1. 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
54410 Arpin, also Bethel
54449 Marshfield, also Bakerville, Lindsey
54454 Milladore, also Sherry
54466 Pittsville, also City Point, Dexterville
54479 Spencer, also Riplinger
54484 Stratford, also Rozellville
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.
2. 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. If you wish to participate in this research project, you will need to sign the informed consent form.
You will be asked to fill out a questionnaire to give researchers additional information about yourself, your medical history, and environmental factors. Since diseases often run in families, this questionnaire will also ask you to identify members of your immediate family who are at least 18 years old and live in the study area. If your family members choose to participate in the Project, researchers can link families, in a coded fashion, within the research database. Researchers will not contact your family members as a direct result of your providing this information.
A research coordinator will measure your height and weight. Lastly, a sample of your blood will be drawn. You will be offered $20 for your participation.
If you choose not to participate, your decision will not affect your relationship with Marshfield Clinic.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.