Attachment 13_BEEA_IRB_Approval_Signature_Pages

Attachment 13: BEEA IRB Approval Signature Pages

13.1). BEEA IRB NCI
13.2). BEEA IRB Westat
13.3). BEEA IRB University of Iowa

Department of Health & Human Services

Public Health Service
National Institutes of Health
National Cancer Institute
Bethesda, Maryland 20892

iRIS Reference Number 320222

Amendment Letter: B
IRB Number: 10CN106
Version Date: 03/30/2012

04/25/2012
TO:

Michael Alavanja
NCI - Occupational and Environmental Epidemiology Branch

FROM:

Chairperson, Special Studies Institutional Review Board, NCI

SUBJECT:

Action on Clinical Research Protocol Amendment

Your amendment to protocol, “Study of Biomarkers of Exposure and Effects in Agriculture,” was reviewed by the
National Cancer Institute Special Studies Institutional Review Board (NCI-SSIRB) by expedited review.
The SSIRB has taken the following action:
X

Approved as written. Forwarded to the CC OPS for administrative processing.
Approved with stipulations pending re-review by SSIRB Chair. See review comments.
Deferred pending response to stipulations and re-review by a subcommittee of the Board.
See review comments.
Tabled pending response to stipulations and re-review by the full SSIRB. See review
comments.

Attachment 13a: Phase IV Buccal Iowa
Agricultural Health Study- Iowa
University of Iowa • 2500 Crosspark Road, Suite W240 • Coralville IA 52241 •
1.800.217.1954

www.aghealth.org

[date]

Executive Committee
Michael C. R. Alavanja, DrPH
Occupational and Environmental
Epidemiology Branch
National Cancer Institute
National Institutes of Health
U.S. Department of Health and
Human Services
Executive Plaza South, RM8000
Rockville, MD 20892
Laura Beane Freeman, PhD
Occupational and Environmental
Epidemiology Branch
National Cancer Institute
National Institutes of Health
U.S. Department of Health and
Human Services
Executive Plaza South, RM8112
Rockville, MD 20892
Jane A. Hoppin, ScD
Epidemiology Branch
National Institute of Environmental
Health Sciences
National Institutes of Health
U.S. Department of Health and
Human Services
P.O. Box 12233
Mail Drop A3-05
Research Triangle Park, NC 27709
Dale P. Sandler, PhD
Epidemiology Branch
National Institute of Environmental
Health Sciences
National Institutes of Health
U.S. Department of Health and
Human Services
P.O. Box 12233
Mail Drop A3-05
Research Triangle Park, NC 27709

To:

Agricultural Health Study Participant
From: Charles Lynch, M.D., Ph.D.
Director, Agricultural Health Study-Iowa
Thank you for continuing to participate in the Agricultural Health Study, which
is designed to learn about how occupation and environmental factors affect an
individual’s health. Thanks to your participation, this now is the largest one of
its kind in the United States.
The main goal of this study is to look at pesticide exposures and chronic health
conditions. Now that we are learning more about possible links between various
cancers and pesticide use, we would like you to consider participating in an
additional research effort. You are one of about 5,000 members of the
Agricultural Health Study who have been selected to be contacted about this
study. Because you have already contributed a tremendous amount of
information about your pesticide exposure in previous interviews and
questionnaires, this new study will have a head-start in understanding the
relationship of cancer to these exposures.
We would like you to collect a sample of loose cells from your mouth. You may

Kent Thomas, BSPH
U.S. Environmental Protection Agency
National Exposure Research
Laboratory
109 T.W. Alexander Drive, MD E205
Research Triangle Park, NC 27709

have done so for us in a previous effort, but this sample will be reserved
specifically for later laboratory analysis that will involve genetic testing. Your
participation will take only a few minutes and will provide important
information for the study.

Cynthia J. Hines, MS, CIH
Division of Surveillance, Hazard
Evaluations, and Field Studies
National Institute for Occupational
Safety and Health
4676 Columbia Parkway, R-14
Cincinnati, OH 45226

We will be calling you within a few days to explain the procedure and answer
any questions you may have. In the meantime, if you have any questions, please
call us at 1-800-217-1954. We will be glad to assist you.

Coordinating Center
Marsha Dunn, MPH
Westat
1600 Research Blvd.
Rockville, MD 20850
Charles F. Lynch, MD, PhD
University of Iowa
College of Public Health, Dept. of
Epidemiology
105 River Street, Room S447 CPHB
Iowa City, IA 52242

Thank you once again for your time and support.

Attachment 14: Phase IV Buccal North Carolina

[date]
To:

Agricultural Health Study Participant
From: Marsha Dunn, MPH
Director, Agricultural Health Study-North Carolina
Thank you for continuing to participate in the Agricultural Health Study, which
is designed to learn about how occupation and environmental factors affect an
individual’s health. Thanks to your participation, this now is the largest one of
its kind in the United States.
The main goal of this study is to look at pesticide exposures and chronic health
conditions. Now that we are learning more about possible links between various
cancers and pesticide use, we would like you to consider participating in an
additional research effort. You are one of about 5,000 members of the
Agricultural Health Study who have been selected to be contacted about this
study. Because you have already contributed a tremendous amount of
information about your pesticide exposure in previous interviews and
questionnaires, this new study will have a head-start in understanding the
relationship of cancer to these exposures.
We would like you to collect a sample of loose cells from your mouth. You may

have done so for us in a previous effort, but this sample will be reserved
specifically for later laboratory analysis that will involve genetic testing. Your
participation will take only a few minutes and will provide important
information for the study.
We will be calling you within a few days to explain the procedure and answer
any questions you may have. In the meantime, if you have any questions, please
call us at 1-800-4AGSTUDY. We will be glad to assist you.
Thank you once again for your time and support.