Attachment 16 Phase IV Buccal Cell Collection Information

Attachment 16: Phase IV Buccal Cell Collection Information
(Kit Letter, Collection Directions/Instructions, FAQs, etc.)

16.1). Phase IV Iowa Buccal Cell Kit Cover Letter
16.2). Phase IV Iowa Buccal Cell Directions
16.3). Phase IV Iowa Buccal Cell Kit Re-mail Cover Letter
16.4). Phase IV North Carolina Buccal Cell Kit Cover Letter
16.5). Phase IV North Carolina Buccal Cell Directions
16.6). Phase IV North Carolina Buccal Cell Kit Re-mail Cover Letter
16.7). Phase IV Buccal Cell FAQs for Both Sites

Attachment 16.1: Phase IV Buccal Iowa
Agricultural Health Study- Iowa
University of Iowa • 2500 Crosspark Road, Suite W240 • Coralville IA 52241 •
1.800.217.1954

[date]

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

Coordinating Center
Marsha Dunn, MPH
Westat
1600 Research Blvd.
Rockville, MD 20850
Charles F. Lynch, MD, PhD
University of Iowa
Department of Epidemiology
C21-L GH
Iowa City, IA 52242

To:

Agricultural Health Study Participant

From: Charles Lynch, M.D., Ph.D.
Director, Agricultural Health Study -Iowa
Thank you for your continued participation in Agricultural Health Study. You
are an essential member of this 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.
As we discussed on the phone, we would like to collect a sample of loose cells
from your mouth. This is done simply by swishing mouthwash in your mouth
and then expelling it into the accompanying container (see the enclosed
DIRECTIONS FOR MOUTHWASH). The cells will be kept in a freezer for
long-term storage, and will be used for later laboratory analysis that will involve
genetic testing. This will take only a few minutes of your time and will provide
very important information for the study. Once you collect this sample, please
return it as soon as possible in the padded envelope enclosed. If we have not
received the kit back in a few weeks, we may contact you to see if you have
any questions or concerns.
We will continue to inform you about the study’s progress on various aspects of
research through periodic communications. If you have any questions, please
call us at 1-800-217-1954. We will be glad to assist you.
We truly value your continued participation in this landmark study of
agricultural workers and their families. Because you have already provided us
with valuable information no other person can take your place.
Thank you once again for your time and support.

Attachment 16.2: Phase IV Buccal Iowa
DIRECTIONS FOR MOUTHWASH
The purpose of this simple procedure is to collect some loose cells from your mouth. 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 envelope we mailed to you:
 2 copies of the Informed Consent Form
 Screw top collection container
 Plastic bottle of mouthwash
 Leak-proof plastic bag with a small absorbent sheet (in case anything spills)
 Pre-stamped mailing envelope

If you have not received all of these materials, please call us at 1-800-2171954
1.

Read and sign one copy of the Informed Consent Form (the other copy is yours to keep).

2.

Do not eat or rinse your mouth for one hour before collecting the saliva sample.

3.

Open the bottle of mouthwash and fill the enclosed screw top collection container half full of
mouthwash (to the red fill line).

4.

Swish the mouthwash from the collection container around in your mouth vigorously for 45
seconds. Watch the clock while you do this.

5.

Holding the container close to your mouth, spit the mouthwash back into the collection container.
Replace the top on the collection container and screw it on tightly. You may keep the remaining
portion of mouthwash for your own use.

MAILING INSTRUCTIONS
Prepare the collection container for mailing as follows:
1.

Place the collection container into the leak-proof plastic bag. Do not remove the absorbent sheet.

2.

Remove any air from the bag and seal the bag.

3.

Place the plastic bag and its contents into the padded envelope that is addressed to the
biorepository.

4.

Make sure the consent form with your signature is placed in the padded envelope.

5.

Try to mail the sample within 24 hours of collection.

If you have any questions or concerns, please call us at 1-800- 217-1954.

Attachment 16.3: 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
Kent Thomas, BSPH
U.S. Environmental Protection Agency
National Exposure Research
Laboratory
109 T.W. Alexander Drive, MD E205
Research Triangle Park, NC 27709
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

Coordinating Center
Marsha Dunn, MPH
Westat
1600 Research Blvd.
Rockville, MD 20850
Charles F. Lynch, MD, PhD
University of Iowa
Department of Epidemiology
C21-L GH
Iowa City, IA 52242

Enclosed is the replacement buccal cell kit that we discussed with you over the phone.
Directions are included. As we discussed, please read, sign, date and return one copy of
the consent form with your sample.
Should you have any questions, please call us at 1-800-217-1954.
Thank you again for your participation.

Attachment 16.4: Phase IV Buccal North Carolina
Buccal Kit Mailing Cover Letter

[date]
To:

Agricultural Health Study Participant

From: Marsha Dunn, MPH
Director, Agricultural Health Study –North Carolina
Thank you for your continued participation in Agricultural Health Study. You
are an essential member of this 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.
As we discussed on the phone, we would like to collect a sample of loose cells
from your mouth. This is done simply by swishing mouthwash in your mouth
and then expelling it into the accompanying container (see the enclosed
DIRECTIONS FOR MOUTHWASH). The cells will be kept in a freezer for
long-term storage, and will be used for later laboratory analysis that will involve
genetic testing. This will take only a few minutes of your time and will provide
very important information for the study. Once you collect this sample, please
return it as soon as possible in the padded envelope enclosed. If we have not
received the kit back in a few weeks, we may contact you to see if you have
any questions or concerns.
We will continue to inform you about the study’s progress on various aspects of
research through periodic communications. If you have any questions, please
call us at 1-800-4AGSTUDY. We will be glad to assist you.
We truly value your continued participation in this landmark study of
agricultural workers and their families. Because you have already provided us
with valuable information no other person can take your place.
Thank you once again for your time and support.

Attachment 16.5: Phase IV Buccal North Carolina
DIRECTIONS FOR MOUTHWASH
The purpose of this simple procedure is to collect some loose cells from your mouth. 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 envelope we mailed to you:
 2 copies of the Informed Consent Form
 Screw top collection container
 Plastic bottle of mouthwash
 Leak-proof plastic bag with a small absorbent sheet (in case anything spills)
 Pre-stamped mailing envelope

If you have not received all of these materials, please call us at 1-8004AGSTUDY
1.

Read and sign one copy of the Informed Consent Form (the other copy is yours to keep).

2.

Do not eat or rinse your mouth for one hour before collecting the saliva sample.

3.

Open the bottle of mouthwash and fill the enclosed screw top collection container half full of
mouthwash (to the red fill line).

4.

Swish the mouthwash from the collection container around in your mouth vigorously for 45
seconds. Watch the clock while you do this.

5.

Holding the container close to your mouth, spit the mouthwash back into the collection container.
Replace the top on the collection container and screw it on tightly. You may keep the remaining
portion of mouthwash for your own use.

MAILING INSTRUCTIONS
Prepare the collection container for mailing as follows:
1.

Place the collection container into the leak-proof plastic bag. Do not remove the absorbent sheet.

2.

Remove any air from the bag and seal the bag.

3.

Place the plastic bag and its contents into the padded envelope that is addressed to the
biorepository.

4.

Make sure the consent form with your signature is placed in the padded envelope.

5.

Try to mail the sample within 24 hours of collection.

If you have any questions or concerns, please call us at 1-800-4AGSTUDY.

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

Attachment 16.6: Phase IV Buccal North Carolina

[Date]

Enclosed is the replacement buccal cell kit that we discussed with you over the phone.
Directions are included. As we discussed, please read, sign, date and return one copy of
the consent form with your sample.
Should you have any questions, please call us at 1-800-4AGSTUDY.
Thank you again for your participation.

Attachment 16.7: Phase IV Buccal FAQs
AHS: BUCCAL CELL COLLECTION
ANSWERS TO QUESTIONS


What are you going to test for?



What about cloning—what could be done with these cells?



I would like the test results. To protect the confidentiality of your sample, we immediately disassociate your

We are looking for genes that may help us identify groups of people that may
be at a higher risk of developing cancer, while other exposed to the same toxins don’t. We’ll be combining this
genetic information with information from questionnaires about exposures. Then we’ll try to determine what genetic
and exposure patterns are associated with cancer.
These cells will never be used for cloning; they can
only be used for this study. Government-funded studies prohibit cloning experiments.

name and other identifying information from the sample and store it by ID number only. That would make it very
difficult to get back to you with results. Also, with the little that is known about genetic markers at this point, your
individual results would be meaningless anyway. They simply don’t know what is normal or abnormal yet and don’t
know which genes contribute to most diseases yet. The purpose of collecting the samples is to try to learn more about
these things.


I would like to be informed as to what tests are going to be performed on the cells and when
they are testing. We will keep you informed through newsletters and other publications on the types of analyses
we are doing as a whole, and will let you know the overall results for the study.



What do you mean by environmental exposures?



What do you mean by other body processes?



I do not want to sign a release form or anything else, but I will send you the sample.

This refers to all of the different things your body
comes into contact with, particularly as the result of where you live and your occupation. It includes chemicals, such
as pesticides, as well as sunlight, grain dust, and other elements in your environment.
We mean for example, how the body defends itself
against infection, how the nervous system is affected and any effects on the reproductive system.
We cannot
use any material you send us unless you consent to its use. We appreciate the fact that you are willing to participate,

and would ask you to reconsider signing the consent form. You are free to withdraw your consent at any time by
simply notifying us that you wish to withdraw from the study and have your materials removed.


Why do you need these samples, can’t you draw blood instead?



What do I have to gain by this if I can’t receive any results?



Okay to collect the sample when I have a cold or other illness?

Collecting cells this way is easier on
our study participants. Many people do not like to give blood, and we can get good information for our purposes
from the cheek cells if the instructions are followed carefully.
Although you personally may not receive
any direct benefits, your participation is helping all farmers and their families, by helping us with research that may
uncover the causes of disease that farmers are more likely to have. This understanding of farmers’ risks may also help
us understand the risks to the general population.
Yes, this should not affect the

sample.


Okay to collect the sample when I’m taking antibiotics or other medicines?

Yes

 Can I substitute my own mouthwash, rather than use the Scope we send me?

We prefer that you
use a mouthwash with alcohol in it to better preserve the sample, but we will accept the sample with any mouthwash
of your choosing.

 If you send it to me now, I may not get to it for a while. Is that okay?
complete it and send it in soon, but if it does take awhile, that will be fine too.

Yes. It helps us if you can