Att3_2_StudyFactSheet_20131205

Attachment 3.2

Anniston Community Health Survey: Follow-up Study and Dioxin Analyses

Study Fact Sheet

Why am I being contacted? You are being contacted because you were part of the Anniston Community Health Survey (ACHS) during 2005-2007. That study provided useful information about polychlorinated biphenyls (PCB) levels in Anniston. We found associations between PCBs and health measures such as blood pressure and diabetes in some groups of people in Anniston, but we would like to study those more. Scientific research also suggests that additional aspects of health may be related to PCBs and other chemical exposures. We would like to study those here in Anniston. You and others who participated in the ACHS last time are the only ones who can help us gather this information. You are invited to be part of a new follow-up study.

What is this new study about? We want to learn how PCB levels have changed over time in Anniston residents and how these changes may be associated with health outcomes in Anniston residents.

Who wants to know these things? Researchers from the Agency for Toxic Substances and Disease Registry (ATSDR), the National Institutes of Health (NIH), and the University of Alabama at Birmingham (UAB) are conducting this study. The Calhoun County Health Department (CCHD) is helping with key parts of this study. NIH and ATSDR are paying for the study.

If I decide to take part in this study, what should I expect? We will contact you to make an appointment at one of our study offices, or you may contact us to set an appointment by calling our office toll-free at (855) 822-1778. The appointment will take about two hours. We will ask your name, address, and date of birth to make sure we are talking with the right person. We will measure your weight, height, and blood pressure and ask you to complete a questionnaire. If you are currently pregnant or in jail (including house arrest) you cannot participate in the study.

A trained staff member will take 125-mL (about 10 tablespoons) of blood from a vein in your arm. If your weight is less than 110 pounds, we will draw 50-ml of blood. Certain medical conditions might interfere with drawing blood or might affect the results of our lab tests. If you have one of these medical conditions, you may not be able take part in all of the study. However, you can still do an interview and have your weight, height, waist and blood pressure measured. One of our staff members will call you to make sure we have the right information.

We ask that you fast for at least eight hours before we draw your blood. Please let us know if you take diabetes medications, so we can give you special instructions for the blood test.

Where will I go to take part? To make it easy for you, we are offering appointments at two locations. One is located at the CCHD clinic. The other is in West Anniston.

It is hard for me to come to the office. Can I still take part? If your house is within a one-hour drive from Anniston, we can set up a home visit.

Can I do the interview by telephone? No. All parts of the study must be done face-to-face. We need to interview everyone the same way.

Can someone else interview for me? No. It is important that we interview only people who took part in the first study. If you are having trouble speaking, a household member may assist you.

What questions will I be asked? We will ask about your health in general and since the last study, your family health history, what you eat, your jobs, and about other ways that you could have been exposed to chemicals. We will also ask about health behaviors such as exercise and use of alcohol and tobacco.

This is personal. Why do you need this information? Your personal information will be kept private to the extent possible under law. The research staff will combine your answers with everyone else’s. We want to know if the health status and blood PCBs are different between groups of people.

What if I don’t know how to answer the questions? If you do not know or do not remember the answer, you simply say so.

Will you measure PCBs in my blood? Yes. We will test your blood for the PCBs we measured before to see how they have changed. We will also measure other PCBs that we didn’t measure before. We will let you know the level of PCBs currently in your blood.

Will you measure other chemicals? Yes. We will test for other chemicals that often are found with PCBs. These include dioxins, some pesticides, and some flame retardants. If you want to know, we will give you a list of all the chemicals we will measure.

Will you do other blood tests? Yes. We will test your blood for health markers like cholesterol, insulin, and thyroid hormones. These markers may help us learn more about how PCB exposures may be associated with health outcomes. Doctors use most of these markers to assess health.

How will I learn about my test results? We will send you the results of your health tests, along with a letter that you can share with your doctor, within three months of blood collection. Due to the time it takes for analysis, you may receive your chemical test results as much as three to 9 months later than your health results. If one of your test results means you might have a health problem, we will contact you when the laboratory sends us the result.

How are you going to use my information? We will write reports or scientific articles about the study results. We will combine everyone’s results to get a picture of the health issues of people in Anniston and how they relate to PCBs. These reports or articles will be made public after the study is finished. The results in these reports will be presented in a way that individuals cannot be identified.

What are the risks of taking part in the study? Your only risks from taking part in the study are possible minor problems from having your blood drawn. It may hurt a little when the blood is drawn and you may have some bruising afterward where the blood is drawn. We will do our best to avoid these problems.

Are there any costs to my taking part? You do not have to pay to be part of this study. The blood tests are free.

What benefit do I get for taking part? We will provide the results of the tests that may be of some benefit to you. The benefit may be limited by the fact that you are likely to receive the results months after you provide a blood sample. Everyone in the community taking part together will help Anniston residents better understand PCB exposures over time and possible associations with health outcomes.

Will I be paid to take part? If you complete all parts of the study, we will give you a $100 gift card. If you only complete the interview, we will give you a $50 gift card; if you only donate blood, we will give you a $50 gift card. This is our way of thanking you for taking part in the study.

Can I change my mind about taking part after I start? You can always choose whether you want to be part of this study, or not. You can stop at any time by telling the study staff that you do not want to go on. You also can refuse to answer any question or to have your blood drawn. There is no penalty for refusal or withdrawal from the study.

Why do I have to sign the consent form? By signing the consent form, you agree to be part of this study. We are required to have your signed consent form before we start any part of the study.

Are you trying to sell me something? This study does not have anything to sell or buy. This is a study paid by NIH and ATSDR at no cost to you.

Will it affect my lawsuit if I take part? No. Any personal or medical information we get from you is only for this study.

How will you protect information I provided? All of the information that you give us will be kept confidential to the extent possible under law. We use a code number instead of your name for your answers and test results. We will keep your locked records at the CCHD office in Anniston. ATSDR and UAB will protect any computer files with your information and keep them secure. Only designated study staff members will have access to your information and your test results. Other scientists may request information from this study. If we share the information with them, we will first make sure that you cannot be identified. If requested by a court, we may have to give them your data with identifiers.

How can I get more information about the study? To ask questions about the study call Dr. Stephen Mennemeyer at (205) 975-8965. You also may e-mail questions or comments to him at smenneme@uab.edu. For questions about protecting your rights related to this study, contact the CDC/ATSDR Human Research Protection Helpline at (800) 584-8814.