Attach 10C_Intro-Consent Letter Spouse

FOR IRB USE ONLY

APPROVED BY: IRB-01

IRB ID #: 200503790

APPROVAL DATE: 12/31/07

EXPIRATION DATE: 12/30/08

Date: [Season and year]

To: Agricultural Health Study Participant

Thank you for your participation in the Agricultural Health Study (AHS), a research study funded by the National Institutes of Health and conducted in Iowa by researchers at the University of Iowa. The AHS is a long-term study to evaluate whether pesticide workers and their families have higher rates of certain cancers and diseases.

You are one of about 21,000 spouses of pesticide applicators in Iowa who enrolled by either completing a written questionnaire or a telephone interview. Even if your spouse or you are no longer farming or applying pesticides, your information is still important to us. Many of the diseases we are studying, such as cancer, are due to exposures that occurred many years ago. This means we need to look well into the past to study the causes of these diseases. The study has been ongoing since 1993, and will continue for at least 10 more years.

Within the next few weeks you will receive a phone call from a member of our research team at the University of Iowa inviting you to participate in an interview. You will be asked about your own pesticide use, as well as certain health conditions you and your family may have experienced since you were last contacted, approximately five years ago. The interview will last for 15 to 35 minutes, depending on what you say.

Participation in this study is voluntary. There will be no penalties if you decide not to respond, either to the information collection as a whole or to any particular question. You will not have any costs by participating and there are no foreseeable risks or direct benefits to you. Study findings are provided on the Internet at www.aghealth.org, through pesticide applicator training sessions, and through fact sheets (enclosed), all of which summarize study findings.

The information you provide will be kept confidential and will not be disclosed in identifiable form to anyone but the researchers and contractors conducting this study or as provided by law. However federal regulatory agencies and the University of Iowa Institutional Review Board (a committee that reviews and approves research studies) may inspect and copy records pertaining to this research. To protect study participant confidentiality, safeguards are in place. When study results are published, only summary information is reported, never names of study members. Personal identifying information is stored in separate password protected computerized files that are accessible only by authorized research staff. Documents containing personal identifiers are stored in lockable file cabinets. Staff members read and sign a confidentiality statement.

If you have any questions or concerns, if your phone number has changed since enrollment, or if you do not wish to be contacted about this follow-up study, please call us at 1-800-217-1954. 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 irb@uiowa.edu. 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.

S incerely,

Charles Lynch Michael Alavanja

Iowa Director Project Officer