We will ask you some questions and ask you to do some activities. We will bring some toys with us to
the visit and ask you use them while you play with your child. As you play, we will record you and
your child with a video camera. We also will ask you to do a few activities, such as reading to us and
answering some questions about things you read. These activities will take about a half hour. If you
have not done it already, we also will ask you to complete an activity that includes answering
questions about words or facts you might know, answering riddles, and finding patterns in pictures.
This activity, if we do it, also will take a half hour.
Questionnaires and Other Forms for You to Complete
We also will give you a form to do on your own after we leave. The form has questions on it that ask
about your relationship with your child’s mother, your jobs, the television programs and movies you
watch, your health, your feelings about your child, and how you parent.
We will pick up these forms from you when we return to get the equipment we need to leave here.
Compensation
After we have completed the interview part of the visit we will give you $80 for your time. We also will
give you $20 once we have received the questionnaire we left for you.
We would like to remind you that being in this Study is voluntary. You can decide to be in the Study
or not. You have the right to not answer any question, or to ask us not to take any sample or
measurement that you do not want us to take. If you decide not to participate, it will not affect any
benefits which you receive now, or may receive in the future.
If you have any further questions about this Study visit, I can try to answer them, or you can call my
supervisor at xxx-xxx-xxxx.

12-Month Father Visit

Appendix B

B.1.6.a–1
AUTHORIZATION TO OBTAIN INFORMATION FROM MEDICAL RECORDS
FOR THE NATIONAL CHILDREN’S STUDY
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
THE NATIONAL INSTITUTES OF HEALTH

ULTRASOUND
A.

Provider Name:
Street Address:
City:

State:

Telephone:

(

)

Zip:

-

Area Code

B.

I am voluntarily participating in the National Children’s Study (NCS), a study of the health and development of the nation’s children being
conducted by the National Institutes of Health (NIH) of the U.S. Department of Health and Human Services. I authorize and request that
you provide the NCS and its contractors with medical information they request about the ultrasound examination services provided to me
during my current pregnancy. This authorization form covers any care I received at your facility and from any medical provider associated
with your facility or who provided care to me in your facility.
I understand that the Health Insurance Portability and Accountability Act of 1996 (HIPAA)(1) prohibits you from releasing my information
without my authorization. This form (or a photocopy of this form) gives you my authorization. I have signed this form voluntarily, with the
understanding that my decision to sign or not to sign the form will have no effect on my eligibility for treatment, payment, enrollment, or
eligibility for any benefits to which I am entitled.
I understand that the NIH and its contractors will use this information to supplement the information I have already given for NCS research
on the health and development of the nation’s children. I also understand that once my information is released to the study, it is no longer
covered by HIPAA but is covered by the Public Health Service Act(2), which prohibits the release of information that would identify me or
my medical providers outside the sponsoring agency and its contractors without my permission or that of my medical providers.
I authorize the study to use information I have given in the survey to help you identify my records. I also understand that I can revoke this
authorization at any time by contacting a study representative in writing or by telephone. Otherwise, this authorization expires 30 months
from the date of signature.

C.

1.

Patient Name (first, middle, last):

2.

Date of Birth

/
Month

D.

3. Other Names Under Which Records May be Filed

/
Day

Year

5. Date Signed

4.
Patient’s Signature—14 and over sign

IF PATIENT IS AGE 14 TO 17, BOTH PATIENT AND PARENT/GUARDIAN MUST SIGN AND DATE.

E.

7. Date Signed

6.
Parent, Guardian, Witness or Proxy’s Signature

9. Reason for Parent, Guardian, Witness or Proxy’s Signature:
Patient 13 or Younger
Patient Disabled
Patient 14-17 Years Old
Patient Deceased

8.
Signer’s Relationship to Patient
FIELD USE ONLY: ID:
(1)
(2)

PROVID:

PID:

Health Insurance Portability and Accountability Act: 42 U.S.C. 1320d-2 and 1320d-4 and the implementing regulation, 45 CFR 164.508, require a detailed authorization for your health
care provider to disclose health information from your records for research purposes.
Public Health Service (PHS) Act: 42 U.S.C. 242m(d) protects the confidentiality of data collected under the research authorities of the National Institutes of Health. The National
Children’s Study will be carried out in compliance with these provisions as well as those in the Children’s Health Act of 2000 (Public Law 106-310 Sec. 1004).

Appendix B

B.1.6.b–1

AUTHORIZATION TO OBTAIN BODILY FLUIDS, TISSUES, AND INFORMATION FROM MEDICAL
RECORDS FOR THE NATIONAL CHILDREN’S STUDY
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
THE NATIONAL INSTITUTES OF HEALTH

BIRTH
A.

Provider Name:
Street Address:
City:

State:

Telephone:

(

)

Zip:

-

Area Code

B.

I am voluntarily participating in the National Children’s Study (NCS), a study of the health and development of the nation’s children being
conducted by the National Institutes of Health (NIH) of the U.S. Department of Health and Human Services. I authorize and request that
you provide the NCS and its contractors with medical information they request about the labor and delivery services, and perinatal services,
including treatment, testing, and test results provided to me and my child during and following my current pregnancy. I also authorize the
NCS and its contractors to obtain and/or collect my urine and blood, as well as my child’s blood, umbilical cord, umbilical cord blood,
placenta, and meconium. This authorization form covers any care I or my child received at your facility, and from any medical provider
associated with your facility or who provided care to me or my child in your facility.
I understand that the Health Insurance Portability and Accountability Act of 1996 (HIPAA)(1) prohibits you from releasing my information
without my authorization. This form (or a photocopy of this form) gives you my authorization. I have signed this form voluntarily, with the
understanding that my decision to sign or not to sign the form will have no effect on my eligibility for treatment, payment, enrollment, or
eligibility for any benefits to which I am entitled.
I understand that the NIH and its contractors will use this information to supplement the information I have already given for NCS research
on the health and development of the nation’s children. I also understand that once my information is released to the study, it is no longer
covered by HIPAA but is covered by the Public Health Service Act(2), which prohibits the release of information that would identify me or
my medical providers outside the sponsoring agency and its contractors without my permission or that of my medical providers.
I authorize the study to use information I have given in the survey to help you identify my records. I also understand that I can revoke this
authorization at any time by contacting a study representative in writing or by telephone. Otherwise, this authorization expires 30 months
from the date of signature.

C.

1.

Patient Name (first, middle, last):

2.

Date of Birth

/
Month

D.

3. Other Names Under Which Records May be Filed

/
Day

Year

5. Date Signed

4.
Patient’s Signature—14 and over sign

IF PATIENT IS AGE 14 TO 17, BOTH PATIENT AND PARENT/GUARDIAN MUST SIGN AND DATE.

E.

7. Date Signed

6.
Parent, Guardian, Witness or Proxy’s Signature

9. Reason for Parent, Guardian, Witness or Proxy’s Signature:
Patient 13 or Younger
Patient Disabled
Patient 14-17 Years Old
Patient Deceased

8.
Signer’s Relationship to Patient
FIELD USE ONLY: ID:
(1)
(2)

PROVID:

PID:

Health Insurance Portability and Accountability Act: 42 U.S.C. 1320d-2 and 1320d-4 and the implementing regulation, 45 CFR 164.508, require a detailed authorization for your health
care provider to disclose health information from your records for research purposes.
Public Health Service (PHS) Act: 42 U.S.C. 242m(d) protects the confidentiality of data collected under the research authorities of the National Institutes of Health. The National
Children’s Study will be carried out in compliance with these provisions as well as those in the Children’s Health Act of 2000 (Public Law 106-310 Sec. 1004).

This page is intentionally blank.

Appendix B.2
Materials for Gaining Cooperation

Appendix B

B.2.1–1

Household Advance Letter
Dear Neighbor,
Do you ever wonder what it takes to have a child grow up healthy? What is it about
the way we live that keeps so many children from enjoying healthy lives? Many
children today suffer from asthma, obesity, diabetes, and other health problems.
(LOCAL CENTER) has joined the National Institutes of Health (NIH) to conduct the
largest and most ambitious research study of children’s health ever to be done in the
United States. The study is called the “National Children’s Study,” or NCS. Results
from the study will improve the health and well being of children for many years to
come.
Your community, along with 104 other communities across the United States, has been
selected to take part. Soon, a staff member from (LOCAL CENTER) will be in your
neighborhood to see if you or anyone in your household may be eligible to participate.
We really need your help. Even if there are no children living with you, or if no one is
planning to become pregnant, we still would like to ask an adult in your household a few
questions to see if anyone is eligible for the study. This will take only about 5 minutes. If
anyone in your household is eligible, we will ask to speak with that person to get some
additional information.
We hope you will join us in our effort to improve our children’s health, but your
participation is voluntary. If you decide not to participate, it will not affect any benefits
which you receive now or may receive in the future. The information you give will be
kept private and is protected by law.
If you have any questions about NCS, please call our toll-free number (xxx-xxx-xxxx)
or visit the NCS website at http://www.nationalchildrensstudy.gov.
Thank you in advance for helping us to learn more about the health and wellbeing
of our nation’s children.
Sincerely,

Local investigator
Enclosure: Study Brochure

M

THE NATIONAL

ost children born today
grow up healthy

CHILDREN’S STUDY

and live longer than

ever before. But the rates of
asthma, diabetes, autism, and other
health problems in many children
are on the rise. We still have many
questions about how children’s
environments—the air they breathe,
the water they drink, and the
communities they live in—affect
their health and well being into
adulthood.
With the help of communities and
individuals like you from across the
country, the National Children’s
Study hopes to find the answers to
these questions among many
others, and to use the answers to
improve the health of children for
years to come.
Appendix B

To learn more about the National Children’s
Study (NCS), please contact:
(CONTACT INFORMATION FOR LOCAL SITE)

or visit the NCS website at:
http://www.nationalchildrensstudy.gov
B.2.2–1

What is the National Children’s Study?

How will the Study be conducted?

The National Children’s Study (NCS) is the
largest research study ever conducted in the
United States to look at the effects of the
environment
on
children’s
health
and
development. The Study is authorized by the
Children’s Health Act of 2000, and will collect
information on 100,000 children from before birth
through age 21.

Across the country, selected areas in 105
counties have been scientifically chosen to
represent the United States. Women in these
areas who are pregnant or who may become
pregnant will be eligible for enrollment in the
NCS. All homes in selected neighborhoods will
be visited by local Study staff to identify women
who may be eligible to enroll. Study teams also
will work with doctors, nurses, community
leaders, and local public health workers to help
recruit eligible women.

For the NCS, “environment” includes air, water,
and soil, as well as what children eat, how they
are cared for, the safety of their neighborhoods,
and their health care.
The Study will look at some of the most
important health issues of our time, including:
„
„
„
„
„

Birth defects and other pregnancy-related
problems
Injuries
Asthma
Obesity and diabetes
Behavior, learning, and mental health

What will participants be asked to do?
Even if there are no children living with you, or if
no one is planning to become pregnant, we
would like to ask an adult in your household a
few questions to see if anyone is eligible for the
Study. This short interview should only take
about 5 minutes. Then, each eligible woman will
be asked to answer a few more detailed
screening questions. Depending on the
information that is provided, a small number of
women will be invited to enroll in the Study.

born to women enrolled in the Study, information
also will be collected about the baby.

Why is participation so important?
Everyone’s cooperation will ensure that the NCS
fairly represents all of America’s children.
Participation is voluntary, but we hope that all
women who are invited will consider joining. If
anyone decides not to participate, it will not
affect any benefits to which they may otherwise
be entitled.

Will information be kept confidential?
All information will be kept private and
confidential and used only for research
purposes. NCS has obtained a Certificate of
Confidentiality from the National Institutes of
Health, which helps to protect privacy. The
Privacy Act of 1974 (USC 552a) requires the
safeguarding of individuals against invasion of
privacy.

During the first phase of the Study, participation
will include interviews, collection of samples
such as blood and urine, simple physical
measures such as weight and blood pressure,
and collection of samples from the environment
such as air, water, dust, or soil. No medicines or
treatments will be provided. When babies are

Appendix B

Environmental
factors in
homes,
schools, and
neighborhoods
will be
measured.

B.2.2–2

Appendix B

B.2.3–1

HOUSEHOLD COOPERATION LETTER
Dear Neighbor,
We recently visited your home to talk about the National Children’s Study. This research study is
the largest and most important research study of children’s health ever to be done in the United
States. Communities all across the country have been scientifically selected to be part of this
study. Because of the way the research is designed, we cannot replace your household with
another.
We really need your help. Even if there are no children living with you, or no one is planning to
become pregnant, we still would like to ask an adult in your household a few questions to see if
anyone is eligible for the study. This will take only about 5 minutes.
I have asked one of our study team members to contact your household again soon. We hope
you will consider taking just a few minutes to talk to her. All information you provide will be kept
private and confidential and used for research purposes only. Your participation is voluntary. If
you decide not to participate, it will not affect any benefits you may be receiving.
Thanks in advance for your help with the National Children’s Study. Results from the study will
give us the chance to improve children’s health for many years to come.
Sincerely,
Local Investigator

Appendix B

B.2.4–1

Pregnancy Screener Cooperation Letter
Dear Neighbor,
We recently visited your home to talk about the National Children’s Study. This research study
is the largest and most important study of children’s health ever to be done in the United
States. A carefully designed scientific process has been used to select communities across the
country to be part of this study. Therefore, women living in these communities cannot be
replaced with anyone else.
We really need your help. Even if you do not have any children, or if you are not planning to
have children, we still would like to ask you a few questions for the study. This will take only
about 5 minutes.
I have asked one of our study team members to contact you again soon. We hope you will
consider taking just a few minutes to talk to her. All information you provide will be kept private
and confidential, and used for research purposes only. Your participation is voluntary. If you
decide not to participate, it will not affect any benefits you may receive now or in the future.
Thanks in advance for your help with the National Children’s Study. Results from the study
will give us the chance to improve children’s health for many years to come.
Sincerely,
Local Investigator

Appendix B

B.2.5–1

Appointment Reminder Letter
[VC Name & Address]
[Date]
[Participant Name &
Address]
Dear [PARTICIPANT NAME]:
This is to remind you about your upcoming appointment for the National Children’s
Study. (You/You and your child) are scheduled for an appointment (in your home/at the
[VC NAME]’s clinic:/at the [NAME OF CLINIC, HOSPITAL, DR. OFFICE]) on:
Date:
Time:
Place:
If you have any questions about this appointment, or if you need to reschedule, please
call our office at (VC TELEPHONE NUMBER).
Thanks for being part of the National Children’s Study! We look forward to seeing you
soon.

Sincerely yours,
(VC Signature)