Attach 14A-14B Phase III Buccal Cell Consent Forms

ATTACHMENT 14

Phase III Buccal Cell Consent Form
14A. Phase III Buccal Cell Consent Form for Iowa Respondents
14B. Phase III Buccal Cell Consent Form for North Carolina
Respondents

Attachment 14A: Phase III Buccal Cell Consent Form for Iowa Respondents
FOR IRB USE ONLY
APPROVED BY: IRB-01
IRB ID #: 200612708
APPROVAL DATE: 3/31/08
EXPIRATION DATE: 3/31/09

The Agricultural Health Study (AHS)
Informed Consent Form
Study Title:

Buccal (Mouth) Cell Collection for the AHS

Principal Investigator:

Charles Lynch, M.D., Ph.D., University of Iowa

Lead Investigator:

Michael Alavanja, Dr. P.H., National Institutes of Health

Co-Investigators:

Aaron Blair, Ph.D., National Cancer Institute; Dale Sandler, Ph.D., National
Institute of Environmental Health Sciences; Charles Knott, M.P.A., Battelle
Centers for Public Health Research and Evaluation

Study Purpose:

The purpose of this study is to collect buccal (mouth) cells from participants in the Agricultural
Health Study. We are inviting you to participate in this research study because you are a
participant in the Agricultural Health Study. The collection of this sample will supplement the
questionnaire information you have already provided to us. We are interested in the way people
process cancer causing substances, such as those coming from environmental exposures. We are
also interested in differences in other body processes that are affected by lifestyle and the
environment. The material in the buccal cell samples will allow us to study these differences in
relation to cancer risk, and help understand the causes of cancer.

Number of
Participants:

Approximately 1,000 people will take part in the collection of buccal cell samples for the
Agricultural Health Study at the University of Iowa.

Study Procedures:

We are asking you to collect loose cells from your mouth by swishing about one tablespoon of
mouthwash in your mouth and then discharging it into the container provided. This should take
only 5 minutes of your time.

Risks and Benefits:

There is no known physical risk associated with this collection of cells from your mouth. There
may be a risk of loss of confidentiality of your information collected during this study. Please
refer to the section below entitles “Future Research Studies and Confidentiality” which describes
the protections in place to protect your confidentiality.
Although you will receive no personal benefit, we hope that the knowledge gained from this
research may eventually benefit others.

Costs and Payments: You will not have any costs from being in this study. All costs of collecting and mailing back the
samples are covered by the study. You will be paid $5 for being in this study.
Funding for 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.

Future Research
Studies and
Confidentiality:

The buccal cell sample you give us will be used to study genes that may play a part in why some
people develop cancer. They will be used only to study cancer and other chronic diseases that
may be related to agricultural exposures. The exact studies that will be performed are not all
known at this time but are likely to include the following: 1) the study of differences in genes that
may be related to how people process disease-causing substances; and 2) the study of how the
effects of diet, lifestyle, the environment, occupational exposures, race/ethnicity, age and other
factors may be related to these genes. We will keep your participation in this research study
confidential to the extent permitted by law. However, it is possible that other people may become
aware of your participation in this study. For example, federal government regulatory agencies,
auditing departments of the University of Iowa, and the University of Iowa Institutional Review
page 1 of 2

Attachment 14A: Phase III Buccal Cell Consent Form for Iowa Respondents
FOR IRB USE ONLY
APPROVED BY: IRB-01
IRB ID #: 200612708
APPROVAL DATE: 03/31/08
EXPIRATION DATE: 03/31/09

Board (a committee that reviews and approves research studies) may inspect and copy records
pertaining to this research. Some of these records could contain information that personally
identifies you. In order to protect the confidentiality of these genetic studies, we have provided
multiple safeguards so that test results cannot be linked directly to you. As you can see on the
collection container, a bar code is being used to identify you. At no time will your name and
address be given to anyone outside your research team. All information will be kept confidential
to the extent provided by law. Your name will not be used in any reports. The study results will
be reported in statistical summary form only. Iowa Field Station personnel, who have access to
your personal identifiers, will not be given your genetic test results.
Research Results:

The results of this study will be used for research purposes only. We do not plan to inform
participants of their results for any genetic tests, because, for almost all tests, we will not know
how to interpret individual risk or benefit. We will provide you with summary findings through
periodic communications about research activities of the Agricultural Health Study.

Voluntary
Participation:

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.

Additional
Information:

If you have any questions about any part of this activity or if you experience a research-related
injury, please call our toll-free number at 1-800-217-1954 to contact the principal investigator at
the University of Iowa, Charles Lynch, M.D., Ph.D.
If you have any questions, concerns, or complaints about your rights as a research subject or
about research related injury, please contact the Human Subjects Office, 340 College of Medicine
Administration Building, The University of Iowa, Iowa City, IA 52242, (319)335-6564, or email
[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.

This informed consent 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 EXPIRATION DATE: 03/31/2009.

____________________________________________________
(Signature of Subject)

_______________________________
(Date)

page 2 of 2

Attachment 14B: Phase III Buccal Cell Collection Informed Consent Form for North Carolina

INFORMED CONSENT FORM FOR BUCCAL CELL COLLECTION
Study Title:

Buccal (Mouth) Cell Collection for the Agricultural Health Study

Principal Investigator

Michael Alavanja, Dr. P.H., National Institutes of Health

Co-Investigators:

Aaron Blair, Ph.D., National Cancer Institute; Dale Sandler, Ph.D.,
National Institute of Environmental Health Sciences; Charles Lynch,
M.D., Ph.D., University of Iowa; Charles Knott, M.P.A., Battelle Centers
for Public Health Research and Evaluation

Study Purpose:

The purpose of this study is to collect buccal (mouth) cells from
participants in the Agricultural Health Study. The collection of this sample
will supplement the questionnaire information you have already provided
to us when you enrolled in the study at your pesticide licensing/training
facility and/or during the last interview approximately 5 years ago. We are
interested in the way people process cancer-causing substances, such as
those coming from environmental exposures and diet. We are also
interested in differences in other body processes that are affected by
lifestyle and the environment. The material in the buccal cell samples will
us to study these differences in relation to cancer risk, and help understand
the causes of cancer.

Study Procedures
and Risks/Benefits: We are asking you to collect loose cells from your mouth by swishing one
tablespoon of Scope mouthwash in your mouth and then discharging it
into the container provided. This is a one-time procedure that should take
only 5 minutes of your time. There is no known physical risk associated
with this procedure. All costs of collecting and mailing back the samples
are covered by the study. Although you will receive no immediate benefit,
the knowledge gained from this research may eventually benefit you and
others.
Compensation:

Future Research
Studies and
Confidentiality:

Participants who agree to provide a buccal cell sample are mailed $5.00
with the kit to compensate for their time and inconvenience.

The buccal cell sample you give us is being collected for use in future
research. The exact studies that will be performed are not all known at this
time but are likely to include the following: 1) the study of differences in
genes that may be related to how people process disease-causing
substances; 2) the study of how the effects of diet, lifestyle, the
environment, race/ethnicity, age and other factors may be related to these
genes. In order to protect the confidentiality of these genetic tests, we have
provided multiple safeguards so that test results cannot be linked directly
to you. At no time will your name and address be given to anyone outside
our research team. All information will be kept strictly confidential to the
1

Attachment 14B: Phase III Buccal Cell Collection Informed Consent Form for North Carolina
extent provided by law. Your name will not be used in any reports. The
study results will be reported in statistical summary form only.
Research Results:

We do not plan to inform participants of their results for any genetic tests.
If the research yields findings that are of any possible medical benefit, we
will provide you with that information through a newsletter. In the event
you then want to determine the relevance of those research findings to
you, we will refer you, upon your request, to certified health professionals
outside the research study, who can assist you.

Additional
Information:

If you have any question about any part of this activity, please call your
toll-free number at 1-800-424-7883. If you have concerns about your
rights as a research participant, or complaints about your treatment in this
study, contact Ms. Brigette Brevard at (919) 544-3717.
By agreeing to participate in this study, you do not waive any rights that
you may have regarding access and disclosure of your records. For further
information on those rights, please contact Dr. Michael Alavanja Dr. P.H.,
Principal Investigator, at (301) 435-4720.

I certify that I have read the above information, that I understand the risks and benefits involved,
that I have been given satisfactory answers to any questions about the project and that my
permission is freely given. I have been advised that I am free to withdraw (take away) my
consent and can refuse to take part further in the study at any time without it making any
difference to my care in the future.
I give my consent to be part of this study with the understanding that such consent does not take
away any of my legal rights, nor does it release the investigator or the institution or any
employee or agent thereof from liability for negligence. I understand that if I am injured in the
course of this research, I alone may be responsible for the costs of treating my injuries.

___________________
Signature of Participant

_________________________
Participant’s Name (Please print)

2

______
Date