Core Units

Personalized Medicine Research Project

Frequently Asked Questions

1. What is "Personalized Medicine"?

Genetic factors play a role in the development of nearly every disease. Certain changes in genes cause an increased risk of development of specific diseases. Additionally, a person's response to certain medications is determined in part by genetic factors. The concept of personalized medicine is a lifelong, individually tailored health care approach to the detection, prevention and treatment of disease based on knowledge of an individual's precise genetic profile. Information gathered through this research project will help to make personalized medicine a health care reality.

2. Why is this research project being done?

The ultimate goal of this project is to learn how to apply genetic science to human health. The project will accomplish this in part by creating a Personalized Medicine Research Database containing three types of information about each volunteer research project participant. These information types are: genetic, which will come from analysis of blood samples; medical, which will come from information contained in medical records; and environmental, background, and family information, which will come from a questionnaire.

The database will then be used for many studies. Examples of the types of studies that could use the database include finding genes responsible for common diseases, such as asthma, diabetes, hypertension, cancer, and determining genes that predict a patient's responses to medicines, including adverse reactions. Additional studies could examine how environmental and genetic factors interact to cause disease or determine the distribution and importance of genetic variations. By comparing the genetic information, medical information, and information from the questionnaire, researchers hope to develop new tests or treatments to improve health care.

3. Why have I been asked to participate?

Individuals are invited to participate if they live in a geographical area selected for this project, are at least 18 years of age, and receive health care at any Marshfield Clinic center. For the first phase, this project will focus on the following 19 zip codes:

19 mesa zip codes and cities

• 54405 Abbotsford
• 54410 Arpin, also Bethel
• 54412 Auburndale
• 54415 Blenker
• 54420 Chili
• 54421 Colby
• 54425 Dorchester
• 54436 Granton
• 54437 Greenwood
• 54441 Hewitt
• 54446 Loyal
• 54449 Marshfield, also Bakerville, Lindsey
• 54454 Milladore, also Sherry
• 54466 Pittsville, also City Point, Dexterville
• 54479 Spencer, also Riplinger
• 54484 Stratford, also Rozellville
• 54771 Thorp
• 54488 Unity
• 54489 Vesper

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The scientific value of this project, as with other long-term studies of the health of a population, increases as the percentage of the population that participates increases. Therefore, the project's goal is to enroll as many adult residents of the study area as possible. Each participant will make a contribution whether or not he or she currently has a medical condition. In the future, the project anticipates also incorporating a northern study area of 10 zip codes that includes, for example, the towns of Park Falls, Phillips, and Ladysmith.

4. What does participation involve?

If you choose to participate, you will meet with a research coordinator to review the informed consent document. The coordinator will explain the research project and answer questions you may have. You will be asked to complete a questionnaire, your height and weight will be measured, and a sample of your blood will be drawn.

5. Where do I go for my appointment and how long will it take?

You should go to the Personalized Medicine Research Project Reception Center. This is located in the Research Foundation on the 1st floor of the Lawton Center, which is attached to Marshfield Clinic at the main facility in Marshfield. There will be signs to assist you in finding this area. The appointment will take 30 minutes to 1 hour. Research staff will be available from 7:00am to 5:00pm Monday, Wednesday, and Friday, and from 7:00am to 7:00pm Tuesday, and Thursday.

6. Will my information be kept confidential?

All attempts will be made to keep all information confidential, including results of DNA analysis, medical record information, and the information participants provide on the questionnaire. Information entered into the research database will be coded to protect your privacy. The research database will be kept on a separate computer system that will not be connected with other Clinic information systems or to any external network, such as the Internet. The computer will be housed in a highly secure location. Only a limited number of authorized staff will have access to the research database. Information from medical records and the questionnaire will not contain personally identifiable information when entered into the research database. Results of DNA analysis will not be entered into patient medical records and will not be shared with you or your family. In accordance with Wisconsin law, DNA analysis will not be released to employers or insurance companies. To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of Health. With this Certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings.

7. Will I directly benefit from this study?

The Personalized Medicine Research Project is being conducted to improve the system of health care that is available to us. You may not personally benefit, except for the satisfaction of helping medical scientists find ways to improve health care in the future. The new knowledge gained will be made available to the medical community and may lead to new treatments, tests, and preventive programs being incorporated into medical practice in the future that are personalized to individual patients based on their genetic code. Project researchers also plan to send a newsletter to all study participants with updates and information that may become available.

8. Will this project involve cloning, stem cell research, or genetic engineering?

No. Rather, major goals are to use knowledge of the human genome to advance medical science and health care in order to improve quality of life.

9. Will you contact my family based on my participation?

Your family members will not be contacted based on your participation or information you provide. They will not be informed that you participated, and will not be given any information you provide. Because the project is recruiting from a geographic region, your relatives who live in the study area may be contacted independently to participate in this project.

10. What types of medical information will investigators use from my records?

The information used will vary based on the specific study. Types of information may include diagnoses, medical events, procedures, laboratory results, and medications. Information from the medical record will not contain personally identifiable information when it is entered into the research database.

11. Will Marshfield Clinic make money from the research project?

Research may result in intellectual property, such as patents. Some intellectual property may have a commercial value, for example, to companies that translate scientific discovery into medications, medical devices and medical diagnostic tests used by health care providers. However, any revenue resulting from the project will be used only to pay research expenses, fund additional research and education, provide incentives to discoverers or inventors at a level comparable with academic and not-for-profit institutions, donate to health care-related charities or community health care programs, or finance other purposes consistent with the not-for-profit mission of Marshfield Clinic and its Research Foundation.

12. How can I find out more information about the research project?

Please call either 715-389-7733 or our toll free number 888-334-2232 to talk with one of our research coordinators, who will answer your questions or provide you with additional information. If you wish to join this research project, the coordinator will help you do that. You may also come by the project reception center located in the Lawton Center on the campus of Marshfield Clinic, Marshfield. Or you can contact us on-line if you would like a research coordinator to call you, would like to request more information, or have any questions.

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