Form 1 Attachment 9.1 Phase IV Buccal IA_NC Verbal Consent Scri

Attachment 9.1: Phase IV Buccal Verbal Consent Script Following Letter
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 three 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.

Introduction
"Hello, this is _______ from the Agricultural Health Study. May I speak to ___________?
“I am calling you about the letter that we sent you recently about collecting cheek
cells for a study of cancer and pesticide exposure. Do you recall getting that letter?
IF DOES NOT REMEMBER GETTING LETTER, OFFER TO
RE-SEND AND CONTINUE WITH THE SCRIPT.
“[As we state in the letter] You are one of about 5,000 members of the Agricultural
Health Study who have been selected to be contacted about a study of cancer. 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 pesticide exposure.
“We would like to obtain a sample of loose cells from your mouth. This is called a buccal
(or cheek) cell sample. This only takes a few minutes and is done simply by swishing plain
Scope mouthwash in your mouth and then expelling it into a container . . . it’s extremely simple
and quick. This is totally voluntary, but is really important to the study.
“We'll mail everything you need, along with materials for you to mail it back to us. We’ll
also enclose a $5 check for your time and effort in collecting and mailing the sample. When
we get samples back from study participants, we store them. We'll later analyze the samples
to identify genetic differences between people that may explain why some develop certain
diseases and some don't.
“Would you be willing to participate in this study?"

IF HESITATING "Do you have any questions or concerns that I could answer for you?”
ANSWER ANY QUESTIONS.
IF YES "Great! We'll mail the kit out to you within the next few days. Will that work for you?"
IF REQUESTED TO HOLD MAILING: "When would you like that mailed?"
“Should we mail that to ^address ^city, ^state ^zip?"
IF NO: What address should we use?
“You'll find some instructions with the kit. Please read those carefully. It would help us
greatly if you could complete them and mail them back to us as soon as you can.
Also, it's really important that you sign the consent form and mail it back to us along
with the mouth rinse sample."
“Thank you again for all that you've done for us. Goodbye!”
IF NO “Okay, not a problem. We really appreciate all the other things that you've done for
us. Goodbye!”

2