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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.
Due to 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
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B.1.1–2
rates. Screening and enrollment begin in January 2009 for the first group of PSUs in the pilot,
and in April 2009 for the second group 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
•
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 booklet 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
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Appendix B
B.1.1–3
increase comprehension for potential participants who may have difficulty reading a
multi-page consent booklet.
However, the video may also 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 over 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 review the booklet with respondents. (If the respondent
indicates a preference for reading the consent booklet on her own, the interviewer does
not have to review it 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
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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 multi-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.
Upon arrival, the interviewer who conducts the consent process will reintroduce herself, if
necessary, answer any questions the respondent may have and then get verbal consent to
continue 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. In
both conditions, the detailed information about each component of data collection for the visit is
given on the “Visit Information Card” or VIC at the time of the first interview.
General Study Design
The consent study only includes English and Spanish speaking women in their first trimester of
pregnancy as identified in the pregnancy screener. Under the current protocol for the first few
months of the enrollment period, the consent process will either occur at the same visit as the
pregnancy screener or as its own visit. The TI interview component will initiate about 3 months
after enrollment begins, so at that point the consent process may be coupled with the pregnancy
screener, the T1 visit, or occur as its own visit. The evaluation does not include women who are
not pregnant at the time of the screening interview since they complete slightly different consent
materials.
Table 1 shows the estimated number of consent opportunities anticipated by February through
September 2009 in the pilot areas for women identified as in their first trimester in the screening
interview. Analysis will be completed by February 2010, and decisions on the method of
consent for the Main Study will be available in April 2010.
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Appendix B
Table 1:
B.1.1–5
The estimated number of consent opportunities in each condition, cumulating
across months in 2009.
Total Video
Total Booklet
Consent
Consent
February
18
18
March
40
40
April
105
105
May
175
175
June
235
235
July
300
300
August
345
345
September
375
375
Month (in 2009)
Analysis of the consent methods will use all data collected through September in order to
maximize the amount of data available for analysis, about 375 cases in each condition. Table
two 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 90% confidence interval will ultimately be larger when reflecting the impact of
clustering. Thus, the small number of cases will only result in statistically significant differences
if enrollment between the two conditions differs by more than 10%.
Table 2:
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
Condition 1
Condition 2
Difference
July
50%
38.3%
11.7%
August
50%
39.1%
10.9%
September
50%
39.6%
10.4%
Month (in 2009) complete
evaluation
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B.1.1–6
As indicated above, respondents will be randomly assigned to condition, though assignment
occurs at an address level rather than a person level. Thus all women eligible for a T1-first
interview living in the same household will receive the same treatment.
In addition to measuring whether the two consent conditions impact enrollment differentially, the
study will also 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.
Women who complete the consent process and decide to enroll receive a two part evaluation
questionnaire. The first part includes questions that collect feedback on format and presentation
of the consent materials, as well as general attitude information about the study. We refer to this
as the Part 1 Consent questionnaire. Interviewers ask respondents to complete the Part 1
questionnaire at the same visit they complete the consent process. The Part 2 questionnaire
includes a short set of questions to assess comprehension in regards to several critical
components of informed consent (i.e., scientific purpose of the research, voluntary nature, risks
with participating, benefits of participating). Interviewers will ask respondents to complete the
Part 2 questionnaire at the end of the portion of the T1 visit during which the interview occurred.
We separated the evaluation into two components with the intention of delaying the amount of
time between the actual administration of consent and the assessment of comprehension. The
delay should diminish the chance that the women in the video condition respond to the
evaluation questions based on memory of the questions in the video rather than an actual
understanding of the study to which they are providing consent. We take this precaution
because even though the wording of the evaluation questions is not the exact same as the
wording used in the questions embedded within the video, the questions are similar.
The IMS will keep track of the dates on which the respondent completes each questionnaire so
the analysis can account for differences in time between the actual consent visit and when the
respondent completed the questionnaires. The questionnaires contain essentially the same
questions for both the video and booklet conditions, with only slight wording differences
necessary to reflect the appropriate video or booklet mode of administration. (Appendices
A.2.1.g, pages 1-4).
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Appendix B
B.1.1–7
Respondents who decide not to enroll in the study after reviewing at least some portion of the
consent materials will also complete an evaluation questionnaire for their condition, but the
questionnaires for non-enrolled women are shorter, and there is only one part. Rather than
asking details about the consent materials she reviewed, the non-enrolled version includes
questions to assess how much of the consent process she completed, why she chose not to
participate in the study as well as an additional opinion question about the study in general.
Women who enroll in the study also answer the same general opinion question about the study
but not as part of the consent evaluation questionnaires. (Appendices A.2.1.g, pages 5-8).
In general, regardless of the consent condition, all respondents will complete a self-administered
paper questionnaire collecting feedback on their consent process and for those who enroll, their
understanding of the consent information. 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.
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Appendix B
B.1.1–8
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?
(Statistical) comparison of attrition
rates between the two groups at
each of the subsequent data
collection visits prior to the birth
visit.
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?
Do the respondents’ attitudes about the survey topic and
objective provide a mediating influence on any observed
differences in enrollment by method of consent?
Comparisons of ratings for each
characteristic between consent
conditions.
5.
6.
Comparison of the average time to
complete the consent process.
By condition, measure correlation
between enrollment and responses
to attitude questions
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Appendix B
B.1.1–9
The evaluation may also 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/difficulty of implementing the two different consent processes.
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Appendix B
B.1.2.a–1
Video script to follow.
Video Script for General Consent content will be based on the Hard-Copy General
Consent booklet.
Appendix B
B.1.2.b–1
OMB #: 0925-xxxx
Expiration Date: xx/xxxx
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
by chance 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 need both pregnant women, and women who are not pregnant, to volunteer to be part of this
study. Things around you now, like the air you breathe and the water you drink, might
influence the health and development of your children or future children, if you get pregnant.
We are asking you to join thousands of women from across the United States to learn things that
may help many people. This information may help in the future, although it may not help you or
your family, right now.
Joining the study is your choice. You can decide not to join. If you do join, you can leave for
any reason at any time. And you can refuse to answer any question.
Sponsors:
The National Children’s Study is a partnership between local organizations in your community, and
four Federal agencies. The Federal agencies are the Eunice Kennedy Shriver National Institute of
Child Health and Human Development, and the National Institute of Environmental Health Sciences
(both are part of the National Institutes of Health), the U.S. Environmental Protection Agency (EPA),
and the Centers for Disease Control and Prevention (CDC).
Public reporting burden for this collection of information is estimated to average 20 minutes per response in conjunction with the signature
page, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this
burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project
Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-xxxx*). Do not return the completed
form to this address.
Appendix B
B.1.2.b–2
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 will help researchers understand how the social and physical environment
affects children’s health, growth, and development. The study is also interested in how the
environment acts together 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 National Children’s Study is an observational study. Observational studies do not involve asking
you to change what you normally do. We will be collecting information about you, and if you are or
become pregnant, your child and your child’s environment. We will not be asking you or your child to
take any medicines or drugs.
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. The study will learn what things in the social and physical environment
affect whether or not children will develop diseases, both while they are young and also later, when
they become adults. Finally, there are medical conditions in children that weren’t around 30 or 40
years ago, or were not at the levels we see now. These include obesity, diabetes, autism, learning
disabilities, and cardiovascular disease to name just a few. The National Children’s Study will help us
understand why this is happening and what we can do about these conditions and others like infant
morality and injuries.
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.
How long will the National Children’s Study last?
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.
What is involved in being in the National Children’s Study?
If you decide to join the study, we will come to your home to collect information about you, your
health and your environment. We will also contact you from time to time by phone, mail or computer
to ask you a few questions. If it is okay with you, we will ask the child’s father to participate in the
study, too.
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Appendix B
B.1.2.b–3
How will the National Children’s Study collect information?
There are several ways the study will collect information. We will ask you questions and ask you to
complete forms. We will do physical exams and collect biological and environmental samples. We
may also ask you to keep track of certain things, like what you eat. We will ask you to collect some
samples yourself.
What kinds of information will be collected?
If you decide to join the study, we will come to your home to collect information about you, your
health, and your environment. During the visit, we’d also like to examine you to get body
measurements, like height, weight and blood pressure.
We will collect samples from you like blood, hair and saliva, and ask you to collect a sample of your
urine and your vaginal fluid. We will also collect samples from your home like air, dust, and water.
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.
How many visits should I expect?
If you are not pregnant, we will visit you once. We will also contact you from time to time by phone,
mail or computer to ask you a few questions.
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.
And if you are or become pregnant, we will visit you more often. Altogether, there are about 15 visits
spread out over the 21 years of the study. There will be a few visits while you are pregnant, and a visit
when you give birth. There will be a few visits after you give birth, and then, as your child grows
older, there will be one visit about every two years.
Will the study need access to my medical records and my future child’s
medical records?
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 can change your mind
and withdraw your permission at any time. Then, no new information from your medical records will
be collected. However, information that has already been collected may still be studied.
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Appendix B
B.1.2.b–4
What will happen to all this information?
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 to look for patterns or relationships between
environment and health. These patterns will help researchers better understand the causes for many
diseases.
Some tests on your samples will be done right away. If we know the results from tests done during a
visit, we will give them to you during that same visit. But there are other tests that we will conduct that
we cannot interpret right away. And, most of the samples we collect from you will be tested some
time in the future using state-of-the-art technologies. Many of those tests may help us understand
more about science someday, but won’t be able to tell us about people’s health right now. This is why
some test results will not be given to you. But we will always tell you during a visit which results we
will give you and which results we will not.
Samples will be stored for at least the duration of the study, so we can do many other tests. Right
now, we don’t know what all of those future tests might be, because science is always improving and
new tests are always being developed. But we do know that 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 are young and 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.
How will my privacy be protected?
The potential loss of confidentiality is a risk to being in the study. We have taken steps 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.
• Separate your number code from your name and address after your responses are
collected and processed. Researchers will study data with the number code but not
your name and address.
• Store your test results and other electronic information in a computer database
protected by advanced security technology and statistical procedures.
• Store your biologic, environmental and other forms of information in a secure
research facility. Access to this facility will be monitored.
• Require researchers to ask permission to examine highly confidential study
information. Applications will be reviewed by experts to determine if researchers
can protect your data.
• Monitor researchers studying sensitive information to make sure that they are
protecting your data in the way they promised.
• Require researchers using your data to sign affidavits of nondisclosure. This means
that researchers must promise to use the information you provide for scientific
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Appendix B
•
•
B.1.2.b–5
purposes only, and to not give information to anyone else who has not made this
promise.
Require researchers to report only group information, not individually-identifiable
information, from the data you provide.
Review these steps over time to improve the ways in which we protect information
that could be used to identify you.
We have obtained a legal document from the U.S. Department of Health and Human Services (DHHS)
that is 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.
With this Certificate, we cannot be forced, for example by court order or subpoena, to disclose
information that may identify you in any federal, state, or local civil, criminal, administrative,
legislative, or other proceedings. But if there is an audit or evaluation of the study by staff of the
DHHS, it may be necessary to disclose information to those staff. You should understand that a
Certificate of Confidentiality does not prevent you, as provider of permission for yourself to
participate in the Study, from voluntarily releasing information about yourself or your involvement in
this study. So if an insurer, employer, or another party learns about your participation, and obtains
your consent to receive research information, then we may not use the Certificate of Confidentiality to
withhold this information. This means that in addition to our efforts, you and your family must also
actively protect your own privacy.
Also, you should understand that we will take actions necessary under federal or local law, including
reporting to authorities, to prevent serious harm to yourself, your child or others such as in cases of
child abuse or neglect that we find out about or observe. The Certificate of Confidentiality does not
stop the reporting of child abuse or neglect.
Will you be obtaining genetic information about me and my child?
Yes, your genetic information comes from your family history and some samples, like blood. The
study plans to look at DNA, or genes, the basic building blocks of our bodies, because doctors know
that genes affect the health and development of children, and that the social and physical environment
affects how genes work. That is why we hope to study the genes of all people in the study.
Some people have concerns about use of their genetic information. As a result, the National
Children’s Study will take the steps I described earlier to protect all of your information, including
your genetic information.
Also, some people are sensitive about genetic information for cultural or religious reasons. If you
don’t want to be in the genetics part of the study, you should let us know, and you can still be in the
rest of the study.
Sometimes doctors and scientists cannot interpret the meaning of new research results. As a result, the
National Children’s Study will not give genetic results to you.
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Appendix B
B.1.2.b–6
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 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 are young and when they grow up. We
might learn things like what causes asthma or what helps children do well in school. We are also
likely to learn about what promotes healthy pregnancies and how to reduce miscarriages and
premature births. As we make these discoveries, we will share them with you.
We will send out news through newsletters, a web site, and other ways. We will also put this
information in books and magazines.
In addition to general health news, we will also give you some specific information about you. We will
give you reports about some of the information we are collecting, like height, weight and blood
pressure.
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 give you names of
people and 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. The study does not include taking any medicines or drugs. There
are some things that might be a risk or discomfort to you, if you decide to join the study.
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.
The potential loss of confidentiality is a risk to being in the study. We will take many steps to protect
the information you provide that could be used to identify you. We will continue to review these
procedures to improve the ways we protect your data over time.
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.
The home visit is likely to take two to three hours at a time convenient to you. But having us come to
your home may interrupt your daily routine. 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.
If you tell us or we see that a child is being abused or neglected, or we learn that you are a danger to
yourselves or others, then we must report this to the proper authorities.
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Appendix B
B.1.2.b–7
Will I be paid for being in the National Children’s Study?
We understand that your time is valuable and we appreciate your helping us. The study will pay you in
appreciation of your time spent during the home visit when someone from the Study Center comes to
ask you questions and take samples. Payment for visits will be about $25 to $100, depending on the
amount of time and effort involved.
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.
What if I want to leave the National Children’s Study?
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 or any other benefits you
may be receiving. 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, 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.
What if I move?
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.
Will it cost me anything to be in the National Children’s Study?
No. There is no cost to you. All 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.
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 procedures are for research purposes only,
and taking part in the study is not a substitute for your usual visits to the doctor.
Will information from the National Children’s Study be used in other
ways?
Yes. After removing your name and address, we will create a computer file of data collected in the
study. Researchers will use this data file to study other things about children’s health.
7
Revised 9/8/08
Appendix B
B.1.2.b–8
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
biological samples we collect and store for this study. By agreeing to be in this study, you are also
agreeing to allow possible future use of your biological materials for these purposes.
If I take part in the National Children’s Study, will I have to be part of other
studies?
No. However, you may be invited to be in other studies that are connected with the National
Children’s Study. If so, we will ask your permission and you can always say “no thanks.”
Who can I contact if I have further questions?
If you have questions, feel free to ask the Study Representative who has talked to you about being in
the study.
If you have any other questions about your or your child’s rights as a research participant, now or in
the future, you may contact the persons listed on the page we will ask you to sign.
After reading this booklet, we hope you will choose to be in the National
Children’s Study. We will ask you to sign a form that says you decided to be in
the study. If you decide to be in the study, you can leave at any time. You can
decide to answer some questions and not others. And you can decide to
participate in some study collections and not others. Either way, you can still be
in the study. Before you sign the form, you may want to talk with your family,
friends, or your doctor about the National Children’s Study. Thank you for
taking the time to learn about this important study.
8
Revised 9/8/08
Appendix B
B.1.2.b.2
NATIONAL CHILDREN’S STUDY
General Consent for Study Participation
•
I have received information about “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 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.
•
I understand that I may leave the study at any time.
•
I understand that at any time in the study, if there is a question I don’t want to answer or part of
the study I don’t want to do, I don’t have to do it, and I can still be in the study.
•
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 choose to join the National Children’s Study.
National contact:
Participant
Printed Legal Name of Participant: ___________________________________________________________
Signature of Participant: ___________________________________________________________________
Date: _______/________/_______
Parent/Legal Guardian (if participant is a non-emancipated minor)
I have received information about “Making an Informed Choice About Being in the National Children’s Study” which
explains the nature and purpose of the National Children’s Study. I give my permission for _______________________
to take part in the study if she agrees to be part of it.
(name)
Printed Legal Name of Parent/Legal Guardian: _________________________________________________
Signature of Parent/Legal Guardian: __________________________________________________________
Date: _______/________/_______
Witness (if required)
I observed the interviewer explain “Making an Informed Choice About Being in the National Children’s
Study” to the participant and she signed or marked this form.
_______________________________________________
_______/________/_______
Signature of Witness
Date
Printed Name of Person Obtaining Consent: ___________________________________
Signature of Person Obtaining Consent: _________________________________ Date: _______/________/_______
Appendix B
B.1.2.c–1
OMB #: 0925-xxxx
Expiration Date: xx/xxxx
JOINING THE BIOLOGICAL SPECIMEN AND ENVIRONMENTAL
SAMPLE COLLECTION IN
THE NATIONAL CHILDREN’S STUDY
You have agreed to participate in the National Children’s Study. Thank you!
You have joined thousands of women across the United States to help researchers better
understand how the social environment, like your neighborhood, and the physical environment,
like the air you breathe and the water you drink, might influence the health and development of
your children or future children, if you get pregnant.
We are now asking you to participate in the biological specimen and environmental sample
collection part of this study. Biological specimens include things like hair, saliva, blood, and
toenail clippings. Environmental samples include things like dust, air, and water. Biological
samples and environmental samples are extremely important to the kinds of things we can learn
about how the environment may influence children’s health.
Each time we ask you for a specimen or sample, we will tell you up front how much, how it
would be collected, and how we would store and protect it. We will also tell you if there are any
risks from giving the specimen or sample.
You can decide if you want to be part of the biological specimen and environmental sample
collection for the National Children’s Study. You can decide not to be part of this collection and
still be in the rest of the study. You can decide to give some specimens and samples, but not
others. And you can decide if the biological specimens you give can be used for genetic research.
Either way, you can still participate. And, if you do join this part of the study, you can leave for
any reason and at any time.
Public reporting burden for this collection of information is estimated to average 20 minutes per response in conjunction with the signature
page, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this
burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project
Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-xxxx*). Do not return the completed
form to this address.
Appendix B
B.1.2.c–2
Sponsors: The National Children’s Study is a partnership between local organizations in your
community, and four Federal agencies. The Federal agencies are the Eunice Kennedy Shriver
National Institute of Child Health and Human Development, and the National Institute of
Environmental Health Sciences (both are part of the National Institutes of Health), the U.S.
Environmental Protection Agency (EPA), and the Centers for Disease Control and Prevention (CDC).
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 will help researchers understand how the social and physical environment
affects children’s health, growth, and development. The study is also interested in how the
environment acts together with a person’s characteristics, such as their genes, to prevent disease and
promote health.
What kind of study is the National Children’s Study?
The National Children’s Study is an observational study. Observational studies do not involve asking
you to change what you normally do. We will be collecting information about you, and if you are or
become pregnant, your child and your child’s environment. We will not be asking you or your child to
take any medicines or drugs.
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. The study will learn what things in the social and physical environment
affect whether or not children will develop diseases, both while they are young and also later, when
they become adults. Finally, there are medical conditions in children that weren’t around 30 or 40
years ago, or were not at the levels we see now. These include obesity, diabetes, autism, learning
disabilities, and cardiovascular disease to name just a few. The National Children’s Study will help us
understand why this is happening and what we can do about these conditions and others like infant
morality and injuries.
How will the National Children’s Study collect information?
There are several ways the study will collect information. We will ask you questions and ask you to
complete forms. We will do physical exams and collect biological and environmental samples. We
may also ask you to keep track of certain things, like what you eat. We will ask you to collect some
samples yourself.
What kinds of information will be collected?
If you decide to join the study, we will come to your home to collect information about you, your
health, and your environment. During the visit, we’d also like to examine you to get body
measurements, like height, weight and blood pressure.
2
Revised 9/8/08
Appendix B
B.1.2.c–3
Over the course of the study, we will ask to collect biological specimens from you. The kind and
amount of these biological specimens will depend on when we contact you. But we will always
explain exactly which specimens we would like to collect, how much, and how we would like to
collect them. For example, if we ask to collect your blood, our specially-trained study center
employees will use a needle from a vein in your arm, and collect about 3-4 tablespoonfuls. A trained
employee may also ask to cut a small sample of hair (about 20 strands) from the back of your head.
We may ask you to collect some specimens yourself. For example, we may ask you to collect your
urine in a cup (about 3 tablespoonfuls), and to collect three vaginal swab samples. We may also ask
you to use a straw to collect about ½ teaspoon of saliva 3 times a day for 2 days. You may also be
asked to clip your toenails and provide us the clippings. We expect to analyze your specimens in the
future for hormones, nutrients, pesticides and other chemicals, heavy metals, and genetic material,
among others, but not all measurements will be made on all specimens.
We will also ask to collect environmental samples from your home, like air, dust, and water, over the
course of the study. The kind and amount of these samples will depend on when we contact you, too.
Just like with your personal biological specimens, we will always explain exactly which samples we
would like to collect, how much, and how we would like to do it. For example, if we ask to collect
dust from your home, our specially-trained study center employees will use a vacuum and several
wipes. We may also ask to collect drinking water. Sometimes, we may ask you to collect air or dust
samples using simple kits, and to keep a diary for a week. We expect to analyze your environmental
samples in the future for metals, pesticides and other chemicals, and substances that may cause
allergies, but not all measurements will be made on all samples.
If you are or become pregnant, we will ask you questions about your pregnancy. We may also ask for
a copy of your baby’s ultrasound, if you have one. We will ask to schedule ultrasounds for you from
time to time during your pregnancy, and we will pay for them. Each time, we will give you a copy of
your baby’s ultrasound picture.
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.
What will happen to all this information?
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 to look for patterns or relationships between
environment and health. These patterns will help researchers better understand the causes for many
diseases.
Some tests on your samples will be done right away. If we know the results from tests done during a
visit, we will give them to you during that same visit. But there are other tests that we will conduct that
we cannot interpret right away. And, most of the samples we collect from you will be tested some time
in the future using state-of-the-art technologies. Many of those tests may help us understand more
about science someday, but won’t be able to tell us about people’s health right now. This is why some
test results will not be given to you. But we will always tell you during a visit which results we will
give you and which results we will not.
3
Revised 9/8/08
Appendix B
B.1.2.c–4
Samples will be stored for at least the duration of the study, so we can do many other tests. Right
now, we don’t know what all of those future tests might be, because science is always improving and
new tests are always being developed. But we do know that before any new kinds of tests are done on
your specimens and 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 are young and when they grow up. If
you decide to join this part of the study and agree to give us specimens and samples, you will be
allowing us to test those specimens and samples both now and in the years ahead.
How will my privacy be protected?
The potential loss of confidentiality is a risk to being in the study. We have taken steps 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.
• Separate your number code from your name and address after your responses are
collected and processed. Researchers will study data with the number code but not
your name and address.
• Store your test results and other electronic information in a computer database
protected by advanced security technology and statistical procedures.
• Store your biologic, environmental and other forms of information in a secure
research facility. Access to this facility will be monitored.
• Require researchers to ask permission to examine highly confidential study
information. Applications will be reviewed by experts to determine if researchers
can protect your data.
• Monitor researchers studying sensitive information to make sure that they are
protecting your data in the way they promised.
• Require researchers using your data to sign affidavits of nondisclosure. This means
that researchers must promise to use the information you provide for scientific
purposes only, and to not give information to anyone else who has not made this
promise.
• Require researchers to report only group information, not individually-identifiable
information, from the data you provide.
• Review these steps over time to improve the ways in which we protect information
that could be used to identify you.
We have obtained a legal document from the U.S. Department of Health and Human Services (DHHS)
that is 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.
With this Certificate, we cannot be forced, for example by court order or subpoena, to disclose
information that may identify you in any Federal, state, or local civil, criminal, administrative,
legislative, or other proceedings. But if there is an audit or evaluation of the study by staff of the
DHHS, it may be necessary to disclose information to those staff. You should understand that a
4
Revised 9/8/08
Appendix B
B.1.2.c–5
Certificate of Confidentiality does not prevent you, as provider of permission for yourself to
participate in the Study, from voluntarily releasing information about yourself or your involvement in
this study. So if an insurer, employer, or another party learns about your participation, and obtains
your consent to receive research information, then we may not use the Certificate of Confidentiality to
withhold this information. This means that in addition to our efforts, you and your family must also
actively protect your own privacy.
Also, you should understand that we will take actions necessary under federal or local law, including
reporting to authorities, to prevent serious harm to yourself, your child or others such as in cases of
child abuse or neglect that we find out about or observe. The Certificate of Confidentiality does not
stop the reporting of child abuse or neglect.
Will you be obtaining genetic information about me and my child?
Yes, your genetic information comes from your family history and some samples, like blood. The
study plans to look at DNA, or genes, the basic building blocks of our bodies, because doctors know
that genes affect the health and development of children, and that the social and physical environment
affects how genes work. That is why we hope to study the genes of all people in the study.
Some people have concerns about use of their genetic information. As a result, the National
Children’s Study will take the steps I described earlier to protect all of your information, including
your genetic information.
Also, some people are sensitive about genetic information for cultural or religious reasons. If you
don’t want to be in the genetics part of the study, you should let us know, and you can still be in the
rest of the study.
Sometimes doctors and scientists cannot interpret the meaning of new research results. As a result, the
National Children’s Study will not give genetic results to you.
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 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 are young and when they grow up. We
might learn things like what causes asthma or what helps children do well in school. We are also
likely to learn about what promotes healthy pregnancies and how to reduce miscarriages and
premature births. As we make these discoveries, we will share them with you.
We will send out news through newsletters, a web site, and other ways. We will also put this
information in books and magazines.
5
Revised 9/8/08
Appendix B
B.1.2.c–6
In addition to general health news, we will also give you some specific information about you. We will
give you reports about some of the information we are collecting, like height, weight and blood
pressure.
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 give you names of
people and 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. The study does not include taking any medicines or drugs. There
are some things that might be a risk or discomfort to you, if you decide to join the study.
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.
The potential loss of confidentiality is a risk to being in the study. We will take many steps to protect
the information you provide that could be used to identify you. We will continue to review these
procedures to improve the ways we protect your data over time.
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.
The home visit is likely to take two to three hours at a time convenient to you. But having us come to
your home may interrupt your daily routine. 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.
If you tell us or we see that a child is being abused or neglected, or we learn that you are a danger to
yourselves or others, then we must report this to the proper authorities.
What if I want to leave the National Children’s Study?
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 or any other benefits you
may be receiving. 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, 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.
6
Revised 9/8/08
Appendix B
B.1.2.c–7
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
biological samples we collect and store for this study. By agreeing to be in this study, you are also
agreeing to allow possible future use of your biological materials for these purposes.
Who can I contact if I have further questions?
If you have questions, feel free to ask the Study Representative who has talked to you about being in
the study.
If you have any other questions about your or your child’s rights as a research participant, now or in
the future, you may contact the persons listed on the page we will ask you to sign.
After reading this booklet, we hope you will choose to be part of the biological
specimen and environmental sample collection for the National Children’s Study.
We will ask you to sign a form that says you decided to be part of this collection
for the study. You can decide to give some specimens and samples and not others.
If you choose to be part of this collection, you can change your mind later and
leave at any time. Either way, you can still be in the study. Before you sign the
form, you may want to talk with your family, friends, or your doctor about the
National Children’s Study. Thank you for taking the time to learn about this
important study.
7
Revised 9/8/08
Appendix B
B.1.2.c.2
NATIONAL CHILDREN’S STUDY
Biological Specimen and Environmental Sample Collection
Consent Signature Form
•
I have received information about “Joining the Biological Specimen and Environmental Sample Collection
in the National Children’s Study.”
•
I understand what is involved, and what the risks and benefits are, if I join this part of the study.
•
I understand that my biological specimens and environmental samples will be stored in a secure research
facility, and that NCS will protect access to my specimens and samples.
•
I understand that test results from my specimens and samples will not be given to me.
•
I understand that at any time in the study, if there is a question I don’t want to answer, a biological
specimen or an environmental sample I don’t want to give, or part of the study I don’t want to do, I don’t
have to do it, and I can still be in the study.
•
I understand that my biological specimens may be used for a variety of future tests, including chemical,
genetic and nutritional tests. I agree to allow my biological specimens to be used for future NCS tests.
•
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 receive a copy of this consent form
for my records.
I choose to join the biological specimen and environmental sample collection of the National Children’s
Study.
At this time, I do NOT want genetic information to be collected from my biological specimens. I understand
that I can still be in the study and other types of tests will be performed on my biological specimens.
National contact:
Participant
Printed Legal Name of Participant: ___________________________________________________________
Signature of Participant: ___________________________________________________ Date: _______/________/_______
Parent/Legal Guardian (if participant is a non-emancipated minor)
I have received information about “Making an Informed Choice About Being in the National Children’s Study” which
explains the nature and purpose of the National Children’s Study. I give my permission for _______________________ to
take part in the study if she agrees to be part of it.
(name)
Printed Legal Name of Parent/Legal Guardian: _________________________________________________
Signature of Parent/Legal Guardian: ___________________________________ Date: _______/________/_______
Witness (if required)
I observed the interviewer explain “Making and Informed Choice About being in the National Children’s Study” to the
participant and she signed or marked this form.
_______________________________________________
_______/________/_______
Signature of Witness
Date
Printed Name of Person Obtaining Consent: ___________________________________
Signature of Person Obtaining Consent: _________________________________ Date: _______/________/_______
Revised 9/8/08
Appendix B
B.1.2.d–1
OMB #: 0925-xxxx
Expiration Date: xx/xxxx
National Children’s Study
Visit Information Sheet
Pre-Pregnancy Visit
Thank you for agreeing to participate in the National Children’s Study, we told you what it means to
be in the study. The last time we visited with you, we described what the study was about in general.
Today, we’d like to tell you more about the kinds of information that we will ask to collect from you
during this particular visit.
Being in this study is your choice. You can skip any question you don’t want to answer. If there is a
part of the study you don’t want to do, you can skip that, too. Either way, you can still be part of the
study if you want to.
And you can decide to be in the study or not at any time. If you leave the study, you can rejoin it
later. If you decide later that you do not want us to keep your information, you can tell us and we will
destroy data we have not yet begun to study. You can also tell us if you don’t want your samples to be
used for genetic, chemical or nutritional tests. But we will not be able to destroy data already given to
researchers or cancel tests already performed.
We also would like to remind you that if you tell us, or if we see, that a child is being abused or
neglected, or if we learn from our visit that you are a danger to yourself or others, then we must
report this to the proper authorities.
Interview
We would like to ask you some questions about such things as your home, the people who live with
you, your jobs, your activities, your health, and any medicines you take. The interview should take
about half an hour.
You might feel uncomfortable about some of the questions we ask. If so, you can skip those questions.
You can decide which questions to answer. However, we 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.
Questionnaires and Other Forms for You to Complete
We will give you two questionnaires to complete on your own after we leave. These forms ask
questions about what you eat.
At the end of the visit, we also will ask for your thoughts about all of the things we did at this visit.
We will pick up these items from you or, if you prefer, we will give you instructions and provide
materials for you to return them by mail.
Biological Specimens
At this visit, we would like you to:
Collect a sample of your urine in a cup we provide (about 3 tablespoonfuls).
Collect three vaginal swabs using swabs we provide. You would do this yourself in
complete privacy using a specially designed kit.
Your urine may be tested for a variety of environmental exposures. The vaginal swabs may be tested
for measures of infection and inflammation. These tests will be done in the future using state-of-theart technologies. Many of the tests may help us understand more about science someday, but won’t
Public reporting burden for this collection of information is estimated to average 10 minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of
information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless
it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection
of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974,
Bethesda, MD 20892-7974, ATTN: PRA (0925-xxxx*). Do not return the completed form to this address.
Appendix B
B.1.2.d–2
be able to tell us about people’s health right now. This is why the results we collect will not be given to
you. Taking part in the study is not a substitute for your usual visits to the doctor.
We also would like to:
Cut a small sample of your hair (about 20 strands) from the back of your head.
Collect about 3 tablespoons of your blood by using a small needle.
We are medical professionals specially trained to do this safely. We are also trained to make you feel
comfortable when we take your blood, but people sometimes feel brief pain when blood is taken, and
there is a very small risk of infection, bruising, or bleeding.
Your blood may be tested for a variety of environmental exposures, hormones, nutrients, and
measures of infection and inflammation. These tests will be done in the future using state-of-the-art
technologies. Many of the tests may help us understand more about science someday, but won’t be
able to tell us about people’s health right now. This is why the results we collect will not be given to
you. Taking part in the study is not a substitute for your usual visits to the doctor.
Physical Measures
We would like to:
Measure your arm and the skin on the back of your arm and upper back.
Measure your weight.
Measure your blood pressure.
We will give you your weight and blood pressure during this visit. But we will not give you medical
advice. Taking part in the study is not a substitute for your usual visits to the doctor.
Environmental Samples
We would like to:
Look at the physical environment inside and outside your home. You can walk with us
while we do this. We will not enter any rooms inside your home or spaces outside of your
home that do you do not want us to enter.
Collect dust from the floor of your home. The dust will be tested in the future for
pesticides. We will collect the dust from the rooms where you spend the most time. We
will not enter any rooms inside your home that do you do not want us to enter.
Set up an air monitor in the room where you spend the most time. The monitor collects
air that will be tested for particles and airborne chemicals found in household
environments. The monitor measures what is in the air and does not release anything into
the air. Because your activities may change from day to day, we will monitor the air for
about 7 days. We will work with you to find an appropriate place for the air monitor. The
air monitor is very stable. However, if you have safety concerns, we can provide a baby
gate to enclose the air monitor. We will return in about a week to pick the monitor up.
We will give you a brochure that can help answer any questions you may have about the
air monitor.
Just as with biospecimen tests, we will not give environmental test results to you. These tests will be
done in the future using state-of-the-art technologies. Many of the tests may help us understand more
about science someday, but won’t be able to tell us about people’s health right now. This is why the
results we collect will not be given to you. Taking part in this study is not a substitute for any other
environmental testing of your home.
Thank you
To thank you for your time spent completing this visit, we will give you $100 in appreciation of your
time.
If you have any questions about this study visit, I can try to answer them, or I will provide you with
contact information for you to call the local office.
2
Revised 9/8/08
Appendix B
B.1.2.e–1
T1 Visit Information Sheet
The Visit-specific Visit Information Sheet is pending.
It will follow the format of the exemplar document of B.1.2.d.
Appendix B
B.1.2.f–1
T2 Visit Information Sheet
The Visit-specific Visit Information Sheet is pending.
It will follow the format of the exemplar document of B.1.2.d.
Appendix B
B.1.2.g–1
T3 Visit Information Sheet
The Visit-specific Visit Information Sheet is pending.
It will follow the format of the exemplar document of B.1.2.d.
Appendix B
B.1.2.h–1
Birth Visit Information Sheet
The Visit-specific Visit Information Sheet is pending.
It will follow the format of the exemplar document of B.1.2.d.
Appendix B
B.1.2.i–1
6-Month Visit Information Sheet
The Visit-specific Visit Information Sheet is pending.
It will follow the format of the exemplar document of B.1.2.d.
Appendix B
B.1.2.j–1
12-Month Visit Information Sheet
The Visit-specific Visit Information Sheet is pending.
It will follow the format of the exemplar document of B.1.2.d.
Appendix B
B.1.3.a–1
Video script to follow.
Video Script for General Consent content will be the same as the hard-copy General
Consent booklet.
Appendix B
B.1.3.b–1
OMB #: 0925-xxxx
Expiration Date: xx/xxxx
MAKING AN INFORMED CHOICE ABOUT BEING IN
THE NATIONAL CHILDREN’S STUDY
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.
Fathers play an important part in the lives their children. That’s why we’re hoping you will
agree to join the study, too. We are asking you to join thousands of fathers from across the
United States to learn things that may help many people. This information may help in the
future, although it may not help you or your family, right now.
Joining the study is your choice. You can decide not to join. If you do join, you can leave for
any reason at any time. And you can refuse to answer any question.
Sponsors:
The National Children’s Study is a partnership between local organizations in your community, and
four Federal agencies. The Federal agencies are the Eunice Kennedy Shriver National Institute of
Child Health and Human Development, and the National Institute of Environmental Health Sciences
(both are part of the National Institutes of Health), the U.S. Environmental Protection Agency (EPA),
and the Centers for Disease Control and Prevention (CDC).
Public reporting burden for this collection of information is estimated to average 20 minutes per response in conjunction with the signature
page, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this
burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project
Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-xxxx*). Do not return the completed
form to this address.
Appendix B
B.1.3.b–2
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 our
nation’s children. The study will help researchers understand how the social and physical environment
affects children’s health, growth, and development. The study is also interested in how the
environment acts together 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 National Children’s Study is an observational study. Observational studies do not involve asking
you to change what you normally do. We will be collecting information about you and your child, and
your child’s environment. We will not be asking you or your child to take any medicines or drugs.
We want to involve both parents of each child because we know that parents are important to the
health of their children.
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. The study will learn what things in the social and physical environment
affect whether or not children will develop diseases, both while they are young and also later, when
they become adults. Finally, there are medical conditions in children that weren’t around 30 or 40
years ago, or were not at the levels we see now. These include obesity, diabetes, autism, learning
disabilities, and cardiovascular disease to name just a few. The National Children’s Study will help us
understand why this is happening and what we can do about these conditions and others like infant
morality and injuries.
How many people will be in the National Children’s Study?
The study will include about 100,000 mothers, fathers, and their babies from all over the United
States.
How long will the National Children’s Study last?
The National Children’s Study will be studying women before and during pregnancy, fathers, and
children from the time they are born until they are 21 years old.
What is involved in being in the National Children’s Study?
If you decide to join the study, we will come to your home to collect information about you, your
health and your environment. We will also contact you from time to time by phone, mail or computer
to ask you a few questions.
2
Revised 9/8/08
Appendix B
B.1.3.b–3
How will the National Children’s Study collect information?
There are several ways the study will collect information. We will ask you questions and ask you to
complete forms. We will do physical exams and collect biological specimens. We will ask you to
collect some samples yourself.
What kinds of information will be collected?
If you decide to join the study, we will come to your home to collect information about you and your
health. During the visit, we’d also like to examine you to get body measurements, like height, weight
and blood pressure.
We will collect samples from you like blood, hair and saliva, and ask you to collect a sample of your
urine.
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.
How many visits should I expect?
There will be one home visit during the pregnancy, and we may ask to visit you at home again later.
In addition, 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.
What will happen to all this information?
The information you give us will be stored with information from all the other fathers in the study.
Doctors and researchers will use all this information to look for patterns or relationships between
environment and health. These patterns will help researchers better understand the causes for many
diseases.
Some tests on your samples will be done right away. If we know the results from tests done during a
visit, we will give them to you during that same visit. But there are other tests that we will conduct that
we cannot interpret right away. And, most of the samples we collect from you will be tested some time
in the future using state-of-the-art technologies. Many of those tests may help us understand more
about science someday, but won’t be able to tell us about people’s health right now. This is why some
test results will not be given to you. But we will always tell you during a visit which results we will
give you and which results we will not.
Samples will be stored for at least the duration of the study, so we can do many other tests. Right
now, we don’t know what all of those future tests might be, because science is always improving and
new tests are always being developed. But we do know that 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 are young and when they grow up. If you decide to
3
Revised 9/8/08
Appendix B
B.1.3.b–4
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.
How will my privacy be protected?
The potential loss of confidentiality is a risk to being in the study. We have taken steps 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.
• Separate your number code from your name and address after your responses are
collected and processed. Researchers will study data with the number code but not
your name and address.
• Store your test results and other electronic information in a computer database
protected by advanced security technology and statistical procedures.
• Store your biologic, environmental and other forms of information in a secure
research facility. Access to this facility will be monitored.
• Require researchers to ask permission to examine highly confidential study
information. Applications will be reviewed by experts to determine if researchers
can protect your data.
• Monitor researchers studying sensitive information to make sure that they are
protecting your data in the way they promised.
• Require researchers using your data to sign affidavits of nondisclosure. This means
that researchers must promise to use the information you provide for scientific
purposes only, and to not give information to anyone else who has not made this
promise.
• Require researchers to report only group information, not individually-identifiable
information, from the data you provide.
• Review these steps over time to improve the ways in which we protect information
that could be used to identify you.
We have obtained a legal document from the U.S. Department of Health and Human Services (DHHS)
that is 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.
With this Certificate, we cannot be forced, for example by court order or subpoena, to disclose
information that may identify you in any federal, state, or local civil, criminal, administrative,
legislative, or other proceedings. But if there is an audit or evaluation of the study by staff of the
DHHS, it may be necessary to disclose information to those staff. You should understand that a
Certificate of Confidentiality does not prevent you, as provider of permission for yourself to
participate in the Study, from voluntarily releasing information about yourself or your involvement in
this study. So if an insurer, employer, or another party learns about your participation, and obtains
your consent to receive research information, then we may not use the Certificate of Confidentiality to
withhold this information. This means that in addition to our efforts, you and your family must also
actively protect your own privacy.
4
Revised 9/8/08
Appendix B
B.1.3.b–5
Also, you should understand that we will take actions necessary under federal or local law, including
reporting to authorities, to prevent serious harm to yourself, your child or others such as in cases of
child abuse or neglect that we find out about or observe. The Certificate of Confidentiality does not
stop the reporting of child abuse or neglect.
Will you be obtaining genetic information about me?
Yes, your genetic information comes from your family history and some samples, like blood. The
study plans to look at DNA, or genes, the basic building blocks of our bodies, because doctors know
that genes affect the health and development of children, and that the social and physical environment
affects how genes work. That is why we hope to study the genes of all people in the study.
Some people have concerns about use of their genetic information. As a result, the National
Children’s Study will take the steps I described earlier to protect all of your information, including
your genetic information.
Also, some people are sensitive about genetic information for cultural or religious reasons. If you
don’t want to be in the genetics part of the study, you should let us know, and you can still be in the
rest of the study.
Sometimes doctors and scientists cannot interpret the meaning of new research results. As a result, the
National Children’s Study will not give genetic results to you.
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 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 are young and when they grow up. We
might learn things like what causes asthma or what helps children do well in school. We are also
likely to learn about what promotes healthy pregnancies and how to reduce miscarriages and
premature births. As we make these discoveries, we will share them with you.
We will send out news through newsletters, a web site, and other ways. We will also put this
information in books and magazines.
In addition to general health news, we will also give you some specific information about you. We will
give you reports about some of the information we are collecting, like height, weight and blood
pressure.
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 give you names of
people and agencies that can help you.
5
Revised 9/8/08
Appendix B
B.1.3.b–6
What are the possible risks or burdens to me from being in the National
Children’s Study?
The risks of this study are very low. The study does not include taking any medicines or drugs. There
are some things that might be a risk or discomfort to you, if you decide to join the study.
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.
The potential loss of confidentiality is a risk to being in the study. We will take many steps to protect
the information you provide that could be used to identify you. We will continue to review these
procedures to improve the ways we protect your data over time.
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.
The home visit will be scheduled for a time convenient to you. But having us come to your home may
interrupt your daily routine. 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.
If you tell us or we see that a child is being abused or neglected, or we learn that you 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 understand that your time is valuable, and we appreciate your helping us. The Study will pay you
in appreciation of your time spent in study-related activities, like a home visit, and for answering
questions. Payment for each task will be about $25 to $100, depending on the amount of time and
effort involved.
What if I want to leave the National Children’s Study?
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 or any other benefits you
may be receiving. 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, 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.
Will it cost me anything to be in the National Children’s Study?
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.
Does the National Children’s Study pay for health care for me or my family?
6
Revised 9/8/08
Appendix B
B.1.3.b–7
No. The study is not able to pay for health care. Study procedures are for research purposes only, and
taking part in the study does not take the place of your usual visits to the doctor.
Will information from the National Children’s Study be used in other ways?
Yes. After removing your name and address, we will create a computer file of data collected in the
study. Researchers will use this data file to study other things about children’s health.
In addition to the tests the National Children’s Study will do on my samples, will
my samples be used in any other way?
It is possible that scientists could create new medicines or health products in the future based on
biological samples we collect and store for this study. By agreeing to be in this study, you are also
agreeing to allow possible future use of your biological materials for these purposes.
If I take part in the National Children’s Study, will I have to be part of other
studies?
No. However, you may be invited to be in other studies that are connected with the National
Children’s Study. If so, we will ask your permission and you can always say “no thanks.”
Who can I contact if I have further questions?
If you have questions, feel free to ask the Study Representative who has talked to you about being in
the study.
If you have any other questions about your or your child’s rights as a research participant, now or in
the future, you may contact the persons listed on the page we will ask you to sign.
After reading this booklet, we hope you will choose to be in the National
Children’s Study. We will ask you to sign a form that says you decided to be in
the study. If you decide to be in the study, you can leave at any time. You can
decide to answer some questions and not others. And you can decide to
participate in some study collections and not others. Either way, you can still be
in the study. Before you sign the form, you may want to talk with your family,
friends, or your doctor about the National Children’s Study. Thank you for
taking the time to learn about this important study.
7
Revised 9/8/08
Appendix B
B.1.3.b.2
NATIONAL CHILDREN’S STUDY
General Consent for Study Participation
•
I have received information about “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 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.
•
I understand that I may leave the study at any time.
•
I understand that at any time in the study, if there is a question I don’t want to answer or part of
the study I don’t want to do, I don’t have to do it, and I can still be in the study.
•
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 choose to join the National Children’s Study.
National contact:
Participant
Printed Legal Name of Participant: ___________________________________________________________
Signature of Participant: ___________________________________________________________________
Date: _______/________/_______
Parent/Legal Guardian (if participant is a non-emancipated minor)
I have received information about “Making an Informed Choice About Being in the National Children’s Study” which
explains the nature and purpose of the National Children’s Study. I give my permission for _______________________
to take part in the study if he agrees to be part of it.
(name)
Printed Legal Name of Parent/Legal Guardian: _________________________________________________
Signature of Parent/Legal Guardian: __________________________________________________________
Date: _______/________/_______
Witness (if required)
I observed the interviewer explain “Making an Informed Choice About Being in the National Children’s
Study” to the participant and he signed or marked this form.
_______________________________________________
_______/________/_______
Signature of Witness
Date
Printed Name of Person Obtaining Consent: ___________________________________
Signature of Person Obtaining Consent: _________________________________ Date: _______/________/_______
Revised 9/8/08
Appendix B
B.1.3.c–1
OMB #: 0925-xxxx
Expiration Date: xx/xxxx
JOINING THE BIOLOGICAL SPECIMEN COLLECTION IN
THE NATIONAL CHILDREN’S STUDY
You have agreed to participate in the National Children’s Study. Thank you!
You have joined thousands of fathers across the United States to help researchers better
understand how the social environment, like your neighborhood, and the physical environment,
like the air you breathe and the water you drink, might influence the health and development of
your children.
We are now asking you to participate in the biological specimen collection part of this study.
Biological specimens include things like hair, saliva, blood, and toenail clippings. Biological
samples are extremely important to the kinds of things we can learn about how the environment
may influence children’s health.
Each time we ask you for a specimen, we will tell you up front how much, how it would be
collected, and how we would store and protect it. We will also tell you if there are any risks from
giving the specimen.
You can decide if you want to be part of the biological specimen collection for the National
Children’s Study. You can decide not to be part of this collection and still be in the rest of the
study. You can decide to give some specimens, but not others. And you can decide if the
biological specimens you give can be used for genetic research. Either way, you can still
participate. And, if you do join this part of the study, you can leave for any reason and at any
time.
Sponsors: The National Children’s Study is a partnership between local organizations in your
community, and four Federal agencies. The Federal agencies are the Eunice Kennedy Shriver
National Institute of Child Health and Human Development, and the National Institute of
Public reporting burden for this collection of information is estimated to average 20 minutes per response in conjunction with the signature
page, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this
burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project
Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-xxxx*). Do not return the completed
form to this address.
Appendix B
B.1.3.c–2
Environmental Health Sciences (both are part of the National Institutes of Health), the U.S.
Environmental Protection Agency (EPA), and the Centers for Disease Control and Prevention (CDC).
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 will help researchers understand how the social and physical environment
affects children’s health, growth, and development. The study is also interested in how the
environment acts together with a person’s characteristics, such as their genes, to prevent disease and
promote health.
What kind of study is the National Children’s Study?
The National Children’s Study is an observational study. Observational studies do not involve asking
you to change what you normally do. We will be collecting information about you, your child and
your child’s environment. We will not be asking you or your child to take any medicines or drugs.
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. The study will learn what things in the social and physical environment
affect whether or not children will develop diseases, both while they are young and also later, when
they become adults. Finally, there are medical conditions in children that weren’t around 30 or 40
years ago, or were not at the levels we see now. These include obesity, diabetes, autism, learning
disabilities, and cardiovascular disease to name just a few. The National Children’s Study will help us
understand why this is happening and what we can do about these conditions and others like infant
morality and injuries.
How will the National Children’s Study collect information?
There are several ways the study will collect information. We will ask you questions and ask you to
complete forms. We will do physical exams and collect biological specimens. We may also ask you to
keep track of certain things, like what you eat. We will ask you to collect some samples yourself.
What kinds of information will be collected?
If you decide to join the study, we will come to your home to collect information about you, your
health, and your environment. During the visit, we’d also like to examine you to get body
measurements, like height, weight and blood pressure.
Over the course of the study, we will ask to collect biological specimens from you. The kind and
amount of these biological specimens will depend on when we contact you. But we will always
explain exactly which specimens we would like to collect, how much, and how we would like to
collect them. For example, if we ask to collect your blood, our specially-trained study center
employees will use a needle from a vein in your arm, and collect about 3-4 tablespoonfuls. A trained
employee may also ask to cut a small sample of hair (about 20 strands) from the back of your head.
2
Revised 9/8/08
Appendix B
B.1.3.c–3
We may ask you to collect some specimens yourself. For example, we may ask you to collect your
urine in a cup (about 3 tablespoonfuls). We may also ask you to use a straw to collect about ½
teaspoon of saliva 3 times a day for 2 days. You may also be asked to clip your toenails and provide us
the clippings. We expect to analyze your specimens in the future for hormones, nutrients, pesticides
and other chemicals, heavy metals, and genetic material, among others, but not all measurements will
be made on all specimens.
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.
What will happen to all this information?
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 to look for patterns or relationships between
environment and health. These patterns will help researchers better understand the causes for many
diseases.
Some tests on your samples will be done right away. If we know the results from tests done during a
visit, we will give them to you during that same visit. But there are other tests that we will conduct that
we cannot interpret right away. And, most of the samples we collect from you will be tested some time
in the future using state-of-the-art technologies. Many of those tests may help us understand more
about science someday, but won’t be able to tell us about people’s health right now. This is why some
test results will not be given to you. But we will always tell you during a visit which results we will
give you and which results we will not.
Samples will be stored for at least the duration of the study, so we can do many other tests. Right
now, we don’t know what all of those future tests might be, because science is always improving and
new tests are always being developed. But we do know that before any new kinds of tests are done on
your specimens, 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 are young and when they grow up. If you decide to
join this part of the study and agree to give us specimens, you will be allowing us to test those
specimens both now and in the years ahead.
How will my privacy be protected?
The potential loss of confidentiality is a risk to being in the study. We have taken steps 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.
• Separate your number code from your name and address after your responses are
collected and processed. Researchers will study data with the number code but not
your name and address.
3
Revised 9/8/08
Appendix B
•
•
•
•
•
•
•
B.1.3.c–4
Store your test results and other electronic information in a computer database
protected by advanced security technology and statistical procedures.
Store your biologic and other forms of information in a secure research facility.
Access to this facility will be monitored.
Require researchers to ask permission to examine highly confidential study
information. Applications will be reviewed by experts to determine if researchers
can protect your data.
Monitor researchers studying sensitive information to make sure that they are
protecting your data in the way they promised.
Require researchers using your data to sign affidavits of nondisclosure. This means
that researchers must promise to use the information you provide for scientific
purposes only, and to not give information to anyone else who has not made this
promise.
Require researchers to report only group information, not individually-identifiable
information, from the data you provide.
Review these steps over time to improve the ways in which we protect information
that could be used to identify you.
We have obtained a legal document from the U.S. Department of Health and Human Services (DHHS)
that is 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.
With this Certificate, we cannot be forced, for example by court order or subpoena, to disclose
information that may identify you in any Federal, state, or local civil, criminal, administrative,
legislative, or other proceedings. But if there is an audit or evaluation of the study by staff of the
DHHS, it may be necessary to disclose information to those staff. You should understand that a
Certificate of Confidentiality does not prevent you, as provider of permission for yourself to
participate in the Study, from voluntarily releasing information about yourself or your involvement in
this study. So if an insurer, employer, or another party learns about your participation, and obtains
your consent to receive research information, then we may not use the Certificate of Confidentiality to
withhold this information. This means that in addition to our efforts, you and your family must also
actively protect your own privacy.
Also, you should understand that we will take actions necessary under federal or local law, including
reporting to authorities, to prevent serious harm to yourself, your child or others such as in cases of
child abuse or neglect that we find out about or observe. The Certificate of Confidentiality does not
stop the reporting of child abuse or neglect.
Will you be obtaining genetic information about me?
Yes, your genetic information comes from your family history and some samples, like blood. The
study plans to look at DNA, or genes, the basic building blocks of our bodies, because doctors know
that genes affect the health and development of children, and that the social and physical environment
affects how genes work. That is why we hope to study the genes of all people in the study.
4
Revised 9/8/08
Appendix B
B.1.3.c–5
Some people have concerns about use of their genetic information. As a result, the National
Children’s Study will take the steps I described earlier to protect all of your information, including
your genetic information.
Also, some people are sensitive about genetic information for cultural or religious reasons. If you
don’t want to be in the genetics part of the study, you should let us know, and you can still be in the
rest of the study.
Sometimes doctors and scientists cannot interpret the meaning of new research results. As a result, the
National Children’s Study will not give genetic results to you.
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 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 are young and when they grow up. We
might learn things like what causes asthma or what helps children do well in school. We are also
likely to learn about what promotes healthy pregnancies and how to reduce miscarriages and
premature births. As we make these discoveries, we will share them with you.
We will send out news through newsletters, a web site, and other ways. We will also put this
information in books and magazines.
In addition to general health news, we will also give you some specific information about you. We will
give you reports about some of the information we are collecting, like height, weight and blood
pressure.
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 give you names of
people and 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. The study does not include taking any medicines or drugs. There
are some things that might be a risk or discomfort to you, if you decide to join the study.
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.
The potential loss of confidentiality is a risk to being in the study. We will take many steps to protect
the information you provide that could be used to identify you. We will continue to review these
procedures to improve the ways we protect your data over time.
5
Revised 9/8/08
Appendix B
B.1.3.c–6
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.
The home visit will be scheduled for a time convenient to you. But having us come to your home may
interrupt your daily routine. 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.
If you tell us or we see that a child is being abused or neglected, or we learn that you are a danger to
yourselves or others, then we must report this to the proper authorities.
What if I want to leave the National Children’s Study?
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 or any other benefits you
may be receiving. 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, 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.
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
biological samples we collect and store for this study. By agreeing to be in this study, you are also
agreeing to allow possible future use of your biological materials for these purposes.
Who can I contact if I have further questions?
If you have questions, feel free to ask the Study Representative who has talked to you about being in
the study.
If you have any other questions about your or your child’s rights as a research participant, now or in
the future, you may contact the persons listed on the page we will ask you to sign.
After reading this booklet, we hope you will choose to be part of the biological
specimen collection for the National Children’s Study. We will ask you to sign a
form that says you decided to be part of this collection for the study. You can
decide to give some specimens and not others. If you choose to be part of this
collection, you can change your mind later and leave at any time. Either way, you
can still be in the study. Before you sign the form, you may want to talk with your
family, friends, or your doctor about the National Children’s Study. Thank you
for taking the time to learn about this important study.
6
Revised 9/8/08
Appendix B
B.1.3.c.2
NATIONAL CHILDREN’S STUDY
Biological Specimen Collection
Consent Signature Form
•
I have received information about “Joining the Biological Specimen Collection in the National Children’s
Study.”
•
I understand what is involved, and what the risks and benefits are, if I join this part of the study.
•
I understand that my biological specimens will be stored in a secure research facility, and that NCS will
protect access to my specimens.
•
I understand that test results from my specimens will not be given to me.
•
I understand that at any time in the study, if there is a question I don’t want to answer, a biological
specimen I don’t want to give, or part of the study I don’t want to do, I don’t have to do it, and I can still be
in the study.
•
I understand that my biological specimens may be used for a variety of future tests, including chemical,
genetic and nutritional tests. I agree to allow my biological specimens to be used for future NCS tests.
•
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 receive a copy of this consent form
for my records.
I choose to join the biological specimen collection part of the National Children’s Study.
At this time, I do NOT want genetic information to be collected from my biological specimens. I understand
that I can still be in the study and other types of tests will be performed on my biological specimens.
National contact:
Participant
Printed Legal Name of Participant: ___________________________________________________________
Signature of Participant: ___________________________________________ Date: _______/________/_______
Parent/Legal Guardian (if participant is a non-emancipated minor)
I have received information about “Making an Informed Choice About Being in the National Children’s Study” which
explains the nature and purpose of the National Children’s Study. I give my permission for _______________________ to
take part in the study if he agrees to be part of it.
(name)
Printed Legal Name of Parent/Legal Guardian: _________________________________________________
Signature of Parent/Legal Guardian: ______________________________________ Date: _______/________/_______
Witness (if required)
I observed the interviewer explain “Making and Informed Choice About being in the National Children’s Study” to the
participant and he signed or marked this form.
_______________________________________________
_______/________/_______
Signature of Witness
Date
Printed Name of Person Obtaining Consent: ___________________________________
Signature of Person Obtaining Consent: _________________________________ Date: _______/________/_______
Revised 9/8/08
Appendix B
B.1.3.d–1
OMB #: 0925-xxxx
Expiration Date: xx/xxxx
National Children’s Study
Visit Information Sheet
Father Visit
Thank you for agreeing to participate in the National Children’s Study, we told you what it means to
be in the study. The last time we visited with you, we described what the study was about in general.
Today, we’d like to tell you more about the kinds of information that we will ask to collect from you
during this particular visit.
Being in this study is your choice. You can skip any question you don’t want to answer. If there is a
part of the study you don’t want to do, you can skip that, too. Either way, you can still be part of the
study if you want to.
And you can decide to be in the study or not at any time. If you leave the study, you can rejoin it
later. If you decide later that you do not want us to keep your information, you can tell us and we will
destroy data we have not yet begun to study. You can also tell us if you don’t want your samples to be
used for genetic, chemical or nutritional tests. But we will not be able to destroy data already given to
researchers or cancel tests already performed.
We also would like to remind you that if you tell us, or if we see, that a child is being abused or
neglected, or if we learn from our visit that you are a danger to yourself or others, then we must
report this to the proper authorities.
Interview
We would like to ask you some questions 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. We will also ask
you to answer some questions about words you might know, things you might have seen in the world
around you, and to do some activities that show the different ways you think about and solve
problems. The interview should take about an hour.
You might feel uncomfortable about some of the questions we ask. If so, you can skip those
questions. You can decide which questions to answer. However, we 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.
Questionnaires and Other Forms for You to Complete
We will give you a questionnaire to fill out about health conditions that 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.
Biological Samples
At this visit, we would like you to
Collect a sample of your urine in a cup we provide (about 3 tablespoonfuls).
Cut or clip your toenails from all toes on both of your feet.
Your urine may be tested for a variety of environmental exposures. These tests will be done in the
future using state-of-the-art technologies. Many of the tests may help us understand more about
science someday, but won’t be able to tell us about people’s health right now. This is why the results
Public reporting burden for this collection of information is estimated to average 10 minutes per response, including the time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing
the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection
of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any
other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch,
6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-xxxx*). Do not return the completed form to this
address.
Appendix B
B.1.3.d–2
we collect will not be given to you. Taking part in the study is not a substitute for your usual visits to
the doctor.
We also would like to
Cut a small sample of your hair (about 20 strands) from the back of your head.
Collect about 2 tablespoons of your blood using a small needle.
We are medical professionals specially trained to do this safely. We are also trained to make you feel
comfortable when we take your blood, but people sometimes feel brief pain when blood is taken, and
there is a very small risk of infection, bruising, or bleeding.
Your blood may be tested for a variety of environmental exposures, hormones, nutrients, and
measures of infection and inflammation. These tests will be done in the future using state-of-the-art
technologies. Many of the tests may help us understand more about science someday, but won’t be
able to tell us about people’s health right now. This is why the results we collect will not be given to
you. Taking part in the study is not a substitute for your usual visits to the doctor.
Physical Measures
We would like to do the following:
Measure parts of your body including your arm, hip, and waist, and the skin on the back of
your arm and upper back.
Measure your weight and your height.
Measure your blood pressure.
We will give you your weight, height and blood pressure during this visit. But we will not give you
medical advice. Taking part in the study is not a substitute for your usual visits to the doctor.
Thank you
To thank you for your time spent completing this visit, we will give you $100 in appreciation of your
time.
If you have any questions about this study visit, I can try to answer them, or I will provide you with
contact information for you to call the local office.
2
Revised 9/8/08
Appendix B
B.1.3.e–1
12-Month Visit Information Sheet
The Visit-specific Visit Information Sheet is pending.
It will follow the format of the exemplar document of B.1.3.d.
Appendix B
B.1.6.a–1
OMB #: 0925-xxxx
Expiration Date: xx/xxxx
National Children’s Study
Authorization to Obtain
Medical Data (Ultrasound)
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
THE NATIONAL INSTITUTES OF HEALTH, THE CENTERS FOR DISEASE CONTROL AND
PREVENTION, AND THE ENVIRONMENTAL PROTECTION AGENCY
___________________________________________
___ ___ ___ - ___ ___ ___ - ___ ___ ___ __
Provider name
Phone number
_____________________________________________________________________________________________
Street address
____________________________________________
___ ___
___ ___ ___ ___ ___
City
State
Zip
I am participating in the National Children’s Study (NCS), a study of the health and development of the nation’s children
being led by the U.S. Department of Health and Human Services-through the National Institutes of Health and the Centers
for Disease Control and Prevention-and the U.S. Environmental Protection Agency. I authorize and request that you provide
the National Children’s Study staff and its contractors with medical information they request about the ultrasound
examination services provided to me during my current pregnancy. This authorization covers any ultrasound exams and
related medical follow-up 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
medical information without my authorization. This form (or a photocopy of this form) gives you my authorization. I have
signed this form voluntarily. 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 National Institute of Health and its contractors will use this information to supplement the information
I have already given to National Children’s Study for 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 study staff 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. This
authorization expires 30 months from the date of signature.
_____________________________________________
Patient name (first, middle, last):
_____________________________________________
Patient’s signature 14 and over sign
____________________________________________
Other names under which medical records may be filed
___ ___ /___ ___ /___ ___ ___ ___
Date signed
If Patient Is Age 14 - 17, Both Patient and Parent/Guardian Must Sign and Date.
_____________________________________
Parent, guardian, witness or proxy’s signature
___ ___ /___ ___ /___ ___ ___ ___
Date signed
______________________________________
Signer’s relationship to patient
1.
2.
Reason for parent, guardian, witness or proxy’s signature:
Patient 13 or younger
Patient disabled
Patient 14-17 years old
Patient deceased
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).
Place Label here
Version 1 08-0613
Revised 7/9/08
Public reporting burden for this collection of information is estimated to average 5 minutes per response, including the time for reviewing instructions, searching
existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or
sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send
comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project
Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-xxxx*). Do not return the completed form to this address.
Appendix B
B.1.6.a–2
OMB #: 0925-xxxx
Expiration Date: xx/xxxx
National Children’s Study
Authorization to Release Medical
Data (Ultrasound)
As part of your participation in the National Children’s Study led by the U.S. Department of Health and Human
Services-through the National Institutes of Health and the Centers for Disease Control and Prevention-and the
U.S. Environmental Protection Agency an ultrasound was performed today. The ultrasound will obtain
specific measurements of your baby. This ultrasound is not considered a substitute for an
ultrasound your health care provider may do. No attempt has been made to diagnose or treat any
of your medical conditions.
Your health care provider may be interested in seeing a copy of your ultrasound scan. With your permission,
we will send a copy of the ultrasound scan to your health care provider. If you agree and give us the name
and address of your health care provider, we will send him or her a copy of your ultrasound scan along with a
letter about the National Children’s Study.
Permission to Send Ultrasound Scan to Your Health Care Provider:
I agree that you may send a copy of my ultrasound scan to my health care provider named below.
I do not agree to send a copy of my ultrasound scan taken to my health care provider.
I do not have a health care provider.
Name of participant:
Birth date:
/
/
Signature of participant:
Date:
/
/ 20
Health Care Provider’s Contact Information:
Name:
Address:
City, State, Zip code:
Phone:
Name of data collector:
Staff ID:
Place Label here
Version 1
08-0709
Revised 7/9/08
Public reporting burden for this collection of information is estimated to average 5 minutes per response, including the time for reviewing instructions, searching
existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or
sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send
comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project
Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-xxxx*). Do not return the completed form to this address.
Appendix B
B.1.6.b–1
OMB #: 0925-xxxx
Expiration Date: xx/xxxx
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.
/
Day
3. Other Names Under Which Records May be Filed
Year
4.
5. Date Signed
Patient’s Signature—14 and over sign
IF PATIENT IS AGE 14 TO 17, BOTH PATIENT AND PARENT/GUARDIAN MUST SIGN AND DATE.
E.
6.
7. Date Signed
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).
Revised 9/8/08
Public reporting burden for this collection of information is estimated to average 5 minutes per response, including the time for reviewing instructions, searching
existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or
sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments
regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch,
6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-xxxx*). Do not return the completed form to this address.
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 to conduct the largest research
study of children’s health ever to be done in the United States. The study is called the
National Children’s Study. Results from the study may 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, 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.
Your participation is voluntary, but we hope you will join us in our effort to improve our
children’s health. The information you give will be kept private and is protected by law.
If you have any questions about the study, please call our toll-free number (xxx-xxx-xxxx)
or visit the National Children’s Study website at http://www.nationalchildrensstudy.gov.
Thank you in advance for helping us to learn more about the health and well-being of our
nation’s children.
Sincerely,
Local Investigator
Enclosure: Study Brochure
Revised 9/2/08
Appendix B
B.2.2–1
The National Children’s Study
Study Brochure
Most children born today grow up healthy 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 many pressing health
concerns.
What is the National Children's Study?
The National Children's Study is the largest research study of children's health
ever conducted in the United States. Its purpose is to look at the effects of the
environment on children's health and development. By recruiting women of childbearing age, information will be collected on 100,000 children beginning before
they are born. The study will continue to collect information on these children
until they reach 21 years of age.
Who will be in the study?
Across the country, selected areas within 105 different counties have been
scientifically chosen to represent the United States. We will be recruiting women
in these areas to join the study if they are pregnant or may become pregnant.
Study teams will also work with doctors, nurses, community leaders, and local
public health workers to help make the study successful. Local study staff will
visit all homes in selected neighborhoods to talk to the men and women who live
Revised 7/10/08
Appendix B
B.2.2–2
there. This will tell us whether anyone living there may be eligible to take part in
the full study.
What will you be asked to do?
First, we would like to talk to an adult in your household. It will only take about 5
minutes for this interview. Even if you do not have any children living with you, or
if you do not plan to have children, it's still important that we get some basic
information. After that, if any women of child-bearing age live in your household,
we will ask them to answer a few questions. Depending on the answers to these
questions, some women will then be invited to enroll in the full study.
If you are a woman who is invited to enroll in the full study, you will be given
more details about what you will be asked to do. Study staff will meet with you to
complete a variety of data collection activities. As babies are born to women who
are enrolled in the full study, information will be collected about their babies as
they grow. Fathers of these babies will also be asked to take part in certain
activities.
Why is your cooperation so important?
Everyone's cooperation will ensure that the National Children's Study fairly
represents all of America's children. You can decide to participate or not. That is
your choice. However, we hope that you will decide to join us in this important
effort. If you decide not to participate, it will not affect any benefits to which you or
your family may be entitled.
Revised 7/10/08
Appendix B
B.2.2–3
Will information be kept confidential?
All information will be kept private and confidential and used only for research
purposes. The 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.
Revised 7/10/08
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 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, 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 our team member. All
information you provide will be kept private and confidential and used for research purposes
only. Your participation is voluntary.
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
Revised 9/2/08
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 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, 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 our team member. All information you provide
will be kept private and confidential, and used for research purposes only. Your participation
is voluntary.
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
Revised 9/2/08
Appendix B
B.2.5–1
Appointment Reminder Letter
[VC Name & Address]
[Date]
[Participant Name &
Address]
Dear [PARTICIPANT NAME]:
This letter is meant to remind you about your upcoming appointment for the National Children’s
Study. You are scheduled for an appointment in your home on:
Date:
Time:
At that time, [DATA COLLECTOR’S NAME] will ask you to answer some questions about your health
and your home.
If any pesticide products have been used in your home or yard in the past 6 months,
please gather the containers, letters from building maintenance about pesticide
application, or receipts from the exterminator that list which products were used. These
products would have been used to control for ants, termites, cockroaches, bees, wasps,
moths, or other insects. Our staff would like to look at the labels during the visit.
If any products were used on your pets to control fleas, ticks, or mites in the past 6
months, please gather the containers for all of those products have been
applied. Products include flea collars; flea and tick powders; shampoos; or other flea,
tick, and mite control products. Our staff would like to look at the labels during the visit
Our staff also would like to look at the labels for any prescription and non-prescription
medicines, as well as any vitamins, minerals, herbals, and other dietary supplements you
have taken since you became pregnant. Please gather the containers and have them
available during the visit.
If you have any personal record or calendar, such as the Medical Care Log, that helps
you remember the dates of any doctor or health care provider visits you had since you
became pregnant, please have it available during the interview.
Revised 7/10/08
Appendix B
B.2.5–2
You are scheduled for another appointment in your home on:
Date:
Time:
At the end of the first visit, [DATA COLLECTOR’S NAME] will give you $100 to thank you for
completing both visits.
If you have any questions about either of these appointments, or if you need to reschedule, please call
our office at [VC TELEPHONE NUMBER].
Thank you for being part of the National Children’s Study! We look forward to seeing you soon.
Sincerely yours,
(VC Signature)
Revised 7/10/08
Appendix B
B.2.6–1
Post Enumeration Letter
_______/_______/________
Date
Dear ___________________________________,
Name
You may be eligible to participate in the National Children’s Study. A member of our staff will be
stopping by in the next few days to ask you a few questions to find out if you can be part of the
National Children’s Study. This will only take a few minutes of your time.
Attached is a copy of the National Children’s Study brochure. Please call {NAME} at (XXX)(XXX)-(XXXX) if you have any questions or to schedule a visit.
Thank you,
____________________________________________
Data collector name
Enclosure: Study Brochure
Revised 7/7/08
Appendix B
B.2.7–1
High Pregnancy Group (No Visit) Letter
_______/_______/________
Date
Dear ___________________________________,
Participant name
Thank you for speaking with me today about the National Children’s Study. We will call you again in
about 4 weeks to see how you are doing and to ask you a few questions. The questions will be
similar to the ones you answered today, and will only take a few minutes of your time.
Your participation is voluntary. If you decide to participate, the information you give will be kept
private and is protected by law.
Please call us if anything changes, for example if you move, change your name or get pregnant.
Please call {NAME} at (XXX)-(XXX)-(XXXX) if you have need to contact us or have any
questions.
Thank you,
____________________________________________
Data collector name
Revised 9/2/08
Appendix B
B.2.8–1
Moderate and Low Pregnancy Group Letter
_______/_______/________
Date
Dear ___________________________________,
Participant name
Thank you for speaking with me today about the National Children’s Study. We will call you again in
a few months to see how you are doing and to ask you some questions. The questions will be similar
to the ones you answered today, and will only take a few minutes of your time.
Your participation is voluntary. If you decide to participate, the information you give will be kept
private and is protected by law.
Please call us if anything changes, for example if you move, change your name or get pregnant.
Please call {NAME} at (XXX)-(XXX)-(XXXX) if you have need to contact us or have any
questions.
Thank you,
____________________________________________
Data collector name
Revised 9/2/08
Appendix B
B.2.9–1
Post Consent Letter
_______/_______/________
Date
Dear ___________________________________,
Participant name
Thank you for agreeing to be part of the National Children’s Study. We are planning to begin
pregnancy visits in the near future.
Your first pregnancy visit will be in your home and include:
Asking you some questions,
Taking some measures such as your blood pressure and weight,
Collecting some environmental samples such as dust and water, and
Asking you for samples of your blood, urine and hair.
We will also be leaving some brief questionnaires for you to complete, and we will come back a
week or so later to pick these up and to complete the visit activities.
We will call you to schedule your visit at your convenience. At that time, we will explain more about
the visit and answer any questions you may have.
Please call {NAME} at (XXX)-(XXX)-(XXXX) if you have any questions.
Thank you,
Revised 7/7/08
Appendix B
B.2.10–1
Incentive “Thank You” Letter
_______/_______/________
Date
Dear ___________________________________,
Participant name
Thank you for your time today. Your participation in the National Children’s Study is very
important and we appreciate your part in making it a success.
Please accept the enclosed reimbursement for your time and your assistance with this very important
research study.
We look forward to your on-going participation in the National Children’s Study. Before your next
scheduled study activity, if you have any questions or need to update any of your information, please
call {NAME} at XXX-XXX-XXXX.
Thank you,
____________________________________________
Data collector name
Revised 7/7/08
Appendix B
B.2.11–1
Study Withdrawal letter
{DATE)
Name
Address
City, State, Zip
Dear ________________________,
We have received your request to no longer be part of the National Children’s Study. The
researchers and staff want to thank you for your help with our study. You have been an important
part of the largest and most ambitious research study of children’s health ever done in the United
States.
If you would like to continue to receive the study newsletter, or if you would like to re-join the study
again at any time in the future, please call (PI NAME) at (XXX) XXX-XXXX or the Study
Coordinator at (XXX) XXX-XXXX.
Sincerely,
Revised 7/7/08
| File Type | application/pdf |
| File Title | REQUEST FOR OMB CLEARANCE |
| Author | Ruth Thomson |
| File Modified | 2008-09-22 |
| File Created | 2008-09-10 |