Attach 4B_Buccal Script Iowa Prostate

OMB NO.: 0925-0406

EXPIRATION DATE: 10/31/2011

Attachment 4B:

Buccal Cell Collection Script-Consent Following Letter to

Iowa Residents with Prostate Cancer

BUCCAL SCRIPT FOLLOWING LETTER

Public reporting burden for this collection of information is estimated to average twenty-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.

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 prostate 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 1,000 members of the Agricultural Health Study who have been selected to be contacted about a study of prostate 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 prostate cancer to pesticide exposure. The study will include people who have not been diagnosed with prostate cancer as well as people who have had this disease. These two groups will then be compared.

“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!”

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