Attachment 17_BEEA_Letters

Attachment 17_BEEA_Letters.pdf

Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Diseases Among Men and Women in Agriculture (NCI)

Attachment 17_BEEA_Letters

OMB: 0925-0406

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Attachment 17: BEEA Letters
(Intro, Cover, Reminder, Results, Show Cards)

17.1). BEEA Introductory Letter for Iowa Respondents
17.2). BEEA Introductory Letter for North Carolina Respondents
17.3). BEEA Consent Mailing Cover Letter for Iowa Respondents
17.4). BEEA Consent Mailing Cover Letter for North Carolina Respondents
17.5). BEEA Pre-Visit Preparation Show Card for Iowa Respondents
17.6). BEEA Pre-Visit Preparation Show Card for North Carolina Respondents
17.7). BEEA Directions for Urine Specimen Collection for Iowa Respondents
17.8). BEEA Directions for Urine Specimen Collection for North Carolina Respondents
17.9). BEEA Pre-Visit Reminder Letter for Iowa Respondents
17.10). BEEA Pre-Visit Reminder Letter for North Carolina Respondents
17.11). BEEA Letter for Scheduling First Post-Diazinon Application Visit for Iowa
Respondents
17.12). BEEA Letter for Scheduling First Post-Diazinon Application Visit for North
Carolina Respondents
17.13). BEEA NCI Letter for CBC Lymphocyte Assay Results
17.14). BEEA Letter to Contact Us for Iowa Respondents – Both Groups
17.15). BEEA Letter to Contact Us for North Carolina Respondents – Both Groups

FOR IRB USE ONLY
$STAMP_IRB
$STAMP_IRB_ID
$STAMP_APPRV_DT
$STAMP_EXP_DT

OMB NO.: 0925-0406
EXPIRATION DATE: XX/XX/2016

Attachment 17.1:
Study of Biomarkers of Exposures and Effects in Agriculture
Pre-Screening Initial Contact Letter (Both Groups)
Date
To:
Mr. 
From: Charles Lynch, M.D., Ph.D.
Director, Iowa Field Station
Thank you for your participation in the Agricultural Health Study (AHS). We appreciate
the time you have already taken over the years to complete the study interviews and
questionnaires.
A new study is underway for the AHS that is designed to measure biologic effects in
relation to different farming exposures and activities. Overall, 1,600 Agricultural Health Study
members will be enrolled over the next five years of the study. The study is being funded by the
National Cancer Institute and the US Environmental Protection Agency.
This study will examine the properties of blood and urine that may be related to
environmental or occupational factors and life-style characteristics. Improving our understanding
of these relationships will help us in our evaluation of possible links between pesticide exposure
and disease. We are particularly interested in cancers. We believe our long-term study of rural
Iowans may help us better understand these illnesses and eventually prevent them.
We plan to call you within the next few weeks to determine if you are truly eligible to
participate in this study. Up to 5 call attempts will be made at different times of the day and at
different days to reach you. Among the questions we will ask are three aimed toward improving
our understanding of your cancer screening practices. The call will take 10 minutes or less.
Once we determine your eligibility for the study and you tell us that you are interested in
participating, we will schedule a home visit with you. Prior to the home visit, you will receive
materials from us including two copies of the consent document, a reminder card for key
elements of the questionnaire, and urine collection materials. At the time of the home visit we
will obtain your signed consent to participate in this study. We will also conduct a 30-minute
interview to obtain information about your recent medication use, medical conditions, smoking
status, alcohol consumption, and pesticide use during the current/previous growing season. We
will ask you to provide about 3 tablespoons of blood and a first morning sample of urine. This
will take about 30 minutes. In all, the visit would take about an hour of your time.
All of the information we collect will be used only for research purposes and will be kept
strictly confidential. However, federal regulatory agencies and the University of Iowa
Institutional Review Board (a committee that reviews and approves research studies) may inspect
and copy records pertaining to this research. Neither your name nor any personal information
will ever appear in any reports generated from this study. The physical risks associated with the
main portion of the study are minimal and include those associated with blood collection. Rarely,
there may be swelling or bruising. It is also possible, but very unlikely, that there may be a risk
of loss of confidentiality of your information collected during this study. There should be no risk
for answering the questions regarding the cancer screening practices. You will not benefit from
being in this study. However, we hope that, in the future, other people might benefit from this
Privacy Act Notification: 42 U.S.C. 285a of the Public Health Service Act authorizes collection of this information. It
will be used to evaluate the role of agricultural exposures and other factors in the development of cancer, neurological
disease, birth defects and other chronic diseases. All information is voluntary and if you decide not to provide all or
any part of the requested information you will not be penalized or lose any benefits for which you otherwise qualify.
We will keep your participation in this research study confidential to the extent permitted by law.

FOR IRB USE ONLY
$STAMP_IRB
$STAMP_IRB_ID
$STAMP_APPRV_DT
$STAMP_EXP_DT

OMB NO.: 0925-0406
EXPIRATION DATE: XX/XX/2016

Attachment 17.1:
study because of the knowledge gained.
You should not have any costs for being in this study. You will receive $75.00 as a thank
you for your participation in the main portion of the research study. You will not receive a
financial incentive for answering the questions regarding cancer screening practices.
We want you to know that your participation in any activity of the Agricultural Health
Study is always voluntary. Be assured that there will be no penalties if you decide not to respond,
either to the information collection as a whole or to any particular question.
If you have any questions, concerns or do not want to participate, please contact
Ellen Heywood, study coordinator at 1-800-217-1954. Please specify that you are calling
about the Biomarkers of Exposures and Effects in Agriculture (BEEA) Study. If you have
questions or concerns about your rights as a research subject please contact the Human Subjects
Office, 300 College of Medicine Administration Building, The University of Iowa, Iowa City,
Iowa, 52242, (319) 335-6564, or e-mail [email protected]. This study’s IRB number is
201002777. Again, we want to thank you for your assistance in making the Agricultural Health
Study an important and successful study of health in the agricultural community. We look
forward to speaking with you soon.

Privacy Act Notification: 42 U.S.C. 285a of the Public Health Service Act authorizes collection of this information. It
will be used to evaluate the role of agricultural exposures and other factors in the development of cancer, neurological
disease, birth defects and other chronic diseases. All information is voluntary and if you decide not to provide all or
any part of the requested information you will not be penalized or lose any benefits for which you otherwise qualify.
We will keep your participation in this research study confidential to the extent permitted by law.

OMB NO.: 0925-0406
EXPIRATION DATE: XX/XX/2016

Attachment 17.2:
Study of Biomarkers of Exposures and Effects in Agriculture
NC Introductory Contact Letter (Both Groups)
Date
To:
Mr. 
From: Marsha Dunn, MPH
Director, Agricultural Health Study in North Carolina
Thank you for your participation in the Agricultural Health Study (AHS). We appreciate
the time you have already taken over the years to complete the study interviews and
questionnaires.
A new study is underway for the AHS that is designed to measure biologic effects in
relation to different farming exposures and activities. Overall, 1,600 Agricultural Health Study
members will be enrolled over the next several years of the study. The study is being funded by
the National Cancer Institute and the US Environmental Protection Agency.
This study will examine the properties of blood and urine as well as dust samples from a
subset of households that may be related to environmental or occupational factors and life-style
characteristics. Improving our understanding of these relationships will help us in our evaluation
of possible links between pesticide exposure and disease. We are particularly interested in
cancers. We believe our long-term study may help us better understand these illnesses and
eventually prevent them.
We plan to call you within the next few weeks to determine if you are truly eligible to
participate in this study. Up to 5 call attempts will be made at different times of the day and at
different days to reach you. Among the questions we will ask are three aimed toward improving
our understanding of your cancer screening practices. The call will take 10 minutes or less.
Once we determine your eligibility for the study and you tell us that you are interested in
participating, we will schedule a home visit with you. Prior to the home visit, you will receive
materials from us including two copies of the consent document, a reminder card for key
elements of the questionnaire, and urine collection materials. At the time of the home visit we
will obtain your signed consent to participate in this study. We will also conduct a 30-minute
interview to obtain information about your recent medication use, medical conditions, smoking
status, alcohol consumption, and pesticide use during the current/previous growing season. We
will ask you to provide about 3 tablespoons of blood and a first morning sample of urine. This
will take about 30 minutes. In all, the visit would take about an hour of your time.
All of the information we collect will be used only for research purposes and will be kept
strictly confidential. However, federal regulatory agencies and the Westat Institutional Review
Board (a committee that reviews and approves research studies) may inspect and copy records
pertaining to this research. Neither your name nor any personal information will ever appear in
any reports generated from this study. The physical risks associated with the main portion of the
study are minimal and include those associated with blood collection. Rarely, there may be
swelling or bruising. It is also possible, but very unlikely, that there may be a risk of loss of
confidentiality of your information collected during this study. There should be no risk for
answering the questions regarding the cancer screening practices. You will not benefit from
being in this study. However, we hope that, in the future, other people might benefit from this
study because of the knowledge gained.
You should not have any costs for being in this study. You will receive $75.00 as a thank
you for your participation in the main portion of the research study. You will not receive a
Privacy Act Notification: 42 U.S.C. 285a of the Public Health Service Act authorizes collection of this information. It
will be used to evaluate the role of agricultural exposures and other factors in the development of cancer, neurological
disease, birth defects and other chronic diseases. All information is voluntary and if you decide not to provide all or
any part of the requested information you will not be penalized or lose any benefits for which you otherwise qualify.
We will keep your participation in this research study confidential to the extent permitted by law.

OMB NO.: 0925-0406
EXPIRATION DATE: XX/XX/2016

Attachment 17.2:
financial incentive for answering the questions regarding cancer screening practices.
We want you to know that your participation in any activity of the Agricultural Health
Study is always voluntary. Be assured that there will be no penalties if you decide not to respond,
either to the information collection as a whole or to any particular question.
If you have any questions, concerns or do not want to participate, please contact
Amy Miller, study coordinator, at 1-800-4AGSTUDY (1-800-424-7883). Please specify that
you are calling about the Biomarkers of Exposures and Effects in Agriculture (BEEA)
Study. If you have questions or concerns about your rights as a research subject please contact

Sharon Zack of the Westat Human Subjects Office, 1-800-937-8281, or e-mail
[email protected]. Again, we want to thank you for your assistance in making the Agricultural
Health Study an important and successful study of health in the agricultural community. We look
forward to speaking with you soon.

Privacy Act Notification: 42 U.S.C. 285a of the Public Health Service Act authorizes collection of this information. It
will be used to evaluate the role of agricultural exposures and other factors in the development of cancer, neurological
disease, birth defects and other chronic diseases. All information is voluntary and if you decide not to provide all or
any part of the requested information you will not be penalized or lose any benefits for which you otherwise qualify.
We will keep your participation in this research study confidential to the extent permitted by law.

FOR IRB USE ONLY
$STAMP_IRB
$STAMP_IRB_ID
$STAMP_APPRV_DT
$STAMP_EXP_DT

OMB NO.: 0925-0406
EXPIRATION DATE: 5/31/2013

Attachment 17.3:
Study of Biomarkers of Exposures and Effects in Agriculture
Consent Mailing Letter (Both Groups)

Date
To:
Mr. 
From: Charles Lynch, M.D., Ph.D.
Director, Iowa Field Station
I want to thank you for taking the time to speak with us recently and for
expressing interest in participating in the Agricultural Health Study’s Study of
Biomarkers of Exposures and Effects in Agriculture (BEEA).
This letter is to confirm our appointment at your home, {address}, on
{Day of week, DATE}
{TIME}
for a home visit for the BEEA Study. Before the appointment, please take some time to
review the enclosed materials, which include a home visit preparation sheet, directions
for collection of the urine sample, and a consent form. The consent form describes what
will happen during the home visit, foreseeable benefits and risks (such as possible
bruising after a blood draw), an explanation of the study’s confidentiality procedures and
who to contact for answers to questions about the home visit. We have provided two
copies of the consent form. Please sign both – one will be collected by the study
examiner at your home visit and the other you may keep for your records.
We will be calling you within the next week to confirm the appointment and
verify receipt of these materials. We will be happy to answer any questions you have at
that time. Please read the information sheet on preparation for the home visit carefully
and follow the instructions precisely. If you have any questions about the instructions,
please ask them when we call you.
If you have any questions or concerns, please contact Ellen Heywood, study
coordinator at 1-800-217-1954. Please specify that you are calling about the
Biomarkers of Exposures and Effects in Agriculture (BEEA) Study. If you have
questions or concerns about your rights as a research subject please contact the Human
Subjects Office, 105 Hardin Library for the Health Sciences, 600 Newton Road,
University of Iowa, Iowa City, IA 52242-1098, (319) 335-6564, or e-mail
[email protected]. Again, we want to thank you for your assistance in making the
Privacy Act Notification: 42 U.S.C. 285a of the Public Health Service Act authorizes collection of this information. It
will be used to evaluate the role of agricultural exposures and other factors in the development of cancer, neurological
disease, birth defects and other chronic diseases. All information is voluntary and if you decide not to provide all or
any part of the requested information you will not be penalized or lose any benefits for which you otherwise qualify.
We will keep your participation in this research study confidential to the extent permitted by law.

FOR IRB USE ONLY
$STAMP_IRB
$STAMP_IRB_ID
$STAMP_APPRV_DT
$STAMP_EXP_DT

OMB NO.: 0925-0406
EXPIRATION DATE: 5/31/2013

Agricultural Health Study an important and successful study of health in the agricultural
community. We look forward to speaking with you soon.

Privacy Act Notification: 42 U.S.C. 285a of the Public Health Service Act authorizes collection of this information. It
will be used to evaluate the role of agricultural exposures and other factors in the development of cancer, neurological
disease, birth defects and other chronic diseases. All information is voluntary and if you decide not to provide all or
any part of the requested information you will not be penalized or lose any benefits for which you otherwise qualify.
We will keep your participation in this research study confidential to the extent permitted by law.

OMB NO.: 0925-0406
EXPIRATION DATE: 5/31/2013

Attachment 17.4:
Study of Biomarkers of Exposures and Effects in Agriculture
NC Consent Mailing Letter (Both Groups)

Date
To:
Mr. 
From: Marsha Dunn, MPH.
Director, Agricultural Health Study in North Carolina
I want to thank you for taking the time to speak with us recently and for
expressing interest in participating in the Agricultural Health Study’s Study of
Biomarkers of Exposures and Effects in Agriculture (BEEA).
This letter is to confirm our appointment at your home, {address}, on
{Day of week, DATE}
{TIME}
for a home visit for the BEEA Study. Before the appointment, please take some time to
review the enclosed materials, which include a home visit preparation sheet, directions
for collection of the urine sample, and a consent form. The consent form describes what
will happen during the home visit, foreseeable benefits and risks (such as possible
bruising after a blood draw), an explanation of the study’s confidentiality procedures and
who to contact for answers to questions about the home visit. We have provided two
copies of the consent form. Please sign both – one will be collected by the study
examiner at your home visit and the other you may keep for your records.
We will be calling you within the next week to confirm the appointment and
verify receipt of these materials. We will be happy to answer any questions you have at
that time. Please read the information sheet on preparation for the home visit carefully
and follow the instructions precisely. If you have any questions about the instructions,
please ask them when we call you.
If you have any questions or concerns, please contact Amy Miller, study
coordinator at 1-800-4AGSTUDY (1-800-424-7883). Please specify that you are
calling about the Biomarkers of Exposures and Effects in Agriculture (BEEA)
Study. If you have questions or concerns about your rights as a research subject please
contact Sharon Zack of the Westat Human Subjects Office, by calling 1-800-937-8281, or
e-mail [email protected]. Again, we want to thank you for your assistance in making the
Agricultural Health Study an important and successful study of health in the agricultural
community. We look forward to speaking with you soon.

Privacy Act Notification: 42 U.S.C. 285a of the Public Health Service Act authorizes collection of this information. It
will be used to evaluate the role of agricultural exposures and other factors in the development of cancer, neurological
disease, birth defects and other chronic diseases. All information is voluntary and if you decide not to provide all or
any part of the requested information you will not be penalized or lose any benefits for which you otherwise qualify.
We will keep your participation in this research study confidential to the extent permitted by law.

Attachment 17.5:  BEEA IA Pre‐Visit Preparation Showcard 
In preparation for your interview, please record the product name,
active ingredient, and EPA registration number of the pesticides
you personally mixed, loaded, handled or applied in the past 12
months. This information is available from the product label. We
will collect this information at your visit.

Attention BEEA Study
Participants!
It is important that you make
the following preparations for
your study visit:

Product Name

Active Ingredient

Consent Form
Please take some time to review the consent form so you can be
prepared to complete it with the interviewer. The interviewer will address
any questions or concerns you may have at the beginning of your visit,
or you may also call us at the number below.

EPA
Registration #

Prescription Medications
We will be asking you about the prescription medications you take
regularly. Please assemble them in their original containers so they are
ready to review with the interviewer.
Pesticide Use in the Past 12 Months
We will be asking you about pesticides you have used in the past 12
months. This includes use of herbicides, insecticides, fungicides,
fumigants, or other chemicals used to kill plants, insects, fungi, molds, or
rodents. Do not include antibiotics, sanitizers, antimicrobial soaps, or
fertilizers. For each product, we will ask for the product name, active
ingredient, and EPA registration number, as well as about total days of
use, and dates of most recent use. Please use the back of this card to
help you prepare this information.
Urine Sample Collection
Please review the Directions for Urine Collection and the materials in the
collection kit. It is very important that you collect the urine sample on the
morning of your visit.

Please call us at 1-800-217-1954 if you have any questions.

 

 
Public reporting burden for this collection of information is estimated to average five 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 

 

Attachment 17.5:  BEEA IA Pre‐Visit Preparation Showcard 
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 (0925‐0406).  Do not return the completed form to this address. 

 

Attachment 17.6:  BEEA NC Pre‐Visit Preparation Showcard 

Attention BEEA Study
Participants!
It is important that you make
the following preparations for
your study visit:

In preparation for your interview, please record the product name,
active ingredient, and EPA registration number of the pesticides
you personally mixed, loaded, handled or applied in the past 12
months. This information is available from the product label. We
will collect this information at your visit.
Product Name

Active Ingredient

Consent Form
Please take some time to review the consent form so you can be
prepared to complete it with the interviewer. The interviewer will address
any questions or concerns you may have at the beginning of your visit,
or you may also call us at the number below.

EPA
Registration #

Prescription Medications
We will be asking you about the prescription medications you take
regularly. Please assemble them in their original containers so they are
ready to review with the interviewer.
Pesticide Use in the Past 12 Months
We will be asking you about pesticides you have used in the past 12
months. This includes use of herbicides, insecticides, fungicides,
fumigants, or other chemicals used to kill plants, insects, fungi, molds, or
rodents. Do not include antibiotics, sanitizers, antimicrobial soaps, or
fertilizers. For each product, we will ask for the product name, active
ingredient, and EPA registration number, as well as about total days of
use, and dates of most recent use. Please use the back of this card to
help you prepare this information.
Urine Sample Collection
Please review the Directions for Urine Collection and the materials in the
collection kit. It is very important that you collect the urine sample on the
morning of your visit.

Please call us at 1-800-424-7883 if you have any questions.

 

 
Public reporting burden for this collection of information is estimated to average five 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 (0925‐0406).  Do not return the completed form to this address. 

Agricultural Health Study
Study of Biomarkers of Exposures and Effects in Agriculture

Attachment 17.7: BEEA IA DIRECTIONS FOR URINE COLLECTION
Please follow the directions below. You may request help reading the instructions from a member of
your household, but please do not permit anyone else to handle the collection materials.
Here is a list of what you should find in the package we mailed to you:
• 2 copies of the Informed Consent Form
• Screw top collection container
• Brown paper bag

If you have not received all of these materials, please call us at 1-800-2171954. Please specify that you are calling about the Biomarkers of Exposures
and Effects in Agriculture (BEEA) Study.
1.

Read and sign both copies of the Informed Consent Form. We will collect one copy at your home
visit (the other copy is yours to keep).

2.

To help you remember to collect your wake-up urine sample on the day of your home visit, leave
the urine collection bottle on the toilet seat lid the night before.

3.

When you wake up in the morning, wash your hands before opening the collection container.

4.

Urinate directly into the container.

5.

Replace the top on the collection container and screw it on tightly. Place the sample inside the
brown paper bag.

6.

Store the sample in the refrigerator.

7.

We will pick up the sample at your home visit.

THANK YOU FOR YOUR HELP!

Agricultural Health Study
Study of Biomarkers of Exposures and Effects in Agriculture

Attacment 17.8: BEEA NC DIRECTIONS FOR URINE COLLECTION
Please follow the directions below. You may request help reading the instructions from a member of
your household, but please do not permit anyone else to handle the collection materials.
Here is a list of what you should find in the package we mailed to you:
• 2 copies of the Informed Consent Form
• Screw top collection container
• Brown paper bag

If you have not received all of these materials, please call us at 1-800-4247883. Please specify that you are calling about the Biomarkers of Exposures
and Effects in Agriculture (BEEA) Study.
1.

Read and sign both copies of the Informed Consent Form. We will collect one copy at your home
visit (the other copy is yours to keep).

2.

To help you remember to collect your wake-up urine sample on the day of your home visit, leave
the urine collection bottle on the toilet seat lid the night before.

3.

When you wake up in the morning, wash your hands before opening the collection container.

4.

Urinate directly into the container.

5.

Replace the top on the collection container and screw it on tightly. Place the sample inside the
brown paper bag.

6.

Store the sample in the refrigerator.

7.

We will pick up the sample at your home visit.

THANK YOU FOR YOUR HELP!

OMB NO.: 0925-0406
EXPIRATION DATE: 5/31/2013

Attachment 17.9:
Study of Biomarkers of Exposures and Effects in Agriculture
Pre-Visit Reminder Letter (Both Groups/All Visits)

Date
To:
Mr. 
From: Charles Lynch, M.D., Ph.D.
Director, Agricultural Health Study in Iowa
This letter is to remind you about our appointment at your home, {STREET
ADDRESS/CITY/STATE/ZIP} on {DATE} at {TIME} for a home visit for the
Biomarkers of Exposures and Effects in Agriculture (BEEA) Study.
We will be calling you within the next week to confirm the appointment and
answer any questions you have.
Please review the information sheet on preparation for the home visit carefully
and follow the instructions precisely. Note that for the duration of the visit, we will need
quiet, uninterrupted time with you, and an area with a table such as a kitchen or dining
room. If you have any questions about the instructions, please ask them when we call
you before the visit.
If you have any questions or concerns, please contact Deb Lande, study
coordinator at 1-800-217-1954. Please specify that you are calling about the BEEA
Study. If you have questions or concerns about your rights as a research subject please
contact the Human Subjects Office, 105 Hardin Library for the Health Sciences, 600
Newton Road, University of Iowa, Iowa City, IA 52242-1098300 College of Medicine
Administration Building, The University of Iowa, Iowa City, Iowa, 52242, (319) 3356564, or e-mail [email protected]. Again, we want to thank you for your assistance in
making the Agricultural Health Study an important and successful study of health in the
agricultural community. We look forward to speaking with you soon.

OMB NO.: 0925-0406
EXPIRATION DATE: 5/31/2013

Attachment 17.10:
Study of Biomarkers of Exposures and Effects in Agriculture
Pre-Visit Reminder Letter (Both Groups/All Visits)

Date
To:
Mr. 
From: Marsha Dunn, MPH
Director, Agricultural Health Study in North Carolina
This letter is to remind you about our appointment at your home, {STREET
ADDRESS/CITY/STATE/ZIP} on {DATE} at {TIME} for a home visit for the
Biomarkers of Exposures and Effects in Agriculture (BEEA) Study.
We will be calling you within the next week to confirm the appointment and
answer any questions you have.
Please review the information sheet on preparation for the home visit carefully
and follow the instructions precisely. Note that for the duration of the visit, we will need
quiet, uninterrupted time with you, and an area with a table such as a kitchen or dining
room. If you have any questions about the instructions, please ask them when we call
you before the visit.
If you have any questions or concerns, please contact Amy Miller, study
coordinator, at 1-800-4AGSTUDY (1-800-424-7883). Please specify that you are calling
about the BEEA Study. If you have questions or concerns about your rights as a research
subject please contact Sharon Zack, of the Westat Human Subjects Office, by calling 1800-937-8281, or e-mail [email protected]. Again, we want to thank you for your
assistance in making the Agricultural Health Study an important and successful study of
health in the agricultural community. We look forward to speaking with you soon.

Attachment 17.11: BEEA IA Scheduling Letter for First Post-Diazinon
Application Visit (Recent Exposure Group only)
Study of Biomarkers of Exposures and Effects in Agriculture
(to be sent in advance of the “month out” call)
Date
To:
Mr. 
From: Charles Lynch, M.D., Ph.D.
Director, Iowa Field Station
I want to thank you for participating in the Agricultural Health Study’s
Biomarkers of Exposures and Effects in Agriculture (BEEA) Study and for taking the
time to complete the first home visit with us. You may recall that you consented to
receiving two additional visits to your home: one within a day after you complete
diazinon use, and one about three weeks later. You noted previously that you thought
that you would {apply/make the decision about applying} diazinon in .
We will be calling you within the next week to verify your schedule for applying
diazinon and to find out when you may be ready to schedule the next home visit. The
call will take 5 minutes or less.
If you have any questions or concerns, please contact Ellen Heywood, study
coordinator at 1-800-217-1954. Please specify that you are calling about the BEEA
Study. If you have questions or concerns about your rights as a research subject please
contact the Human Subjects Office, 300 College of Medicine Administration Building,
The University of Iowa, Iowa City, Iowa, 52242, (319) 335-6564, or e-mail
[email protected]. Again, we want to thank you for your assistance in making the
Agricultural Health Study an important and successful study of health in the agricultural
community. We look forward to speaking with you soon.

Attacment 17.12: BEEA NC Scheduling Letter for First Post-Diazinon Application Visit
(Recent Exposure Group only)
Study of Biomarkers of Exposures and Effects in Agriculture
(to be sent in advance of the “month out” call)
Date
Dear Mr. ,
I want to thank you for participating in the Agricultural Health Study’s Biomarkers of
Exposures and Effects in Agriculture (BEEA) Study and for taking the time to complete the first
home visit with us. You may recall that you consented to receiving two additional visits to your
home: one within a day after you complete diazinon use, and one about three weeks later. You
noted previously that you thought that you would {apply/make the decision about applying}
diazinon in .
We will be calling you within the next week to verify your schedule for applying
diazinon and to find out when you may be ready to schedule the next home visit. The call will
take 5 minutes or less.
If you have any questions or concerns, please contact Margaret Hayslip, study
coordinator toll free at 1-800-424-7883. Please specify that you are calling about the Biomarkers
of Exposures and Effects in Agriculture (BEEA) Study. If you have questions or concerns about
your rights as a research subject please contact the Battelle Institutional Review Board toll-free
at (877) 810-9530 ext. 500.Again, we want to thank you for your assistance in making the
Agricultural Health Study an important and successful study of health in the agricultural
community. We look forward to speaking with you soon.

Sincerely,

Charles Knott, MPA, PMP
Director, North Carolina Field Station

Attachment 17.13: BEEA NCI Letter for CBC lymphocyte Assay Results
DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

National Institutes of Health
Bethesda, Maryland 20892

Dear Mr.,xxxxx
We would like to thank you once again for taking the time and effort to participate in the
Agricultural Health Study (AHS) and the Study of Biomarkers of Exposures and Effects in
Agriculture (BEEA). I hope we were able to answer any questions you had about our
research, but if you have additional questions or concerns, please do not hesitate to contact
us at any time. We are conducting the BEEA study because we are interested in changes
that may occur in the blood and urine when people are exposed to occupational and
environmental chemicals and substances. We are also interested in differences in other
body processes that are affected by lifestyle and the environment. The material in the blood
and urine samples that we collected will allow us to study these differences in relation to
cancer risk, and help understand the causes of cancer and other chronic diseases.
I am enclosing a copy of the clinical lab results which were done as part of our home visit.
Your [INSERT RELEVANT MEASUREMENT] was slightly elevated. You might wish to have
this test repeated by your local physician.
Thank you again for your interest and participation in our research. Without the help of
individuals such as you our work would not be possible. We truly appreciate the time and
effort on your part to be a part of this study. Please feel free to contact us at any time if you
have questions with which we can be of assistance.
Sincerely,

Neil Caporaso, MD
National Cancer Institute
Genetic Epidemiology Branch
6120 Executive Blvd. MSC 7236
Rockville, MD 20850-7236
(301) 496-4377
[email protected]

FOR IRB USE ONLY
$STAMP_IRB
$STAMP_IRB_ID
$STAMP_APPRV_DT
$STAMP_EXP_DT

OMB NO.: 0925-0406
EXPIRATION DATE: XX/XX/2016

Attachment 17.14:
Study of Biomarkers of Exposures and Effects in Agriculture
Contact the Field Station Letter (Both Groups)
Date
To:
Mr. 
From: Charles Lynch, M.D., Ph.D.
Director, Iowa Field Station
Thank you for your participation in the Agricultural Health Study (AHS). We appreciate
the time you have already taken over the years to complete the study telephone interviews and
questionnaires.
We recently sent you a letter to invite you to take part in a new study designed to measure
biologic effects in relation to different farming exposures and activities. We would like to tell you
more about the study and find out if you may be eligible for the study and interested in
participating. If so, we will schedule a home visit with you which will take a little over an hour of
your time. You will receive $75.00 as a thank you for your participation in this research study.
We tried to reach you to determine if you are truly eligible to participate in this study.
Unfortunately, your telephone number was no longer in service. Could you please call
[study coordinator], study coordinator, at  to let us know whether or not you
are interested in participating in this study, or if you have any questions? Please specify
that you are calling about the Biomarkers of Exposures and Effects in Agriculture (BEEA)
Study.
Again, we want to thank you for your assistance in making the Agricultural Health Study
an important and successful study of health in the agricultural community. We look forward to
speaking with you soon.

OMB NO.: 0925-0406
EXPIRATION DATE: XX/XX/2016

Attachment 17.15:
Study of Biomarkers of Exposures and Effects in Agriculture
NC “Contact Us” Letter (Both Groups)
Date
To:
Mr. 
From: Marsha Dunn, MPH.
Director, Agricultural Health Study in North Carolina
Thank you for your participation in the Agricultural Health Study (AHS). We appreciate
the time you have already taken over the years to complete the study telephone interviews and
questionnaires.
We recently sent you a letter to invite you to take part in a new study designed to measure
biologic effects in relation to different farming exposures and activities. We would like to tell you
more about the study and find out if you may be eligible for the study and interested in
participating. If so, we will schedule a home visit with you which will take a little over an hour of
your time. You will receive $75.00 as a thank you for your participation in this research study.
We tried to reach you to determine if you are truly eligible to participate in this study.
Unfortunately, your telephone number was no longer in service. Could you please call Amy
Miller, study coordinator, at 1-800-4AGSTUDY (1-800-424-7883) to let us know whether
or not you are interested in participating in this study, or if you have any questions? Please
specify that you are calling about the Biomarkers of Exposures and Effects in Agriculture
(BEEA) Study.
Again, we want to thank you for your assistance in making the Agricultural Health Study
an important and successful study of health in the agricultural community. We look forward to
speaking with you soon.


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File TitleMicrosoft Word - Attachment 17_BEEA_Letters_Cover.docx
AuthorErevak
File Modified2012-11-07
File Created2012-09-24

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