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Attachment 15.1: Phase IV Iowa Buccal Informed Consent Document
INFORMED CONSENT DOCUMENT
Study Title:
Buccal (Mouth) Cell Collection for the AHS
Principal Investigator: Charles Lynch, M.D., Ph.D., University of Iowa
Lead Investigator:
Co-Investigators:
Michael Alavanja, Dr. P.H.,
Laura Beane Freeman, Ph.D., National Institutes of
Health; Gabriella Andreotti Ph.D., M.P.H., National Institutes of Health
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 in
previous studies. 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 5,000 people will take part in the collection of buccal cell samples
for the Agricultural Health Study.
Study Procedures We are asking you to collect loose cells from your mouth by swishing about one
and Risks/Benefits: 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 Incentives: 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 receive $5 as a thank you for your
participation in this study.
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
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
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. 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.
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 researchrelated injury, please call our toll-free number at 1-800-217-1954. 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, 105 Hardin Library for
the Health Sciences, 600 Newton Road, University of Iowa, Iowa City, IA 52242-1098,
(319)335-6564, or email irb@uiowa.edu.
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.
Do not sign this form if today’s date is on or after $STAMP_EXP_DT.
_________________________
Signature of Participant
_________________________
Participant’s Name (Please print)
_______________
Date
Attachment 15.2: Phase IV North Carolina Buccal Informed Consent Document
INFORMED CONSENT DOCUMENT
Study Title:
Buccal (Mouth) Cell Collection for the AHS
Principal Investigator: Marsha Dunn, MPH, Westat
Lead Investigator:
Michael Alavanja, Dr. P.H., and Laura Beane Freeman, Ph.D., National Institutes of
Health;
Co-Investigators:
Gabriella Andreotti Ph.D., M.P.H., National Institutes of Health
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 in
previous studies. 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 5,000 people will take part in the collection of buccal cell samples
for the Agricultural Health Study.
Study Procedures We are asking you to collect loose cells from your mouth by swishing about one
and Risks/Benefits: 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 Incentives: 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 receive $5 as a thank you for your
participation in this study.
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
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.
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. 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.
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 researchrelated injury, please call our toll-free number at 1-800-4AGSTUDY. If you have any
questions, concerns, or complaints about your rights as a research subject or about
research related injury, please contact Sharon Zack of the Westat Human Subjects Office,
by calling 1-888-920-7631, or e-mail IRB@westat.com.
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.
Do not sign this form if date is on or after ____________________.
_________________________
Signature of Participant
_________________________
Participant’s Name (Please print)
_______________
Date
| File Type | application/pdf |
| Author | paulsenj |
| File Modified | 2016-04-06 |
| File Created | 2016-04-06 |