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pdfATTACHMENT 23
BEEA Consent Mailing Cover Letter, Pre-Visit
Preparation Show Card, and Urine Collection
Instructions
23A. BEEA Consent Mailing Cover Letter for Iowa Respondents
23B. BEEA Consent Mailing Cover Letter for North Carolina
Respondents
23C. BEEA Pre-Visit Prep Show Card for Iowa Respondents
23D. BEEA Pre-Visit Prep Show Card for North Carolina
Respondents
23E. BEEA Urine Collection Instructions for Iowa Respondents
23F. BEEA Urine Collection Instructions for North Carolina
Respondents
Attachment 23A: BEEA IA Consent Mailing/Urine Kit Cover Letter (Both Groups)
Study of Biomarkers of Exposures and Effects in Agriculture
Date
To:
Mr.
From: Charles Lynch, M.D., Ph.D.
Director, Iowa Field Station
I want to thank you for taking the time to speak with us recently and for
participating in the Agricultural Health Study’s Study of Biomarkers of Exposures and
Effects in Agriculture (BEEA).
This letter is to confirm our appointment at your home, {STREET
ADDRESS/CITY/STATE/ZIP} on {DATE} at {TIME} for a home visit for the BEEA
Study. Before the appointment, please take some time to review the enclosed materials,
which include an information sheet, directions for collection of the urine sample, and a
consent form. The consent form describes the contents of the home visit, foreseeable
benefits and risks (such as possible bruising after a blood draw), an explanation of the
study’s confidentiality procedures and who to contact for answers to questions about the
home visit. We have provided two copies of the consent form. Please sign both – one
will be collected by the study examiner at your home visit and the other you may keep for
your records.
We will be calling you within the next week to confirm the appointment and
verify receipt of these materials. We will be happy to answer any questions you have at
that time. Please read the information sheet on preparation for the home visit carefully
and follow the instructions precisely. If you have any questions about the instructions,
please ask them when we call you.
If you have any questions or concerns, please contact Ellen Heywood, study
coordinator at 1-800-217-1954. Please specify that you are calling about the
Biomarkers of Exposures and Effects in Agriculture (BEEA) Study. If you have
questions or concerns about your rights as a research subject please contact the Human
Subjects Office, 300 College of Medicine Administration Building, The University of
Iowa, Iowa City, Iowa, 52242, (319) 335-6564, or e-mail [email protected]. Again, we
want to thank you for your assistance in making the Agricultural Health Study an
important and successful study of health in the agricultural community. We look forward
to speaking with you soon.
Privacy Act Notification: 42 U.S.C. 285a of the Public Health Service Act authorizes collection of this information. It
will be used to evaluate the role of agricultural exposures and other factors in the development of cancer, neurological
disease, birth defects and other chronic diseases. All information is voluntary and if you decide not to provide all or
any part of the requested information you will not be penalized or lose any benefits for which you otherwise qualify.
We will keep your participation in this research study confidential to the extent permitted by law.
Attachment 23B: BEEA NC Consent Mailing/Urine Kit Cover Letter (Both Groups)
Study of Biomarkers of Exposures and Effects in Agriculture
Date
Dear Mr. ,
I want to thank you for taking the time to speak with us recently and for participating in
the Agricultural Health Study’s Study of Biomarkers of Exposures and Effects in Agriculture
(BEEA).
This letter is to confirm our appointment at your home, {STREET
ADDRESS/CITY/STATE/ZIP} on {DATE} at {TIME} for a home visit for the BEEA Study.
Before the appointment, please take some time to review the enclosed materials, which include
an information sheet, directions for collection of the urine sample, and a consent form. The
consent form describes the contents of the home visit, foreseeable benefits and risks (such as
possible bruising after a blood draw), an explanation of the study’s confidentiality procedures
and who to contact for answers to questions about the home visit. We have provided two copies
of the consent form. Please sign both – one will be collected by the study examiner at your home
visit and the other you may keep for your records.
We will be calling you within the next week to confirm the appointment and verify
receipt of these materials. We will be happy to answer any questions you have at that time.
Please read the information sheet on preparation for the home visit carefully and follow the
instructions precisely. If you have any questions about the instructions, please ask them when
we call you.
If you have any questions or concerns, please contact Margaret Hayslip, study
coordinator toll free at 800424-7883. Please specify that you are calling about the Biomarkers of
Exposures and Effects in Agriculture (BEEA) Study. If you have questions or concerns about
your rights as a research subject please contact the Battelle Institutional Review Board toll-free
at (877) 810-9530 ext. 500. Again, we want to thank you for your assistance in making the
Agricultural Health Study an important and successful study of health in the agricultural
community. We look forward to speaking with you soon.
Sincerely,
Charles Knott, MPA, PMP
Director, North Carolina Field Station
Privacy Act Notification: 42 U.S.C. 285a of the Public Health Service Act authorizes collection of this information. It will be
used to evaluate the role of agricultural exposures and other factors in the development of cancer, neurological disease, birth
defects and other chronic diseases. All information is voluntary and if you decide not to provide all or any part of the requested
information you will not be penalized or lose any benefits for which you otherwise qualify. We will keep your participation in
this research study confidential to the extent permitted by law.
Attachment 23C: BEEA IA Pre‐Visit Preparation Showcard
In preparation for your interview, please record the product name,
active ingredient, and EPA registration number of the pesticides
you personally mixed, loaded, handled or applied in the past 12
months. This information is available from the product label. We
will collect this information at your visit.
Attention BEEA Study
Participants!
It is important that you make
the following preparations for
your study visit:
Product Name
Active Ingredient
Consent Form
Please take some time to review the consent form so you can be
prepared to complete it with the interviewer. The interviewer will address
any questions or concerns you may have at the beginning of your visit,
or you may also call us at the number below.
EPA
Registration #
Prescription Medications
We will be asking you about the prescription medications you take
regularly. Please assemble them in their original containers so they are
ready to review with the interviewer.
Pesticide Use in the Past 12 Months
We will be asking you about pesticides you have used in the past 12
months. This includes use of herbicides, insecticides, fungicides,
fumigants, or other chemicals used to kill plants, insects, fungi, molds, or
rodents. Do not include antibiotics, sanitizers, antimicrobial soaps, or
fertilizers. For each product, we will ask for the product name, active
ingredient, and EPA registration number, as well as about total days of
use, and dates of most recent use. Please use the back of this card to
help you prepare this information.
Urine Sample Collection
Please review the Directions for Urine Collection and the materials in the
collection kit. It is very important that you collect the urine sample on the
morning of your visit.
Please call us at 1-800-217-1954 if you have any questions.
Public reporting burden for this collection of information is estimated to average five 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
Attachment 23C: BEEA IA Pre‐Visit Preparation Showcard
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.
Attachment 23D: BEEA NC Pre‐Visit Preparation Showcard
Attention BEEA Study
Participants!
It is important that you make
the following preparations for
your study visit:
In preparation for your interview, please record the product name,
active ingredient, and EPA registration number of the pesticides
you personally mixed, loaded, handled or applied in the past 12
months. This information is available from the product label. We
will collect this information at your visit.
Product Name
Active Ingredient
Consent Form
Please take some time to review the consent form so you can be
prepared to complete it with the interviewer. The interviewer will address
any questions or concerns you may have at the beginning of your visit,
or you may also call us at the number below.
EPA
Registration #
Prescription Medications
We will be asking you about the prescription medications you take
regularly. Please assemble them in their original containers so they are
ready to review with the interviewer.
Pesticide Use in the Past 12 Months
We will be asking you about pesticides you have used in the past 12
months. This includes use of herbicides, insecticides, fungicides,
fumigants, or other chemicals used to kill plants, insects, fungi, molds, or
rodents. Do not include antibiotics, sanitizers, antimicrobial soaps, or
fertilizers. For each product, we will ask for the product name, active
ingredient, and EPA registration number, as well as about total days of
use, and dates of most recent use. Please use the back of this card to
help you prepare this information.
Urine Sample Collection
Please review the Directions for Urine Collection and the materials in the
collection kit. It is very important that you collect the urine sample on the
morning of your visit.
Please call us at 1-800-424-7883 if you have any questions.
Public reporting burden for this collection of information is estimated to average five 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.
Agricultural Health Study
Study of Biomarkers of Exposures and Effects in Agriculture
Attachment 23E. BEEA IA DIRECTIONS FOR URINE COLLECTION
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 package we mailed to you:
• 2 copies of the Informed Consent Form
• Screw top collection container
• Brown paper bag
If you have not received all of these materials, please call us at 1-800-2171954. Please specify that you are calling about the Biomarkers of Exposures
and Effects in Agriculture (BEEA) Study.
1.
Read and sign both copies of the Informed Consent Form. We will collect one copy at your home
visit (the other copy is yours to keep).
2.
To help you remember to collect your wake-up urine sample on the day of your home visit, leave
the urine collection bottle on the toilet seat lid the night before.
3.
When you wake up in the morning, wash your hands before opening the collection container.
4.
Urinate directly into the container.
5.
Replace the top on the collection container and screw it on tightly. Place the sample inside the
brown paper bag.
6.
Store the sample in the refrigerator.
7.
We will pick up the sample at your home visit.
THANK YOU FOR YOUR HELP!
Agricultural Health Study
Study of Biomarkers of Exposures and Effects in Agriculture
Attacment 23F: BEEA NC DIRECTIONS FOR URINE COLLECTION
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 package we mailed to you:
• 2 copies of the Informed Consent Form
• Screw top collection container
• Brown paper bag
If you have not received all of these materials, please call us at 1-800-4247883. Please specify that you are calling about the Biomarkers of Exposures
and Effects in Agriculture (BEEA) Study.
1.
Read and sign both copies of the Informed Consent Form. We will collect one copy at your home
visit (the other copy is yours to keep).
2.
To help you remember to collect your wake-up urine sample on the day of your home visit, leave
the urine collection bottle on the toilet seat lid the night before.
3.
When you wake up in the morning, wash your hands before opening the collection container.
4.
Urinate directly into the container.
5.
Replace the top on the collection container and screw it on tightly. Place the sample inside the
brown paper bag.
6.
Store the sample in the refrigerator.
7.
We will pick up the sample at your home visit.
THANK YOU FOR YOUR HELP!
| File Type | application/pdf |
| File Title | Microsoft Word - Attach 23 - BEEA consent mailing letters and pre-visit prep.docx |
| Author | Marshall_C |
| File Modified | 2010-04-28 |
| File Created | 2010-04-28 |