Consent Materials - English

Population Assessment of Tobacco and Health (PATH) Study (NIDA)

Attachment 12 English
PATH Study
Consent Materials
June 26, 2014

Population Assessment of Tobacco and Health (PATH) Study (NIDA)

Table of Contents
Section

Page

Attachment 12. PATH Study Consent Materials
CM1 – English Adult Interview Consent Form ............................................
CM2 – English Parent Consent and Permission for Youth
Interview Form......................................................................................
CM3 – English Youth Permission for Interview form .................................
CM4 – English Biological Samples Consent Pamphlet ................................
CM4a – English Biological Consent for Samples Signature Form .............
CM5 – English Consent for Emancipated Youth Interview Form ............

3
8
14
18
23
25

Population Assessment of Tobacco and Health (PATH) Study (NIDA)

Attachment 12 English
PATH Study Consent Materials
CM1 – English Adult Interview Consent Form
June 26, 2014

CM1 – Adult Interview Consent

OBM Control Number 0925-0664
Expiration Date: xx/xx/2017

Population Assessment of Tobacco and Health (PATH) Study
Adult Interview Consent Form
Introduction
The Population Assessment of Tobacco and Health (PATH) Study is sponsored by the National
Institutes of Health (NIH) in partnership with the Food and Drug Administration (FDA). Westat,
an independent research firm, is conducting the study.
What is the purpose of the study?
The study will look at tobacco use and health in the U.S. population. You don’t have to be a tobacco
user to take part in the study. What we learn will help to improve the health of millions of
Americans.
Why was I selected for this study?
Your household was selected by chance from a list of addresses. We selected you to represent many
other people throughout the country.
Participation is voluntary. Because our information will be more useful and complete if you
participate, we hope you’ll agree to be part of the study.
What would you like me to do?
We’d like you to complete an interview using a computer. We’ll ask about your attitudes, knowledge,
and personal experiences with tobacco; we’ll also ask about substance use, mental health, your
relationships with friends and family, and your general health. You’ll hear the interview questions in
private, using headphones, and answer by touching a computer screen. You can skip any questions
you don’t want to answer. The questions take about 60 minutes to answer. After the interview, we’ll
ask you to participate in other activities, but you can say no.
The PATH Study will continue until November 2015 and perhaps longer. We’d like to interview you
once a year until the study ends. We may also ask you to participate in other activities, but you can
say no at any time.
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 208927974, ATTN: PRA (0925-0664). Do not return the completed form to this address.

CM1_V1

CM1 – Adult Interview Consent

We’ll contact you occasionally to update your contact information, and we may send you letters and
messages throughout the year. A Westat quality control person may call you to ask about your
experience with the interviewer.
What other information will you collect?
We’ll collect personal information, such as your name, address, and date of birth. We’ll store this
information in a highly secure location to protect it. We may use it to link to public health records,
such as state and federal vital statistics records, and health and cancer registries. These registries are
updated by state public health agencies to keep current information on the health status of patients
who visit hospitals, clinics, laboratories, and doctors’ offices.
Can I change my mind about participating?
Yes. You may refuse to participate in any interviews and you can stop at any time. If you don’t
participate or if you stop participating, you will not lose any benefits.
If you are in the study for a while and then stop, we won’t ask for any more data from you. We
would like to use the data already collected about you, unless you ask us not to. You will not be able
to withdraw your data after the study has ended; until then, you may request that your data be
destroyed.
What are the possible benefits and risks of participating in the study?
Participating in the study may not help you individually, but it may provide useful information on
new ways to help protect the Nation’s public health. The interview involves no risk of injury. The
main risk, which is small, is your personal information or data could be revealed. We are taking
several steps to protect your privacy and prevent that from ever happening.
How will you protect my privacy?
The researchers will do several things to protect your identity and the privacy of your data.


We’ll secure your personal information in a protected computer file.



We’ll secure your interview answers in a separate file.



Your name will not appear on the interview. Your answers can only be linked to a number,
not to your name. This means that your answers cannot be used to identify you.



Your answers will be combined with answers from other adults in the study and secured in a
protected computer file.



We’ll report on this information only for groups of people, not individuals.



We’ll destroy your personal information when the study is over.



We won’t put your personal information in any report about this study.

We’ve also obtained a legal document called a Certificate of Confidentiality. In this legal document,
the Federal government certifies that PATH Study researchers can’t be forced by any person or

CM1_V1

CM1 – Adult Interview Consent

court of law to give your name with any of your answers. PATH Study researchers do have to give
this information, if a project funded by NIH requests it for an audit or program review.
You may tell anyone you’re participating in this study. We may provide your information to others if
you have given them written permission to have it. Even though it is not what PATH Study
researchers are studying, if we learn that you or someone else is harming you, your child, or others
around you, we will report this to the police or a social services agency in your community to protect
you or others.
Do I get anything for completing the interview?
Yes. You’ll receive a $35 debit card after you finish the interview this time as a thank you for
participating. You can receive additional thank you gifts for participating in future interviews and
other study activities. Also, each year you’re in the study, you’ll receive up to $10 a year as a thank
you for updating your contact information.
Can the sponsors stop this study?
Yes. If this happens, we will notify you.
Whom can I contact if I have further questions?
You can ask the interviewer any questions you have about the study.
If you have any questions about the study, call Westat’s toll-free number, 1-888-311-1819, weekdays
between 9:00 a.m. and 9:00 p.m. Eastern Time.
If you have any questions about your rights as a PATH Study participant, call Westat’s Human
Subjects Protections office at 1-888-920-7631.
Do you have any questions now?

CM1_V1

CM1 – Adult Interview Consent

Consent signatures
By signing this form, you give your consent to participate in the PATH Study. This participation
includes completing an interview and being contacted again to complete future interviews and
possibly other study activities if you choose.
You give your consent to having the study securely maintain your personal information so that we
can use it when we look at public health records, and state health and cancer registries.
You also authorize state cancer registries to release medical information about you to our
researchers to learn about or confirm any cancer diagnosis in the future.
I have read the information about this study or someone has read it to me, and I have been given
the chance to discuss it and to ask questions. I will receive a copy of this consent form for my
records. I consent to take part in this study.
__________________________________________
Signature of Participant

_______ / ______ /______
Month
Day
Year

__________________________________________
Printed Name of Participant

_________________
ID # of Interviewer

__________________________________________
Signature of Person Obtaining Consent

_______ / ______ /______
Month
Day
Year

THANK YOU

CM1_V1

Population Assessment of Tobacco and Health (PATH) Study (NIDA)

Attachment 12 English
PATH Study Consent Materials
CM2 – English Parent Consent and Permission for
Youth Interview Form
June 26, 2014

CM2 Parent Permission for Youth Interview/Consent for Parent Interview
OMB Control Number 0925-0664
Expiration Date xx/xx/2017

Population Assessment of Tobacco and Health (PATH) Study
Parent Consent and Permission for Youth Interview Form
Name of Child ___________________________________________
Introduction
The Population Assessment of Tobacco and Health (PATH) Study is sponsored by the National
Institutes of Health (NIH), in partnership with the Food and Drug Administration (FDA). Westat,
an independent research firm, is conducting the study.
What is the purpose of the PATH Study?
The PATH Study will look at the use of tobacco and how it may affect the health of people in the
United States. What we learn will help to improve the health of millions of Americans. You don’t
have to be a tobacco user to take part in the study.
Why was my child selected for this study?
Your child was selected to take part in this study for two reasons. First, your household has been
chosen by chance to represent many others like it in the country. Second, your child is in the 12- to
17-year-old age group being asked to participate in this study.
What information will I provide?
We’d like to ask you a few questions about your child before we ask his or her permission to do the
interview. The questions will ask about your child’s age and education, your relationship with your
child, what your child knows and how he or she feels about tobacco, and any tobacco use.
The questions will take about 15 minutes to answer. Your participation is completely voluntary. If
you do not want to participate, you will not lose any benefits. You may refuse to participate in this
and any future interviews.
We are also asking your permission for your child to participate in the PATH Study.
Public reporting burden for this collection of information is estimated to average 2 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 208927974, ATTN: PRA (0925-0664). Do not return the completed form to this address.

1

CM2 V1

CM2 Parent Permission for Youth Interview/Consent for Parent Interview

What does my child’s participation involve?
The interview asks your child questions about different areas of life, including his or her attitudes,
knowledge, and personal experiences with tobacco. We will also ask about substance use, mental
health, relationships with friends and family, and overall physical health.
The interview will be conducted in private and take about 40 minutes. Your child will use a
computer, hear questions through headphones, and enter his or her answers directly into the
computer by touching the screen. Your child can skip any questions he or she does not want to
answer. You will not see your child’s answers.
The PATH Study will continue until November 2015 and perhaps longer. We’d like your permission
to interview your child now and once a year until the study is over. We may also ask your permission
for you and your child to participate in other activities, but you can say no at any time.
We may contact you occasionally to update your contact information, and we may send you letters
and messages throughout the year as reminders of the next visit. A Westat quality control person
also may call you to ask about your experience with the interviewer.
When your child turns 18, he or she will be invited to enroll into the study as an adult and sign a
consent form.
What other information will you collect?
Your child’s personal information (such as name, address, date of birth) may be used in the future to
get information from public health records, such as health registries, cancer registries, and vital
statistics databases, on your child’s health. Health registries are part of public health agencies that
collect information from hospitals, clinics, laboratories, and doctors’ offices.
We will protect your identity and your child’s. Your child’s personal information will be secured and
will not be shared with anyone but a small group of qualified researchers who work on the study and
will be destroyed when the PATH Study is over.
Can I or my child change our minds about participating?
Yes. You and your child may refuse to participate in any interviews and can stop at any time. If you
don’t want to participate or don’t want your child to participate, you will not lose any benefits. Your
child must also agree by signing a form that states he or she agrees to take part.
If you or your child stops, we won’t ask for any more data. We would like to use the data already
collected about you and your child unless you ask us not to. You will not be able to withdraw your
data or your child’s data after the study has ended, but until then, you may request that the data be
destroyed.

2

CM2 V1

CM2 Parent Permission for Youth Interview/Consent for Parent Interview

What are the possible benefits and risks of participating in the study?
Participating in the study may not have a direct benefit to you or your child individually. Information
from the study may benefit your community and the Nation by improving health strategies and
programs.
If you or your child feels uncomfortable about any of the questions, it’s OK to skip those questions.
The main risk, which is small, is your answers or your child’s answers could be revealed. We are
taking steps to protect your privacy and your child’s privacy, and to prevent this from ever
happening.
How will you protect my privacy and my child’s?
The study has safeguards in place to protect the identities of all participants, including yours and
your child’s. The information you provide will not be shared with your child; and information your
child provides in the interview will not be shared with you, the child’s school, or the authorities.
The researchers will take additional steps to protect your identity and your child’s identity.


We’ll secure personal information in a protected computer file.



We’ll secure interview answers in a separate file.



Your names will not appear on the interview. Your answers can only be linked to a number,
not to your names. This means that your answers cannot be used to identify you or your
child.



Your answers will be combined with answers from others in the study and secured in a
protected computer file.



We’ll report on this information only for groups of people, not individuals.



We’ll destroy your personal information and your child’s when the study is over.



We won’t put your personal information in any report about this study.

Also, we’ve obtained a legal document called a Certificate of Confidentiality. In this legal document,
the Federal government certifies that PATH Study researchers can’t be forced by any person or
court of law to give your name or your child’s name with any of your answers. PATH Study
researchers do have to give this information, if a project funded by NIH requests it for an audit or
program review.
You and your child may tell anyone you’re participating in this study. We may provide your
information to others if you have given them written permission to have it. Even though it is not
what PATH researchers are studying, if we learn that you or someone else is harming you, your
child, or others around you, we will report this to the police or a social services agency in your
community to protect you or others.

3

CM2 V1

CM2 Parent Permission for Youth Interview/Consent for Parent Interview

Will I or my child receive anything for completing the interview?
You will receive a $10 debit card upon completion of the interview about your child and each future
interview as a thank you for your participation.
Your child will receive a $25 debit card upon completion of the youth interview and each future
interview as a thank you for his/her participation. Also, each year your child is in the study, he/she
will receive up to $10 as a thank you when you update contact information for him/her.
Whom can I contact if I have further questions?
You can ask the interviewer any questions you have about this study.
If you have any questions about the study, call Westat’s toll-free number, 1-888-311-1819, weekdays
between 9:00 a.m. and 9:00 p.m. Eastern Time.
If you have any questions about your rights as a PATH Study participant, call Westat’s Human
Subjects Protections office at 1-888-920-7631.
Do you have any questions now?
Consent signatures
By signing this form, you give your consent to answer questions about your child, and your
permission for this interview and future interviews with your child. You also give your permission
for the researchers to contact you regarding future interviews, and possibly other study activities
with you and your child. Your child must also agree by signing a form. That form states that he or
she agrees to take part but has the right to stop the interview at any time and may refuse to
participate in this or any future interviews.
You give your consent to having the study securely maintain your child’s personal information to
access public health records in the future, and authorize state cancer registries to release medical
information about your child to the researchers to learn about and confirm any cancer diagnosis in
the future.
I have read the information about this study and have been given the chance to discuss it and to ask
questions. I understand that my child must also agree to participate by signing a form. I understand I
will receive a copy of this permission form for my records.
I agree to answer questions about my child.

 Yes

 No

I give permission for my child to take part in this study.

 Yes

 No

__________________________________________
Signature of Parent/Guardian

_______ / ______ /______
Month
Day
Year

__________________________________________

______________________

4

CM2 V1

CM2 Parent Permission for Youth Interview/Consent for Parent Interview

Printed Name of Parent/Guardian

ID # of Interviewer

__________________________________________
Signature of Person Obtaining Consent

_______ / ______ /______
Month
Day
Year

THANK YOU

5

CM2 V1

Population Assessment of Tobacco and Health (PATH) Study (NIDA)

Attachment 12 English
PATH Study Consent Materials
CM3 – English Youth Permission for Interview
Form
June 26, 2014

CM3 Youth Assent for Interview

OMB Control Number 0925-0664
Expiration Date: xx/xx/2017

Population Assessment of Tobacco and Health (PATH) Study
Youth Permission for Interview Form
Introduction
The Population Assessment of Tobacco and Health (PATH) Study is sponsored by the National
Institutes of Health (NIH), in partnership with the Food and Drug Administration (FDA). Westat,
an independent research firm, is conducting the study.
This form describes what we’ll be doing. Please read it or ask me to read it to you. Then, if you
decide to be in the study, I’ll ask you to sign the form.
Why are you doing this study?
We want to know more about tobacco and health in the United States. You don’t have to be a
tobacco user to take part in the study. What we learn from you and others in the study may help
your community and millions of Americans to be healthier.
Why was I selected for this study?
We can’t talk to every young person in America so we had to pick a smaller number of young people
by chance to take part in the study. This means your answers will represent the answers that many
other young people like you would give if they were in the study, too.
Your parent or guardian has given permission for you to participate.
What would you like me to do?
We’d like you to answer some questions on a computer. We call this an interview, even though you’ll
do it on a computer, rather than talking with another person. You’ll listen to the questions on
headphones. Your parents or guardians will not watch or see your answers. You’ll answer the
questions by touching the computer screen. The interview will take about 40 minutes to complete.
We’ll ask about:






What you think about tobacco use and tobacco advertising.
What you know about tobacco.
Your experiences with tobacco.
Your friends’ experiences with tobacco.
Your life and your health.

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 208927974, ATTN: PRA (0925-0664). Do not return the completed form to this address.

CM3_V1

CM3 Youth Assent for Interview

You can skip any question you don’t want to answer, and you can stop the interview at any time.
You’re in charge, but we hope you will answer all the questions because your answers are important.
The study will continue until November 2015 and perhaps longer. We will ask you questions once a
year until the study ends. We may ask you to be part of other study activities, too, and you can
decide if you want to or not. We’d like you to be part of the study even when you turn 18. We’re
studying adults, so when you turn 18, you can be in the adult part of the study.
What other information will you get about me?
We’ll collect personal information, such as your name, address, and date of birth. We’ll store this
information in a highly secure location to protect it. We may use it to get information about you
from public health records, such as health registries, cancer registries, and vital statistics databases.
Health registries collect health information from hospitals, clinics, laboratories and doctors’ offices.
We will protect your identity. Your personal information will not be shared with anyone but a small
group of qualified researchers who work on the study and will be destroyed when the PATH Study
is over.
Can I change my mind about being in this study?
Yes, you can say no or stop whenever you want. You or your family will not lose any benefits if you
say no now or stop later. If you’re in the study for a while and then stop, we would like to use the
information you already gave us, unless you ask us not to. You will not be able to take back your
information after the study is over; until then, you can ask that your information be destroyed.
Will anything good or bad happen to me if I’m in this study?
Being part of this study may not help you individually. However, the answers you give will be
combined with the answers from many other young people and may help to improve the health of
your community and millions of Americans.
The main bad thing that could happen is that people might find out personal information about you,
but we have safeguards in place to keep this from happening.
How will you stop people from seeing my information?
We will keep your personal information, like your name and address, in a protected and secure
computer file. We will keep your answers to the interview questions in a different file with answers
from all the other people in the study.
This means:


Your name will not be on your answers so people who work on the study will not know who
you are.



Your family will not know what you tell us and no one in your school or the authorities will
know what you tell us.



We will combine your answers with those from many other people in the study. We will
report on this information only for groups of people, not individuals. This means we cannot
put personal information about you in a report about the study.



We will destroy your personal information when the study is over.
CM3_V1

CM3 Youth Assent for Interview

Also, we have a Certificate of Confidentiality. This means that no one doing the study can be forced
to give anyone information about you, including your name. PATH Study researchers do have to
give this information, if a project funded by NIH requests it for an audit or program review.
You may tell anyone you want that you’re in this important study. Even though it is not what
PATH researchers are studying, if we learn that you or someone else is harming you or others, we’ll
report this to the police or social services agency in your community to protect you or others.
Do I get anything for doing the interview?
Yes. You’ll receive a $25 debit card after you finish the interview this time and in future years as a
thank you for participating. Also, each year you’re in the study, you’ll receive up to $10 as a thank
you when your parent updates your contact information.
Can the people in charge of this study stop it?
Yes. If this happens, we will tell you.
Is there someone I can talk to if I have more questions?
Yes. If you have questions now, you may talk to the interviewer.
If you have any questions about the study, call Westat’s toll-free number, 1-888-311-1819, weekdays
between 9:00 a.m. and 9:00 p.m. Eastern Time.
If you have questions about your rights as a PATH Study participant, call Westat’s Human Subjects
Protections office at 1-888-920-7631. This office that makes sure we’re doing this study the right
way.
Do you have any questions now?
Assent signatures
By signing this form, you agree to participate in the PATH Study and answer interview questions.
You also agree to participate in future interviews and possibly in other activities if you choose.
You agree to let the study securely keep your personal information, so we can look for public health
records in the future. You also agree to let state cancer registries give medical information about
you to the study about any cancer diagnosis in the future.
I have read the information about this study or someone has read it to me. I have had a chance to
talk about it and ask questions. I agree to take part in the study. I will get a copy of this form.
__________________________________________
Signature of Participant

_______ / ______ /______
Month
Day
Year

__________________________________________
Printed Name of Participant

_______________________
ID # of Interviewer

__________________________________________
Signature of Person Obtaining Assent

_______ / ______ /______
Month
Day
Year

THANK YOU
CM3_V1

Population Assessment of Tobacco and Health (PATH) Study (NIDA)

Attachment 12 English
PATH Study Consent Materials
CM4 – English Biological Samples Consent
Pamphlet
June 26, 2014

OMB Control Number 0925-0664

Expiration Date: xx/xx/2017

Population Assessment of Tobacco and Health (PATH) Study
Consent for Biological Samples Pamphlet
The National Institutes of Health (NIH), in partnership with the Food and Drug Administration
(FDA), is sponsoring the PATH Study. This study is one of the most important national health
studies ever done in the United States. By participating, you are an essential part of what is learned
about tobacco products and health.
In addition to an interview, we ask adults to give biological samples. These samples are critical to the
success of the study. We need samples from both tobacco users and non-users.
For this part of the study, we’d like you to give us two kinds of biological samples:


Urine and



Blood (taken with sterile equipment by medically trained and certified health professionals).

This pamphlet tells you more about why we want these samples, explains what you need to do,
discusses the risks and benefits of giving samples, and describes what you get for participating. After
you’ve read this pamphlet or someone has read it to you, we will ask you to sign a form saying you
agree to give samples.
Why do you want me to give you samples?
We can learn a lot more about tobacco products and health by combining information from samples
and interviews. The samples give valuable information on these topics we can’t get any other way.
We will mainly test samples for chemicals associated with exposure to tobacco products and with
health outcomes. We will not look for illegal drug use.
We will use information from samples and interviews for research purposes only. The study will
keep this information private; it will only be seen by individuals working on the study.
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 208927974, ATTN: PRA (0925-0664). Do not return the completed form to this address.

1

CM4_V2

If I say yes, what happens?
A PATH Study interviewer will come to your home once a year to interview you. At that time, the
interviewer may ask you to give biological samples. Giving them is easy and quick; the interviewers
and health professionals are trained to make you feel comfortable and respect your privacy.


This year, and possibly in the future, the interviewer will ask you to give a urine sample; this
takes about 10 minutes. It’s just like giving a urine sample at your doctor’s office.



This year, and possibly in the future, we’ll ask if a health professional can collect a sample of
your blood. If you agree to give a blood sample, the interviewer will schedule an appointment
for a medically trained and certified health professional to come to your home at a time that’s
convenient for you. This person will draw a small amount of blood (about 3 tablespoons) from
your arm using sterile equipment. It’s just like giving a blood sample at your doctor’s office. It
takes about 20 minutes.



Each time you give a sample, we will ask questions about your recent use of tobacco products.
This takes about 4 minutes.

Do I have to give you samples?
No. You decide whether to give us samples. You can decide to give us some samples but not others.
Even if you don’t give us samples, you can still be part of the PATH Study.
You can stop being part of the study at any time. If you stop, we’d like to keep the samples that you
already gave us, but we’ll destroy them if you tell us to.
Will you do research on my genes?
If you agree, we may use your samples for genetic research in the PATH Study and possibly in
future studies. We’ll look at how genes affect health among people who do and don’t use tobacco
products. We’ll also look at how people’s background and lifestyle—like age, education, and
smoking—may work together with genes to affect their health.
If you don’t want us to use your samples for genetic research, we’ll only use them for other kinds of
tests. These other tests are mainly for chemicals associated with exposure to tobacco products and
with health outcomes.
Will I get the results of tests done on my samples?
You won’t get the results of any tests done on your samples. Your results will be combined with
results from other people in the study to help us understand the health of the general population.
How will you store my samples?
We’ll ship your samples to a secure facility called a repository where they will be frozen and stored
until they are tested. Your samples will be labeled with a code number only. This means your name
won’t be on the samples.

2

CM4_V2

How long will you keep my samples?
If you agree that your samples can be used for research in the PATH Study and in future studies, we
will keep your frozen samples at the repository for an unlimited period of time. We may keep using
your samples for research unless you decide to withdraw your samples from the study or we close
the secure repository where they are stored, at which time the samples will be destroyed.
What are the risks of providing samples?


Giving us a urine sample has no risks.



Giving a blood sample may hurt for a moment; rarely, it causes light-headedness, fainting,
infection, bruising, hematoma, or bleeding. The health professionals who draw your blood are
trained to make you feel comfortable and to make this a safe procedure.



The risks from genetic research are very low. Only a code number will be on your samples, not
your name. A Federal law (the Genetic Information Non-Discrimination Act, or GINA) will
help make sure that health insurance companies or employers can’t use what we find out from
your genes.

Who will have access to my samples and data?
Only qualified researchers will have access to your samples. The PATH Study Biospecimen Access
Committee will make sure these researchers are qualified and have procedures to protect the privacy
of the results they get from your samples. These researchers won’t be able to identify you because
your name won’t be on the samples. They will only have a code number on them.
How will you protect my privacy?
Your privacy is very important to the PATH Study.


We’ll treat all of the information in this study as private. The information will be used only for
research purposes.



We’ll label your samples and interview answers with a code number only, not your name.



We’ll store your personal information in a protected computer file separate from your samples
and the rest of your data. Your samples and data will only be identified by a code number. We’ll
keep the key to the code in a password-protected database.



We’ll combine your results with the results of the thousands of other people in the study. In
addition, we’ll only put information about groups of people in our reports. This means we can’t
put information about individuals in any report about the PATH Study.



We’ll destroy all personal information that could identify you, like your name, address, and
phone number, after the study is over.

Also, we’ve obtained a legal document called a Certificate of Confidentiality. In this legal document,
the Federal government certifies PATH Study researchers can’t be forced by any person or court of
law to give your name with any of your answers. PATH Study researchers do have to give this
information, if a project funded by NIH requests it for an audit or program review.

3

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You may tell anyone you’re participating in this study. We may provide your information to others if
you have given them written permission to have it. Even though it is not what PATH researchers
are studying, if we learn that you or someone else is harming you, your child, or others around you,
we will report this to the police or a social services agency in your community to protect you or
others.
Do I get anything for providing samples?
Yes. In addition to the $35 debit card for the interview, every year you provide samples you will get
the following as a thank you:



$25 for your time providing a urine sample at a visit from an interviewer, and
$25 for your time providing a blood sample at a follow-up visit from a health professional.

What happens if I’m hurt as a result of taking part in this research?
You are not likely to get hurt while we are collecting your samples. Our procedures minimize any
risks. If you are hurt, though, please see your doctor.
What are the costs to me?
Giving samples has no costs to you.
What if I have questions about the study?
You can ask the interviewer any questions you have right now. Do you have any questions now?
If you have any questions about the study, call Westat’s toll-free number, 1-888-311-1819, weekdays
between 9:00 a.m. and 9:00 p.m. Eastern Time.
If you have any questions about your rights as a PATH Study participant, call Westat’s Human
Subjects Protections office at 1-888-920-7631.

4

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Population Assessment of Tobacco and Health (PATH) Study (NIDA)

Attachment 12 English
PATH Study Consent Materials
CM4a – English Biological Consent for Samples
Signature Form
June 26, 2014

Population Assessment of Tobacco and Health (PATH) Study
Consent for Biological Samples Signature Form
I have read the Biological Samples Consent Pamphlet or it has been read to me. My questions about the
PATH Study have been answered and I understand the following.
•

What is involved if I decide to give samples.

•

I decide whether to give samples. I can decide not to give any sample and still be part of the PATH
Study.

•

I decide whether my samples are used in genetic research. I can decide not to have my samples used in
this research and still be part of the PATH Study.

•

I can tell the PATH Study to stop storing and using my samples at any time. Also, I can tell the PATH
Study to destroy my samples.

•

The PATH Study will store my samples in a secure facility and make sure only qualified researchers who
have agreed to keep my information private have access to them.

•

The PATH Study will use my samples for a variety of tests.

•

I will not get results back from the tests done on my samples.

•

What the risks and benefits are if I give samples.

•

I can ask more questions at any time.

•

I’ll get a copy of this consent form.

I agree to give:
A urine sample.
A blood sample.

o Yes
o Yes

o No
o No

I agree to the use of my samples for genetic research.

o Yes

o No

__________________________________________
Signature of Participant

_______ / ______ /______
Month
Day
Year

__________________________________________
Printed Name of Participant

_______________________
ID # of Interviewer

__________________________________________
Signature of Person Obtaining Consent

_______ / ______ /______
Month
Day
Year

THANK YOU

Revised May 2014

CM4a V1

Population Assessment of Tobacco and Health (PATH) Study (NIDA)

Attachment 12 English
PATH Study Consent Materials
CM5 – English Consent for Emancipated Youth
Interview Form
June 26, 2014

OMB Control Number 0925-0664
Expiration Date: xx/xx/2017

Population Assessment of Tobacco and Health (PATH) Study
Consent for Emancipated Youth Interview Form
Introduction
The Population Assessment of Tobacco and Health (PATH) Study is sponsored by the National Institutes
of Health (NIH), in partnership with the Food and Drug Administration (FDA). Westat, an independent
research firm, is conducting the study.
This form describes what we’ll be doing. Please read it or ask me to read it to you. Then, if you decide to be
in the study, I’ll ask you to sign it.
Why are you doing this study?
We want to know more about tobacco and health in the United States. You don’t have to be a tobacco user
to take part in the study. What we learn from you and others who are taking part in the study may help your
community and millions of Americans to be healthier.
Why was I selected for this study?
We can’t talk to every young person in America so we had to pick a smaller number of young people by
chance to take part in the study. This means your answers will represent the answers many other young
people like you would give if they were in the study, too.
What would you like me to do?
We’d like you to answer some questions on a computer. We call this an interview, even though you’ll do it
on a computer, rather than talking with another person. For privacy, you’ll listen to the questions on
headphones. You’ll answer the questions by touching the computer screen. The interview will take about 40
minutes to complete.
We’ll ask about:






What you think about tobacco use and tobacco advertising.
What you know about tobacco.
Your experiences with tobacco.
Your friends’ experiences with tobacco.
Your life and your health.

Public reporting burden for this collection of information is estimated to average 2 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 (0925-0664). Do not return the completed form to
this address.

CM5_V1

You can skip any question that you don’t want to answer and you can stop the interview at any time. You’re
in charge, but we hope you’ll answer all the questions because your answers are important.
The study will continue until November 2015 and perhaps longer. We’ll ask you questions once a year until
the study ends. We may ask you to be part of other study activities too, and you can decide if you want to or
not. We’d like you to be part of the study even when you turn 18. We’re studying adults, so when you turn
18, you can be in the adult part of the study.
What other information will you get about me?
We’ll collect personal information, such as your name, address, and date of birth. We’ll store this
information in a highly secure location to protect it. We may use it to get information about you from
public health records, such as health registries, cancer registries, and vital statistics databases. Health
registries are updated by state public health agencies to keep current information on the health status of
patients who visit hospitals, clinics, laboratories, and doctors’ offices.
We will protect your identity. Your personal information will not be shared with anyone but a small group
of qualified researchers who work on the study; this information will be destroyed when the PATH Study is
over.
Can I change my mind about participating?
Yes, you can say no or stop whenever you want.
If you’re in the study for a while and then stop, we won’t ask for any more data from you. We would like to
use the data already collected about you, unless you ask us not to. You will not be able to withdraw your
data after the study is over; until then, you can ask that your data be destroyed.
Will anything good or bad happen to me if I’m in this study?
Being part of this study may not help you individually. However, the answers you give will be combined
with the answers from many other young people. This information may help to improve the health of your
community and millions of Americans.
Being in the study has a small risk that people might find out personal information about you. We are
taking steps and using safeguards to protect your privacy and keep this from happening at all.
How will you stop people from seeing my information?
We’ll keep your personal information, like your name and address, in a protected and secure computer file.
We’ll keep your answers to the interview questions in a different file with answers from all the other people
in the study.
This means:


Your name won’t be on your answers, so people who work on the study won’t know who you are.



No one in your school or the authorities will know what you tell us.



We’ll combine your answers with those from many other people in the study. We’ll report on this
information only for groups of people, not individuals. This means we can’t put personal
information about you in a report about the study.
CM5_V1



We’ll destroy your personal information when the study is over.

Also, we have a Certificate of Confidentiality. This means that no one doing the study can be forced to give
anyone information about you, including your name. PATH Study researchers do have to give this
information, if a project funded by NIH requests it for an audit or program review.
We’ll protect what you tell us, but you may tell anyone you are participating in this important study. We
may provide your information to others if you have given written permission for them to have it. Even
though it is not what the PATH researchers are studying, if we learn that you or someone else is harming
you or others, we’ll provide information to the police or a social services agency in your community to
protect you or others.
Do I get anything for doing the interview?
Yes. You’ll receive a $25 debit card after you finish the interview this time and in future years as a thank you
for participating. Also, each year you’re in the study, you’ll receive up to $10 as a thank you when you
update your contact information.
Can the people in charge of the study stop it?
Yes. If this happens, we will tell you.
Is there someone I can talk to if I have more questions?
You can ask the interviewer any questions you have about this study.
If you have any questions about the study, call Westat’s toll-free number, 1-888-311-1819, weekdays
between 9:00 a.m. and 9:00 p.m. Eastern Time
If you have any questions about your rights as a PATH study participant, call Westat’s Human Subjects
Protections office at 1-888-920-7631.
Do you have any questions now?
Consent signatures
By signing this form, you give your consent to participate in the PATH Study and complete the interview.
You also agree to being contacted again about participating in future interviews and possibly other study
activities if you choose.
You agree to let the study securely keep your personal information, so we can look for public health records
in the future. You also agree to let state cancer registries give medical information about you to the study
about any cancer diagnosis in the future.
I have read the information about this study or someone has read it to me. I have had a chance to talk about
it and to ask questions. I agree to take part in the study. I will get a copy of this form.
__________________________________________
Signature of Participant

_______ / ______ /______
Month
Day
Year

__________________________________________

_______________________
CM5_V1

Printed Name of Participant

ID # of Interviewer

__________________________________________
Signature of Person Obtaining Consent

_______ / ______ /______
Month
Day
Year

THANK YOU

CM5_V1