Home Visit Consent

Attachment 1h

National Health Interview Survey (NHIS) Follow-up Health Study

Consent form

NHIS Follow-up Health Study

HOME VISIT CONSENT

Thank you for participating in the National Health Interview Survey (NHIS). You have been chosen to take part in the NHIS Follow-up Health Study. This study, like the NHIS, is conducted by the National Center for Health Statistics (NCHS), part of the Centers for Disease Control and Prevention (CDC).

We will use what we learn from this study to develop methods to measure liver, and kidney health, and better understand public health challenges such as diabetes, at the national level.

You will get: 1. Health test results which you can use to start conversations about your health with your doctor and your family. 2. A $75 prepaid card that you can use in stores, restaurants, and to make purchases on-line.

The health representative will measure your height, weight, waist, blood pressure, resting heart rate, and collect a blood sample. You will be asked to provide a urine sample and answer some questions about your study experience. The health visit will take about an hour. We may contact you after the visit to check the work of our staff.

Your safety is important to us. The health representatives working on this study are experienced and highly skilled. They are employees of <Company Name>. They will wear a face shield, surgical mask, lab coat or long sleeves under scrubs, gloves, and close-toed shoes. NCHS recommends you wear a facemask during the visit. Study staff will follow standard safety procedures during the visit.

The tests are safe. Some tests may cause you a bit of discomfort. One example is having a blood sample taken. For the blood sample, you will have some blood drawn from a vein in your arm with a needle. We will not ask you to have any test that is wrong for you because of a health condition you have.

You will get some results immediately and some a few weeks later. At the end of the visit, the health representative will give you a written report. That report will contain your height, weight, waist measurement, heart rate and blood pressure findings. If your blood pressure findings indicate an urgent health problem, the health representative will let you know.

Your blood and urine samples will be shipped to a lab. That lab will test your samples for standard health measures. Those measures are explained in the Measures and Tests handout that goes with this form. Seven days after the testing is done, the lab will destroy your samples.

A second report will be mailed to you several weeks after this visit. That report will have the results from your blood and urine tests, if they were successfully performed. If they were not successfully performed, your report will tell you why. If these results show urgent health problems, we will notify you as soon as possible. NHIS does not cover the cost of any health care you may decide to get after the visit. If you have questions about your results, you can call our Medical Officer, Dr. Duong (Tony) Nguyen, toll-free at 1-833-872-0534.

Your information will be protected. We take your privacy very seriously. The information you give us will be kept confidential and used for statistical purposes only. This means that your information will be combined with other people’s information in a way that keeps everyone’s identity confidential. As required by federal law, only those NCHS employees, our contractors, and our specially designated agents who must use your personal information for a specific reason can see it. Otherwise, your data will only be shared after all information that could identify you and/or your family has been removed. After that information has been removed, your data might be used by NCHS for future studies. Please refer to the box below for more detailed information on the strict federal laws that protect your privacy.

You may choose to take part in this study. That is your choice. There is no penalty if you refuse. If you choose to participate, you don’t have to do every part of the study and you can stop at any time. The more parts you do, the more complete and valuable your results will be.

Do you have more questions about the study? Your health representative can discuss other questions or concerns you might have. You can also make a free call to our Medical Officer Dr. Duong (Tony) Nguyen to discuss any aspect of the study. He can be reached toll-free at 1-833-872-0534, Monday-Friday, 9:00 AM-4:00 PM ET. If you have questions about your rights as a participant in this study, call the NCHS Ethics Review Board, toll free, at 1-800-223-8118. Please leave a brief message with your name and phone number. Say that you are calling about Protocol # 2019-09. Your call will be returned promptly.

I have read the information above and in the accompanying handouts. I freely choose to take part in the study.

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Signature of person participating in the study Date

Print: ________________________________________________________________________

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Assurance of Confidentiality – We take your privacy very seriously.  All information that relates to or describes identifiable characteristics of individuals, a practice, or an establishment will be used only for statistical purposes.  NCHS staff, contractors, and agents will not disclose or release responses in identifiable form without the consent of the individual or establishment in accordance with section 308(d) of the Public Health Service Act (42 U.S.C. 242m) and the Confidential Information Protection and Statistical Efficiency Act (Title III of the Foundations for Evidence-Based Policymaking Act of 2018 (Pub. L. No. 115-435, 132 Stat. 5529 § 302)).  In accordance with CIPSEA, every NCHS employee, contractor, and agent has taken an oath and is subject to a jail term of up to five years, a fine of up to $250,000, or both if he or she willfully discloses ANY identifiable information about you.

Medical errors and injuries are very rare. The NHIS program cannot provide money or other compensation if they occur. However, if you believe you have been harmed as a result of your participation in NHIS or the NHIS Follow-up Health Study, we want to know about it. Please call us at 1–833-872-0534. You also have a right to file a claim under the Federal Tort Claims Act with the Centers for Disease Control and Prevention. We can provide you with information about how to do so. You must file the claim within two years after the date you became aware of the personal injury, loss of property, or other damage.