Attach 7 - Contact and Consent_Forms_2-26-12

Script for initial contact with potential study subjects

You are being asked to participate in a research study that is being conducted by the
[INSERT LOCAL HOSPITAL NAME] and the United States National Institutes of
Health to understand the influence of occupational, environmental, and lifestyle factors
on health. We are carrying out a large health study in your area. Approximately 6600
people from Hong Kong, Taiwan, Chengdu and Tianjin will participate in this study. You
are invited to participate in this study because you have come to this hospital for health
care. To carry out the study, we will interview you with a questionnaire and will collect
some biological samples from you. These activities will not cause any adverse health
effects to you. Your participation will help to understand the health effects of
environmental and occupational exposures and lifestyle. Your participation is totally
voluntary and will not in any way affect your health care. If you decide to participate in
this study, you will be provided with an incentive as a thank you for your time.

Case Consent Form

A Study of Occupation, Environment, and Lifestyle and Health
Informed Consent Form for Cases
INTRODUCTION
You are being asked to participate in a research study that is being conducted by the
[insert local hospital name
] and the United States National Institutes of Health. Your
participation in this study is completely voluntary. You may refuse to participate and/or withdraw your
consent and discontinue participation at any time without any penalty or loss of benefits to which you
would otherwise be entitled. No matter what you decide to do, it will not affect your medical care. The
purpose of this study is to compare the effect that different types of occupational and environmental
exposures have on health. To understand the health effects of these exposures on health, it is important
to collect information on the types of jobs you have had over the course of your life and where you
have lived, as well as additional factors that may influence your health. These include lifestyle factors
(e.g., your diet) and inherited differences in genes that you were born with. Biologic samples including
blood and buccal cells (e.g., mouth cells present in saliva) will be collected to measure your exposure to
several types of exposures that may affect health. Also, we will carry out analyses to determine the
genetic contribution to health using your blood or buccal cell sample, as well as to determine if
variation in your genes is associated with increased or decreased risk of health effects from occupational
and environmental exposures and lifestyle factors. Approximately 6,600 hospitalized men and women
from Hong Kong, Chengdu and Tianjin, China, and Taiwan will participate in this study. If you agree
to participate, you will be asked to complete the following study activities.
PROCEDURES
If you agree to participate in the study, you will be asked to participate in an interview. The interview
will take approximately 60-75 minutes to complete. In addition to the interview, your permission will be
requested to collect blood and buccal cell samples. The minimum requirement for enrollment in this
study is to provide consent to participate in the interview or to provide either a blood or buccal cell
sample.
Collection of Blood, Buccal Cell, and Tissue Specimens
You will be asked to donate a 27 ml blood sample (about 6 teaspoons) and one buccal cell sample
collected by swishing water in your mouth for about a minute. It will take about 30 minutes to collect
these biologic samples. The blood collection will be carried out by a person who is trained and
experienced in drawing blood, and will be collected at the same time as your routine clinical blood draw

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if possible to minimize any discomfort or adverse effects. Also, if you give permission, a tissue sample
that has been obtained from you as part of your regular care at the hospital also will be collected.
The blood, buccal cell, and tissue samples will be kept in storage indefinitely so that we may use them
for this study and for other types of health research of importance to people living in Hong Kong,
Chengdu and Tianjin, China, and Taiwan. This means that your samples may be used both now and in
the future for other types of health research, including genetic studies.
Medical Records
If you give permission, medical records from the hospitals and clinics where you were treated will be
scanned and uploaded into our secure study management system. The medical records will be used to
verify and provide more information about your health. The scanned medical records may be used to
obtain information related to your current diagnosis. Further, if you give permission, your treatment
data and health status will also be collected from your medical records in the future so that we can
study how occupational and environmental exposures, lifestyle, and genetic variation contribute to your
future health.
BENEFITS
You will not benefit directly from participating in this study. However, your participation will benefit
the general population by increasing knowledge related to the health effects of environmental and
occupational exposures.
RISKS
There are no known risks involved with this study. The collection of blood may cause a small amount
of pain and/or temporary bruising at the site of collection.
COMPENSATION
You will receive $22.50 as a thank you for completing the interview, and for donating buccal cells,
tissue, and 27 ml of blood.
NOTIFICATION
Because the importance, meaning, and clinical significance of the research is not known at this time, the
results from the research tests using your blood, buccal cell, and tissue samples will not be given to you,
your doctor, or any irrelevant persons. However, your doctor will be informed if clinically relevant
information is obtained from study review of your tissue sample.
VOLUNTARY PARTICIPATION/RIGHT TO WITHDRAW
The choice to participate in the questionnaire interview, and the collection of blood, buccal cell, and
tissue samples, is up to you. You may choose to participate in some parts of the study, but refuse to
participate in others. You may refuse to answer any specific questions in the questionnaire. You may
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refuse to participate and/or withdraw your consent and discontinue participation at any time without
any penalty or loss of benefits to which you would otherwise be entitled. No matter what you decide to
do, it will not affect your medical care. You may also change your mind at any time about the use of
your blood, buccal cell, and tissue samples, as well as any data collected from the interview or from
medical records. If you decide later that your blood, buccal cell, tissue samples, or any collected data
cannot be kept for research, you should contact [insert local hospital contact name
] , the
leader of the study in [insert local hospital name
] , at the telephone number or address
provided in the “Contact and Questions” section below. The researchers will then destroy any of your
blood, buccal cell, and tissue samples that remain in storage. Otherwise, the blood, buccal cell, and
tissue samples may be kept until they are used up. Your blood, buccal cell, and tissue samples will only
be used for health research and will not be used for any commercial activities. The authority to collect
this information is under 42 USC 285.
All information that is obtained in connection with this study and that could identify you will remain
secure to the extent allowed by applicable laws in [insert country ] and the United States. This
information will be used only for scientific purposes. Only grouped data will be used in analysis, and
no individuals will be able to be identified in the results. None of your biological samples will be labeled
with your name or other personally identifiable information at any point. Biological samples will be
labeled with only a study ID number. Any records that include your name will be kept in locked file
cabinets at [insert local hospital name
] . Access to these records will be restricted to the
designated staff in [insert local hospital name
].
CONTACTS AND QUESTIONS
Please feel free to ask questions about the study. If our study staff cannot answer your questions, you
may contact[insert local hospital contact name and contact information
] . Or, you
may contact [insert respective study center contact name and contact information
].

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Subject ID
(Affix label here)

Now please read the following statements and circle the answer that is right for you. You will be asked
to provide consent to each study activity separately.
(Yes = Agree to the statement; No = Do not agree to the statement).
1. I have read the above information about this research study or it has been explained to
me and I have had the opportunity to ask questions. I understand what will be involved
to participate in the study. I voluntarily agree to participate in this study.
Yes
No
2. I agree to answer questions for the questionnaire part of the study.
Yes
No
3. I agree to make my current medical records available for the study.
Yes
No
4. I agree to make my future medical records available for the study.
Yes
No
5. I agree that my buccal cell sample may be collected for use in the study.
Yes
No
6. I agree that my tissue samples may be used in the study.
Yes
No
7. I agree to provide a 27 ml blood sample (about 6 teaspoons) for use in the study.
Yes
No

Please sign here after you respond to the above statements.

__________________________________________
Signature of Study Subject

_______________________
Date

__________________________________________
Signature of Person Obtaining Consent

_______________________
Date

ID number ____________

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Control Consent Form
A Study of Occupation, Environment, and Lifestyle and Health
Informed Consent Form for Controls
INTRODUCTION
You are being asked to participate in a research study that is being conducted by the
[insert local hospital name
] and the United States National Institutes of Health. Your
participation in this study is completely voluntary. You may refuse to participate and/or withdraw your
consent and discontinue participation at any time without any penalty or loss of benefits to which you
would otherwise be entitled. No matter what you decide to do, it will not affect your medical care. The
purpose of this study is to compare the effect that different types of occupational and environmental
exposures have on health. To understand the health effects of these exposures on health, it is important
to collect information on the types of jobs you have had over the course of your life and where you
have lived, as well as additional factors that may influence your health. These include lifestyle factors
(e.g., your diet) and inherited differences in genes that you were born with. Biologic samples including
blood and buccal cells (e.g., mouth cells present in saliva) will be collected to measure your exposure to
several types of exposures that may affect health. Also, we will carry out analyses to determine the
genetic contribution to health using your blood or buccal cell sample, as well as to determine if
variation in your genes is associated with increased or decreased risk of health effects from occupational
and environmental exposures and lifestyle factors. Approximately 6,600 hospitalized men and women
from Hong Kong, Chengdu and Tianjin, China, and Taiwan will participate in this study. If you agree
to participate, you will be asked to complete the following study activities.
PROCEDURES
If you agree to participate in the study, you will be asked to participate in an interview. The interview
will take approximately 60-75 minutes to complete. In addition to the interview, your permission will be
requested to collect blood and buccal cell samples. The minimum requirement for enrollment in this
study is to provide consent to participate in the interview or to provide either a blood or buccal cell
sample.
Collection of Blood and Buccal Cell Specimens
You will be asked to donate a 27 ml blood sample (about 6 teaspoons) and one buccal cell sample
collected by swishing water in your mouth for about a minute. It will take about 30 minutes to collect
these biologic samples. The blood collection will be carried out by a person who is trained and
experienced in drawing blood, and will be collected at the same time as your routine clinical blood draw
if possible to minimize any discomfort or adverse effects.

B-5

The blood and buccal cell samples will be kept in storage indefinitely so that we may use them for this
study and for other types of health research of importance to people living in Hong Kong, Chengdu
and Tianjin, China, and Taiwan. This means that your samples may be used both now and in the future
for other types of health research, including genetic studies.
Medical Records
If you give permission, medical records from the hospitals and clinics where you were treated will be
scanned and uploaded into our secure study management system. The scanned medical records may be
used to obtain information related to your current diagnosis. The medical records will be used to verify
and provide more information about your health.
BENEFITS

You will not benefit directly from participating in this study. However, your participation will benefit
the general population by increasing knowledge related to the health effects of environmental and
occupational exposures.
RISKS

There are no known risks involved with this study. The collection of blood may cause a small amount
of pain and/or temporary bruising at the site of collection.
COMPENSATION

You will receive $22.50 as a thank you for completing the interview, and for donating buccal cells and
27 ml of blood.
NOTIFICATION

Because the importance, meaning, and clinical significance of the research is not known at this time, the
results from the research tests using your blood and buccal cell samples will not be given to you, your
doctor, or any irrelevant persons.
VOLUNTARY PARTICIPATION/RIGHT TO WITHDRAW

The choice to participate in the questionnaire interview, and the collection of blood and buccal cell,
samples, is up to you. You may choose to participate in some parts of the study, but refuse to
participate in others. You may refuse to answer any specific questions in the questionnaire. You may
refuse to participate and/or withdraw your consent and discontinue participation at any time without
any penalty or loss of benefits to which you would otherwise be entitled. No matter what you decide to
do, it will not affect your medical care. You may also change your mind at any time about the use of
your blood and buccal cell samples, as well as any data collected from the interview or from medical
records. If you decide later that your blood, buccal cell, or any collected data cannot be kept for
research, you should contact [insert local hospital contact name
] local hospital contact
name], the leader of the study in [insert local hospital name
] , at the telephone number or
address provided in the “Contact and Questions” section below. The researchers will then destroy any
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of your blood or buccal cell samples that remain in storage. Otherwise, the blood and buccal cell
samples may be kept until they are used up. Your blood and buccal cell samples will only be used for
health research and will not be used for any commercial activities. The authority to collect this
information is under 42 USC 285.
All information that is obtained in connection with this study and that could identify you will remain
secure to the extent allowed by applicable laws in [insert country ] and the United States. This
information will be used only for scientific purposes. Only grouped data will be used in analysis, and
no individuals will be able to be identified in the results. None of your biological samples will be labeled
with your name or other personally identifiable information at any point. Biological samples will be
labeled with only a study ID number. Any records that include your name will be kept in locked file
cabinets at [insert local hospital name
] . Access to these records will be restricted to the
designated staff in [insert local hospital name
].
CONTACTS AND QUESTIONS

Please feel free to ask questions about the study. If our study staff cannot answer your questions, you
may contact [insert local hospital contact name and contact information
] . Or, you
may contact [insert respective study center contact name and contact information
].

B-7

Subject ID
(Affix label here)

Now please read the following statements and circle the answer that is right for you. You will be asked
to provide consent to each study activity separately.
(Yes = Agree to the statement; No = Do not agree to the statement).
1. I have read the above information about this research study or it has been explained to
me and I have had the opportunity to ask questions. I understand what will be involved
to participate in the study. I voluntarily agree to participate in this study.
Yes
No
2. I agree to answer questions for the questionnaire part of the study.
Yes
No
3. I agree to make my medical records available for the study.
Yes
No
4. I agree that my buccal cell sample may be collected for use in the study.
Yes
No
5. I agree to provide a 27 ml blood sample (about 6 teaspoons) for use in the study.
Yes
No

Please sign here after you respond to the above statements.
________________________________________
Signature of Study Subject

_______________________
Date

________________________________________
Signature of Person Obtaining Consent

_______________________
Date

ID number ____________

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