Form 15 Attachment 18-7 and 18-8 BEEA IA/NC Informed Consent Air

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

Attachment 18.7: BEEA IA Consent Form for Recently Exposed Group–Air Monitoring Farm
Visit
INFORMED CONSENT DOCUMENT
Study Title:

Biomarkers of Exposures and Effects in Agriculture (BEEA) Study

Principal Investigator:

Charles Lynch MD, PhD, The University of Iowa

Research Team Contact:

Deb Lande, Study Coordinator, The University of Iowa

Lead Investigator:

Jonathan Hofmann, PhD, MPH, National Institutes of Health

This consent form describes the research study to help you decide if you want to participate. This form
provides important information about what you will be asked to do during the study, about the risks and
benefits of the study, and about your rights as a research subject.
• If you have any questions about or do not understand something in this form, you should ask the
research team for more information.
• You should discuss your participation with anyone you choose such as family or friends.
• Do not agree to participate in this study unless the research team has answered your questions
and you decide that you want to be part of this study.
WHAT IS THE PURPOSE OF THIS STUDY?
This is a research study. We are inviting you to participate in this research study because you are a
participant in the Agricultural Health Study.
The purpose of this research study is to investigate how levels of dust in the air are related to different
activities on the farm.
HOW MANY PEOPLE WILL PARTICIPATE?
Approximately 2,200 people in Iowa and North Carolina will take part since the Agricultural Health
Study includes participants from these two states. Of this group, approximately 50 people will take part
in this monitoring study by completing up to four visits where the air around them is monitored while
they are working.
HOW LONG WILL I BE IN THIS STUDY?
Your involvement for the air monitoring study will consist of a full regular work day of up to 8 hours for
each of up to 4 visits.
OMB #: 0925-0406
Expiration date: 09/30/2016
Public reporting for this collection of information is estimated to average 5 minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of
information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it
displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of thisPage
collection
1 of 6of
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.

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

WHAT WILL HAPPEN DURING THIS STUDY?
Study participation will involve completing a maximum of four visits to your farm. During the visit a
person trained in the collection of dust will come to your farm and provide you with a wearable air
sampling pack, which weighs about 4 pounds. You will be asked to wear the air sample pack for a full
day. The trained study personnel will also observe you throughout your working day and record
information about your work. You may ask us to not enter any particular farm equipment, building, or
structure.
You already have received mailings and telephone calls from the study field station in order to schedule
the home visit.
Dust Storage for Future Use
As part of this study, we are obtaining dust samples from your workplace. We would like to study this
dust when the study is over.
The tests we might want to use to study the dust samples may not even exist at this time. Therefore, we
are asking for your permission to store the dust so that we can study it in the future. These future studies
may provide additional information that will be helpful in understanding how occupational and
environmental exposures and lifestyle characteristics cause cancer and other chronic diseases, but it is
unlikely that what we learn from these studies will have a direct benefit to you. It is possible that the
dust collected might be used to develop products or tests that could be patented and licensed. There are
no plans to provide financial compensation to you should this occur.
If you agree now to future use of the dust, but decide in the future that you would like to have it
removed from future research, you should contact Dr. Charles Lynch at 319-384-1558. However, if
some research with the dust has already been completed, the information from that research may still be
used.
Photographs
One aspect of this study involves taking digital photographs of specific farm tasks to help assign
exposure levels to specific activities on the farm. At the end of each farm visit, you can review the
photographs taken, and refuse release of any specific photographs. Only research personnel directly
involved with this study will have access to the photographs you approve for release.
[ ] Yes

[ ] No

I give you permission to take photographs of me and my work setting during this
study.

WHAT ARE THE RISKS OF THIS STUDY?
You may experience one or more of the risks indicated below from being in this study. It is possible,
but very unlikely, that there may be a risk of loss of confidentiality of your information collected during

Page 2 of 6

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

this study. In addition to this, there may be other unknown risks, or risks that we did not anticipate,
associated with being in this study.
WHAT ARE THE BENEFITS OF THIS STUDY?
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.
WILL IT COST ME ANYTHING TO BE IN THIS STUDY?
You will not have any costs for being in this research study.
WILL I RECEIVE A FINANCIAL INCENTIVE FOR PARTICIPATING?
At each farm visit, you will receive $100 as a thank you for your participation in this research study. A
personal check in your name will be provided to you immediately at the end of the farm visit. If you
agree to take part in the four air monitoring visits, you will receive $400 altogether.
WHO IS FUNDING THIS STUDY?
The Department of Health and Human Services (DHHS) National Institutes of Health (NIH) is funding
this research project. This means that the University of Iowa is receiving payments from DHHS/NIH to
support the activities that are required to conduct the study. No one on the research team will receive a
direct payment or increase in salary from DHHS/NIH for conducting this study.
WHAT IF I AM INJURED AS A RESULT OF THIS STUDY?
•
•
•

If you are injured or become ill from taking part in this study, medical treatment is available at the
University of Iowa Hospitals and Clinics.
The University of Iowa does not plan to provide free medical care or payment for treatment of any
illness or injury resulting from this study unless it is the direct result of proven negligence by a
University employee.
If you experience a research-related illness or injury, you and/or your medical or hospital insurance
carrier will be responsible for the cost of treatment.

WHAT ABOUT CONFIDENTIALITY?
We will keep your participation in this research study confidential to the extent permitted by law.
However, it is possible that other people such as those indicated below may become aware of your
participation in this study and may inspect and copy records pertaining to this research. Some of these
records could contain information that personally identifies you.
• Federal government regulatory agencies,
• Iowa Field Station working with the Agricultural Health Study,
• Auditing departments of the University of Iowa,

Page 3 of 6

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

•
•
•

The University of Iowa Institutional Review Board (a committee that reviews and approves
research studies),
Westat, the Agricultural Health Study coordinating center, and
NIH, the sponsor.

To help protect your confidentiality, we will provide multiple safeguards. A study number will identify
you in the database. As you can see on the collection containers, a bar code is being used to identify
you. Your consent forms will be stored in securely locked cabinets when not in use. Computerized data
will be entered into password-protected computers, stored in a secure area, and transmitted in a secure
manner. Training sessions and annual signed confidentiality pledges will emphasize and remind
research personnel the importance of keeping all data strictly confidential. If we write a report or article
about this study or share the study data set with others, we will do so in such a way that you cannot be
directly identified. All statistical analyses and publication of study results will involve grouped data.
To further protect your privacy, we have obtained a Certificate of Confidentiality from the National
Institutes of Health. The researchers can use this Certificate to legally refuse to disclose information that
may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other
proceedings, for example, if there is a court subpoena. The researchers will use the Certificate to resist
any demands for information that would identify you, except for the following: The Certificate cannot
be used to resist a demand for information from personnel of the United States federal or state
government agency sponsoring the project and that will be used for auditing or program evaluation of
agency funded projects. You should understand that a Certificate of Confidentiality does not prevent you
or a member of your family from voluntarily releasing information about yourself or your involvement
in this research. If an insurer, medical care provider, or other person obtains your written consent to
receive research information, then the researchers will not use the Certificate to withhold that
information. You may receive a copy of the Certificate of Confidentiality upon request.
IS BEING IN THIS STUDY VOLUNTARY?
Taking part in this research study is completely voluntary. You may choose not to take part at all.
If you decide to be in this study, you may stop participating at any time. If you decide not to be in this
study, or if you stop participating at any time, you won’t be penalized or lose any benefits for which you
otherwise qualify.
WILL I RECEIVE RESEARCH RESULTS?
The air monitoring results will be used for research purposes only, and the interpretation is unknown at
this time, so we will not be sending any individual results to you.
WHAT IF I HAVE QUESTIONS?
We encourage you to ask questions. If you have any questions about the research study itself, please
call our toll-free number at 1-800-271-1954 and speak to the Study Coordinator, Deb Lande, or ask to
speak with the principal investigator at The University of Iowa, Charles Lynch, MD, PhD. If you
experience a research-related injury, please contact: Charles Lynch, MD, PhD at 319-384-1558.
Page 4 of 6

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

If you have questions, concerns, or complaints about your rights as a research subject or about research
related injury, 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]. General information about being a research subject can be found by clicking “Info for
Public” on the Human Subjects Office web site, http://research.uiowa.edu/hso. To offer input about your
experiences as a research subject or to speak to someone other than the research staff, call the Human
Subjects Office at the number above.

Page 5 of 6

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

This Informed Consent Document is not a contract. It is a written explanation of what will happen
during the study if you decide to participate. You are not waiving any legal rights by signing this
Informed Consent Document. Your signature indicates that this research study has been explained to
you, that your questions have been answered, and that you agree to take part in this study. You will
receive a copy of this form.
Subject's Name (printed): __________________________________________________________

Do not sign this form if today’s date is on or after $STAMP_EXP_DT.

__________________________________________
(Signature of Subject)

_______________________________
(Date)

Statement of Person Who Obtained Consent
I have discussed the above points with the subject or, where appropriate, with the subject’s legally
authorized representative. It is my opinion that the subject understands the risks, benefits, and
procedures involved with participation in this research study.

__________________________________________
(Signature of Person who Obtained Consent)

_______________________________
(Date)

Page 6 of 6

Attachment 18.8: BEEA NC Consent Form for Recently Exposed Group–Air Monitoring Farm
Visit
INFORMED CONSENT DOCUMENT
Study Title:

Biomarkers of Exposures and Effects in Agriculture (BEEA) Study

Principal Investigator:

Marsha Dunn, MPH, Westat

Research Team Contact:

Amy Miller, North Carolina Study Coordinator, Westat

Lead Investigator:

Jonathan Hofmann, PhD, MPH, National Institutes of Health

This consent form describes the research study to help you decide if you want to participate. This form
provides important information about what you will be asked to do during the study, about the risks and
benefits of the study, and about your rights as a research subject.
• If you have any questions about or do not understand something in this form, you should ask the
research team for more information.
• You should discuss your participation with anyone you choose such as family or friends.
• Do not agree to participate in this study unless the research team has answered your questions
and you decide that you want to be part of this study.
WHAT IS THE PURPOSE OF THIS STUDY?
This is a research study. We are inviting you to participate in this research study because you are a
participant in the Agricultural Health Study.
The purpose of this research study is to investigate how levels of dust in the air are related to different
activities on the farm.
HOW MANY PEOPLE WILL PARTICIPATE?
Approximately 2,200 people in Iowa and North Carolina will take part since the Agricultural Health
Study includes participants from these two states. Of this group, approximately 50 people will take part
in this monitoring study by completing up to four visits where the air around them is monitored while
they are working.
HOW LONG WILL I BE IN THIS STUDY?
Your involvement for the air monitoring study will consist of a full regular work day for up to 4 visits.

OMB #: 0925-0406
Expiration date: 09/30/2016
Public reporting for this collection of information is estimated to average 5 minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of
information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it
displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of
Page
of 5
information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive,
MSC1 7974,
Bethesda, MD 20892-7974, ATTN: PRA (0925-0406). Do not return the completed form to this address.

WHAT WILL HAPPEN DURING THIS STUDY?
During the visit a person trained in the collection of dust will come to your farm and provide you with a
wearable air sampling pack, which weighs about 4 pounds. You will be asked to wear the air sample
pack for a full day. The trained study personnel will also observe you throughout your working day and
take some notes. You may ask us to not to enter any particular farm equipment, building, or structure.
You already have received mailings and telephone calls from the study field station in order to schedule
the farm visit.
Dust Storage for Future Use
As part of this study, we are obtaining dust samples from your workplace. We would like to study this
dust when the study is over.
The tests we might want to use to study the dust samples may not even exist at this time. Therefore, we
are asking for your permission to store the dust so that we can study it in the future. These future studies
may provide additional information that will be helpful in understanding how occupational and
environmental exposures and lifestyle characteristics cause cancer and other chronic diseases, but it is
unlikely that what we learn from these studies will have a direct benefit to you. It is possible that the
dust collected might be used to develop products or tests that could be patented and licensed. There are
no plans to provide financial compensation to you should this occur.
If you agree now to future use of the dust, but decide in the future that you would like to have it
removed from future research, you should contact Marsha Dunn at 1-800-4AGSTUDY (1-800-4247883). However, if some research with the dust has already been completed, the information from that
research may still be used.
Photographs
One aspect of this study involves taking digital photographs of specific farm tasks to help assign
exposure levels to specific activities on the farm. At the end of each farm visit, you can review the
photographs taken, and refuse release of any specific photographs. Only research personnel directly
involved with this study will have access to the photographs you approve for release.
[ ] Yes

[ ] No

I give you permission to take photographs of me and my work setting during this
study.

WHAT ARE THE RISKS OF THIS STUDY?
You may experience one or more risks from being in this study. It is possible, but very unlikely, that
there may be a risk of loss of confidentiality of your information collected during this study. In addition
to this, there may be other unknown risks, or risks that we did not anticipate, associated with being in
this study.
WHAT ARE THE BENEFITS OF THIS STUDY?

Page 2 of 5

You will not receive any direct benefits from being in this study. However, we hope that, in the future,
other people might benefit from this study because of the knowledge gained.
WILL IT COST ME ANYTHING TO BE IN THIS STUDY?
You will not have any costs for being in this research study.
WILL I RECEIVE A FINANCIAL INCENTIVE FOR PARTICIPATING?
At each farm visit, you will receive $100 as a thank you for your participation in this research study. A
personal check in your name will be provided immediately to you immediately at the end of the farm
visit. If you agree to take part in the four air monitoring visits, you will receive $400 altogether.
WHO IS FUNDING THIS STUDY?
The Department of Health and Human Services (DHHS) National Institutes of Health (NIH) is funding
this research project. This means that the Westat is receiving payments from DHHS/NIH to support the
activities that are required to conduct the study. No one on the research team will receive a direct
payment or increase in salary from DHHS/NIH for conducting this study.
WHAT IF I AM INJURED AS A RESULT OF THIS STUDY?
•
•

Westat does not plan to provide free medical care or payment for treatment of any illness or injury
resulting from this study unless it is the direct result of proven negligence by a Westat employee.
If you experience a research-related illness or injury, you and/or your medical or hospital insurance
carrier will be responsible for the cost of treatment.

WHAT ABOUT CONFIDENTIALITY?
We will keep your participation in this research study confidential to the extent permitted by law.
However, it is possible that other people such as those indicated below may become aware of your
participation in this study and may inspect and copy records pertaining to this research. Some of these
records could contain information that personally identifies you.
• Federal government regulatory agencies,
• Westat staff working with the Agricultural Health Study,
• The Westat Institutional Review Board (a committee that reviews and approves research
studies), and
• NIH, the sponsor.
To help protect your confidentiality, we will provide multiple safeguards. A study number will identify
you in the database. On sample collection containers, a bar code is used to identify you. Your consent
forms will be stored in securely locked cabinets when not in use. Computerized data will be entered into
password-protected computers, stored in a secure area, and transmitted in a secure manner. Training
sessions and annual signed confidentiality pledges will emphasize and remind research personnel the
importance of keeping all data strictly confidential. If we write a report or article about this study or
share the study data set with others, we will do so in such a way that you cannot be directly identified.
All statistical analyses and publication of study results will involve grouped data.
Page 3 of 5

To further protect your privacy, we have obtained a Certificate of Confidentiality from the National
Institutes of Health. The researchers can use this Certificate to legally refuse to disclose information that
may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other
proceedings, for example, if there is a court subpoena. The researchers will use the Certificate to resist
any demands for information that would identify you, except for the following: The Certificate cannot
be used to resist a demand for information from personnel of the United States federal or state
government agency sponsoring the project and that will be used for auditing or program evaluation of
agency funded projects. You should understand that a Certificate of Confidentiality does not prevent you
or a member of your family from voluntarily releasing information about yourself or your involvement
in this research. If an insurer, medical care provider, or other person obtains your written consent to
receive research information, then the researchers will not use the Certificate to withhold that
information. You may receive a copy of the Certificate of Confidentiality upon request.
IS BEING IN THIS STUDY VOLUNTARY?
Taking part in this research study is completely voluntary. You may choose not to take part at all.
If you decide to be in this study, you may stop participating at any time. If you decide not to be in this
study, or if you stop participating at any time, you won’t be penalized or lose any benefits for which you
otherwise qualify.
WILL I RECEIVE RESEARCH RESULTS?
The air monitoring results will be used for research purposes only, and the interpretation is unknown at
this time, so we will not be sending any individual results to you.
WHAT IF I HAVE QUESTIONS?
We encourage you to ask questions. If you have any questions about the research study itself, please
call our toll-free number at 1-800-4AGSTUDY (1-800-424-7883) and speak to the Study Coordinator,
AmyMiller, or the principal investigator at Westat, Marsha Dunn MD, PhD. If you experience a
research-related injury, please contact: Marsha Dunn at 1-800-4AGSTUDY.
If you have questions, concerns, or complaints about your rights as a research subject or about research
related injury, please contact the Westat Human Subjects Protections Office, by calling 1-888-920-7631,
or e-mail [email protected]. Please leave a message with your full name, the name of the research study
that you are calling about (the Biomarkers of Exposures and Effects in Agriculture or BEEA Study), and
a phone number beginning with the area code. Someone will return your call as soon as possible. To
offer input about your experiences as a research subject or to speak to someone other than the research
staff, call the Human Subjects Protections Office at the number above.

Page 4 of 5

This Informed Consent Document is not a contract. It is a written explanation of what will happen
during the study if you decide to participate. You are not waiving any legal rights by signing this
Informed Consent Document. Your signature indicates that this research study has been explained to
you, that your questions have been answered, and that you agree to take part in this study. You will
receive a copy of this form.
Subject's Name (printed): __________________________________________________________

Do not sign this form if today’s date is on or after $STAMP_EXP_DT.

__________________________________________
(Signature of Subject)

_______________________________
(Date)

Statement of Person Who Obtained Consent
I have discussed the above points with the subject or, where appropriate, with the subject’s legally
authorized representative. It is my opinion that the subject understands the risks, benefits, and
procedures involved with participation in this research study.

__________________________________________
(Signature of Person who Obtained Consent)

_______________________________
(Date)

Page 5 of 5