Form 3 Attachment 9.2 thru 9.5 Phase IV Buccal kit Follow up Sc

Attachments 9.2 - 9.5: Buccal Kit Follow-up Scripts (Used as Needed)
9.2). Phase IV Buccal Reminder Call Script for Iowa Buccal Cell Respondents
9.3). Phase IV Buccal Reminder Call Script for North Carolina Buccal Cell
Respondents
9.4). Phase IV Buccal Missing Buccal Cell Consent Forms Call Script for Both
Sites
9.5). Phase IV Buccal Damaged or Missing Buccal Cell Sample Call Script for
Both Sites

Attachment 9.2: Phase IV Buccal Iowa – Buccal Kit Follow-up/Reminder Call
OMB NO.: 0925-0406
EXPIRATION DATE: 09/30/2016
Collection of this information is authorized by The Public Health Service Act (42 USC 285l). Rights of study participants are protected by The
Privacy Act of 1974. Participation is voluntary, and there are no penalties for not participating or withdrawing from the study at any time.
Refusal to participate will not affect your benefits in any way. The information collected in this study will be kept private to the extent provided
by law. Names and other identifiers will not appear in any report of the study. Information provided will be combined for all study participants
and reported as summaries. You are being contacted to complete this health follow-up survey because, as a member of the Agricultural Health
Study, your continued involvement can help us learn more about how agricultural and environmental factors may affect the health of farmers
and their families.
Public reporting burden for this telephone contact is estimated to average two minutes per response, including the time for reviewing
instructions, and answering questions. 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.

Hello Ms/Mr.__________________. This is __________at the University of Iowa. I’m calling about the
Agricultural Health Study.
Several weeks ago you consented to the mailing of a buccal cell collection kit. The reason I’m calling is
to make sure that you received this kit.
…they did not receive the kit, but YES they would like to participate.
I’m sorry about that. We will mail another collection kit to you, but first I would
like to verify that we have your correct address. Is it___________? Okay, the
collection kit should arrive in the next few days. Please carefully read the
instructions that are included. If possible, we would like to ask if you could
complete this activity as soon as you can. It is very important to mail the cell
sample within 24 hours of collection. Also, please sign and return the consent
form with your cell sample. Did you have any other questions or concerns?
(address these).
Thank you for your participation.
…they did not receive the kit, and NO they do not want to participate.
Okay, I can understand. Thank you for the help you have already
given to the study.
…they received the kit, but NO they do not want to participate.
Okay, I can understand. Thank you for the help you have already
given to the study.

…they received the kit, and are RECEPTIVE to participating.
Good. Did you have any questions or concerns?
(address these)
Now there are a few things I’d like to remind you to do before we close. Please
carefully read the instructions that came with the collection kit. If possible, we
would like to ask if you could complete this activity as soon as you can. It is very
important to mail the cell sample within 24 hours of collection. Also, please sign
and return the consent form with your cell sample.
Thank you for your participation
…they already returned the buccal cell sample.
Good. Did you include the signed consent form when you did this? Thank you
for helping us out.

2

Attachment 9.3: Phase IV Buccal North Carolina - Buccal Kit Follow-up/Reminder Call
OMB NO.: 0925-0406
EXPIRATION DATE: 09/30/2016
Collection of this information is authorized by The Public Health Service Act (42 USC 285l). Rights of study participants are protected by The
Privacy Act of 1974. Participation is voluntary, and there are no penalties for not participating or withdrawing from the study at any time.
Refusal to participate will not affect your benefits in any way. The information collected in this study will be kept private to the extent provided
by law. Names and other identifiers will not appear in any report of the study. Information provided will be combined for all study participants
and reported as summaries. You are being contacted to complete this health follow-up survey because, as a member of the Agricultural Health
Study, your continued involvement can help us learn more about how agricultural and environmental factors may affect the health of farmers
and their families.
Public reporting burden for this telephone contact is estimated to average two minutes per response, including the time for reviewing
instructions, and answering questions. 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.

Hello Ms/Mr.__________________. This is ______________. I’m calling about the Agricultural Health
Study.
Several weeks ago you consented to the mailing of a buccal cell collection kit. The reason I’m calling is
to make sure that you received this kit.
…they did not receive the kit, but YES they would like to participate.
I’m sorry about that. We will mail another collection kit to you, but first I would
like to verify that we have your correct address. Is it___________? Okay, the
collection kit should arrive in the next few days. Please carefully read the
instructions that are included. If possible, we would like to ask if you could
complete this activity as soon as you can. It is very important to mail the cell
sample within 24 hours of collection. Also, please sign and return the consent
form with your cell sample. Did you have any other questions or concerns?
(address these).
Thank you for your participation.
…they did not receive the kit, and NO they do not want to participate.
Okay, I can understand. Thank you for the help you have already
given to the study.
…they received the kit, but NO they do not want to participate.
Okay, I can understand. Thank you for the help you have already
given to the study.

…they received the kit, and are RECEPTIVE to participating.
Good. Did you have any questions or concerns?
(address these)
Now there are a few things I’d like to remind you to do before we close. Please
carefully read the instructions that came with the collection kit. If possible, we
would like to ask if you could complete this activity as soon as you can. It is very
important to mail the cell sample within 24 hours of collection. Also, please sign
and return the consent form with your cell sample.
Thank you for your participation
…they already returned the buccal cell sample.
Good. Did you include the signed consent form when you did this? Thank you
for helping us out.

1

Attachment 9.4: Phase IV Buccal - Missing Buccal Consent Forms Script
OMB NO.: 0925-0406
EXPIRATION DATE: 09/30/2016
Collection of this information is authorized by The Public Health Service Act (42 USC 285l). Rights of study participants are protected by The
Privacy Act of 1974. Participation is voluntary, and there are no penalties for not participating or withdrawing from the study at any time.
Refusal to participate will not affect your benefits in any way. The information collected in this study will be kept private to the extent provided
by law. Names and other identifiers will not appear in any report of the study. Information provided will be combined for all study participants
and reported as summaries. You are being contacted to complete this health follow-up survey because, as a member of the Agricultural Health
Study, your continued involvement can help us learn more about how agricultural and environmental factors may affect the health of farmers
and their families.
Public reporting burden for this telephone contact is estimated to average two minutes per response, including the time for reviewing
instructions, and answering questions. 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.

This is _______ with the Agricultural Health Study. May I please speak to
Mr./Ms.___________________?
I’m calling about the buccal cell sample that you sent in for the Agricultural Health Study in
(mo/yr). Thank you for doing this for us . . . we really appreciate it.
The reason I’m calling (today/tonight) is because we didn’t get a signed consent form along
with the sample you sent. We have a strict policy that won’t allow us to use your sample
without a signed consent form from you. Do you have any questions or concerns about the
form that I can answer?
I’ll go ahead and send out a new consent form so that you can read it over and sign it. We’ll
include a postage-paid return envelope so you can send it back to us. Is your address still
(cohort member’s address)?

Thanks again for all your help with the study.

Attachment 9.5: Phase IV Buccal - Missing Or Damaged Buccal Sample Script
OMB NO.: 0925-0406
EXPIRATION DATE: 09/30/2016
Collection of this information is authorized by The Public Health Service Act (42 USC 285l). Rights of study participants are protected by The
Privacy Act of 1974. Participation is voluntary, and there are no penalties for not participating or withdrawing from the study at any time.
Refusal to participate will not affect your benefits in any way. The information collected in this study will be kept private to the extent provided
by law. Names and other identifiers will not appear in any report of the study. Information provided will be combined for all study participants
and reported as summaries. You are being contacted to complete this health follow-up survey because, as a member of the Agricultural Health
Study, your continued involvement can help us learn more about how agricultural and environmental factors may affect the health of farmers
and their families.
Public reporting burden for this telephone contact is estimated to average two minutes per response, including the time for reviewing
instructions, and answering questions. 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.

This is ____from the Agricultural Health Study. May I please speak with Mr/Ms _________?
Hello, Mr/Ms ________, this is ___________ with the Agricultural Health Study. I’m calling about
the buccal cell sample that you sent us in (mo/yr). Unfortunately when we received the
envelope your sample had been damaged in shipping / your sample was missing.
I’m sorry to take up more of your time, but I’m calling to ask if we can mail you another
collection kit to replace the damaged/missing sample?
IF YES Good. We will mail a replacement kit to you with a complete set of instructions and
return envelopes. Is your address still…
(IF NOT, UPDATE ADDRESS ON CALL SHEET).
Please note that in addition to the buccal cell collection materials, the kit will contain
two copies of a consent form. Please read this carefully, sign and return one copy with
your sample. You may keep the other copy for your records. This is very important, as
we cannot process your sample without a signed consent form.
[IF RESPONDENT MENTIONS THAT THEY SENT A CONSENT FORM WITH THE
FIRST SAMPLE, EXPLAIN THAT WE WOULD LIKE FOR THEM TO SIGN AND DATE
A NEW FORM TO CORRESPOND TO THIS SAMPLE.]
If you have any concerns or questions about how to collect or mail this sample, please
call us at the 800 number listed on the instruction sheet. We are always happy to assist
you. Thanks again for all your help with the study.
IF NO Thank you very much for the time you have already given to the study.